9789241548274_eng

Laborator
y Quality
Manageme
nt System
Handboo
k
WHO Library Cataloguing-in-Publication
Data Laboratory quality management
system: handbook.
1.Laboratories — organization and administration. 2. Laboratories —
handbooks. 3.Laboratories techniques and procedures — standards. 4.Quality
control. 5.Manuals. I.World Health Organization.
ISBN 978 92 4 154827 4 (NLM classification: QY 25) Version 1.1
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Laboratory Quality Management
System
Table of contents
Acknowledgements...........................................................................................p 6
Foreword.........................................................................................................p 7
Key words.............................................................................................................p 8
1............................................................................................... Introdu
ction to quality........................................................................................................p 9
1-1.............................................................................................................................. :The
importance of laboratory quality.............................................................................................p 10
1-2.............................................................................................................................. : Overview
of the quality management system..............................................................................................p 11
1-3.............................................................................................................................. :The
quality management system model.......................................................................................p 13
1-4.............................................................................................................................. : History
of laboratory quality management................................................................................................p 16
1-5.............................................................................................................................. :
International laboratory standards.................................................................................................p 17
1-6.............................................................................................................................. :
Summary....................................................................................................................................................p 18
2............................................................................................. Facilities
and safety.....................................................................................................................p 19
2-1.............................................................................................................................. :
Overview...........................................................................................................................................p 20
2-2.............................................................................................................................. :
Laboratory design..........................................................................................................................p 22
2-3.............................................................................................................................. :
Geographic or spatial organization................................................................................................p 23
2-4.............................................................................................................................. : Physical
aspects of premises and rooms................................................................................................p 24
2-5.............................................................................................................................. : Safety
management programme...................................................................................................................p 25
2-6.............................................................................................................................. :
Identification of risks.............................................................................................................................p 27
2-7.............................................................................................................................. : Personal
protective equipment...........................................................................................................................p 31
2-8.............................................................................................................................. :
Emergency management and first aid.........................................................................................p 32
2-9.............................................................................................................................. :
Summary....................................................................................................................................................p 34
3............................................................................................. Equipm
ent.....................................................................................................................p 35
3-1.............................................................................................................................. :
Overview...........................................................................................................................................p 36
3-2.............................................................................................................................. : Selecting
and acquiring equipment....................................................................................................................p 38
3-3.............................................................................................................................. : Getting
equipment ready for service.............................................................................................................p 40
3-4.............................................................................................................................. :
Implementing an equipment maintenance programme.......................................................p 42
3-5.............................................................................................................................. :Troublesh
ooting, service, repair and retiring equipment.........................................................................p 44
3-6.............................................................................................................................. :
Equipment maintenance documentation....................................................................................p 46
3-7.............................................................................................................................. :
Summary....................................................................................................................................................p 48
4............................................................................................. Purchasi
ng and inventory..................................................................................................p 49
4-1.............................................................................................................................. :
Overview...........................................................................................................................................p 50
4-2.............................................................................................................................. :
Purchasing.................................................................................................................................................p 52
4-3.............................................................................................................................. :
Implementing an inventory management programme........................................................p 53
4-4.............................................................................................................................. :
Quantification...........................................................................................................................................p 54
4-5.............................................................................................................................. : Forms
and logs.............................................................................................................................................p 56
4-6.............................................................................................................................. : Receipt
and storage of supplies.......................................................................................................................p 57
4-7.............................................................................................................................. :
Monitoring inventory....................................................................................................................p 59
4-8.............................................................................................................................. :
Summary....................................................................................................................................................p 60
5............................................................................................. Process
control—sample management.......................................................................p 61
5-1.............................................................................................................................. :
Overview...........................................................................................................................................p 62
5-2.............................................................................................................................. :The
laboratory handbook....................................................................................................................p 63
5-3.............................................................................................................................. :
Collection and preservation.......................................................................................................p 64
5-4.............................................................................................................................. : Sample
processing..................................................................................................................................................p 66
5-5.............................................................................................................................. : Sample
storage, retention and disposal........................................................................................................p 68
5-6.............................................................................................................................. : Sample
transport.....................................................................................................................................................p 69
5-7.............................................................................................................................. :
Summary....................................................................................................................................................p 72
Laboratory Quality Management System 3

6............................................................................................. Process
control—introduction to quality control...............................................p 73
6-1: Introduction...................................................................................................................................p 74
7............................................................................................. Process
control—quality control for quantitative tests.........................................p 77
7-1.............................................................................................................................. :
Overview...........................................................................................................................................p 78
7-2.............................................................................................................................. : Control
materials...........................................................................................................................................p 79
7-3.............................................................................................................................. :
Establishing the value range for the control material...........................................................p 81
7-4.............................................................................................................................. :
Graphically representing control ranges...............................................................................p 86
7-5.............................................................................................................................. :
Interpreting quality control data......................................................................................................p 87
7-6.............................................................................................................................. : Using
quality control information.................................................................................................................p 89
7-7.............................................................................................................................. :
Summary....................................................................................................................................................p 90
8. Process control—quality control for qualitative and

semiquantitative procedures..........................................................................p 91
8-1.............................................................................................................................. :
Overview...........................................................................................................................................p 92
8-2.............................................................................................................................. : Quality
control materials.....................................................................................................................................p 94
8-3.............................................................................................................................. : Quality
control of stains..............................................................................................................................p 96
8-4.............................................................................................................................. : Quality
control of microbiological media..............................................................................................p 98
8-5............................................................................................................................ : Summary
p 100
9............................................................................................ Assessm
ent—audits..............................................................................................p 101
9-1............................................................................................................................ : Overview
p 102
9-2............................................................................................................................ : External
audit...........................................................................................................................................................p 105
9-3............................................................................................................................ : Internal
audit...........................................................................................................................................................p 107
9-4............................................................................................................................ : Internal
audit programme.................................................................................................................................p 108
9-5............................................................................................................................ : Actions as
result of audit........................................................................................................................................p 110
9-6............................................................................................................................ : Summary
p 111
10..........................................................................................Assessme
nt—external quality assessment..............................................................p 113
10-1.......................................................................................................................... : Overview
p 114
10-2.......................................................................................................................... :
Proficiency testing.............................................................................................................................p 117
10-3.......................................................................................................................... : Other
external quality assessment methods..............................................................................p 119
10-4.......................................................................................................................... :
Comparison of external quality assessment methods...............................................p 121
4
10-5.......................................................................................................................... : Managing
external quality assessment in the laboratory...................................................................p 122
10-6.......................................................................................................................... : Summary
p 124
11..........................................................................................Assessm
ent—norms and accreditation.............................................................p 125
11-1.......................................................................................................................... : Overview
p 126
11-2.......................................................................................................................... :
International standards and standardization bodies.........................................................p 127
11-3.......................................................................................................................... : National
standards and technical guidelines...........................................................................................p 129
11-4.......................................................................................................................... :
Certification and accreditation.....................................................................................................p 131
11-5.......................................................................................................................... : Process of
accreditation........................................................................................................................................p 134
11-6.......................................................................................................................... : Benefits
of accreditation...................................................................................................................................p 135
11-7.......................................................................................................................... : Summary
p 136
12..........................................................................................Personn
el...............................................................................................................p 137
12-1.......................................................................................................................... : Overview
p 138
12-2.......................................................................................................................... :
Recruitment and orientation........................................................................................................p 140
12-3.......................................................................................................................... :
Competency and competency assessment....................................................................p 142
12-4.......................................................................................................................... :Training
and continuing education.......................................................................................................p 145
12-5.......................................................................................................................... : Employee
performance appraisal.....................................................................................................................p 147
12-6.......................................................................................................................... : Personnel
records...........................................................................................................................................p 149
12-7.......................................................................................................................... : Summary
p 150
Laboratory Quality Management System

13..........................................................................................Custome
r service......................................................................................................p 151
13-1.......................................................................................................................... : Overview
p 152
13-2.......................................................................................................................... :The
laboratory clients—the customers.....................................................................................p 154
13-3.......................................................................................................................... : Assessing
and monitoring customer satisfaction..............................................................................p 157
13-4.......................................................................................................................... : Customer
satisfaction surveys..................................................................................................................p 158
13-5.......................................................................................................................... : Summary
p 160
14..........................................................................................Occurren
ce management..............................................................................................p 161
14-1.......................................................................................................................... : Overview
p 162
14-2.......................................................................................................................... : Sources
and consequences of laboratory error.............................................................................p 163
14-3.......................................................................................................................... :
Investigation of occurrences........................................................................................................p 165
14-4.......................................................................................................................... : Rectifying
and managing occurrences...........................................................................................................p 166
14-5.......................................................................................................................... : Summary
p 168
15..........................................................................................Process
improvement....................................................................................................p 169
15-1.......................................................................................................................... : Continual
improvement concept..............................................................................................................p 170
15-2.......................................................................................................................... :Tools for
process improvement..............................................................................................................p 172
15-3.......................................................................................................................... : Quality
indicators...............................................................................................................................................p 174
15-4.......................................................................................................................... : Selecting
quality indicators................................................................................................................................p 175
15-5.......................................................................................................................... :
Implementing process improvement.................................................................................p 178
15-6.......................................................................................................................... : Summary
p 180
16..........................................................................................Documen
ts and records...........................................................................................p 181
16-1.......................................................................................................................... :
Introduction..................................................................................................................................p 182
16-2.......................................................................................................................... : Overview
of documents..............................................................................................................................p 183
16-3.......................................................................................................................... :The quality
manual....................................................................................................................................................p 186
16-4.......................................................................................................................... : Standard
operating procedures (SOPs)................................................................................................p 187
16-5.......................................................................................................................... :
Document control.....................................................................................................................p 190
16-6.......................................................................................................................... : Overview
of records.....................................................................................................................................p 193
16-7.......................................................................................................................... : Storing
documents and records..........................................................................................................p 195
16-8.......................................................................................................................... : Summary
p 196
17..........................................................................................Informati
on management..............................................................................................p 197
17-1.......................................................................................................................... : Overview
p 198
17-2.......................................................................................................................... : Elements
of information management.........................................................................................................p 199
17-3.......................................................................................................................... : Manual
paper-based systems.......................................................................................................................p 202
17-4.......................................................................................................................... :
Computerized laboratory information systems.............................................................p 204
17-5.......................................................................................................................... : Summary
p 207
18..........................................................................................Organiza
tion................................................................................................................p 209
18-1.......................................................................................................................... :
Organizational requirements for a quality management system................................p 210
18-2.......................................................................................................................... :
Management role...............................................................................................................................p 212
18-3.......................................................................................................................... :
Organizational structure..........................................................................................................p 214
18-4.......................................................................................................................... :
Organizational functions: planning.............................................................................................p 216
18-5.......................................................................................................................... :
Organizational functions: implementation..............................................................................p 218
18-6.......................................................................................................................... :The
laboratory quality manual......................................................................................................p 220
18-7.......................................................................................................................... : Summary
p 222
Glossary.......................................................................................................p 223
Acronyms....................................................................................................p 235
References and resources by chapter...........................................................p 237
Notes.............................................................................................................p 245

Acknowledgeme
This handbook was developed through collaboration between the WHO
Lyon Office for National Epidemic Preparedness and Response, the
United States of America Centers for Disease Control and
Prevention (CDC) Division of Laboratory Systems, and the Clinical
and Laboratory Standards Institute (CLSI). It is based on training
sessions and modules provided by the CDC and WHO in more than 25
countries, and on guidelines for implementation of ISO 15189 in
diagnostic laboratories, developed by CLSI.
WHO, the CDC and the CLSI would like to acknowledge with thanks
all those who contributed to the development and review of this
training package, more specifically:
Adilya
Albetkova
Robin Barteluk
Anouk Berger
Sébastien
Cognat Carlyn
Collins
Philippe
Dubois
Christelle
Estran Glen
Fine
Sharon
Granade
Stacy Howard
Devery
Howerton
Kazunobu
Kojima Xin Liu
Jennifer
McGeary
Robert Martin
Sylvio Menna
Michael Noble
Antoine
Pierson Anne
Pollock Mark
Rayfield John
Ridderhof
Eunice Rosner
Joanna
Zwetyenga
Acknowledgeme
6 Laboratory Quality Management System

Forewo
Achieving, maintaining and improving accuracy, timeliness and reliability
are major challenges for health laboratories. Countries worldwide
committed themselves to build national capacities for the detection of,
and response to, public health events of international concern when
they decided to engage in the International Health Regulations
implementation process.
Only sound management of quality in health laboratories will enable
countries to produce test results that the international community
will trust in cases of international emergency.
This handbook is intended to provide a comprehensive reference on
Laboratory Quality Management System for all stakeholders in health
laboratory processes, from management, to administration, to bench-work
laboratorians.
This handbook covers topics that are essential for quality management of a
public health or clinical laboratory. They are based on both ISO
15189 and CLSI GP26-A3 documents.
Each topic is discussed in a separate chapter. The chapters follow the
framework developed by CLSI and are organized as the “12 Quality
System Essentials”. A diagram representing these 12 essentials is
shown below.
Organization Personnel Equipment
Purchasing and inventory

Process control
Information management
Documents and records

Occurrence management
Assessment
Facilities and safety

Process improvement
Customer service
Forewo
Note:
Health laboratories, in this handbook, is a term that is meant to be
inclusive of clinical laboratories, diagnostic laboratories, medical
laboratories, public health laboratories, animal and environmental
health laboratories or any other laboratories performing testing for the
purpose of disease diagnosis, screening, prevention, medical treatment
decisions, surveillance or public health. Because all these terms for
laboratories are frequently used interchangeably, the terms may likewise
be used interchangeably in this handbook.
Revision information:
The version 1.1 of the present handbook includes updated Glossary,
Acronyms, and References and resources by chapter sections.
Key words
Laboratory quality management system, laboratory quality, laboratory
quality systems, laboratory information management, laboratory
information system, laboratory documents and records, laboratory
quality manual, quality control, laboratory facilities and safety,
laboratory equipment, laboratory sample management, laboratory
sample transport, laboratory purchasing and inventory, laboratory
assessment, laboratory customer service, occurrence management,
process improvement, quality essentials, laboratory process control,
clinical laboratory, ISO 15189.
8
1. Introduction
to quality
1-1:The importance of laboratory
Definition of
quality Laboratory quality can be defined as accuracy, reliability and timeliness of
reported test results. The laboratory results must be as accurate as
possible, all aspects of the laboratory operations must be reliable, and
reporting must be timely in order to be useful in a clinical or public
health setting.
Level of accuracy
required
When making measurements, there is always some level of inaccuracy.
The challenge is to reduce the level of inaccuracy as much as
possible, given the limitations of our testing systems. An accuracy level
of 99% may at first glance appear acceptable, but the resulting 1% error
can become quite large in a system where many events occur, such as
Negati laboratory testing.
ve
consequences Laboratories produce test results that are widely used in clinical and
of laboratory public health settings, and health outcomes depend on the accuracy
error of the testing and reporting. If inaccurate results are provided, the
consequences can be very significant, including:
 unnecessary treatment
 treatment complications
 failure to provide the proper treatment
 delay in correct diagnosis
 additional and unnecessary diagnostic testing.
These consequences result in increased cost in time and personnel

effort, and often in poor patient outcomes.
Minimizin In order to achieve the highest level of accuracy and reliability, it is
g laboratory essential to perform all processes and procedures in the laboratory
error in the best possible way. The laboratory is a complex system, involving
many steps of activity and many people. The complexity of the system
requires that many processes and procedures be performed properly.
Therefore, the quality management system model, which looks at the
entire system, is very important for achieving good laboratory
performance.
1-1:The importance of laboratory

1-2: Overview of the quality management
Definition of
qualit A quality management system can be defined as “coordinated activities
y to direct and control an organization with regard to quality”. This
manageme definition is used by the International Organization for Standardization
nt (ISO) and by the Clinical and Laboratory Standards Institute (CLSI). Both
system groups are internationally recognized laboratory standards organizations,
and will be discussed later in this handbook.
In a quality management system, all aspects of the laboratory operation,
including the organizational structure, processes and procedures, need
to be addressed to assure quality.
Patient client
prep Sample
collection
Reporting
Personnel
competency test
evaluations
HIGH
Sample receipt
x
and
accessioning
Record keeping
Sample transport
Quality control
testing
Complexi There are many procedures and processes that are performed in the
ty of laboratory, and each of these must be carried out correctly in order
laboratory to assure accuracy and reliability of testing. An error in any part of the
processe cycle can produce a poor laboratory result.A method of detecting errors
s at each phase of testing is needed if quality is to be assured.
1-2: Overview of the quality management

11
1-2: Overview of the quality management system
ISO standards group laboratory processes into pre-examination,

examination and post-examination categories. Comparable terms in
current laboratory use include: pre-analytic, analytic and post-analytic
processes; or pre-test, test and post-test processes.
Path of The entire set of operations that occur in testing is called the path of
workflow workflow. The path of workflow begins with the patient and ends in
reporting and results interpretation, as shown in the figure below.
The concept of the path of workflow is a key to the quality model or the
quality management system, and must be considered when developing
quality practices. For example, a sample that is damaged or altered
as a result of improper collection or transport cannot provide a
reliable result. A medical report that is delayed or lost, or poorly
written, can negate all the effort of performing the test well.
Test
The patient selectio
Sampl
n
e
P collectio
n Sampl
e
transpor
t
Laboratory
analysis
Examination
phase
Repor
t
creatio
Repor n
t
transpor
t
Qualit The complexity of the laboratory system requires that many factors
y
must be addressed to assure quality in the laboratory. Some of these
managemen
factors include:
t system  the laboratory environment
addresses all  quality control procedures
processes  communications
 record keeping
 competent and knowledgeable staff
 good-quality reagents and equipment.
1-3 :The quality management system model
Overview When all of the laboratory
of the procedures and processes are Organization Personnel Equipment
quality organized into an

manageme understandable and workable
nt system structure, the opportunity to
Purchasing and inventory
model ensure that all are appropriately Process controlInformation management
managed is increased. The

quality model used here Path of workflow
organizes all of the laboratory Documents
activities into 12 quality system and records
Occurrence
managementAssessment
essentials. These quality system
essentials are a set of
coordinated activities that serve
as building blocks for quality Process improvement
Facilities and safety
Customer service
management. Each must be
addressed if overall laboratory
quality improvement is to be
achieved. This quality
management system model was
developed by CLSI,1 and is fully
compatible with ISO
standards.2,3
Organization Assuring accuracy and reliability throughout the path of workflow

depends on good management of all of the quality essentials.
In order to have a functioning quality management system, the

structure and management of the laboratory must be organized so that
quality policies can be established and implemented. There must be a
Personnel strong supporting organizational structure—management commitment is
crucial—and there must be a mechanism for implementation and
monitoring.
Equipment The most important laboratory resource is competent, motivated

staff.The quality management system addresses many elements of
personnel management and oversight, and reminds us of the
importance of encouragement and motivation.
Many kinds of equipment are used in the laboratory, and each piece of
equipment must be functioning properly. Choosing the right
equipment, installing it correctly, ensuring that new equipment works
properly, and having a system for maintenance are all part of the
equipment management programme in a quality management
system.
1 CLSI/NCCLS. A quality management system model for health care; approved guideline—second edition, CLSI/NCCLS
document HS1-A2. Wayne, PA, NCCLS, 2004.
2 ISO 15189:2007. Medical laboratories–particular requirements for quality and competence. Geneva: International
Organization for Standardization, 2007.
3 ISO 9001:2000. Quality management systems–requirements. Geneva: International Organization for Standardization, 2000.

13
1-3:The quality management
Purchasing and The management of reagents and supplies in the laboratory is often a
inventory challenging task. However, proper management of purchasing and
inventory can produce cost savings in addition to ensuring supplies and
reagents are available when needed. The procedures that are a part of
management of purchasing and inventory are designed to ensure that all
reagents and supplies are of good quality, and that they are used and
stored in a manner that preserves integrity and reliability.
Process control
Process control is comprised of several factors that are important in
ensuring the quality of the laboratory testing processes.These factors
include quality control for testing, appropriate management of the
sample, including collection and handling, and method verification
and validation.
The elements of process control are very familiar to laboratorians;

quality control was one of the first quality practices to be used in the
Informatio laboratory and continues to play a vital role in ensuring accuracy of
n testing.
manageme
nt The product of the laboratory is information, primarily in the form of
test reporting. Information (data) needs to be carefully managed to
ensure accuracy and confidentiality, as well as accessibility to the
laboratory staff and to the health care providers. Information may be
managed and conveyed with either paper systems or with computers;
both will be discussed in the section on information management.
Documents and Many of the 12 quality system essentials overlap. A good example is the
records close relationship between "Documents and records" and "Information
management". Documents are needed in the laboratory to inform
how to do things, and laboratories always have many documents.
Records must be meticulously maintained so as to be accurate
Occurren and accessible.
ce
manageme An “occurrence” is an error or an event that should not have
nt happened.A system is needed to detect these problems or occurrences,
to handle them properly, and to learn from mistakes and take action so
that they do not happen again.
Assessment
The process of assessment is a tool for examining laboratory
performance and comparing it to standards, benchmarks or the
performance of other laboratories. Assessment may be internal
(performed within the laboratory using its own staff) or it may be
external (conducted by a group or agency outside the laboratory).
Laboratory quality standards are an important part of the assessment
process, serving as benchmarks for the laboratory.

Proces The primary goal in a quality management system is continuous

s
improvement of the laboratory processes, and this must be done in a
improveme
systematic manner.There are a number of tools that are useful for
nt
process improvement.
The concept of customer service has often been overlooked in

Customer laboratory practice. However, it is important to note that the laboratory
service is a service organization; therefore, it is essential that clients of the
laboratory receive what they need.The laboratory should understand who
the customers are, and should assess their needs and use customer
feedback for making improvements.
Facilities and
Many factors must be a part of the quality management of facilities
safety and safety. These include:
 Security—which is the process of preventing unwanted risks
and hazards from entering the laboratory space.
 Containment—which seeks to minimize risks and prevent
hazards from leaving the laboratory space and causing harm to the
community.
 Safety—which includes policies and procedures to prevent harm
to workers, visitors and the community.
 Ergonomics—which addresses facility and equipment adaptation to
allow safe and healthy working conditions at the laboratory site.
Qualit
y
manageme In the quality management system model, all 12 quality system
nt system essentials must be addressed to ensure accurate, reliable and timely
model laboratory results, and to have quality throughout the laboratory
operations. It is important to note that the 12 quality system essentials
may be implemented in the order that best suits the laboratory.
Approaches to implementation will vary with the local situation.
Laboratories not implementing a good quality management system

are guaranteed that there will be many errors and problems
occurring that may go undetected. Implementing a quality management
system may not guarantee an error-free laboratory, but it does yield a
high-quality laboratory that detects errors and prevents them from
recurring.

15
1-4: History of laboratory quality
Definitio
n of quality ISO 9000 defines quality management as “coordinated activities to
manageme direct and control an organization with regard to quality”. This is intimately
nt related to the definition of a quality system—“organizational structure,
resources, processes and procedures needed to implement quality
management”. Quality management concepts in use today had their
onset in the 20th century, and are primarily an outgrowth of
manufacturing and shop processes.
Princip
al One of the earliest concepts of the quality management movement
innovator was that of quality control of the product. Shewhart developed a
s and their method for statistical process control in the 1920s, forming the basis for
contributio quality control procedures in the laboratory. Quality control methods
ns were not applied in the laboratory until the 1940s. Other critical thinkers
and innovators, including Arman Feigenbaum, Kaoru Ishikawa and
Genichi Taguchi, added to the concepts. The most recent method that
is of importance to the laboratory is Galvin’s work on micro-scale
error reduction.
Quality management is not new.

1-4: History of laboratory quality
1-5: International laboratory
Need for
international A part of quality management is assessment, measuring
laboratory performance against a standard or benchmark. The concept of quality
standards management requires that standards be set, and again industry has been
in the lead.
Important Using a set of standards established by the United States of America

laboratory military for the manufacture and production of equipment, the ISO
standards established standards for industrial manufacturing; we know these
organizations standards as ISO standards.
The ISO 9000 documents provide guidance for quality in
manufacturing and service industries, and can be broadly applied to
IS many other kinds of organizations. ISO 9001:2000 addresses general
quality management system requirements and applies to
O
laboratories. There are two ISO standards that are specific to
laboratories:
 ISO 15189:2007. Medical laboratories—particular requirements for quality
and competence. Geneva: International Organization for Standardization,
2007.
 ISO/IEC 17025:2005. General requirements for the competence of testing
and calibration laboratories. Geneva: International Organization for
Standardization, 2005.
Another important international standards organization for laboratories
CLS is the Clinical and Laboratory Standards Institute, or CLSI, formerly
known as the National Committee for Clinical Laboratory Standards
I
(NCCLS). CLSI uses a consensus process involving many stakeholders
for developing standards. CLSI developed the quality management
system model used in this handbook. This model is based on 12 quality
system essentials, and is fully compatible with ISO laboratory standards.
CLSI has two documents that are very important in the clinical laboratory:
 A quality management system model for health care; approved guideline
—second edition. CLSI/NCCLS document HS1-A2.Wayne, PA,
NCCLS, 2004.
 Application of a quality management system model for laboratory services;
approved guideline—third edition. CLSI/NCCLS document GP26-A3.
Wayne, PA, NCCLS, 2004.
The information in this handbook is based on the CLSI
quality management system model and the ISO 15189
standard.
There are many other standards organizations, and many examples of
Othe laboratory standards. Some countries have established national laboratory
r quality standards that apply specifically to laboratories within the
standar country. Some laboratory standards apply only to specific areas in the
ds laboratory or only to specific tests. The World Health Organization has
established standards for some specific programmes and areas.
1-5: International laboratory

17
1-6:
Qualit
y Quality management is not new; it grew from the work of innovators
manageme who defined quality over a span of 80 years. Quality management is as
nt applicable for the medical laboratory as it is for manufacturing and
industry.
Key  A laboratory is a complex system and all aspects must function

properly to achieve quality.
messages  Approaches to implementation will vary with the local situation.
 Start with changes that can be easily accomplished and have the biggest
impact.
 Implement in a stepwise process but ultimately, all quality
essentials must be addressed.
1-6:
2.Facilities
and safety
2-1: Overview
Role in The laboratory work space and
quality facilities must be such that the
manageme workload can be performed
nt without compromising the

system quality of work and the safety of
the laboratory staff, other health
care
personnel, patients and the Purchasi
Process Informatio
community. ng and
inventor
control n
managemen
y
t
This chapter will describe
essential elements for
Occurrenc
laboratory design and safety Documen
e
ts and
that prevent and control records
manageme
Assessme
nt
exposure to physical, chemical nt
and biological hazards.

Process
This chapter addresses improveme Custom
Facilitie
nt er
pathogens and chemicals of service
s and
safety
moderate or low- level risk, rather
than highly dangerous
substances. As a general rule, all diagnostic laboratories should be

designed and organized for biosafety level 2 or above.
Importance of A laboratory safety programme is important in order to protect the

safety lives of employees and patients, to protect laboratory equipment and
facilities, and to protect the environment.
Neglecting laboratory safety is very costly. Secondary effects of a
laboratory accident are:
 loss of reputation
 loss of customers / loss of income
 negative effect on staff retention
 increased costs—litigation, insurance.
Responsibiliti Ensuring quality and safety during laboratory processes is a major

es concern for laboratory managers. Often, the laboratories they manage
are designed by architects and/or administrators who have little
knowledge of specific laboratory needs, making the job of the manager
more difficult.
As a laboratory director, it is important to:
 actively participate in the design and planning stages of new laboratory
facilities;
 assess all potential risks and apply basic concepts of organization in
order to provide a proper and safe environment for conducting
laboratory activities, including services to patients;
 consider the organization of the laboratory when developing new
activities or new diagnostic techniques in the laboratory.

2-1 : Overview
As a quality manager (or designated safety officer), it is necessary

to:
 develop a complete and thorough description of basic safety rules
and organization, and ensure that personnel are trained in their specific
duties when new activities or techniques are introduced into the
laboratory;
 know the basics of safety and biosafety management issues when
working with chemicals and pathogens of moderate or low level of
risk;
 know how to perform an extensive risk assessment when
developing new activities in the laboratory;
 conduct laboratory safety audits.
As a laboratorian, it is important to:

 be aware of basic safety rules and processes;
 understand the basics of safety and biosafety management issues when
working with toxic chemicals, biological samples and physical
hazards, and when interacting with patients.
Everyone in the laboratory is responsible for quality and

safety.
21
2-2: Laboratory
Access
When designing a laboratory or organizing workflow, ensure that
patients and patient samples do not have common pathways.
Circulation paths should be designed in such a way that contact
between the public and biological materials can occur only in the rooms
where patient samples are collected. The reception desk where
incoming patients register should be located as close as possible to the
entry door.
Access to rooms where manipulation or analysis of samples takes

place, or where hazardous chemicals or other materials are stored,
must be restricted to authorized persons, usually laboratory technical
staff and maintenance staff. Restriction of access may be
accomplished using signs on doors, locks when appropriate and
Circulatio staff identification badges.
n
pathwa
To identify where improvements in laboratory design may be needed
ys
in order to prevent or reduce risks of cross-contamination, follow the
path of the sample as it moves through the laboratory during the pre-
examination, examination and post-examination phases of testing.
Pathways to assess include:
 Sample collection areas—a laboratory layout with both the reception
and the sample collection room located at the entrance saves time
and energy.
 Sample processing areas—here, samples are centrifuged as needed,
allocated for different examinations and dispersed to the appropriate
sections of the laboratory for analysis. If possible, the sample
processing area should be separated from, but nearby, the testing
areas.
 Start with changes that can be easily accomplished and have the biggest
impact.
 Circulation pathways of biological samples between different sections
of the laboratory—These pathways should be assessed for the
purpose of minimizing contamination risks. If possible, circulation
pathways of clean and dirty laboratory materials should never cross, and
circulation pathways of contaminated waste should be isolated.
 Post-examination pathways—After the analysis of the samples, the
results must be accurately recorded, properly filed, and delivered on
time to the right person. Communication systems appropriate to the
size and complexity of the laboratory, including the efficient and
reliable transferring of messages, should be part of the laboratory
design.
For the most efficient design, all related services should be

located in close proximity.
2-2: Laboratory

2-3: Geographic or spatial
Distribution of When organizing laboratory work space, divide the laboratory into areas
activities with different access control in order to separate patients from
biological samples. Where samples are actually processed, plan for
spatial organization that ensures the best service.
For optimal organization of the laboratory, consider:
 Delineation of laboratory activities —Care should be taken to
either group related activities in a single room, or to clearly delineate
bench space for specific activities. Measures must be taken to prevent
cross-contamination of samples.
 Location of service rooms—Service rooms to accommodate
autoclaves, sinks for cleaning glassware, preparation and sterilization of
culture media, and so on, should be located in a central area to minimize
distances and facilitate circulation paths of materials, samples and goods.
A responsible staff member should be designated to oversee cleaning
and maintenance of the service rooms.
 Location of activities with specific requirements, such as:
- molecular biology—needs to be located in a separate space, with at
least two rooms, so that preparation of DNA extracts is not
performed in the same room as where the subsequent steps
(preparation of reagent mixes and DNA amplification) are
performed;
- fluorescence microscopy—requires a dark room with proper
ventilation which must not be used for storage of stock materials
Spati and other chemicals;
al - ultraviolet illumination systems for DNA gel photography—
provision requires a dark room and appropriate eye protection equipment.
for
equipmen The laboratory director and safety officer must consider special needs
t for equipment when designing laboratory space. Some things to
consider are:
 Access to equipment for entry and maintenance—Make sure that
there are no physical restrictions for access, such as door and elevator
size, that could pose a problem for the delivery and maintenance of
new machines and equipment.
 Power supply—Consider the need for a stable power supply for
sensitive equipment and a backup power supply or emergency
generator for times when the laboratory’s primary power source
is down.
 Managing disposal of liquids from equipment—Disposal of liquid
reagents, by- products and wastes from laboratory equipment and
procedures is a major concern for laboratories. When placing
equipment in the laboratory, be sure to consider how liquid wastes
will be handled. It is important to be aware of, and comply with, local
and national requirements for liquid waste disposal, in order to prevent
contamination of community sewage systems with pathogens or
toxic chemicals.
2-3: Geographic or spatial

23
2-4: Physical aspects of premises and
Facilities
The laboratory must be designed to ensure proper ventilation
throughout, with an active ventilation system and adequate space for
circulation of people, laboratory carts and trolleys.
Rooms should have a high ceiling to ensure proper ventilation, and walls
and ceilings should be painted with washable, glossy paint or coated with a
material suitable for cleaning and disinfection.The floor must also be easy
to clean and disinfect, and have no edges between the walls and floor.
Work benches
Laboratory work benches should be constructed of materials that are
durable and easy to disinfect. If the laboratory’s budget allows, ceramic
tiles are good materials to use for benchtops, as they are easy to clean and
are resistant to deterioration from harsh disinfectants and aggressive
cleaning products. However, be aware that the grout between them can
sometimes harbour contaminating microorganisms, so must be
disinfected regularly.
Wood should not be used, as it is not easy to clean or disinfect, and will
deteriorate over time when repeatedly exposed to disinfectants and
detergents. Wood also support the growth of contaminants when wet or
damaged.
The disadvantage of using steel for benchtops is that steel will rust
when washed with chlorine.
It is advisable to organize work benches according to the type of
analysis that is performed, with adequate space for benchtop equipment
and enough space to place a standard operating procedure while in use
and display job aids. In areas where microbiology procedures are
performed, work benches should be separated according to the different
Cleaning types of samples or pathogens that are analyzed, in order to minimize
risks of cross-contamination.
It is very important that all areas of the laboratory are cleaned and
maintained on a regular basis. Examples of areas that need daily attention
are:
 Benchtops—clean and disinfect benchtops after completing examinations,
and
after any spills of samples or reagents.This responsibility is generally
assigned to the technical staff performing the tests.
 Floors—these are usually cleaned by cleaning staff, unless restricted
access allows only technical staff to disinfect the floors at the end of
the day.
Other areas of the laboratory should be scheduled for cleaning on a
weekly or monthly basis, depending on laboratory conditions. For
example, ceilings and walls may require cleaning weekly, whereas items
such as refrigerators and storage areas might be scheduled for a monthly
2-4: Physical aspects of premises and
cleaning. Cleaning and disinfection of laboratory areas should be recorded, including
the date and name of the person performing the maintenance.

2-5: Safety management
Developing
a laboratory Often, the responsibility for developing a safety programme and
safety organizing appropriate safety measures for the laboratory is assigned
programme to a laboratory safety officer. In smaller laboratories, the responsibility for
laboratory safety may fall to the laboratory manager or even to the quality
officer. The steps for designing a safety management programme
include:
 developing a manual to provide written procedures for safety and
biosafety in
the laboratory;
 organizing safety training and exercises that teach staff to be aware of
potential hazards and how to apply safety practices and techniques
—training should include information about universal precautions,
infection control, chemical and radiation safety, how to use personal
protective equipment (PPE), how to dispose of hazardous waste, and
what to do in case of emergencies;
 setting up a process to conduct risk assessments—this process
should include initial risk assessments, as well as ongoing laboratory
General safety audits to look for potential safety problems.
safety
equipme
nt The safety officer should be assigned responsibility for ensuring that
there is an adequate supply of appropriate equipment for safety and
biosafety, such as:
 PPE
 fire extinguishers and fire blankets
 appropriate storage and cabinets for flammable and toxic chemicals
 eye washers and emergency shower
 waste disposal supplies and equipment
 first aid equipment.
Standard safety
practices
Policies should be put in place that outline the safety practices to be
followed in the laboratory. Standard laboratory safety practices include:
 limiting or restricting access to the laboratory;
 washing hands after handling infectious or hazardous materials and
animals, after removing gloves, and before leaving the laboratory;
 prohibiting eating, drinking, smoking, handling contact lenses, and
applying cosmetics in work areas;
 prohibiting mouth pipetting;
 using techniques that minimize aerosol or splash production when
performing procedures—biosafety cabinets should be used whenever
there is a potential for aerosol or splash creation, or when high
concentrations or large volumes of infectious agents are used;
2-5: Safety management

25
2-5 : Safety management programme
 preventing inhalation exposure by using chemical fume hoods or

other containment devices for vapours, gases, aerosols, fumes, dusts or
powders;
 properly storing chemicals according to recognized compatibilities—
chemicals posing special hazards or risks should be limited to the
minimum quantities required to meet short-term needs and stored
under appropriately safe conditions (i.e. flammables in flammable
storage cabinets)—chemicals should not be stored on the floor or
in chemical fume hoods;
 securing compressed gas cylinders at all times;
 decontaminating work surfaces daily;
 decontaminating all cultures, stocks and other regulated wastes before
disposal via autoclave, chemical disinfection, incinerator or other
approved method;
 implementing and maintaining an insect and rodent control programme;
 using PPE such as gloves, masks, goggles, face shields and laboratory
coats when working in the laboratory;
 prohibiting sandals and open-toed shoes to be worn while
working in the laboratory;
 disposing of chemical, biological and other wastes according to
laboratory policies.
Procedures and Monthly and yearly exercises must be organized for fire drills and
exercises laboratory evacuation procedures. This is an occasion for the safety
officer to emphasize risks to laboratory staff and to review with them
the specific procedures for evacuation, handling of incidents and basic
security precautions.
Wast
e Laboratory waste management is a critical issue. All potentially harmful
manageme and dangerous materials (including liquids and radioactive
nt materials) must be treated in a specific way before disposing.
Separate waste containers should be used depending on the nature of the
waste, and must be clearly identified by a colour code. Specific attention
should be given to the management of potentially harmful contaminated
waste such as sharps, needles or broken glassware. Sharps containers
must be available on work benches so they are conveniently accessible
to staff.
International Many labels that give warnings and instructions for safety
ly recognized precautions are internationally recognized. A list of websites that provide
labels these labels can be found in the references and resources section.
2-6 : Identification of risks
Laboratori Laboratory workers encounter a significant number of risks, which vary
es are with the types of activities and analyses that are performed.
hazardous Risk assessment is compulsory in order for the laboratory director to
environmen manage and reduce risks to laboratory employees. Assistance from a
ts safety officer is needed to appreciate potential risks and incorporate
appropriate preventive measures. It is important to develop safety
procedures that describe what to do in case of accidents, injuries or
contamination. In addition, it is important to keep a record of staff
exposures to hazards, actions taken when this occurs, and procedures
put into place to prevent future occurrences.
The outcome of a
study of Laceration 32%
physical risks Bruise, sprain, strain, fracture 21%
encountered by
Chemical exposure 11%
laboratory staff
that was Eye injury 10%
conducted by Repetitive stress 8%
the Howard Needle puncture 7%

Hughes Medical Animal bite, scratch 4%
Institute Office of
Burn 3%
Laboratory Safety
is shown in the Other 3%
chart.This study Allergy 1%

only addressed
physical risks,
but personnel
contamination
and infection
have been
reported in
many
instances, and recent reports on laboratory-acquired infection leading to
severe acute respiratory syndrome (SARS) show that the risks are never
reduced to zero, even in high-confinement facilities.
Physic Laboratory equipment is a significant source of potential injury to

al laboratory staff, thus making training in specific safety procedures
hazar imperative. Examples of equipment in which safety training and
ds precautions are important include autoclaves, centrifuges, compressed
gas cylinders and fume hoods. Many laboratory instruments pose a
danger of electrical shock, and some equipment can emit dangerous
microwaves or radiation if not properly used or maintained.
Storage of compressed gases in the laboratory requires precautions

unique to the unusual containers in which these materials are kept, and
the high pressures they are subject to. Cylinders are kept chained to the
wall so that they cannot fall over.The safety cap must be secured over
the valve of the cylinder whenever it is moved or taken out of
service.

