Transcript File

International institute of Health Management Research, Delhi
Minakshi Gautam
Assistant Professor
History of Blood Bank
 Early development leading to establishment of banks dates back to 1915.
 It was when Richard Lewison of Mount Sinai Hospital, New York
initiated the use of sodium citrate as an anticoagulant.
 This discovery transformed the blood transfusion procedure from direct
(vein to vein) to indirect.
 The introduction of a citrate-glucose solution by Francis Peyton Rous
and JR Turner 2 years later permitted storage of blood in containers for
several days.
 Thus opening way for the first “blood Depot” established in Britain
during World War I.
History of Blood Bank
 Within a few years, hospital and community blood banks were
established across United States.
 Willem Johan Kolff organized the first blood bank in Europe (in
1940)
 An important breakthrough came in 1939-40 when Karl Landsteiner,
Alex Wiener, Philip Levine, and R. E. Stetson discovered the Rh Blood
group system, which was found to be the cause of majority of
transfusion reactions upto that time.
History of Blood Bank
 Three years later, the introduction by J.F. Loutit and Patrick L. Mollison
of acid-citrate-dextrose (ACD) solution, which reduces the volume of
anticoagulant, permitted transfusions of greater volumes of blood and
allowed longer term storage.
 An anticoagulent preservative, CPDA-1 was introduced in 1979.
 It decreased wastage from expiration and facilitated resource sharing
among blood banks.
 Newer solutions contain Adenine and extend the shelf life of red cells
to 49 days.
Definition
The transfusion services can be defined as “A medical
facility, designed, equipped and staffed, to procure, draw,
process, and store and distribute human blood and its
derivatives.”
(American Association of Blood Banks)
Some Facts
 Millions of lives are saved each year through blood
transfusions.
 In many countries, people still die due to an
inadequate supply of blood and blood products.
 To maintain an adequate blood supply, 1-3% of the
population needs to be blood donors.
Some Facts
 More than 92 million units of blood are collected
globally every year. (WHO 2012)
 Nearly 50% of these blood donations are collected in high-
income countries, home to 15% of the world’s population.
 However only 45% of these are donated in developing and
transitional countries where more than 80% of the world’s
population lives.
 Where blood is available, it is often unsafe.
Some Facts
 WHO estimates that the lack of effective screening
results in up to
 16 million new infections with hepatitis B,
 5 million new infections with hepatitis C
 16,000 cases of HIV infections every year
 Overall, 5-10% of HIV infections worldwide are the
result of transfusions of contaminated blood or blood
products.
Some Facts
 Hence every country has a common need to ensure;
 Availability of adequate supplies of blood and blood
products and their accessibility to all patients requiring
transfusion;
 Safety of blood and blood products;
 Safe and appropriate clinical use of blood and blood
products
Some Facts
 During last two decades there has been an increased
awareness in the field of blood transfusion medicine.
 This is due to advances in basic medical sciences such
as
immunology,
biotechnology,
genetics,
cryobiology, physiology as well as technical
progress.
 Greater stress has been laid on voluntary blood
donation.
Some Facts
 The major aim of blood transfusion has been to make
transfusion safe.
 Other aims have been in prolongation of the shelf
life of blood.
 It’s optimum utilization.
 Development of synthetic substances to supplement
human source.
Some Facts
 Through better understanding of red cell metabolism,
the red cell preservatives can preserve the red cells
upto 49 days as against 21 days earlier.
 The emphasis is now rightly put on the use of various
components of blood
 This helps to utilize one unit of donated blood for
more than one patient.
Some Facts
 Therapeutic applications of cell separators have also
enabled clinicians
mortality.
to
reduce
morbidity
and
 More sensitive methods for screening have helped in
prevention of diseases like hepatitis B, C and
HIV/AIDS.
 Methods of HLA (leukocyte antigens) typing have
been useful for transplant surgeries.
Some Facts
 Efforts are being made for use of artificial substitute
for specific components of blood.
 Genetic engineering techniques have isolated
recombinant DNA clones for adequate and safe
production of plasma proteins especially factor VIII.
 The most important managerial issue of a blood
bank is the donor recruiter and bleeding donors.
Some Facts
 Ideally no blood or blood components should be
allowed to outdate.
 Every effort should me made to reduce the waste of
blood.
 As per the available data, the wastage due to outdating
of blood is to the tone of about 10%, which is a
significant in the light of such a scarce
commodity.
General Considerations
 The blood transfusion centre should be located where it
provides easy access for donor and staff,
 And allow quick and safe transportation of blood and
components to hospitals
Tasks of Transfusion Centre and Planning a facility
 Total amount of blood to be taken
 The level at which centre will operate (national, regional,
district)
Functions of Blood Bank
