blood bank quality manage 2797670

8/2/2019 Blood Bank Quality Manage 2797670

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Blood Bank Quality

ManagementParnab Roy


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Introductio

n-Blood Transfusion Service is a vital partof the health care service. Increasingadvancement in the field of

Transfusion Medicine and Technologyhas necessitated enforcing measuresto ensure quality of Blood and itsproducts.

In order to improve the standards ofBlood Banks and the Blood Transfusionservices, well-equipped blood centers

with adequate infrastructure andtrained man ower is an essential


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Blood bank-

Blood bank means, a centre within anorganization or an institution forcollection, grouping, cross-matching,storage, processing and distribution ofWhole Human Blood or Human BloodProducts from selected human donors.


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Generalguidelines-

The

Blood Bank or Blood TransfusionService should have its ownconstitution, which defines theresponsibility and authority of the

management.

The blood bank should function under

the direction of a licensed physicianqualified by training and by experienceas Transfusion Medicine Specialist(Medical Officer, Blood Bank) who

should be responsible for all medical,


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All blood banks should be licensed byState Drug Controller and approved byDrugs Controller General-(India) andshould be regulated by Drugs andCosmetics Act and rules there under.

Blood bank should comply with laid-down standards in Drugs and Cosmetic

Rules in recruitment and selection ofblood donors, collection, processing,storage and distribution.


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Each blood bank should maintain a detailedstandard operating procedure manual, as

well as records (forms, registers, labels) in aprescribed format prescribed by Drug &Cosmetics Rules.

There should be adequate and competentstaff as prescribed in Schedule F Part XII B &C of Drug and Cosmetic rules. The records

of their qualifications, training andcompetency should be maintained.


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Suitable space, environment andequipment should be available to

maintain safe and acceptablestandards of housekeeping.All materials for blood collection and

transfusion should be sterile, pyogenfree and disposable and should bestored in an air conditioned area.All containers and anticoagulants usedfor storage, preservation of blood andblood components and requiredreagents used for testing of blood

samples should meet the standards of


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QUALITY ASSURANCESYSTEM-

The blood banks should establish and

maintain a quality assurance systembased on-

q

Organization and Managementq Equipmentq Supply and customer issuesq Process controlq Documents and recordsq Deviations non conformances and

complicationsq Assessmentsq Process improvementsq

Facilities and safety


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Accommodation for a Blood

Bank-Minimum total area shall be 100

square meters having appropriatelighting and ventilation with washablefloors and shall consist of following

rooms-

q Registration and Medical Examinationroom with adequate furniture and

facilities for registration and selection ofdonors.

q Blood Collection Room (This shall be air-conditioned).

q Room for Laboratory for blood group

serology. (This shall be air-conditioned).


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Laboratory

Equipment -

Refrigerator maintaining a temperature of 4 to6 degrees with RecordingThermometer. The refrigeratorshall have temperature recordingand alarm device.

CompoundMicroscope with low and high power objectives

Centrifuge Table

WaterBaths

Rhviewingbox

Incubator with thermostatic control.

Mechanicalshakers for serological tests for Syphilis

Handlens for observing tests conducted intubes

Serological graduated pipettes

Glass slides

Testtubes of various sizes/micro


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Testtubesracks of differentspecifications

Equipment and materials forcleaningglasswares adequately

RPHA/ELISA Test Kits withReader for Hepatitis

Wash bottles; filter papersIcebox for transport of blood units

Hot air oven

Plain and EDT.A Vials

Reagents

Autoclave with temperatureand pressure recording device


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Personnel -

Designation Qualification

Doctor Degree in Medicine of a University recognized by theCentral Government having experience in BloodBank for 6 months during regular services. He shallhave adequate knowledge and experience in BloodGroup serology. Blood Group Methodology andmedical principles involved in procurement of blood.

Registerednurse

BloodBanktechnician

with MLT qualification or its equivalent havingadequate experience in blood grouping and serologywork

Laboratory

Assistant

with MLT qualifications or its equivalent


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Organizationalhierarchy-Medical

superintendent

Head of theDepartment

Departmental incharge

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 technicianAttainder 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-DonorReception

Generalexamination and

Physical checkup Bloodcollection

Preservation ofblood stage -1

Test for TTIPreservation ofblood stage -2

Served asrequired


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Records to bemaintained-

1. Blood Donor Register Indicating

serial number, date of bleeding,name of donor with particulars, age,weight, hemoglobin, blood pressure,

medical examination, signature ofMedical Officer bleeding the donor,bottle bag number and patientsdetail for whom donated in case ofrecipient donation, remarks ondonation (voluntary/replacement/professional).


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3. Issue Register Indicating serialnumber, date and time of issue, bottle

number, ABO/Rh group, total quantityin ml., name of the recipient, group ofrecipient, unit/institution, details ofcross-matching report, indication fortransfusion. Particulars of productsupplied (whole human blood, redcell/platelet concentrates,

cryoprecipitate etc), quantity supplied,compatibility report, signature ofissuing persons.

4. Register for Bottles/packs giving


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CRH Blood bank an overview-The department is well equipped and

fully furnished.The whole department is well dividedinto separate section as per the

activities needed.There is adequate space for patientwaiting.

The department is capable of storing

50 blood units per day.There is proper cold storage space forstoring blood components.

Under utilization of Refrigerator


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Conclusion-

To attain maximum safety, therequirements of good laboratorypractices (GLP), good manufacturing

practices (GMP) and moving towardstotal quality management is vital fororganization and management of

Blood Transfusion Services.

Therefore a well-organised BloodTransfusion Service (BTS), with qualitysystems in all areas, is a pre-requisite


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Thank You


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