27
2-6: Identification of
Needles and Needles, broken glass and other sharps need to be handled and
sharps disposed of appropriately to prevent risks of infection to laboratory
and housekeeping (custodial) staff. Instructions for proper disposal of
sharps are:
 Avoid needle recapping. If recapping is crucial, the correct procedure is
for the person doing the recapping to keep one hand behind the back
of the needle, and use the other hand to scoop the cover onto the
needle.
 Put sharps in a puncture-resistant, leak-proof sharps container.
Label the container "Sharps". If the sharps are not biohazardous,
deface any biohazard markings or symbols. Seal the container tightly.
Laboratory glassware and plasticware are not considered to be sharps

for disposal purposes. Laboratory glassware and plasticware include
any item that could puncture regular waste bags and therefore
endanger waste handlers. Laboratory glass must be placed in cardboard
boxes for safety during transport through the building.Any cardboard box
may be used, provided it is sturdy and of a size that will not weigh more
than 40 pounds when full.
Contaminated laboratory glass must be appropriately decontaminated
prior to disposal.
Never use boxes for the disposal of:
 sharps
 biohazardous materials that have not been autoclaved
 liquid wastes
Chemical  chemically contaminated laboratory glassware or plasticware
hazards  chemical containers that cannot be disposed of as regular solid waste.
Exposure to toxic chemicals poses a real threat to the health and safety
of laboratory staff.There are three main routes by which chemicals
enter the body.
 Inhalation—this is the major route of entry when working with solvents;
there
is great rapidity of absorption when fumes are inhaled.
 Absorption through skin—this may produce systemic poisoning; the
condition of the skin determines the rate of absorption. Examples
of chemicals with these risks are organic lead, solvents such as
xylene and methylene chloride, organophosphate, pesticides and
cyanides.
 Ingestion—accidental ingestion is generally due to poor hygiene
practices, such as eating or smoking in the laboratory.
To prevent or reduce incidents caused by exposure to toxic chemicals, all

chemicals, including solutions and chemicals transferred from their original
containers, should be labelled with their common names, concentrations
and hazards. Additional information, such as the date received, date
opened and date of expiration, should also be recorded.
It is crucial that properly. Store corrosive, toxic and highly reactive chemicals in a well-
chemicals are ventilated area, and store chemicals that can ignite at room temperature
stored in a flammables cabinet.

Radiochemicals require special precautions, and dedicated benches

with specific bench covers for manipulation of radiolabelled elements
are needed. Specific storage areas for radioactive materials are
needed.These must provide appropriate protection (Plexiglas™, lead)
and specific waste containers, depending on the chemical nature of
waste and radioactive elements.
Material The material safety data sheet (MSDS) is a technical bulletin providing
safety detailed hazard and precautionary information.1 Businesses are
data required to provide to their customers the MSDS for all chemicals
sheet they manufacture or distribute. Laboratories need to heed
precautions listed in the MSDS in order to ensure the chemicals they
use are handled and stored safely.
The MSDS provides: FLAMMABILITY
 product information;
 fire and explosion precautions;
 toxicology; HEALTH REACTIVITY
 health effects;
 recommended PPE;
PROTECTIVE EQUIPEMENT
 storage recommendations;
 leaks and spills—
recommended actions;
 waste disposal recommendations;
 first aid.
The MSDS should be:

 available to all employees prior to use of hazardous materials;
 kept close to where the hazardous material is used and located.
Laboratory-acquired infections are not infrequent in medical

Biological laboratories. The following tables show the most frequently reported
hazards infections acquired in laboratories in the United States of America from
1979 to 1999.2
1 ISO 15190:2003. Medical laboratories—requirements for safety. Geneva: International Organization for Standardization, 2003.
2-6:2 Harding
Identification ofByers K. Epidemiology of laboratory-associated infections. In: Fleming, DO, Hunt DL, eds. Biological
AL, Brandt
safety: principles and practices.Washington, DC, ASM Press, 2000, 35–54.

29
Disease or agent No. of

cases
Mycobacterium tuberculosis 223
Q fever 176
Hantavirus 169
Hepatitis B 84
Brucella sp. 81
Salmonella sp. 66
Shigella sp. 56
Hepatitis non-A, non-B 28
Cryptosporidium sp. 27
Total 910
Maximum No
Disease Probable source distance from .
source infecte
d
Brucellosis Centrifugation Basement to 3rd 94
floor
Coccidioidomyco Culture transfer, solid 2 building floors 13
sis media
Coxsackie Spilled tube of infected 5 feet estimated 2
virus mouse tissue on floor
infection
Murine typhus Intranasal inoculation of 6 feet estimated 6
mice
Tularemia 20 petri plates dropped 70 feet 5
Venezuela 9 lyophilized 4th floor stairs to 24
n ampoules dropped 3rd or 5th floor
encephaliti
s
Aerosols are the main sources of contamination within diagnostic

laboratories; contamination can occur over very long distances. This is
why the major target of containment systems is the blockage of aerosol
diffusion inside and outside the laboratory. Diagnostic laboratories of
physical containment level 2, where activities concern only pathogens
of moderate risks, must have appropriate ventilation. Higher
containment level laboratories or working cabinets must ensure a
continuous inward airflow, as well as absolute filtration of exhausted air,
to avoid aerosol dissemination outside the working area or the whole
laboratory.1
1 Reitman M,Wedum AG. Microbiological safety. Public Health Reports, 1956, 71(7):659–665.

2-7: Personal protective
Basi
c The major routes by which laboratory staff acquire work-related infections are:
informatio  percutaneous inoculation
n  contact between mucous membranes and contaminated material
 accidental ingestion.
To reduce the risk of these occurrences, it is imperative that staff have

access to PPE, be trained in how to properly use it, and habitually use the PPE
while working in the laboratory. Approved goggles, face shields, splatter
guards, masks, or other eye and face protection should be worn when
handling infectious or other hazardous materials outside the biosafety
cabinet.
Han Gloves should be worn in all instances, and should be available to

d laboratory staff on a routine basis. Effective use of gloves relies on two
protectio simple practices.
n 1. Remove gloves when leaving the working area to prevent
contamination of other areas such as the telephone, door handles and
pens.
2.Never reuse gloves. Do not attempt to wash or decontaminate gloves—
they will develop microcracks, become more porous and lose their
protective properties.After use, gloves must be disposed of in the
contaminated waste.
Fac
e Goggles—The projection of droplets is a frequent occurrence when
protectio opening patient sample containers. Protection of eyes with goggles is
n strongly recommended as a routine procedure to prevent contact with
these droplets.
Another way to protect eyes and other mucous membranes from
projection is to manipulate the specimen tubes behind a screen (glass
or Plexiglas™) or face shield.This equipment should be compulsory when
manipulating dangerous liquids, such as liquid nitrogen or some
solvents.
Contact lenses do not offer protection from splashes.Additional eye
protection must be worn with contact lenses.
Masks—Masks serve as a barrier when splashes or sprays
occur.Furthermore,in order to reduce laboratory workers' respiratory
exposure to airborne highly dangerous pathogens, it is recommended to use
fit-tested particulate respirators with adequate filtering (e.g. EU FFP2, US
Body NIOSH-certified N95) during specimen collection or handling.
protection
Laboratory coats are compulsory in all instances in the physical
containment level 2 laboratory. Be aware of the composition of fabrics, as
some might be highly flammable.
A disposable laboratory coat is compulsory in physical containment level 3
2-7: Personal protective
laboratories or instances such as sample collection when highly dangerous pathogens can
in specific be involved, such as suspected cases of H5N1 avian influenza or SARS.

31
2-8: Emergency management and
Emergencies
Laboratories need to have procedures in place for how staff should
deal with accidents and emergencies. General written procedures for
first aid should be developed and made available to all staff so they know
the first things to do, and who to call or notify in case of minor cuts and
bruises, major wounds or skin contamination.
Chemical spills
A chemical spill is considered to be minor only if the person who
spilled it is familiar with the chemical, knows the associated hazards and
knows how to clean up the spill safely.The recommended steps for
dealing with a minor spill include:
 alert coworkers, then clean up spill;
 follow procedures for disposal of materials used to clean up spill;
 absorb free liquids with an appropriate absorbent, as follows
- caustic liquids—use polypropylene pads or diatomaceous earth
- oxidizing acids—use diatomaceous earth
- mineral acids—use baking soda or polypropylene pads
- flammable liquids—use polypropylene pads;
 neutralize residues and decontaminate the area.
Anything beyond a minor spill and that requires help from outside
of the laboratory group constitutes a major spill. Steps to deal with
major spills include alerting coworkers, moving to a safe location and
calling authorities to report the situation.
Biological spills
When surfaces are contaminated by biological spills, the
appropriate actions to take are:
1. Define/isolate the contaminated area.
2. Alert coworkers.
3. Put on appropriate PPE.
4. Remove glass/lumps with forceps or scoop.
5. Apply absorbent towel(s) to the spill; remove bulk and reapply if needed.
6. Apply disinfectant to towel surface.
7. Allow adequate contact time (20 minutes).
8. Remove towel, mop up, and clean the surface with alcohol or soap and water.
9. Properly dispose of materials.
10. Notify the supervisor, safety officer, and other appropriate authorities.
Disinfectant: For most spills, use a 1:50 solution (1 g/l chlorine) of

household bleach (sodium hypochlorite solution containing 50 g/l
chlorine).
2-8: Emergency management and
2-8: Emergency management and first aid
For spills containing large amounts of organic material, use a 1:10

solution (5 g/l chlorine) of household bleach, or an approved
mycobactericidal.1 Suggested sources of mycobactericidals are registered
with the United States of America Environmental Protection Agency
(http://www.epa.gov/oppad001/chemregindex. htm).
Alcohols are not recommended as surface decontaminating agents
because they evaporate quickly, thus decreasing contact time.
If laboratory personnel become contaminated with biological

hazards due to splashes or spills, immediate steps to take include:
1. Clean exposed skin or body surface with soap and water, eyewash
(for eye exposures) or saline (for mouth exposures).
2. Apply first aid and treat as an emergency.
3. Notify supervisor, safety officer, or security desk (after hours).
4. Follow appropriate reporting procedures.
5. Report to physician for treatment or counselling.
Laboratory Laboratory personnel need to be alert for conditions that might pose a
fires risk for fires. Keep in mind that liquids with low flash points may ignite if
they are near heat sources such as hotplates, steam lines or equipment
that might produce a spark or heat.
A small laboratory fire is considered to be one that is extinguishable

within 1–2 minutes. The appropriate action to take is to cover the fire
with an inverted beaker or wet paper towels. If this fails, use a fire
extinguisher. For large fires, call the appropriate local authorities, usually
the fire department and the police department.
Laboratories should have the appropriate class of extinguisher for the fire
hazards in the laboratory. In general, a class BC or class ABC
extinguisher is appropriate. Fire extinguishers must be inspected annually
and replaced as needed. Laboratory personnel should be trained in the
various classes of fires and basic fire extinguisher use in annual laboratory
safety and hazardous waste management training.
All laboratory personnel must learn how to operate a

portable fire extinguisher.
1 See World Health Organization. Laboratory biosafety manual, 3rd ed. Geneva,WHO, 2004
33
2-9: Summary
Summary When designing a laboratory or organizing workflow, ensure that
patients and patient samples do not have common pathways.To
identify where improvements in laboratory design may be needed in
order to prevent or reduce risks of cross- contamination, follow the path
of the sample as it moves through the laboratory during the pre-
examination, examination and post-examination phases of testing.
The design of laboratory work areas should ensure proper

ventilation and surfaces that can be cleaned and disinfected.
In establishing a safety management programme, it is important to

appoint a responsible supervisor.The laboratory should have a safety
manual that establishes policy and describes standard procedures for
handling safety and emergency issues. Personnel need to be trained in
how to apply safety practices and techniques, and to be aware of
Key message potential hazards.
Neglecting laboratory safety is costly. It jeopardizes the lives and

health of employees and patients, laboratory reputation, equipment and
facilities.
3. Equipment
3-1 : Overview
Role Equipment management is one
in quality of the essential elements of a Organization Personnel Equipment
manageme quality management system.
nt Proper management of the
system equipment in the laboratory is
necessary to ensure
accurate, reliable and timely Purchasin
Proces Informatio
g and
testing. The benefits of a good inventory
s n
contro manageme
equipment management l nt
programme are many:
 helps to maintain a high level Documen
ts
of boratory performance;
Occurrenc
e
and
 reduces variation in test record management
Assessment
results, nd improves the s
technologist’s confidence in the

accuracy of testing results; Facilities
Process Custom
 lowers repair costs, as fewer improveme
er
servic
and
nt safety
repairs will be needed for a well- e
maintained instrument;
 lengthens instrument life;
 reduces interruption of services due to breakdowns and failures;
 increases safety for workers;
 produces greater customer satisfaction.
Progra A great deal of thought and planning should go into equipment

m management. As the laboratory puts an equipment management
consideratio programme in place, the following elements should be considered.
ns  Selection and purchasing—When obtaining new equipment, what
criteria should be used to select equipment? Should equipment be
purchased or would it be better to lease?
 Installation—For new equipment, what are the installation
requirements and who will install the new instrument?
 Calibration and performance evaluation—What is needed to
calibrate the equipment and validate that it is operating correctly?
How will these important procedures be conducted for both old and
new instruments?
 Maintenance—What maintenance schedule is recommended
by the manufacturer? Will the laboratory need additional preventive
maintenance procedures? Are current maintenance procedures being
conducted properly?
 Troubleshooting—Is there a clear procedure for troubleshooting
for each instrument?
 Service and repair—What is the cost? Can the laboratory obtain the
necessary service and repair in its geographical area?
 Retiring and disposing of equipment—What must be done to
dispose of old equipment when it needs to be replaced?
3-1: Overview
Oversig It is the responsibility of the laboratory director to:

ht  oversee all the equipment management systems in the laboratory;
 ensure that all persons who will be using the instruments have been
appropriately trained and understand how to both properly operate
the instrument and perform all necessary routine maintenance
procedures.
Equipment management responsibility may be specifically assigned to a

technologist in the laboratory. In many laboratories, there is a person
who has good skills with equipment maintenance and troubleshooting.
Giving this person the role of oversight of all equipment is
recommended.
Oversight of an equipment management programme includes:

 assigning responsibilities for all activities
 ensuring that all personnel are trained in operation and maintenance
 monitoring the equipment management activities, including
- reviewing all equipment records routinely
- updating maintenance procedures as necessary
- ensuring that all procedures are followed.
Note: day-to-day maintenance should be the responsibility of the

technical operator. Everyone who uses the equipment should be
trained in calibration and daily maintenance.
37
3-2 : Selecting and acquiring equipment
Selectin Selecting the best instrument for the laboratory is a very important
g part of equipment management. Some criteria to consider when
equipme selecting laboratory equipment are listed below.
nt  Why and how will the equipment be used? The instrument should be
matched against the service the laboratory provides.
 What are the performance characteristics of the instrument? Is it
sufficiently accurate and reproducible to suit the needs of the testing
to be done?
 What are the facility requirements, including the requirements for
physical space?
 Will the cost of the equipment be within the laboratory’s budget?
 Will reagents be readily available?
 Will reagents be provided free of charge for a limited period of time? If
so, for how long?
 How easy will it be for staff to operate?
 Will instructions be available in a language that is understood?
 Is there a retailer for the equipment in the country, with available services?
 Does the equipment have a warranty?
 Are there any safety issues to consider?
If the decisions about purchasing are made outside the laboratory (e.g. by a
central purchasing body), the laboratory manager should provide
information that will support selecting equipment that will best serve
the needs of the laboratory. In areas where there are national
programmes for purchasing standard equipment, the laboratories of the
country should have some input to decisions. In addition, in areas
where donors are likely to provide some of the equipment that is
used, laboratory management should have input into the choice of
equipment. If this is not possible, management should consider
declining equipment if it is inappropriate for laboratory needs.
Acquirin Is it better to purchase or lease equipment? When making this decision,

g it is a good idea to factor in repair costs. The manufacturer should provide
equipme all of the necessary information to operate and maintain equipment. The
nt initial cost of an instrument may seem reasonable, but it may be
expensive to repair.Also consider savings that could be negotiated if
the laboratory needs more than one piece of equipment.
Before purchasing ask if:

 wiring diagrams, computer software information, a list of parts needed,
and an operator’s manual are provided;
 the manufacturer will install the equipment and train staff
(covering travel expenses as necessary) as part of the purchase
price;
3-2: Selecting and acquiring equipment
 the warranty includes a trial period to verify that the instrument

performs as expected;
 the manufacturer’s maintenance can be included in the contract and,
if so, whether maintenance is provided on a regular basis.
Determine if the laboratory can provide all the necessary physical
requirements, such as electricity, water, and space. There must be
adequate room to move the equipment into the laboratory; consider door
openings and elevator access.
Installin
g Before equipment is installed, verify that all physical requirements
equipme (electrical, space, doors, ventilation and water supply) have been met.
nt Other things to consider are:
 The vendor’s responsibilities for installation should be confirmed in
writing prior to beginning the installation process.
 A checklist of the expected performance specifications should be
developed, so that performance can be quickly verified as soon as the
equipment is installed.
Whenever possible, it is best to have the manufacturer install

laboratory equipment; this will likely improve the conditions of the
warranty, and also may ensure that the installation is done properly
and quickly.
If equipment is installed by the laboratory:

 check that the package contents contain all of the parts;
 make a copy of any software that is part of the system;
 do not allow the equipment to be used before it is completely
installed, performance is verified and testing personnel are
trained.
39
3-3 : Getting equipment ready for service
After After equipment has been installed, the following details need to be
installation addressed before putting the equipment into service.
 Assign responsibility for performing the maintenance and operation
programmes.
 Develop a system for recording the use of parts and supplies (see Chapter
4).
 Implement a written plan for calibration, performance verification, and
proper operation of the equipment.
 Establish a scheduled maintenance programme that includes daily,
weekly and monthly maintenance tasks.
 Provide training for all operators; only personnel who have been
trained specifically to properly use the equipment should be
authorized as operators.
Designate those authorized to use the equipment and

when it is to be used.
Inventory
record
Operatin
Calibration g
🗸Verificatio 🗸 procedur
n es
🗸Maintenance
program Train all
operators
Equipme Follow the manufacturer’s directions carefully when performing the

nt initial calibration of the instrument. It is a good idea to calibrate the
calibratio instrument with each test run, when first putting it into service.
n Determine how often the instrument will need to be recalibrated,
based on its stability and the manufacturer’s recommendation. It
may be advantageous to use calibrators provided by or purchased
from the manufacturer.

3-3: Getting equipment ready for service
Performan
Prior to testing patient specimens, it is important to evaluate the
ce
performance of new equipment to ensure it is working correctly with
evaluatio
respect to accuracy and precision.
n
In addition, test methods using kits or laboratory instruments need
to be evaluated for the ability to detect disease (sensitivity, specificity,
positive and negative predictive value) and to determine normal and
reportable ranges.
Verification of manufacturers’ performance claims—

Manufacturers provide performance evaluations for testing
methods using their kits or instruments, and include the information
in the package inserts or operator's manuals. However, laboratories
need to verify the manufacturer's performance claims, and demonstrate
they can get the same results using the kits or equipment in their
laboratory, with their personnel.
Some of the steps that should be followed to verify performance include:

 testing samples with known values and comparing the results to the
expected or certified value;
 if equipment is temperature controlled, establishing the stability and
uniformity of the temperature.
Validation of new equipment and associated techniques

—If the equipment and associated techniques are new, validation
processes will be important.Validation can be carried out by running
samples in parallel using both old and new equipment and methods
for a period of time to determine that the expected results can be
obtained. These validation procedures should be completely recorded.
Functio In order to verify that equipment is working according to the

n manufacturer’s specifications, it is necessary to monitor instrument
chec parameters by performing periodic function checks.This should be done
ks before using the instrument initially, then with the frequency
recommended by the manufacturer. These function checks should also
be done following any instrument repairs. Some examples of function
checks are daily monitoring of temperatures and checking the accuracy
of wavelength calibration.
41
3-4 : Implementing an equipment maintenance
Preventiv programme
e Preventive maintenance includes measures such as systematic and
maintenan routine cleaning, adjustment and replacement of equipment parts at
ce scheduled intervals. Manufacturers generally recommend a set of
equipment maintenance tasks that should be performed at regular
intervals: daily, weekly, monthly or yearly. Following these
recommendations will ensure that the equipment performs at maximum
efficiency and will increase the lifespan of the equipment.This will also help
to prevent:
 inaccurate test results due to equipment failure
 delays in reporting results
 low productivity
 large repair costs.
Maintenance A maintenance plan will include preventive maintenance procedures

plan as well as provision for inventory, troubleshooting and repair of
equipment. When implementing an equipment maintenance program,
some of the initial steps will include:
 assigning responsibility for providing oversight;
 developing written policies and procedures for maintaining equipment,
including routine maintenance plans for each piece of equipment
that specify the frequency with which all maintenance tasks should
be performed;
 developing the format for records, creating logs and forms, and
establishing the processes to maintain records;
 training staff on the use and maintenance of the equipment, and
ensuring that all staff understand their specific responsibilities.
Equipme
nt It is recommended that a label is attached to the instrument indicating
inventor when the next maintenance or service should be performed.
y
The laboratory should keep an inventory log of all equipment in the
laboratory. The log should be updated with information on new
equipment and include documentation of when old equipment is
retired. For each piece of equipment, the equipment inventory log
should have a record of:
 instrument type, make and model number, and serial number so
that any problems can be discussed with the manufacturer;
 date the equipment was purchased, and whether it was purchased
new, used or reconditioned;
 manufacturer/vendor contact information;
 presence or absence of documentation, spare parts and maintenance
contract;
 warranty’s number indicating the year of acquisition (this is especially useful for
expiration date; larger laboratories); for example, use the style “YY-number” (04- 001,
 specific 04-002, etc.) where “YY-number” equals the last two numbers of the
inventory year followed by a number attributed in the year.

3-4: Implementing an equipment maintenance programme
An inventory process must be conducted if the laboratory does not

have an existing inventory system for equipment. This could be
conveniently organized following a model grid, room by room; for
example, conduct an inventory of equipment in the reception area,
then the sample collection area, the serology testing area, and the
parasitology testing area. During the inventory, the condition of the
equipment should be documented as functional, partially functional or
nonfunctional. Equipment that is not functioning needs to be evaluated
as to whether or not it can be repaired. Nonrepairable equipment
should be retired, and work should be scheduled for equipment
Inventory needing repair.
of spare
parts To ensure that the laboratory does not run out of spare parts, an
inventory record of those used most frequently should be kept for each
piece of equipment. The record should include:
 part name and number;
 average use of the part, and the minimum to keep on hand;
 cost;
 date when the part is placed into storage and when it is used (in and
out stock log);
 quantity of each part remaining in inventory.
43
3-5 : Troubleshooting, servicer repair and retiring
equipment
What is
the source Problems with equipment may present in many ways. The operator may
of the notice subtle changes such as drift in quality control or calibrator values,
problem? or obvious flaws in equipment function. Sometimes, the equipment fails to
operate. It is important to teach operators to troubleshoot equipment
problems in order to quickly get the equipment functioning and resume
testing as rapidly as possible.
When an operator observes instrument drift, it is important to

repeat the preventive maintenance procedures as a first step to resolve
the problem. If this does not work, proceed with troubleshooting
Troubleshooti processes.
ng
Manufacturers frequently provide a flowchart that can help determine
the source of problems. Some of the questions to consider are listed
below.
 Is the problem related to a poor sample? Has the sample been
collected and stored properly? Are factors such as turbidity or
coagulation affecting instrument performance?
 Is there a problem with the reagents? Have they been stored properly,
and are they still in date? Have new lot numbers been introduced
without updating instrument calibration?
 Is there a problem with the water or electrical supply?
 Is there a problem with the equipment?
When Make one change at a time based on symptoms. If the equipment is the
problems problem, review the manufacturer’s instructions to verify that all
cannot procedures are being followed correctly.
be
correcte If problems cannot be identified and corrected in-house, attempt to find a
d way to continue testing until the equipment can be repaired. Some ways
to achieve this are as follows.
 Arrange to have access to backup instruments. It is often too costly
for the laboratory to have its own backup instruments, but sometimes
a central stores agency can maintain backup instruments to be shared
throughout the local area or country.
 Ask the manufacturer to provide a replacement instrument during repairs.
 Send the samples to a nearby laboratory for testing.
Be sure to notify the appropriate providers that there are problems

and that there will probably be delays in completing the testing.
3-5:Troubleshooting, service, repair and retiring equipment
Do not use faulty equipment! Seek help from the manufacturer or other
technical expert. Place a note on the equipment so all staff are aware
that it is not in use.
Service and
repair Manufacturers may provide service and repair of equipment that is
purchased from them. Be sure to set up a procedure for scheduling
service that must be periodically performed by the manufacturer. When
instruments need repair, remember that some warranties require
that repairs be handled only by the manufacturer. Large facilities
sometimes have biomedical service technicians in- house who perform
equipment maintenance and repair.
Retiring Routine service should be scheduled so as not to interrupt the flow of work.
and
disposing It is very important to have a policy and procedure for retiring older
of laboratory equipment. This will usually occur when it is clear that the
equipme instrument is not functioning and is not repairable, or when it is outmoded
nt and should be replaced with new equipment.
Once a piece of equipment is fully retired and it has been determined

that it has no further use, it should be disposed of in an appropriate
manner.This last step is often neglected in laboratories and old equipment
accumulates, taking up valuable space and sometimes creating a
hazard.
When disposing of equipment, salvage any usable parts,

particularly if the equipment is being replaced with another similar
one.Then consider any potential biohazards and follow all safety
disposal procedures.
45
3-6 : Equipment maintenance documentation
Developi Equipment documents and records are an essential part of the quality
ng system. The policies and procedures for maintenance should be defined
documents in appropriate documents, and keeping good equipment records will
and policies allow for thorough evaluation of any problems that arise (see
for Chapter 16).
recordkeepi
ng Each major piece of equipment will have its own equipment
maintenance document. Smaller, commonly used equipment such as
centrifuges and pipettes may be managed with an equipment
maintenance document or manual that deals with all such equipment in the
laboratory. An equipment maintenance document should include:
 step-by-step instructions for routine maintenance, including
frequency of performance and how to keep records of
maintenance;
 instructions for carrying out function checks, frequency of
performance, and how to record the results;
 directions for calibrating the instrument;
 guide for troubleshooting;
 any required manufacturer’s service and repair;
 list of any specific items needed for use and maintenance, such as spare
parts.
For major equipment, include identification of the specific instrument and

perhaps information on its performance.
Recordi Each piece of equipment should have a dedicated logbook

ng documenting all characteristics and maintenance elements, including:
maintenan  preventive maintenance activities and schedule;
ce  recording of function checks and calibration;
informatio  any maintenance performed by the manufacturer;
n  full information on any problem that the instrument develops, the
subsequent troubleshooting activity and follow-up information
regarding resolution of the problem. In recording problems, be sure to
record
- date problem occurred and when equipment was removed from service;
- reason for breakdown or failure;
- corrective action taken, including a note about any service provided
by the manufacturer;
- date returned to use;
- any changes to procedure for maintenance or function checks as a
result of the problem.
3-6 : Equipment maintenance documentation
Some of the tools that are helpful for keeping records of equipment
management are:
 charts
 logs
 checklists
 graphs
 service reports.
The logbook should be available for review during the entire life of the
equipment.
47
3-7 : Summary
Summary All laboratories should have a well-organized equipment management
programme. The programme should address equipment selection,
preventive maintenance, and procedures for troubleshooting and
repair.
It is essential that good documents and records be maintained.These

will include a complete and accurate inventory of all laboratory
equipment, documents provided by the manufacturer on operation,
maintenance and troubleshooting, and records of all preventive
Key messages maintenance and repair activities.
 A good equipment maintenance programme results in a high level of

performance and greater confidence in the reliability of results.
 A significant benefit to the laboratory will be fewer interruptions in
test performance, lower repair costs and elimination of premature
replacement of equipment.
 Increased safety for laboratory workers will result from well-
maintained equipment.
4. Purchasing
and
inventory
4-1: Overview
Role in Purchasing and inventory

quality management is a critical and
manageme essential component of the quality
nt management system.
system Purchasin
g Proces Informatio
and s n
Efficient and cost-effective inventory contro manageme
l nt
laboratory operations need the
uninterrupted availability of
Documen
reagents, supplies and ts
Occurrenc
e
services. Inability to test, even for a and
management
Assessment
record
short time, is very disruptive to s
clinical care, prevention activities
and public health programmes.
Process Facilities
Custom
improveme and
er
nt safet
servic
y
e
Benefits Careful management of inventory helps to prevent waste, which can

occur if reagents and supplies are stored improperly, or if reagents
become outdated before they can be used. Establishing a purchasing
and inventory management programme will ensure that:
 supplies and reagents are always available when needed;
 high-quality reagents are obtained at an appropriate cost;
 reagents and supplies are not lost due to improper storage, or kept
and used beyond expiration.
Considerations Methods for obtaining reagents and supplies vary considerably

between laboratories. Some laboratories may purchase directly but, in
many countries, a national procurement system is in place with a central
stores area that distributes directly to the laboratories. Also, in many
places, donors have a major role in the procurement of supplies and
reagents.
The laboratory system for managing the reagents and supplies must
take into account these variables.
Challenges
The challenge of inventory management is balancing the availability of
supplies and reagents in stock with their expiration dates. The lifespan
of reagents can vary from a few weeks to a number of years. It is
important to continuously monitor the expiration dates to make sure
needed reagents are always on hand and have not expired. However, it
is too costly and wasteful to overstock.
4-1: Overview
Equipment and supplies received or accepted from donors must meet

the clients’ needs and the operational needs of the laboratory.
Managers may sometimes need to refuse donations, but this should be
done in a diplomatic way to ensure future offers are not
discouraged.
Key
components Successful purchasing and inventory management requires that
policies and procedures be established for managing all critical materials
and services. Some of the key components to address are:
 vendor/manufacturer qualifications;
 purchase agreements;
 receiving, inspecting, testing, storing, and handling of materials—all
purchased material should be inspected and appropriately tested
to ensure that specifications are met, and policies should be
established for storing and handling materials as they are
delivered to the laboratory;
 tracking materials to individual patients—the management system
must allow for tracking materials to individual patients; that is, the
laboratory should be able to identify specific test materials used for
performing tests on any given day, so that if there is a problem with a
patient result, the laboratory will know what reagents were used;
 assessing and maintaining inventory;
 controlling expiration periods;
 dispatching supplies to satellite laboratories.
51
4-2:
Selecting vendors
It is very important to set expectations and build and maintain
relationships with providers of materials and services. Laboratories that
purchase directly should look very carefully at vendors’ and
manufacturers’ qualifications, examining such things as specifications and
methods of transport. Laboratories that receive reagents and supplies
from a central stores area managed by their government should
interact with those managing the central stores area to accomplish
these same objectives.
At the outset, the laboratory should:

 define criteria for supplies or materials to be purchased;
 look for the best price, taking into account the qualifications and
credibility of the supplier;
 consider the advantages and disadvantages of purchasing “brand
name” compared to “generic” products (e.g. is it better to
purchase specific pipette tips for a specific pipette, or is it just as
effective to use generic pipette tips that cost less?).
It may be useful to seek information from other laboratories when

considering quality, reliability of supply, and cost.
It is equally important to evaluate vendors after purchase. Consider

such factors as whether the vendor delivered the specified goods, or
whether the central procurement body assured that user
Considerations specifications were met.
When setting up procedures for purchasing, there are a number of

considerations.
 Understand any local or national government requirements that
need to be accommodated in the contracts.
 Negotiate for the best price without undermining quality.
 Carefully review all contracts to make sure the laboratory’s
requirements are being met. Contracts should clearly address
payment mechanisms and provisions to assure reliable availability
and delivery of reagents and supplies. Ask if there are penalties for
ending a contract.
 Determine how payments will be made, and how the vendor will
assure reliable availability and delivery of supplies and reagents.
4-2:

4-3: Implementing an inventory management
Implementation
steps In establishing an inventory control programme there are a number of
factors to consider.A system should be designed so that the laboratory
can closely monitor the condition of all supplies and reagents, know what
quantities are available and be alerted when there is a need to
reorder.
The following are important steps for implementation.

 Assign responsibility—without this, nothing may get done.
 Analyze the needs of the laboratory.
 Establish the minimum stock needed for an appropriate time period.
 Develop needed forms and logs.
 Establish a system for receiving, inspecting and storing supplies.
 Maintain an inventory system in all storage areas, and for all
Analyz reagents and supplies used in the laboratory.
e
need A laboratory needs a process for analyzing its needs for materials
s and for determining how many kits for a particular test should be on
hand.
The laboratory should make a list of all the tests it performs and
identify all the supplies and reagents that are needed for each test. It is
wise to use all available information to help estimate the usage of
supplies and reagents for the period of time between ordering new
materials.The information necessary for analyzing needs includes:
 a complete description of each item used;
 the package count or number of units in which the item is supplied
(e.g. a kit can include 12 tests or 100 tests, and pipette tips can be
packaged as 100 per box or 1000 per box);
 approximate usage per month (quantification, e.g. 6 boxes used per month);
 the priority or importance level the item has in doing the work of the
laboratory (e.g. used every day or only once a month?);
 length of time required to receive a delivery (will the order take a day,
week or month to arrive?);
 storage space and conditions (will a bulk order use too much
storage space? Does the item require storage in a
refrigerator?).
4-3: Implementing an inventory management

53
4-4:
Why?
How can a laboratory determine how much of any particular item to order?
Quantification is a very important process that can help calculate how

much is required of any particular item for a given period of time, and it is
an essential part of a successful inventory management programme.
Accurate quantification will:
 ensure essential supplies will be available when needed
 prevent overstocking, which can lead to wastage of expensive materials.
Quantification provides information for:

 estimating annual budget requirements;
 allowing for better planning;
 making decisions and monitoring performance of the inventory
management system.
When?
Quantification is performed when making annual plans for the
laboratory and this planning will take into account the usual usage of
supplies and reagents.
There are times when it is important to consider how new demands

on the laboratory will create a need for greater testing volume. This
often occurs when new health programmes are being implemented, and in
How?
preparation for epidemics, either identified or potential.
The two frequently used methods are consumption-based quantification

and morbidity-based quantification.
Consumption-based quantification
Laboratories most frequently use the consumption-based method,
drawing on their experience over time.This method is based on actual
consumption, so there are a number of factors to consider. For example,
to determine the actual usage, it is important to also estimate how
much wastage has occurred and how many expired or spoiled reagents
and supplies have been discarded. An example of this type of monitoring
is shown below.
100
Slides
Immersion oil
80
Collection containers
60
40
20
4-4: 0
1st
2nd 3r 4th
d
Quarte
r
4-4: Quantification
For planning, it is a good idea to consider whether any supplies or reagents

have been out of stock for more than 15 days during any time of the
year. This may mean that supplies are not ordered in sufficient quantities,
or that the wastage or expiry is higher than predicted.
Morbidity-based quantification
In using the morbidity-based quantification method (shown below), the
laboratory must take into account the actual number of episodes,
illnesses and health problems that require laboratory testing. In other
words, the laboratory needs to estimate an expected frequency of the
disease in question—how many cases will occur per unit of population
(per 1000, per 10 000, etc.)? Then, considering how many people the
laboratory serves, it can estimate the total number of cases the
community might reasonably expect to observe. Using standard
guidelines for diagnosis and treatment, and considering how well
health care providers adhere to these guidelines, can help to estimate
how many laboratory tests will be performed.
180 Influenza
Diarrhoea Tuberculosis
160
140
120
100
80
60
40
20
0
1st 2nd 3rd 4th
Quarter
A good morbidity-based quantification method is more accurate

than the quantification by consumption method, but it depends on
accurate data.
55
4-5: Forms and
Developing forms
and logs Developing an appropriate record-keeping system is an important
step for inventory management. Good tools for managing the stock
include:
 standardized forms
 card systems
 log books.
For any system that is used, the following information should be recorded:
 date reagent or set of supplies are received;
 lot numbers for all supplies, reagents and kits;
 pass or fail acceptance criteria;
 date the lot number or box of supplies was put into service or, if not
Logbo usable, the date and method of disposition.
ok
The stock logbook or card system will provide a way to keep track of all
supplies and reagents that are on hand at any given time. In
addition to information mentioned above, it is a good idea to record:
 name and signature of the person receiving the materials
 date of receipt
 expiration date
 quantity of the material received
 minimum stock that should be on hand
 current stock balance.
Additional information to record could include:

 shelf number or name
 destination (e.g. to –20 oC freezer to media room).
It is a good idea to keep the stock logbook in the storage area.