 The main functions of the blood bank are;
 Recruitment of donors and maintenance of donor’s record.
 Collection, preservation, and distribution of blood and blood
components.
 Laboratory procedures like, testing for hepatitis B, Hepatitis
C, HIV, VDRL for Syphilis and Malaria Parasite.
 Teaching, training and research
 Clinical and therapeutic functions like transfusion and
daycare service.
Functions of Blood Bank
 Organizing of outreach programs for blood donation camps
in the community on a regular basis.
 Community Awareness programmes in close liaison with
mass media for motivating people to donate blood.
 Awareness
program for treatment of hematological
disorders like Hemophilia, Thalessemia, etc.
 Community
Awareness
transmitted diseases.
Programs
for
transfusion
 Maintaining a database for various types of blood groups;
particularly rare blood groups; with details of contact
telephone numbers or email ID, etc.
BLOOD COMPONENTS
 Packed Cells
 Fresh Frozen Plasma
 Single Donor Plasma
 Cryoprecipitate
 Hemoglobin
 Factor VIII concentrate
 Factor IX concentrate
 Platelet rich plasma
 Platelet concentrate
How long can the blood be stored at blood bank?
 Whole blood can be stored for 35 days.
 The various blood components can be stored as under;
* Platelet Concentrate - 5 days
* Packed Cells - 42 days
*Fresh Frozen Plasma – 1 year
* Cryo Anti Hemophilic Factor – 1 year
 Deep Freezer (-40°C and -80°C) are used to preserve plasma, related
blood components while platelets are store in agitator machine at 20°C
for proper storage.
Indications
 Packed Cells: Severe Anaemia and edema, chronic leukemia, hemolytic
anemias, etc.
 Fresh frozen plasma: Inborn deficiency of coagulation factors, DIC,
Thrombocytopenic purpura
 Cryoprecipitates: Chronic Renal failures, congenital platelet disorders,
Haemophilia
 Specific Immunoglobuliins: passive immunization for Hepatitis B,
Varicella, Tetanus
 Fresh Blood: Massive transfusion, Bleeding Disorders
Note: Fresh blood is especially ordered as certain components of blood
deteriorate rapidly on storage and these are: Platelets, Factor V and VIII,
Granulocytes
Exercise
 List major functions of BTS
 Advantages of using disposable plastic bags
 List areas which blood bank should have
 Criteria for accepting and rejecting blood donor
 Blood transfusion committee in hospital and its role
 Statutory requirements for BTS
Level of Blood Banks
Category I
Category II
Category III
3-7 units of blood/
hospital bed/ yr.
8-15 UOB/ bed/ year.
16 UOB/ bed/ year
6000-15000 UOB
consumed per year (4001000 bed hospital)
More than 15000 UOB
consumed per year (more
than 1000 bed hospital)
like medical college
hospital blood banks
1000-6000 Units of blood
consumed per year like
District Hospital Blood
Bank (100 – 400 beds
hospital)
Physical Facilities
 LOCATION
 Ideally on the ground floor.
 Direct access from main entrance.
 Signage system for easy visibility
 Close to emergency department
 Close proximity with/accessibility to hospital’s clinical service
departments
Physical Facilities
 Physical facilities and space of a Blood Bank can be grouped under the
following areas;
Donor
Recruitment
Office
Bleeding
Complex
Therapeutic Area
Laboratories
Administration
Area
Teaching and
Training Facility
The Path of the Donor
Entrance
Donor Records
Exit
Waiting Room
Donor Laboratory
Waiting
Room
Medical Examination
Resting
Room
Blood
Collection
Donor Cafeteria
The Path of the Blood
Blood
Collection
Refrigeration
and Freezing
Preparation
of blood
components
Plasma
Fractionation
Path of Blood Components
Path of Whole Blood
Path of Plasma and Plasma
Fractions
Distribution
The Path of the Blood Samples
Blood
Grouping
Labeling
Blood
Collection
Testing for
transmissible
diseases
Results
Blood Samples
Path of Plasma and Plasma
Fractions
Discarding
after agreed
period
Path of Materials
Source of Supply
Central Store
Non Sterile
Waste
Sterile
Department for use
Cleaning
Sterilization
Department for use
Waste
Designing a Blood Transfusion Centre
 Building must be designed so that closed working
areas (e.g. aseptic rooms) are not exposed to strong
sunshine.
 Climatic conditions to be considered, like, if wind
carries dust ventilation by filtered air may be required
 Donor, blood and outpatients shoud follow separate
paths
 Stand by generator
Designing a Blood Transfusion Centre
 If a transfusion centre is not located within a hospital, the
following supporting facilities must be needed;
 Sterilizing Room
 Laundry
 Garage
 Store Rooms
 Changing room
 Canteen for the staff of the centre
 Workshop for maintenance of building and equipment
 Suggested that a separate room be available for sterilizing
equipment and stills
Designing a Blood Transfusion Centre
 District level Transfusion Centre
 A district centre with 50 donors per day needs floor space of 120 m
sq
 Regional Level Transfusion Centre
 If daily bleedings number is 200, donor department floor space
should be 300 m sq.
 This assumes that more than half of the total donations taken by
mobile teams
• National Level transfusion Centre
•Approx. 900 sq m
Physical Facilities
 Donor Recruitment Office
 Most vital activity for any blood bank.
 Recruiting voluntary donors requires spread of public awareness
through mass media or community approach.
 It should have following facilities;






