NOTICEComments are invited on Draft Accreditation standards on BloodBanks/ Blood Centres and Transfusion Services, 3rd editionSeeking comments/feedback from stakeholders on ‘Draft Accreditationstandards on Blood Bank/ Blood Centre and Transfusion Services3rd edition’, (Last date for sending comments is 30th June 2016). Thecomments may kindly be sent to Dr. Anil Kumar, National AccreditationBoard for Hospitals and Healthcare Providers (NABH), Quality Council ofIndia, at email id: [email protected]


Standards for Blood Banks/ Blood Centres and Transfusion Services No part of these publications may be reproduced in any form without the prior permission inwriting of NABH/Quality Council of Indiaiii

Standards for Blood Banks/ Blood Centres and Transfusion ServicesFOREWORDThere is no other fluid, which can totally substitute blood in the human body. Bloodcontains nutrients along with oxygen in adequate quantities and helps in maintaining abalanced temperature of the body. In many cases transfusion of blood or bloodcomponents becomes necessary to save the life of an individual. Therefore we need tohave a network of blood banks/ blood centres. The blood stored in blood banks/ bloodcentres should be pure, safe and free from contamination.The collection and storage ofblood/ blood components is done by blood banks/ blood centres attached to hospitals.Voluntary agencies and private sector blood banks/ blood centres also provide thisservice. The process is controlled through regulation which to great extent isresponsible to ensure purity of blood and blood products.The accreditation programme by NABH strives to maintain the quality and safety ofblood and blood products. The accreditation programme assesses the quality andoperational systems in place within the facility before accreditation is awarded.The basis for assessment of blood banks/ blood centres includes compliance with theaccreditation standards and guidelines set by National AIDS Control Organisation(NACO).The independent assessment under accreditation helps the facility to preparecomprehensively for regulatory requirements as well as accreditation standards. Itensures safety as well as quality culture within the facility. Accreditation is granted forcollection, processing, testing, distribution and administration of blood and bloodcomponents.The accreditation standards have been prepared by the technical committee constitutedby NABH. The standards are a dynamic document and shall be kept up-dated asrequired.For information on accreditation programme and related aspects, please contact NABHat [email protected]

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Standards for Blood Banks/ Blood Centres and Transfusion ServicesTABLE OF CONTENTSSl.12ContentsTerms and definitions1-5Organisation and Management6-71.1Legal identity61.2Responsibility61.3Ethics in blood bank/ blood centre61.4Management system61.5Policies, processes and procedures7Accommodation and environment2.13Page No.8 - 10Space allocation82.1.1Location and surroundings82.1.2Accommodation of blood bank/ blood centre82.1.3Processing of blood component from whole blood by ablood bank/ blood centre92.1.4Plasmapheresis, Plateletpheresis and Leucapheresis92.1.5Blood donation camp92.2Environment Control102.3Biological, Chemical and Radiation Safety102.4Internal Communication System10Personnel11 - 133.1Personnel requirement113.2Qualification113.2.1Medical Director/ In-Charge/ Medical Officer113.2.2Blood bank/ blood centre technician(s)113.2.3Registered Nurse(s)113.2.4Technical Supervisor123.3Job description/ responsibilities123.4Responsibilities of Medical Director/ In-charge/ Medical Officer,Technical Manager and Quality Manager123.5Training133.6Competence13v

Standards for Blood Banks/ Blood Centres and Transfusion Services4563.7Personnel health133.8Personnel records133.9Confidentiality of information13Equipment14 - 164.1Equipment requirement144.2Selection and validation of equipment144.3Use of equipment144.4Equipment detail record, unique identification144.5Programme for calibration and maintenance of equipment154.6Equipment for storage of blood and component154.7Computer system164.8Breakdown of equipment16External Services and supplies17 - 185.1Policies and procedures for supplier’s selection175.2Inventory control175.3Evaluation of suppliers18Process Control6.16.219 - 52Policies and validation of processes and procedures196.1.1Traceability of blood unit and sample from blood collectionto issue blood196.1.2Standard procedure19aWritten procedure20bNew procedures/ changes and validation20Donor laboratory206.2.1Blood donation206.2.1.1Donor recruitment206.2.1.2Pre-donation counseling216.2.1.3Donor registration, consent and selection21aDonor registration21bConsent21cCriteria for selection of donors21dDonation interval22Phlebotomy procedure226.2.1.4vi

