MEDICAL LABORATORY

NATIONAL GUIDELINES FOR SETTING UP A MEDICAL

SCIENCE COUNCIL OF LABORATORY IN NIGERIA
NIGERIA

DECEMBER 2012
 Foreward Acknowledgment
The World Health Organization (WHO) recognizes quality laboratory The MLSCN sincerely appreciates the efforts of all that contributed to the
services as key to improving global health and reaching Millennium successful development of this document.
Development Goals. Strengthening the breadth of laboratory services
accessible to clients, and ensuring that results are accurate, reliable,
reproducible, and rapid enough to be useful, is crucial to improved health We appreciate the tremendous efforts of the United States Government
outcomes. through US Centers for Disease Control and Prevention (CDC) for funding
Until recently, however, the majority of public health laboratories in the MELTNA (Mentoring Laboratories towards National Accreditation)
Nigeria delivered suboptimal service and were not in a position to project. We also appreciate the technical and logistics support of all CDC,
contribute to a quality health system. Many performed poorly, hindered USAID and DOD implementing partners.
by dilapidated infrastructures, and poor development and
implementation of quality management systems (QMS), including
inadequate participation in external quality assessment (EQA) programs.
Council under section 4(h) and 19(d) of MLSCN Act 2003 is mandated to
inspect, approve, monitor and accredit Medical Laboratories in the
country. Council accreditation is a validation process established to
ensure that Medical Laboratories deliver high quality services that meets Dr. Lawrena C. Okoro
the needs and requirement of their clients. It also demonstrates Director Laboratory Accreditation & Regulation
competence and impartiality while promoting national and international MLSCN
recognition. At present, through strong commitment and leadership by
the Federal Ministry of Health (FMOH), the Medical Laboratory Science
Council of Nigeria (MLSCN) in collaboration with international partners
(CLSI, CDC) has adopted the ISO 15189 standard to improve the quality of
medical laboratory services in Nigeria.
This document has been developed to regulate the accreditation
processes of Medical Laboratory Services in Nigeria to ensure accuracy,
reliability and sustainability in the quality of service delivery.
I therefore encourage all stakeholders both in public and private health
sectors at all levels in Nigeria to use this guideline in setting up Medical
Laboratories which is geared towards improving the quality of laboratory
services in Nigeria.

Professor Anthony O. Emeribe

Registrar/CEO
MLSCN

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 Abbreviations TABLE OF CONTENT
AFB- Acid Fast Bacilli
ASV – Anodic Strip Voltameter Forward……………………………………………………………………………………………….3
BSC – Biosafety Cabinet Acknowledgement…………………………………………………………………...…………4
CBC – Complete Blood Count
Abbreviation………………………………………………………………………..…….……….5
CHCs – Community Health Centers
CV - Curriculum Vitae Table of Content………………………………………………………………………….........6
ELISA – Enzyme Linked Immunosorbent Acid
EQA – External Quality Assurance Introduction ………………………………………………………………………...……........8
EQAS – External Quality Assurance Scheme
ESR – Erythrocyte Sedimentation Rate Categories of Laboratory Services……………………………………………..…….....8
HB – Haemoglobin
HIV – Human Immunodeficiency Virus Laboratory Space……………………………………………………………….……….........9
IDSP – Integrated Disease Surveillance Programme
Quality System Requirement for Medical Laboratory Services..............10
ISE – Ion Specific Electrodes
MLSCN – Medical Laboratory Science Council of Nigeria Laboratory Finishes and Furniture……………………………………………………..17
MP – Malaria Parasite
PCR – Polymerase Chain Reaction Laboratory Fittings……………………………………………………………………......…18
PCV – Packed Cell Volumn
PHC – Primary Health Centers Waste Management …………………………………………………………….…......…..19
POCT – Point of Cure Testing
RST – Rapid Syphilis Test Human resource and personnel……………………………………………..……...….19
SQA – Sperm Quality Analyzer
Equipment and Supplies ……………………………………………………………......…19
VCT – Vinyl Composition Tiles
WBC – White Blood Count Quality manual………………………………………………………………………….........20

Appendices…………………………………………………………………………….........…21
LIST OF CONTRIBUTORS……………………………………………………………..…...…………24