Donor Organizer’s space
Space for clerical staff
Space for type writer/ printer/ fax machine/ photocopier
machine
Telephone with intercom facility
Computer for database management for recording and retrieval
of data
Facility for printing and publicity material.
Physical Facilities
 Bleeding Complex
 It should be close to the front entrance, to ensure easy visibility, it
will consist of following rooms;






Reception Room
Examination Room
Bleeding Room and Aphaeresis Room
Rest Room
Kitchen / Pantry
Daycare Room/ Treatment Room
Physical Facilities
 Therapeutic Area
 Consists of the facilities required for blood transfusion
of those patients who require frequent transfusion of
blood or blood components like patients of thalessemia
and hemophilia.
Physical Facilities
 Laboratory
 Minimum movement of the persons in the corridor of the
laboratory
 Minimum access to the outsiders
 The processing, typing and cross matching of blood is
performed in this area
Physical Facilities
Laboratory
 The laboratories of the blood banks are of following types


1.
Laboratory for processing donor’s blood
Blood component laboratory
Basic Work
a) Fresh Frozen Plasma
b) Cryoprecipitate
c) Platelets
d) Packed RBCs
e) Leukocytes poor RBCs
f) Relevant Coagulation Work
Physical Facilities
Laboratory
2.
Advance Work
a)
b)
3.
Freeze dried and heated coagulation factors
Plasma Fraction
Donors Serological laboratory
a)
b)
c)
d)
ABO and Rh Grouping
Antibody Screening
Labeling Donor’s Blood
Storing of tested blood
Physical Facilities
Laboratory
4.
Infectious Diseases Laboratory
The laboratory will have provision for testing of:
a)
b)
c)
d)
e)
5.
HIV
Malaria Parasite
Syphilis
HBV
Hepatitis C Virus
Special Laboratory
The laboratory will do platelet and granulocytes serology.
Physical Facilities
 Laboratory
6.
Patient’s Serological Laboratory
The laboratory will do following functions:
a)
b)
c)
d)
ABO and Rh Grouping
Antibody Screening
Cross matching of blood
Antenatal work up
Physical Facilities
 Administrative Area
 Consultant’s Chambers
 Departmental office
 Administrative and Clerical Office Rooms
 Staff’s Common Room
 Store Room
 Wash Room and Toilet
 Housekeeping Room
 PRO’s Room
 Medico Social Worker Room
 Voluntary Counseling and Testing Center (VCTC)
Physical Facilities
 Teaching and training Facilities
 If the blood bank is a part of teaching/ training institution it will
participate in teaching and training program.
 In some of the hospitals blood bank is the part of Transfusion
Medicine
 It will have facilities of;