4-5: Forms and
4-6: Receipt and storage of
Receiving
and A system should be established so when supplies are received,
inspecti personnel know what is expected. All supplies and reagents should be
ng inspected as they arrive in the laboratory to be sure that they are in
supplie good condition and to verify that what is received is what was
s ordered.
In addition, the person receiving supplies should:

 sign their name verifying receipt of goods
 date each item received
 note expiration date
 store new shipment behind existing shipment
 create or update logbook records.
Storage of reagents and supplies is a very important part of

Storage inventory control. Good practices to keep in mind are:
 Keep the storeroom clean, organized and locked to protect the inventory.
 Make sure storage areas are well ventilated and protected from direct
sunlight.
 Ensure storage conditions are in accordance with the
manufacturer’s instructions, paying particular attention to any
temperature requirements or other specifications, such as safety
requirements.
 Use good shelving strong enough to support items, and organize
items carefully on the shelves to prevent movement shifts or falls.
Shelves should be attached firmly to support walls to prevent
tipping.
 Ensure items are accessible to staff. Sturdy step stools should be
available for reaching higher shelves and heavier items should be
stored on lower shelves; laboratory staff should not be required to
lift heavy items.
 When storing, put the new shipment behind existing materials that are
Organizati already in the laboratory. Organize the reagents and materials so that
on of the older materials get used first (i.e. items with the first expiry dates
shelves are the first used).
Labelling shelves is a useful tool for storing inventory and will help to
systemize and organize storage space.
 Assign a number (or name) to different areas of the shelves.
 Record in the logbook what shelves are used for which reagents and
supplies.
4-6: Receipt and storage of

57
4-6: Receipt and storage of supplies
This system helps to avoid “losing” a product, and will save staff
time when searching for a product. Even someone who is not familiar
with the storeroom can find a product if this system is in place. It is
also useful to number cold rooms, refrigerators and freezers for the
same purpose. An example of this type of system is shown below.
3
1 2 2 4
5
2 2 4
6 6 7
1
8 9 10 11 12
Labelling Establishing a system for labelling reagents will be very helpful. It is

reagents important to label reagents with the date they are opened and to make
sure the expiration date is clearly visible.

4-7: Monitoring
Continuo
us Procedures should be developed and put in place for continuous
monitoring monitoring of the inventory.To ensure this is done effectively:
of  assign the responsibility for this task to an appropriate person or
inventory persons— someone must be in charge;
 be sure that all supplies and reagents in the laboratory are covered
by the system and maintain inventory management in all of the
storage areas;
 conduct weekly physical counts of reagents and supplies in order to
check the system, and as a part of the monitoring process;
 make sure that all records relevant to inventory management are
updated and maintained.
Computerized In many laboratories, a simple computerized system can be set up for

inventor management of inventory.There are many advantages to using a
y computer. A computer will:
manageme  keep track of the exact number of supplies and reagents on hand, as it
nt can be updated daily;
advantages  allow for good management of expiration dates—the system can
and be set up to alert when lot numbers are near the expiration date, and
drawbacks therefore use of resources can be optimized;
 generate statistics that will help when planning and making purchases;
 help manage the process for distributing reagents to satellite laboratories;
 ease the burden of inventory management.
Some drawbacks to setting up a computerized system are:

 an on-site computer is needed and it could be expensive to purchase
 staff using the system will need to be trained.
4-7: Monitoring
59
4-8:
Summary
A well-managed laboratory will have a system for inventory
maintenance and purchasing. The system will require planning and
monitoring to ensure that appropriate quantities of supplies and reagents
are always available, and to prevent wastage.
In implementing an inventory management system, the laboratory
must assign responsibility for the programme, analyze the needs of
the laboratory and establish the minimum stock needed for an
appropriate time period. Appropriate logs and forms will be needed, as
well as a procedure for receiving, inspecting and storing supplies.
The laboratory will need to maintain an inventory system for all
reagents and supplies used in the laboratory; this system must include all
areas where reagents and supplies are stored.
Key messages
Properly managing inventory will:
 increase the efficiency and effectiveness of the laboratory, because
it will provide an uninterrupted flow of needed materials;
 ensure products are available when they are needed;
 ensure that patient and clinical needs are met.

5. Process
control— sample
management
5-1: Overview
Role in Sample management is a part

quality of process control, one of the
manageme essentials of a quality
nt management system.
system Purchasin
g Proces Informatio
and s n
The quality of the work a inventory contro manageme
laboratory produces is only as l nt
good as the quality of the

samples it uses for testing. The Documen
ts
laboratory must be proactive in Occurrenc
e
and Assessment
management
ensuring that the samples it record
s
receives meet all of the
requirements for producing
accurate test results.
Process Facilities
Custom
improveme and
er
nt safety
servic
e
Sample nt components
vs
specim
en
Importance
of
good
manageme
nt
Sampl
e
manageme
The from the human body, but the terminology used throughout ISO documents
International is “primary sample”, or just “sample”. In this handbook, the terms “sample”
Organization and “specimen” should be considered interchangeable.
for It is useful to note that in some of the existing transport regulations,
Standardizatio the term “specimen” continues to be used.
n (ISO) and
Clinical and Proper management of samples is critical to the accuracy and reliability of
Laboratory testing, and therefore to the confidence in laboratory diagnosis.
Standards Laboratory results influence therapeutic decisions and can have
Institute (CLSI) significant impacts on patient care and outcomes. It is important to
define a provide accurate laboratory results in order to ensure good
sample as treatment.
“one or more
parts taken Inaccuracies in testing can impact length of hospital stays, as well as
from a system hospital and laboratory costs. Inaccuracies can also affect laboratory
and intended efficiency, leading to repeat testing with resultant waste of personnel
to provide time, supplies and reagents.
information on
the system” Written policies for sample management must be established and
(ISO reflected in the laboratory handbook. Components to be addressed
15189:2007). include:
The term  information needed on requisitions or forms;
“specimen” is  handling urgent requests;
very commonly  collection, labelling, preservation and transport;
used in the  safety practices (leaking or broken containers, contaminated
laboratory to forms, other biohazards);
indicate a  evaluating, processing and tracking samples;
sample taken  storage, retention and disposal.

5-2:The laboratory
Purpose
and To ensure that all samples are managed properly and that persons
distributio collecting samples have the needed information, the laboratory should
n develop a laboratory handbook.This handbook should be made available
at all sample collection areas, including those that are distant from
the laboratory.
All laboratory staff should also be familiar with the information in the
handbook, and should be able to answer questions about the
information included. The laboratory handbook is an important
laboratory document. It must be kept up to date and be referenced in
the laboratory’s quality manual.
Conte
Important information that should be included in the laboratory handbook:
nt  contact names and telephone numbers of key personnel;
 name and address of the laboratory;
 hours of operation of the laboratory;
 list of tests that can be ordered;
 detailed information on sample collection requirements;
 sample transport requirements, if any;
 expected turnaround times;
 description of how urgent requests are handled—this should
include a list of what kinds of tests are done on an urgent basis,
what are the expected turnaround times, and how to order these
tests.
The laboratory should periodically provide training sessions to health

care and laboratory personnel who are responsible for the collection of
samples.
5-2:The laboratory

63
5-3: Collection and
The
laboratory’s The collection of appropriate and optimum samples is the
responsibilit responsibility of the laboratory, even though the actual collection process
es is often carried out by persons who are not part of the laboratory staff.The
sample may be collected at the bedside by a nurse if the patient is being
managed in a hospital.The health care provider may collect a sample in a
clinic setting.
The laboratory can help to ensure good samples by providing collection

information to health care personnel at the collection site, making sure that
appropriate containers and collection supplies are available, defining a good
labelling system and checking all samples carefully when they arrive in the
laboratory.
Tes
t The first step in the
requisitio process of obtaining the
n sample is the request for
testing. The laboratory must
make available a test
request form that specifies
all the information that will
be needed for proper
handling and reporting.
Essential information for the test

request form includes:
 patient identification;
 tests requested;
 time and date of the
sample collection;
 source of the sample,
when appropriate;
 clinical data, when indicated;
 contact information for the health care provider requesting the test.
Sample
collection Collection of samples in the field for epidemiological studies should
requiremen be accompanied by a form that includes the patient’s name, a unique
ts identification number, demographic information and the patient’s health
status. The additional information is necessary to assist in identifying the
source of an infection and finding potential contacts.
Sample collection and preservation will vary, depending on the test

and the type of sample to be collected. The laboratory must carefully
define a sample collection process for all tests it performs. The following
should be considered when preparing instructions.
 Patient preparation—Some tests require that the patient be
5-3: Collection and
fasting. There special timing issues for tests such as blood glucose, drug levels and
may also be hormone tests.

5-3 : Collection and preservation
 Patient identification—The person collecting the sample must

accurately identify the patient.This might be done by questioning the
patient, by questioning an accompanying family member, or by the use of
an identifying wrist band or other device.
 Type of sample required—Blood tests might require serum,
plasma or whole blood. Other tests might require urine or saliva.
Microbiology testing deals with a variety of sample types, so specific
information as to what is required for the test is needed.
 Type of container—The container for the sample is often very
important, as it will affect volume and any needed additives such as
anticoagulants and preservatives. If the container does not control
volume, for example as with Vacutainer® tubes, this will need to be
clearly specified. Some microbiology samples will require specific
transport media to preserve microorganisms.
 Sample labelling—All requirements for labelling of the sample at
the time of collection will need to be explained in detail in the
instructions for collection.
 Special handling—Some samples may require special handling,
such as immediate refrigeration, protection from light or prompt
delivery to the laboratory. Any important safety precautions should be
explained.
Patient samples are sometimes collected by the patient themselves; for

example, faecal parasitological samples. It is important that the
laboratories have set protocols to ensure that appropriate collection
kits with instructions for collection, safety precautions and labelling
are available for their patients. It is suggested that instructions for the
patients be in the languages for the community the laboratory is serving,
or presented as simple, easy-to-understand graphics.
Sampl
e Each sample should be clearly labelled with:
labellin  the patient’s first and last name;
g  a unique identification number—this might be a hospital number or a
number assigned by the laboratory;
 the test that has been requested;
 the time and date of collection;
 the initials of the person collecting the sample.
Proper sample collection is an important element for good laboratory

Outcomes practice. Improper collection of samples can lead to poor outcomes, such as:
of collection  delays in reporting test results
errors  unnecessary redraws/retests
 decreased customer satisfaction
 increased costs
 incorrect diagnosis or treatment
 injury
 death.
65
5-4 : Sample processing
Verification of Once a sample enters the laboratory, there are a number of steps
quality needed prior to testing.
 Verify the sample is properly labelled, adequate in quantity, in good
condition and appropriate for the test requested.The test request
must be complete and include all necessary information.
 Record sample information into a register or log.
 Enforce procedures for handling suboptimum samples, including
sample rejection when necessary.
Rejection of The laboratory should establish rejection criteria and follow them
samples closely. It is sometimes difficult to reject a sample, but remember that a
poor sample will not allow for accurate results. It is the responsibility of the
laboratory to enforce its policies on sample rejection so that patient care
is not compromised.
Management should regularly review the number of rejected

samples and reasons for rejections, conduct training on sample collection,
and revise written procedures for sample management as needed.
The following are examples of samples that should be rejected:

 unlabelled sample;
 broken or leaking tube/container;
 insufficient patient information;
 sample label and patient name on the test request form do not match;
 haemolysed sample (depending on test requested);
 nonfasting samples, for tests that require fasting;
 sample collected in wrong tube/container (e.g. using the wrong
preservative or a nonsterile container);
 inadequate volume for the quantity of preservative;
 insufficient quantity for the test requested;
 prolonged transport time or other poor handling during transport.
Record the reason for rejection in the logbook and include

all pertinent information.
When rejecting a sample, it is important to:

 promptly inform the authorized person that the sample is unsuitable for
testing;
 request another sample to be collected following procedures
outlined in the laboratory handbook;
 retain the rejected sample pending a final decision regarding disposition.
In some circumstances, and after consultation with the requester, it

may be necessary to proceed with the testing of a sample that is not
optimal.

5-4: Sample processing
Regist The laboratory should keep a register (log) of all incoming samples. A
er or
master register may be kept, or each specialty laboratory may keep
log
its own sample register.
Assign the sample a laboratory identification number—write the

number on the sample and the requisition form. If computers are used
for reports, enter the information into the computer.
The register should include:

 date and time of collection
 date and time the sample was received in the laboratory
 sample type
 patient name and demographics, as required
 laboratory assigned identification (e.g. number 276_01_06_2009)
 tests to be performed.
The laboratory needs a system to allow for tracking a sample

Trackin throughout the laboratory from the time it is received until results are
g
reported.
syste
This can be done manually by careful keeping of records as follows.
m
 Confirm receipt of samples and include date and time.
 Label samples appropriately and keep with the test requisition until
laboratory identification is assigned.
 Track aliquots—they should be traceable to the original sample.
If computers are available, maintain a database for tracking. The

following information about each sample should be entered into the
database:
 identification number
 patient information
 collection date and time
 type of sample (e.g. urine, throat, cerebrospinal fluid for culture)
 tests to be performed
 name of ordering physician (or other health care provider)
 location of patient (e.g. ward, clinic, outpatient)
 diagnostic test results
 time and date results are reported.
Handle all samples as if they are infectious.

Sampl
e
handlin
g
67
5-5: Sample storage, retention and
Sampl
e Written policies should be developed that include:
storag  description of what samples should be stored;
e  retention time;
 location (consider ease of access);
 conditions for storage, such as atmospheric and temperature
requirements;
 system for storage organization—one method is to store samples
by day of receipt or accession number.
Sampl Set a laboratory policy for retention of each type of sample. Some samples
e can be quickly discarded and others may need to be retained for longer
retentio periods. Monitor stored samples and do not keep for longer than
n necessary, as refrigerator and freezer space may be limited. Sample
freeze/thaw cycles must be monitored, as samples may deteriorate
under these conditions.
Planning is required for samples that may need long-term storage. An

organized, accessible system using computer tracking would be useful
for these samples. The inventory of stored samples should be
reviewed at specified intervals to determine when they should be
discarded.
When referring samples to other laboratories for testing:

Sampl
e  Obtain a laboratory handbook with detailed procedures from each
referr laboratory.
al  Ensure the sample is labelled correctly, in the correct container,
accompanied by a requisition form that specifies the required test(s) and
includes the sending laboratory’s contact information.
 Carefully monitor samples that are referred:
- keep a record of all tests and samples referred, date of referral and
name of person referring the test;
- record and report results received for each referred sample;
- monitor turnaround times and record any problems encountered.
The laboratory is responsible for ensuring that disposal of all laboratory

Sampl waste is handled in a safe manner.To ensure proper disposal of patient
e samples:
dispos  Develop a policy for sample disposal; apply local as well as country
al regulations for disposal of medical waste.
 Establish and follow procedures to disinfect samples prior to disposal.
5-5: Sample storage, retention and

5-6: Sample
Need
for Frequently, samples are collected outside the laboratory and must be
transpo transported for subsequent processing and testing. Transport may be
rt for a short distance, but sometimes a distant clinic or collection site
requires the use of vehicles or aeroplanes. In addition, it may be
necessary for the laboratory to ship samples to referral laboratories. In all
cases, transport must be managed carefully in order to maintain
integrity of the sample, giving attention to temperature, preservation
needs, special transport containers and time limitations. It is also
important to ensure the safety of those handling the material before,
during and after transport.
Safet
y Laboratories that mail or transport samples by air, sea, rail or road between
requiremen local, regional and reference laboratories, or between laboratories in
ts other countries, must adhere to a number of regulations. These
regulations are designed to deal with transportation accidents and
spills, reduce biohazards and keep samples intact for testing.
Regulations for transporting samples come from several sources, including:

Regulations  national transport regulations;
 International Civil Aviation Organization (ICAO), as conveyed by
the International Air Transport Association;
 rail and road traffic agencies;
 postal services.
Private courier companies may have their own requirements.
Compliance with industry standards and regulations is mandatory.

Heavy fines may be imposed on personnel who violate these
regulations.At risk are the safety of courier, carrier and laboratory
personnel, as well as passengers.
The United Nations committee of experts, consisting of voting

representatives from over 30 countries and nonvoting advisers from
various organizations, makes recommendations for the transport of
dangerous goods. Many countries adopt the United Nations regulations
in their entirety to stand as their national dangerous goods regulations.
Some countries apply variations. National authorities should provide
details of their own national requirements.
Classification
Sample transport requirements are based on the category of
samples being transported. Infectious substances are classified as
Category A or Category B. There is no direct relationship between Risk
Groups and Categories A and B.
Category A: Infectious substances capable of causing permanent

disability or life-threatening or fatal disease to humans or animals.
5-6: Sample

69
5-6: Sample
These are assigned the following proper shipping name and UN number:
 Infectious substance affecting humans, UN 2814.
 Infectious substance affecting animals only, UN 2900.
Category B: Infectious substances that do not meet the criteria for

inclusion in Category A. They are assigned the proper shipping name
Biological substance, Category B, and UN number UN 3373.
Medical or clinical wastes that contain infectious substances also need

to be classified as Category A or B, depending on the infectious material
and whether it is present in the culture.
Exemptions: The United Nations Model Regulations for the

Transport of Infectious Substances includes a list of exemptions, which
are samples that have a minimal likelihood that pathogens are present.
They do not have the same requirements for packaging and shipping as
Categories A and B.
Packagi
ng All three categories of samples have specific packaging instructions
requiremen and labelling requirements depending on their classification. All potentially
ts hazardous material requires triple packaging.
 The primary container is a tube or vial containing the sample; it
is made of glass, metal or plastic. It must have a leak-proof seal; if
necessary it can be wrapped with waterproof tape. The tube or vial must
be labelled with a permanent marker.
 The secondary container is a watertight polyethylene box
intended to protect the primary container. It is supplied with
cardboard or bubble-wrap, or a vial holder in which several primary
containers can be placed in order to protect them. Absorbent material
(gauze, absorbent paper) must be added in a sufficient quantity to
absorb the fluid completely in case of breakage.
 The outer container is a strengthened cardboard box used to
protect the secondary container. Both the secondary and outer
containers are reusable as long as they are intact, but old labels must
be removed.
There is specific packaging for samples requiring shipment on dry ice.

5-6: Sample

5-6: Sample
Managing sample Ensure that all regulations and requirements are met when transporting
transport samples; be aware of any national requirements that apply to
samples transported by hospital or laboratory vehicles.
All personnel who package samples or who drive transport vehicles

should be trained in the proper procedures for safety and good
maintenance of samples. If ICAO regulations must be met, staff must
have specific training in packaging of dangerous goods.
When transporting locally, whether by ambulance, or by clinic or

laboratory staff, it is important to maintain sample integrity. Ensure that
temperatures are controlled, using ice boxes or air-conditioning, set an
acceptable transport time and monitor compliance.

5-6: Sample
71
5-7: Summary
Summary A laboratory handbook describing sample collection and
providing testing information must be available to everyone who
needs this information.
It is important to have a system for tracking samples as they move

through the laboratory.
Establish and implement a policy for sample storage and sample

disposal. Maintain sample integrity and assure that all regulations and
requirements are met.
It may be useful to appoint someone with oversight responsibilities for

sample management.
Key messages
 The laboratory must have good samples in order to ensure
accuracy and reliability of testing and confidence in results.
 Sample management directly affects patient care and outcome.
6. Process
control—
introduction to
quality control
6-1: Introduction
Role in Process control is an essential
quality element of the quality Organization Personnel Equipment
manageme management system, and refers
nt to control of the activities
system employed in the handling of
samples and examination
processes in order
to ensure accurate and reliable Purchasin
Proces Informatio
g and
testing. Sample management, inventory
s n
contro manageme
discussed in Chapter 5, and all l nt
quality control (QC) processes
are a part of process control. Documen
ts
Occurrenc
e
and Assessment
record management
QC monitors activities related to s
the examination (analytic) phase of

testing. The goal of QC is to Facilities
detect, evaluate,
Process Custom
nd correct errors due to test improveme er and
servic safet
system failure, environmental nt
e y
conditions or operator
performance, before patient
results are reported.
What is QC is the part of quality management focused on fulfilling quality

QC? requirements (ISO 9000:2000 [3.2.10]). Simply put, it is examining “control”
materials of known substances along with patient samples to monitor the
accuracy and precision of the complete analytic process. QC is required
for accreditation purposes.
In 1981, the World Health Organization (WHO) used the term "internal
quality control" (IQC), which it defined as “a set of procedures for
continuously assessing laboratory work and the emergent results”.The
terms QC and IQC are sometimes used interchangeably; cultural setting
and country may influence preferences for these terms.
In the past few years, "internal quality control' has become

confusing in some settings because of the different meanings that
have been associated with the term. Some manufacturers of test kits for
qualitative tests have integrated "built-in" controls in the design of their
kits, which they sometimes refer to as internal controls. Other
manufacturers include their own control materials with the kits they sell
and they refer to these as "internal controls", meaning that the materials
are meant specifically for that manufacturer’s kit. Finally, some people refer
to any quality control materials that are used in conjunction with test
runs as IQC, as in the 1981 WHO definition.

6-1:
To avoid confusion, the term "quality control" will be used here to

mean use of control materials to monitor the accuracy and precision of
all the processes associated with the examination (analytic) phase of
testing.
QC for varying
methods Quality control processes vary,depending on whether the laboratory
examinations use methods that produce quantitative, qualitative or
semiquantitative results. These examinations differ in the following
ways.
Quantitative examinations measure the quantity of an analyte

present in the sample, and measurements need to be accurate and
precise. The measurement produces a numeric value as an end-point,
expressed in a particular unit of measurement. For example, the result
of a blood glucose test might be reported as 5 mg/dL.
Qualitative examinations are those that measure the presence

or absence of a substance, or evaluate cellular characteristics such as
morphology. The results are not expressed in numerical terms, but in
qualitative terms such as “positive” or “negative”; “reactive” or
“nonreactive”; “normal” or “abnormal”; and “growth” or “no growth”.
Examples of qualitative examinations include microscopic
examinations, serologic procedures for presence or absence of
antigens and antibodies, and many microbiological procedures.
Semiquantitative examinations are similar to qualitative

examinations, in that the results are not expressed in quantitative
terms. The difference is that results of these tests are expressed as an
estimate of how much of the measured substance is present. Results
might be expressed in terms such as “trace amount”, “moderate amount”,
or “1+, 2+, or 3+”. Examples are urine dipsticks, tablet tests for ketones
and some serologic agglutination procedures. In the case of other
serologic testing, the result is often expressed as a titre—again
involving a number but providing an estimate, rather than an exact
amount of the quantity present.
Some microscopic examinations are considered semiquantitative

because results are reported as estimates of the number of cells
seen per low-power field or high-power field. For example, a urine
microscopic examination might report 0–5 red blood cells seen per
high-power field.
Because QC processes differ for these various types of

examinations, the presentations for QC will be divided into two
chapters. Chapter 7 will address QC for quantitative examinations, and
Chapter 8 will address QC for qualitative and semiquantitative
examinations.
6-1:

75
6-1:
Elements of Regardless of the type of examination that is performed, steps for

a QC implementing and maintaining a QC programme include:
programme  establishing written policies and procedures, including corrective actions
 training all laboratory staff
 ensuring complete documentation
 reviewing quality control data.
These responsibilities will be described in more detail in Chapters 7 and 8.
 QC is part of the quality management system and is used to

Summa monitor the examination (analytic) phase of testing.
ry  The goal of QC is to detect, evaluate and correct errors due to test
system failure, environmental conditions, or operator performance,
before patient results are reported.
 Different QC processes are applied to monitor quantitative,
qualitative and semiquantitative tests.

7. Process
control—
quality control
for quantitative
tests
7-1:
Role in
quality Quality control (QC) is a
manageme component of process control, Organization Personnel Equipment
nt and is an essential element of the
system quality management system. It
monitors the processes related to
the examination phase of testing
and
allows for detecting errors in the Purchasin
g and
Proces Informatio
testing system. These errors may inventory
s
contro
n
manageme
be due to test system failure, l nt
adverse environmental conditions
or operator performance. QC gives Documen
ts
the laboratory confidence that test Occurrenc
e
and Assessment
results are accurate and reliable record management
before patient results are reported. s
This chapter explains how quality Facilitie

Process Custom
control methods are applied to improveme er
s and
quantitative laboratory nt servic
safety
e
examinations.
Overview
of the Quantitative tests measure the quantity of a substance in a sample,
process yielding a numeric result. For example, the quantitative test for blood
glucose can give a result of 5 mg/dL. Since quantitative tests have
numeric values, statistical tests can be applied to the results of QC
material to differentiate between test runs that are “in control” and “out
of control”.This is done by calculating acceptable limits for control
material, then testing the control with the patient’s samples to see if it
falls within established limits.
As a part of the quality management system, the laboratory must

establish a QC programme for all quantitative tests. Evaluating each test
run in this way allows the laboratory to determine if patient results are
Implementation accurate and reliable.
process
The steps for implementing a QC programme are:
 establish policies and procedures
 assign responsibility for monitoring and reviewing
 train all staff in how to properly follow policies and procedures
 select good QC material
 establish control ranges for the selected material
 develop graphs to plot control values—these are called Levey–Jennings
charts
 establish a system for monitoring control values
7-1:
 take immediate needed
corrective action if  maintain records of QC results and any corrective actions taken.

7-2: Control
Defining control
materials Controls are substances that contain an established amount of the
substance being tested—the analyte. Controls are tested at the same
time and in the same way as patient samples. The purpose of the
control is to validate the reliability of the test system and evaluate the
operator’s performance and environmental conditions that might
Differentiati impact results.
ng
controls It is important not to confuse calibrators and control materials.
and Calibrators are solutions with a specified defined concentration that
calibrator are used to set or calibrate an instrument, kit, or system before
s testing is begun. Calibrators are often provided by the manufacturer of
an instrument. They should not be used as controls since they are
used to set the instrument. Calibrators are sometimes called standards,
but the term calibrator is preferred.They usually do not have the same
consistency as patients’ samples.
It is critical to select the appropriate control materials. Some

Characteristics important characteristics to consider when making the selection
of control
are:
materials
 Controls must be appropriate for the targeted diagnostic test—the
substance being measured in the test must be present in the control in
a measurable form.
 The amount of the analyte present in the controls should be close
to the medical decision points of the test; this means that controls
should check both low values and high values.
 Controls should have the same matrix as patient samples; this usually
means that the controls are serum based, but they may also be based
on plasma, urine or other materials.
Because it is more efficient to have controls that last for some months, it
is best to obtain control materials in large quantities.
Types
and sources Control materials are available in a variety of forms. They may be frozen,
of control freeze- dried or chemically preserved. The freeze-dried or lyophilized
material materials must be reconstituted, requiring great care in pipetting in
order to ensure the correct concentration of the analyte.
Control materials may be purchased, obtained from a central or

reference laboratory, or made in-house by pooling sera from different
patients.
Purchased controls may be either assayed or unassayed. Assayed

controls have a predetermined target value, established by the
manufacturer.When using assayed controls, the laboratory must verify
the value using its own methods. Assayed controls are more
expensive to purchase than unassayed controls.
7-2: Control
either unassayed or “in-house” controls, the laboratory must establish
When using the target value of the analyte.

79
7-2: Control materials
The use of in-house controls requires resources to perform validation

and testing steps. An advantage is that the laboratory can produce very
large volumes with exact specifications.
Remember that QC materials are usually serum based.

Universal precautions should be used when handling.
Choosi When choosing controls for a particular method, select values that
ng cover medical decision points, such as one with a normal value, and
control one that is either high or low, but in the medically significant range.
s
Controls are usually available in "high", "normal" and "low" ranges.
Shown in the graphic are normal, abnormal high and low, and critical high
and low ranges. For some assays, it may be important to include
controls with values near the low end of detection.
PATIENT CONTROLS
? Critical
Critical high
Abnorm N
and low
al range
Normal Normal range

N
Abnorm Abnormal high

al and low ranges
Critical N
Preparing When preparing and storing QC materials, it is important to carefully

and storing adhere to the manufacturer’s instructions for reconstituting and storage. If
control in-house control material is used, freeze aliquots and place in the freezer
material so that a small amount can be thawed and used daily. Do not thaw and
refreeze control material. Monitor and maintain freezer temperatures to
avoid degradation of the analyte in any frozen control material.
Use a pipette to deliver the exact amount of required diluent to

lyophilized controls that must be reconstituted.
7-3: Establishing the value range for the control
material
Assaying control
over time Once the appropriate control materials are purchased or prepared, the
next step is to determine the range of acceptable values for the control
material. This will be used to let the laboratory know if the test run is “in
control” or if the control values are not reading properly—“out of
control”. This is done by assaying the control material repeatedly over
time. At least 20 data points must be collected over a 20–30-day
period. When collecting this data, be sure to include any procedural
variation that occurs in the daily runs; for example, if different testing
personnel normally do the analysis, all of them should collect part of the
data.
Once the data is collected, the laboratory will need to calculate the
mean and standard deviation of the results. A characteristic of repeated
measurements is that there is a degree of variation. Variation may be due
to operator technique, environmental conditions or the performance
characteristics of an instrument. Some variation is normal, even when all
of the factors listed above are controlled. The standard deviation gives a
measure of the variation.This process is illustrated below.
Obtain control material
Run each control

20 times over 30 days
3 SD
2 SD
1SD
Calculate mean and Mea
+ 1, 2, 3 standard
deviations n1
SD
2SD
3SD
One of the goals of a QC programme is to differentiate

between normal variation and errors.
A few theoretical concepts are important because they are used

Characteristi to establish the normal variability of the test system. QC
cs of materials are run to quantify the variability and establish a normal
repeated range, and to decrease the risk of error.
measure
s The variability of repeated measurements will be distributed around a
central point or location. This characteristic of repeated measurements
is known as central tendency.

81
The three measures of central tendency are:

 Mode—the number that occurs most frequently.
 Median—the central point of the values when they are arranged in
numerical sequence.
 Mean—the arithmetic average of results.The mean is the most
commonly used measure of central tendency used in laboratory QC.
Statistic Statistical notations are symbols used in mathematical formulas to

al calculate statistical measures. For this chapter, the symbols that are
notatio important to know are:
ns
 the sum of
 number of data points (results or observations)
X1 individual result
X1 – Xn data point 1–n where n is the last result
X the symbol for the mean
 the square root of the
data. The formula for the mean

Mean
is:
X1 + X2 + X 3... Xn
X= N
As an example of how to calculate a mean, consider enzyme-linked
immunosorbent assay (ELISA) testing. The method is to gather data as
ratios, add the values and divide by the number of measurements.
Before calculating
QC ranges The purpose of obtaining 20 data points by running the QC sample is to
quantify normal variation and establish ranges for QC samples. Use the
results of these measurements to establish QC ranges for testing.
If one or two data points appear to be too high or low for the set of
data, they should not be included when calculating QC ranges.They are
called “outliers”.
 If there are more than 2 outliers in the 20 data points, there is a
problem with the data and it should not be used.
Norm  Identify and resolve the problem and repeat the data collection.
al
distributio If many measurements are taken, and the results are plotted on a graph,
n the values form a bell-shaped curve as the results vary around the mean.
This is called a normal distribution (also termed Gaussian
distribution).

The distribution can be seen if data points are plotted on the x-axis
and the frequency with which they occur on the y-axis.
The normal curve shown (right) is

really a theoretical curve obtained
Frequen
when a large number of
measurements are plotted. It is
cy
assumed that the types of
measurements used for
quantitative QC are normally
distributed based on this theory.
Accuracy and mean

If a measurement is repeated many times,
precision the result is a mean that is very close to the true
mean.
Accuracy is the closeness of a measurement to its true value.
Precision is the amount of variation in the measurements.

 The less variation a set of measurements has, the more precise it is.
 In more precise measurements, the width of the curve is smaller
because the measurements are all closer to the mean.
Bias is the difference between the expectation of a test result and an

accepted reference method.
The reliability of a method is judged in terms of accuracy and precision.
A simple way to portray precision and accuracy is to think of a

Target target with a bull’s eye. The bull’s eye represents the accepted reference
illustration value which is the true, unbiased value. If a set of data is clustered around
the bull’s eye, it is accurate.
The closer together the

hits are, the more Accurate Precise Imprecise
precise they are. If and but
most of the hits are in precise biased
the the bull’s eye, as in the
figure on the left, they are
both precise and accurate.
The values in the

middle figure are
precise but not accurate Accurate = precise but not biased
because they are

clustered together but not at the bull’s eye.The figure on the right shows
a set of hits that are imprecise.
Measurements can be precise but not accurate if the values are close
together but do not hit the bull’s eye.These values are said to be
biased.The middle figure demonstrates a set of precise but biased
measurements.

83
The purpose of quality control is to monitor the accuracy

and precision of laboratory assays before releasing
patient results.
Measures
of The methods used in clinical laboratories may show different variations
variabilit about the mean; hence, some are more precise than others. To determine
y the acceptable variation, the laboratory must compute the standard
deviation (SD) of the 20 control values.This is important because a
characteristic of the normal distribution is that, when measurements are
normally distributed:
 68.3% of the values will fall within –1 SD and +1 SD of the mean
 95.5% fall within –2 SD and +2 SD
 99.7% fall between –3 SD and +3 SD of the mean.
Knowing this is true for all normally shaped distributions allows the
laboratory to establish ranges for QC material.
Once the mean and SD are computed for a set of measurements, a QC

material that is examined along with patients' samples should fall
within these ranges.
Standa SD is a measurement of variation in a set of results. It is very useful

rd to the laboratory in analyzing QC results.
deviatio
n The formula for calculating standard(X 
1 – X)2 is:
SD = deviation
n–1
The number of independent data points (values) in a data set are

represented by “n”. Calculating the mean reduces the number of
independent data points to n – 1. Dividing by n –1 reduces bias.
The values of the mean, as well as the values of + 1, 2 and 3 SDs are
needed to develop the chart used to plot the daily control values.
Calculatin
g  To calculate 2 SDs, multiply the SD by 2 then add and subtract each
acceptabl result from the mean.
e limits  To calculate 3 SDs, multiply the SD by 3, then add and subtract each
for the result from the mean.
control
For any given data point, 68.3% of values will fall between + 1 SD, 95.5%
between

+ 2 SD and 99.7% between + 3 SD of the mean.
When only one control is used, we consider an examination run to be

“in control” if a value is within 2 SD of the mean.
The coefficient of variation (CV) is the SD expressed as a percentage of the

Coefficient of mean.
variation
CV (%) = SD x 100
Mean
The CV is used to monitor precision. When a laboratory changes from
one method of analysis to another, the CV is one of the elements that
can be used to compare the precision of the methods. Ideally, the value
of the CV should be less than 5%.
85
7-4: Graphically representing control
Using
graphs for Once the appropriate range of control values has been established, the
analysis and laboratory will find it very useful to represent the range graphically for
monitoring the purpose of daily monitoring. The common method for this graphing
is the use of Levey–Jennings charts.
Developi In order to develop Levey–Jennings charts for daily use in the

ng data for laboratory, the first step is the calculation of the mean and SD of a
Levey– set of 20 control values as explained in 7-3.
Jennings
charts A Levey–Jennings chart can then be drawn, showing the mean value as
well as
Levey–Jennings + 1, 2, and 3 SD. The mean is shown by drawing a line horizontally in
chart the middle of the graph and the SD are marked off at appropriate
intervals and lines drawn horizontally on the graph, as shown below.
Draw lines for mean and

SD
(calculated from 20 controls)
Chart name: Lot
196.5 number: +3 SD
194.5 +2 SD
192.5 +1 SD
190.5 MEAN
188.5 –1 SD
186.5 –2 SD
184.5 –3 SD
Days
This Levey–Jennings chart was developed using 20 repeated

measurements of the control value. In order to use the Levey–Jennings
chart to record and monitor daily control values, label the x-axis with
days, runs,or other intervals used to run QC. Label the chart with the
name of the test and the lot number of the control being used.
7-4: Graphically representing control

7-5: Interpreting quality control
Plotting control
values A QC sample tested along with patient’s samples can now be used to
determine if daily runs are “in control”. A control sample must be run with
each set of patient samples.
Run the control and plot it on the Levey–Jennings chart. If the value is
within
+2 SD, the run can be accepted as “in-control”.
Draw lines for mean and

SD
(calculated from 20 controls)
Chart name: Lot
196.5 number: +3 SD
194.5 +2 SD
192.5 +1 SD
190.5 MEAN
188.5 –1 SD
186.5 –2 SD
184.5 –3 SD
Days
The values on the chart are those run on days 1, 2 and 3 after the chart
was made. In this case, the second value is “out of control” because it
falls outside of 2 SD.
When using only one QC sample, if the value is outside 2 SD, that run is
considered “out of control” and the run must be rejected.
Number If it is possible to use only one control, choose one with a value that
of controls lies within the normal range of the analyte being tested. When evaluating
used results, accept all runs where the control lies within +2 SD. Using this
system, the correct value will be rejected 4.5% of the time.
In order to improve efficiency and accuracy, a system using two or

three controls for each run can be employed. Then another set of rules
can be used to avoid rejecting runs that may be acceptable. These rules
were applied to laboratory QC by a clinical chemist named James
Westgard. This Westgard multirule system requires running two
controls of different target values for each set of examinations,
developing a Levey–Jennings chart for each, and applying the rules.
The use of three controls with each run gives even higher assurance of
accuracy of the test run. When using three controls, choose a low, a
7-5: Interpreting quality control
normal and a value.There are also Westgard rules for a system with three controls.
high range

