Blood Bank Organization and its Management

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Introduction
• Blood transfusion service (BTS) is a vital component of any
health care delivery system.
• The aim of blood transfusion services should be to provide
effective blood and blood products, which are safe as
possible and adequate to meet patients’ needs.
• A blood transfusion service is a complex organization,
requiring careful designing and management.
National Blood Policy (2007)
A need for modification and changes in the blood transfusion
service has necessitated formulation of National Blood Policy
(2002, revision 2007).32
Objectives
1. To provide safe and adequate quantity of blood and blood
components.
2. To make available adequate resources to develop and re-
organize the BTS in the entire country.
3. To make latest technology available for operating the BTS
and ensures its functioning in an updated manner.
4. To launch extensive awareness programmed for donor
information, motivation, education, recruitment and reten-
tion in order to ensure adequate availability of safe blood.
5. To encourage appropriate clinical use of blood and blood
products.
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Blood Bank Organization
and its Management
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Essentials of Blood Banking and Transfusion Medicine
6. To strengthen the manpower through human resource
development.
7. To encourage research and development in the field of trans-
fusion medicine.
8. To take adequate regulatory and legislative steps for
monitoring and evaluation of blood. Transfusion services
and to take steps to eliminate profiteering in blood banks.
General Considerations for Setting Up a Blood Bank
• General guidelines
• Basic structure and designing of a blood bank
• Location
• Aims and operating policies
• Staffing pattern
• Personnel management
General Guidelines
• Location
– Not exposed to strong sunshine
– Proper natural lighting of rooms and protection from dust
and insects
– Adequate protection against rains and snow
– Stand by generator
• Equipment and instruments for different sections
• Utilities—water, electricity, fuel
• Consumable supplies
• Lab reagents, bags, etc.
• Office supplies
• Quality control program followed in BTC
• Laboratory safety precautions
• Basic financial consideration and budgeting.
Building
• Located in hospital premises
• Provides easy access for donors and staff, allows quick and
safe transportation of blood and components
• Well lighted, ventilated protected
• Away from sewage, drain or similar unhygienic surroundings.

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Standard Floor Space Requirement
Standard floor space shall cover a minimum area of 100 sq.m.
for whole blood collection and an additional area of 50 sq.m.
for component preparation.
Donor Area
• Reception and donor waiting area
– Spacious
– Well ventilated
– Proper and comfortable sitting arrangement
– Social worker or technical staff to answer queries and
alleviate anxiety
• Medical examination room
• Donor refreshment-cum-resting room
• Should have AC with proper and comfortable seating
• Drinking water and refreshments
• Observation room
Medical Examination Room
• Jar with copper sulphate
• Sterile lancet and swabs, spirit
• Capillary tubes with rubber bulb
Blood Donation/Collection Room
• Should have AC, proper light, washable floors
• Should not be visible for people in waiting room
• Should have comfortable beds
• Sterile equipment
• Refrigerators and resuscitation equipment
• Dust free, quite and pleasant with privacy for recording
history and examination
• Should have emergency drugs
• Connected to reception on one side and refreshment room
on other
Equipment in Blood Donation Room
• Donor beds, chairs and tables
• Bedside table

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Essentials of Blood Banking and Transfusion Medicine
• Sphygmomanometer and stethoscope
• Clinical thermometer
• Disposable blood collection bags and sets: 3 types
– 350 mL with 49 mL CPD-A1 anticoagulant (single bag)
– 450 mL with 63 mL CPD-A1 anticoagulant (double bag)
– 450 mL with 63 mL CPD-A1 anticoagulant (triple bag).
• PVC sterile bags, easy to store with attached tubing and needle.
• Disposable needles and syringes.
• Shaking apparatus for proper mixing of blood and anti-
coagulant.
• Blood bag weighing scale.
• Heat sealer or tube sealer artery forceps and scissors.
• Test tubes for typing and serological testing.
• Emergency drugs: Adrenaline, corticosteroids, metachlopro-
mide, dextrose, normal saline, etc.
• Oxygen cylinders with mask gauges and pressure regulators.
• Cotton, sterile gauge, antiseptic solution and adhesive tapes.
Laboratory
Should be spacious, AC with proper lighting.
Samples are processed for grouping and crossmatching;
blood is issued accordingly.
Equipment Used in Laboratory
• Microscope, centrifuge, water baths
• Refrigerators
• Incubators
• Graduated pipettes, glass slides, test tubes
• Test tube racks of different specifications
• Wash bottles, plain and EDTA vials
Refrigerator
• Tested and untested blood stored separately with constant
temperature of 2–6°C.
• Digital dial thermometer, recording thermograph and alarm
device.
• Constant power supply.

