Laboratory Management
Laboratory Management
Laboratory Management
LABORATORY
MANAGEMENT
A. BASIC MANAGEMENT CONCEPTS
1. Management/Leadership Styles
a. Authoritarian - manager makes all decisions
without input from others; least acceptance and
commitment from staff
2. Management/Leadership Theories
a. Maslow’s Hierarchy of needs - psychology theory
proposed by Abraham Maslow in which all
individuals focus on the fundamental needs and
once fulfilled will progress to higher needs.
NEED DEFINITION WORKPLACE CONTERPART
Physiological Survival needs (food, water, air, rest) Income
Safety Physical and psychological security Insurance, safe work
environment, job security
Social Sense of belonging, acceptance Social relationship with
affection coworkers
Esteem Respect, independence, Job title, privileges, respect of
appreciation, recognition colleagues
Self-actualization Realization of full potential Challenging work, autonomy,
professional growth
A. BASIC MANAGEMENT CONCEPTS
2. Management/Leadership Theories
b. Frederick Herzberg’s Motivator-Hygiene
Theory - employees base their satisfaction or
dissatisfaction with work, on hygiene factors
(company policies, wages, job security) and
motivator factors (status, advancement
opportunity, recognition, personal achievement)
c. Douglas McGregor’s Theory X and Y
Theory X is that humans have an inherent
dislike of work and will avoid it if they can –
therefore they need to be “controlled”
Theory Y is that the expenditure of physical
and mental effort in work is as natural as in
play or rest – therefore, it the job is satisfying,
the employee will be self-motivated.
A. BASIC MANAGEMENT CONCEPTS
2. Management/Leadership Theories
d. Tannerbaum -Schmidt Theory - a manager uses
a broad range of leadership styles based on the
prevailing circumstances in the current
environment.
e. Blake-Mouton Theory – describes five types of
management situations:
1. Impoverished management – low concern for
people and production
2. Authority-compliance – low concern for people,
but high concern on production
3. Middle-of-the-road management – medium
concern for people and production
4. Country club management – high concern for
people, but low concern for production
5. Team management – high concern for people
and production
A. BASIC MANAGEMENT CONCEPTS
2. Management/Leadership Theories
f. Hershey-Blanchard Theory - based on
situational models; there is no single “best” style of
leadership, but is more dependent on the task,
knowledge, and group dynamics for each
situation.
3. Skills of Managers
a. Organizational skills – ability to conceptualize
and apply management process, systematize
workflow, make decisions, and communicate with
coworkers.
b. People skills – understanding basic theories of
human needs and work motivation.
c. Financial skills – effective use of and accounting
for the monetary assets of the company
d. Technical skills – synthesis of the first three skills
and the management of physical resources into
the operational parameters.
A. BASIC MANAGEMENT CONCEPTS
4. Foundation of Management
Processes
a. Mission – organization’s purposes
5. Functions of a Manager
a. Planning – establishing goals and objectives,
formulating policies to carry out objectives;
involves SWOT analysis: Strengths, Weaknesses,
Opportunities, and Threats
TYPES OF PLANS
1. Short range or tactical plan – covers a 1-5year
period and focuses on tasks that can be
completed in this time frame
2. Operational plan – may be for 1 year or one
budget period and concerns operations
3. Strategic plan – maps out the course of an
organization for approximately 20 years; evaluated
and modified yearly
A. BASIC MANAGEMENT CONCEPTS
5. Functions of a Manager
b. Organizing – coordinating resources to achieve
plans, defining working relationships, including line
of authority and workflow.
c. Directing – communicating, motivating,
delegating, and coaching; creating a climate that
meets the needs of individuals and the
organization.
Major techniques for directives
1. Autocratic – detailed instructions given of
exactly how and what is to be done
2. Consultative – input is sought from
employees to help solve a problem or tackle a
project
d. Controlling – defining standards of performance,
developing a reporting system, and taking
corrective action when necessary.
