GOOD LABORATORY PRACTICES

IN
BLOOD TRANSFUSION SERVICES
 LEARNING OBJECTIVES
By the end of this session, participants would be
able to;
 Define the term; Good Laboratory Practices

 List the components of Good Laboratory

Practices in Blood safety

 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 AND PURPOSE

 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 IN THIS CASE SAFE
BLOOD AND BLOOD PRODUCTS
 PURPOSE

 The quality and safety of all blood and

blood products must be assured
throughout the process, from the
selection of blood donors through to the
administration of the product to the
patient (WHO)
 REQUIREMENT OF GLP IN
BLOOD SAFETY
 National standards and specifications for
blood products and a system of good
manufacturing practice to ensure these
standards are maintained at all times
 The development and correct use of standard
operating procedures
 The training of all blood transfusion service
lab staff to develop and maintain their
knowledge and skills
 REQUIREMENT OF GLP IN
BLOOD SAFETY

 Monitoring and evaluation to check that

the correct procedures are being used
correctly by all lab staff at all times
 An efficient system of independent
inspection and accreditation of the
facilities that collects, process and
distribute blood products.
 COMPONENTS OF GOOD
LABORATORY PRACTICES IN
BLOOD TRANSFUSION SERVICE

 Facility
 Personnel
 Identification of potential donors
 Processing of Blood/Preparation of blood products
 Documentation and records
 Standard Operating Procedures (SOPs)
 Quality Assurance/Quality Control of reagents and
equipment
 Safety
 Waste management
 FACILITY
 Adequate physical infrastructure in place
 Adequate and spacious working environment and
well lit
 Water- public, borehole and reservoir
 Electricity-Public and/or backup
 Appropriate Equipment with backup lab materials-
Refrigerator, Freezer, Hand lens, Viewing Box Bench
centrifuge, donor couch etc.
 Provide donor with a measure of privacy
 Clean with well organized waste disposal system in
place
 PERSONNEL
 Qualified - Appropriate educational credentials
 Skilled with Appropriate experience
 Adequately trained in the laboratory
component of blood transfusion services
 Competent
 Have a pleasant and welcoming attitude
 DONOR SELECTION

 To protect potential transfusion recipients

from the dangers of disease transmission.
 To minimize risks to the health of blood
donors.
 CRITERIA FOR
DONOR ACCEPTANCE
 Availability of voluntary, non-remunerated
donors
 Epidemiological data regarding the local
prevalence of, or immunity to, various
transmissible infections
 Demographic data such as age distribution,
indicators of average weight ,hemoglobin
concentration
 These criteria should form the basis of a
detailed donor manual.
 EQUIPMENT

 Selection, calibration and cleaning of

equipment such as scales and
sphygmomanometers must be
undertaken according to standard
operating procedures.
 EQUIPMENT

 Monitoring the performance of laboratory

equipment is an essential part of quality
assurance program.
 Equipment specifications should meet
technical,electrical,health and safety
standards
 Each piece of equipment should be assessed
when it is first installed and after any repairs
or adjustments that may alter the way it
functions.
 CONSUMABLES

 Consumables supplies should be selected

and evaluated for their suitability,
reliability and cost-effectiveness
compared with agreed specifications.
 Test should be introduced to monitor
their performance.
 DOCUMENT
AND
RECORD KEEPING