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Blood Bank Organization and its Management
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Cleaning, Sterilization and Other Rooms
• Divided into 2 portions:
1. Washing area
2. Sterilization area (with autoclave and distillation plant)
• Administrative room, doctor’s room and cleaner’s room
• Office: Telephone, card index cabinets, filing cabinets,
computer with printer, stationary, donor registration card
• Accessories
• Reagents:
– Standard blood group sera-anti-A, anti-B, anti-AB with
known controls
– Rh typing sera
– Anti-human globulin (Coombs’ test)
– Bovine albumin
– ELISA test kits for hepatitis, HIV and malaria, syphilis
Infrastructure
• Water: Adequate, round the clock, uncontaminated
• Electricity: Reliable supply and powerful standby generator
• Sewage
• Communication system
Staff
Medical officers: 2
With MD degree in pathology with suitable experience in
transfusion med (or as per the guidelines of drugs controller,
India).
Technicians: 11
A degree/diploma in medical laboratory technology with
at least 6 months of training. They can also perform a role of
phlebotomist.
Registered nurse: 1
Attend donor and perform phlebotomy
Technical supervisor: 1
• In blood bank where components are prepared

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Essentials of Blood Banking and Transfusion Medicine
• Degree/diploma medical laboratory technology with 1 yr
experience in preparation and handling of blood and blood
components
Public relation/information personnel: 1
To answer queries, motivate donors, educate them and alleviate
their anxiety
Lab assistants:
2
Cleaner:
1
Secretary/clerk-cum-typist:
1
Record keeper:
1
Note: Staffing for blood bank varies according to workload
and this is the minimum staffing for 1000–5000 blood units
collection per year.
Waste Disposal
Bag colour
Type of waste
Yellow
Human anatomical waste, lab cultures
Red
Material contaminated with blood, non-sharp
disposable items, gloves, catheters, tubes, IV sets
Blue or white
Needles, syringes, scalpels, blades, broken glasses
Black
Discarded medicines
Non-infectious Material is Recycled
Biodegradable waste
• Landfill
• Vermiculture
• Buried
Infectious solid waste
• Incinerated
Infectious liquid waste
• Disinfected
• Flushed out

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Component Separation Room
• Units of whole blood are separated into various components
and stored at optimal conditions.
• Area has to be 50 sq m.
• Completely secluded, sterile with restricted entry.
• With AC, temperature of 20–25°C.
• Well equipped with refrigerators, deep freezers, etc.
Advantages of blood components
• Enable selective transfusion of blood products according to
specific needs.
• Allow optimal survival of each of the components.
• Maximizes the number of transfusion recipients.
• Enables blood collection agencies to maximize their financial
returns.
Following are the components
• Packed red cells
• Fresh frozen plasma
• Platelet rich plasma
• Platelet concentrates
• Cryoprecipitate
• Cryo-poor plasma
• Granulocyte concentrate
Equipment in component separation room
• Plasma expressor
• Refrigerated centrifuge
• Dielectric sealer
• Weighing device
• Refrigerator
• Platelet agitator with incubator (+20°C)
• Deep freezer (–30°C to –60°C)
• Cell separator
Refrigerator
• To keep processed blood like packed red cells and whole blood
• Should have capacity to store 210 bags of 450 mL capacity

