Blood Bank Quality Management Parnab Roy

Introduction- Blood Transfusion Service is a vital part of the health care service. Increasing advancement in the field of Transfusion Medicine and Technology has necessitated enforcing measures to ensure quality of Blood and its products. In order to improve the standards of Blood Banks and the Blood Transfusion services, well-equipped blood centers with adequate infrastructure and trained manpower is an essential requirement.

Blood bank- Blood bank means, a centre within an organization or an institution for collection, grouping, cross-matching, storage, processing and distribution of Whole Human Blood or Human Blood Products from selected human donors.

General guidelines- The Blood Bank or Blood Transfusion Service should have its own constitution, which defines the responsibility and authority of the management. The blood bank should function under the direction of a licensed physician qualified by training and by experience as Transfusion Medicine Specialist (Medical Officer, Blood Bank) who should be responsible for all medical, technical and administrative services.

All blood banks should be licensed by State Drug Controller and approved by Drugs Controller General-(India) and should be regulated by Drugs and Cosmetics Act and rules there under. Blood bank should comply with laid-down standards in Drugs and Cosmetic Rules in recruitment and selection of blood donors, collection, processing, storage and distribution.

Each blood bank should maintain a detailed standard operating procedure manual, as well as records (forms, registers, labels) in a prescribed format prescribed by Drug & Cosmetics Rules. There should be adequate and competent staff as prescribed in Schedule F Part XII B & C of Drug and Cosmetic rules. The records of their qualifications, training and competency should be maintained.

Suitable space, environment and equipment should be available to maintain safe and acceptable standards of housekeeping. All materials for blood collection and transfusion should be sterile, pyogen free and disposable and should be stored in an air conditioned area. All containers and anticoagulants used for storage, preservation of blood and blood components and required reagents used for testing of blood samples should meet the standards of Drugs and Cosmetics Act and Rules and Bureau of Indian Standards (BIS).

QUALITY ASSURANCE SYSTEM- The blood banks should establish and maintain a quality assurance system based on- Organization and Management Equipment Supply and customer issues Process control Documents and records Deviations non conformances and complications Assessments Process improvements Facilities and safety

Accommodation for a Blood Bank- Minimum total area shall be 100 square meters having appropriate lighting and ventilation with washable floors and shall consist of following rooms- Registration and Medical Examination room with adequate furniture and facilities for registration and selection of donors. Blood Collection Room (This shall be air-conditioned). Room for Laboratory for blood group serology. (This shall be air-conditioned). Room for Laboratory for Transmissible diseases like Hepatitis, Syphilis, Malaria, and HIV antibodies etc. (This shall be air-conditioned). Sterilization and washing room. Refreshment room. Store and Records Room.

Laboratory Equipment - Refrigerator maintaining a temperature of 4 to 6 degrees with Recording Thermometer. The refrigerator shall have temperature recording and alarm device. Compound Microscope with low and high power objectives Centrifuge Table Water Baths Rh viewing box Incubator with thermostatic control. Mechanical shakers for serological tests for Syphilis Hand lens for observing tests conducted in tubes Serological graduated pipettes Glass slides Test tubes of various sizes/micro titer plates (U or V type) Precipitating tubes 6 mm x 50-mm glass beakers of different sizes

Test tubes racks of different specifications Equipment and materials for cleaning glass wares adequately RPHA/ELISA Test Kits with Reader for Hepatitis Wash bottles; filter papers Ice box for transport of blood units Hot air oven Plain and EDT.A Vials Reagents Autoclave with temperature and pressure recording device

Personnel - Designation Qualification Doctor Registered nurse Degree in Medicine of a University recognized by the Central Government having experience in Blood Bank for 6 months during regular services. He shall have adequate knowledge and experience in Blood Group serology. Blood Group Methodology and medical principles involved in procurement of blood. Registered nurse Blood Bank technician with MLT qualification or its equivalent having adequate experience in blood grouping and serology work Laboratory Assistant with MLT qualifications or its equivalent Laboratory Attendant

Organizational hierarchy- Medical superintendent Head of the Department Departmental in charge Attainder Cleaner

Functions: Designation Job responsibilities Senior resident Supervise of over all function Policy making Reporting to the MS Technician Tests and making report under supervision of sr. resident Rerecord maintaining Indenting Stock checking Nursing staff Physical checking of donor Phlebotomy Assisting the technician Attainder Dispatching records to the other departments Maintaining of log book Receiving requisition and patient registration cleaner Handling of waste material

Operating procedure- Donor Reception General examination and Physical check up Blood collection Preservation of blood stage -1 Served as required Preservation of blood stage -2 Test for TTI

Records to be maintained- Blood Donor Register – Indicating serial number, date of bleeding, name of donor with particulars, age, weight, hemoglobin, blood pressure, medical examination, signature of Medical Officer bleeding the donor, bottle bag number and patient’s detail for whom donated in case of recipient donation, remarks on donation (voluntary/replacement /professional). Blood Stock Register – Indicating bottle bag number, date of collection, date of expiry, quantity in ml., ABO/Rh Group, results for testing of HIV antibodies, malaria, VDRL, Hepatitis-B surface antigen, irregular antibodies (if any), name of donor with particulars, utilization issue number, components prepared or discarded, certified by Medical Officer In-charge)

3. Issue Register – Indicating serial number, date and time of issue, bottle number, ABO/Rh group, total quantity in ml., name of the recipient, group of recipient, unit/institution, details of cross-matching report, indication for transfusion. Particulars of product supplied (whole human blood, red cell/platelet concentrates, cryoprecipitate etc), quantity supplied, compatibility report, signature of issuing persons. 4. Register for– Bottles/packs giving details of firm, batch number, date of supply and results of testing. 5. Register for Diagnostic Reagents used 6. Transfusion Adverse Reaction Records. 7. Records of Purchase, use and stock in hand of disposable needles, syringes, plastic bags, sets shall be maintained

CRH Blood bank an over view- The department is well equipped and fully furnished. The whole department is well divided into separate section as per the activities needed. There is adequate space for patient waiting. The department is capable of storing 50 blood units per day. There is proper cold storage space for storing blood components. Under utilization of Refrigerator centrifuge machine. Reception and registration room requires more space. Since they are also using that room for keeping and maintaining some sorts of necessary records; so the availability of space is not sufficient as they have.

Conclusion- To attain maximum safety, the requirements of good laboratory practices (GLP), good manufacturing practices (GMP) and moving towards total quality management is vital for organization and management of Blood Transfusion Services. Therefore a well-organised Blood Transfusion Service (BTS), with quality systems in all areas, is a pre-requisite for the safe and effective use of blood and blood products.

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