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Standard Operating Procedures in Blood Banking

You are here : Home/ Blood Bank Zone/ Quality Asssurance in Blood Transfusion Service/ 2. Standard Operating Procedures in Blood Banking

2. Standard Operating Procedures in Blood Banking

Principles

Blood transfusion services face plenty of challenges. With the increasing demand for quality and safe blood and blood components due to advances in surgical practices and newer indications for requirement of blood, the blood bank assumes a special position in health care. At the same time the occurence of Transfusion transmittable diseases has given greater responsibility to the blood banks in delivering quality and safe blood and blood components. In the course of two decades, the field of Transfusion Medicine assumed greater autonomy and status to prepare and supply safe and potent blood and blood components in adequate quantity.

To achieve our goal of making the availability of safe blood at all times without shortage, a Uniform and updated national blood policy should be introduced all over the country. This will definitely give confidence in introducing good quality control, quality assurance and accreditation at all levels of transfusion practices. To make it run the practice effectively and sustain, We must produce a "Standard Operating Procedures" (SOP) for the blood banks. For the current Good Manufacturing Practices of blood bank component preparations, the manual of S.O.P. should be comprehensive, prospective and system based Model. It is very difficult to produce an exhaustive presentation here, but we attempt to give the basic approach to be followed.


The Work study should include :
  1. Elements of organization of blood banks
  2. Staff needed in a blood bank
  3. Blood donation
  4. Laboratory procedure followed in blood group serology
  5. Screening procedure practised for transfusion transmittable diseases.
  6. Preparations of and storage conditions of blood components
  7. Maintenance of coldchain and mechanical equipments and other monitoring methods of their performance
  8. Requirements and proper maintenance of records

The elements needed and basic philosophy required in the organization of blood bank and staff requirement can only be dealt on the appropriate status of the blood bank.


A. Blood donation

The basic requirements are
  1. Education, Motivation and Retention of blood donors.
  2. Options of blood donations, at the mobile camps or at the premises of the blood bank. The minimum requirements for an ideal blood collection programme.
  3. Exhaustive questionnaire on the health history of the blood donor.
  4. Physical examination of the donor.
  5. Details procedure followed in blood collection.
  6. Post donation care of the donor.
  7. Management of adverse reactions of the donor.
  8. Ideal follow up program of the blood donors to build and sustain effective donor registry.
  9. Proper steps of operations for transport of blood and shipment to the blood bank from the blood donation camps.
  10. Proper methods followed for the disposal of non-reusable materials used in the blood collection site.

B. Procedure followed in blood group serology laboratory :
  1. Proper care of the glassware used in the blood bank and the cleaning methods.
  2. Preparation of anticoagulant solutions for blood sample collection.
  3. Preparation of normal saline used in the blood bank laboratory.
  4. Procedure of Washing the red cells before the regular tests.
  5. ABO cell grouping (a) Moist chamber slide Method. (b) Tube method, conventional and rapid technique.
  6. Subgroup identification method.
  7. Reserve or serum grouping methods.
  8. Rh Typing technique, both slide and tube methods.
  9. Avidity test for all grouping sera.
  10. Potency test (Titration of antibodies) for all the diagnostc grouping sera.
  11. Master dilution technique of sera for multiple antibody titration.
  12. ABO antibody titration for agglutinin and haemolysins.
  13. Antiglobulin tests (coombs) both Indirect and Direct.
  14. Rh antibody detection and titration methods.
  15. Compatibility test procedure.
  16. Storage and proper care of all reagents, blood samples and stock control sera.
  17. MICRO ELISA Procedure for the detection of antibodies to HIV1&2 HCV and HBSAg.
  18. Serology test for Syphilis.
  19. QBC Method for the detection of MP&MF and Haemotocrit.
  20. Labelling of blood and blood components according International standards.

C. Maintenance of all cold chain and mechanical equipments

All the cold chain equipment should be regularly inspected, recorded of the performance including the alarms. Calibrate, if required and temperature to be recorded at periodic intervals. The important equipment are
  1. Blood Bank Refrigerators.
  2. Deep Freezeers. -40 & -80 deg C.
  3. Refrigerated Centrifuge
  4. Weighing Balance.
  5. Electronic Sealers
  6. Thawing Bath
  7. Desk Centrifuges & Cell Washers.
  8. Cell Separators.

D. requirement and maintenance of records - record keeping

The Following Registers should be maintained
  1. ABO Grouping and Rh Typing Register.
  2. Blood Collection Register.
  3. Preparation of stock of Various Components Register.
  4. Issue Register for various components supplied.
  5. Screening tests of Blood donors for TTD Register.
  6. Compatibility Register.
  7. Stock Register for all Materials purchased, stocked and issued.
  8. Transfusion Requests received from Clinicians - File
  9. Register for Disposal of Infected and Contaminated materials.
  10. Inspection Record Register for all Instruments.
  11. Register for Error Detection and Rectification.
  12. Register on the Details of the Blood Donation camps held.

All the Records should be retained

The Presentation on SOP is not fully analysed, but this will help interested Blood Bank Workers to make their own Manual of operation. If the reader needs any clarification on my Presentation or if there is any doubt, the Participant is welcome.


Laboratory Record Documentation and Maintenance

Blood transfusion service should develop and maintain documents that demonstrate the achievement of specified quality standards.

Documentation provides’ability to trace prospectivety and retrospectively all the steps in all procedures which are necessary far monitoring the techniques, component preparation, laboratory testing, etc.


Quality Monitoring

A regular quality monitoring is essential to ensure that a full quality assurance system has been implemented and is effective.

The purpose of a quality monitoring is to check the integrity of the QA programme.

For example, during screening for viral markers, data other than just the final screening results must be recorded:
  1. Temperature monitoring record for the laboratory equipments i.e. incubator, refrigerators used for storing kits, reagents, water baths, etc.,
  2. Records of maintenance of equipment e.g. centrifuges, incubators, refrigerators, ELISA reader, etc.
  3. The results obtained should be reviewed in light of the test run validity and the control values.
  4. Records of disposal of any positive donation.
If during quality monitoring, problems are identified they must be resolved as soon as possible. A follow-up audit is required later to ensure that changes have actually been incorporated.

A sequence of events can be followed from collection of a unit, passing through all the processes till it is issued, by checking all the necessary documentation.

Quality monitoring
  • Monitoring of the results obtained
  • Monitoring of the control values
  • Monitoring of operation of the equipment
  • Routine monitoring
  • Calibrations (incubator, pipettes, etc.)



Blood bank zone Next Articles
  1. Quality Asssurance in Blood Transfusion Service - Introduction
  2. Standard Operating Procedures in Blood Banking
  3. Quality Control of Equipments
  4. Quality Control of Reagents
  5. Quality Assurance Process Monitoring
You are here : Home/ Blood Bank Zone/ Quality Asssurance in Blood Transfusion Service/ 2. Standard Operating Procedures in Blood Banking


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