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Essentials of Blood Banking and Transfusion Medicine
• Maintain constant temperature
• 4–6°C+/– 2°C
• Attached digital dial thermometer
• Continuous power supply
Deep freezer
• Maintaining temperature of –30° to –60°C
• 500 liters capacity
• Store fresh frozen plasma and cryoprecipitate
Platelet rotator/agitator
• Provide constant gentle agitation
• Room temperature
• Store platelet concentrates
Standard Operating Procedures (SOPs)
Maintenance of written standard operating procedures (SOPs)
which include all steps to be followed in collection, processing,
compatibility testing, storage of blood and/or preparation of
components.
• Written by blood bank director
• Reviewed and revised every year
• These minimize the human mistakes
Note: Also refer to Quality Improvement and Quality Control
in Blood Transfusion.
Medicolegal Concerns and Ethical Aspects
Blood transfusion services in a blood bank have high potential
risk of adverse reactions to recipients and high risk of legal
liability to hospital.
Risks include
• Acceptance of donor
• Extraction of blood
• Storage of blood and its derivative
• Procedures like grouping, crossmatching
• Transfusion to the donor

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Documentation and Record Maintenance
• To judge the performance of blood bank
• To trace any unit of blood from its source to final position
• In legal or investigation process
• Compilation of statistical data of performance monthly and
yearly
• Written as well as computerized documentation and records
should be maintained.
Various records to be maintained
• Blood donor record including rare donor panels, donor
referrals and donor reactions
• Master records
• Issue register
• Records of blood bags
• Transfusion adverse reaction records
• Recipient’s register
• Blood stock register
• Register of blood grouping and crossmatching
• Register for grouping and typing of OPD and ward patients
• Records of apparatus, reagents, etc.
• Quality control records
• Patient/recipient’s record
• Attendance registers for staff
Quality Assurance
• Customer focused, strategic and systemic approach to conti-
nuous improvement involving all persons in the organization.
• Provides opportunity for all staff to be a part of team approach.
• Provides common structure for improvement of problems
and processes.
• Customer needs to be satisfied with quality services, on time
and at best possible cost.
Quality Control
• Testing routinely performed to ensure proper functioning
of materials, equipment and methods.

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Essentials of Blood Banking and Transfusion Medicine
• QC performance characteristics and acceptable ranges should
be readily available for the prompt detection and appropriate
handling of unacceptable variations.
• A separate QC department and medical officer should take
appropriate actions.
• It includes:
– Proper construction of premises
– Continuous monitoring of the equipment
– Competence of the personnel
– Testing of defined number of units of each product for
appropriate parameters
– When unfavorable results—procedures must be reviewed
and appropriate measures taken
– Proper documentation and record maintenance
According to Drugs and Cosmetics Act it is mandatory that in
any storage equipment in the blood bank the following are a must:
• Digital display of temperature inside
• Thermograph
• Alarm system
• Temperature of the thermometer should be compared
periodically to the temperature on the recording chart
• A difference of more than 2°C is not acceptable.
Accreditation
Laboratory accreditation is a procedure by which an authorita-
tive body gives formal recognition that a laboratory is compe-
tent to carry out specific tasks based on third party assessment.
Emphasis is on technical competence which also includes
quality system management
• Currently Drugs and Cosmetic Rules under Government
of India,33 provide accreditation services for blood bank.
• With the national blood policy now in place, the government
is all set to take the next step towards improving transfusion
services in the country.
• National Aids Control Organization (NACO)34 plans to come
up with an accreditation programmed for blood banks, blood
storage centers and other centers involved in providing
transfusion services.

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Worldwide accreditations for blood banks
• Food and Drug Administration (FDA)
• American Association of Blood Banks (AABB)
• College of American Pathologists (CAP)
• National Committee for Clinical Laboratory Standards
(NCCLS)
Legislation
• India has a procedure for mandatory licensing under the
Drugs and Cosmetics Rules for blood banks.
• Any blood bank can function only if it qualifies the criteria
laid down by the organization.
• These range from quality and variety of the equipment used,
to the qualification of the working staff, source of procure-
ment of blood and blood components to labeling of blood
units/components licensing is renewed every year if trans-
fusion center fulfils all specifications.