87
7-5: Interpreting quality control data
Detecting Errors that occur in the testing process may be either random or
error systematic.
With random error, there will be a variation in QC results that show no

pattern. This type of error generally does not reflect a failure in some
part of the testing system, and is therefore not like to reccur.
Random error is only a cause for rejection of the test run if it
exceeds +2 SD.
Systematic error is not acceptable, as it indicates some failure in the

system that can and should be corrected. Examples of evidence of
systematic error include:
 shift—when the control is on the same side of the mean for five
consecutive runs;
 trend—when the control is moving in one direction, and appears to be
heading toward an out-of-control value.
Even when a control value falls within 2 SD, it can be a cause for concern.
Shifts and Levey– Jennings charts can help distinguish between normal variation
trends and systematic error.
Shifts in the mean occur when an abrupt change is followed by

six or more consecutive QC results that fall on one side of the mean,
but typically within 95% range as if clustered around a new mean. On
the sixth occasion this is called a shift and results are rejected.
Trends occur when values gradually, but continually, move in one

direction over six or more analytical runs. Trends may display values
across the mean, or they may occur only on one side of the mean. On
the sixth occasion, this is determined to be a trend and results are
rejected.
Measureme
nt The source of the problem must be investigated and corrected before
uncertaint patients’ samples are reported.
y
As variation occurs in measurements, uncertainty exists as to the true
value. Uncertainty represents a range of values in which the true value
is reasonably expected to lie. In most situations, measurement
uncertainty is estimated at “95% coverage”. For most instances, a
range of +2 SD is accepted as measurement uncertainty that is
explained by random variation.
But the degree of variation also depends on the method used. Methods
that are more precise have less uncertainty because the amount of
variation included in the 95% limits is smaller.
Laboratories should strive to use methods that have a high degree of

precision, and always follow standard operating procedures.
7-6: Using quality control
When QC is out
of range When the QC sample that is used in a test run is out of the
acceptable range, the run is considered to be “out of control”.When
this happens, there are several steps that the laboratory must
follow.
 The testing process should be stopped and the technologist must
immediately try to identify and correct problems.
 Once possible sources of error have been identified and corrections
have been made, the control material should be rechecked. If they
read correctly, then patient samples, along with another QC
specimen, should be repeated. Do not simply repeat the testing
without looking for sources of error and taking corrective action.
 Patient results must not be reported until the problem is
Proble resolved and the controls indicate proper performance.
m
solvin When attempting to solve QC problems, it is useful to have established
g policies and procedures for remedial action. Often, manufacturers of
either equipment or reagents will provide guidelines that can be helpful.
Use any troubleshooting guides that are available.
Possible problems to consider include:

 degradation of reagents or kits
 control material degradation
 operator error
 failure to follow manufacturer’s instructions
 an outdated procedure manual
 equipment failure
 calibration error.
7-6: Using quality control Laboratory Quality Management System
89
7-7:
Summary
A QC programme for quantitative tests is essential to ensuring
accuracy and reliability of laboratory testing. The laboratory must
establish a QC programme that monitors all quantitative tests.The
programme will have written policies and procedures that are followed
by all laboratory staff.
The overall responsibility of managing the QC programme is usually

assigned to the quality manager, who monitors and reviews all QC data
on a regular basis.The recording of the QC data must be complete
and easy to access.
For quantitative testing, statistical analysis can be used for the monitoring
process, and the use of Levey–Jennings charts provides a very useful
visual tool for this monitoring.
When controls are out of range, corrective action and troubleshooting

must be undertaken; the problem must be fixed before reporting patient
results.Therefore, good protocols for troubleshooting and corrective
Key messages action are an important part of the QC process.
 A QC programme allows the laboratory to differentiate between

normal variation and error.
 The QC programme monitors the accuracy and precision of laboratory
assays.
 The results of patient testing should never be released if the QC
results for the test run do not meet the laboratory target values.
7-7:

8. Process
control—
quality control
for qualitative and
semiquantitative
procedures
8-1 : Overview
Quality control (QC) is a
Role in component of process control,
quality which is a major element of
manageme the quality management
nt system. It monitors the processes
system related to the examination phase Purchasing
of testing and allows for detecting

Process
errors in the testing system. a
n
control
These errors may be due to test Semiquant d
system failure, adverse itative
i
environmental conditions or examinati n
Occurrence
operator performance. QC gives ons are v
management
e
the laboratory confidence that test similar to n
results are accurate and reliable qualitative t
o
before patient results are examinati r
reported. ons; y Customer
service
testing
This chapter explains how QC does not
D
methods are applied to measure o
qualitative and semiquantitative the c
u
laboratory examinations. precise m
Qualitative e
n
and t
semiquantitati Qualitative examinations are s
a
ve those that measure the presence n
examination or absence of a substance, or d
r
s evaluate cellular characteristics e
such as morphology. The c
o
results are not expressed in r
numerical terms, but in d
s
descriptive or qualitative terms
such as “positive”, “negative”,
“reactive”, “nonreactive”, “normal”
or “abnormal”. Pr
oc
es
Examples of s
im
qualitative pr
examinations include ov
em
microscopic examinations for en
cell morphology or presence of t
parasitic organisms, serologic

procedures for presence or
absence of antigens and
antibodies, some microbiological
procedures and some molecular
techniques.
Information Assessment Facilitie
management s and
safety

8-1: Overview
quantity of a substance.The difference is that results of these tests are

expressed as an estimate of how much of a measured substance is
present. This estimate is sometimes reported as a number. Therefore,
test results for semiquantitative tests may be shown as “trace
amount”,“1+, 2+ or 3+”, or positive at 1:160 (titre or dilution).
Examples of semiquantitative examinations are urine dipsticks, tablet tests
for ketones and serological agglutination procedures.
Some microscopic examinations are considered semiquantitative

because results are reported as estimates of the number of cells seen
per low-power field or high- power field. For example, a urine
microscopic examination might report 0–5 red blood cells seen per
high-power field.
Importa
nt As with quantitative procedures, it is important to verify that results of
concept qualitative and semiquantitative examinations are correct prior to
s reporting them to the requesting health care provider.
Conducting QC for many of these tests is not as easily accomplished

as with quantitative tests.Therefore, it becomes essential that other
processes within the quality system are carefully conducted, in addition
to traditional QC methods. Following are some important overarching
concepts for quality that apply to qualitative and semiquantitative
tests.
 Sample management is important in all laboratory testing. Examinations
that are dependent on a viable organism in the sample may need
closer monitoring and better communication with nonlaboratory
staff (see Chapter 5).
 Dedicated, professional staff who understand the principles of QC are
key to quality.
 Incubators, refrigerators, microscopes, autoclaves and other
equipment must be maintained and monitored carefully (see
Chapter 3).
 Positive and negative controls must be used to monitor the effectiveness
of test procedures that use special stains or reagents and tests with
end-points such as agglutination, colour change or other non-numeric
results.
 Reagents should be stored according to the manufacturer’s instructions,
labelled with the date they are opened and put into use, and discarded at
the expiration date (see Chapter 4).
 Keeping records of all QC processes and corrective actions is
necessary for continual improvement of the laboratory quality
system (see Chapter 16).
 When problems occur, investigate, correct, and repeat patient testing
(see Chapter 14).
If QC results are not what are expected, do not report

patient results.
93
8-2 : Quality control materials
Qualitative and semiquantitative examinations include tests that utilize a
Control
variety of control materials.These controls may be built-in (on-board or
types procedural) controls, traditional controls that mimic patient samples, or
stock cultures for use with microbiological examinations.
Built-in controls are those that are integrated

Built-
in into the design of a test system such as a test kit
control device.Usually,the device is marked with
s designated areas where coloured lines, bars or
dots should appear to indicate success or
failure of positive and negative controls, and
these controls are performed automatically with
each test.The manufacturer’s product
instructions may also refer to these as
procedural controls, on-board controls or
internal controls.
Most built-in controls monitor only a portion of the

examination phase, and they vary from one test to another as to what
is being monitored. For example, built-in controls for some kits may
indicate that all the reagents impregnated into the device are active
and working properly, whereas built-in controls for other kits may only
indicate that a sample was added and solutions flowed through the
device correctly. It is important to carefully read the instructions provided
by the manufacturer to understand what the built-in controls monitor,
and to determine whether additional controls may be needed.
Examples of test kits with built-in controls are rapid tests that
detect the presence of antigens or antibodies, such as those for
infectious disease (human immunodeficiency virus [HIV], influenza,
lyme disease, streptococcal infection, infectious mononucleosis), drugs of
abuse, pregnancy or faecal occult blood.
Even though these built-in controls give some degree of confidence, they
do not monitor for all conditions that could affect test results. It is advisable
to periodically test traditional control materials that mimic patient samples,
for added confidence in the accuracy and reliability of test results.
Tradition In some settings, these built-in controls are referred to

al as internal controls.
control
s
Traditional control materials are made to mimic patient samples and they
are tested with the patient samples to evaluate the examination
component. Positive controls have known reactivity and negative controls
are nonreactive for the analyte being tested. The controls should have
the same samples, including viscosity, turbidity and colour, in order to properly
composition, or evaluate the test performance. Control materials are often lyophilized
matrix, as when received, and need to be carefully reconstituted before use.
patient Some manufacturers may provide

8-2: Quality control materials
these controls with their test kits but, more frequently, they need to be
purchased separately.
Traditional controls evaluate the testing process more broadly than built-
in controls. They assess the integrity of the entire test system, the
suitability of the physical testing environment (temperature, humidity,
level workspace), and whether the person conducting the test
performs it correctly.
Positive and negative controls are recommended for many

qualitative and semiquantitative tests, including some procedures that
use special stains or reagents, and tests with end-points such as
agglutination or colour change. These controls should generally be used
with each test run. Use of controls will also help to validate a new lot
number of test kits or reagents, to check on temperatures of storage
and testing areas, and to evaluate the process when new testing personnel
are carrying out the testing.
Things to keep in mind when using traditional controls for

qualitative or semiquantitative tests are:
 test control materials in the same manner as testing patient samples;
 use a positive and negative control, preferably once each day of testing,
or at least as often as recommended by the manufacturer;
 choose positive controls that are close to the cut-off value of the test, to
be sure the test can detect weak positive reactions;
 for agglutination procedures, include a weak positive control as well as a
negative control and a stronger positive control;
 for tests with an extraction phase, such as some rapid group A
Streptococcus tests, choose controls that are capable of detecting
errors in the extraction process.
Stoc
k QC in microbiology requires use of live control organisms with
culture predictable reactions to verify that stains, reagents and media are
s working correctly. They must be kept on hand and carefully
maintained in the form of stock and working cultures. For each
reaction, organisms with both positive and negative results should
be tested.
The following organizations offer reference strains, which are available

from local distributors:
 American Type Culture Collection (ATCC)
 National Type Culture Collection (NTCC, United Kingdom)
 Pasteur Institute Collection (CIP, France).
Purchased reference strains are usually lyophilized and kept in the

refrigerator. Once they are reconstituted, plated and checked for purity,
they can be used to make working cultures for quality control.
Some laboratories may choose to use isolates from their own

laboratories for should be monitored closely to verify that reactions tested are sustained
QC. If so, they over time.

95
8-3 : Quality control of stains
Procedur In performing many qualitative and semiquantitative procedures, stains are
es using needed for evaluating microscopic morphology of cells, parasites or
stains microbes, or to determine their presence or absence. Stains are used
for microscopic procedures that provide information for either preliminary
or definitive diagnosis. These are frequent in haematology, urinalysis,
cytology, histology, microbiology, parasitology and other laboratory
areas.
In microbiology, permanent stains such as acridine orange, trichrome

and iron- haematoxylin for faecal parasites, and Giemsa stain for
malaria, are frequently used. Gram stains are used for identification of
bacteria and yeast from colonies and samples. Acid-fast stains are
particularly important for preliminary diagnosis, since growth of
mycobacteria takes several weeks. In many sites, Mycobacterium
tuberculosis (TB) cultures are not available and acid-fast smears will
provide the final diagnosis for patients. For wet mounts, iodine solutions
are used to detect cysts and eggs in faecal samples, and potassium
hydroxide preparations are used to detect fungal elements.
Examination of blood smears requires a

stain that allows for clear visualization of red
blood cells, white blood cells, platelets and
inclusions within cells. Differentiation of
cells in blood most frequently employs a
Wright stain, and some haematology
procedures use special stains to help
differentiate infection from leukaemia.
Cytology and histology tests require a wide

variety of stains that provide valuable information for diagnosis. Many
other stains are available to laboratory staff for special uses.
The common elements for QC are the same: the stains should be
prepared and stored properly, and checked to be sure they perform as
expected. Remember that many of the microscopic examinations
Stai that rely on stains are critical in diagnosis of many diseases.
n
manageme Some stains can be purchased commercially, but others must be
nt prepared by the laboratory, following an established procedure. Once
stains are made, their bottles should be labelled with the following
information:
 name of the stain
 concentration
 date prepared
 date placed in service
 expiration date/shelf life
 preparer’s initials.

8-3: Quality control of stains
It may be useful to keep a logbook for recording information on each

stain in use, including the lot number and date received. The expiration
date must be noted on the label. Some stains deteriorate and lose their
ability to produce the correct reactions.
Stains should be stored at the correct temperature at all times and in an

appropriate staining bottle. Some stains must be protected from light. In
some cases, working solutions can be made from stock solutions. If so,
storage of working solutions should be carefully monitored.
Qualit Because of their importance, stains should be checked each day of

y use with positive and negative QC materials, to make sure their
contr reagents are active and they provide the intended results. In most
ol cases, positive and negative controls should be stained with each batch
of patients’ slides. All QC results must be recorded each time they
are run.
Stains should also be examined to look for precipitation or crystal

formation, and to check for bacterial contamination. Careful maintenance
and care of the stock and working solutions of stains is an essential
component in a system to provide good quality in microscopic
examinations.
Be aware that many stains are toxic, therefore, take

appropriate safety precautions when working with them.
97
8-4 : Quality control of microbiological media
QC is essential The quality of media used in the microbiology laboratory is crucial to
for media achieving optimal and reliable results. Some media are essential to
isolation of microbes, so it is imperative that they function as expected.
QC procedures provide the confidence that media has not been
contaminated prior to use, and that it supports the growth of the
organism with which it was inoculated.
Verifyin
g The performance characteristics of all media used in the laboratory
performan must be verified by the appropriate QC methods. For media that is
ce prepared in-house, this evaluation must be conducted for each batch
prepared; for all commercially prepared media, the performance verification
will be performed for each new lot number.
In all cases, in-house and purchased media should be carefully checked for:
 sterility—incubate overnight before use
 appearance—check for turbidity, dryness, evenness of layer, abnormal
colour
 pH
 ability to support growth—using stock organisms
 ability to yield the appropriate biochemical results—using stock
organisms.
Use of The laboratory must maintain sufficient stock organisms to check all its
control media and test systems. Some examples of important stock organisms,
organisms and the media checked, include:
for  Escherichia coli (ATCC 25922): MacConkey or eosin methylene
verificatio blue (EMB), some antimicrobial susceptibility testing;
n  Staphylococcus aureus (ATCC 25923): blood agar, mannitol salt
and some antimicrobial susceptibility tests;
 Neisseria gonorrhoeae (ATCC 49226): chocolate agar and Thayer–Martin
agar.
8-4: Quality control of microbiological media
For selective media, inoculate a control organism that should be inhibited

as well as one that should grow. Discard any batch of media that
does not work as expected.
For differential media, inoculate the media with control organisms that
should demonstrate the required reactions. For example, inoculate
both lactose- fermenting and non-lactose-fermenting organisms onto
EMB or MacConkey agar to verify that the colonies exhibit correct
visual appearance.
Note: sheep and horse blood are preferred in preparing media for
routine cultures. Blood agar made from human blood should not be
used as it will not demonstrate the correct haemolysis pattern for
identification of certain organisms, and it may contain inhibitory
substances. In addition, human blood can be biohazardous.
In-house
media It is important to keep careful records for media that is prepared in the
preparati laboratory. A logbook should be maintained that records:
on  date and preparer's name
records  name of the medium, the lot number and manufacturer
 number of prepared plates, tubes, bottles or flasks
 assigned lot and batch numbers
 color, consistency and appearance
 number of plates used for QC
 sterility test results at 24 and 48 hours
 growth test(s)
 pH.
99
8-5 : Summary
Examinatio Qualitative and semiquantitative examinations are those that give non-
ns with non- numerical results. Qualitative examinations measure the presence or
numerical absence of a substance, or evaluate cellular characteristics such as
results morphology. Semiquantitative examinations provide an estimate of
how much of the measured substance is present.
Qualitative and semiquantitative testing must be monitored by QC

processes. These processes should use controls that mimic patient
samples as much as possible. Quality controls that check kits,
reagents, stains and microbiological media and ensure that they work
as expected must be used whenever they are available.
The laboratory must establish a QC programme for all of its

qualitative and semiquantitative tests. In establishing this programme, set
policies, train staff and assign responsibilities, and ensure that all
resources needed are available. Make sure that recording of all QC data
is complete, and that appropriate review of the information is carried
out by the quality manager and the laboratory director.
Key  All staff must follow the QC practices and procedures.

 Always record QC results and any corrective actions that are taken.
messages
 If QC results are not acceptable, do not report patient
results.
9. Assessment—
audits
9-1 : Overview Organization Personnel Equipment
Role in Assessment is an important

quality element of the 12 quality system
manageme essentials. It is the
nt
system means for determining the Purchasin
g and
Proces Informatio
effectiveness of a laboratory’s inventory
s
contro
n
manageme
quality management system l nt
through internal and external
audits, and evaluation of Documen
ts
performance in an external quality Occurrenc
e
assessment (EQA)
and Assessment
programme. This chapter is record management
focused on descriptions of internal s
and external audits; EQA will be

described in
Chapter 10. Process Custom
Facilitie
s and
improveme er
safety
nt servic
e
What
is An assessment can be defined as the systematic examination of
assessme some part (or sometimes all) of the quality management system to
nt? demonstrate to all concerned that the laboratory is meeting regulatory,
accreditation and customer requirements. Central-level laboratories are
generally familiar with assessment processes, as most will have had some
kind of assessment by an external group. However, intermediate or
peripheral-level laboratories may not be assessed very often in
resource-limited countries.
Accepted standards, whether international, national, local, or standards

from accrediting organizations, form the basis for laboratory
assessment. In that respect, assessment is interrelated with norms and
accreditation (Chapter 11).
In an assessment, someone is asking the following questions:

 What procedures and processes are being followed in the laboratory;
what is being done?
 Do the current procedures and processes comply with written
policies and procedures? And in fact, are there written policies and
procedures?
 Do written policies and procedures comply with standards,
Why perform regulations, and requirements?
an
assessme Assessments are performed in a variety of ways and under a number of
nt? different circumstances.The International Organization for
Standardization (ISO) standards are very specific about assessment
requirements, and the term “audit” is used instead of “assessment”. The
terms may be usage will determine the actual terminology required.The ISO definition
considered for audit is a “systematic, independent and documented process for
interchangeable obtaining evidence and evaluating it objectively to determine the extent
, and local to which required criteria are fulfilled.”

9-1:
An assessment, or audit, allows the laboratory to understand how

well it is performing when compared to a benchmark or standard.
Any gaps or nonconformities in performance can show if the policies
and procedures that the laboratory has set require revision or are not
being followed.
A laboratory needs this information about its performance for:

 planning and implementing the quality system
 monitoring effectiveness of the quality system
 correcting any deficiencies that are identified
 working toward continuous improvement.
External Assessments conducted by groups or agencies from outside the

and internal laboratories are called external audits. They can include
audits assessments for the purpose of accreditation, certification or licensure.
Another type of assessment that laboratories can utilize is the

internal audit, where staff working in one area of the laboratory
conduct assessments on another area of the same laboratory.This
provides information quickly and easily on how the laboratory is
performing and whether it is in compliance with policy requirements.
Test
The patient lectio
sen Sample collection
P
Sample transport
Laboratory analysis Examination phase
Report creation
Report transport
Audits should include the evaluation of steps in the whole

Laboratory laboratory path of workflow.They should be able to detect problems
path of throughout the entire process.
workflow
9-1:

103
9-1:
Auditin The value of a well-designed audit is that it will reveal weaknesses in

g the pre- examination, examination and post-examination phases. During
audits, information is gathered about:
 processes and operating procedures
 staff competence and training
 equipment
 environment
 handling of samples
 quality control and verification of results
 recording and reporting practices.
The findings are compared with the laboratory’s internal policies

and to a standard or external benchmark.Any breakdown in the system
or departure from procedures will be identified.

9-2 : External audit
Extern Assessments conducted by groups or agencies from outside the
al laboratory are called external audits. Some examples of external
audit auditors are described below.
s
 Health authorities may assess laboratories to evaluate the quality of
performance, or compliance with licensing requirements and national
regulations. They may also assess as part of a capacity strengthening
plan of action, or for public health programme needs.
 Accreditation bodies are organizations that provide accreditation
or certification. When a laboratory seeks accreditation, an initial audit will
be required to evaluate compliance with standards. In order to maintain
accredited status, the accreditation bodies will require periodic audits
(see Chapter 11).
 An audit may be requested by major public health programmes, or by
agencies that provide funding for programmes.These groups want to
ensure that quality standards are being met and that quality
practices are in place. International programmes such as the World
Health Organization (WHO) Polio Initiative regularly assess disease-
specific laboratories according to their own standards with their own
checklists; for example, WHO polio laboratory accreditation standard
and WHO measles accreditation standard.
Standards
In conducting external audits, the assessors will verify that laboratory
policies, processes and procedures are documented and comply with
designated standards. Different standards can be used for the
assessment processes, ranging from international standards to a
locally developed checklist.
Laboratory management must demonstrate to the assessment

Preparation team that all requirements as laid down in the standard are being
followed.
When a laboratory undergoes an external audit, the laboratory needs to

be fully prepared so that the assessment experience is as easy as
possible for both the assessors and the laboratory staff, and so the
assessment yields the maximum amount of information.
To be ready for the external audit, it is necessary to:

 plan thoroughly and carefully;
 organize everything ahead of time, including documents and
records, to save valuable time during the audit;
 make all staff aware of the audit, and arrange schedules so that all staff
needed for the audit will be available.
On occasion, some external audits might occur without prior

notification. In this case, the laboratory would not be able to make
special the laboratory should always be sure its system is operating properly.
preparation, so

105
9-2: External audit
Audit report After the audit, the recommendations of the assessors are often
and plan of presented as a verbal summary to the laboratory management and staff,
action which are then followed by a thorough written report. After the external
audit has been completed the laboratory should:
 review the recommendations of the assessors;
 identify gaps or nonconformities, learning where benchmarks or
standards were not fully met;
 plan to correct the nonconformities—this will result in a plan for all
needed corrective actions to be taken by the laboratory, which should
include a timeline, as well as indicate who is responsible for doing
the work;
 record all results and actions taken so that the laboratory has a
permanent record of the event—often a written report is useful for
preserving all information.
9-3 : Internal audit
Purpos Most technologists in central-level laboratories are relatively familiar
e with external audits; however, the idea of conducting internal audits might
be new to some people.
An internal audit allows the laboratory to look at its own

processes. In contrast to external audits, the advantages of
internal audits are that laboratories can perform them as frequently
as needed, and at very little or no cost. Internal audits should be a
part of every laboratory quality system, and are a requirement of ISO
standards.1
The audits should be conducted regularly and when problems that

need to be studied have been identified. For example, internal audits
should be performed after receiving a poor performance on a
proficiency testing survey, after an increased number of unexpected
abnormal results for a particular test, or after an increase in
expected turnaround time.
Value of
an internal The internal audit is a valuable tool in a quality management system. An
audit internal audit can help the laboratory to:
 prepare for an external audit;
 increase staff awareness of quality system requirements;
 identify the gaps or nonconformities that need to be corrected—
the opportunities for improvement;
 understand where preventive or corrective action is needed;
 identify areas where education or training needs to occur;
 determine if the laboratory is meeting its own quality standards.
Internal audit ISO standards put much emphasis on internal audits, and for those
and seeking accreditation under ISO, internal audits are required. ISO
ISO requirements state that:
 the laboratory must have an audit programme;
 the auditors should be independent of the activity;
 audits must be documented and reports retained;
 results must be reported to management for review;
 problems identified in the audits must be promptly addressed and
appropriate actions taken.
1 ISO 19011:2002. Guidelines for quality and/or environmental systems auditing. Geneva, International Organization for
107
Responsibilities 108
Process
Select
areas
for
audits
Establish
a
schedul
e
9-4 : the process. The follow-up activities will also usually be the responsibility
of the quality manager, and these include managing all corrective action
Internal efforts. The quality manager must be sure that laboratory management
audit and the laboratory staff are fully informed about outcomes of the
programme audit.
The laboratory The commitment of laboratory management and the

director is quality manager will be key to successfully establishing
responsible for a process for internal audits.
setting overall
policies for the The quality manager or other designated qualified personnel should
internal audit organize the internal audit following these steps:
programme.  develop a formal plan
Responsibilities  prepare a checklist based on selected guidelines or standards
will include  meet with all staff and explain the audit process
assigning  select staff to serve as auditors
authority for  collect and analyze information
the  share results with staff
programme  prepare a report
(usually to the  present the report to management
quality  retain the report as a permanent laboratory record.
manager) and
supporting the In order to facilitate the internal audit process, it is useful to keep it simple.
corrective Focus on defined areas of the laboratory activities, identified by issues such
action as customer complaints or quality control problems. Narrowing the
measures that audit to the specific corresponding process will save time and energy.
are indicated. Perform short and frequent audits rather than initiating an annual
It is essential comprehensive and overwhelming effort.
that the
laboratory ISO 15189:2007 [4.14.2] states: “The main elements of the quality
director be management system should normally be subject to internal audit once
fully informed every twelve months”. This requirement does not mean that a complete
about the audit needs to be done annually. Rather, it means that over a period of a
results of all year, every part of the laboratory should have at least one inspection. Doing
internal audits. a number of small, bench-specific or section- specific audits is much easier
The quality than trying to do them all at the same time.
manager is
responsible for Establish a policy that, at specified intervals, some section of the laboratory
organizing and or a specific process will have an internal audit. In general, audit regularly
managing the and consider three to six-month intervals between audits. If audits reveal
laboratory specific problems, it may be necessary to include more frequent audits.
internal audit
programme.
This includes
setting a
timeframe for
the audits,
choosing and
training the
auditors, and
coordinating
9-4: Internal audit programme
Checklists When developing checklists for internal audits:

and  Take into account any established national policies and standards. For
forms example, most countries have standards for human
used immunodeficiency virus (HIV) and tuberculosis testing; laboratories
conducting this testing need to ensure checklists reflect these
standards.
 Ensure checklists are easy to use and include areas for recording
information.
 Focus on specific tests or processes; whatever the area of focus,
address all areas of the quality system. If auditing enzyme-linked
immunosorbent assay (ELISA) tests, consider personnel competency
or equipment maintenance, sample handling, and quality control
associated with these tests.
Select Forms will be needed for recording corrective actions and for making
auditors reports.
When the laboratory initializes an internal audit programme, selection of

auditors is one of the first steps to address. It is very important, and
required by ISO standards, that the auditors are independent of the area
audited. Some things to consider are:
 The availability of staffing and level of technical expertise—
depending on the area for auditing, there might be many kinds of
personnel who would be appropriate for conducting the audit; for
example, if the laboratory is looking at safety issues, a hospital
safety expert, or even a housekeeping expert might be
appropriate.
 Whether to hire a consultant—this could still be conducted as an
internal audit: the audit is planned by the laboratory itself, without
any external constraints, but consultants or peers recruited by the
laboratory for this specific audit will help the laboratory staff to
conduct it.
Important
skills for Any knowledgeable person in the laboratory can perform
auditors internal audits, not just the manager or supervisor.
When deciding the personnel to choose for the audit process, take into
account the skills that will be needed for a good result. A good
auditor will:
 pay attention to details—for example, check expiry dates, open and
inspect refrigerators and storage areas;
 be able to communicate effectively, but also diplomatically—
diplomacy is an important skill, since it is easy to imply criticism during
an audit process.
The auditors chosen must have the technical skills needed to evaluate
the area being audited, and must have a good understanding of the
laboratory’s quality management system. Some staff may have specialized
expertise in a limited area, such as sample transport or housekeeping,
but could serve these areas. Some in-house training on how to conduct an audit should
as auditors in be provided to those who will serve as auditors.

If auditors are poorly chosen, the audits will be much less effective.
9-5 : Actions as result of audit
Audits
should lead Audits should lead to actions—this is why laboratories conduct them, to
to actions further the process of continual improvement in the laboratory.
Audits identify opportunities for improvement (OFIs). Both

preventive and corrective actions are steps taken to improve a process
or to correct a problem.
A record of OFIs should be kept, along with actions that are taken.
Preventive and corrective actions should be carried out within an
agreed-upon time. Normally the quality manager is responsible for
initiating actions.
Proble
m
Sometimes the cause of the problem is not obvious or easily found; in
solvin
such cases a problem-solving team may be necessary to:
g
 look for root causes;
 recommend the
appropriate corrective action;
 implement the actions
decided upon;
 check to see if the corrective
actions are effective;
 monitor the procedures over time.
All actions and findings from the

monitoring should be recorded so
the laboratory can learn from its
activities.
Continuo
us
Continuous monitoring is the
monitorin
key element to success in the
g
quality system. It is through this
process that we are able to
achieve the continual
improvement that is our overall Quality
goal. improveme
Monitoring nt plan
and
evaluation
customer
satisfaction
quality control
proficiency
testing
audit Continuous
quality
improveme
nt
Corrective
action

9-6 : Summary
Summa Assessment is important in monitoring the effectiveness of the
ry laboratory quality management system. Both external and internal
audits yield useful information. Audits are used to identify problems
in the laboratory, in order to improve processes and procedures. An
outcome of assessment is finding root causes of problems and taking
corrective actions.
Ke  All laboratories should establish an internal audit programme.

y Conducted on a regular basis, it will provide information for continual
messag improvement.
es  Problems become opportunities for improvement.
111
10. Assessment
— external
quality
assessment
10-1 : Overview
Role in Assessment is a critical aspect
quality of laboratory quality
manageme management, and it can be
nt conducted in several ways. One
system of the commonly employed
assessment methods is that of Purchasing
external quality assessment

(EQA).
and Proces Information
s management
inventor
contro
y l
Documen Occurrence
ts and management
records Assessment
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Definition
The term EQA is used to describe a method that allows for
of comparison of a laboratory’s testing to a source outside the
EQA laboratory. This comparison can be made to the performance of a
peer group of laboratories or to the performance of a reference
laboratory. The term EQA is sometimes used interchangeably with
proficiency testing; however, EQA can also be carried out using
other processes.
EQA is here defined as a system for objectively

checking the laboratory’s performance using an
external agency or facility.
Types of
EQA Several EQA methods or processes are commonly used.These include:
1. Proficiency testing—external provider sends unknown samples
for testing to a set of laboratories, and the results of all
laboratories are analyzed, compared and reported to the
laboratories.
2. Rechecking or retesting—slides that have been read are
rechecked by a reference laboratory; samples that have been
analyzed are retested, allowing for interlaboratory
comparison.
3. On-site evaluation—usually done when it is difficult to conduct
traditional proficiency testing or to use the rechecking/retesting
method.
Another is the exchange of samples among a set of laboratories, usually
method of reserved for specialized tests for which no proficiency testing is
interlaborat available. This method is used by very specialized or sophisticated
ory laboratories and therefore will not be further discussed in this
comparison chapter.

10-1:
EQA Participation in an EQA programme provides valuable data and information,

benefits which:
 allows comparison of performance and results among different test sites;
 provides early warning for systematic problems associated with
kits or operations;
 provides objective evidence of testing quality;
 indicates areas that need improvement;
 identifies training needs.
EQA helps to ensure customers, such as physicians, patients and health

authorities, that the laboratory can produce reliable results.
Individual laboratories can use EQA to identify problems in laboratory

practices, allowing for appropriate corrective action. EQA participation will
help to evaluate reliability of methods, materials and equipment, and to
evaluate and monitor training impact.
For laboratories performing public health–related testing, EQA can help to

ensure that results from different laboratories during surveillance activities
are comparable. EQA participation is usually required for accreditation.
Also, EQA participation creates a network for communication, and can
be a good tool for enhancing a national laboratory network. Samples
received for EQA testing, as well as the information shared by the EQA
provider, are useful for conducting continuing education activities.
Princip
al EQA programmes vary, but principal characteristics include the following:
characteristi  EQA programmes can either be free of charge or require a fee.
cs of an Free EQA programmes include those offered by a manufacturer to
EQA ensure equipment is working correctly, and those organized by a
scheme regional or national programme for quality improvement.
 Some EQA programmes are obligatory, either required by an
accrediting body or by law. Others are voluntary, and the quality
manager may choose to voluntarily participate in an EQA programme
in order to achieve improvement in the quality of the laboratory’s
performance.
 The EQA programme can be organized at different levels: regional,
national or international.
 Individual laboratory results are kept confidential, and generally are
only known by the participating laboratory and the EQA provider. A
summary is generally provided and allows comparison to the
overall group.
10-1:

115
10-1:
 Some EQA schemes may address a single disease; for example,

the EQA programme for tuberculosis. Others may address many
kinds of laboratory tests, looking at the overall testing performance
for microbiology. An example of this multidisease or test
programme is the national microbiology EQA in France, which is
obligatory.
Successful performance in an EQA programme reflects the

effectiveness of the laboratory’s quality management, and allows for
recognition of laboratory quality by external groups.
EQA is important for improvement of the laboratory

quality management system, as it is a measure of
laboratory performance.
10-1:
10-2 : Proficiency testing
Definitio Proficiency testing, or PT, has been in use by laboratories for many years. It
ns is the most commonly employed type of EQA, as it is able to address
many laboratory methods. PT is available for most of the commonly
performed laboratory tests, and covers a range of chemistry,
haematology, microbiology and immunology testing. Most laboratorians
are familiar with the PT process, and many laboratories employ some
kind of PT.
Standards organizations recognize the importance of this tool, and the

following are examples of formal definitions that are in use.
• ISO/IEC Guide 43-1:1997:“Proficiency testing schemes (PTS) are
interlaboratory comparisons that are organized regularly to assess the
performance of analytical laboratories and the competence of the
analytical personnel”.
• Clinical and Laboratory Standards Institute: “A program in which
multiple samples are periodically sent to members of a group of
laboratories for analysis and/or identification; whereby each laboratory’s
results are compared with those of other laboratories in the group and/or
with an assigned value, and reported to the participating laboratories
Proficienc and others”.
y testing
process In the PT process, laboratories receive samples from a PT provider.This
provider may be an organization (non-profit or for-profit) formed
specifically to provide PT. Other providers of PT include central
reference laboratories, government health agencies, and manufacturers
of kits or instruments.
In a typical PT programme, challenge samples are provided at regular

intervals. An optimal frequency will be 3–4 times yearly. If the
programme cannot provide challenges with this frequency, the
laboratory may be able to seek additional sources.
The laboratories participating in the programme analyze the samples

and return their results to the central organization. Results are evaluated
and analyzed, and the laboratories are provided with information
about their performance and how they compared with other
participants. The participating laboratories use the information
regarding their performance to make appropriate changes and
Role of improvements.
the
laborator To be successful, PT instructions must be followed carefully, all
y paper work completed accurately and results submission deadlines
met. All PT results, as well as corrective actions, should be recorded and
the records maintained for an appropriate period of time.
117
10-2 : Proficiency testing
PT is a tool to measure laboratory performance. Therefore, there must

be no difference in the treatment of PT samples and the patient’s sample.
PT providers make every effort to produce samples that exactly mimic,
or closely resemble, usual samples received from patients. PT samples
must be processed by normal testing method(s) and involve personnel
who routinely perform the testing.
When PT is used for any purpose other than internal quality

improvement, the provider or central organization generally prohibits
the discussion of results with other laboratories. Some PT organizers
send different samples to different groups of laboratories to avoid
interlaboratory discussion.
PT participation is valuable only if the information

received is directed to improvement in the laboratory.
Limitatio It is important to remember that PT does have some limitations and

ns it is not appropriate to use PT as the only means for evaluating the
quality of a laboratory. PT results are affected by variables not related
to patient samples, including preparation of the sample, matrix effects,
clerical functions, selection of statistical methods of evaluation, and peer
group definition. PT will not detect all problems in the laboratory,
particularly those that address the pre-examination and post-
examination procedures.
A single unacceptable result does not necessarily indicate that a

problem exists in the laboratory.
10-3 : Other external quality assessment methods
Using other In situations where it is difficult to provide appropriate external
EQA samples, or sometimes when normal laboratory quality control
metho methods cannot be applied, other procedures have been developed and
ds used for EQA.The primary examples and their uses are as follows:
 Rechecking/retesting has been used traditionally for EQA for
microscopic slides for acid-fast bacilli (AFB), and for human
immunodeficiency virus (HIV) rapid testing. It can also be used in
other situations, but is not usually employed if traditional PT is
feasible.
 On-site evaluation has proven a useful technique for the same
situations—AFB examination and HIV rapid testing. It allows for an
external evaluation of quality on-site, and can be conducted in
conjunction with PT or rechecking/retesting.
These procedures can be time-consuming and costly, and so are used

only when there are not good alternatives. It is essential to have a
reference laboratory with the capacity to do the repeat testing; the use
of a reference laboratory gives assurance that the re-examination process
will give a dependable result.The turnaround for the retesting must be
accomplished in a timely manner, allowing for immediate corrective
actions. In some settings, transport of samples or slides to the
reference laboratory will present problems.
This EQA method is used for HIV rapid testing. HIV rapid testing
Retesting presents some special challenges, because it is often performed outside a
process traditional laboratory, and by persons who are not trained in laboratory
medicine. Additionally, the kits are single use, and cannot be subjected to
the usual quality control methods that laboratories employ.Therefore,
retesting of some of the samples using a different process such as
enzyme immunoassay (EIA) or enzyme-linked immunosorbent assay
(ELISA) helps to assess the quality of the original testing.
Characteristically, the retesting is:

 done by a reference laboratory to ensure quality;
 performed on dried blood spots or serum collected at the time of
the rapid test performance;
 not performed as a blinded process, as this is unnecessary.
The number of samples retested must provide statistically significant

data in order to detect error. This becomes difficult in settings where
small numbers of rapid tests are performed. A full discussion of the
statistical issues in retesting is found in the Centres for Disease Control
and Prevention and World Health Organization Guidelines for assuring the
accuracy and reliability of HIV rapid testing: applying a quality system
approach.
119
10-3 : Other external quality assessment methods
Rechecking This method is most commonly used for acid-fast smears; the slides
process that were read in the original laboratory are “rechecked” in a central or
reference laboratory. This allows for the accuracy of the original report to
be evaluated, and also allows assessment of the quality of the slide
preparation and staining.
The following principles are important when performing recheck procedures:

 The slides for re-examination must be collected randomly. Every effort
should be made to avoid systematic sampling bias.
 Rechecking must be based upon statistical considerations. A common
method is for the central laboratory to recheck 10% of negative
and 100% of positive slides.
 When discrepancies occur, there should be procedures in place to resolve
them.
Advantage  The outcome of rechecking must be analyzed for effective and timely
of performing feedback.
blind
recheck It is usually recommended that rechecking be done in a blinded
fashion, so that the laboratorian performing the retest does not know
the original results. In the study carried out by Martinez et al. 1,
random blinded rechecking provided more accurate estimates of AFB
microscopy results than on the nonrandomly selected, nonblinded
On- smears. This resulted in improved diagnosis and monitoring of
site treatment response.
evaluatio
n A periodic visit by evaluators for on-site laboratory assessment is a type
of EQA that has been used when other methods of EQA are not
feasible or effective. Again, this method has most frequently been
employed for assessment of sites performing AFB smears and those
performing HIV rapid testing.
On-site evaluation can be a valuable tool to:

• obtain a realistic picture of laboratory practices by observing the
laboratory under routine conditions in order to check that it is meeting
quality requirements;
• provide information for internal process improvement;
• measure gaps or deficiencies—learn “where we are”;
• assist the laboratory in collecting information for planning and
implementation of training, monitoring and corrective actions.
On-site evaluation for the purpose of EQA may be conducted by a

central reference laboratory or other health authorities. On-site
evaluation can be used together with retesting and rechecking
schemes to provide more information about performance.
1 Martinez A et al. Evaluation of new external quality assessment guidelines involving random blinded rechecking of
acid-fast bacilli smears in a pilot project setting in Mexico. International Journal of Tuberculosis and Lung Diseases,
2005,9(3):301–305.

