Naco Guidelines

Guidelines For Blood Storage Centres

BACKGROUND

• To achieve the objective of providing safe & quality blood to all in need wherever and whenever required, it was felt necessary to establish storage centres which can receive tested and processed blood and blood components from authorised centres. This facility can be used for patients in the hospitals in the area where storage centre is located. The need for establishing such centres were:
• Many doctors working in the first referral units and other hospitals in the rural areas, especially those working in the vicinity of highways, constantly complained of unavailability of blood.
• In large cities and towns the number of blood banks have been increasing, as all hospitals small and big were required to establish their own blood banks. This has resulted in unnecessary proliferation of blood banks.
• For supplying blood to many private nursing homes, small private blood banks have mushroomed.
• For proper regulation of the system and to maintain quality, it is necessary to reduce the number of blood banks.

LOCATION

• The storage centre can be established at any hospital, government or private. It may be in a rural or urban area.
• Any blood bank presently collecting up to 2000 units of blood annually can be converted into a storage centre provided it can get affiliated to a larger blood bank for regular supply of blood.
• The storage centre can get affiliated to any government or regional blood bank, which is approved by State Blood Transfusion Council (SBTC) and licensed for the purpose. Private or commercial blood banks should not be given permission to supply blood to storage centres by the SBTC.

REQUIREMENTS

• The area required is only 10 sq.mts. well lighted, clean and preferably air-conditioned and should have equipments for storage as prescribed by Drugs & Cosmetics Rules.
• The storage centre should have following equipment:
  1. Blood bank refrigerator
  2. Insulated boxes for transport of blood.
  3. Microscope
  4. Centrifuge
  5. Incubator
  6. Pipettes
  7. Glassware
• The storage centre should have adequate provision for blood grouping reagents.
• The centre will have to maintain records for procurement, cross-matching and issue of blood and blood components and archive these for at least 5 years.
• The license issued to the storage centre will require renewal every 2 years. In case if the license of the affiliated parent centre is cancelled the license of the storage centre will also be automatically cancelled.
• The storage centre can procure blood or components from more than one blood bank to ensure availability but an approval will be required for each case from SBTC and Drug Controller.
• The storage centre will adhere to biosafety guidelines.

STAFF

• The staff i.e. M.O and technician are not required to be full time employees for the storage centre. They may have other duties in the hospital.
• The staff should preferably undergo an orientation training of approximately 1 week at the regional centre to which the storage centre is affiliated.
• The storage centre should work round the clock.

STORAGE

• It is necessary to maintain the cold chain at all times during transport, storage and issue. Proper insulated carry boxes should be used during transportation of blood.
• The ice in use should be clean and should not come in direct contact with blood bags.
• Whole Blood and Packed Cells should be kept in blood bank refrigerator at 4 -6oC ± 2 up to 35 days. Red cells in additive solutions can be stored up to 42 days.
• When packed cells are prepared from a whole blood unit after sedimentation using an open system, the packed cells should be used within 24 hours.
• Fresh Frozen Plasma (FFP)/Cryo can be stored up to one year at –300 C or lower.
• Platelet concentrates can be stored at 20 -22oC for 3 -5 days depending on the bags in which these are prepared.
• Due care should be taken to maintain sterility of blood and blood components by keeping all storage areas clean.
• The temperature of all storage areas should be monitored continuously preferably using a graphic recorder. The alarm system should indicate any deflection in temperature and this should be checked every month.
• The storage centres should check the condition of the blood on receipt from the regional centre and also during the period of storage, as the responsibility of problems arising from storage, cross-matching, issue and transfusion will be of the storage centre. Any unit showing haemolysis, turbidity or change in colour should not be taken on stock for transfusion.

ISSUE OF BLOOD/BLOOD COMPONENT:

• Blood may be issued to any hospital in the area against the prescription of a registered medical practitioner.
• Patient’s blood grouping and cross-matching should be carried out before issue
• First in first out (FIFO) policy where by older blood closer to expiry date is used first, should be followed. Unused blood should be sent back to the regional centre after its expiry date.

BLOOD GROUPING

• ABO/Rh grouping should be done by tube technique
• Cell and serum grouping should be done and crosschecked.
• Blood grouping reagents in use should be approved by regional centre and should undergo Quality Control test on receipt and daily.

CELL GROUPING:

• Add 1 drop of Anti -A, Anti-B, Anti AB and Anti – D in 4 different tubes.
• Add 1 drop of 2-5% cell suspension of patient’s blood in each tube.
• Mix the contents and incubate at room temperature for 15 minutes
• Centrifuge at 1000 rpm for 1 minute
• Look for agglutination and record. All the negative results should be confirmed under microscope.

SERUM GROUPING:

• Add 2 drops of patient’s serum in each of the 4 different tubes.
• Add 1 drop of 2% pooled A cells in first tube.
• Add 1 drop of 2% pooled B cells in second tube.
• Add 1 drop of 2% pooled O cells in third tube.
• Add 1 drop of 22% albumin and O cells in fourth tube.
• Incubate first 3 tubes at room temperature for 15 minutes.
• Incubate fourth tube at 37oc for 30 minutes.
• Centrifuge at 1000 rpm for 1 minute
• Look for agglutination and record.
• Proceed by washing cells in the 4th tube 3 times with saline and add 2 drops of AHG
• Incubate for 15 minutes at room temperature.
• Centrifuge, read and record.
• While carrying out grouping always record results before documenting interpretations.
• If there is discrepancy between cell and serum grouping, repeat the test.

CROSS-MATCHING

• For cross -matching routinely use saline and albumin or enzyme method. When a patient requires regular or massive transfusion use IAT method. Saline Method
• Add 2 drops patient ’s serum in a test tube.
• Add 1 drop 5% donor’s cells in the same tube.
• Mix, incubate at room temperature for 15 minutes.
• Centrifuge, read and record.

Albumin/Enzyme method

• Add 2 drops patient ’s serum.
• Add 2 drops 22% bovine albumin or 1 drop papain crysteine.
• Add 1 drop 5% donor’s red cells.
• Incubate at 370C for 15 minutes.
• Centrifuge, read and record.

IAT method

• Add 2 drops patient ’s serum.
• Add 1 drop 5% donor’s red cells.
• Add 2 drops 22% bovine albumin.
• Incubate at 370c for 15 minutes.
• Wash cells with isotonic saline three times.
• Decant after last wash
• Add 2 drops AHG
• Mix well, centrifuge
• Read and record.

POINTS TO REMEMBER:

• All tests performed should be recorded and signed by technician.
• Medical officer should supervise the technician’s work of grouping, cross-matching and storage.
• Samples of patients and donors should be stored for 7 days after issue but when transfusion is required 48 hours after one transfusion, fresh sample should be asked for cross-matching.
• Standard Operating Procedures (SOP) for storage, transport, issue, equipment maintenance, grouping and cross-matching should be written and made available for use.
• The storage centres should maintain adequate stocks of colloids and crystalloids for initial volume replacement in emergency.
• Medical officer will be responsible for the overall working of the storage centre and hence he/she should ensure that the work is carried out systematically to avoid any errors leading to adverse transfusion reactions.