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 1.0 INTRODUCTION 2.0 CATEGORIES OF LABORATORY SERVICES

In Nigeria, the laboratory services are integrated with the 3- tier public 2.1 Primary Laboratory
health system at the primary, secondary and tertiary levels. Besides - Primary laboratory performs simple laboratory tests and could
these, there are Reference Laboratories, Research Laboratories and be managed by a registered a Medical laboratory Scientist or a
Disease Specific Reference Laboratories to provide services for complex Medical Laboratory Technician. They include primary healthcare
and special tests. Both public and private sector provides laboratory laboratories, side Laboratories within clinics. Point of care
support at all levels of health care both in rural and urban areas. Each testing They perform test such as:
laboratory should identify the scope, functions and the capacity of the
services offered by it and appropriate infrastructure with requisite - MP, Widal test, PCV/HB, Rapid serology test, urinalysis urine
biosafety measures in place. Qualified and trained staff should be microscopy, and stool microscopy, pregnancy screening test
employed with periodic up- graduating of their skills.
2.2 Secondary Laboratory
Laboratory test results play an important and sometimes singular role in - These are labs that can carry out diagnostic services as may be
the diagnosis and treatment of disease processes. When combined with required by the community and may serve as research centers
the history, physical examination, x-ray studies and other diagnostic and must be managed by a Medical Laboratory Scientist.
procedures, laboratory diagnoses always lead to sound Medical
Diagnostic judgments. 2.3 Tertiary Laboratory
The importance of quality in the function of health care laboratories is - These are laboratories that can carry out diagnostic services as
recognized worldwide. Poor quality laboratory results can lead to well as training and research at sophisticated level, and could
misdiagnosis, wrong treatment, wastages, and litigation among others. also act as reference laboratories. It could have all or
In order to harmonize existing standards that ensure Medical specialized disciplines/ department of medical laboratory
Laboratories are producing quality test results, the international services such as:
organization for standardization in 2004 officially announced ISO15189 - Chemical Pathology, Haematology, Blood transfusion service,
bacteriology, mycology, parasitology, virology, molecular
for adaptation as the international quality standard for Medical
diagnostics, histopathology, forensics laboratory, etc.
Laboratories globally. The requirements of ISO 15189 are quite
comprehensive and in a way tasking to achieve. However, very few
3.0 THE LABORATORY SPACE
laboratories conform to these standards because of inadequate
- The laboratory has evolved from a service unit to a business entity
knowledge of implementation.
and quality space must be provided to enhance quality services.
This guideline is therefore being developed to guide stakeholders
- Medical Laboratories shall not be located within two hundred
understand the requirements for setting up a medical laboratory in to
meters radius of another laboratory, market or an environment
Nigeria.
where wastes from the facility could pose any form of HEALTH
HAZZARD to the public.
- The laboratory space shall have enough working space and
appropriate conditions to ensure quality services. The laboratory

