BLOOD BANK

&TRANSFUSIO
N SERVICES
Dr. Sujeet Sinha
Sr. Resident
 INTRODUCTION
• Blood transfusion is a broadly based discipline
that overlaps and intersects many other
medical, scientific and managerial fields,
including hematology, immunology, genetics,
histo -compatibility, cellular function and
metabolism, protein structure and function,
cryobiology, disposable equipment, statistics,
bioengineering, data-processing, public
relations, logistics, and standardization.
 INTRODUCTION
• “Blood banks” were an adjunct to the all
encompassing laboratory services.
• Now a days most hospitals have separate
blood transfusion services as an integral part
of ancillary services.
 ROLE AND FUNCTIONS
• Blood Transfusion Services play a vital role in daily functioning of
a hospital.
• The major functions of blood transfusion service are:
a) Selection of voluntary donors to determine suitability for
donation history and medical examination
b) Collection, storage and preservation of blood and blood
components using aseptic measures. Optimum storage of
blood and blood products (incl. components)for specific
duration of time so as to ensure availability during
emergencies.
c) Screening of collected blood for various blood borne
diseases (as is mandatory in India for HIV, Hep. B, syphilis,
malaria and Hep. C virus)
 ROLE AND FUNCTIONS
d) Component preparation as per established protocols
depending upon the mandate of the hospital.
e) To carry out emergency grouping and cross-matching
of samples before issue.
f) Record keeping of all blood bank processes.
g) Teaching and training of medical/ para-medical staff
and research
h) To conduct camps for voluntary blood donation to
meet any shortfall between demand and supply
i) To develop and nurture pool of healthy voluntary
donors.
 PLANNING CONSIDERATIONS
Key Planning And Design Parameters
The following factors must be considered in the planning of a blood
transfusion service either as a part of the hospital or as a ‘stand
alone’ type that provides services to a number of hospitals:
• Number of beds(incl. surgical discipline beds)
• Types of surgeries done in the hospital(general/specialized/
super-specialized/trauma)
• No. of ICUs (esp. surgical)
• Whether the hospital has separate department of hematology,
• oncology-where the blood requirement is likely to be on a regular
basis.
PLANNING CONSIDERATIONS
 PLANNING CONSIDERATIONS
Physical Facilities and Layout
 It should preferably be located at the ground floor, close to the
emergency and the operation theatres with prominent signage
for donors and patients/attendants.
 The premises must be of suitable size, construction, and
location to facilitate their proper operation, cleaning, and
maintenance in accordance with accepted rules of hygiene.
 Premises must be well-lighted(min.200 lux),ventilated and mesh
screened or have air curtains to prevent entry of flies and other
insects.
 A proper access with ample parking space definitely is beneficial
for the donors.
PLANNING CONSIDERATIONS
They must comply with the Requirements for Biological
Substances
No. 1 (Geneva Requirements for Manufacturing Establishments
and Control Laboratories) and provide adequate space, lighting,
and ventilation for the following activities:
 Medical examination of the individuals to determine their
fitness as donors of blood and for blood components
 Taking blood from donors with minimum risk of contamination
or error
 Care of donors, including those who suffer adverse reactions
 Storage of whole blood and blood components pending
completion of processing and testing
PLANNING CONSIDERATIONS
 Laboratory testing of blood and blood components;
processing and distribution of whole blood and blood
components in a manner that minimizes the risk of
error
 Performance of all steps in apheresis procedures
where applicable
 Labeling, packing and other additional operations
 Storage of equipment, reagents and disposable
material
 Documentation and recording of data of the donor,
the donated blood and, the recipient
 PLANNING CONSIDERATIONS
• Further in planning a transfusion centre, due
consideration should be given to the
following;
Total amount of blood to be taken;
and the level at which the centre will operate
(national, regional or district), which will
determine the different tasks requiring different
premises, working conditions, equipment and
personnel.
 PLANNING CONSIDERATIONS-(General
Considerations)

Location and Space

• The blood transfusion centre should be located where
it provides easy access for donors and staff, and allows
quick and safe transportation of blood and
components to hospitals.
• The areas of the blood bank should be contiguous. The
blood bank should have the following areas:
 Donor Recruitment area
 Bleeding complex
 Therapeutic area
 Laboratories
 Administrative and clerical offices
 Teaching Facilities
 PLANNING CONSIDERATIONS-(General
Considerations)

• Donor Recruitment Area

 Hospital-based blood transfusion services may either
initiate their own donor recruitment drive or
coordinate with the central voluntary agencies such as
Red Cross, Red Crescent, which are involved in blood
collection.
 The coordination may be in terms of sending a team of
medical officer, laboratory technologist and donor
attendant for outdoor mobile blood donation camps to
participate in collection of blood organized by
voluntary agencies.
 PLANNING CONSIDERATIONS-(General
Considerations)

• Donor Recruitment Area

 This programme is required to develop a voluntary donor base

in the regional community by donor appeals, community or
personal-based approach. It is of utmost importance to retain
the motivated and once recruited blood donors. Success of any
donor recruitment programme can be assessed by the number
of regular donors donating blood.