Conference Room
Demonstration Room
Departmental Library
Reading Room
Other Physical Facilities
 Water Supply: It should be pyrogen free water
 Electricity Supply: round the clock, uninterrupted to maintain cold







storage temperature.
Sewage Disposal System: Effluent Treatment Plant
Storage System: separate facility for blood and blood components
Steam: for cleaning of glassware, equipments and sterilizers
Supply of Distilled Water: Especially deionized, for blood transfusion
center
High Pressure Air Vacuum
Intercom System
Mobile Van for conducting blood donation camps as community
programs
Staffing
Staff
Blood Bank Category
I
II
III
Bleeding Complex
1. Junior Doctor
2. Nurses
1
2
1-2
3
2
4
3. Social Worker
4. Lab Attendant
1
1
2
1
3
2
Staffing
Staff
Blood Bank Category
I
II
III
Laboratory
1. Technical Supervisor
2. Technical assistant
2
1-2
4
4
8
3. Laboratory Technician
4. Laboratory Assistant
5. Lab Attendants
4
1
2
11
2
4
13
4
5
Staffing
Staff
Donor Organizer
1. Associate/ Classical Staff
2. Social Worker (mobile
team)
3. Vehicle + Driver
Blood Bank Category
I
II
III
Part
Time
1
2
2
5
10
Part
Time
1
2
Staffing
Staff
Service Staff
1. Clerks / Typist
2. Store Keeper
3. Housekeeping Attendant
Blood Bank Category
I
II
III
Part
Time
1
2
Part
Time
Part
Time
1
2
1
2
Staffing
Staff
Blood Bank Category
I
II
III
Medical Director
1. Professor
2. Associate Professor
-
1
1
1
3. Lecturer
-
2
3
EQUIPMENTS
 Can be grouped as following:
 Equipments for Routine Work
Refrigerator – for maintaining temperature to 1-4 degree with audiovisual alarm, temperature display, temperature recording, 24 hr power
supply. Minimum number of refrigerator should be 3
i.