Standards for Blood Banks/ Blood Centres and Transfusion Services6.2.2General22bMethod of preparation of phlebotomy site23cEquipment and blood bag23dAnticoagulant solutions23eAdditive solution23fVolume23gDuration of blood collection236.2.1.5Post donation care246.2.1.6Adverse donor reaction management246.2.1.7Blood donation camp/ drives246.2.1.8Procedure for autologous blood collection(predeposite) notification of abnormal findings, testresult and counselling24aInformation of test results24bDonor and25blood/ ofcomponents6.2.1.11Therapeutic plasmapheresis and cytapheresis26Handling of samples and blood units276.2.2.1Samples for laboratory tests276.2.2.2Identification and traceability27aBlood unit tation27Component ation of components28aRed blood cells components28bPlatelet concentrate (random donor platelets)29cGranulocyte concentrate30dPlasma30eSingle donor cryoprecipitate (cryoprecipitated antihemophilic factor)30vii

Standards for Blood Banks/ Blood Centres and Transfusion Servicesf6. apheresis30Quarantine and Storage316.4.1Refrigerator and freezers for storage316.4.2Quarantine and storage32Labelling346.5.1Labelling for whole blood/ component346.5.2Instructions for transfusion356.5.3Special requirements for component label35Testing of Donated Blood356.6.1Determination of ABO group356.6.2Determination of Rh(D) type356.6.3Determination of unexpected antibodies366.6.4Test for Transfusion Transmitted Infection366.6.4.1Screening for HIV antibody366.6.4.2Test for Viral Hepatitis366.6.4.3Test for Syphilis366.6.4.4Test for Malaria36Compatibility Testing376.7.1Request for blood and its components376.7.2Sample receiving, acceptance and preservation376.7.3Pre-transfusion testing386.7.3.1Testing of recipient blood386.7.3.2Repeat testing of donor blood386.7.4Issue of blood and its component396.7.4.1Issue of blood396.7.4.2Re-issue of blood406.7.4.3Urgent requirement of blood406.7.4.4Selection oftransfusion6.7.4.5Massive transfusion416.7.4.6Neonates416.7.5Records of recipient426.7.6Transfusion related advices (for clinicians)426.7.6.1Informed consent426.7.6.2Identification of recipient and donor unit43bloodandcomponentsfor40viii

Standards for Blood Banks/ Blood Centres and Transfusion on of blood and blood component436.7.6.5Guidelines for transfusion practices436.7.6.6Special considerations for use of components44Red cells transfusion44Fresh frozen plasma44Cryoprecipitate44Single donor plasma44Platelets and leucocytes44Irradiation45Transfusion Reaction and Evaluation466.8.1Error prevention466.8.2Immediate complication466.8.3Delayed complications476.8.4Detection, reporting & evaluation of transfusion reaction476.9Documentation in Transfusion Service476.10Histocompatibility Testing486.11Quality Control486.11.1ABO and anti-D reagents486.11.2Reagent red blood cells496.11.3Red cell panel496.11.4Anti-human globulin reagent496.11.5Bovine serum albumin496.11.6Enzyme reagents496.11.7Hepatitis B antigen, anti-HCV and anti-HIV 1 & 2 test506.11.8Test for Syphilis506.11.9Normal saline and buffered solutions506.11.10Blood component506.12Proficiency Testing Programme506.13Bio-medical waste disposal and laboratory safety in blood bank/blood centre516.13.1Protection of blood bank/ blood centre personnel againstlaboratory infection516.13.2Safety in the laboratory516.13.3Disposal of blood and laboratory material51ix