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 space should be such that the contaminated area is well drafted PRIMARY LABORATORY SECONDARY LABORATORY TERTIARY LABORATORY
and separated from the clean area. The laboratory shall monitor, Laboratory a. Maybe attached to
control and document all environmental conditions which may Site other health facilities or
affect the quality of its services. The laboratory shall design can be independent
appropriate room/space for collection of samples which should b. It should not be less than
300m from restaurants Same as Same as
not affect the quality of its services. Primary Primary
or eating houses and
- The Laboratory shall have a clear procedure for waste Laboratory Laboratory
residential houses
management and environment protection.
c. Proximity to other
laboratory should not be
less than 200m
Space One room (5mx6m) or -Office of Director of 1. Office of Director of
(16.4ft x19.7ft) which may Medical Laboratory Medical Laboratory
be partitioned as may be Services Services
required. Eight Rooms: 4 rooms of 2. Waiting room/space
12ft x 14ft in dimension 3. Specimen
Convenience and 4 rooms of 16 ft. x collection/Dispatch
19,7ft. 4. Minimum of 5 rooms for
The rooms are for the laboratory staff offices in
following each specialty
1. Reception 5. Record/I.T. offices
2. The manager’s office 6. Seminar / Training Room
3. Media/wash-up room 7. Conveniences
4. Seminar / Training 8. Staff common room
Room 9. Call duty room
5. Laboratories 10. Wash-up room
6. Staff common room 11. Store
7. Call duty room 12. Main laboratory room
N/B: These are minimum 8. Store 13. N/B Each dep artment.
requirements convenience Should have a minimum
9. N/B: These are of 5 laboratory rooms’
minimum requirements space of 5m x6m each.
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4.0 QUALITY SYSTEM REQUIREMENTS FOR MEDICAL 4.2 Personnel
LABORATORY SERVICES - Policies and plans for employing sufficient staff shall be
implemented. The laboratory shall have sufficient number of
The Laboratory shall develop and implement a quality management registered medical laboratory scientists proportional to the work
system that satisfies the requirement under the following twelve (12) load and shall be available at all times.
clauses. The head of the Laboratory shall be experienced professional
1. Organization and Management medical Laboratory Scientist and must be registered member of
2. Personnel MLSCN. He or she will be responsible for duties related to
3. Equipment instructing, managing, advising, training, budgeting, etc.
4. Purchasing and Inventory
5. Process Control
Personnel qualification shall be specified in relation to the job
6. Documents and Record
description.
7. Occurrence Management
- There shall be staff development and appropriate continuing
8. Assessment
9. Process Improvement education program available at all levels of organization to
10. Client Management upgrade the knowledge attitudes and skills of staff.
11. Information Management - Work performance evaluation shall be regularly monitored for
12. Facility and Safety designing the training plan.
- Curriculum vitae, training records and other relevant records of
4.1 Organization and Management laboratory personnel shall be maintained.
The organization of the Medical Laboratories shall be legally identifiable. - Person(s) who can have access to the confidential laboratory data
All services of the Medical Laboratories shall meet relevant requirement, stored in computers or in files shall be defined.
and the scope of service shall be defined. - Annual medical checkup and vaccinations shall be supported.
- The Medical Laboratory management shall be responsible for the
design implementation, maintenance and improvement of the 4.3 Laboratory Instrument and Equipment
quality management system. These include equipment, reference materials, reagents and test kits.
- Quality policies, procedures, and manual shall be documented The analytical and logistic technology has to be available on a level which
and communicate to all relevant personnel. The management fulfills the minimal requirements for quality diagnostic services. The
shall ensure that the documents are understood and equipment shall be operated only by authorized personnel. It is
implemented. important to stress that, most recent sophisticated equipment and
- Laboratory management shall review internal audit reports, technology without the support of the local suppliers and easy access to
surveillance reports, quality index results, laboratory services
reagents is a negative critical success factor and will not make the
evaluation reports, and complaint records for management
recommended equipment list.
planning. The management reviews shall be documented.
- The quality index for quality monitoring shall be specified.
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4.4 Procurement and External Services · Specimen receiving date
4.4.1 Procurement · Reporting date
The Laboratory shall define and document its policy and procedure for · Test result and SI units
selection of suppliers. There shall be inventory control system for · Name and signature of laboratory scientist reporting the result
suppliers of critical reagents and services that affect the quality of test · Name and signature of laboratory scientist authorizing release of
result. The laboratory shall maintain records of approved suppliers. the result
· Biological reference where applicable
4.4.2 External Services
The Laboratory shall maintain copy of report for an appropriate period of
The Laboratory shall define and document procedures for selection of
time.
the referral Laboratories and advisory matters. The list of referral
Laboratories and advisory matters shall be documented.
The Laboratory shall establish procedures to ensure that the reports 4.6 Document and Record Control
A list of all documents shall be maintained. The document shall be
received from external Laboratories are correct. A copy shall be
reviewed and approved by authorized persons. Obsolete or discontinued
maintained for an appropriate period of time.
documents shall be labeled and archived / removed. Only authorized
personnel shall access to the laboratory records and data.
4.5 Process Control
The Laboratory shall implement internal quality control for monitoring
4.7 Control of Non-Conformities
the quality system and record all factors affecting the quality of services. The criteria and procedure for the control of non-conformance shall be
The testing procedures shall be calibrated using reference material The defined. Root cause analysis should be undertaken to forestall future
Laboratory shall participate in External Quality Assessment Scheme EQAS occurrence. Testing may be stopped and results held until the
The Laboratory shall develop a specimen collection manual which, nonconformance is resolved, depending on the nature and criticality of
among others shall include procedures for collection, transporting, the nonconformance. Results reported during the nonconformance
storage, handling, acceptance or rejection of specimens. should be recalled when the nonconformance is of a critical nature to
The Laboratory shall use only the standard or validated methods for patient care.
specimen testing. The procedures for all test methods shall be
documented and maintained.. 4.8 Internal Audit
The reporting procedures shall be clearly established including reporting The laboratory quality system must undergo internal audits to verify that
via computer network and reporting the critical results. the laboratory is in compliance with the quality system. The laboratory
The report form shall be designed with appropriate format stating management shall ensure that the internal audit is done at least once a
clearly; year.
· The name of the Laboratory and Logo
· Name and age of the patient 4.9 Continual Quality Improvement
· The hospital number of the patient All operational procedures shall be systematically reviewed by laboratory
· The Laboratory number of the patient. management at regular intervals in order to identify any potential
· Test request sources of nonconformance or other opportunities for improvement in
· Nature of specimen the quality management system or technical practices. Action plans for
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improvement shall be developed, documented and implemented, as 6.2 Lighting system:
appropriate. Laboratory management shall ensure that the laboratory The laboratory must be well lit at all times. Multiple white energy saving
participates in continual improvement activities that encompass relevant or fluorescent tubes are recommended.
areas and outcomes of patient care.
6.3 Plumbing system:
4.10 Client Management The plumbing for water and gas must be conduit wiring devoid of
The Laboratory shall develop a process for monitoring clients' satisfaction crisscrossing to avoid accidents. The tap must be elbow and sink enamel.
and complaint. Procedures shall be developed for receiving client The drainage must be connected to soak-away, sited away from the
feedback, opinion analysis, reporting to laboratory personnel and top laboratory and domestic water source. There must be constant running
management. An implementation plan shall be developed to address all water available.
complaints.
6.4 Laboratory floor and ceiling:
5.0 Laboratory Finishes and Furniture No form of carpeting is acceptable. The floor can be tiled with vinyl
composition tiles (VCT), sheath vinyl, rubber floors, or monolithic
5.1 Bench height: flooring. Floors must be mopped not swept.
Laboratory work benches should be between 28-35 inches above the
floor and should have adequate leg and knee clearance under the Acoustic type ceiling is recommended for high sound absorbance. Ceiling
workbench. Work benches should be 4-6 inches below elbow height must be solid, no liquid penetration, no access panels. Open ceiling is
while practitioner is seated on the stool. Laboratory stool, chairs with acceptable if there are no exposed ducts/tapes. It should be free from
height 20''-25'' and should not have rollers. decorations and high enough for free movement.