ii.
iii.
iv.
v.
vi.
For untested blood -1
For tested blood – 1
Tested and Cross matched blood – 1
Centrifuge table top
Water bath
Incubators
Hot Air Oven
Binocular Microscope
EQUIPMENTS
vii.
viii.
ix.
x.
xi.
xii.
xiii.
Weighing Scale for blood bags
Domestic Refrigerator
Ph Meter
VDRL Agitator
Weighing Machine for donors
Distillation Plant
Analytical Balance
EQUIPMENTS
 Additional Equipments
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
Dielectric Sealer – 2
Vortex Mixer
Plasma Separation Stand
Magnetic Stirrer
Laminar Air Flow
Micro Plate Agitator
Plasma Separation Stand
Platelet Agitator
Cryoprecipitate Thawing Bath
ELISA System with washer, incubator and reader kits for HIV/ HBV/
HCV/ VDRL tests for screening of blood equipments
Apheresis System when procedure is carried out
BLOOD COLLECTION MONITOR
Blood Collection Monitor is a
compact
instrument
to
provide smooth and gentle
rocking for homogeneous
mixing with anticoagulant
without clot formation of
blood cells during collection
of blood from a donor.
BLOOD BAG TUBE SEALER
Blood Bag Tube Sealer is a
compact equipment to seal
the Blood Bag pilot tube by
radio frequency sealing
system. Sealing can be
achieved in less than 1.5
seconds per tube by simple
operation. Sealed tube can
be easily separated by
pulling the sealing section
by
both
sides.
PLASMA THAWING BATH
Micro controller based
Plasma Thawing Bath is a
tabletop model, for quick
thawing of plasma at
37.0 °C. Temperature is
controlled
by
micro
controller
based
temperature controller.
VERTICAL PLAZMA FREEZER
Microcontroller based Plasma
Freezers are designed for quick
freezing and storing of plasma and
related blood components at
desired low temperature up to -35
ºC.
The
System
includes
temperature controller with digital
temperature display, Temperature
recorder,
Temperature
alarm
system with adjustable high / low
alarm limits, includes audio visual
alarm on temperature deviation.
Platelet Incubator
Micro controller based platelet
incubators are designed to store
Platelet concentrates in continuous
motion at controlled temperature.
The platelet Incubators are
constructed of double walls the
exterior is made of mild steel and
the inner chamber is fabricated of
imported stainless steel medicalgrade.
Blood Bank Refrigerator
Blood Bank Refrigerators are
designed to fit a variety of space
and storage requirements Combine
Superior refrigeration technology
and precise temperature control to
ensure reliable blood storage.
Blood Bank Refrigerators are
equipped
with
Heavy-duty
compressors and direct air flow
cooling system to maintain a vital
operation temperature of 4 °C.
Donor’s Couch
Micro-controller based donor
couch is designed to provide a
comfortable position for the donor.
Donor's position can be easily
shifted from upright body position.
Plasma Extractor
Micro-controller
based
Plasma Extractor is designed
for automatic separation of
blood components from the
blood bag.
Plasma Expresser
High Volume Centrifuges are
designed
&
developed
for
centrifuging
larger
volume
centrifuge tubes, bottles, blood
bags etc. The unit is provided with
control panel with speed control,
digital speed indicator, and 0-99
minutes digital timer with a bypass
switch for operating beyond 99
minutes and automatic switching
off alarm signal and digital
temperature control cum indicator.
Layout
FRONT OF THE HOSPITAL BLOOD BANK
Donor Recruitment
Office
Bleeding
Complex
Therapeutic
Area
Department
Admin. and
Clerical Offices
Component
Basic
laboratory
Donor Serology
Storage Refrigerator
Doctor’s office
Component
Stores
Infection Test
Laboratory
Trainee’s office
Components
Advanced
laboratory
Library &
Conference
Room
Staff
Store Room
Issuing
Counter
Emergency lab
Platelets Serology
Antenatal Workup
Special Lab
RBC Serology
Platelet Serology
Leukocyte
Serology
Toilets
Wash Room
Record Room
Distillation Plant
Schedule of Accommodation
Room/ Space
Public Access Areas (Bleeding
Complex)
• Reception
• Medical Exam Room
• Bleeding Room
• Refreshment Room
• Kitchen/ Pantry
• Aphaeresis
• Daycare/ Therapeutic
Area in sq m
40
12
20
12
8
30
40
Schedule of Accommodation
Room/ Space
Laboratory Areas
• Routine Donor Work – up
Area in sq m
20
• Patient Sample and ANC Work up
• Specialized Lab Work
• TTI Lab (Transfusion Transmissible
Infection)
20
30
30
• Component Separation
• Wash Room
• Emergency Lab
30
20
15
• Issue Counter
10
Schedule of Accommodation
Room/ Space
General and Administrative Areas
• Doctor Office
Area in sq m
12
• Donor Recruitment
• Office
• Stores
• Technicians Common Room
10
12
15
10
• Toilets (separate for male and female)
• Training and Seminar room
• Library/ Conference
4
20
30
Other Specifications
 According to existing statutory provisions, the
blood bank should have an area of 100 m sq for its
operations and an additional area of 50 m sq for
preparation of blood components.
Other Specifications
 It should consist of at least a room each for
 Registration
 Medical examination
 Blood collection
 Component Preparation
 Lab for transfusion transmissible infections
 Sterilization cum washing
 Refreshment cum rest room
 Store cum records
Other Specifications
 Licensing authorities have to record reasons in writing,
if relaxation is to be provided in respect of testing
laboratories and sterilization cum washing room
 Temperature should be maintained between 20-25
degree C and recommended air changes are 10-15 /
hour
Movement of Each Unit of Blood
Bleeding Room
Blood Collected in blood bags
and pilot tubes
Stored untested in refrigerator
Pilot tubes sent
to
Infectiou
s disease
lab
Donor
lab
Blood bank
sent to
Issued to patients
Cross-matched blood in issue
counter
Cross-matched blood stored in
Components
Room
Donor Blood
labeling Area
Labeled, tested blood stored in tested
stock refrigerator in donor lab
Components Refrigerator in
patient lab, for cross match
Blood bags shifted each
day to
Policy and Procedures
 Every blood bank should develop and maintain the
written policy and procedures in form of SOPs
 NACO, under GOI, Ministry of Health and family
welfare has designed various procedures and step by
step approach while dealing with transfusion services of
the hospital.
 It
is available in document prepared by NACO,
“Standards for Blood Bank and Blood transfusion
Services.”
Policy and Procedures
 Selection of donor and Bleeding Donor

1)
2)

Whenever a decision is made regarding acceptance
or rejection of a blood donor, these two things
should be kept in mind, i.e.
Safety of Donor
Safety of Recipient
Each blood donor must be screened by medical
history and appropriate physical examination
Policy and Procedures

The donor should have

Age between 18 yrs to 65 yrs

Body weight of 110 pounds or more for 450 ml of
blood collected

Body temperature should be less than 37.5 degree C
or 99.5 degree F

Pulse rate should be between 50 – 100 beats per
minute.
Policy and Procedures
 Blood Pressure: The systolic BP between 90-160 mm
Hg: diastolic between 50-100 mmHg
 Haemoglobin estimation: It should be 13.5 gm/ dl
(male) and 12.5 gm/ dl (female): or minimum
haematorcit: 41% male and 38% female
 Specific Gravity: It should be > 1.055 (male) and >1.053
(female)
Policy and Procedures
 Deferral of Donor for Donation of Blood

It can be a permanent or temporary Deferral, depending
upon the situation.