 Repeated donor appeals before conducting an outdoor

voluntary donation camp help in effective donor motivation and
recruitment.
camps.
 PLANNING CONSIDERATIONS-(General
Considerations)

• Donor Recruitment Area

 Recruiting voluntary donors requires techniques of mass
contact, therefore, the donor recruitment area should be
provided with adequate space for interaction with the
donor. It should be air conditioned and comfortable, so
that any apprehensions in the mind of a donor are
removed.
 Adequate facilities for maintaining and retrieving donor
data as and when required.
 Printing facilities to provide required information to the
donor should be available.
 The bleeding complex should have adequate space and
facilities for a comfortable bleeding of the donor.
 PLANNING CONSIDERATIONS-
(General Considerations)
• Hygienic Conditions:
The best hygienic conditions must be ensured
throughout the premises of a transfusion centre
since there is a continuous movement of donors,
staff, materials, and blood and blood samples.
Blood and blood components taken from the
centre are used in hospitals, and external
contamination of containers should, therefore, be
avoided.
 PLANNING CONSIDERATIONS-
(General Considerations)
 Doors should be wide (1800 mm) and rooms in the
laboratory area spacious enough for proper
installation of mandatory equipment.
 Adequate provision should be made for power points
in all rooms where equipment are installed including
provision for power backup ( through UPS) especially
for critical equipment.
 Furniture should be modular with provision for future
expansion
 In public access and administrative areas , furniture
should be comfortable, provision for health
education and messages should exist.
 PLANNING CONSIDERATIONS-
(General Considerations)
• Air-conditioning is desirable for the greater
comfort of donors and staff.
• Central AC–recommended for large ,regional
level blood transfusion services;
• Individual AC(Split/window)-recommended
for smaller hospitals and help to maintain
temperature between 20-25° C.
Recommended air changes must be
10-15/hour.
 PLANNING CONSIDERATIONS-
(General Considerations)
• Electricity Supply:
A reliable electrical supply is essential for lighting
and for operation of equipment.
A power failure to refrigerators may damage
stored blood and blood components, and
a transfusion centre must, therefore, have its own
stand-bye generators. The cost of damage caused
by a power cut will almost certainly exceed the
cost of the generator.
 PLANNING CONSIDERATIONS-
(General Considerations)
• Storage:
 Whole blood and blood components must be
stored separately in a refrigerator, refrigerated
room, or freezer, as appropriate, which is used
only for this purpose.
Refrigerated rooms are more economical for
larger transfusion centres, where large quantities
of blood and components must be
accommodated,.
 Standards for Space for Blood Bank
Depending upon the type of the Blood Bank the standards for space are as follows:
Blood Rank Category
I II III
Bleeding Complex
1 Reception Room 25 25 40
2 Medical Examination Rooms 15 25

3 Bleeding Room 40 55 100

4 Refreshment Room 15 25 30
5 Kitchen Pantry 5 5 10
6 Apheresis area 40
7 Day Care Therapeutic area 30 50

Laboratory Area
1. Laboratory for routine Donor work 25 50

2. Laboratory for routine patient and 25 50

antenatal work
3. Laboratory for specialized work: 50
Platelets HLA granulocyte serology
 Standards for Space for Blood Bank
standards for space CONTD……………
Blood Rank Category
I II III
Bleeding Complex
4. Issue counter 20
5. Emergency Laboratory 18 20 20
6. Hepatitis, HIV, VDRL, Malaria 20 25 30
7. Wash room, distillation plant etc. 20 25 30
8 Component basic and coagulation 25 30
work
9 Component advanced freeze-drying 50
General Areas