B. QUALITY MANAGEMENT
1. APPROACHES TO QUALITY
MANAGEMENT
a. Management by Objective (MBO) targets
organizational and employee performance by
aligning goals and objectives throughout the
organization, including timelines and feedback in
the process
1. APPROACHES TO QUALITY
MANAGEMENT
c. Continuous Quality Improvement (CQI) is an
element of TQM that strives to continually improve
practices and not just meet established quality
standards. It is a team effort approach to identify
potential problems and correct them.
1. APPROACHES TO QUALITY
MANAGEMENT
e. Lean – is designed to reduce waste (nonvalued
activities) and improve customer satisfaction. It is
often used in clinical laboratories to improve a
process such as turnaround time.
1. APPROACHES TO QUALITY
MANAGEMENT
h. Benchmarking – process whereby the best
process in one organization is modified to fit
similar processes in another organization.
2. REGULATORY ELEMENTS
a. Accreditation: the approval of an institution, part
of an institution, or program, demonstrating that it
meets all formal standards as defined by the
accrediting body
4. EMPLOYEE PERFORMANCE
APPRAISAL
a. Error of central tendency. Everyone is rated
toward middle of scale
b. Contrast error. An individual is rated lower
than justified because of comparison with
another exceptional individual.
c. Error of leniency. Everyone is rated high
d. Halo effect. Good performance in one are
influences evaluation in another areas
e. Reverse halo effect. Poor performance in
one area influences evaluation in other areas
f. Recency phenomenon. Judgments are
made based on recent events or unusual
incidents.
C. LABORATORY STATISTICS
1. Measurements of Center
a. Mean – average or arithmetic mean
1. Phases
a. Pre-analytical – include test requisition, patient
preparation, patient identification, specimen collection,
labeling, specimen transport, handling and processing
1. Phases
c. Post-analytical – include verification of calculations and
reference ranges, flagging and notification of panic/critical
values, delta checks, reporting of results
2. Quality control
a. Accuracy – closeness of the result to the true or actual
value
b. Precision – ability to produce a series of results that
agree closely with each other; commonly expressed in
terms of coefficient of variation; also called reproducibility
c. Internal/Intralaboratory QC
- Involves the analysis of at least 2 levels of control
every 24h for at least 20days
- Important for the daily monitoring of accuracy and
precision of analytical methods
d. External/Inter-laboratory QC= Proficiency testing
- Involves testing samples of unknown concentration of
analytes sent periodically by regulatory agencies to
participating laboratories
- Poor performance is indicated by an SDI of >2.0
D. QUALITY ASSURANCE
3. Analytical Variation
a. Types of Error in Laboratory testing
1. Random Error
- Present in all measurements due to chance or an
unpredictable cause
- Mislabeling, pipetting error, improper mixing of
sample and reagent, temp fluctuation
2. Systematic Error
- Influences observations, consistently in one
direction
- Deterioration of reagents, unstable reagent
blanks, calibration error, changes in the standard
concentration, contaminated control solutions,
instrument malfunction.
D. QUALITY ASSURANCE
3. Analytical Variation
b. Patterns in QC charts that indicate errors
1. Shift – formed by control values that distribute
themselves on one side or either side of the
mean for 6 consecutive days; usually indicates
calibration error
3. Analytical Variation
c. Interpretation of Quality Control Results
3. Analytical Variation
c. Interpretation of Quality Control Results
3. Analytical Variation
d. Steps taken when a control is outside acceptable
range
1. Hold patient results until problem is resolved
2. Rerun control (1 time only)
3. If control is still out, run a new vial of control or
another lot number
4. If control is still out, look for and correct any
problems, then run control
5. If control is still out, recalibrate, then run
control
6. If control is still out, get assistance from
supervisor or service representative
7. Once resolved, document corrective action
8. Evaluate all patient results in rejected run and
since last run with acceptable QC. Repeat
tests and issue corrected reports, as needed.