Permanent Deferral

History of Viral Hepatitis, History of jaundice of unknown
cause, malignant cases, Leukemia, convulsions, fainting spells,
abnormal bleeding tendency, non positive HBsAg (Australia
Antigen Test), serious Cardiopulmonary Disease , high risk
behavior, drug addicts etc.
Policy and Procedures
 Deferral of Donor for Donation of Blood

Temporary Deferral

Conditions requiring rest or medication, cold, flu,
diabetes, TB, sexually transmitted diseases like
syphilis, etc.
Policy and Procedures
 Deferral of Donor for Donation of Blood

The period of deferral may vary for many other conditions like
various vaccination, major surgery, termination of pregnancy
or delivery, dental or minor surgery and symptomatic asthma.

A minimum of 72 hrs deferral is made for a donor who has
consumed aspirin.

Under the directive of Honorable Supreme Court of India
it is unlawful to take blood from any professional donor.
Policy and Procedures
 Other Important Considerations
Identification Details:
1.





2.
Full Name
Address
Contact Details
Telephone Number
Age, Sex and Race
Consent: A written consent of the prospective donor is
required
Policy and Procedures
 Other Important Considerations
Preparation before donation
3.

Eat a regular meal, avoid fatty food, and no alcohol within 12
hrs prior to donation
4. Exceptions

A physician can make exceptions specially for therapeutic
bleeding, auto transfusions, immunization and specially
rare blood donors.
Policy and Procedures
 Phlebotomy

Bleeding of the donor should be smooth and painless

Strict aseptic procedures must be followed and only
disposables used.

The vein-puncture site should be free of skin lesions of an
infectious nature.

The donor blood bank, sample tube and donor record
should be properly identified and labelled before drawing
blood
Policy and Procedures
 Phlebotomy

Plastic blood bags with additional satellite bags should be
selected according to need.

For instance single bag may be used for whole blood, double
bags for RBC concentrates, triple bags for platelets, and
quadruple bags for both platelets and cryoprecipitate.

Universal precautions must be followed in each case

Thorough inspection of bags for defects and anticoagulant
inside
Policy and Procedures
 Phlebotomy

Thorough mixing of blood in the bag and tubing is essential

It should be ensured that there is no leaking from the
puncture site and that the donor is in satisfactory condition
before leaving the room.

An adhesive bandage should be applied to the phlebotomy
site

Donor should be made to rest for 15-20 minutes before being
asked to get up
Policy and Procedures
 Phlebotomy

He should be then taken to the refreshment room for light
refreshment.

In case the donor complaints of giddiness or faints,
immediately make him lie down with foot-end raised.

Check his BP and other vitals

Give necessary post donation advice to the donor

Every donor must be thanked before he leaves the blood
bank
Policy and Procedures
 Labeling and Storage of Donor Blood

Donor blood should be stored at 1-4 degree in proper blood
bank refrigerator.

Untested, tested and cross matched blood should be stored
in separate refrigerators.

These should never be allowed to mix under any case

Standard colored labels should be used for labelling the
donor units
Policy and Procedures
 Labeling and Storage of Donor Blood

The donor bag number, date of collection, date of expiry,
blood group and other relevant information should be
properly and boldly mentioned on every bag.

It must be ensured that correct information being made
available on the cross-matched label, so that the blood goes
to the correct patient.
Policy and Procedures
 Tests on Donor Blood

ABO and Rh Typing

Every donors blood must be tested in infectious deseases
laboratory for HIV I and II, hepatitis B, HCV, VDRL, and
malaria.
Policy and Procedures
 Pre transfusion testing of the Recipient's blood

Recipient’s first and last name, age and sex, bed no. and
hospital registration no. and other relevant details available
must identify the recipient

Specimens must be labeled at the bedside; with the full
name of the patient, date, identification no., initials of the
person drawing blood.

If the blood sample has to be drawn from the intravenous
tubing it should be flushed with saline and the first 5 ml of
blood discarded.
Policy and Procedures
 Pre transfusion testing of the Recipient's blood

When additional transfusions are requested, a new
specimen should be obtained at each 48 hr interval to
identify an incompatibility from an antibody developed .