5.2 Bench-Top materials: 6.5 Electrical system:

The top materials for work benches should be made of Epoxy resin, silica, Electrical sockets should be placed on the laboratory benches or walls
and chemically resistant plastic laminate. Stainless steel is good for glass proximal to the workbench depending on the bench design. Crisscrossing
wash rooms and cold rooms. However, work bench top materials must of wires should be avoided, while conduit wiring or surface trunking is
have chemical, impact, moisture, and bacteria resistance. Floor tiles and recommended.
kitchen granite work tops are not recommended.
If local electricity supply is intermittent or inadequate a generator of
6.0 Laboratory fittings: adequate capacity should be provided.

6.1 Laboratory windows: 7.0 Waste management system:

The windows must be glass (opaque, translucent/tinted) but devoid of Laboratory wastes should be separated appropriately into hazardous,
window blind drabs. The windows must be positioned in a way that good non-hazardous and sharps. Liquid waste should be either heat- treated or
cross ventilation is achieved. The windows must be secured and netted. chemically treated before being discarded into the drainage system.
Fans should not be allowed in the laboratory. There must be incinerator, needle destroyer or pit. All microbial wastes
must be sterilized before incineration.
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8.0 HUMAN RESOURCES /PERSONNEL APPENDIX 1. LIST OF EQUIPMENT FOR EACH LABORATORY LEVEL