e. Retention of QC records
E. INFORMATION SYSTEM
DEFINITION EXAMPLES
Capital expense Money used for physical assets Acquiring or upgrading facilities or
and is often depreciated over a equipment
5-plus year period
Operational Money used for day-to-day Employee wages, taxes, and the
expense operations general costs of doing business
Fixed costs Expenses that don’t fluctuate Instrument leases, maintenance
when volume of work changes contracts, computer services,
over short term equipment costs, facilities upkeep,
management salaries, custodial
salaries, employee benefits, lease
payments, rent, taxes
F. LABORATORY OPERATING COSTS
DEFINITION EXAMPLES
Variable costs Expenses that fluctuate directly Labor costs, supplies, reagents,
with change in work load disposables
Direct costs Costs associated with Supplies, reagents, controls,
performance of a test standards, disposables, equipment
costs, equipment maintenance
contracts, technical and supervisory
labor
Indirect costs Overhead Administration, plant maintenance,
security, utilities, building
depreciation, rent, taxes, insurance,
housekeeping, purchasing, billing,
regulatory expenses, LIS expenses
Unit cost/ cost Total of direct and indirect
per test expenses of producing a test
results
G. LABORATORY SAFETY
1. Biohazards
a. Four levels of biosafety
1. Biosafety level 1 – agents that have no known
potential of infecting healthy people
1. Biohazards
b. Biohazard label of chain of infection
Hand washing
Biohazardous waste disposal
Decontamination
Specimen bagging
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1. Biohazards
c. Hand washing – most important means of preventing the
spread of infection
- If hands are visibly soiled, wash hands with soap and
water for 1-2mins
- If hands are not visibly soiled, wash hands for at least
30secs or use alcohol-based hand cleansers.
1. Biohazards
e. Decontaminating of Body Fluid Spills
- 5.25% NaOCl or 10% chlorine bleach
- 1:10 dilution → 1 part household bleach + 9 parts
water
- Inactivates HBV for _______ and HIV for __________
f. Biological Safety Cabinet
Class Description Use
I Open front. Air passes through hepa Minimal personnel protection.
filter before being exhausted Doesn’t protect work surface
II Also called laminal flow; air passes Most commonly used in micro
through 2 hepa filters labs. Provides protection for both
worker and work
III Completely enclosed with glove For extremely hazardous
ports. Equipped with negative organisms.
pressure
G. LABORATORY SAFETY
2. Chemical Hazard
- MSDS (Material Safety Data Sheets)
- TLV (Threshold Limit Value) – allowable exposure value
during an 8hour shift
- The United Nations (UN) established nine classes of
hazardous materials
a. Class 1 – explosives
b. Class 2 – compressed gas
c. Class 3 – flammable liquids
d. Class 4 – flammable solids
e. Class 5 – oxidizer materials
f. Class 6 – toxic materials
g. Class 7 radioactive materials
h. Class 8 – corrosive materials
i. Class 9 – miscellaneous materials not otherwise
classified
G. LABORATORY SAFETY
2. Chemical Hazard
- Standard hazards identification system by the NFPA
Color codes and hazard types:
BLUE = toxic/ health
RED = flammability/ fire hazard
YELLOW = instability/ reactivity?
WHITE = specific
Degree of hazard:
0 = no hazard
1 = slight
2 = moderate
3 = serious
4 = extreme
G. LABORATORY SAFETY
3. Radiation Hazard
- Nonionizing forms of radiation emitted by equipment
5. Fire Hazard
Class Combustible materials Extinguishers
A Ordinary combustibles Ordinary combustibles,
water, dry powder, halon
B Flammable liquids and Carbon dioxide, dry powder,
gases halon
C Electrical equipment Carbon dioxide, dry powder,
halon
D Combustible metals Special agents
G. LABORATORY SAFETY
5. Fire Hazard
- Actions to take in the event of fire:
Rescue Alarm Contain Extinguish