Hemolyzed blood samples should be avoided.

ABO and Rh typing should be done on every recipient
before blood is issued.

Cross matching should be done on every unit of blood to be
transfused to the patient
General Guidelines

The provision of safe and adequate blood is the
responsibility of government.

The formation of a nationally organized and managed
blood program should be an integral part of each
country’s national health care policy and health care
infrastructure.

The Blood Transfusion Services should be established in
accordance to National Blood Policy and plan within
the legislative framework.

The blood bank should function under the direction of
licensed physician qualified by training and experience as
Transfusion Medicine Specialist
General Guidelines
It should be responsible for establishing and maintaining
a national quality system, including;


The development of guidelines and standards,

staff training,

a data/ information management system

System for monitoring and evaluation of all the blood
transfusion activities
General Guidelines

All blood banks should be licensed by State Drug
Controller and approved by Drugs Controller
General, India.

It should be regulated by Drugs and Cosmetics Act
and rules there under
General Guidelines

Compliance with laid down rules for recruitment
and selection of donors, collection, processing,
storage and distribution. (as per drug and cosmetic
Act)

All blood banks to have their quality policy and
prepare quality manual.

Each blood bank should maintain a detailed SOP
manual as well as records (forms, registers, labels) in
a prescribed format by Drug and Cosmetics Rules.
General Guidelines

Adequate and competent staff as prescribed in
Schedule F Part xii B & C of drug and cosmetic
Rules.

The record of their qualifications, training and
competency should be maintained.

All containers, anticoagulants and reagents used
should meet the standards of Drug and Cosmetics
Act.
General Guidelines

All materials for blood collection and transfusion
should be sterile.

Pyrogen free and disposable materials should be
used and storage should be in an air conditioned
area.

Aim should be to accept blood from only voluntary
non remunerated safe blood donors.

Gradual phase out of replacement donors.

Blood sellers are banned as per Supreme Court
directive.
General Guidelines

Full time competent staff ensuring proper cadres for
both medical and paramedical staff.

All medical colleges to have a blood bank or
department of transfusion medicine and have
faculty as per MCI guidelines.

All blood banks collecting more than 10,000 units of
blood or having blood component license should
employ a diploma or M.D. (TM) or M.D. Pathology
with minimum 1 year experience in blood bank.
General Guidelines

Blood banks collecting < 10,000 units should at least
have an MBBS doctor with minimum one year
experience in blood bank to manage services.

A quality manager should be appointed preferably a
medical officer or senior MLT trained in quality
management in all blood banks collecting > 10,000
units per year.

Training and facilities for implementing universal
precautions for HAI
Policy for Outdoor Blood Donation Camps

Blood donation camps should be organized to
augment blood stocks.

Donor organizer/ medical social worker of the blood
bank should contact offices, institutions, industries,
social and religious organizations, colleges and
schools.

Adequate publicity and IEC material should be made
available to the organizations.
Policy for Outdoor Blood Donation Camps

The donation site should be inspected prior to the day of
camp.

All facilities should be as per drugs and cosmetics rules.

Blood bank should maintain quality at each step from
donor recruitment, selection and collection to the final
product.

The methods of collection and management should be as
per fixed sites.

Predonation counseling procedures should not be
compromised.
Policy Regarding Aphaeresis

Aphaeresis is a procedure carried out to harvest a
particular component and returning the rest of the
blood to the donor, by an automated machine.

This procedure should be carried out only in a blood
bank licensed for this purpose.

A medical officer trained in aphaeresis technique
should be responsible for the procedure.

Provision for emergency medical care, in the event of
any adverse reaction to the donor.
Policy Regarding Aphaeresis

The staff working on the machine should be trained
in aphaeresis procedure and should work directly
under supervision of MO.

Donor should be asked to sign the consent form in
the language, which he understands after being
explained the procedure and risk involved.
Plasmapheresis: Procedure to harvest plasma from
the whole blood and returning the cellular
components to the donor.
Selection of donor for Aphaeresis

In an occasional plasmapheresis in which donors
undergo the process once every 12 weeks the
standards for whole blood donation should apply.

In higher frequency then stated above, the donor
should be tested before every procedure for
Hemoglobin and hematocrit.

It should be as Hg > 12g/dl and Hct 36%.

Total serum protein should not be less than 6
gm/dl.
Selection of donor for Aphaeresis

In serial plasmapheresis minimum interval should
be of 48 hrs between two procedures.

