Chapter-15: BLOOD BaNK
Points to be covered in this topic
➜ 15.1 INTRODUCTION
➜ 15.2 REQUIREMENTS OF A BLOOD BANK
➜ 15.3 FUNCTIONS OF A BLOOD BANK
15.1 INTRODUCTION
• Blood bank’ means a place or organization or unit or
institution or other arrangements made by such
organization, unit or institution for carrying out all or any
of the operations for collection, storage, processing and
distribution of blood drawn from donors and/or for
preparation, storage and distribution of blood components.
• Blood banking includes tasks related to blood collection, processing, testing,
separation, and storage.
• State Drug Controller issues the license to the blood bank. All such blood banks
are to be approved by Drugs Controller General of India (DCGI) and regulated by
Drugs and Cosmetics Act and Rules there under.
15.2 REQUIREMENTS OF A BLOOD BANK
SCHEDULE F: PART XII B: Requirements for the functioning and operation of a
blood bank and/or for preparation of blood components.
I. Blood Banks / Blood Components
1. GENERAL
i. Location and Surroundings: The blood bank shall be located at a place which
shall be away from open sewage, drain, public lavatory.
ii. Building: The building used for operation of a blood bank and/or preparation of
blood components shall be constructed in such a manner so as to permit the
operation of the blood bank and preparation of blood components under hygienic
conditions.
iii. Health, clothing and sanitation of staff: The employees shall be free from
contagious or infectious diseases. They shall be provided with clean overalls, head-
gears, foot-wears and gloves, wherever required.
2. ACCOMMODATION FOR A BLOOD BANK
A blood bank shall have an area of 100 square meters for its operations and an
additional area of 50 square meters for preparation of blood components. It shall be
consisting of a room each for:
i. Registration and medical examination with adequate furniture and facilities for
registration and selection of donors.
ii. Blood collection (air-conditioned)
iii. Blood component preparation. (This shall be air-conditioned to maintain
temperature between 20°C to 25°C)
iv. Laboratory for blood group serology (air-conditioned)
v. Laboratory for blood transmissible diseases like hepatitis, syphilis, malaria, HIV-
antibodies (air-conditioned)
vi. Sterilization-cum-washing
vii. Refreshment-cum-rest room (air-conditioned)
viii. Store-cum-records
3. PERSONNEL
Every blood bank shall have following categories of whole time competent
technical staff:
i. Medical Officer; possessing the qualifications
ii. Blood Bank Technician(s) possessing:
a. Degree in Medical Laboratory Technology (M.L.T) with six months experience
in the testing of blood and/or its components.
b. Diploma in Medical Laboratory Technology (M.L.T) with one years experience
in the testing of blood and/or its components, the degree or diploma being from a
University / Institution recognized by the Central Government or State
Government.
4. MAINTENANCE
The premises shall be maintained in a clean and proper manner to ensure adequate
cleaning and maintenance of proper operations. The facilities shall include:
a) Privacy and thorough examination of individuals to determine their suitability as
donors.
b) Collection of blood from donors with minimal risk of contamination of exposure
to activities and equipment unrelated to blood collection.
c) Storage of blood or blood components pending completion of tests.
d) Storage of finished products prior to distribution or issue.
e) Proper conduct of all packaging, labelling and other finishing operations.
f) Provision for safe and sanitary disposal of –
i. Blood and/or blood components not suitable for use, distribution or sale.
ii. Trash and items used during the collection, processing and compatibility testing
of blood and/or blood components.
5. EQUIPMENT
• Equipment used in the collection, processing, testing, storage and sale/distribution
of blood and its components shall be maintained in a clean and proper manner and
so placed as to facilitate cleaning and maintenance.
• The equipment shall be observed, standardized and calibrated on a regularly
scheduled basis as described in the Standard Operating Procedures Manual.
• Equipment that shall be observed, standardized and calibrated with at least the
following frequencies: Temperature Recorder, Refrigerated.
6. SUPPLIES AND REAGENTS
All supplies and reagents used in the collection, processing, compatibility, testing,
storage and distribution of blood and blood components shall be stored at proper
temperature in a safe and hygienic place, in a proper manner and in particular:–
a) All supplies coming in contact with blood and blood components intended for
transfusion shall be sterile, pyrogen-free and shall not interact with the product in
such a manner as to have an adverse effect upon the safety, purity, potency or
effectiveness of the product.
b) Supplies and reagents that do not bear an expiry date shall be stored in a manner
that the oldest is used first.
c) Supplies and reagents shall be used in a manner consistent with instructions
provided by the manufacturer.
d) Representative samples of each lot of the following reagents and/or solutions
shall be tested regularly on a scheduled basis by methods described in the Standard
Operating Procedures Manual to determine their capacity to perform as required.
