GOOD

LABORATORY
PRACTICES

LABORATORY SERVICES
DEPARTMENT
IHVN
 Objectives
At the end of this session, PS would be able to;
• Define the term; good laboratory practices
• Describe procedures for maintaining a clean and
organized laboratory
• Describe standard safety measures required in a
laboratory
• Disinfect and dispose of infectious materials
appropriately
 DEFINITION

• DEFINITION
GLP REFERS TO GENERAL BUT
IMPORTANT GUIDELINES THAT
SHOULD BE FOLLOWED TO
ENSURE THAT A LABORATORY
FACILITY MEETS THE
EXPECTATIONS FOR
PRODUCING QUALITY RESULTS
 PURPOSE

To ensure that laboratory investigations

are conducted under the conditions that
allow the results of the investigation to
be interpreted and presented to the
medical community with confidence.
 COMPONENTS OF GLP
• Testing facility
• Personnel
• Quality Assurance Unit
• Testing process
• Documentation
• Equipment
• Standard Operating Procedures
• Reagents, solutions, and test kits
• Safety
 FACILITY
• Adequate physical infrastructure in
place
• Adequate and spacious working
environment
• Water- public, borehole and reservoir
• Electricity-Public and/or backup
• Appropriate Equipment with backups
 THE LABORATORY STAFF
YOU ARE:
• The most critical
part of the quality
system
• The laboratory’s
greatest asset
• An important partner
in patient care
YOU ALSO:
• Bring your integrity
and professionalism
to the healthcare
community
 JOB DESCRIPTIONS
• Specify responsibilities and duties
• Reflect education, training and
experience
• Incorporate activities or tasks to be
performed
• Competency based
– General skills
• Specify QA responsibilities
Quality
QualitySystem
System

Quality Assurance

Quality Control
 QUALITY
ASSURANCE
DEFINITION
QA encompasses all measures taken by a
laboratory to ensure that reported results
are as accurate as possible.
QA activities are direct responsibilities of
the technical staff but should be
monitored by Supervisor/Director.
 LABORATORY WORK FLOW

The Patient
or P
P o
Test Selection Clinic
r s
Report
e t
Interpretation
A Collection The
A
n Laboratory
n
a Flow Report
Transport a
l Transmission
l
y y
t Report t
I Access Creation I
c c
Analytical
11
 ORGANIZATION

Strong commitment from top-level managers

(national/state level) is essential to…
• Plan and organize the quality program
• Define scope of authority and
responsibility of quality coordinator and
other staff in the organization
• Allocate sufficient resources to maintain
quality requirements
 PERSONNEL

• Develop job descriptions (duties

and responsibilities)
• Provide orientation, training, and
continuing education programs
• Assess employee competence
and performance
 EQUIPMENT
• Select equipment and assure
appropriate use
• Provide for installation and initial
calibration
• Set up schedules and mechanisms
for routine calibration, service,
maintenance and repairs.
• Provide information for
troubleshooting
PURCHASING AND INVENTORY

• Define criteria for products and services to

be purchased
• Establish a system to receive, inspect,
accept, store and inventory
• Assess and maintain inventory
• Establish a system to connect materials to
appropriate patients, activities, or records
 PROCESS CONTROL

• Concerns all operations of the

laboratory
• Includes:
– SOPs, Validation procedures,
– Specimen management
– Quality Control
– External Quality Assessment
 DOCUMENTS
AND RECORDS

• Develop uniform format for each document

type.
• Develop and implement a system for
document revision, approval and distribution
• Manage patient test records. Ensure
confidentiality
• Maintain a document storage, retrieval and
destruction system
 INFORMATION
MANAGEMENT
The laboratory;
• Must have a documented system in
operation to detect and correct clerical and
analytical errors that could affect patient
management.
• Must have a documented system in
operation to verify highly unusual results
for each test or instrument.
• Should protect the Privacy and
confidentiality of patient information
 OCCURRENCE
MANAGEMENT
Definition: The process of dealing
with laboratory problems and
errors as they occur
Each lab should have a method for
detecting and correcting problems
• Keep a record of problems and
corrective actions
• Information should be provided to
those affected by the problem or error
 OCCURRENCE MANAGEMENT
contd…..
• The system for detecting clerical errors,
significant analytical errors, and unusual
laboratory results must provide for timely
correction of errors.
It is important to understand the root
causes and take corrective action.
 PROCESS
IMPROVEMENT
A systematic and periodic approach to
improving laboratory quality (using
information from Assessments)