Not more than 2 procedures in week should be
allowed.

If a participant of such program donates a unit of
blood or if it is not possible to return red cells, the
donor should not undergo platelet/ plasmapheresis
for 12 weeks.
RECORDS

Records of donor’s like;

Periodic examination

Laboratory tests

Consent of Donor patient

Date of last apheresis procedure

Certificate of the attending physician

Procedure

Volume of product separated

Drug used

Adverse reaction if any and their treatment
Volume of Plasma

Volume of plasma from a donor weighing at least 55
kg, should not exceed 500 ml with serum protein
within normal limit during one procedure.

Or not more than 1000 ml per month with a
maximum of 12L/year
Cytapheresis

Procedure for separation of individual cellular
component of blood.

Can be achieved by cell separator machine

Plateletpheresis is the harvesting of platelets from
whole blood using continuous or intermittent flow
cell separator.

Leukapheresis is harvesting of granulocytes from
whole blood.
Cytapheresis: Selection of Donor

Donors who undergo cytapheresis, not more than
once every 12 weeks should be treated as ordinary
blood donors with regards to laboratory studies.

More than once in 12 weeks should be examined as
in donor selection procedure for apheresis. (Hg,
Haematocrit and serum protein)

Platelet count should be determined before
plateletpheresis and should not be below 150000/dl.
Cytapheresis: Selection of Donor

Total and differential white cell count should be
normal.

Persons who have ingested aspirin or similar
antiplatelet drugs in the last 72 hrs should not be
suitable for plateletpheresis.

Donors with personal and family history of bleeding
tendency should not be suitable for plateletpheresis.
Cytapheresis: Selection of Donor

Before leukapheresis total WBC counts should be
4000/dl.

In serial pheresis minimum interval should be 48 hrs
and not more than two procedures in a week.

A participant of such program donates a unit of
blood or if it is not possible to re-infuse the red cells
during a pheresis procedure should not be accepted
for cytapheresis for 12 weeks.

Supreme Court Judgment and Directions 1996

Establishing national and state councils of blood
transfusion.

Activities of national and state councils to cover
entire range of services related to blood transfusion.

Developing good quality technical manpower for
transfusion services;

Training of technical personnel

Post graduate course

Drug inspectors training
Supreme Court Judgment and Directions 1996

Institution for conducting research on various areas of
transfusion medicine.

Banning unlicensed blood banks within 1 year.

Banning professional donors within 2 years

Income tax exemption for donation to councils

NACO for coordinating the development of national
blood transfusion network in India

Hindustan Latex Ltd. engaged to assist NACO in
preparation of comprehensive plan for setting up national
and state councils.
Supreme Court Judgment and Directions 1996

Union government should take steps to establish
forthwith a National Council of Blood Transfusion as
a society registered under the Society Registration Act.

It would be a representative body having representation
from;







Directorate General of Health Services of GOI
Drug Controller of India
Ministry of Finance from GOI
Indian Red Cross Society
Indian Association of blood Banks
Major medical institutions
NGOs active in field of voluntary blood donations
Blood Transfusion Reactions
 About 2-4% transfusions lead to minor or major reactions
 Causes are;
 Clerical mistakes



Upto 80% cases are due to incorrect labeling
Errors in writing correct particulars on requisition
Confusion in identity of the patient
 Technical errors
 Wrong grouping and cross matching
 Rare blood group
 Minor cross match errors
Investigations in case of Transfusion Reaction
 Ranges from minor reactions like rigors to severe reactions of
fatal nature.
 The occurrence should be immediately reported to the blood
bank.
 The reporting authority should send:




A post transfusion blood sample
A post transfusion urine sample
A pre-transfusion blood sample
Blood bag along with tubing
Role of
organization
s in blood
transfusion
services of
India
To overcome Transfusion Reactions the Blood
Bank should maintain
 The patient’s original cross match specimen, which should
normally be preserved for at least 48 hrs after dispatching the
blood or its products.
 The donor’s pilot tubing/ bottle, which must be preserved; for
at least 48 hrs
 The laboratory and blood bank records
 The blood bank should take urgent steps to establish the
cause of transfusion reaction.
 The record of transfusion reaction should be maintained.
Blood transfusion Committee in
Hospital
 Medical director/ administrator
 Blood bank Chief
 Representatives from clinical department
 Representatives from nursing staff
 Blood bank technicians