Reagents and solutions Frequency of testing along with controls
Anti-human serum Each day of use
Blood grouping serums Each day of use
Lectin Each day of use
Antibody screening and reverse grouping cells Each day of use
Hepatitis test reagents Each run
Syphilis serology reagents Each run
Enzymes Each day of use
HIV I and II reagents Each run
Normal saline Each day of use
Bovine Albumin Each day of use
7. STORAGE & TRANSPORTATION
• Storage: Immediately after processing, the Packed Red Blood Cells shall be kept
at a temperature maintained between 2°C to 6°C.
• The blood storage centres should ensure rapid and safe delivery in emergency
cases. If the blood shows the turbidity, haemolysis, or change in colour, it should
not be taken on stock for transfusion.
• The blood should be properly packed into cold boxes surrounded by ice packs
during transportation and ice should be clean and should not come in direct contact
with the blood bags.
8. RECORDS
The records which the licensee is required to maintain shall include inter alia the
following particulars, namely:
i. Blood donor record: It shall indicate serial number, date of bleeding, name,
address and signature of donor with other particulars of age, weight, blood
grouping, bag number and patient’s detail etc. for whom donated in case of
replacement donation, category of donation and deferral records and signature of
Medical Officer In-charge.
ii. Master records for blood and its components: It shall indicate bag serial number,
date of collection, date of expiry, quantity in ml. ABO/Rh Group, results for testing
of HIV I and HIV II antibodies, Malaria, V.D.R.L. and name and address of the
donor with particulars, utilization issue number, components prepared or discarded
and signature of the Medical Officer in charge.
iii. Issue Register: It shall indicate serial number, date and time of issue bag serial
number, ABO/RH Group, total quantity in ml, name and address of the recipient,
group of recipient, unit/institution, details of crossmatching report, indication for
transfusion.
iv. Records of components supplied: Quantity supplied; compatibility report, details
of recipient and signature of issuing person.
v. Records of purchase, use and stock in hand of disposable needles, syringes,
blood bags, shall be maintained.
15.3 FUNCTIONS OF A BLOOD BANK
1. Compliance with laid-down standards in Drugs and Cosmetic Act and Rules:
The Blood Bank is accountable for adhering to the guidelines set forth in the D and
C Act and Rules regarding the recruitment, selection, and processing, distribution,
and storage of blood and blood components.
2. Storage of blood and blood components:
Blood and its components are stored. Only approved blood storage freezers with
temperature monitoring charts and alarm systems may be used to store blood and
blood components.
3. Response to urgent requests for blood components:
The Blood Bank is required to give immediate response to the request of customer
for blood or blood components after consulting with the blood bank staff.
4. Checking pre-transfusion samples and request forms:
• Sample receiving from the blood bank and it is the duty of the respective blood
bank employee to confirm that the information on the label.
• The patient’s serological and transfusion history shall be checked to know the
previous results and the results of current testing are required to be compared with
those of previous tests.
• If any difference is observed, these issues need to be resolved before any blood or
blood component is released for transfusion.
5. Assessment of immunological compatibility between donor and patient:
• Before transfusing RBC components, the blood bank tests the patient’s serum for
compatibility with the donor red blood cells (crossmatch).
• Initially, the technician must draw blood from the patient to ascertain their RhD
type and ABO group. Additionally, a screening test must be performed to identify
any dangerous clinically relevant red cell antibodies.
• In order to choose suitable donor units, further testing is carried out to detect red
cell antibodies if the screening test is positive.
6. Selection of suitable blood component:
The blood bank will use the test results and with information provided on the
request form to select and label the correct blood component.
7. Safe delivery of blood and blood components:
• Blood should be stored in the blood storage refrigerator with the monitoring chart
temperature and an alarm system.
• Blood bank ensure that the correct unit of blood withdrawn.
8. Record maintenance, Traceability and Hemovigilance:
• Record must be maintained manually or preferably electronically.
• All steps from donor management to blood supply must be carefully recorded.
• The record of returned blood bags and all reactions and events must also be
maintained.
• It is required to have full traceability of blood and blood components, from donor
to recipient and vice versa.
• Blood Banks are required to collect and access information on unexpected or
undesirable effects resulting from the therapeutic use of labile blood products.
9. Inventory and stock management:
• Blood bank is responsible for the management of blood and blood component
stock and this may include:
i. Blood's average age at the moment of issue
ii. Volume of blood is expired or not used for any other reasons.
• To prevent overstocking and waste, stock levels should be set roughly based on
weekly use and activity.