10-4 : Comparison of external quality assessment
Comparison
methods
of Some of the characteristics of PT and rechecking are compared in the table
some below.
characteristi
cs Comparison of proficiency testing (PT) and
rechecking/retesting (RC)
Method/characteristics PT RC
Interlaboratory comparison Yes Yes
Simulated samples Yes No
Real samples Yes/No Yes
Time and resources needed Less More
Analytes evaluated Many Few
Summary
of Proficiency testing:
comparis  gives a good, objective measure of the laboratory performance
on  can be organized to address most kinds of laboratory testing
 is cost-effective and can therefore be used frequently.
Retesting/rechecking:
 is useful when it is difficult or impossible to prepare samples to test
all of the testing process;
 is expensive and uses considerable staff time.
On-site evaluation:
 can give a true picture of a laboratory’s overall performance, and offer
real-time guidance for improvements that are needed;
 is probably the most costly, requiring staff time, travel time and expenses
of those performing the evaluation.
121
10-5 : Managing external quality
assessment in the laboratory
Participation in All laboratories should participate in EQA challenges, and this should
EQA include EQA for all testing procedures performed in the laboratory, if
possible.The benefits of this participation are considerable, and EQA
provides the only means available to a laboratory to ensure that its
performance is comparable to that of other laboratories.
For laboratories that are accredited, or that plan to seek

accreditation, EQA participation is essential. ISO 15189 addresses EQA
requirements for laboratories as follows.
 There is a requirement that the laboratory participate in
interlaboratory comparisons.
 Where an established EQA scheme is not available, an alternate EQA
mechanism will have to be considered for interlaboratory comparison,
such as exchange of samples with other laboratories.
 The laboratory management shall monitor the results of EQA and
participate in the implementation of corrective actions.
Management
process When participating in EQA programmes, the laboratory needs to
develop a process for the management of the process. A primary
objective is to assure that all EQA samples are treated in the same
manner as other samples tested. Procedures should be developed
that address:
 Handling of samples—These will need to be logged, processed
properly and stored as needed for future use.
 Analyses of samples—Consider whether EQA samples can be
tested so that staff do not recognize them as different from patient
samples (blinded testing).
 Appropriate record keeping—Records of all EQA testing reporting
should be maintained over a period of time, so that performance
improvement can be measured.
 Investigation of any deficiencies—For any challenges where
performance is not acceptable.
 Taking corrective action when performance is not acceptable—The
purpose of EQA is to allow for detection of problems in the laboratory,
and to therefore provide an opportunity for improvement.
 Communication of outcomes to all laboratory staff and to management.
10-5: Managing external quality assessment in the laboratory
EQA If the laboratory performs poorly on EQA, the problems may lie
performan anywhere along the path of workflow. All aspects of the process will
ce need to be checked. Some examples of problems that may be identified
proble include the following.
ms
Pre-examination:
 The sample may have been compromised during preparation, shipping,
or after receipt in the laboratory by improper storage or handling.
 The sample may have been processed or labelled improperly in the
laboratory.
Examination:
 The EQA challenge materials may exhibit a matrix effect in the
examination system used by the participating laboratory.
 Possible sources of analytical problems include reagents,
instruments, test methods, calibrations and calculations.Analytical
problems should be investigated to determine whether error is
random or systemic.
 Competency of staff will need to be considered and evaluated.
Post-examination:
 The report format can be confusing.
 Interpretation of results can be incorrect.
 Clerical or transcription errors can be sources of error.
Incorrect data captured by the EQA provider is another possible source of

error.
123
10-6 : Summary
Summary EQA is a system for objectively checking the laboratory’s performance
using an external agency or facility. All laboratories should participate in
an EQA process for all tests performed, whenever possible. Accredited
laboratories are required to participate in EQA.
There are several methods for conducting EQA.Traditional PT is

available for many tests, is cost-effective and provides useful
information.When PT is not practical or does not provide enough
information, other methods should be employed.
There must be no difference in the treatment of a PT sample and a patient

sample. The normal testing methods must be followed and the
procedure must involve personnel who routinely perform the
Key messages testing.
 As EQA uses valuable resources, the laboratory should make the

best use possible of its participation in EQA.
 EQA should not be punitive. It should be viewed as educational and
used as a tool to help direct improvement efforts in the laboratory.
 EQA is one of the critical elements of a laboratory quality management
system.
11. Assessment
— norms
and
accreditatio
n
11-1:
Role
in quality Assessment is the means of
manageme determining the effectiveness of Organization Personnel Equipment
nt a laboratory’s quality management
system system. Standards, as well as other
normative documents that provide
guidelines, form the basis
for assessment.They may be Purchasin
Proces Informatio
g and
developed at international, national inventory
s n
contro manageme
or local levels. l nt
Organizations that establish Documen

ts
norms or standards, and that
Occurrenc
provide for e
and
accreditation or certification of record management
Assessment
laboratories, play a vital role in s
the assessment process.

Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Overview
An important way for a laboratory to be recognized as delivering
of the
accurate and reproducible results is to go through evaluation or
process
assessment processes conducted by a credible, qualified organization.
Successful completion of this process gives the laboratory recognition
that it is in compliance with the quality standards and norms used
for the assessment.
Responsibiliti
Laboratory directors need to be aware of the importance of
es gaining accreditation, certification and licensure, by implementing
international or national standards, in line with the scope of laboratory
activities and in accordance with national legislation. A major duty of
laboratory managers should be to seek information about appropriate
norms and standards, and about accreditation and certification processes,
so that these can be used to provide better service.
Quality managers must convey to the laboratory staff the need for
compliance with standards, whether international or national. The quality
officer will explain the process for meeting standards, and will organize
and prepare the laboratory for assessments.
Laboratorians must be aware of requirements of the chosen

standards, contribute to the development of tasks for meeting
standards, be aware of assessment processes and help to assure
readiness for assessment processes.
11-1:

11-2: International standards and standardization
Definitio Normative document—a document that provides rules,
ns guidelines or characteristics for activities or their results. It covers such
documents as standards, technical specifications, codes of practice and
regulations.1
Standard document—a document established by consensus and

approved by a recognized body, that provides for common and
repeated use, guidelines or characteristics for activities or their results,
aimed at the achievement of the optimum degree of order in a
given context.1
Regulation—any standard that is mandated by a governmental

agency or authoritative body.
Standards may be developed internationally, nationally or locally.

Compliance to a standard may be required by government or another
authoritative body, or may be voluntary.
Standardization Standards developed internationally may have the broadest

consensus or agreement, but may be less specific. Standards
bodies
developed locally may have the highest degree of applicability, but may
not be useful for comparison with other regions or countries.
Examples of international organizations are given below.
ISO (International Organization for Standardization)

ISO is the world's largest developer and publisher of international
standards, and ISO standards are applicable to many kinds of
organizations, including clinical and public health laboratories.
ISO is a network of the national standard institutes of 157 countries, one

member per country, with a Central Secretariat in Geneva, Switzerland,
that coordinates the system. It is a nongovernmental organization and it
forms a bridge between the public and private sectors. On the one hand,
many of its member institutes are part of the governmental structure of
their countries or have been mandated by government. However, many
members have roots uniquely in the private sector, having been set up
by national partnerships of industry associations.Therefore, ISO enables
a consensus to be reached on solutions that meet both the
requirements of business and the broader needs of society.
The work of preparing standards is conducted by ISO technical

committees. Each member body has the right to be represented on the
11-2: International standards and standardization
committees. both governmental and nongovernmental, also take part in the
International committee activities. Draft international standards adopted by the
organizations, technical
1 ISO/IEC Guide 2:1996 (EN 45020:1998) Standardization and related activities—general vocabulary. Geneva, International

127
11-2 : International standards and standardization bodies
committees are circulated to the member bodies for voting. Publication

as an International Standard requires approval by at least 75% of the
member bodies casting a vote.
CLSI (Clinical and Laboratory Standards Institute)

CLSI is a global, non-profit, standards-developing organization that
promotes the development and use of voluntary consensus standards
and guidelines within the health care community. CLSI documents are
developed by experts working on subcommittees or working groups
under the direction and supervision of an area committee.
Development of CLSI standards is a dynamic process. Each CLSI area
committee is committed to producing consensus documents related to
a specific discipline, as described in its mission statement.
CEN (European Committee for Standardization)

CEN was founded in 1961 by the national standards bodies in the
European Economic Community and associated countries. The
general terms include openness, transparency, consensus and
integration.
Formal adoption of European Standards is decided by a weighted

majority vote of the CEN national members and is binding on all of
them. The responsibilities are shared between 30 national members
from each country, 7 associate members and 2 counsellors, as well as
the CEN Management Centre in Brussels.
WHO (World Health Organization)

WHO has developed several standards for disease-specific diagnostic
laboratories. One example is polio, where accreditation is required in
order for a laboratory to participate in the Polio Network for Eradication
of Poliomyelitis. Seven criteria have been selected, including a minimum
activity of 150 samples annually, successful participation in proficiency
testing, and accuracy and timeliness of reports of cases to the network.
11-3: National standards and technical guidelines
Country-specific Standards may be developed within a country to apply only to national
standards use.These may be created by governmental organizations, or may also
be developed by a recognized body with a specific area or domain for
application.
In some instances, national standards have been developed based

on an international standard such as ISO, and adapted to the
culture and general condition of the country.
Guidelin
es Guidelines are developed in a variety of situations. Usually ISO
standards need more technical guidance for actual implementation in
laboratories and in countries. Several national and international
organizations have developed those guidelines.
Another use for guidelines is to address a specific kind of testing or

to provide guidance for certain parts of the laboratory. For example, there
may be guidelines for performance of human immunodeficiency virus
(HIV) rapid testing, or guidelines for obtaining the appropriate
biological safety cabinet for the testing being conducted.
Exampl
Many national guidelines and standards have been developed. Some
es examples include the following.
GBEA (Guideline for Good Analysis Performance), France

French legislation created these guidelines to assure the quality of the
services offered by French laboratories in 1994. It was revised in 1999 and
2002.All clinical laboratories in France are required by law to comply
with GBEA.
BLQS (Bureau of Laboratory Quality Standards),Thailand

The BLQS of the Department of the Medical Sciences has developed
national quality standards for health laboratories based on ISO 17025
and ISO 15189. A checklist with 110 items was developed and a
stepwise approach was devised. Depending on the score obtained when
compared to the checklist, laboratories will be accredited against
country-wide national standards, or can apply for the ISO
accreditation process.
129
11-3 : National standards and technical guidelines
CLIA (Clinical Laboratory Improvement Amendments of

1988), United States of America
CLIA was mandated by legislation in 1988, and brings all medical
laboratory testing in the United States under federal regulation. Quality
standards are defined based on the complexity of testing performed.
The objective of the CLIA programme is to ensure quality laboratory
testing, regardless of where it is performed (e.g. physician’s office,
hospital laboratory, health clinic, nursing home).
11-4 : Certification and accreditation
Applyin Standards are used when a laboratory seeks recognition of its ability to
g use quality practices in carrying out its work. Remember that meeting the
standar standards may be a legal requirement, or may be voluntary.There are
ds three processes that may be used to indicate that the laboratory is
complying with defined standards.
 Certification—the procedure by which an independent body

gives written assurance that a product, process or service conforms
to specific requirements.1 In the certification process, a laboratory is
visited by representatives from a certification body. These
representatives are looking for evidence of compliance with standards,
policies, procedures, requirements, and regulations. Primarily, the
inspection team checks for physical presence of texts, procedures and
documents.
 Accreditation—the procedure by which an authoritative body

gives formal recognition that a body or person is competent to carry
out specific tasks.2 A laboratory is visited by representatives from an
accreditation body who are looking for evidence of compliance with
standards, policies, procedures, requirements and regulations, and also
observe laboratory staff to ensure that they perform functions and duties
correctly and competently.
Accreditation provides a higher level of assurance to

those using the laboratory that its testing is reliable and
accurate because it includes an evaluation of competency.
 Licensure—the granting of ability to practise, usually provided by

Elements a local governmental agency. Licensure is usually based on
of demonstrated knowledge, training and skills.3 Generally, when
accreditati laboratory licensure is used, it is a legal requirement for operation.
on
The accreditation process requires:
 an accreditation body that oversees the assessments and grants
accreditation—this body may also set the standards used in the
accreditation process;
 standards with which a laboratory must comply in order to gain accreditation;
 knowledgeable assessors or inspectors who seek to establish
compliance with the standards by conducting the assessment;
 a user laboratory which is required to, or voluntarily seeks to, comply
with the standards by being assessed.
1 ISO/IEC 17000:2004. Conformity assessment—vocabulary and general principles. Geneva, International Organization for
2 ISO 15189:2007. Medical laboratories—particular requirements for quality and competence. Geneva, International
3 Wikipedia 2007.

131
11-4: Certification and
Certification A certification or accreditation body is an organization or agency

and with the authorized right and authority to inspect a facility, and provide
accreditati written evidence of its compliance (certification) and competence
on (accreditation) with a standard.
bodies
Certification and accreditation bodies have the following common
characteristics:
 Approved—accreditation and certification bodies usually require
their own accreditation status. This accreditation is commonly
performed under the authority of national or international bodies, such
as national standards agencies. International accreditation bodies often
are accredited to ISO 17011.1
 Knowledgeable—these bodies must be knowledgeable and skilled
in the content and interpretation of the standards against which they
accredit, as well as in the discipline they accredit. An accreditation body
team includes both discipline content experts and accreditation
requirement experts.
 Standards-based—assessments are always based on established
standards.
 Objective—interpretation of competence and skill is based on
evidence rather than impression.The inspection teams do not write
their own rules, but rather measure compliance with given rules
or standards.
 Competent—these organizations ensure that all staff are trained and
skilled, and that auditing teams involve members knowledgeable in
Commonly both technical and quality management information. The bodies
used maintain competency because of professionalism, and because of
standards for the importance of sustaining their own accredited status.
accreditation
or Standards may be applicable to accreditation or to certification, or they
certification may be regulatory. Some important examples of accreditation
standards include ISO 17025 and IS0 15189, both international
standards in wide use. ISO 15189 is a preferred standard for
medical laboratories because it applies to the total laboratory,
regardless which tests it performs, as opposed to ISO 17025, which is
designed and intended to be implemented on an individual, test-by-test
basis.
ISO 17025 specifies general requirements for competence to carry

out tests and/or calibrations, including sampling. It is applicable to testing
and calibration laboratories, and can be used for developing quality,
administrative, and technical systems that govern operations. It can
be used by laboratory clients, regulatory authorities, and accreditation
bodies wishing to confirm or recognize competence of laboratories. It
does not cover compliance with regulatory and safety requirements.
1 ISO/IEC 17011:2004. Conformity assessment—general requirements for accreditation bodies accrediting

conformity assessment bodies. Geneva, International Organization for Standardization, 2004.

Medical laboratory
Based on ISO 17025 : 1999
Particular requirements
and for quality and competence or recognize
9001 : 2000
competence
Laboratory quality management

Quality
technical
administrative
processes
technical systems
ISO 15189 is sector specific, meaning that it is designed and intended for
use only by medical laboratories. ISO 15189 specifies particular
requirements for quality and competence of medical laboratories. It
provides guidance for laboratory quality management and technical
processes to ensure quality in medical laboratory examinations. ISO
15189 is applicable to all currently recognized disciplines of medical
laboratory services, and is based on both ISO 17025 and ISO 9001. It is
for use by medical laboratories for developing quality, administrative and
technical systems that govern their operations, and is also for use by
organizations wishing to confirm or recognize competence of medical
laboratories.
133
11-5: Process of
The decision to pursue accreditation is not one to be taken
lightly or without forethought.
Accreditation visits are expensive, therefore laboratory directors and

quality managers must prepare well in advance of the visits to
ensure resources are not wasted. Accreditation could begin with one
part of the laboratory and then continue with the other sections.
Preparatio Seeking accreditation requires the following:

n  Commitment—the path towards meeting standards and
recognition is rarely straightforward. When the process becomes
difficult, challenging and requires time and effort, it is not uncommon to
quit or postpone the process. Once stopped, it becomes very difficult to
begin again.
 Planning—the path towards accreditation will take time. Laboratories
should organize their staff and time to ensure that the process
goes to completion with a minimum of obstruction.
 Knowledge—application of standards requires knowledge of the
standards and how to interpret them. If there are no people in the
laboratory that have that knowledge, the laboratory may consider
sending staff for special training or hiring a consultant.
 Resources—the process to accreditation may require
reorganization, restructuring, trained staff or additional equipment.
Recognition of potential costs should be considered in the planning
phase at the start of the process.
Interpretation
of terms When using standards to prepare for accreditation, keep in mind the
following interpretations of terms commonly used in standards.
 Consensus—agreement between delegations representing all the
stakeholders concerned—suppliers, users, government regulators and
other interest groups. Consensus is not a numeric or majority
determination.Consensus represents general agreement in the
absence of strong and compelling objection.
 Normative statement—information within a document that is a
requirement and essential part of the standard. Includes the word “shall”.
 Informative statement—information within a document that is
informational only; often it is in the form of a "note". Information may
be explanatory or cautionary, or provide an example.
 Compliance—meets both the text and the spirit of a requirement.
 Nonconformity—failure to fulfil the requirements of a specified
process, structure or service. May be categorized as major (complete)
or minor (partial).
 Verification of conformity—confirmation by examination of evidence.
11-5: Process of

11-6: Benefits of
Value
of It is through the accreditation of third-party evaluators that the laboratory’s
accreditatio clients can have confidence that when something is measured,
n calibrated, inspected, tested or certified, the job has been done
competently.
The essential aspect of accreditation is that it promotes confidence in

results and services because it is a valid means of verifying claims about
quality, performance and reliability. The use of internationally recognized
standards as the reference criteria for laboratory accreditation is the
key to building trust across borders and promoting best practices
worldwide.
Outcom
es The outcomes of accreditation are:
 measurement of the strength and integrity of the quality system
 continual monitoring of the quality system
 recognition for your efforts.
Accredited laboratories tend to perform better on proficiency testing

and are more likely to have a working quality management system.
Accreditation as Accreditation is a valuable tool to determine the effectiveness of the

a tool quality management system. However, it is not the ultimate goal. Once
accreditation status is obtained, the important challenge will be to
maintain that status.
A well-managed laboratory will know that it is meeting its goals. The

laboratory should look at accreditation as one form of audit that the
quality managed laboratory puts into place to ensure that the system
is working properly.
Accreditation status must be renewed regularly and the laboratory

challenged each time to maintain and improve the quality level.
11-6: Benefits of

135
11-7:
Summary
Standards or norms provide guidelines that form the basis for quality
practices in the laboratory. They are developed by organizations, often
through a consensus process. Accreditation and certification are two
processes that can allow for recognition that a laboratory is meeting
designated standards.
When a laboratory seeks this recognition, careful planning will be needed

to have a successful outcome. An active quality management
Key message programme can ensure that a laboratory is in a constant state of
"accreditation readiness".
 Accreditation is an important step in the continual improvement of

the quality management system.
 It is an accomplishment to be accredited; it is an achievement to
maintain accreditation.
11-7:
12. Personnel
12-1 : Overview
Role in Personnel are the most
quality important laboratory resource. Organization Personnel Equipment
manageme Critical to the implementation
nt of the quality management
system system are people who
possess integrity, recognize
Purchasin
the importance of their work g and
Proces Informatio
s n
and participate in continuous inventory
contro manageme
improvement. Laboratorians are l nt
important partners in health
care. Documen
ts
Occurrenc
e
and
Assessment
record management
s
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Overview
Recruiting and retaining qualified staff is essential to laboratory quality.
of the
Failure to check the education qualifications and references for a new
process
hire can lead to problems in the future.
As a laboratory director it is important to:

 Hire an appropriate number of staff to cover workload.
 Verify that items on the job application are correct.
 Develop complete and thorough job descriptions for each employee.
 Train each employee in their specific duties.
 Provide orientation for new employees. Even with a credible
background, differences between laboratories are common, so a
manager needs to ensure new employees have adequate orientation
and training.
 Conduct and record competency assessments on all personnel. It
is management’s responsibility to verify that trained employees are
sufficiently competent to do their work.
 Provide opportunities for continuing education; new techniques or
updates for existing methods can be introduced using continuing
education courses.
 Conduct annual employee performance appraisals.
As a quality manager it is necessary to:

 Provide employees with orientation and training.
 Keep track of employee records and make sure they are confidential.
 Include policies relevant to personnel in the quality manual.
12-1: Overview
As a laboratorian it is important to:

 Participate in training and continuing education opportunities.
 Request training that may be needed as job responsibilities increase.
 Maintain records of personal professional development.
Importance Success or failure depends on the knowledge and skills of the

of people in the laboratory, and their commitment and motivation to
motivatio perform tasks as described in the job description. Motivated employees
n are more likely to be committed to their work.
Elements of motivation vary for different people.

 Some people respond to concrete rewards such as bonuses and praise.
 Some people respond best to flexible work schedules that fit their
responsibilities to home and children.
 Most people respond to recognition and feeling that they are an
integral part of the health care team.
The manager can motivate the team by emphasizing that

everyone’s job is important; whether it is performing testing, collecting
specimens, making reagents or managing the laboratory.
Migration and turnover of staff have been described as major

challenges in many countries. Apart from economic factors, the lack of
Retention a good working environment and improper management practices can
of staff contribute to loss of staff. A good personnel management programne
can contribute to the retention of staff.
Laboratory
Quality
Management System
139
12-2 : Recruitment and orientation
Personn Management must establish appropriate personnel qualifications for all
el positions in the laboratory. These should include requirements for
qualifications education, skills, knowledge and experience.When defining qualifications,
and job keep in mind any special skills and knowledge that are needed, such as
description language, information technology and biosafety.
Job descriptions give a clear and accurate picture of responsibilities and

authorities for each staff position. Job descriptions should:
 lay out all activities and tasks that should be performed;
 specify responsibilities for conducting testing and implementing the
quality system (policies and activities);
 reflect the employee’s background and training;
 be kept current and be available for all people working in the laboratory.
Job descriptions should be competency based and reflect any skills

needed. The requirements for each staff position may vary
depending on the size of the laboratory and complexity of testing
services offered. For example, in small laboratories with limited
personnel, staff may have many responsibilities and perform many
tasks, whereas in larger laboratories with more personnel, staff may be
more specialized.
Remember, not only are clear job descriptions a guideline,

but they can be used to formally assess personnel
competency.
Orientatio
Orientation is the process of introducing a new staff member to the
n
new work environment and to their specific tasks or duties. Nothing is
more frustrating to an employee than not knowing where to find the
necessary resources.
Orientation is different from training.
Orientation of laboratory personnel should include the following aspects.

 General orientation—a tour of the workplace and introduction to
all management and staff. Information about
- how the organization fits into the medical community and/or the
public health system;
- key personnel and lines of authority;
- the laboratory interaction with both users and customers of the
laboratory;
- the policies and procedures regarding facilities and safety.
12-2 : Recruitment and orientation
 Personnel policies
- ethics
- confidentiality
- employee benefits
- work schedules.
 An employee handbook that outlines the policies of the
organization and information about the laboratory quality
system.
 A copy of the employee’s job description and a detailed review of its
contents.
 An overview of standard operating procedures (SOPs).
A checklist that addresses each aspect of the orientation is

important. Ask employees to initial and date the checklist to document
discussion of each topic.
141
12-3 : Competency and competency assessment
Definitio Competency is defined as the application of knowledge, skills and
ns behaviours used in performing specific job tasks.1 Accurate laboratory
test results depend on staff being competent in performing a range of
procedures that occur throughout the entire examination process.
Competency assessment is defined as any system for

measuring and documenting personnel competency. The goal of
competency assessment is to identify problems with employee
performance and to correct these issues before they affect patient
care.
Overvie An initial competency assessment may reveal the need for specific
training of the employee. Competency assessment should be
w conducted at regular intervals during the employee’s tenure.
Competency assessments conducted either initially or periodically help to

identify or prevent performance problems that may be solved
through task-specific training.
Competency assessment methods include the following.

 Direct observation helps identify and prevent any performance problems:
Competen - The employee’s techniques are watched during the examination
cy process, which allows the observer to see if the employee is
assessme
following the SOP.
nt
- To avoid subjectivity during a competency assessment, the
method
observer uses a custom-designed checklist; checklists are used
s
when there are specific, observable items, actions or attributes to be
observed.
Observation is the most time-consuming way to assess employee

competence, but this method is advised when assessing the areas that
may have a higher impact on patient care.
 Monitor records (e.g. review worksheets and logs prepared by the
employee).
 Review and analyze quality control records and results of
proficiency tests performed by the employee being evaluated.
 Retest or recheck results to compare results among personnel;
discrepancies should be resolved.
 Assess knowledge or problem-solving skills using case studies.
Employees are asked to respond orally or in writing to simulated
technical problems.
1 ISO 10015:1999. Quality management—guidelines for training. Geneva, International Organization for Standardization, 1999.

12-3: Competency and competency
Methods for determining personnel competency may

need to be adapted to local customs and concerns.
Policies Policy writing for competency assessment is a critical quality systems

an issue and is the responsibility of the management. Each policy should be
d shared with everyone in the laboratory and assessments of all personnel
process should be documented.
es
An example of policy for competency assessment is “Every employee shall
regularly be assessed for competency for the tasks defined in their job
description”.
Processes describe how the policy will be enacted. For example, the
following questions should be addressed.
 Who will conduct assessments? Responsibility for conducting the
assessment should be assigned to someone who has previously
demonstrated competency in the area to be assessed.The responsible
person must document and evaluate the results of the
assessment.
 What will be assessed? Which job task or tasks and procedure
performed in the pre-examination, examination and post-examination
testing process will be assessed? Critical competencies for each task
should be identified. First-line supervisors should be involved in this
step. Examples of critical competencies include
- patient identification
- sample collection
- evaluation of adequacy of samples
- use of equipment
- application of quality control procedures
- interpretation of results.
 When will assessments occur (annually or biannually)? It is important
to develop a timeline for periodic assessment of each employee. A
period of training and then assessment should be implemented for
everyone as new procedures and equipment are introduced into
the laboratory.
Policies and processes should be reviewed annually and

modified when necessary.

143
Procedur Procedures describe specifically how each element of the processes will
es be performed.An employee competency assessment would follow these
procedures,
1. The assessor contacts the employee in advance to inform them
that the assessment will be done at a prearranged time.
2. The assessment is done while the employee is performing tasks
using routine samples.
3. The assessment is done by a specified method previously
described and is recorded in a logbook.
4. The results of the assessment are shared with the employee.
5. A remedial action plan is developed defining required retraining. The
plan should be written and the manager must ensure that the plan is
understood by the employee.The plan should outline specific steps
to be taken to resolve or correct the problem with related deadlines.
Needed resources should be clearly outlined in the plan. For example,
the employee may need an updated version of the SOP.
6. The employee is asked to acknowledge the assessment, related
action plan, and reassessment.
Competen If more than one person makes the same error even
cy after training has occurred, consider the root cause of the
assessmen error, such as equipment malfunction and operating
t procedure ambiguity.
documentati
on Standard forms should be generated in advance and used so all
employees are assessed the same way. This will prevent employees from
thinking that the assessments are biased.
All competency assessments must be recorded, showing date and

results, and should be kept in a place where they remain
confidential.These records are part of a laboratory’s quality documents,
and should be periodically reviewed and used for continuous
improvement.

12-4 :Training and continuing education
Definitions Training is a process to provide and develop knowledge, skills, and
behaviours to meet requirements. In this context, training is linked to
the job description and competency assessment, and addresses identified
gaps in specific tasks to be performed by the employee. Competency
should be reassessed after any job- specific training.
Retraining is required when competency assessment reveals the

need for improving an employee’s knowledge and skills.
Cross-training provides an opportunity for staff to acquire skills

outside their own discipline. This allows for flexibility in shifting or
reassigning personnel whenever needed; this may occur in crisis
situations or with absences of staff due to illness or vacation.
Continuing education is an educational programme that brings

employees up- to-date in a particular area of knowledge or skills. Since
laboratory medicine is constantly changing, keeping current takes effort
on the part of both employee and management.
Rationale Reasons for training and continuing education are to:

 achieve quality practices in the laboratory and produce accurate,
reliable and timely test results;
 help staff achieve personal career goals;
 improve the organization’s capabilities and achievement of quality
objectives.
In laboratory medicine, new testing methodologies and instruments

are continuously introduced to the marketplace that could have
implications for laboratory testing and improved patient care.
Methods
When planning a training or continuing education activity, consider:
 identification of training needs
 design of training
 provision of training
 evaluation of training results.
Activities can often be organized at low cost, for example:

 starting a journal club;
 starting case study discussion groups;
 watching videotapes and DVDs;
 researching a topic and presenting findings to colleagues;
 using interactive self-study programmes, including e-learning
freeware or printed courses;
 collecting and maintaining a set of teaching slides (e.g.
haematology and parasitology).
145
12-4 :Training and continuing education
Resourc Local resources—When organizing internal continuing education

es programmes, local resources available from the health care community
should be considered. Some of these resources include:
 quality assurance committee
 clinicians
 nurses
 pathologists
 infection control personnel
 epidemiologists or surveillance officers
 external assessors.
Each of these groups may offer specialized knowledge and experience

they can share with laboratory staff. They can be invited to give lectures,
lead discussions and exchange information.
External resources—External continuing education programmes

can also be presented by topic experts, such as those associated with:
 proficiency testing services
 manufacturers
 scientific societies
 World Health Organization
 United States Centers for Disease Control and Prevention
 nongovernmental organizations.

12-5 : Employee performance appraisal
Periodic appraisal Employees should have a periodic formal appraisal of their overall
performance. This is broader than competency assessment and includes
the following elements:
 technical competency
 efficiency
 adherence to policies
 observance of safety rules
 communication skills
 customer service
 punctuality
 professional behaviour.
Feedback
Appraisal can affect an employee’s morale, motivation and self-esteem, and
should be conducted equitably for all employees. People respond to
criticism differently, even if delivered tactfully; therefore, consider
unique approaches that match personality when counselling employees.
Positive feedback, as well as suggestions for improvement, should be
provided.
All identified problems should be addressed with the employee

when they occur, so that they can correct any issue before the formal
evaluation. A periodic appraisal that is part of the employee’s record
Caus should not have items that were not previously discussed with the
e of poor employee.
performan
ce Poor performance may not always be due to technical incompetence.
Performance may be affected by:
 distractions—especially personal issues such as a sick child or
parent, or financial problems, which can make the employee’s
concentration difficult;
 excessive workloads that pressure or hurry the employee, which
may cause them to inadvertently make errors;
 insufficient initial orientation or training;
 resistance to change—some people may not want to use new
procedures (“We’ve always done it this way, why change?”).
147
12-5 : Employee performance appraisal
The following factors could also contribute to poor results performance.

 Compromised sample—the laboratorian may or may not know that
the sample arrived in the wrong preservative or was improperly
stored.
 Absence of SOPs or failure to update them—test kits may come with
modified manufacturer’s instructions, and these modifications need to be
reflected in the SOPs.
 Poorly written procedures—including omitting certain steps, the
wrong sequence of steps, or incorrect sample or reagent quantities—
can cause very serious errors and should always be suspected when
several employees obtain erroneous results.
 Job descriptions that are not clear may be a source of error—for
example, confusion about who has responsibility for calibrating an
instrument could result in the calibration not being done, causing
erroneous results.
12-6: Personnel
Policy
Medical laboratories should maintain employee records that contain
information integral to their laboratory-related work. Keep records of
positions held and dates for each of these positions. This information is
important for calculating employee benefits. All terms and conditions of
employment should be a part of the personnel record.
What
Personnel information that the laboratory maintains may differ in different
regions and settings.While a complete list of information may include the
following, some parts may not be required in all regions and all
settings:
 employment details;
 original application and resume;
 tests the employee is authorized to perform;
 conditions of continued employment;
 job description;
 both original and subsequent competency assessments;
 continuing education programmes attended;
 personnel actions—corrective, disciplinary;
 leave records;
 health information, including records of work injury or exposure to
occupational hazards, vaccine status, skin tests (if any);
 performance appraisals;
Where  emergency contact information.
The personnel files should be kept in a secure site to protect

confidentiality. Not all information needs to be maintained within the
laboratory offices. Some institutions maintain a human resources or
personnel department that may be responsible for employee records.
Consider what is essential to be maintained in the laboratory itself, such
as emergency contact information or job descriptions.
12-6: Personnel

149
12-7:
Importa
nt Management of personnel is critical to the success of a quality
principles management programme. Several elements are important in this
of management process. Job descriptions should reflect all skills needed
personne and accurately describe tasks, roles, and authorities. The competency of
l personnel will need to be evaluated at the time of hiring and on a
manageme regular, recurring basis. A very important part of the management process
nt is to seek ways to attract qualified personnel, and to provide motivation
and appropriate benefits and working conditions so as to retain staff.
 Personnel are the most important resource in the laboratory.

 Managers must create an environment that will fully support all
Key laboratory personnel in order to maintain a high quality of laboratory
messages performance.
 Continuing education is vital to personnel competency, but does
not need to be expensive. New testing methodologies and
instruments are constantly introduced to the marketplace, and
employees need to update their knowledge and skills.
12-7:

13. Customer
service
13-1 : Overview
Role This chapter will describe basic
in quality elements that are essential for Organization Personnel Equipment
manageme developing an effective
nt customer service programme.
system
Customer satisfaction is a Purchasin
Proces Informatio
major component of a quality g and
s n
inventory
management system, and a contro manageme
l nt
significant focus in the
International Organization for Documen
Standardization (ISO) standards. ts
Occurrenc
e
and Assessment
Ultimately, the laboratory record management
produces a product—the test s
result—for its customers. If

the customer is not
well served, the laboratory is Process Custom
Facilitie
s and
not achieving its primary improveme er
safety
nt servic
function. e
Overview
Philip Crosby defined quality practice as meeting the
of requirements of the customer. He applied this practice to business
the
and manufacturing, but it is equally important for a medical laboratory.
proce
The medical laboratory needs to know who its clients are, and
ss
understand clients’ needs and requirements.
Medical laboratories have a range of customers including patients,

physicians, public health agencies and the community.
It is the responsibility of the laboratory director to ensure that the

Laborato customers’ needs are met, and that there is customer satisfaction. The
ry quality manager is responsible for measuring the degree of customer
responsibiliti satisfaction, using surveys, indicators and audits to take preventive
es and corrective action.
All laboratory staff must understand the importance of customer

satisfaction. Laboratory personnel must always interact with
customers in a way that is appropriate, providing needed information,
and being courteous.
13-1: Overview of customer service
Establishing Seeking customer satisfaction requires the following:

a programme 1. Commitment—customer satisfaction is a requirement of several
to address international standards for laboratory quality, but some laboratory staff
customer might consider it secondary to technical competency. Because of the
satisfaction importance of customer satisfaction in a quality system, all staff
must be strongly committed to the process.
2. Planning—monitoring takes time and planning to be done
properly.Appropriate monitoring tools need to be developed prior to
gathering information. Poor planning results in inadequate
information and often leads to uninterpretable information.
3. Knowledge—creation of useful monitoring tools requires specific
knowledge. If there are not people in the laboratory that have
that knowledge, the laboratory may consider sending staff for special
training or hiring a consultant.
4. Resources—the process to monitoring does not have to be heavily
resourced, but it does take time. Some of that time can be saved by
having access to calculators, computers and the internet.
153
13-2 :The laboratory clients—the customers
The The laboratory has many clients and the needs of all must be carefully
laboratory addressed. A central figure in the client list is the physician or
and its health care provider.The initial request for service originates with
clients this person, and the laboratory staff generally identifies the ordering
physician as the primary client. Remember that in a hospital setting, the
health care provider will be assisted by many other people, including
nurses, medical assistants, phlebotomists, and
secretaries or clerks. These vital hospital personnel should also be
considered clients of the laboratory, and their needs must be considered.
Another important client for the laboratory is the patient, usually

including their family. Family members may play a very important role
in patient management, and may help with sample collection and
transport.
When laboratory testing is being performed to meet a public health

need, public health officials or workers become clients of the
laboratory.The laboratory is a critical partner in surveillance, disease
detection and prevention, and other public health programmes.
Laboratories need to meet the needs of the public health workers in
addressing problems. They sometimes need to share information
without compromising the confidentiality of the patient. Specialized
laboratories such as food safety or water testing laboratories would
have other customers to consider, such as food producers,
manufacturers, or water systems managers.
The community in which a laboratory works also has

expectations. The community needs to be assured that the
laboratory will not create a risk for workers, visitors or the public.
In many countries, laboratory tests can only be ordered by a

licensed health care provider—a physician, nurse or dentist. In
some countries, laboratory tests can be ordered by the patient directly
without referral from a physician or nurse. Some patients do not have
the knowledge or expertise to order the right test or to interpret results.
Laboratory personnel may have to provide assistance in test selection
Leg and interpretation.
al
identit International standards usually require that any laboratory clearly
y identifies itself to the public, giving assurance that an identified person is
in charge and accessible. At a minimum, every laboratory must make
public a laboratory name and address, and the name of the director,
including relevant contact information.
13-2:The laboratory clients—the
Physician The health care provider expects to have access to accurate, clinically
or health relevant information that can be understood and used in a timely
care manner. Health care professionals need assurance of laboratory
provider responsibility throughout the testing process, including pre-examination
requiremen steps, the testing process itself and the post- examination process.
ts
In the re-examination phase, physicians will be particularly interested in the
test menu.They benefit from an accurate collection manual, requisition
forms that are complete but user friendly, and a timely delivery system.
For the testing or examination phase, physicians would like to be sure

of working with competent personnel.They need to know that the test
methods being used have been validated, and that testing is done
with good process control and with quality control procedures in place.
Appropriate management of all adverse occurrences or errors will
significantly affect physician laboratory use.
The physician looks to the laboratory to do an excellent job in

Patien managing the post-examination steps, as these are critical to
t receiving the results of testing. A solid laboratory information system, a
requiremen method for results verification, and for delivering timely and
ts interpretable results to the right place, are all important.
The patient expects to receive personal care, keeping in mind comfort and
privacy. He or she also expects to be assured that the testing has been
done correctly and properly, and provided to the health care provider in a
timely manner.
The laboratory actions needed to meet the patient requirements include:

 providing adequate information, both for collection of a specimen,
and also information about the laboratory;
 providing good collection facilities;
 having available trained and knowledgeable personnel—personnel
should know how to collect a sample properly, and should be trained
to be courteous to all patients;
 giving assurance that the laboratory records are maintained properly
so that they can be easily retrieved, and also giving assurance of
protection of the confidentiality of the records.
Public health professionals have the same needs as health care providers,
Public requiring that all parts of the pre-examination, examination and post-
health examination processes are carried out properly. They may need special
requiremen kinds of information in dealing with an outbreak or epidemic, such as
ts specific collection processes or forms designed for the particular
project or investigation. Public health officials will also be particularly
concerned with safety issues and containment of infectious material.
Food manufacturers and producers, and water plant managers will

need information from the laboratory to help them comply with their
specific quality requirements.