8.1 The medical laboratory shall be managed by a licensed Medical The list of equipment for each laboratory level shall be appropriate for the range of tests provided.
Laboratory Scientist certified by the Medical Laboratory Science Please refer to appendix for details.
PRIMARY LABORATORY SECONDARY LABORATORY TERTIARY LABORATORY
Council of Nigeria. - Binocular mi croscope with The following equipment are needed In addition to the equipments
(x100) objective minimum depending on in the seconday laboratory,
- centrifuge discipline/department: the tertiary laboratory must
8.2 In areas where Medical Laboratory Scientists are not available a - Hematocrit centrifuge, Chemical Pathology have the following –
MLSCN certified Medical Laboratory Technician with a three (3) Reader - Flame photometer or ISE
- Refrigerator - Colorimeter Virology
years training on clinical laboratory sciences quality control and - ESR tubes & stand - Spectrophotometer Virology reagent and facility
laboratory management, may manage a primary category clinical - Stop watch
- Ambient room
- Refrigerator
- Chemical balance
for viral culture
ELISA System
laboratories with supervision by a licensed Medical Laboratory thermometer - Automatic Pipette
Scientist. - Refrigerator thermometer
- Glasswares
- Water bath
- Water Distiller
HistoPathology
- Microtome
- Automatic pipettes - Stopwatch - Tissue Incubator
- Consumable & - Cryotome ( Refrigerator
8.3 The clinical laboratory shall employ qualified and adequately reagents/kits Haematology Microtome
trained personnel for the level of service. Work assignment shall - Weighing balance - Haematocrit centrifuge & - Slide Staining Rack
Reader (Assorter)
be consistent with the qualification of the concerned personnel. - Binocular Microscope - Binocular Microscope
- Electric Centrifuge - Cytocentrifuge
- Colorimeter - Automatic Slide Staining
8.3.1 A clinical laboratory shall have sufficient number of registered - ESR stand & Tubes Machine
medical scientists, proportional to the work load and shall be - Electrophoretic machine - COnsumables
- And tank.
available at all times during hours of laboratory operation. For - WBC Counter
hospital based clinical laboratory, there shall be at least one - Automatic Pipettes
- Neubaeur Counting Chamber
Medical Microbiology
- Anaerobic Wink Station
registered medical scientist per call duty to cover the laboratory - Water Bath - Bacel Blood culture
operation. - Glasswares and Reagents system
- BSC II
- Staining Racks
- ELISA Machine and
- Refrigerator, Freezer
Reader
9.0 EQUIPMENT/INSTRUMENT/SUPPLIES Parasitology - Florescent Microscope
1. There shall be sufficient number and types of appropriate - Binocular Microscope - Carbon Dioxide Incubator
- Centrifuge - Inspissator
equipment/instrument to undertake all the laboratory - Hot air oven - Laminar Flow Cabinet
examinations and procedures for each test menu. All - Reagent & Consumable - Sperm Quality Analyser
(SQA-V)
equipment/instrument shall comply with safety requirements. - Glasswares
- API Systems
- Standing rack
The head of the laboratory shall be responsible for overseeing the - Automatic Pipettes
Chemical Pathology
management of all equipment including point of care testing - Refrigerator - This laye r
(POCT) devices irrespective of where they are located. - Stopwatch Chromatography
- Micro-ELISA Systems - Atomic Absorption
NOTE: Please refer to appendix 1 for comprehensive list of Bacteriology Spectro
equipment required for different laboratory levels. - Microscope - Photometer
- Autoclave - Electrophoretic System
- Hot air oven - HPLC
10.0 Quality & Safety manual - Anaerobic Jar
- Facility for Co2 incubation
- ELISA System
- Densitometric Scanner
The laboratory shall establish and maintain quality and safety manual. - Centrifuge - Turbidometer
- incubator - Autoanalysers (Chemistry)
Refer to MLSCN for guidelines. - Refrigerator - Ion Specific Electrodes
- Freezer (ISE)

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 APPENDIX 2: LIST OF TESTS FOR EACH LABORATORY LEVEL (at a minimum)

