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Blood Bank Quality Management

Parnab Roy

Introductio BloodnTransfusion 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

Blood bankBlood 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- Blood Transfusion The Blood Bank or


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,

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 laiddown 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

QUALITY ASSURANCE SYSTEM- establish and The blood banks should


maintain a quality assurance system based onq q q q q q

q q q

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 Minimum total area shall be 100 Bank-appropriate square meters having
lighting and ventilation with washable floors and shall consist of following roomsq

Registration and Medical Examination room with adequate furniture and facilities for registration and selection of donors. Blood Collection Room (This shall be airconditioned). Room for Laboratory for blood group serology. (This shall be air-conditioned).

Refrigerator

Laboratory maintaining a temperature of 4 to 6 degrees with Recording Equipment Thermometer. The refrigerator
shall have temperature recording and alarm device. with low and high power objectives

Compound Microscope Centrifuge Table Water Baths Rh viewing box Incubator Mechanical shakers Hand lens Serological graduated pipettes Glass slides Test tubes of various sizes/micro

with thermostatic control. for serological tests for Syphilis for observing tests conducted in tubes

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 Hot air oven Plain and EDT.A Vials Reagents Autoclave with temperature and pressure recording device for transport of blood units

Personne Doctor l-

Designation

Qualification

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 with MLT qualification or its equivalent having adequate experience in blood grouping and serology technician work Laboratory with MLT qualifications or its equivalent Assistant

Organizational Medical hierarchysuperintendent


Head of the Department Departmental in charge

Attainder

Cleaner

Functions:
Senior resident Technician

Designation

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

Nursing staff

Attainder

cleaner

Operating procedureDonor
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

1.

Records to be maintainedBlood 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 patients detail for whom donated in case of recipient donation, remarks on donation (voluntary/replacement /professional).

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

CRH Blood bank an over viewThe 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

ConclusionTo 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

Thank You

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