Communi The community in which a laboratory does its work expects that
ty dangerous materials will be kept within the confines of the facility, and
requiremen that the laboratory will protect their own workers from risk. The
ts community should be aware of communicable disease alerts, and
surveillance and response activities.
The laboratory is responsible for assuring safety and security, for

containment of any infectious materials, for dealing appropriately with
waste management, and for following all regulations for the transport
of dangerous goods.
Serving All clients benefit when a laboratory chooses to put in place a quality
all clients system and to seek recognition that it is accredited to the highest
well standards. This provides assurance that the laboratory is following quality
practices, and that the results it produces are accurate and reliable.
Good customer service provides:

 valuable information for best patient care
 valuable information to improve surveillance and other public health
actions
 a professional image for the laboratory.
Customer service is an integral part of a quality management system.


13-3: Assessing and monitoring customer
Methods
for In order to understand whether client needs are being met, the
assessme laboratory will need to employ tools for gaining information. The
nt laboratory needs to actively seek information from customers, rather
than just waiting for customers to contact the laboratory with a
complaint.
Important information on customer satisfaction may be obtained using:

 complaint monitoring
 quality indicators
 internal audit
 management review
 satisfaction surveys
 interviews and focus groups.
The monitoring of customer service and customer satisfaction is

part of the continual improvement performed by the laboratory.
Usin When the laboratory is contacted about a problem, this can provide
g important and helpful information. All such complaints should be
assessme thoroughly investigated, and remedial and corrective action taken.
nt However, remember that received complaints may reflect only the
method “tip of the iceberg”, because many people do not complain. The
s laboratory cannot use received complaints as the only means of
assessing customer satisfaction.
Quality indicators are an objective measure of laboratory

practices.Indicators can be developed that look at complaints,
timeliness, patient refusals, and lost or delayed laboratory reports as
examples. When these indicators are being monitored, information about
customer needs and satisfaction will be acquired.
When the laboratory conducts internal audits, some aspects of

laboratory practice that affect patient satisfaction can be examined.
Examples might include turnaround times—always of great concern to
physicians or health care providers.
All findings from these investigations should be very carefully

reviewed by management and followed up with appropriate
action.
13-3: Assessing and monitoring customer

157
13-4: Customer satisfaction
Custom
er In order to actively seek information about how clients view the
surve laboratory’s service, it will be necessary to conduct surveys (paper-
ys based or electronic) or to use interviews and focus groups. In this way the
laboratory can address specific questions to areas of concern, and can
look at areas not commonly covered by complaints or internal
processes.
ISO standards put a heavy emphasis on the importance of customer

satisfaction; customer surveys are required in ISO 9001 standards
for quality management systems. Any laboratory that implements a
quality management system, whether accredited or not, needs to use
some method for surveying clients in order to understand whether
needs are being met.
To be successful, surveys should be carefully planned and

organized.Deciding which clients to ask to participate in a survey is
important. Surveying health care practitioners is often easier than
surveying patients. Laboratory staff can also be asked to participate in
surveys and may offer good suggestions for streamlining operations
to improve customer service.
Any survey questionnaire should be pretested for clarity. When

developing material, avoid leading and biased questions. Be sure to
analyze the results in a timely manner and, when possible, provide some
feedback to the group that has been surveyed.
If the survey is to be conducted using interviews, the following tips

can be helpful.
 Write out all questions in advance, so that everyone is asked the same
questions.
 After asking some specific questions about their satisfaction with the
laboratory, ask an open-ended question that allows customers to
provide honest feedback. For example, ask how the laboratory could
improve its service.
Employing focus groups can be a very useful technique for gathering

information on customer satisfaction. The process of a group discussion
will often elicit comments and ideas from all the participants that might
not otherwise surface. When conducting focus group discussions,
consider the following:
 assemble small groups of 8–10 people
 include people with diverse backgrounds and laboratory needs
 start by asking questions that build trust
 develop a focus group guide for consistency between groups
 ask open-ended questions—not “yes or no” questions.
13-4: Customer satisfaction
Summarize responses in a written report that can be used by the laboratory as a
verbal tool to improve customer service.

13-4: Customer satisfaction surveys
Successf When measuring customer satisfaction, whether by survey, indicators

ul surveys or audits, much will be learned when the method is successful. This
identify information and the insights on customer service that it provides can be
opportunities used to help the laboratory identify opportunities for improvement
for (OFI).The OFI will lead to preventive and corrective actions.
improvemen
t
Information gathering must lead to change in a continual
improvement process.

159
13-5: Summary
Summary Seeking customer satisfaction requires commitment from the
laboratory management and staff. It is important to remember that
technical competency is not the only goal for the laboratory.
A programme for addressing customer satisfaction requires good

planning, the development of appropriate monitoring tools, and the
knowledge to apply the tools to gain usable information.
Customers or clients of the laboratory include physicians and other

health care providers, hospital and clinic staff, patients and their families,
public health officials and the general community.
Monitoring customer satisfaction requires some resources, primarily

involving staff time. Managers need to ensure that these resources are
available.
Key messages
 Meeting customer needs is a primary goal of the laboratory.
 Everyone in the laboratory is responsible for quality and, therefore,
for customer service.
 An active quality management system ensures laboratories meet
all client requirements.
14.
Occurrenc
e
manageme
nt
14-1:
Role in Occurrence management, or
quality dealing with laboratory errors, is
manageme important in ensuring good
nt service from the laboratory. It is

systems one of the 12 quality essentials
and must be addressed in
laboratory quality management. Purchasin
Proces Informatio
g and
s n
inventory
contro manageme
This chapter will describe and l nt
explain basic elements that are
essential for developing an Documen
ts
effective
Occurrenc
e
and
occurrence management record management
Assessment
programme. s
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Overview Occurrence management is a central part of continual improvement. It

of is the process by which errors or near errors (also called near
the misses) are identified and handled.The goal of an occurrence
proce management programme is to correct the errors in either testing or
ss communication that result from an event, and to change the process
so that the error is unlikely to happen again.
Well-managed laboratories will also review their systems and detect

process problems that could possibly cause error at some time in the
future, allowing for prevention of these errors.
An occurrence is any event that has a negative impact on an organization,

Definitio including its personnel, the product of the organization, equipment, or the
n environment in which it operates.All such events must be addressed in
an occurrence management programme.
14-1:

14-2: Sources and consequences of
Causes
of laboratory Some of the common causes of error in the laboratory are easily
error identifiable, and are also readily correctable.
For example, some errors may occur because staff are unclear
about who is responsible for carrying out a particular task, so it may
remain undone.To prevent these types of errors, individual
responsibilities must be clearly defined and communicated.
Other errors occur when procedures are not written or followed, and
staff are not adequately trained.Written procedures serve as a guide for
all staff, and help to ensure that everyone knows what to do. It is
essential to ensure that these written procedures are followed
correctly. Staff need to be trained in how to conduct the procedures and,
if this training is neglected, errors can result.
There are many other sources of error in addition to

these, which are frequently observed. While they often
occur during pre-examination
and post-examination processes, errors can occur
throughout the
testing process.
Useful studies for understanding sources of laboratory errors

include a retrospective data collection that found Australian pathology
laboratories had a transcription error rate of up to 39%, and an error
rate of up to 26% for analytical results.1 A report from the College of
American Pathologists in collaboration with the Centres for Disease
Control and Prevention Outcomes Working Group describes error
stratification in the working process for clinical laboratories. In more
than 88 000 defects, 41% were observed in the pre-examination phase
of testing, 55% in the post-examination phase and only 4% in the
Pre-examination examination phase.2
errors
Some examples of pre-examination errors that are frequently seen include:
 collecting the wrong sample;
 mislabelling or failing to label the sample;
 storing the sample incorrectly prior to testing, so that the sample
deteriorates;
 transporting the sample under conditions that damage the
sample or that endanger staff and public safety;
 damaging the reagents or test kits by storing them improperly.
14-2: Sources and consequences of
1 Khoury M et al. Error rates in Australian chemical pathology laboratories. Medical Journal of Australia, 1996, 165:128–130
(http://www. mja.com.au/public/issues/aug5/khoury/khoury.html).
2 Bonini P et al. Errors in laboratory medicine. Clinical Chemistry, 2002, 48:691–698
(http://www.clinchem.org/cgi/content/full/48/5/691).

163
14-2: Sources and consequences of laboratory error
Examination A list of common errors that occur during the testing process include:
errors  failing to follow an established algorithm (e.g. for HIV testing);
 reporting of results when the quality control material tests out of range;
 incorrect measuring of the sample or reagents (usually these are
dilution or pipetting errors);
 using reagents that have been improperly stored, or after their expiration
date.
Post-examination
errors Many of the common laboratory errors occur following the testing of the
sample, and some of these may be more difficult to detect. Common
examples of these kinds of errors include:
 making a transcription error when preparing the report;
 producing a report that is illegible, usually caused by poor
handwriting, but sometimes by damage to the report form;
 sending the report to the wrong location, which often results in
complete loss of the report;
 failing to send the report.
Consequences
of laboratory The laboratory is a critical partner in all health systems, and it must perform
error its functions well in order to help ensure good outcomes of health
programmes and interventions. A failure in the laboratory role can have s
significant effect, producing:
 inadequate or inappropriate patient care
 inappropriate public health action
 undetected communicable disease outbreaks
 wasting of resources
 death of an individual.
14-3: Investigation of
Occurren
ce cycle A cycle of events reflects the process of occurrence management.
includes When occurrences are found, they must all be investigated to find the
investigatio causes of the problem.The investigation will help to identify the actions
n needed to correct the problem and to ensure that it does not occur
again.All necessary communication must take place, including informing
any health care providers whose clients are affected.
Occurrences are detected through a variety of investigative

Detectin techniques. Monitoring of complaints and satisfaction surveys will yield
g much information. Once the laboratory establishes and monitors
occurrenc quality indicators, deficits will be noted. The tools of external
es assessment, such as proficiency testing, external quality assessment,
accreditation and certification processes, will be very useful in occurrence
management. A very valuable tool is the internal audit, which can be
performed at any time in the laboratory. The laboratory’s process
improvement efforts will identify opportunities for improvement.
It is the responsibility of management to review all the information that

results from use of these tools, and to look for underlying patterns and
potential causes for persistent or repeated error.
Investigation involves gathering complete and detailed information

about events that led to a problem, and a thorough analysis to determine
all the factors that contributed to the problem occurrence.
The most aggressive and complete approach to addressing occurrences

is to seek the root cause of the problem.This is more than just a
Root cause thorough examination, but is a planned and organized approach toward
analysis finding not only the superficial causes of a problem, but also the deeper
or core problems.With some occurrences, they are likely to reccur
until such time as the true root causes are discovered and
addressed.
Wrong blood group
Cross- givensample mislabelled
match
Samples not labelled at bedside
Major
transfusion reaction
Two patients collected
Samples taken to nursing station

Switched samples
14-3: Investigation of
165
14-4: Rectifying and managing
Correction
of As a reminder, an occurrence is any event that has a negative
occurrenc impact on an organization, which includes personnel, product, equipment
es or the environment.
There are several levels of action that may be undertaken to rectify

occurrences, including the following.
 Preventive actions involve a planned and organized evaluation of
processes and procedures to identify potential error points, so action
can be taken to prevent the errors from ever occurring. Preventive
actions require planning and team participation.
 Remedial action, or remediation, is the fixing of any consequences that
result from an error. For example, if an erroneous result has been
reported, it is essential to immediately notify all persons concerned
about this error and to provide the correct result.
 Corrective actions address the cause of the error. If a test was done
incorrectly, resulting in an incorrect result, corrective actions sort out
why the test was not performed properly and steps are taken so that
the error does not happen again. As an example, a piece of equipment
may have been malfunctioning, and the corrective actions would be to
recalibrate, repair or otherwise address the equipment problem.
Occurren The laboratory should develop a system for prompt investigation of

ce every laboratory problem and error. The management process for
manageme dealing with errors or occurrences involves several steps.
nt 1. Establish a process to detect all problems, using the tools that are
process available. Remember that problems may go undetected unless there
is an active system for looking for them.
2. Keep a log of all problem events that records the error, any
investigation activities and any actions taken.
3. Investigate the cause of any problem that is detected and carefully
analyze the information that is available.
4. Take the necessary action (remedial and corrective)—if the
problem is detected before the error actually occurs, take preventive
action.
5. Monitor and observe for any recurrence of the original problem,
keeping in mind that there may be a systemic problem.
6. Provide information to all those who need it, and to those who are
affected by the error.
14-4: Rectifying and managing
14-4: Rectifying and managing occurrences
Responsibiliti The responsibility for monitoring for occurrences belongs to

es everyone in the laboratory. It is important, however, that someone be
designated as the person responsible for marshalling the energies and
activities of all staff into an effective management process. In many
instances, this is the responsibility of the laboratory director, laboratory
manager or quality manager.
167
14-5: Summary
Summary Occurrence management is an integral component of laboratory
quality management. It establishes the methods for finding errors and
preventing them from occurring again, and also seeks to identify potential
errors and prevent them from happening.
The laboratory should employ an active process for occurrence

management and take a positive approach. Make an effort to detect
problems as early as possible, and then take immediate remedial and
corrective action. Be proactive and see opportunities to identify
potential error, thus preventing an occurrence. Finally, keep good
records of all problems, investigations and actions taken.
Key messages
The difference between a quality-managed laboratory and laboratories
with no system in place is that the quality laboratory detects the problem,
investigates and takes actions.
15. Process
improvement
15-1 : Continual improvement concept
Role in Process improvement, one of the
quality
management 12 quality system essentials, Organization Personnel Equipment
system establishes a programme for
helping to ensure continual
improvement in laboratory
quality over time. This
continual
improvement of the laboratory Purchasi
Proces Informatio
ng and
processes is essential in a inventor
s n
contro manageme
quality management system. y
l nt
Documen
ts and Occurrence
records management
Assessment
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Historical W. Edwards Deming is one of the originators of the concept of

basis continual improvement, the primary goal of a quality management system.
Beginning in the 1940s, he worked with manufacturing and industrial
processes, and introduced many of the tools used in quality
improvement efforts; his ideas and concepts are used today to produce
reliable, quality laboratory results. Deming outlined 14 points for quality,
many of which can easily be applied to the laboratory. For the purposes of
this discussion, two of his points are particularly important:
1. Create constancy of purpose for improvement. The
message here is that there is a need to be constantly working
toward making the process better.
2. Improve constantly and forever.This statement points out
that continual improvement will always be a goal. Perfection is never
achieved, but we try to get as close to it as possible. Process
improvement is something that is never finished, but rather continues
Demin on “forever”.
g’s
PDC The Deming Plan-Do-Check-Act (PDCA) cycle shows how to achieve
A continual improvement in any process.
cycle  Plan—identify the problems and the potential sources of system
weakness or error. Decide on the steps to be used to gather
information. Ask the question, “How can you best assess the current
situation and analyze root causes of problem areas?” Using the
information that is gathered through these techniques, develop a plan
for improvement.
 Do—implement whatever plans have been developed—put the plan into action.

15-1 : Continual improvement concept
Plan
Act Do
Chec k
 Check—this refers to the monitoring process. It will be important

to assess the effectiveness of the action taken, using focused review
and audit processes. If the system weakness is complex, a pilot study
may be needed in order to understand all the complexities. After
“checking”, revise the plan as required to achieve the improvements
needed.
 Act—Take any corrective action that is required, and then recheck to
be sure that the solution has worked.This cycle is a continuous
process, so the laboratory will begin again with a planning process to
continue the improvements.
This is the continual improvement process and, in the laboratory, this

process is applied to all procedures and processes that are a part of the
path of workflow.
ISO
process for ISO 15189 [4.12] describes a very similar set of activities for achieving
continual continual improvement in the laboratory.These are outlined as
improveme follows:
nt  identify potential sources of any system weakness or error;
 develop plans to implement improvement;
 implement the plan;
 review the effectiveness of the action through the process of
focused review and audit;
 adjust the action plan and modify the system in accordance with the
review and audit results.
171
15-2 :Tools for process improvement
What is A process is a series of actions or operations contributing to an end. In
process every case, inputs (patient samples) are turned into outputs (patient
improveme examination results) because some kind of work, activity or function is
nt? carried out. Process improvement is a systematic and periodic
approach to improving laboratory quality and the inputs and outputs
that glue these processes together. It is a way of solving problems. If
there is a problem, however hard to describe, one or more processes
needs to be improved.
Many useful techniques have been developed to use in process

Conventional improvement, and some have been discussed in other chapters of this
tools handbook. For example, both internal and external audits will
for identify system weaknesses and problem areas. Participation in an
improveme external quality assessment is another useful tool; it allows for
nt comparing laboratory performance to that of other laboratories.
Management review of all information gathered through these

activities should be conducted. In addition, there should be management
reviews of the laboratory records on a regular basis; for example, quality
control, inventory management and equipment maintenance.These
reviews will provide useful information about areas for improvement.
Quality plan
Monitoring Monitoring Monitoring
Internal audit External audit
Quality Quality control
assessme
nt
Opportunities
for improvement
Quality goal
Using information from these reviews and from audits, and through the
process of monitoring the organization’s customer complaints, worker
complaints, errors, near errors or near misses, opportunities for
improvement (OFIs) will be identified.These OFIs will be the focus
for corrective action.
15-2:Tools for process improvement
When conducting audits or evaluating laboratory records, it is

important to have a goal or standard of performance.Therefore,
quality indicators will be needed and will have an important role
to play.
The plan leads to the goals; OFIs, which are the result of monitoring, lead to
the creation of a new plan, with the process leading to continual
improvement.
Newer
tools New ideas for tools to use for continual improvement continue to come
from the manufacturing industry.Two of these new tools are now being
used in laboratory quality improvement.
1. Lean is the process of optimizing space, time and activity in
order to improve the physical paths of workflow. This tool of industry
is applicable to laboratories, and many laboratories are currently
engaged in creating a lean system. Lean analysis may lead to revised
processes and changes in laboratory floor plans. This should save time
and financial resources, as well as help to reduce errors in the path
of workflow.
2. Six Sigma is also a concept that has come to us from the
manufacturing industry. This consists of a formal structure
for project planning in order to implement change and
improvement. In Six Sigma, the focus is to move toward reducing
error to very low levels.The processes that are described in Six Sigma
are define, measure, analyze, improve and control. These are similar
ideas to those already discussed. The Six Sigma concept applies a very
structured method for achieving these processes. (This chapter will
not explore Six Sigma in depth; it is included here so that participants
will become familiar with the term. See Chapter 15 reference list for
sources of Six Sigma information.)
15-3: Quality
Reminde
r: What is It is often useful to consider a number of definitions in order to make
quality? very clear what is meant by a term such as quality. Philip Crosby, in his
essays on quality management from the 1960s, defined quality as
“conformance to requirements, not as ‘goodness’ or ‘elegance’”.
What is a quality Established measures used to determine how well an organization

indicator? meets needs and operational and performance expectations is a good
working explanation of a quality indicator.
Quality indicators are addressed in ISO 9001 and ISO 15189 documents.
ISO 9001 [5.4.1] requires that quality objectives should be measurable.

Thus, the objectives or indicators must be quantifiable or otherwise
capable of analysis, allowing for an assessment of the success of the
quality system.
ISO 9001 [8.4] more specifically requires collecting and analyzing
specific information or data upon which one can determine
effectiveness and continual improvement. Some of the indicators that
are required to be considered include customer satisfaction,
conforming to customer requirements for products, counting the
number of preventive actions addressed, and ensuring that suppliers are
providing materials that will not adversely affect quality.
ISO 15189 [4.12.4] states that the laboratory shall implement quality
indicators to systematically monitor and evaluate the laboratory’s
contribution to patient care. When the programme identifies
opportunities for improvement, the laboratory management shall address
them, regardless of where they occur. Also, it is stated that laboratory
management shall ensure that the medical laboratory participates in
Purpose of quality quality improvement activities that deal with relevant areas and
outcomes of patient care.
indicators
Quality indicators are information that is measured.The indicators:
 give information about the performance of a process
 determine quality of services
 highlight potential quality concerns
 identify areas that need further study and investigation
 track changes over time.
15-3: Quality

15-4: Selecting quality
Gener
al In selecting quality indicators for measuring performance, Mark
guidelin Graham Brown, a leading expert on performance measurement,
es suggests the following useful guidelines.1
 Fewer are better; that is, do not try to have too many quality
indicators, as tracking becomes difficult. Few laboratories can effectively
address more than five or six indicators at a single time.
 Link the indicators to the factors needed for success. Choose the
quality indicators that relate to areas that need correction in order to
achieve good performance; select those that will be most meaningful
to the laboratory.
 Measures (indicators) should be based around customer and stakeholder
needs.
 Measures should look at all levels of the laboratory; if possible, include
indicators that will evaluate function at the top management level, but
also flow down to all levels of employees.
 Measures should change as the environment and strategy changes.
Do not stick with the same indicators over long periods of time.
 Base the targets and goals for the measures on rational values,
rather than values of convenience. They should be established on the
basis of research rather than arbitrary estimates.
Developi
ng Quality indicators—also called metrics—are the specific targets that are
successf regularly examined using objective methods, in order to determine if the
ul goals of compliance are being met. When developing quality indicators
indicato an organization should ensure the following.
rs  Objective—the indicators must be measurable, and not
dependent on subjective judgements. It must be possible to have
concrete evidence that the event (or indicator) either occurs or does
not, or that the target is clearly met.
 Methodology available—be sure that the organization has the
tools needed to accomplish the necessary measurements. The
laboratory must have the ability to gather the information. If the data or
information collection requires special equipment, then make sure the
special equipment is available before starting.
 Limits—the laboratory will need to know the acceptable value,
including the upper and lower range, before starting measurements.
Determine in advance the limits of acceptability, and at what point a
result causes concern. Also consider what action will be required. For
example, how many delayed reports per month would be considered
acceptable? How many would be considered as requiring corrective
actions? How many would require immediate revision of the action
plan?
award winning quality: How to interpret the Baldridge criteria for performance excellence. Milwaukee, ASQ Quality Press,
1 Brown MG. Baldridge 2006.

 Interpretation—decisions must be made as to how indicator

information will be interpreted before beginning measurements.
Know in advance how to interpret the information that has been
collected. For example, if you are monitoring completed requisitions
to see if they are correct, you need to know how many samples you
have examined, if they have come from multiple sources or all sources,
and whether they are for only one type of sample or all sample types.
 Limitation—the organization should understand exactly what
information is being provided by the indicator, and be clear on what is
not being determined by the measurement of a particular indicator.
For example, if collecting the number of accidents or errors, do you
know if all are being reported?
 Presentation—the organization must decide how to present the
information in order to fully display its value. Some information is best
presented in a table, whereas other information might be best shown
by a longitudinal graphic bar or in text. Presentation of information is
important when looking for trends that predict future outcome.
 Action plan—before beginning the use of an indicator, the laboratory
should have some idea of what to do if the indicator shows that
there is a problem. Also decide how to collect the information, who
will collect it, and how long it will be collected.
 Exit plan—because making these measurements takes time and
resources, there should be a plan as to when to stop using a
particular indicator and replace it with another. Generally, this is done
when the original indicator shows that the operation is working and
stable.
When developing quality indicators, be sure to engage the bench-level

staff— those who do the work have a clear understanding of the
tasks and outcomes. The planning process is best done in groups
rather than by the quality manager alone. By engaging the people who
actually do the work, the opportunity for success improves.
Characteristi Good quality indicators (also called metrics) have the following
cs of good characteristics:
quality  measurable—the evidence can be gathered and counted;
indicators  achievable—the laboratory has the capability of gathering the evidence it
needs;
 interpretable—once it is gathered, the laboratory can make a
conclusion about the information that is useful to the laboratory;
 actionable—if the indicator information reports a high or
unacceptable level of error, it is possible to do something about the
problem identified;
 balanced—consider indicators that examine multiple aspects of the
total testing cycle in the pre-examination, examination, and post-
examination phases;
 engaging—indicators should examine the work of all staff, not just one
group;
 timed—consider indicators with both short-term and long-term
implications.

The laboratory produces much information, but all the things that can be
measured are not necessarily informative. As an example, a computer can
analyze data in a variety of ways, but this does not always mean that the
information is useful for continual improvement activities.
Mark Graham Brown warns, “Many organizations spend thousands

of hours collecting and interpreting data. However many of these hours
are nothing more than wasted time because they analyze the wrong
measurements, leading to inaccurate decision making”.1
Some All laboratories should consider implementing a process for using a

examples set of indicators which cover pre-examination, examination, and post-
of examination issues, as well as patient care systems.
quality
indicator A 2005 study of medical laboratories carried out in the United
s States showed the most commonly monitored indicators in use at
that time were related to proficiency testing, quality control, personnel
competencies, turnaround time, and patient identification and its
accuracy.2
Most common indicators tracked (%), 2005

Patien
t
identificatio
n
Result turnaround
time
Competen
cy of
personnel
Qualit
y
contro
l
Proficiency
testing
40 60
80 100
It is important to note that, ideally, quality indicators used in health care

should be linked to patient outcomes. However, this is very difficult with
laboratory indicators because patient outcome is dependent upon a
complex set of circumstances, including age and underlying illness,
stage of illness, stage of diagnosis and stage of therapy. Therefore,
laboratories often use quality indicators other than health outcomes of
patients.
1 Brown MG. Using the right metrics to drive world-class performance. New York, American Management Association, 1996.
2 Hilborne L. Developing a core set of laboratory based quality indicators. Presented at Institute for Quality in
Laboratory Medicine Conference, Centers for Disease Control and Prevention, Atlanta, GA United States, 29 April
2005 (http://cdc.confex.com/cdc/ qlm2005/techprogram/paper_9086.htm).

177
15-5 : Implementing process improvement
Essentials Regardless of the technique used, continual improvement requires
for action from the people within the organization. Some of the necessary
implementati steps are important management roles, and others require the entire
on laboratory staff for success. These essential factors and steps
include:
 Commitment from all levels of the laboratory staff. Improvement
requires continual awareness and activity. This is a full-time task and
requires dedicated staff time .
 Careful planning so that goals can be achieved. Before action
plans are implemented, there is much to consider: root causes of
error; risk management; failures, potential failures and near misses;
costs, benefits and priorities; and the costs of inaction.
 An organizational structure that supports the improvement activities.
 Leadership—top management must be engaged and supportive.
 Participation and engagement of the people that normally perform
the tasks being addressed.These are the staff most likely to know and
understand what is done on a regular and daily basis, and without their
participation, improvement programmes have little opportunity for
lasting success.
Plannin When undertaking and implementing action plans for quality improvement,
g for quality there are a number of factors to consider.
improveme  What are the root causes of error? In order to correct errors, it is
nt important to identify the root causes, or underlying causes, of the
problem.
 How will risk be managed in the laboratory? Risk management
takes into account the trade offs between the risk of a problem, and the
costs and effort involved in fixing it.
 Failures, potential failures and near misses are categories into which
laboratory problems fall. Failures are most commonly identified, as a
failure in the system will usually be immediately obvious. Failures need to
be addressed as a part of continual improvement. However, a good
process improvement programme will try to identify potential failures,
which are not so obvious, as well as near misses (those situations
where a failure has almost occurred).
 Any process improvement programme must take into account the
costs of making changes, the benefits of making the changes and the
priorities for action. These decisions relate to the concept of risk
management.
 Finally, it is important to consider the cost of inaction, or failure to take
action. What will be the cost, in money, time or adverse effects, of not
Role of correcting a problem in the laboratory quality system?
leadership
Early on, Deming observed that quality managers working without
the clear, active, and open participation of top management cannot
succeed in implementing continual improvement. Sustained leadership
must come from the top.

15-5: Implementing process improvement
Good leadership fosters the culture for improvement, including:

 openness—the process must be understood by all and there must be
a recognition that all laboratory staff will have good ideas to help with
improvements.
 commitment—it must be clearly communicated that there is
support for the process and that improvements will occur.
 opportunity—a good leader will ensure that all staff have the
opportunity to participate in the process.
Participation
in the Always remember that top management, quality managers and
process consultants do not know everything that the bench-level staff know,
and often are not aware of all of the staff’s tasks. It is vital to engage all
bench-level staff in the process improvement programme, as their
knowledge and support are also essential. Furthermore, when staff know
they can make a difference, they will benefit the laboratory by pointing
out potential problems that can be avoided.
Continual improvement requires both leadership and engaged team
Qualit participation. The following steps show how to plan quality

y
improveme improvement activities:
nt  use a timeline and do not take on more than can be accomplished
activitie within a
s timeframe;
 use a team approach, involving bench-level staff;
 use appropriate quality improvement tools;
 implement corrective or preventive actions;
 report quality improvement activities, findings and corrective action
progress to management and also to laboratory staff.
2008 2009
ID activity I II III IV I II III IV
1 Specimen collection—
haematology 2 ELISA
turnaround time
3 Physicians complaints—AFB
smears 4 QC of chemistry
instruments
If possible, design a study so that results can be statistically measured. Use

available information to select a topic for study, for example:
 customers' suggestions or complaints
 identified errors from occurrence management programme
 problems identified in internal audits.
Retiring a Consider as a guideline to have no more than one
qualit project every six months.
y
indicat Use a quality indicator only as long as it provides useful information.
or Once it is indicating a stable and error-free operation, select a new quality
indicator.

179
15-6 : Summary
Continu The process for continual improvement includes:
al  identification of the problem;
improveme  analysis of the data and the processes;
nt  determination of the root cause of the problem;
 generation of ideas for solutions.
The quality cycle
Plan Each step is

essential to
keep the
quality cycle
cycling
Act
Do
CHECK
Continual improvement is the core of quality management, but it

requires commitment, planning, structure, leadership, participation and
engagement.
Ke
y  Quality counts—it is a very important goal for any laboratory.
messag  Continual improvement is an outcome of an active laboratory
es quality management system.
16. Documen
ts and
records
16-1:
Role in
quality The management of documents
manageme and records is one of the 12
nt essential elements of the quality
system system. The management
system addresses both use and
maintenance of documents and Purchasing
records. A major goal of keeping

Proces Information
documents and records is to and s management
inventor contro
find information whenever it y l
is needed.
Documen
ts and Occurrence
records management
Assessment
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Documen
Documents provide written information about policies, processes and
ts and
procedures. Characteristics of documents are that they:
records—
what are the  communicate information to all persons who need it, including
differences laboratory staff, users and laboratory management personnel;
?  need to be updated or maintained;
 must be changed when a policy, process or procedure changes;
 establish formats for recording and reporting information by the
use of standardized forms—once the forms are used to record
information, they become records.
Some examples of documents include a quality manual, standard

operating procedures and job aids.
Records are the collected information produced by the laboratory in the

process of performing and reporting a laboratory test. Characteristics of
records are that they:
 need to be easily retrieved or accessed;
 contain information that is permanent, and does not require updating.
Some examples of records include completed forms, charts, sample logs,

patient records, quality control information and patient reports.
Information is the major product of the laboratory, so

manage it carefully with a good system for the
laboratory’s documents and records.
16-1:

16-2: Overview of
Documents include all the written policies, processes and
procedures of the laboratory. In order to develop laboratory
documents, it is important to understand each of these elements and
how they relate to each other.
What is a
policy? A policy is “a documented statement of overall intentions and direction
defined by those in the organization and endorsed by management”. 1
Policies give broad and general direction to the quality
system.They:
 tell “what to do”, in a broad and general way;
 include a statement of the organizational mission, goals and purpose;
 serve as the framework for the quality system, and should always be
specified in the quality manual.
What is
Although there are national policies that affect
a
laboratory operations, each laboratory will develop
proces
s? policies specific to its own operations.
Processes are the steps involved in carrying out quality policies. ISO
9000 [4.3.1]2 defines a process as a “set of interrelated or interacting
activities that transform inputs into outputs”.
Some examples of laboratory inputs include test requests, samples, and

requests for information. Examples of laboratory outputs include
laboratory data and reports of results. Using these examples, one
process might be how to transform a test request (input) into a test
result (output).
Another way of thinking about a process is as “how it happens”.

What
Processes can generally be represented in a flow chart, with a series of
are
steps to indicate how events should occur over a period of time.
procedure
s?
Procedures are the specific activities of a process (ISO 9000 [3.4]).
Procedures are very familiar to laboratorians—a procedure is easily
described as the performance of a test.
A procedure tells “how to do it”, and shows the step-by-step

instructions that laboratory staff should meticulously follow for each
activity. The term standard operating procedure (SOP) is often
used to indicate these detailed instructions on how to do it.
Job aids, or work instructions, are shortened versions of SOPs that

can be posted at the bench for easy reference on performing a procedure.
They are meant to supplement, not replace, the SOPs.
16-2: Overview of
1 CLSI/NCCLS. A quality management system model for health care; approved guideline—second edition. CLSI/NCCLS
document HS1-A2. Wayne, PA, NCCLS, 2004.
2 ISO 9000:2005. Quality management systems—fundamentals and vocabulary. Geneva, International Organization for

16-2: Overview of
Docume
nt A good way to represent the relationship of policies, processes and
hierarch procedures is as a tree. The policies are represented by the roots, and
y they form the base for all the other parts. The processes can be viewed as
the trunk of the tree, representing a series of steps or flow of actions
through the laboratory.The leaves of the tree can be thought of as the
procedures; there will be many procedures in the laboratory for
accomplishing the activities or the work.
The quality manual is the overall guiding document that defines the quality
system through policies established by the laboratory. Next in the
hierarchy of documents are the processes, the sets of activities.
Procedures either flow from processes, or make up a part of a process;
these will generally be described as SOPs. Work instructions or job aids
are shortened versions of SOPs. Finally, forms are used to record
results; when completed, they become records.
Why Documents are the essential guidelines for all of the laboratory
are operations.Some of the important documents that every laboratory
documen should have include:
ts  Quality manual—this is the overall guiding document for the
important quality system and provides the framework for its design and
? implementation. A laboratory is required to have a quality manual for
ISO accreditation (the quality manual is discussed further in
sections 16-3 and 16-4).
 SOPs—SOPs contain step-by-step written instructions for each
procedure performed in the laboratory. These instructions are essential
to ensure that all procedures are performed consistently by everyone
in the laboratory.
 Reference materials—good reference materials are needed in
order to find scientific and clinical information about diseases,
laboratory methods, and procedures. Sometimes, there are difficult
interpretive issues, for which references or textbooks will be
needed. As an example, when examining samples microscopically for
parasites, photographs and descriptive information can be very
helpful.
Written documents are required by formal laboratory standards,

16-2: Overview of
including those generally require that policies and procedures be written and available.
leading to Most inspection or assessment activities include an examination of the
accreditation. laboratory’s documents. The documents are an important element on
Standards which the laboratory is assessed.

16-2: Overview of
Documents are the communicators of the quality system. All policies,

processes and procedures must be written, so that everyone will
know the proper procedures and can carry them out. Verbal
instructions alone may not be heard, may be misunderstood, are quickly
forgotten and are difficult to follow. Everyone, both inside and outside the
laboratory, must know exactly what is being done and what should be
done at each step.Therefore, all of the guidelines must be written so that
they are available and accessible to all who need them.
Documents are a reflection of the laboratory’s organization and its

quality management. A well-managed laboratory will always have a
strong set of documents to guide its work.
A good rule to follow is “Do what you wrote and write what you are doing”.
What makes Documents communicate what is done in the laboratory. Good documents
a are:
good  written clearly and concisely—it is better to avoid wordy,
documen unnecessary explanations in the documents;
t?  written in a user-friendly style—it might be helpful to use a standard
outline so the general structure will be familiar to staff and easily used
by new personnel;
 written so as to be explicit and accurate, reflecting all implemented
measures, responsibilities and programmes;
 maintained to ensure that it is always up to date.
Accessibili The documents needed in the work process must be accessible to

ty all staff. Persons managing samples should have the procedures for
sample management directly available to them. Testing personnel will
need the SOPs in a convenient place, and perhaps a job aid posted in clear
view of the workspace where testing is performed. The testing personnel
need immediate access to quality control charts and troubleshooting
instructions for equipment. All staff must have access to safety
manuals.
16-2: Overview of

16-3:The quality
What is a quality
manual? The quality manual is a document that describes the quality
management system of an organization (ISO 15189). Its purpose is to:
 clearly communicate information
 serve as a framework for meeting quality system requirements
 convey managerial commitment to the quality system.
As the quality manual is an important guide or roadmap, all persons

in the laboratory should be instructed on its use and application. The
manual must be kept up to date, and responsibility for the updating
Writing a quality should be assigned.
manual
Although ISO 15189 standards require that laboratories have a quality
manual, the style and structure are not specified. There is considerable
flexibility in how to prepare it, and a laboratory can construct the manual
so that it is most useful and suited to the needs of the laboratory and
its customers.
When writing a quality manual, it is a good idea to use a steering

committee. Because the quality manual needs to be tailored to the
specific needs of the laboratory, each facility should carefully consider
how to best involve those who are needed. Involve the policy makers
for the laboratory. It is also essential to involve the bench technologists,
to take advantage of their expertise and get their buy-in.
The quality manual should state policies for each of the twelve
essentials of the quality system. Also describe how all the related quality
processes occur, and make note of all versions of procedures (SOPs)
and where they are located. For example, SOPs are a part of the overall
Key quality system.Although there are usually too many to include directly in
the quality manual, the manual should specify that SOPs be developed
points and indicate that they be compiled in the SOP manual.
The key points to remember about the quality manual are:

• there is only one official version
• the quality manual is never finished—it is always being improved
• it should be read, understood and accepted by everyone
• it should be written in clear, easily understood language
• the quality manual should be dated and signed by the management.
Developing a quality manual is a very big job, but it is also

very rewarding and useful for the laboratory.
16-3:The quality

16-4: Standard operating procedures
What
is an SOPs are also documents, and contain written step-by-step
SOP? instructions that laboratory staff should meticulously follow when
performing a procedure. A laboratory will have many SOPs, one for
each procedure conducted in the laboratory.
Written SOPs ensure the following.