• Identify an area to study, collect information

and take corrective action
• This should be one of the duties of a lab
Quality Officer.
 CUSTOMER
SATISFACTION

• Actively seek information on

customer/patient satisfaction
• Value and reward staff providing
good service
 FACILITIES AND SAFETY

Ensure that lab facilities are adequate for

producing reliable test results
• Work surfaces easy to clean and maintain
• Appropriate temperature
• Refrigeration
• Facilities for hand washing / cleaning
• Sites must have procedures to safely
handle biohazardous materials
 SAFETY IN THE
LABORATORY
• Why Is Safety Important?
– Performing testing is a potential health
hazard.
– Safety involves taking precautions to
protect yourself and your client against
infection.
 UNIVERSAL
PRECAUTIONS
Universal precautions are simple infection
control measures that reduce the risk of
transmission of bloodborne pathogens
through exposure to blood or body fluids
among patients and health care workers.
Under the “universal precaution” principle,
blood and body fluids from all persons
should be considered as infected with HIV,
regardless of the known or supposed status
of the person,
( WHO definition).
 EVERY INDIVIDUAL’S
SPECIMEN SHOULD BE
TREATED AS INFECTIOUS
 WHAT ELSE NEEDS
PROTECTION?
• Other People
• Products
• Environment
 HOW IT IS DONE
Ensure Universal Precautions
• Barrier Protection should be used whenever
samples are obtained from patients.
• Personal protective equipment should be worn
in the laboratory when handling and processing
specimens and performing diagnostic testing.
• All technical procedures should be performed
in a way that minimizes the creation of
aerosols, droplets, splashes or spills.
• Mouth pipetting of all substances should be
prohibited.
 HOW IT IS DONE
• After use, hypodermic needles should not
be recapped, clipped or removed from
disposable syringe. The complete assemble
should be placed in a sharps container.
• Adequate and conveniently located
biohazard containers should be available for
disposal of contaminated materials.
• Designate all lab areas and equipment as
“Dirty” or “Clean” (including benches,
desks,refrigerators,freezers and sinks)
 HOW IT IS DONE
• Work surfaces must be decontaminated
after any spill of potentially dangerous
materials at the end of the working day.
• Personnel must wash their hands, before
leaving the laboratory working areas and
before eating.
• Personal protective clothing must be
removed before leaving the laboratory.
 DEVELOP PERSONAL SAFE
WORK HABITS

• Pipetting by mouth is
strictly forbidden
• Never eat, drink or
smoke at the test site
• Keep food out of the
laboratory/testing site
refrigerator
• Do not apply cosmetics
in the laboratory

Lab workers Health workers Counselors

 WASTE
MANAGEMENT
Waste is anything that is to be discarded.
In laboratories, decontamination of
wastes and their ultimate disposal are
closely related.
All infectious materials should be
decontaminated/autoclaved and
incinerated properly.
 Medical waste disposal

BEFORE AFTER
 Incineration of Waste
• Incineration is burning of contaminated waste
to destroy and kill micro-organisms.
• Incineration:
– Is effective against potential re-use
– Protects the environment
– Must be supervised
*Autoclave all hazardous waste before it leaves
the lab.
 Incineration- Types