1. Doctor's office 15 15 20
2. Donor, Recruiter, Social Worker, 25 30 50
3. Blood Bank Office 15 20 25
4. Stores 20 25 35
5. Technician's common room 15 20 25
6. Toilets 5x2 5x2 5x3
7. Trainee doctors room 25
8. Library/Conference room 30
TOTAL 248 460 895
• Minimum Area Requirements for different categories of
blood bank are:
 For category I : 100 Sq.M
 For category II: 300Sq.M
 For category III: 895 Sq.M
 EQUIPMENT
• In a blood bank, equipment is required for:-
 routine work,
 blood component work and
 for screening purpose of blood.
A) For Routine Work
1)Refrigerator: The refrigerators should maintain
a temperature of 1-4° C, have audio-visual alarm
system, temperature display, and recording, air
circulation and 24 hours power supply. The inside
should be of stainless steel and removable or pull
out shelves.
 EQUIPMENT
Although the number of refrigerators will depend
upon the size and work load of the blood bank, yet a
minimum of 3 are required:
 1 for storing untested blood,
 1 for tested blood and
 1 for cross-matched blood.
 EQUIPMENT
2)Table Top Centrifuge: Capable of 3500Xg with
accurate timer in 1 min. increment up to 30
minutes 'Accurate Tachometer. Acceleration to
desired speed in approximately 30 sec., rapid
deceleration Rotor for swing head capable of
taking minimum of 16-20, 12x100 mm tubes
and microplate carrier. Number depends on
size of blood bank but approximately equal to
the number of daytime technicians.
 EQUIPMENT
3) Water bath 37°C with temperature control of + IO°C, of
fiber glass
4) Incubator 37°C with temperature control of + 10°C
5) Hot Air oven for drying glass ware
6) Microscope binocular
7)1 kg balance for weighing blood bags during collection
8) Tube stripper cutter and aluminium clips to seal blood bags
9) B.P. Apparatus
10) Domestic Refrigerator for storing anti-sera, kits etc.
I I) pH meter
12) VDRL Agitator
Needle destroyer
 EQUIPMENT
13) Blood bag stand (stainless) for keeping bag
upright
14) Test tube racks test tubes and glass slides,
marker pencils etc,
15) Flexible table lamps with concave mirror
16) Blood bags-single (350 ml. and 450 ml.) and
multiple (double, triple and multiple)
17) Sera for grouping and other reagents
18) Distillation and double distillation plant
 EQUIPMENT
• Additional equipment for blood bank collecting
more than 10,000 units:
1) Dielectric tube sealer
2) Vortex mixer.
3) Magnetic Stirrer
4) Analytical Balance
5) Laminar Air Flow
6) If using microplate technique-Microplate agitator
Blood Bag tube sealer
 EQUIPMENT
B) For Blood Component Work
I) Blood bank refrigerated centrifuge for 450 ml blood
bags. windshield. Temperature of 0-25°C. Timer at I
min, interval tachometer.
2) Freezer: 70°C with alarm system, temperatures
display,
hours power supply and standby power.
3)Freezer: 20°C to 40°C with alarm system, temperatures
24 hours power supply and standby power.
4) Dielectric Tube Sealer
 EQUIPMENT
5) Plasma Separation Stand
6) Tube Stripper, cutter and aluminum rings
7) Platelet Agitator cum incubator for platelet storage
8) Cryoprecipitate Thawing Bath
9) Laminar air flow
10) Weighing scale of 2 kg with sensitivity of 100 mg.
11) 1 kg, balance in 5 mg increments for weighing plasma
bags
12) Computers, Printer etc.
 EQUIPMENT
C) For Screening of the Blood
1) Elisa System with washer, incubator and Reader
2)Kits for HIV, HBsAg, HCV,VDRL
D)Apheresis System: If apheresis procedures are
carried out.
STAFFING
 POLICY AND PROCEDURES
Every blood bank should maintain document
carrying Policy and Procedures being followed
in the form of Standard Operating
Procedures(SOPs).Each person working should
strictly follow the laid down protocol for every
procedure.
POLICY AND PROCEDURES(Contd..)
POLICY AND PROCEDURES(Contd..)
POLICY AND PROCEDURES(Contd..)
POLICY AND PROCEDURES(Contd..)
POLICY AND PROCEDURES(Contd..)
PROCEDURES(Contd..
POLICY AND PROCEDURES(Contd..)
 POLICY AND PROCEDURES(Contd..)
Tests on Donor Blood
1) ABO and Rh Typing: Confirmation of donor’s blood group and
antibody screening (for irregular antibodies) should be carried out
in the donor laboratory.
2) Every donor’s blood must be tested in Infectious Diseases
laboratory for HIV I and II , Hepatitis B,VDRL and Malaria. Though it
is not yet mandatory but it is desirable to screen the donor’s blood
for Hepatitis C also.
3) The blood bank must have separate facilities for carrying out these
tests in its own premises.
4) Strict confidentiality should be maintained about any positive
results. It is imperative that written documentary proof should be
maintained of the results.
 POLICY AND PROCEDURES(Contd..)
Issue of Blood
Only a hospital employee( Doctor, Nurse or
Nursing orderly)should receive the blood on
behalf of the patient. Patient receiving blood
and technician issuing the blood should sign in
the issue register. Blood should be transfused
without delay. All empty bags should be
returned the blood bank within 24 hours.
 POLICY AND PROCEDURES(Contd..)
Movement of Donor Blood
• Donor blood after collection is moved into either the untested refrigerator for
storage till screening tests are over , or moved to the component preparation
room, if components are to be prepared.
• The pilot tubes collected along with the blood bags are sent to the routine
laboratory for grouping and serological work up , and to the infectious disease
laboratory for tests for Hepatitis , syphilis , AIDS , etc.
• Once the components are prepared and the tests on the pilot tubes are
completed, the donor blood is moved to the labeling area, where each unit is
appropriately labeled with blood group and other relevant information.
• The labeled and tested blood is stored in the stock refrigerator. Each morning
sufficient number of donor units is shifted from the stock refrigerator to the
refrigerator, which stores the blood to be cross matched.
• Once the blood is cross matched, the blood unit is moved to the refrigerator
enmarked for this purpose and kept in the issue room for issue to the patient.
 POLICY AND PROCEDURES(Contd..)
Movement of Patient Blood
The person on duty there receives patient samples in the
counter room. Emergency requests are separated and
proceeded
on priority for immediate grouping, cross-matching and issuing
of the blood.