 Consistency—everyone should perform the tests exactly the same
way so that the same result can be expected from all staff. Consistency
enables people who use laboratory results to observe changes in a
particular patient’s results over time. If different laboratories use the
same SOPs, comparisons of their results can be made; it should be
emphasized that all laboratory staff must follow the SOPs exactly.
 Accuracy—following written procedures helps laboratory staff
produce more accurate results than relying on memory alone
because they will not forget steps in the process.
 Quality—consistent (reliable) and accurate results are primary
goals of the laboratory, and could be considered as the definition of
quality in the laboratory.
A good SOP should be:

 detailed, clear and concise, so that staff not normally performing the
procedure will be able to do so by following the SOP—all necessary details
(e.g. ambient temperature requirements and precise timing
instructions) should be included;
 easily understood by new personnel or students in training;
 reviewed and approved by the laboratory management—approval is
indicated by a signature and a date (this is important to ensure that
the procedures being used for testing in the laboratory are those that
Standardized are up to date and appropriate);
format  updated on a regular basis.
It is a good idea to standardize the formats of SOPs so staff can easily

recognize the flow of the information.
Headers are a very important part of the format. Below are examples of
two different types of headers that could be used when writing an SOP.
 Complete standardized header—typically the standardized header
would appear on the first page of each SOP. The standardized form
makes it easy for staff to quickly note the pertinent information.

187
TLM/MSH Microbiology Policy # Page 1 of 5

Department MI/RESP/11/v05
Policy & Procedure Manual
Section: Respiratory Tract Culture
Subject Title: SPUTUM (Including
Manual Endotracheal
Tube and Tracheostomy Specimens)
Issued by: LABORATORY MANAGER Original Date: September 25, 2000
Approved by: Laboratory Director Revision Date: September 14, 2006
Annual Review Date: August 13, 2007
 Reduced standardized header—this standardized form includes

a smaller version of the header that would appear on all pages other
than the first.
TLM/MSH Microbiology Policy # Page 2 of 5

Department MI/RESP/11/v05
Policy & Procedure Manual
Respiratory Tract Culture
Manual
Preparin There are a few things to keep in mind when preparing an SOP.
g Firstly, it is important to assess the scientific validity of the
SOPs procedure.Then, when writing the procedure, include all steps and details
explaining how to properly perform the procedure.The SOP should refer to
any relevant procedures that may be written separately, such as
instructions for sample collection or quality control. Finally, a mechanism
should be established for keeping SOPs updated.
SOPs should include the following information:

 title—name of test;
 purpose—include information about the test (why it is important, how
it is used, and whether it is intended for screening, to diagnose, or to
follow treatment and if it is to be used for public health
surveillance);
 instructions—detailed information for the entire testing process,
including pre- examination, examination and post-examination phases;
 name of the person preparing the SOP;
 signatures of approving officials and dates of approval—it is
necessary to follow the laboratory’s quality policy and regulatory
requirements.
Pre-examination instructions should address sample collection and

transport to the laboratory, and conditions needed for proper sample
handling. For example, instructions should indicate whether the sample
needs a preservative, and whether it should be refrigerated, frozen, or
kept at room temperature. Instructions should also reflect laboratory
policies for sample labelling, such as requirements to verify more than one
type of patient identification, to write the collection date on the sample
label, and to make sure all information needed is included on the test request form.

Examination instructions should address the actual step-by-step

laboratory procedures to follow and the quality control procedures
needed to ensure accuracy and reliability.
Post-examination instructions should provide information on reporting

the results, including the unit of measurement to be used, the normal
(reference) range, ranges that are life-threatening (sometimes called
“panic values”) and instructions for how to deal with an urgent report.
They should also include references to the published sources of the
procedures, including published evidence that the procedures are
scientifically valid.
Manufacture
r’s The instructions that manufacturers provide in their product inserts
instructio tell how to perform the test, but do not include other important
ns information that is specific to laboratory policy, such as how to record
results, algorithms outlining the sequence of testing and safety
practices. The manufacturer’s instructions may describe
recommended quality control procedures for the test, but the
recommendations may not be as comprehensive as protocols that a
laboratory has put into place. Do not rely solely on
manufacturer product inserts for SOPs. Use information
from these inserts, but develop SOPs specific to your
laboratory.
What is
a job A job aid is a shortened version of an SOP. It is designed for use directly
aid? at the testing site. It should be placed in a visible location, and serves as
a reminder of the steps that need to be completed. The job aid and the
SOP must include the same instructions. If a job aid is distributed to
sources outside the laboratory, ensure that the information illustrated
matches that which is instructed in the SOP. External laboratory
assessors often check to see if job aids and SOPs are in accordance.
Job aids supplement—not replace—the SOP. They do not include all the
details that are provided in the SOP.

189
16-5 : Document control
Purpose Documents, by definition, require updating. A system must be
of established for managing them so that current versions are always
docume available. A document control system provides procedures for
nt formatting and maintaining documents and should:
control  ensure that the most current version of any document is the one that is in
use;
 ensure availability and ease of use when a document is needed;
 provide for the appropriate archiving of documents when they
need to be replaced.
A document control system provides a method for formatting

Elements documents so that they are easily managed, and sets up processes for
of maintaining the inventory of documents. In this system the laboratory will
docume need:
nt  a uniform format that includes a numbering system, to include a
control method for identifying the version (date) of the document;
 a process for formal approval of each new document, a distribution plan
or list, and a procedure for updating and revising laboratory
documents;
 a master log or inventory of all documents of the laboratory;
 a process to ensure that the documents are available to all who
need them, including users outside the laboratory;
 a method for archiving documents that become outdated but need to
be kept for future reference.
All documents that are produced by and/or used in the laboratory

Controlle must be included in the control system. Some important examples
d include:
documen  SOPs—these must be up to date, showing the procedures that are in
ts current use and, when work instructions or job aids are used, they
must exactly match the SOPs for the tasks described;
 texts, articles and books that are part of the documents
referenced in a laboratory;
 documents of external origin, such as instrument service manuals,
regulations and standards, and new references (that may change over
time).
While establishing a document control programme, the following

should be considered.
 A system for standardizing the format and/or numbering—it is
very useful to have a numbering or coding system that applies to all
Developi documents created within the organization. Because documents are
ng the “living” and require updating, the numbering system should indicate
document the document version.
control - One suggestion for a numbering system is to use a letter for the
system type of document, then an incremented number for each of the
documents of this type. All pages of the documents would contain
the B1, B2, B3, … for books ;T1,T2, ... for official texts. A location code
appropriate could be used, and would be useful for the master log or file. For
number. For example, “Book number 2, pages 188–200, on bookshelf 1” B2,
example, 188–200, BS1.

16-5: Document
- Establishing a document numbering system can be a difficult and

time- consuming process. If the laboratory already has an effective
system in place, there is no need to change it.
 Approval, distribution and revision process—control of documents
requires that they be reviewed on a regular basis, with revision as
needed, followed by approval and distribution to those who need them.
The review and approval process is generally performed by
laboratory management, and approval is indicated by signatures
with appropriate dates. Policies for the approval, distribution and
revision of documents should be clearly established as a part of the
documents and records policy.
 Master log—this will allow the person responsible for document
control to know exactly what is in circulation and where copies can be
found. The log should be kept up to date at all times.
 Accessibility—the document control plan must provide a process for
ensuring that relevant versions of documents are available at the point of
use. This may include provision for having current sample collection
information available outside the laboratory if collection is performed in
other places, such as hospital wards or physician offices.
 System for archiving—remember that archiving old versions of
documents will be very important. It is frequently necessary to refer
to older versions of documents when researching a problem or when
reviewing quality practices.As a part of the distribution process, it will
be necessary to collect all old versions of the documents for
Implementi archiving or destruction.
ng
docume When implementing a new document control system, the following
nt steps will be needed.
control  Collect, review and update all existing documents and records—
usually a laboratory without a document control system will find
many outdated documents that will need to be revised.
 Determine additional needs—once all documents have been
collected, it should be possible to determine needs for new process or
procedure descriptions. If the quality manual has not yet been
developed, this should probably be done at that time, as it serves as the
framework for all the efforts.
 Develop or obtain examples of documents, including forms and
worksheets, if needed—remember that forms of all kinds are
documents, but once they have information added they become
records. In order to help with formatting, examples from other
laboratories or from published materials can be used.
 Involve stakeholders—it is useful when creating documents to be
used in the laboratory to involve all staff who will be using them. For
documents that will be used outside the laboratory, such as reports, it is
very helpful to seek input from those who will use the reports.
16-5: Document

191
16-5: Document
Commo Some of the common problems found in laboratories that do not have
n document control systems, or that do not manage their document
problem control systems include:
s  Outdated documents in circulation.
 Distribution problems—if multiple copies of documents are
dispersed throughout different areas of the laboratory, it will be
cumbersome to gather all copies when it is time to update them, and
some could be overlooked. For this reason, multiple copies should be
avoided.Documents should not be distributed more widely than
needed and a record should be kept of where all documents are
located.
 Failure to account for documents of external origin—these
documents may be forgotten in the management process, but it is
important to remember that they may also become outdated and
need to be updated.
16-5: Document

16-6 : Overview of records
Importance of Remember that records are laboratory information, either written by
records hand or computer-printed. They are permanent, and are not revised or
modified. They should be complete, legible and carefully maintained, as
they are used for many purposes, such as:
 Continuous monitoring—without access to all the data collected as a
part of a quality system process, continuous monitoring cannot be
accomplished.
 Tracking of samples—well-kept records allow for tracking of samples
throughout the entire testing process; this is essential for
troubleshooting, looking for sources of error in testing and
investigating identified errors.
 Evaluating problems—well-kept equipment records will allow for
thorough evaluation of any problems that arise.
 Management—good records serve as a very important management tool.
Examples Never change a record. If new information needs to be

of added to a record, it should be noted as an addition, with a
laborator date, and signature or initials.
y
records Many kinds of records are produced in a laboratory. Some examples include:
 sample logbook, registers;
 laboratory workbooks or worksheets;
 instrument printouts—maintenance records;
 quality control data;
 external quality assessent or proficiency testing records;
 patient test reports;
 personnel records;
 results of internal and external audits;
 continuous improvement projects;
 incident reports;
 user surveys and customer feedback;
 critical communications (e.g. letters from regulatory agencies,
government or administrative offices within the health care
system).
A method to record any information that must be kept should be

established.The following type of records could be easily forgotten.
 Information on the management and handling of rejected samples.
 Data needed on any sample referred to another laboratory; to include
when the sample was transported, where it was sent and when the
report was issued. The sample should be able to be tracked
throughout the referral process.
193
16-6: Overview of records
 Information about adverse occurrences or problems. Include all

information that is pertinent, such as the results of any investigation
of the problem (see Chapter 14).
 Inventory and storage records. These help keep track of reagents and
supplies; (see Chapter 4).
 Equipment records.
Test Test reports should be designed so that all information that is

report needed by the laboratory, the laboratory users, and for any accreditation
content requirement, is included. The following is a list of test report contents
s required by ISO 15189:
 identification of test;
 identification of laboratory;
 unique identification and location of patient, where possible, and
destination of the report;
 name and address of requestor;
 date and time of collection, and time of receipt in laboratory;
 date and time of release of report;
 primary sample type;
 results reported in SI units or units traceable to SI units, where applicable;
 biological reference intervals, where applicable;
 interpretation of results, where appropriate;
 applicable comments relating to quality or adequacy of sample,
methodology limitations or other issues that affect interpretation;
 identification and signature of the person authorizing release of the
report;
 if relevant, notation of original and corrected results.
Many of the items listed above are used by laboratories

for their report forms. Some may be used less often,
depending on the test and the context. For some tests,
the report form may also need to include the patient’s
gender, as well as the date of birth (or age).
16-7: Storing documents and
Where to
keep documents Storage must be given careful consideration, as the main goal of
and records documentation is finding the information when it is needed.
Using a paper It is important to consider the following when using a paper system for
system records:
 Permanence—paper records must last for as long as needed.This
should be ensured by binding pages together, or using a bound book (log
register). Pages should be numbered for easy access, and permanent ink
should be used.
 Accessibility—paper systems should be designed so that
information can be easily retrieved whenever needed.
 Security—documents and records must be kept in a secure
place.Security considerations include maintaining patient
confidentiality. Care should be taken to keep documents safe from any
environmental hazards such as spills. Consider how records can be
protected in the event of fires, floods or other possibilities.
 Traceability—it should be possible to trace a sample throughout all
processes in the laboratory, and later to be able to see who collected the
sample, who ran the test, and what the quality control results were for
the test run, including issuing of the report. This is important in the
event there are questions or problems about any reported laboratory
Using result. All records should be signed, dated and reviewed to ensure
an that this traceability throughout the laboratory has been
electroni maintained.
c
system Electronic systems have essentially the same requirements as paper
systems. However, the methods for meeting these requirements will be
different when using computers.The following are factors to
consider:
 Permanence—backup systems are essential in case the main
system fails. Additionally, regular maintenance of the computer system
will help to reduce system failures and loss of data.
 Security—it can be more difficult to assure confidentiality with a
computer system, as many people may have access to the data.
However, computer access codes can be established to protect the
data.
 Traceability—electronic record systems should be designed in a way that
Recor allows for tracing the specimen throughout the entire process in the
d laboratory. Six months after performing an examination, it should be
retentio possible to look at the records and determine who collected the
n specimen and who ran the test.
Retention times for records should be determined in each laboratory,

based on a number of factors:
 the length of time the laboratory will need to have access to its records;
 government requirements or standards that dictate record retention times;
16-7: Storing documents and
 whether the engaged in ongoing research requiring many years of data;
laboratory is  the time interval between the laboratory’s assessments or audits.

195
16-8:
Summary
Documents include written policies, processes and procedures, and
provide a framework for the quality system.They need to be updated
and maintained.
Records include information captured in the process of performing and

reporting a laboratory test.This information is permanent and does not
require updating.
Having a good document control programme ensures that the most

Key messages current version of a document is used, and ensures availability and ease of
access when a document is needed.
 Information is our product.

 Documents are essential for assuring accuracy and consistency in the
laboratory.
16-8:

17. Informatio
n
manageme
nt
17-1:
Role in
quality Information management is a system
manageme that incorporates all the processes
nt needed for effectively managing data
system —both incoming and outgoing
patient information.The information
management system may be Purchasing
entirely paper-based, computer-

based,
Proces Information
or a combination of both. and s
manageme
inventor control
Whatever technology is y
nt
employed, information
management is another of the
essentials of a quality system, and is Documen Occurrenc
ts and e Assessment
closely related to documents and records manageme
records (Chapter 16). nt
Remember that data, and in Process

Facilitie
s and
particular test results, are the final improveme
Custom safety
product of the laboratory. nt
er
Laboratory directors need to service
ensure that the laboratory has an

effective information management
system in place in order to
achieve accessibility, accuracy,
timeliness, security, confidentiality
and privacy of patient information.
Importa When planning and developing an information management system,

nt whether it is a manual, paper-based system, or an electronic system, there
element are some important elements to consider:
s  unique identifiers for patients and samples
 standardized test request forms (requisitions)
 logs and worksheets
 checking processes to assure accuracy of data recording and transmission
 protection against loss of data
 protection of patient confidentiality and privacy
 effective reporting systems
 effective and timely communication.
17-1:

17-2: Elements of information
Uniqu
e A unique identifier is an important tool for managing information, and
identifier careful thought should be given to how best to assign identifiers to
s patients and samples within the information management system.
Patient identifiers—Sometimes hospitalized patients are assigned

a unique identifier upon admission, to be used for the duration of the
hospital stay.A patient may get a new number each time they are seen or
admitted. In other settings, the unique identifier may be assigned to the
patient on a more permanent basis, to be used each time the patient
has any health care.
Sample identifiers—Laboratories need to assign unique

identifiers to patient samples so they can be tracked throughout
the laboratory. The method for generating and assigning unique
identifiers within an information management system will depend on
many factors. Some commercially available computer systems for
laboratories have a numbering system built in to the software.
Laboratories using paper-based systems will need to establish their own
system.
An example of a simple system for generating unique identifiers is using a

number consisting of the year, the month, the day and a four digit
number:YYMMDDXXXX. At the beginning of each day, the last four
digits will be 0001.
For example, the number 0905130047 can be read 09 05 13 0047, and it

would
represent sample number 47, received on 13 May 2009.
To avoid confusion or mix-up of samples, use the sample’s full identifying

number throughout the laboratory.At a minimum, the unique number will
need to be used on all aliquots of the sample, on the request form, the
laboratory register or log, and the result sheet.
Whatever system a laboratory chooses, unique

identifiers should be used to eliminate confusion and mix-
up of samples, and make samples and information easier
to find.

199
systems
Test
request
forms, logs
and
worksheet
s
Securit
y
Reportin
g
request form is incomplete, communicate with the requestor to try to
The test secure the needed information. It may become necessary to refuse
request form is nonurgent test examination until the form is completed.
where the
entire testing Logs that allow for recording data at the time of arrival of the
process begins, sample in the laboratory are very important, as are worksheets that
and is document which patient samples are being tested during a given
important for procedure. In a paper-based system, this will be a written record, usually
both paper and in a bound book. For an electronic system, logs and worksheets may be
electronic generated from the computer. Thought should be given as to what
systems.To information should be recorded.
optimize test
requests: There are certain points in data handling where it is easy for errors
 Standardize to occur, such as during manual transfer of patient data from
the test form requisition forms to logs, keyboard electronic entry of data into a
—the form computerized information system, or transcription from worksheets to
should reports.The laboratory should put processes in place to safeguard
indicate all against errors at these points. Sometimes it may be necessary to adopt
information formal checking processes to ensure the accuracy of data recording and
that needs to transmission of handwritten or keyed information.
be provided
when One example of a simple checking process is to always have two
ordering and people review data transcription to verify its accuracy. Some
submitting a computerized systems have electronic checks built into the system
test request, that require duplicate entry of data. If these duplicate entries do not
and sufficient match, an error alert is generated to the person entering the data.
space for
recording the It is important to establish a means to protect against loss of data. For
information. paper- based systems, this will involve using safe materials for
ISO 15189 recording and storing the records properly. For computerized systems,
requirements scheduled or regular backup processes become very important.
for the
request form It is of utmost importance to safeguard a patient’s privacy and, in this
are regard, security measures must be taken to protect the confidentiality of
addressed laboratory data. Laboratory directors are responsible for putting policies
in Chapter and procedures in place to ensure confidentiality of patient
16. information is protected.
 Ensure the
request form The product of a laboratory is the test result or the report. Give
is completed sufficient attention to the reporting mechanism to ensure that it is timely,
—when the accurate, legible and easily understood.

The report should provide all information needed by the health care
provider or the public health official using the data, and include any
comments that are appropriate, such as “sample haemolysed” or “repeat
sample”. It should be verified and signed by the appropriate
laboratory staff.
Whether issuing paper-based or computer-based test reports,

laboratories must ensure reports arrive on time to the right person.
Reports might be delivered by laboratory staff to the hospital ward, by
courier or by mail to an off-site facility, or through electronic
mechanisms using a sophisticated laboratory information management
system. A telephone is often used to give urgent results. A record of the
telephone call must be kept and should include the caller’s signature,
date and time, and whenever possible, the recipient’s name. Telephone
results should be followed by a written report.
The test result report reflects the laboratory’s image to the

client, the test requestor, and others who may use or need
the report.
Communicati
on When planning for paper-based or computer-based information
consideratio systems, be sure to consider the need for a good system for
ns communicating within and external to the laboratory. This is especially
important in larger organizations. It may be necessary to devise a system
for passing along information between staff covering different shifts or
areas of the laboratory, to make sure important details are not
overlooked.The laboratory might also need to develop a policy for
communicating with its customers, such as health care providers,
central reference laboratories and official agencies. The policy should
describe what communication channels need to be followed and when,
and state who has authority to communicate with the different levels
of customers.
Commo
n There are many points where problems can occur when managing
problem laboratory information.The laboratory should carefully consider
s potential problems and plan on how to avoid them. Some of the most
common problems are:
 incomplete data for test interpretation, or insufficient or illegible
identification— systems should be designed to minimize this occurrence;
for example, when using electronic systems, it is possible to design fields
so that if information is missing, data entry cannot be completed;
 forms that are inadequately designed to meet laboratory and client needs;
 standardized forms prepared by others that may not be
suitable for all laboratories;
 inability to retrieve data due to poor archiving processes or
insufficient backup of computerized information;
 poor data organization, which may hinder later data analysis efforts
to meet research or other needs;
 incompatibility between computerized information systems and
equipment or other electronic systems, resulting in problems with data transmission.

201
17-3 : Manual, paper-based systems
Developing Financial constraints may require that a laboratory use a manual,
a manual paper-based system for all its information management. Careful
system planning, attention to detail nd awareness of problems can allow for the
development of a good paper-based system that will provide
satisfactory service.
Registers, Manual registers, logs and worksheets are widely used, and most
logs and laboratorians are very familiar with use of manual systems for
worksheets managing samples through the laboratory. Even laboratories with some
computerization will often have partially or totally handwritten
worksheets.
Laboratory registers or sample logs take many forms, and almost all
laboratories will have one that has been in use. When reviewing
information management needs, consider whether an existing register is
satisfactory, or whether it should be redesigned.
Registers and logs with good design:

•are practical to use and easy to complete
•make it easy to find the data
•make summarizing data and writing reports easier.
The logbook or register can be supplemented by the use of daily

logbooks. For example, a separate logbook might be used to keep
track of the numbers of patients and samples, or a logbook could be
developed that is organized by the type of test. For some specialties
such as microbiology or parasitology, a laboratory might decide to keep
a specific logbook showing the total number of tests and the
percentage of positive results.
Data Registers and logbooks are unique sources of

entry information for preparing statistics and reports,
although they can be more cumbersome to use and less
complete than a computerized information system.
When using a staff that all data entry must be complete.A computerized system usually
paper system, it requires that all “essential fields” contain data, but in handwritten records
is important to there is no check on this point. An example of a handwritten record
emphasize to book with missing data is shown in the following image.

17-3: Manual paper-based systems
Results recorded
Age not recorded in village column
Village name
not recorded
Legibilit Illegible writing may be a problem, but it must be addressed;

y emphasize to employees the importance of legibility.
Carefully consider the ease of use and legibility of the final report of
results—it is the primary product of the laboratory, so make sure it is
done properly and professionally.
When handwritten reports are issued, the laboratory needs a copy for
Handwritten its files or archives. Not having an exact copy of the report can lead to later
reports problems, if errors in transcription occur.
It is imperative that the records are kept in a safe place where they can
be easily retrieved.
When storing paper-based materials, keep in mind that the goals are to
Storin be able to find a result, trace a sample throughout its pathway in the entire
g paper- process, and evaluate a problem or an occurrence to find its source.
based
material Some useful rules to think about are:
s  keep everything, but develop a system for when and how to
discard (for example, after the appropriate established retention
time, shred records to maintain patient confidentiality);
 ensure easy access to information by those who need it;
 use a logical system for filing;
 use numbers to help keep things in chronological order.
Paper is fragile and vulnerable to water, fire, humidity

and vermin (rodents and insects). Use a storage area
that will protect against these elements as much as
possible.
Laboratory
Quality Management System
203
17-4 : Computerized laboratory information
Developing
systems
a A computerized system for laboratory data is often called a
computeriz laboratory information management system and is referred to by the
ed acronym LIMS or LIS. The use of a computerized system is becoming
system more common in laboratories around the world. An appropriately
designed and installed LIMS brings accuracy and accessibility to the
flow of samples and data in the clinical laboratory.
There are a number of options available to those interested in

developing a LIMS. Some laboratories may elect to develop an in-house
computer network and use locally developed systems based on
commercially available database software, such as Microsoft Access.
Others may choose to purchase fully developed laboratory systems,
which usually include computers, software and training.
One source of information that may be helpful for planning and

implementing a LIMS is the Association for Public Health Laboratories'
Guidebook for implementation of laboratory information systems in
Choosing a resource poor settings.1
system
If the decisions about purchasing are made outside the laboratory
(e.g. by the information system department), the laboratory director
should provide information that will support selecting equipment that
will best serve the needs of the laboratory.The most up-to-date
hardware or software may not add to the functionality of the laboratory
and can end up increasing overhead (e.g. more data handling) in order to
use LIMS that have been designed not for the laboratory, but for the
accounting or central supplies departments.
A LIMS with flexibility, adaptability, ease of evolution and support, and

system speed will most benefit the laboratory.The speed issue is critical, as
Advantages laboratorians will not use something that is slow or awkward, but if it
of saves time they will quickly accept the project and aggressively move
computeriz the process forward.
ed
systems A complete computerized information system will be able to handle all
 the basic information management needs. A computer system has the
capacity to quickly and easily manage, analyze and retrieve data. The
computerized system offers some definite advantages over paper-based
systems. Some of these advantages are listed below.
 Error reduction—a well-planned computer system, with check
systems for errors, will help to alert the user of inconsistencies and
reduce the number of errors. It will also provide information that is
legible.
 Quality control management—it becomes easy to keep good
quality control records, perform analysis on quality control data
and y.
generate
statistics
automaticall 1 Information about this guidebook is available at: http://www.aphl.org/aphlprograms/global/initiatives/Pages/lis.aspx

17-4: Computerized laboratory information
 Provision of options for data searching—a variety of parameters

can be used for data retrieval; it is usually possible to access data by
name, by laboratory or patient number, and sometimes by test result
or analysis performed. This kind of data searching is almost
impossible with paper-based systems.
 Access to patient information—most computer systems allow
access to all recent laboratory data for a patient. This is very useful in
the process of checking the most recent results against previous
data to look for changes, which is a good practice and helps to
detect errors. Some computer systems give enough information to
determine the admitting diagnosis or access other useful
information related to the illness.
 Generate reports—it is easy to generate detailed, legible reports
quickly. A LIMS will provide standardized (or customized) reports.
 Ability to track reports—a computer system makes it much easier
to track reports, to know when work was finished, who performed the
work, when the data was reviewed and when the report was
sent.
 Ability to track and analyze trends—the computer and its
databases provide very strong search capabilities and, with careful
design, it will be possible to retrieve and use large amounts of data
effectively to track and analyze trends of various kinds.
 Improved capability for maintaining patient confidentiality—it is often
easier to maintain confidentiality of laboratory data when using a
computer than when dealing with a handwritten report form, if computer
user codes are established to control access to the data.
 Financial management—some systems will allow for financial
management; for example, patient billing.
 Integration with sites outside the laboratory—a LIMS can be set up so
that data comes into the laboratory system directly from a patient or
client registration point. Data can be transmitted to many sites or
interfaces as needed. Results can be provided directly to computers
accessible to the health care provider or public health official.
Computers can handle data entry into a national laboratory database
and almost any other data application that is needed.
Disadvanta  Manufacturer-provided training—purchased LIMS often include on-site
training for staff. To make the full use of the system, it is essential that
ges
either on-site training of all staff, or training at the manufacturer’s
headquarters, is provided.
It is important to remember that, in spite of all of the advantages,

computers do have disadvantages. Some of these are as follows:
 Training—personnel training is required and, because of the
complexity of LIMS, this training can be time-consuming and
expensive.
 Time to adapt to a new system—when starting up a computer
system, it may seem inconvenient and unwieldy to laboratory staff.
Personnel accustomed to manual systems may be challenged by
such tasks as correcting errors, and uncertain of how to proceed
when encountering situations where a field must be filled in.

205
 Cost—purchase and maintenance are the most expensive parts of a

computerized system, and the costs can be prohibitive in some settings.
Additionally, some settings will not have good maintenance that is
locally available. Surprisingly, computers use lots of paper, and the
cost of materials must be planned for, as this can add up. Also
remember that technology changes rapidly, and the life of a computer
may not be more than a few years. This might require repurchase of
computer equipment periodically in order to remain current and
compatible with other systems.
 Physical restrictions—adequate space and dedicated electrical
requirements are necessary, as well as placement of the computer away
from heat, humidity and dust.
 Need for backup system—all computer information must be carefully
backed up. Loss of data due to a damaged disk or system crash cannot
be tolerated, and backup systems will be critical.
17-5 : Summary
Informatio Information management is a system that incorporates all the
n processes needed for effectively managing data—both incoming
manageme and outgoing patient information. The system can be entirely paper-
nt based, or it can be partly paper-based with some computer support, or it
system may be entirely electronic.
For either paper-based or computer systems, unique identifiers for

patient samples will be needed. Standardized test request forms, logs
and worksheets are also important to both systems. In helping to
prevent transcription errors, a checking process is beneficial.
When considering adding a computer-based system to a laboratory,

cost is a big factor. In implementation, careful planning and training will
help to ensure good results.
A good information management system will:

Key  ensure that all data—the final product of the laboratory—is well managed;
messages  consider all the ways laboratory data will be used when planning a
system;
 ensure the accessibility, accuracy, timeliness and security of data;
 ensure confidentiality and privacy of patient information.
18. Organization
18-1 : Organizational requirements for
a quality management system
Definitio The term organization in the
n context of a quality management
model is used
to indicate the management and
the supporting organizational
structure of the laboratory.
Purchasin
Proces Informatio
g and
Organization is one of the inventory
s n
contro manageme
essential elements of the quality l nt
system, and is intimately related to
all the other elements in the model. Documen
ts
Occurrenc
e
and Assessment
record management
s
Facilitie
Process Custom
s and
improveme er
safety
nt servic
e
Characteristi The principal element for a successful quality management system is

cs managerial commitment.
essential  Management at all levels must fully support and actively participate in
to the quality system activities.
success  Support should be visible to staff so that there is an
understanding of the importance of the effort.
 Without the engagement of management, including the decision-
making level of the organization, it will not be possible to put in place the
policies and the resources needed to support a laboratory quality
management system.
A second vital element is that the organizational structure must

be designed to ensure that the quality goals of the organization are
met.
 The laboratory must be a legally structured entity according
to local requirements.
 All the organizational elements required to ensure a properly
functioning quality management system must be in place.
18-1: Organizational requirements for a quality management system
definition
Ke The important organizational requirements for achieving a successful

y quality system include the following:
organization  Leadership—laboratory leaders must be fully committed to
al implementation of the system, and these leaders will also need
componen vision, team-building and motivational skills, good communication
ts techniques, and the ability to use resources responsibly.
 Organizational structure—the structure of the organization
should be clearly defined, and this should be reflected by a functional
organizational chart with clear assignment of responsibility.
 Planning process—skills for planning are needed, and planning
should address a time frame, responsibility for conducting the activities,
the availability and use of human resources, management of workflow
and financial resources.
 Implementation—implementation requires that a number of
issues must be addressed by the management staff.These include
management of projects and activities, directing resources to
accomplish plans, and ensuring that timelines are met and goals
achieved.
 Monitoring—as components of the quality management system
are put in place, processes for monitoring will be needed to
ensure that the system is working, and that benchmarks and
standards are being met. This element is essential to the primary
goal of a quality system, which is continuous improvement.
211
18-2 : Management role
Providin Leadership can be defined in many ways, but it is an important
g factor in the success of any organization’s efforts for improvement.
leadershi
p A good leader will exercise responsible authority. Important roles for
a leader include:
 providing vision
 giving a direction for goal-setting
 motivating staff
 providing encouragement.
A strong leader will help staff understand the importance of the task at
hand.
ISO 15189 [4.1.5] states that “Laboratory management shall have

Responsibilities of responsibility for the design, implementation, maintenance, and
managers improvement of the quality management system”.
A quality management system outlines specific responsibilities of

managers. Management must be responsible for:
 establishing the policies and processes of the quality system;
 ensuring all policies, processes, procedures, and instructions are
documented;
 making sure that all personnel understand documents, instructions,
and their duties and responsibilities;
 providing personnel with the appropriate authority and resources to
carry out their duties.
Management is charged with providing a quality manual which

describes the quality management system.The quality manual is the
means by which the policies are established and communicated to the
staff and the users of the laboratory.
Laboratory directors have the principal responsibility for setting

up an organization that can support the quality system model. They
are responsible for developing policies, assigning authority and
responsibility to the appropriate persons, ensuring resources and
reviewing the organizational aspects of the system for optimal
functioning of quality processes. Laboratory directors must ensure that
staff follow the quality policies established by the quality manual.
Quality managers assist in developing policies, planning and

implementing the quality management system. They are usually
responsible for many of the implementing and monitoring processes, and
must communicate all aspects of the quality management system
processes to the laboratory director or head of the laboratory.
18-2: Management role
Laboratory staff (laboratorians) are responsible for

understanding the organizational structure of the laboratory,
including where authority and responsibility are assigned.The laboratory
staff will follow all of the quality policies in their daily work routine.
Commitment Most critical in beginning any new programme is to seek approval from
of the top. Management needs to be involved at a sufficiently high level
manageme to assure success of the programme. When implementing a quality
nt system, determine what the “sufficiently high level” is; be sure to include
those who make decisions as their approval and support is vital. Finally, it
is important that laboratory managers communicate their commitment
to the entire laboratory staff. Managers must show the way, and
encourage and foster the “spirit” of the organization.
213
18-3 : Organizational structure
Elements When considering organizational structure to support a quality
of management system, a number of elements should be considered:
structur  The path of workflow is the route of a sample through the
e laboratory, from collection to reporting of a result.The organizational
structure of the laboratory must support an optimal path of workflow,
by allowing processes that yield efficient sample handling while
minimizing error. Considerable attention should be given to the
design of this system.
Test
The patient selectio
Sampl
n
e
P collectio
n Sampl
e
transpor
t
Laboratory analysis
Examination phase
Repor
t
creatio
n
Report
transpo
rt
 An accurate and complete organizational chart is necessary. Many

problems can be prevented if responsibilities are clearly defined and
all members of the laboratory team understand what each is
supposed to do.
HOSPITAL DIRECTOR
LABORATO
NURSIN
RY
G
DIRECTO
DIRECTO
R
R
Charge
Quality manager
technologi
st
Assistant
NURSING

18-3: Organizational structure
 A quality management system must have a quality manager.