 Standard documents and records should be

developed to assure conformity to National
standards and for ease in collecting National
data.
 Regularly up dated,accurate,readily accessible
by laboratory staff and protected from
damage and deterioration.
 Ensure confidentiality of all documents and
records.
 DOCUMENTS
 Documents are the written policies,
process descriptions procedures, and any
blank forms used in the testing process.
 It constitutes the history and evidence
relating to all elements that contribute to
the quality of products and services.
 An integral part of quality assurance
 TYPES OF DOCUMENTS
 Patient log book/register.
 Receipts for materials delivered
 Information on receipts, installation,
commissioning, validation and
schedules of preventive maintenance
and repair of equipment used in blood
collection, processing etc.
 TYPES OF DOCUMENTS
 SOPS
 Product recall records.
 Processing and testing records
 Shipment documents
 Compatibility-testing records
 Dispatch record book.
 Blood transfusion reaction record
 TYPES OF DOCUMENTS
 Information from reagent
manufacturers, references from journals
and equipment service manuals.
All documents should be current and
managed with a tracking system and
consistent with National policy to assure
uniformity and adequacy of data
 RECORDS
 Records result from carrying out processes
and procedures within the testing process;
 Records are everything used to capture
information, activities or results when
performing a procedure.
PURPOSE:
Allows for the continuous monitoring of the
quality system.
 PURPOSE OF
DOCUMENTATION
 To provide that specific standards have been applied
to donor selection, to the collection, processing and
issue of blood and to track down the history of any
donation.
 To define the quality policy
 To minimize the potential error that is inherent in oral
communication.
 To instruct personnel on the details of all methods
and procedures.
 To ensure that consistency and reliability are applied-
to donor selection, blood collection and processing.
 Documentation Process
 Develop uniform format for each
document type, including standardized
format for forms
 Develop and implement a system for
document revision, approval and
distribution
 Manage patient test records
 Maintain a document storage, retrieval
and destruction system
STANDARD OPERATING
PROCEDURES
 The SOP is a document covering all
procedures undertaken in the blood
transfusion service, including record-
keeping, validation and documentation.
 Written SOPs should be available at the
work station where each task is
performed.
 They will vary in format and content
according to need
 EXAMPLES OF BTS
SOPs
 Donor selection SOP
 Blood collection SOP
 Testing and processing of blood and
blood components
 Training of staff
 Health and safety
 Use and maintenance of equipment
 LABORATORY
ASPECTS

Purpose of laboratory testing is to ensure

that blood and blood components meet
specific standards of safety and
efficacy.
 SPECIMENS
Specimens of blood and blood
components received in the laboratory
for testing should be
 Clearly labelled and documented

 Collected at the same time as the

donations and in such away as to

prevent errors of identity
 GENERAL
CONSIDERATIONS
 Sterility of the donation system is not
compromised.
 Collected,transported,and stored in a manner
that does not interfere with their suitability for
testing
 Reagents must meet nationally agreed
specifications.
 Techniques used must be specifically
recommended, validated and quality controlled.
 PROCESSING
REQUIREMENTS
 The ABO blood group of each donation
should be determined and the blood
and blood components labeled
appropriately.
 It should be determined by testing of
both red cells and serum or plasma of
the donor.
 Rh(D) GROUPING
 Rh (D)group of each blood donation
should be determined, and the blood/
blood component labelled appropriately.
 The red cells of the donor should be
tested against an Rh(D) grouping
reagent according to the manufacturer’s
recommended method.
 If positive report positive. If negative
perform another second test.
 QUALITY ASSURANCE
OF TESTS
QUALITY CONTROL QUALITY
MONITORING
Refers to the sampling, Is the regular analysis of
specifications and testing of randomly selected components
blood components. and ensures that certain
specifications are being met to
an acceptable degree.

Results of tests determine It should identify any problems

whether or not components that develop within the quality
are released. program.
 QUALITY CONTROL OF
ABO GROUPING
CONTROL TEST CRITERIA OF ACCEPTABILITY FREQUENCY

ABO reagent cells (A1

and B)
No visible haemolysis or turbidity Each series of
Appearance in supernatant tests
Clear-cut appropriate reactions
Specificity and with anti-A, anti-B (and anti-A,B if
sensitivity used)

ABO blood-grouping
anti-sera (anti-A, anti-B Each batch of
and anti-A,B if used) supply
No visible haemolysis, precipitate,
Appearance particles, or gel formation
Clear-cut appropriate reactions Each series of
Specificity and with positive and negative control tests
sensitivity (avidity) red cells
 QUALITY CONTROL OF Rh(D)
BLOOD GROUP REAGENT