Routine requests are serially numbered and sent to the patient

laboratory for serological workup.
POLICY AND PROCEDURES(Contd..)
ORGANIZATIONAL STRUCTURE
INVENTORY CONTROL
 BLOOD TRANSFUSION COMMITTEE
To ensure appropriate use of blood and minimise wastage it is essential for a

transfusion committee to meet periodically as part of medical audit.

Members of the committee would consist of the Medical

Director/Administrator of the Hospital/Blood Bank Chief, representatives of
each Clinical department specially those which consume large quantities of
blood, representatives of the nursing staff and the blood bank technical staff.

The functions of the Transfusion Committee are to ensure safe transfusion

practice for the hospital. This involves two main divisions, i.e. systems audit
and clinical practice audit.
FUNCTIONS OF THE TRANSFUSION
COMMITTEE
 CONTROL AND EVALUATION
• The aim of blood transfusion services is to
supply good quality of blood and components
to the patient an avoid any risk to the donor.
• The Standard Operating Procedures Manual
should be maintained in every Blood Bank and
should carry a chapter on Quality Control
measures being undertaken by the blood
bank. A few of these measures are:
BLOOD COMPONENTS
BLOOD COMPONENTS(contd..)
BLOOD TRANSFUSION REACTIONS
INVESTIGATIONS IN A CASE OF
TRANSFUSION REACTIONS
 Regulation - Why?
• To ensure quality of blood & products
• To ensure blood and products benefit and not
harm the patient
• To ensure the maximum efficacy
• To prevent the transfusion of unsafe blood or
blood products to patients
 Status of BTS in INDIA
• Blood Transfusion Service is a vital part of the
National Blood Programme
• Govt has the full responsibility for the
National blood program which is under NACO
• National Blood Policy adopted in April 2002
and Action plan is ready for implementation
• National Blood transfusion council and state
blood transfusion councils established –
supreme court judgment are functional
• Legislation under Drug Controller
 Blood - Drug
• Human blood is covered under the definition
of ‘Drug’ under Sec. 3(b) of Drugs & Cosmetics
Act. Hence, it is imperative that Blood Banks
need to be regulated under the Drugs &
Cosmetics Act and rules
 Regulatory Authorities
• Licence Approving Authority
Drug controller General of India
• Regulatory Control
Central Govt
State Govt
Management Of Blood Banks

State blood transfusion council

Regional blood transfusion centers
Govt Hospital based blood banks
Private hospital based blood banks
Red cross blood banks
NGO run blood banks
 Blood Collection- National
• Reported Annual Collection: 6 million units.

• Estimated Need : 8.5 to 9 million units.