- Reagent and Consumable - PH Meters LIST OF TESTS FOR EACH LABORATORY LEVEL
- Glass ware - Mass Spectrometers
PRIMARY LABORATORY SECONDARY LABORATORY TERTIARY LABORATORY
- Weighing balance - Pluorimeters 1. HIV Serology: Rapid Test 1. All the tests listed in 1. All the tests listed in
- Automatic Pipettes Thermometer - Chemiluminometers 2. Hemoglobin/PCV primary level and the secondary level and
- Safety Hood 3. Urine Test for following: the following:
70oC freezer
Pregnancy 2. Histopathology
- Anodic Strip Voltameter(ASV)
- Facility for TB culture 4. Urinalysis 2. Full blood count 3. Mycology
- Lead Analysers (FBC) 4. Viral Load
Blood Transfusion Science 5. Stool microscopy/ 3. CSF analysis 5. DNA PCR
- Votex Mixer
- Blood Bank occult blood 3. CD4 6. Drug resistance
- Microplate Reader
6. AFB 4. Blood Chemistry monitoring (DRM)
- Facility for bleeding (Bleeding Couch) - Osmometer 7. MP 5. Bacteriology 7. Immunology
- Centrifuge - 70o Freezer 8 6. Parasitology 8. Any other specialized
- Microscope
9. Direct Microscopy 7. Blood transfusion assay
- Chemistry Analyser
9. Rapid Syphilis Test service
- Water Bath - Immunology Analyser (RST)
- Chemical balance - Microplate Washer 10 Other Rapid POC
- Deionizer
Tests
- Refrigerator
- Freezer
Mycology
- Plasma Extractor - Microscope
- Weighing Balance
- Incubator APPENDIX 3: QUALITY SYSTEM REQUIREMENTS FOR MEDICAL
- Mycology reagents
LABORATORY
- Blood Pressure monitor
Molecular LAB
- Bath Weighing Scale Three rooms with unidirectional
workflow for a manual PCR lab. The Laboratory shall develop and implement a quality management
- Safety hood /cabinet.
- Standard work benches system that satisfies the requirement under the following ten (10)
-
-
(Thermocycler)
Automatic Pipettes
clauses. This section provides guidance on the requirements of a quality
designated for each room. management system.
- Area Specific Laboratory Coat
1) Organization and Management
- UV Transilluminator
2) Personnel
- DNA Sequencer 3) Equipment
- Ultracentrifuge 4) Purchasing and Inventory
- Gel Documentation System 5) Process Control
- Gel Turing device 6) Documents and Record
- Gel Electrtophoretic System 7) Occurrence Management
- Fraction Collector
8) Assessment
9) Process Improvement
10) Client Management
11) Information Management
12) Facility and Safety
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 LIST OF CONTRIBUTORS Dr. Donald I. Ofili Medical Laboratory Science
Dr. Lawrena Okoro Director, Department of Council Nigeria.
Laboratory Accreditation and
Regulation, MLSCN Dr. Jemikalajah D.J. Delta State Hospital Management
Professor Eugene Ikeh University of Jos Board, Warri.

Dr. Callista Osuocha US Department of Defence, Walter

Reed Program-Nigeria Dr. Josephine Akpotuzor University of Calabar
Captain Ikechukwu Ogueri Nigeria Ministry of
Defence/Emergency Plan Mr. Emmanuel Ojo Achieving Health Nigeria Initiative
Implementation Committee (AHNi)

Kingsley Ochei Family Health International 360 Prof. Nneka Agbakoba Nnamdi Azikiwe University Awka

Sani Iliya Department of Laboratory Mr. Efobi Henry University of Calabar Teaching
Accreditation and Regulation, Hospital Calabar
MLSCN
Mr. Eke Ofuche AIDS Prevention Initiative in
Dr. Nkiru Nwokoye Association of Medical Laboratory Nigeria (APIN) Abuja
Scientists of Nigeria Lagos State
Mrs. Amaka Anoke National Hospital Abuja
Branch
Mrs. Oyebimpe Balogun Institute of Human Virology
Prof. John Anetor University of Ibadan Nigeria (IHVN) Abuja

Mr. Tosan Erhabor Medical Laboratory Science

Mr. Manason Rubainu University of Abuja Teaching Council of Nigeria
Hospital
M.O.O. Mbuko Medical Laboratory Science
Council of Nigeria
Mrs. D. Oriaku Federal Capital Territory
Administration (FCTA) Health Professor Anthony O. Emeribe Registrar/CEO MLSCN
Management Board

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