Blood bank Quality management

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Blood Bank Quality Management

• Parnab Roy

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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.

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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.

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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.

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• 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.

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• 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.

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• 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).

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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

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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.

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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
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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
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Personnel -
Designation Qualification
Doctor 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
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Organizational hierarchy-
Medical superintendent
Head of the Department
Departmental in charge
Attainder
Cleaner
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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
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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
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Records to be maintained-

1. 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
   patients detail for whom donated in case of
   recipient donation, remarks on donation
   (voluntary/replacement /professional).
2. 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)

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• 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

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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.

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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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Thank You