• Voluntary Blood Donation: 55%

• Proportion separated into components : 20%

 Ferguson report 1990
De-centralized Infrastructure
Lack of critical resources
Lack of Trained manpower
Lack of Equipment
Lack of Supplies
Lack of financial support
Lack of voluntary donation
 Amendment rules 1992
Following M/s. Ferguson’s Report which brought out various
deficiencies with regard to quality control of blood and blood
products etc. in the year 1990 and based on concern expressed,
the D&C Rules were again amended (Rules 68A, Part XB and
Part XIIB of Schedule F) in the year 1992-93 and Drugs
Controller General (India) was vested with the power of Central
License Approving Authority (CLAA) to approve the license of
notified drugs viz. Blood and Blood Products, I.V. Fluids and
Vaccines and Sera.
 Evolution Of National Blood Safety
Programme—1992-99
Implemented by NACO
• Formulation of Guidelines for HIV Testing
• Establishment of HIV testing facilities
• Modernization of 815blood banks
• 40 Component separation units set up
• Formulation of National blood transfusion
council
• TRG constituted on blood safety
 National Blood safety Programme
(NACO 1999-2004)
• Strengthen blood banks at District levels
• Establish 20 major blood banks and 40
Component Separation
• HCV testing mandatory from June1,2001.
• Training imparted at regional centers designated
by NACO through NIB
• Establishment of project on State of the art blood
banks
• Quality assurance workshops country wide
• Establishment of storage centers at First Referral
Unit
 Procedure Licensing Of Blood Banks
• Application for license for operation of Blood
Bank/processing of whole human blood for
components/manufacture or Blood Products
• Inspection before grant or renewal.
• Report by Inspector
• Delegation of powers by the Central
Licensing Approving Authority
-Duration of License
-Cancellation and suspension of licenses
Regulatory requirements of QA in BTS

As per Revised drug rules-

• PREMISES
• PERSONNEL
• EQUIPMENT
• SUPPLIES AND REAGENTS
• GOODMANUFACTURING PRACTICES
• STANDARD OPERATING PROCEDURES (SOPs)
• DOCUMENTATION
 Personnel
• Qualified Medical Doctors
• Trained staff Nurses
• Qualified Sr Technical Assistant BSC MLT
Qualified Technicians MLT
• Laboratory Attendants
• Quality Managers
 Equipments
• Equipments Per gazette notification is
mandatory for procurement of licence for
blood bank as well as compoment separation
unit

• Installation certificate & validation

certification

• Maintainence of Equipment with records

 Supplies and Reagents
Quality control of Each lot of
• Anti Sera
• Reagents
• Blood bags with certificate from supplier
• Elisa kits
Quality control of storage of supplies and
reagents
 FUNCTIONAL PLAN OF PREMISES

Donor Donor Blood Requisitions

Entrance & Areas Laboratory
Exit & Issue of blood
Blood Storage
Areas

Apheresis
Refreshment

Washing areas Blood Discard

Sterlisation
Teaching Administrative areas
Conference room Records /database Blood Mobiles
Stores Entrance for
Staff room Deliveries
 PATH OF A DONOR

Entry/ Reception Donor

Exit and Registration
Waiting area

Medical
Bleeding Examination
Refreshment room and
Predonation
Counselling
 PATH OF BLOOD

Blood Collection

Storage Components

(RBC’s) (FFP & Cryo)

(Platelets) Agitator
Refrigerate Deep Freezer
220C
at 20-60 C _-400C- 800C
 Blood Collection and Donor care
• Labeling with appropriate Colour coding
• Ensure correct amount of blood to be taken
as per capacity of bag duly on a Biomixer
• Ensure pilot tubes and samples for TTI testing
are properly labeled and drawn
• Provide Pre and Post donation Care in an Air
conditioned Room
• Proper Refreshment is provided to the donor
 Blood Group Serology
• Testing by Coombs Cross Match
• And by Better Methods Initiated
• SOP Essential
• Standardization
• Adequate documentation is desired
 Quality Assurance In Screening
Laboratory
• Test kits provided by state Aids control
societies to all Govt blood banks and all
centers are Mandatory screening of blood for
• HIV
• HCV
• Hepatitis B surface antigen
• Syphilis
• Malaria
 Quality Assurance Of Blood
Component Preparation
• QC of donor selection
• Blood bag and Anticoagulant used
• Duration of venesection
• Storage and transport
• Procedures involved in prep
• Administration to the patient
 Quality Assurance Of Storage
• Daily checking of refrigerators and freezers for
storage temps
• Ensure uniform temp distribution
• Weekly monitoring of temp chart
recorders/dial thermometers
• Quarterly alarm activation checks
• Periodic preventive maintenance
• Periodic check for orderliness
 Quality AssuranceTransportation
• Ensure storage temps for blood and blood
components
• Maintain cold chain for transportation
• Check for leaks,hemolysis,change in color of
red cells
• Record time and temp of issue and receipt
of blood
Training And Education Programmes

Clinical Use Of
Blood

Quality Management Training courses