CONTROL TEST CRITERIA OF FREQUENCY

ACCEPTABILITY

Appearance No visible haemolysis, Each batch of supply

precipitate, particles or gel
formation. Each series of tests
Specificity and sensitivity
(Avidity) Clear-cut appropriate
reactions with known
positive and negative
control red cells.
 RED CELL ANTIBODY
SCREENING
 Screen for the presence of clinically
significant red cell antibodies by examination
of the serum or plasma of the donor using
recognized and appropriate technique.
 Validate and quality control testing method by
using a selection of weak red cell antibodies.
 Positive screening results must be confirmed
and antibodies must be identified.
 TRANSMISSIBLE
DISEASES

All units of blood must be tested for

transfusion transmissible infections.
TRANSFUSION-TRANSMISSIBLE
INFECTIONS
 Human Immunodeficiency virus (HIV)
 Hepatitis B
 Hepatitis C
 Syphilis
 Malaria
 Chagas disease
 Cytomegalovirus
 HUMAN IMMUNODEFICIENCY
VIRUS
 Presence of HIV should be determined
by examination of the serum or plasma
from the donation using the National
algorithm: 4th generation Ag-Ab ELISA
 Screening of pooled serum samples may
be considered where the prevalence of
HIV is adequately documented.
 QUALITY CONTROL OF
HIV TESTING
CONTROL TEST CRITERIA OF FREQUENCY
ACCEPTABILITY
Specificity Clear-cut appropriate reactions
with a panel of known anti-HIV Each batch of test
negative and weakly positive sera. kits

If appropriate, clear-cut positive

Sensitivity
reaction with at least one sample
of a serum whose anti-HIV
concentration is equal to that
specified for the national Each series of tests.
minimum sensitivity.
 HEPATITIS B VIRUS
 Each unit of blood must be tested for hepatitis
B surface antigen (HBsAg) by a sensitive
method.
 Only validated methods should be used.
 No material from a donation should be released
from the quarantine unless the donation has
been tested and found to be HBsAg-negative.
 QUALITY CONTROL OF HBsAg
TESTING
CONTROL CRITERIA OF FREQUENCY
TEST ACCEPTABILITY
Specificity Clear-cut appropriate
reactions with a panel of Each batch of test
known HBsAg-negative and kits
weakly positive sera.

Sensitivity
If appropriate, clear-cut
positive reaction with at least
one sample of a serum whose Each series of
HBsAg concentration is equal tests.
to that specified for the
national minimum sensitivity.
 SYPHILIS
 Each unit of blood should be screened for
syphilis by a reliable method such as Treponema
pallidum haemagglutination or VDRL test.
 Only validated methods should be used.
 Depending on national or local policy,
seropositive blood should be either discarded or
kept for at least 72 hours at 2oC to 8oC before
use
 Test kits should be validated.
 QUALITY CONTROL OF
SYPHILIS TESTING
CONTROL CRITERIA OF ACCEPTABILITY FREQUENCY
TEST
Specificity Clear-cut appropriate reactions Each batch of
with a panel of known negative test kits
and weakly and strongly
positive ,sera.

If appropriate, clear-cut positive Each series of

Sensitivity reaction with at least one sample tests.
of a serum whose antibody
concentration is equal to that
specified for the national
minimum sensitivity.
 OTHER INFECTIOUS
AGENTS
 Where national or local policy requires
screening for other transfusion
transmissible infectious agents should be
performed.
 Quality control measures should include
tests to determine specificity and
sensitivity using nationally or locally
accepted criteria.
 Only validated method should be used
 STORAGE AND TRANSPORT OF
BLOOD AND BLOOD COMPONENTS
 Quality control of storage and transport
begins with the collection of the unit of blood
or blood components and ends with its
transfusion( or disposal if unused).
 Storage and transportation must meet the
national or local specifications and should be
such that the quality and integrity of
components are maintained.
 STORAGE AND TRANSPORT OF
BLOOD AND BLOOD COMPONENTS
 Quality monitoring, especially of temperatures,
should be defined in SOPs, and records must be
maintained to document the history of the blood
or blood components.
 There should be a designated storage for
quarantine of blood and blood components
which are still being tested, so that the material
cannot be released for issue until it has met all
the quality standards and has been documented
 SAFETY AND WASTE
MANAGEMENT

 AS SEPARATE PRESENTATION
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