Standards for Blood Banks/ Blood Centres and Transfusion Services7891011Identification of Deviations and Adverse Events537.1Policies and procedures when non-conformity is detected537.2Procedures for release of non-conforming blood component537.3Preventing recurrence of non-conformity53Performance Improvement548.1Addressing complaints548.2Corrective action548.2.1Root cause analysis548.2.2Implementation and monitoring changes resulting fromcorrective action548.2.3Documentation of corrective action548.3Preventive action548.4Continuous quality improvement55Document Control56 – 579.1Procedure for document control and review of documents569.2Document required569.3Maintenance of documents in computer software57Record5810.1Record identification5810.2Quality and technical records5810.3Record retaining period58Internal Audit and Management Review5911.1Policy for internal audit and management review5911.2Procedure of internal audit5911.3Procedure of management review5911.4Documentation of internal audit and management review59Annexure A: Requirements for Storage, Transportation and Expiration60 - 62Annexure B: Requirements for Allogeneic Donor Qualification63 - 68Annexure C: Requirements of Apheresis Donor Qualification69 - 70Annexure D: Quality Control71 - 791Frequency of testing for reagent and solution71x

Standards for Blood Banks/ Blood Centres and Transfusion Services2Quality control of reagent red blood cells713Quality control of ABO reagent (anti-A, anti-B, and anti-AB)714Acceptable titre and avidity of ABO reagents725Quality acceptable of Rh anti sera (Anti-D)726Acceptable titre and avidity of anti-D in anti-Rh (D) reagent737Acceptable quality of anti-globulin reagent738Quality control of proteases (Enzymes)749Quality control of 22% Bovine Serum Albumin (BSA)7410Quality control of normal saline7411Quality control of distilled water7512Quality control of whole blood7513Quality control of red cell concentrate (prepared from 450 ml blood)7514aQuality control of red cell in preservative solution prepared from 450ml whole blood (ADSOL/ SAGM)7614bQuality control of red cell in preservative solution prepared from 350ml whole blood (ADSOL/ SAGM)7615Quality control of Leucocytes-poor red cells7616Quality control of platelet concentrate prepared from 350/ 450 ml ofwhole blood7617Quality control of platelet concentrate prepared from buffy coat7718Quality of platelet concentrate by apheresis7719Quality control of Fresh Frozen Plasma (FFP)7820Quality control of cryoprecipitate (Factor-VIII)7821Quality control of plasma (Frozen)7822Quality control of granulocytes78Annexure E: Records80 - 81Annexure F: Good Manufacturing Practice (GMPs)/ Standard OperatingProcedures (SOPs)82 - 83Annexure G: List of Equipments available in Blood Bank/ Blood centre84 - 85Annexure H: Calibration Frequency for Equipments86 - 87References88xi

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Standards for Blood Banks/ Blood Centres and Transfusion ServicesTERMS AND DEFINITIONSFor the purpose of this document, the terms and definitions are given as followsAccuracy of measurement: Closeness of the agreement between the result of a measurementand a true value of the measurand.Agreement: A contract, order, or understanding between two or more parties, such as betweena facility and one of its customers.Agreement review: Systematic activities carried out before finalizing the agreement to ensurethat requirements are adequately defined, free from ambiguity, documented, and achievable.Apheresis: The process, by which blood drawn from a donor, after separating desired plasmaor cellular component, is returned simultaneously to the same donor.Autologous blood: The blood drawn from the patient/ recipient for re-transfusion into him/ herlater on.Biological reference interval: Central 95% interval of the distribution of reference values.Blood: Includes whole human blood, drawn from a donor and mixed with an anti-coagulant.Blood bank/ blood centre: A place/ organisation/ unit/ institution or other arrangements madeby any such organisation, unit or institution for carrying out all or any of the operations forcollection, apheresis, storage, processing and distribution of blood drawn from donors and/ orfor preparation, storage and distribution of blood components.In-Charge or Director of blood bank/ blood centre: Competent person (s) with responsibilityfor, and authority over, a Blood bank/ Blood centre.Blood bank/ blood centre Management: Person (s) who manages the activity of a Bloodbank/ Blood centre headed by a blood bank/ blood centre director.Blood component: A drug, prepared, obtained, derived or separated from a unit of blood drawnfrom a donor.Blood product: A drug manufactured or obtained from pooled plasma of blood drawn fromdonors by fractionation.Closed system: A system, the contents of which are not exposed to air or outside elementsduring preparation and separation of components.Collection facility: A facility that collects blood, components or tissue from a donor.Competence: Ability of an individual to perform a specific task according to procedureConformance: Fulfilment of requirements. Requirements may be defined by customers,practice standards, regulatory agencies, or law.1