1 2
 Policy for Handling Sharps
 Dispose of sharps yourself, immediately after
use
 Must dispose of sharps after each test
 Must place sharps in sharps boxes
 Do not drop sharps on the floor or in the office
waste bin
 Place sharps container near your workspace
 Seal and remove when box is ¾ full
 Incinerate all waste (or burn in a hole)
 SHARPS CONTAINERS
• If your site does not
have access to one of
these sharp containers,
you can use a pedal
bucket, thick plastic
(e.g. paint bucket) or
metal container having
a slightly wide
opening with a lid

Lab workers Health workers Counselors

SHARPS PIT
• Sharps can be
burnt and buried
in a deep pit.
• The Pit should be
colored yellow to
signify hazardous
waste
 Take Precautions to Avoid
Needle Stick Injury
What can cause needle stick injury?
• Lack of concentration
(e.g. worker burn-out)
• Inexperience
• Lack of concern for others
• Improper disposal of sharps
NEVER PLACE NEEDLES OR SHARPS IN OFFICE
WASTE CONTAINERS

2.4
Lab workers Health workers Counselors
 DISINFECT WORK AREAS
BLEACH ;
• Kills germs and
pathogens
• Keeps work surface
clean
• Prevents cross-
contamination
• Reduces risks of
infection
 Bleach Solutions for
Large
LARGE SPILLS and Small spills
SMALL SPILLS

UNDILUTED FROM 10% (1 : 9)

THE BOTTLE 1 PART BLEACH TO 9
PARTS WATER
(EQUAL VOLUME)

ALWAYS HAVE 10% BLEACH FRESHLY PREPARED DAILY AND

READILY AVAILABLE AT YOUR TEST SITE
 What to do if there is a Spill or
Splash
 Wear disposable gloves
 Immediately and thoroughly wash any skin splashed
with blood
– Large spills - Cover with paper towels and soak with
undiluted household bleach and allow to stand for at least 30
minutes
– Small spill - wipe with paper towel soaked in 10% bleach
 Discard contaminated towels in infectious waste
containers
 Wipe down the area with clean towels soaked in same
dilution of household bleach
 What to do if there is a Spill or
Splash
• If report/ result forms or printed matter
is contaminated, the information
should be copied on to another form
and the original discarded into the
contaminated waste container.
 ACCIDENTAL
CUTS/INJURIES
• Remove protective clothing
• Wash hands and affected part
• Apply appropriate skin disinfectant
• Inform supervisor about the cause and
nature of cut/injury
• If considered necessary, a physician should
be consulted and his/her advice followed
• Appropriate medical records should be kept
 Accidental Ingestion of Hazardous
Material
Remove protective clothing

Inform physician of material ingested and

follow his/her advice

Appropriate and comprehensive medical

records should be kept
 PLEASE NOTE
• INFORMATION ON HOW TO HANDLE
SPILLS/SPLASHES AND ACCIDENTS
MUST BE PASTED AND READILY
ACCESSIBLE TO ALL TESTING SITE
STAFF
 FIRE SAFETY
• Prevention
• Response
• Evacuation
 FIRE PREVENTION
• Do not smoke in the laboratory.
• Be knowledgeable of the
characteristics of all flammable and
reactive chemicals.
• Limit the use of flammable and
reactive chemicals to very minimum.
• Make small aliquots of flammable and
reactive chemicals.
 RESPONSE TO FIRE
• RESCUE anyone in immediate danger.
• ALERT the appropriate authorities as well
as all others in the area and/or building.
• CONFINE by closing all windows and
doors.
• EXTINGUISH the fire with a fire
extinguisher.
 EVACUATION
• Evacuate in an orderly fashion.
• Don’t panic
• Walk, don't run
SAFETY ISSUES
PROVIDE APPROPRIATE
TECHNOLOGY
 REAGENT AND
SPECIMEN STORAGE
LABORATORY
LAYOUT
 APPROPRIATE USE
OF
STORAGE FACILITIES
ORGANIZE WORK
SPACE PROPERLY
AVOID DRINKING IN THE
LAB
POOR RECORD KEEPING
 AKNOWLEDGMENT
• Dr. Ezekiel Akintunde
• APHL
• CDC
• WHO