 Resource allocation must be sufficient to ensure that personnel
and infrastructure needs are met.
Qualit ISO 15189 [4.1.5 i] states that a laboratory must have a quality
y manager. The quality manager is the person most directly
manag responsible for ensuring that the quality policies and procedures
er are carried out.
The quality manager should sit high in the organizational structure; they
must be delegated the appropriate responsibility and authority to
ensure compliance to the quality system requirements. The quality
manager should report directly to the decision maker(s) in the
organization.
A very large laboratory may need several quality managers, perhaps one for
each section. On the other hand, in a small laboratory this may be a
part-time job for a senior technologist, or even a job that is carried out by
the laboratory manager.
The quality manager may be assigned many tasks. Some typical

responsibilities of the quality manager will include:
 monitoring all aspects of the quality system;
 ensuring staff are following quality policies and procedures;
 regularly reviewing all records; for example, quality control and external
quality assessment that are part of the quality system;
 organizing internal audits and coordinating external audits;
 investigating any deficiencies identified in the audit process;
 informing management on all aspects of the quality system monitoring.
18-4 : Organizational functions: planning
Approaches to Once management is committed to instituting a quality system in the
planning laboratory, a planning process is needed.Approaches used will vary,
depending on many factors in the local situation.
 What quality practices are already in use in the laboratory?
 What is the level of knowledge of current staff?
 What resources will be available?
All elements of the quality system should be included in the planning

process. It is not necessary (usually not possible) to implement all parts of
the plan at once; a stepwise approach will often be more practical.
In many laboratories, the implementation of a quality system may involve

many changes. It is therefore important to keep all staff involved, and to not
proceed too rapidly, as personnel may find it difficult to meet the goals and
can get discouraged. Communicate with staff frequently, clearly and
positively; this will help to keep morale high.
During planning, priority areas will emerge as the bigger problems are
identified. It will be important to keep objectives realistic and measurable.
Inevitably, there will be some factors that are beyond the control of the
laboratory. Recognize these and move on to other factors that can be
addressed. If these factors are vital to the ultimate success of the
quality programme, then look for ways to influence those who can
control them. Always advocate for quality.
Establish a
In planning for implementation of a quality system, the first step is to
plan
analyze and understand the current practices.A useful way to accomplish
this is the technique of gap analysis.To conduct a gap analysis:
 use a good quality systems checklist to evaluate the practices in the
individual laboratory;
 identify gaps or areas where the laboratory is not using the good
laboratory practices required in the quality system.
Using the information provided by the gap analysis, develop a task list of
everything needing to be addressed, and then set priorities. In
determining priorities, consider first addressing problems that can be
easily fixed; this will give some early successes and boost staff morale.
Also evaluate what would have the most impact on laboratory quality and
give these factors high priority.
18-4: Organizational functions: planning
Problems commonly identified in laboratories using a gap analysis include:

 test ordering
 sample management
 incompetent technical staff
 quality control
 analytical process
 recording and reporting results
 reagent and equipment management.
The The implementation of a quality system in the laboratory requires a

quality written plan. A written plan makes clear to all staff and all users of
system the laboratory how the process will proceed.The plan should contain
plan the following components:
 objectives and tasks—what should be done;
 responsibilities—who will get the job done, who will be responsible;
 timeline—when will each task be worked on, when will it be completed;
 budget and resource needs—additional staff, training needs, facilities,
equipment, reagents and supplies, quality control materials;
 benchmarks—essential for monitoring progress in implementation.
The written plan should be made available to all laboratory staff, as

everyone must understand the plan and the process of
implementation.
217
18-5 : Organizational functions: implementation
Beginnin Once a plan has been written and agreed upon, implementation will begin.
g These suggestions will help the laboratory in this process:
implementati  Commit from the beginning to complete the project and achieve
on the established objectives. Go in with a positive attitude.
 Prepare to implement in stages. It is important to prevent staff
from getting discouraged, so choose manageable “bites” at the
beginning. Staggering start dates will also be helpful; use established
priorities to determine start dates.
 Determine resource requirements early in the process, and
secure the necessary resources before starting tasks. If working in
a highly resource- limited environment, choose as initial activities
those things that can be done with available funds and staff—there are
many such activities, such as improving documents, records, or
developing up-to-date and improved standard operating procedures.
 Engage all staff by communicating effectively. If training is needed
to have personnel understand the quality system and its goals, this
training should probably be done before starting other tasks.
As a part of the planning process, the laboratory will have established a

Following the timeline for tasks to be performed, including a projected completion
timeline date. This timeline is a critical part of the process, as it allows
everyone in the laboratory to observe progress.A Gantt chart
(shown below) is a very useful tool for visually representing the
proposed timeline; it shows tasks to be done, with times of
beginning and completion.
18-5: Organizational functions: implementation
The timeline should be very carefully prepared, so as to

allow appropriate times for completion. Do not let the
laboratory staff become overwhelmed with the tasks that
need to be accomplished.
Providin
g During the planning process, all additional resources that are needed
resourc will have been identified. As implementation begins, be sure that these
es resources are in place and available. Several kinds of resources need to
be considered:
 all financial requirements— establish a budget;
 personnel needs—are additional laboratory staff required, will training
be needed for any of the staff?
 facilities, equipment, supplies, and computer needs.
Monitoring Establishing a system for monitoring quality management is

basics essential in implementing a quality system. It is the monitoring and
maintenance part of the effort that will produce the continuous
improvement that is the overall goal of a good quality system.
Monitoring involves being able to check each part of the system to be
sure that the system is working properly.
Establishin
g a There are several steps in setting up a programme to monitor compliance to
monitoring the quality system.
programm  Assign responsibility for the process. Usually the quality manager
e will be the person who is primarily responsible for the monitoring
programme.
 Develop indicators or benchmarks using the laboratory quality
policy. These indicators will be monitored over time.
 Develop a system for the monitoring process; establish time or
frequency of checks, decide how the monitoring will be managed.
 Conduct an audit, followed by a management review; these
constitute two important tools in monitoring compliance.
Internal audits should be conducted at regular intervals. They are valuable for
evaluation, and they are required by ISO 15189.
Management reviews are a particularly valuable component of the

monitoring process. It is the responsibility of management to review all
appropriate quality systems information, and to look for opportunities for
improvement.
219
18-6 :The laboratory quality manual
Definitio The quality manual is a document which fully describes the quality
n management system of an organization. It is key to the process, serving as
a guide for the entire system. The manual will clearly lay out the quality
policies, and will describe the structure of the other laboratory
documents.
In a laboratory that is implementing a quality management system, there

must be a quality manual. However, there is considerable flexibility in
how to prepare it, and a laboratory can construct the manual so that it
is most useful and suited to the local need (see Chapter 16 for
additional information).
ISO 15189 [4.2.4] requires that laboratories have a quality manual,

although style and structure are not specified.
Writing a quality
manual The purpose of a quality manual is to clearly communicate information,
and to serve as a framework or roadmap for meeting quality system
requirements. The manual is the responsibility of laboratory
management, and thus conveys managerial commitment to quality and
to the quality management system.
The manual should contain the following:

 All quality policies of the laboratory—these should address all 12
essential elements of the quality system.
 A reference to all processes and procedures—for example, standard
operating procedures (SOPs) are a part of the overall quality system.
There are usually too many to include directly in the quality manual,
but the manual should say that all procedures must have an SOP and
that these can be found in the SOP manual.
 A table of contents—ISO 15189 provides a suggested table of
contents, and this includes a description of the laboratory, staff
education and training policies, and all the other elements of a quality
management system (e.g. documents and records).
18-6:The Laboratory quality manual
Maintaining The quality manual is the framework for the entire quality management
and using the system, therefore it must always be correct and up to date. The
quality laboratory will need to establish a process to ensure this. The following
manual steps offer suggestions for developing, maintaining and using the quality
manual.
 When the quality manual is written and prepared, it must be approved

by the head of the laboratory. In some laboratories, approval by
another appropriate person, such as the quality manager, might also be
required.This approval should be indicated by having official signatures
and dates of signing recorded in the manual itself.
 A process or system for updating needs to be established. This

system should specify the frequency for reviewing the manual, assign
responsibility for updating to someone (usually the quality manager),
and define how changes in the manual will be incorporated and
documented. Changes to the quality manual will need to be
approved; approval should be indicated by having signatures of the
person(s) with authority to make changes, and the date of the change,
recorded in the manual.
 Instruction on use of the manual should be provided to all

laboratory staff; laboratory personnel must understand that the
policies detailed in the quality manual are always to be followed.
18-7 : Summary
Steps As the laboratory moves from intent to action in the development of
for a quality management system, the major organizational steps will be to
organizati assign responsibility for implementation, allocate resources, develop and
on distribute a quality manual, begin implementation, and monitor
compliance with the quality policy and the quality management
system requirements.
Successful implementation of a quality management system requires

planning, management commitment, understanding the benefits, engaging
staff at all levels, setting realistic time frames and looking for ways to
continually improve.
Key Remember:
messages  Quality is not a science; it is a way of thinking.
 Time invested today will help gain quality results, professional and
personal satisfaction, and peer recognition.
 Everyone in the laboratory is responsible for quality performance:
- Laboratory leaders and managers must commit to meeting quality
needs.
- Laboratory personnel must follow all quality assurance
procedures and adhere to requirements and standards.
Glossary
 A
Accident An undesirable or unfortunate event that occurs
unintentionally.
Accreditation Procedure by which an authoritative body gives
formal recognition that a body or person is competent to carry
out specific tasks. Reference: ISO 15189:2007.
Accreditation (and certification) body An organization or
agency with the authorized right and authority to inspect a facility
and provide written evidence of its compliance (certification) and
competence (accreditation) with a standard.
Accuracy The closeness of a measurement to its true value.
Analytical phase See Examination.
Audit Systematic, independent and documented process for
obtaining evidence and evaluating it objectively to determine the
extent to which audit criteria are fulfilled. Reference: ISO 9000:2005.
 B
Benchmark A point of reference or a criterion of quality. A
benchmark is
intended to serve the user as a guide for measuring optimum
performance or to suggest solutions to problems or deficiencies. It
implies the best practice.
Bias Difference between the expectation of the test results and an
accepted reference value. Reference: ISO 15198:2004.
Biohazard An infectious agent, or part thereof, that presents a
real or potential risk to the well-being of humans, animals or plants. It
can present a hazard directly through infection or indirectly through
the disruption of the environment.
Biological safety cabinet An enclosure in which entry and
exhaust air is filtered through a high efficiency particulate air
(HEPA) filter to remove any particles from potential aerosols; used to
contain a biological hazard, protecting the operator and the
environment. Depending on the class of the safety cabinet, it may
or may not protect the actual biohazard itself from contamination.
Biological safety levels Also known as physical containment levels:
 Biological safety level 1 A laboratory that works with agents
not known to cause disease in healthy adults; standard
microbiological practices apply; no special safety equipment required;
sinks required.
 Biological safety level 2 A laboratory that works with agents
associated with human disease; standard microbiological practices
apply plus limited access, biohazard signs, sharps precautions and
biosafety manual required; biological safety cabinet used for
aerosol/splash-generating operations; laboratory coats, gloves,
face protection required; contaminated waste is autoclaved. An
appropriate ventilation system should be in place.

223
Gloss
 Biological safety level 3 A laboratory that works with

agents that may have serious or lethal consequences and with
potential for aerosol transmission; biological safety level 2
practices plus controlled access; decontamination of all waste and
laboratory clothing before laundering; determination of baseline
serums; biological safety cabinet used for all sample
manipulations; respiratory protection used as needed; physical
separation from access corridors; double-door access; negative
airflow into laboratory. The ventilation system must ensure removal of
particulates by filtering entry and exhaust air through HEPA filters.
 Biological safety level 4 A laboratory that works with dangerous
or exotic agents of life-threatening nature or unknown risk of
transmission; biological safety level 3 practices plus clothing change
before entering laboratory; shower required for exit; all materials are
decontaminated on exit; positive pressure personnel suit required for
entry; separated or isolated building; dedicated air supply and
exhaust with HEPA filters; and decontamination systems.
Biosafety The active, assertive, evidence-based process that
laboratorians use to prevent microbial contamination, infection or
toxic reaction as they actively manipulate live microorganisms or
their products, thus protecting themselves, other laboratory staff, the
public and the environment.
 C
Calibrators Solutions with specified defined concentrations that are
used to
set or calibrate an instrument, kit or system before testing is begun.
Calibrators are often provided by the manufacturer of an
instrument.
Certification Procedure by which a third party gives written
assurance that a product, process or service conforms to specific
requirements. Reference: ISO/IEC 17000:2004.
Certification (and accreditation) body An organization or
agency with the authorized right and authority to inspect a facility
and provide written evidence of its compliance (certification) and
competence (accreditation) with a standard.
Checklist A list used to ensure all important steps or actions in an
operation have been taken. Checklists contain items important or
relevant to an issue or situation.
Coefficient of variation (CV) The standard deviation (SD)
expressed as a percentage of the mean.
Competence Demonstrated ability to apply knowledge and skills.
Reference: 19011:2002.
Compliance An affirmative indication or judgement that the
supplier of a product or service has met the requirements of the
relevant specifications, contract or regulation; also the state of meeting
the requirements. Meets both the text and the spirit of a
Gloss
requirement.

Gloss
Confidentiality Pertains to the disclosure of personal

information in a relationship of trust, with the expectation that it will
not be divulged to others in ways that are inconsistent with the
original disclosure.
Consensus General agreement, characterized by the absence of
sustained opposition to substantial issues by any important part
of the concerned interests and by a process that involves seeking to
take into account the views of all parties concerned and to reconcile
any conflicting arguments. Reference: ISO/IEC Guide2:2004.
Continual/continuous improvement The cornerstone of
quality management systems; allows the laboratory to gain insights
from setting objectives, monitoring through audit and management
review, addressing complaints and nonconformities, and performing
client satisfaction surveys. A recurring activity to increase the ability to
fulfill requirements. Includes the steps Plan, Do, Check, Act.
Continuous quality improvement A philosophy and attitude
for analyzing capabilities and processes and improving them
repeatedly to achieve the objective of customer satisfaction.
Control chart A chart with upper and lower control limits on
which values of some statistical measure for a series of samples or
subgroups are plotted. The chart frequently shows a central line to
help detect a trend of plotted values toward either control limit.
Control material Substance, material or article used to
verify the performance characteristics of an in vitro diagnostic medical
device. Reference: ISO 15198:2004.
Controlled documentation A system for maintaining and
ensuring the proper use of time-sensitive or version-sensitive
documents.
Correction Action to eliminate a detected nonconformity.
Customer Organization or person that receives a product or
service from a supplier organization.
Customer satisfaction Customer's perception of the degree to
which the customer's requirements have been fulfilled. It can vary
from high satisfaction to low satisfaction. If customers believe that you
have met their requirements, they experience high satisfaction. If they
believe that you have not met their requirements, they experience low
satisfaction.
Gloss

225
Gloss
 D
Deming cycle for continuous improvement A visualization
of the
continuous quality improvement process usually consisting of
four points— Plan, Do, Check, Act—linked by quarter circles.The
cycle was first developed by Dr Walter A Shewhart, but was
popularized in Japan in the 1950s by Dr W Edwards Deming.
Deming's 14 principles The foundation of Deming's
philosophy.The points are a blend of leadership, management
theory and statistical concepts that highlight the responsibilities of
management while enhancing the capacities of employees.
Document Information and its supporting medium; digital or
physical. The International Organization for Standardization (ISO)
identifies five types of documents: specifications, quality manuals,
quality plans, records and procedure documents. See Normative
document and Standard document.
Documentation Written material defining the process to be followed.
 E
Error A deviation from truth, accuracy or correctness; a mistake; a
failure of
a planned action to be completed as intended, or the use of a wrong
plan to achieve an aim.
Event An occurrence of some importance and frequently having an
antecedent cause.
Examination 1. Activities and steps related to performing
laboratory examinations. 2. Set of operations having the object
of determining the value or characteristics of a property. In some
disciplines (e.g. microbiology) an examination is the total activity of
a number of tests, observations or measurements. Reference: ISO
15189:2007. 3. One phase of the three-phase framework for the
total testing process to describe issues related to the quality of
laboratory testing. Also referred to as an analytical phase. See Pre-
examination and Post-examination.
External quality assessment (EQA) A system for objectively
checking the laboratory’s performance using an external agency or
facility.
 F
False negative In the case of a clinical microbiology test, a negative
test
result for a person who is actually infected.
False positive In the case of a clinical microbiology test, a positive
test result for a person who is actually not infected.
Gloss

Gloss
Flowchart A graphical representation of the flow of a process. A

useful way to examine how various steps in a process relate to each
other, to define the boundaries of the process, to identify
customer and supplier relationships in a process, to verify or form
the appropriate team, to create common understanding of the
process flow, to determine the current best method of performing the
process, and to identify redundancy, unnecessary complexity and
inefficiency in a process.
Form Forms are the blank pages or computer screens, labels, or
tags on which data, information, or results are recorded. After data,
information, or results are entered onto a form, screen, label, or tag, it
becomes a record.
 G
Gantt chart A very useful tool for visually representing the proposed
time
line: it shows tasks to be done, with times of beginning and completion.
Gap analysis Planning tool used to compare the present/current
state with the future desired state. Basis for development of action
plans to address high-priority gaps.
 I
Incident An individual occurrence of brief duration or secondary
importance.
Incident report A document, usually confidential, describing any
accident or deviation from policies or orders involving a patient,
employee, visitor, or student on the premises of a health care
facility.
Indicators Established measures used to determine how well an
organization is meeting its customers' needs, as well as other
operational and financial performance expectations.
Infrastructure System of facilities, equipment and services needed
for the operation of an organization. Reference: ISO 9000:2005.
Informative statement Information within a document that is
informational only; often it is in the form of a "note". Information
may be explanatory or cautionary, or provide an example.
Inspection Examination of a product, process, service, or
installation or their design and determination of its conformity with
specific requirements or, on the basis of professional judgment, with
general requirements. Reference: ISO/ IEC 17020:2012.
Internal audit An audit carried out by the laboratory personnel
who examine the elements of a quality management system in their
laboratory in order to evaluate how well these elements comply with
quality system requirements.
Gloss

227
Gloss
ISO standards A set of international standards providing guidance

for quality in the manufacturing and service industries; developed
by the International Organization for Standardization (ISO) to help
companies effectively document the quality system elements to be
implemented to maintain an efficient quality system. The standards,
initially published in 1947, are not specific to any particular industry,
product or service; they are broadly applicable to many kinds of
organizations.
ISO 9001:2008 The most important and internationally well-
recognized series of standards for quality management are referred
to as the ISO 9000 series or family. It includes a series of policy
statements.
ISO 15189:2007 Standard for medical laboratories; a series of
policy statements.
 L
Laboratory director Person(s) with responsibility for, and authority
over, a
laboratory. Reference: ISO 15189:2007.
Laboratory manager Person(s) who manage the activities of a
laboratory headed by a laboratory director.
Laboratorian Person who works in a laboratory and is trained to
perform laboratory procedures.
Lean A system of methods that emphasize identifying and
eliminating all non-value-adding activities. Tools include S5—sort,
set, shine, standardize, sustain—and CANDO—clearing up,
arranging, neatness, discipline, ongoing improvement.An English
phrase coined to summarize Japanese manufacturing techniques
(specifically, the Toyota production system).
Licensure Granting of permission by a competent authority
(usually a government agency) to an organization or individual to
engage in a practice or activity.
 M
Management Coordinated activities to direct and control an
organization.
Reference: ISO 9000:2005.
Management review Evaluation of the overall performance
of an organization's quality management system and identification
of improvement opportunities. These reviews are carried out by
the organization's top managers and are done on a regular
basis.
Material safety data sheet (MSDS) Technical bulletin
providing detailed hazard and precautionary information.
Metric A measurement for standard of quality for comparing
Gloss
different items or time periods—you can't improve what you can't
measure. Decision makers examine the outcomes of various
measured processes and strategies and track the results to guide
the company and provide feedback.

Gloss
 N
Nonconformity Non-fulfilment of a requirement. Reference: ISO
9000:2005.
Normative document A document that provides rules,
guidelines or characteristics for activities or their results. It
covers such documents as standards, technical specifications, codes
of practice and regulations.
Normative statement Information within a document that is a
required and essential part of the standard. Includes the word “shall”.
 O
Occurrence An event, accident or circumstance that happened
without
intent, volition or plan.
Occurrence management A central part of continual
improvement; the process by which errors or near errors (also
called near misses) are identified and handled.
Organization Group of people and facilities with an
arrangement of responsibilities, authorities and relationships.
Organizational chart Defines the working structure for the
organization; organizes jobs along lines of authority; defines
reporting structure and span of control; defines authority to make
decisions and accountability for results; works together with job
descriptions to define the working structure of the organization.
Organizational structure The pattern of responsibilities,
authorities and relationships that control how people perform
their functions and govern how they interact with one another.
 P
Path of workflow (clinical laboratory) Sequential processes in
pre-
examination, examination and post-examination clinical laboratory
activities that transform a physician's order into laboratory
information.
PDCA Plan, Do, Check,Act (quality improvement tool).A checklist of
the four stages which you must go through to get from "problem
faced" to "problem solved". See Deming cycle for continuous
improvement.
Policy An overarching plan (direction) for achieving an organization's
goals.
Post-examination (also post-analytical phase) Processes
following the examination including systematic review, formatting
and interpretation, authorization for release, reporting and
transmission of the results, and storage of samples after the
Gloss
examinations. One phase of the three-phase framework for the
total testing process to describe issues related to the quality of
laboratory testing.

229
Gloss
Precision Closeness of agreement between quantity values

obtained by replicate measurements of a quantity, under specified
conditions. See Quantitative examination.
Pre-examination (also pre-analytical phase) Steps, in chronological
order from the clinician’s request, including the examination
requisition, preparation of the patient, collection of the primary
sample, and transportation to and within the laboratory, and ending
when the examination phase begins. One phase of the three-phase
framework for the total testing process to describe issues related to
the quality of laboratory testing.
Preventive action Plan steps that are taken to remove the causes
of potential nonconformities or to make quality improvements.
Preventive actions address potential problems, ones that have not yet
occurred. In general, the preventive action process can be thought
of as a risk analysis process.
Problem solving The act of defining a problem; determining the
cause of the problem; identifying, prioritizing and selecting alternatives
for a solution; and implementing a solution.
Process The use of resources to transform inputs into outputs. In
every case, inputs are turned into outputs because some kind of work,
activity, or function is carried out.
Process control Concerns monitoring all operations of the
laboratory.
Process improvement Process management focused on reducing
variation and improving process effectiveness and efficiency.
Reference: ISO 3534- 2:2006.
Product Result of a process; may be services, software, hardware
or processed materials, or a combination thereof.
Proficiency testing 1. ISO Guide: 43 (EA-2/03): Proficiency testing
schemes are interlaboratory comparisons that are organized
regularly to assess the performance of analytical laboratories and
the competence of the analytical personnel. 2. CLSI definition: “A
program in which multiple samples are periodically sent to
members of a group of laboratories for analysis and/or identification;
whereby each laboratory’s results are compared with those of other
laboratories in the group and/or with an assigned value, and
reported to the participating laboratories and others”. See External
quality assessment.
Project Unique process, consisting of a set of coordinated and
controlled activities with start and finish dates, undertaken to
achieve an objective conforming to specific requirements, including
the constraints of time, cost and resources. Reference: ISO
9000:2005.
 Q
Gloss
Qualitative examination Measurement of the presence or
absence of a

Gloss
substance, or evaluation of cellular characteristics such as morphology.

The results are not expressed in numerical terms, but in qualitative
terms such as “positive” or “negative”; “reactive” or “nonreactive”;
“normal” or “abnormal”; and “growth” or “no growth”.
Quality Degree to which a set of inherent characteristics fulfils
requirements. Reference: ISO 9000:2005.
Quality assurance A planned and systematic set of quality
activities focused on providing confidence that quality requirements
will be fulfilled.
Quality audit (also quality assessment or conformity
assessment) A systematic and independent examination and
evaluation to determine whether quality activities and results comply
with planned arrangements, and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Quality control A set of activities or techniques whose purpose is
to ensure that all quality requirements are being met. Simply put, it is
examining “control” materials of known substances along with
patient samples to monitor the accuracy and precision of the
complete examination process.
Quality improvement Part of quality management focused on
increasing the ability to fulfil quality requirements. Reference: ISO
9000:2005.
Quality indicator Established measure used to determine how
well an organization meets needs and operational and performance
expectations.
Quality management Coordinated activities that managers carry
out in an effort to implement their quality policy.These activities include
quality planning, quality control, quality assurance and quality
improvement. See Quality system essentials.
Quality management standards (such as ISO 9001:2008
and ISO 15189:2007) A series of policy statements. Required
statements include the term “shall”. Full compliance with the
standard requires that all “shall” statements are implemented. Were
the laboratory to be inspected to ensure compliance with the
standard, the auditor or inspector would expect to see evidence that
each required policy was being met. “Shall” statements are often
supplemented by notes or comments that often contain examples or
statements using the term “should”. These statements are intended to
give guidance on what would be considered as reasonable
activities, content or structure to demonstrate that the “shall”
statement is being followed. The organization is not required to
meet all the comments, suggestions or recommendations included
within these notes or commentary.
Quality management system Coordinated activities to direct
and control an organization with regard to quality.
Quality manual Document specifying the quality management
Gloss
system of an organization. Reference: ISO 9000:2005.

Gloss
Quality plan Document specifying which procedures and

associated resources shall be applied, by whom, and when, to a
specific project, product, process or contract. Reference: ISO
9000:2005.
Quality policy Overall intentions and direction of an organization
related to quality as formally expressed by top management.
Quality record Objective evidence which shows how well a
quality requirement is being met or how well a quality process is
performing. It always documents what has happened in the past.
Quality system The defined organizational structure,
responsibilities, processes, procedures and resources for
implementing and coordinating the quality assurance and quality
control activities.
Quality system audit A documented activity performed to
verify, by examination and evaluation of objective evidence, that
applicable elements of the quality system are suitable and have been
developed, documented and effectively implemented in accordance
with specified requirements.
Quality system essentials The necessary infrastructure or
foundational building blocks in any organization that need to be in
place and functioning effectively in order to support the
organization’s work operations so that they proceed smoothly. See
Quality management. CLSI developed the quality management
framework and organized the topics as the "12 Quality System
Essentials" based on both ISO 15189 and CLSI GP26-A3
documents.
Quality system review A formal evaluation by management of
the status and adequacy of the quality system in relation to quality
policy and/or new objectives resulting from changing
circumstances.
Quality tools The diagrams, charts, techniques and methods that,
step by step, accomplish the work of quality improvement.
Quantification A process for calculating how much is required
of any particular item for a given period of time.
Quantitative examination Measures the quantity of an
analyte present in the sample. The measurement produces a numeric
value as an end-point, expressed in a particular unit of
measurement.
 R
Record Document stating results achieved or providing evidence of
activities
performed. Reference: ISO 9000:2005. Information captured on
worksheets, forms and charts.
Gloss
Referral laboratory External laboratory to which a sample is
submitted for a supplementary or confirmatory examination
procedure (Reference: ISO 15189:2007), or for testing not performed
in the originating laboratory.
Regulation Any standard that is mandated by a governmental
agency or authoritative body.

Gloss
Requirement A need, expectation or obligation. It can be stated or

implied by an organization, its customers or other interested
parties.There are many types of requirements; some of these include
quality requirements, customer requirements, management
requirements and product requirements.
Risk The combination of severity of harm and probability of
occurrence of that harm.
Risk analysis The systematic use of available information to
identify hazards and estimate the risk.
Risk assessment Identifying potential failure modes,
determining severity of consequences,identifying existing
controls,determining probabilities of occurrence and detection, and
evaluating risks to identify essential control points.
Risk management The identification, analysis and economic
control of those risks which can threaten the assets or earnings of
an enterprise.
Root cause A factor that caused a nonconformity and should be
permanently eliminated through process improvement.
Root cause analysis A tool designed to help identify not only what
and how an event occurred, but also why it happened.
 S
Safety Those processes implemented to protect laboratory workers,
visitors,
the public and environment.
Sample (also specimen) One or more parts taken from a system
and intended to provide information on the system, often to serve
as a basis for decision on the system or its production. Reference:
ISO 15189:2007.
Semiquantitative examination Test whose results are
expressed as an estimate of how much of the measured
substance is present.
SI units Modernized metric system, called SI from the French name,
le Système International d'Unités.
Six Sigma A quality process that measures defects in parts per
million; stands for six standard deviations (sigma is the Greek letter
“s” used to represent standard deviation in statistics) from the
mean. Six Sigma methodology provides the techniques and tools
to improve the capability and reduce the defects in any process by
constantly reviewing and retuning the process.
Specimen See Sample.
Standard document A document established by consensus
and approved by a recognized body that provides, for common and
repeated use, guidelines or characteristics for activities or their
Gloss
results, aimed at the achievement of the optimum degree of
order in a given context.
Statistical tools Methods and techniques used to generate,
analyze, interpret and present data.

233
Gloss
Supplier Organization or person that provides a product or service.

Survey The act of examining a process or of questioning a selected
sample of individuals to obtain data about a process, product or service.
 T
Task A specific, definable activity to perform an assigned piece of work,
often
finished within a certain time.
Team A group of individuals organized to work together to
accomplish a specific objective.
Test Determination of one or more characteristics according to a
procedure. Reference: ISO 9000:2005.
Traceability Ability to trace the history, application or location of
that which is under consideration.
Turnaround time Length of time that a sample’s final result may
be issued to the ordering physician.
 U
Universal precautions An approach to infection control in which all
human
blood and certain human body fluids are treated as if known to be
infectious.
 V
Validation Confirmation, through provision of objective evidence, that
the
requirements for a specific intended use or application have been
fulfilled. Reference: ISO 15198:2004.
Verification Confirmation, through provision of objective
evidence, that specified requirements have been fulfilled. Reference:
ISO 15198:2004.
Verification of conformity Confirmation, by examination of
evidence, that a product, process or service fulfils specified
requirements.
Vision An overarching statement of the way an organization wants
to be; an ideal state of being at a future point.
 W
Waste Any activity that consumes resources and produces no added
value to
the product or service a customer receives.
Work environment All the factors that influence work; these
include social, cultural, psychological, physical and environmental
conditions.The term work environment includes lighting, temperature,
Gloss
and noise factors, as well a well as the whole range of ergonomic
influences. It also includes things like supervisory practices, as well
as reward and recognition programmes. All of these things
influence how work is performed.

Acronyms
 A
AFB acid-fast bacilli
ANSI American National Standards Institute
ASQ American Society for Quality
 C
CDC Centers for Disease Control and Prevention (United States of
America)
CEN Comité Européen de Normalisation (European

Committee for Standardization)
CLIA Clinical Laboratory Improvement Amendments (United States,

1988)
CLSI Clinical and Laboratory Standards Institute (Wayne,

Pennsylvania, United States of America), uses a consensus process
to develop standards
CLSI GP26-A3 Application of a quality management system

model for laboratory services (quality document)
CLSI HS1 A quality management system model for health care (quality
document)
 D
DNA deoxyribonucleic acid
 E
ELISA enzyme-linked immunosorbent assay
EQA external quality assessment

235
Acronyms
 H
HIV human immunodeficiency virus
 I
IATA International Air Transport Association
IEC International Electrotechnical Commission. IEC is the world's

leading organization that prepares and publishes International
Standards for all electrical, electronic and related technologies.
ISO International Organization for Standardization
 L
LIMS laboratory information management system
 M
MSDS material safety data sheet
 N
NCCLS National Committee for Clinical Laboratory Standards
(former name of Clinical and Laboratory Standards Institute)
 P
PDCA Plan, Do, Check, Act (quality improvement tool)
PT proficiency testing
 Q
QC quality control
 S
SD standard deviation
 W
WHO World Health Organization

References and resources by
chapter
There are two International Organization for Standardization (ISO)
standards that are specific to laboratories and the Clinical and Laboratory
Standards Institute (CLSI) has two documents that are very important in the
clinical laboratory. These four documents are referred to throughout each of the
18 chapters and are therefore not cited in the individual chapters listed
below.
•ISO 15189:2007. Medical laboratories—Particular requirements for quality and
competence. Geneva, International Organization for Standardization, 2007.
•ISO/IEC 17025:2005. General requirements for the competence of testing and
calibration laboratories. Geneva, International Organization for Standardization,
2005.
•CLSI/NCCLS. Application of a quality management system model for laboratory
services; approved guideline—3rd ed. GP26-A3.Wayne, PA, NCCLS, 2004.
•CLSI/NCCLS. A quality management system model for health care; approved
guideline—2nd ed. HS1-A2.Wayne, PA, NCCLS, 2004.
Chapter 1 Introduction to quality

Crosby PB. Quality without tears: the art of hassle-free management. New York,
McGraw-Hill, 1995.
Deming WE. Out of the crisis. Cambridge, MIT Press, 1982.
ISO 9000:2005. Quality management systems–Fundamentals and vocabulary.
Geneva, International Organization for Standardization, 2005.
ISO 9001:2008. Quality management systems–Requirements. Geneva,
International Organization for Standardization, 2008.
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D.Van Nostrand Company, 1931.
Shewart WE. Statistical methods from the viewpoint of quality control, WE
Deming, ed., Washington, DC, Graduate School, Department of Agriculture,
1939. Reprinted New York, Dover Publications Inc, 1986.
Walton M. The Deming management method. New York, Perigee Books, 1986.
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en.pdf, accessed 11 April 2011).
Chapter 2 Facilities and safety

CDC and NIH. Biosafety in microbiological and biomedical laboratories, 4th ed.
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and Human Services, Public Health Service, Centers for Disease Control and
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infections: history, incidence, causes and preventions, 4th ed. Oxford, United
Kingdom, Butterworth- Heinemann, 1999:1–37.
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Fleming DO, Hunt DL, eds. Biological safety: principles and practices.
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Howard Hughes Medical Institute, Office of Laboratory Safety. Laboratory safety
study 1993–1997 (http://www.hhmi.org/).
ISO 15190:2003. Medical laboratories–Requirements for safety. Geneva,
ISO 3864-1:2002. Graphical symbols—Safety colours and safety signs—Part 1:
Design principles for safety signs in workplaces and public areas. Geneva,
ISO 3864-3:2006. Graphical symbols—Safety colours and safety signs—Part 3:
Design principles for graphical symbols for use in safety signs. Geneva, International
Internationally recognized labels:
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April 2011)
 http://ehs.unc.edu/labels/bio.shtml (accessed 11 April 2011)
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11 April 2011).
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April 2011).
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665.
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Chapter 3 Equipment
King B. NIOSH Health Hazard Evaluation Report No. 2004-0081-3002. NewYork
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installation and use of biological safety cabinets, 2nd ed. United States Government
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Chapter 4 Purchasing and inventory

WHO.Guidelines for health care equipment donations.Geneva,World Health
Organization,2000 (http://www.who.int/hac/techguidance/pht/en/1_equipment
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Chapter 5 Process control—sample management

ICAO. Technical instructions for the safe transport of dangerous goods by air,
2007–2008 ed. (Doc 9284). Montreal, Canada, International Civil Aviation
Organization, 2006.
ISO 15394:2000. Packaging—Bar code and two-dimensional symbols for shipping,
transport and receiving labels. Geneva, International Organization for Standardization,
2000.
ISO 21067:2007. Packaging—Vocabulary. Geneva, International Organization
for Standardization, 2007.
UN. Recommendations on the transport of dangerous goods: model regulations,15th
revised ed. New York, Geneva, United Nations, 2007.These recommendations
include:
•UN 2900 Infectious substances affecting humans—infectious
substances included in Category A in any form unless otherwise
indicated;
•UN 2900 Infectious substances affecting animals only—"Exempt" human
or animal samples;
•Shipper’s Declaration for Dangerous Goods Form;
•Flowchart for Classification of Infectious Agents for Transport;
•Packaging and Labeling of Category A Infectious Substances;
•Packaging and Labeling of Category B Infectious Substances;
•Packaging and Labeling of Exempt Substances;
• Thermal Control Shipping Unit;
•Dry Ice Shipping Label.
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Chapter 6 Process control—introduction to quality

control
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Chapter 7 Process control—quality

control for quantitative tests
CLSI. C24-A3—Statistical quality control for quantitative measurement procedures:
principles and definitions, approved guideline—3rd ed. Wayne, PA, Clinical and
Laboratory Standards Institute, 2006.
ISO 15198:2004. Clinical Laboratory medicine-In vitro diagnostic medical devices-
Validation of user quality control procedures by the manufacturer. Geneva,
Chapter 8 Process control—quality

control for qualitative and
semiquantitative procedures
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2nd ed. EP12-A2 (electronic document). Wayne, PA, Clinical and Laboratory
Standards Institute, 2008.
CLSI. Abbreviated identification of bacteria and yeast, approved guideline—2nd ed.
M35-A2. Wayne, PA, Clinical and Laboratory Standards Institute, 2008.
CLSI. Performance standards for antimicrobial disk susceptibility tests, approved
standards— 18th informational supplement. M100-S18. Wayne, PA, Clinical and
Laboratory Standards Institute, 2008.
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methods. In: Murray PR et al. (eds). Manual of Clinical Microbiology, 9th ed.
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Turnidge JD, Ferraro MJ, Jorgensen JH. Susceptibility test methods: general
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Chapter 9 Assessment—audits
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novel approach. World Health Organization Regional Office for South-East Asia, 2005
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April 2011).

Chapter 10 Assessment—external quality assessment

APHL. External quality assessment for AFB smear microscopy. Silver Spring,
MD,Association of Public Health Laboratories, 2002
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and Prevention/Geneva, World Health Organization, 2005 (http://
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ed. GP27-A2.Wayne, PA, Clinical and Laboratory Standards Institute, 2007.
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approved guideline—2nd ed, GP29-A2.Wayne, PA, Clinical and Laboratory
Standards Institute, 2008.
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quality and competence. Geneva, International Organization for Standardization,
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Geneva International Organization for Standardization, 2004.
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Part 1: Development and operation of proficiency testing schemes. Geneva,
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Mexico. International Journal of Tuberculosis and Lung Diseases, 2005.9(3):301-
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WHO. Accreditation of health laboratories in the countries of the SEA region: report of a
regional consultation, Bangkok, Thailand, 6–10 October, 2003. WHO Project: ICP
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WHO. Policy and procedures of the WHO/NICD microbiology external quality
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Chapter 11 Assessment—norms and accreditation

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addresses (http://www.dar.bam.de/indexe.html).
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Kumari S, Bhatia R. Guidelines for peripheral and intermediate laboratories in quality
assurance in bacteriology and immunology. World Health Organization Regional
Office for South-East Asia, Series No. 28, 2003.
Silva P. Guidelines on establishment of accreditation of health laboratories. World
Health Organization Regional Office for South-East Asia, 2007.
WHO. Accreditation of health laboratories in the countries of the SEA region: report of a
regional consultation, Bangkok, Thailand, 6–10 October 2003. WHO Project ICP
BCT 001. World Health Organization Regional Office for South-East Asia, 2004,
SEA-HLM-379.
WHO. Handbook: Good laboratory practice—quality practices for regulated nonclinical
research and development. UNDP/World Bank/WHO Special Programme for
Research and Training in Tropical Diseases. Geneva, World Health Organization,
2001 (http://www.who.int/tdr/
svc/publications/training-guidelinepublications/good-laboratory-practice-
handbook).
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Chapter 12 Personnel
Bello M. Employee handbook. eScholarship Repository, University of California, 2008
(http:// repositories.cdlib.org/lbnl/LBNL-937E).
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ISO 10001:2007. Quality management—Customer satisfaction—Guidelines for codes
of conduct for organizations. Geneva, International Organization for
Chapter 14 Occurrence management

Bonini P et al. Errors in laboratory medicine. Clinical Chemistry, 2002, 48:691–698
(http:// www.clinchem.org/cgi/content/full/48/5/691).
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management and continual improvement. Geneva, International Organization for
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PhilipCrosby/QualityManagementTheRealThing.pdf).
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(http://cdc.confex.com/cdc/qlm2005/techprogram/paper_9086.htm).
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Chapter 16 Documents and records

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analysis/LIMS_example. html#BM1_).
Chapter 18 Organization

Glossary
The definitions provided in the glossary come from the references mentioned
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Standards Institute/American Society for Quality Control, 1987.
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September 2012).
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Milwaukee, WI, 2005.

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Laborator

ISBN 978 92 4 154827 4 (NLM classification: QY 25) Version 1.1

© World Health Organization 2011

WHO Lyon Office – International Health Regulations

CDC – National Center for Preparedness, Detection and Control of

Clinical and Laboratory Standards

Laboratory Quality Management System 3

8. Process control—quality control for qualitative and

Laboratory Quality Management System

Laboratory Quality Management System 5

6 Laboratory Quality Management System

Organization Personnel Equipment

Purchasing and inventory

Documents and records

Facilities and safety

These consequences result in increased cost in time and personnel

10 Laboratory Quality Management System

Laboratory Quality Management System

ISO standards group laboratory processes into pre-examination,

quality organized into an

managed is increased. The

Organization Assuring accuracy and reliability throughout the path of workflow

In order to have a functioning quality management system, the

Equipment The most important laboratory resource is competent, motivated

Laboratory Quality Management System

The elements of process control are very familiar to laboratorians;

14 Laboratory Quality Management System

Proces The primary goal in a quality management system is continuous

The concept of customer service has often been overlooked in

Laboratories not implementing a good quality management system

Laboratory Quality Management System

Quality management is not new.

Important Using a set of standards established by the United States of America

Laboratory Quality Management System

Key  A laboratory is a complex system and all aspects must function

nt without compromising the

and biological hazards.

substances. As a general rule, all diagnostic laboratories should be

Importance of A laboratory safety programme is important in order to protect the

Responsibiliti Ensuring quality and safety during laboratory processes is a major

20 Laboratory Quality Management System

As a quality manager (or designated safety officer), it is necessary

As a laboratorian, it is important to:

Everyone in the laboratory is responsible for quality and

Access to rooms where manipulation or analysis of samples takes

For the most efficient design, all related services should be

22 Laboratory Quality Management System

Laboratory Quality Management System

24 Laboratory Quality Management System

Laboratory Quality Management System

 preventing inhalation exposure by using chemical fume hoods or

conducted by Repetitive stress 8%

the Howard Needle puncture 7%

chart.This study Allergy 1%

Physic Laboratory equipment is a significant source of potential injury to

Storage of compressed gases in the laboratory requires precautions

Laboratory Quality Management System

Laboratory glassware and plasticware are not considered to be sharps

To prevent or reduce incidents caused by exposure to toxic chemicals, all

28 Laboratory Quality Management System