N A B H.PDF

7/29/2019 N A B H.PDF

1/92

Standards onBlood Banks / Blood

7/29/2019 N A B H.PDF

2/92

,

j!

L_

Standards onBlood Banks / Blood C:entresand Transfusion ServicesFirst editionIssued on November 2007

NationalAccreditation Board Dar Hospitalsand Healthcare Providers

7/29/2019 N A B H.PDF

3/92

No part of these publications may be reproduced in any form without the prior permissionin writing of NASH, Quality Council of India

7/29/2019 N A B H.PDF

4/92

L

Standards for Blood Banks! Blood Centres and Transfusion Services

FOREWORDThere is no other fluid, which can totally substitute blood in the human body. Blood containsnutrients, oxygen in adequate quantities and h e l ~ s in maintaining a balanced tempel'ature ofthe body. In many cases transfusion of blood becomes necessary to save the life of anindividual. Therefore we need to have network of blood banks. The blood stored in bloodbanks should be pure and free from contamination.The collection and storage of blood is done by blood banks attachlsd to hospitals. Voluntaryagencies and private sector blood banks also provide this service The process is controlledthrough regulation and to great extent is responsible to ensure purity of blood.The accreditation programme by NABH strives to the quality and safety of collecting,processing, testing and transfusion of bl009 products. The accreditation programmeassesses the quality and operational systems in:place witilin the faGility.The basis for assessment of blood bank inGludes compliance with the accreditation standardand 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. It ensuressafety as well quali ty culture within the facility. Accreditation is granted for collection,processing, testing, distribution and administration of blood and blood components.The accreditation standard has been prepared by the technical Gommittee constituted byNABH. The standard is dynamic document and shall be kept up-dated as required.For information on accreditation programme and related aspects, please contact [email protected].

.. ",

Girdhar J. GyaniSecretary GeneralQuality Council of India

NationalAccreditation Board for Hospitals and Healthcare providers

7/29/2019 N A B H.PDF

5/92

Standards for Blood Banks/ Blood Centres and Transfusion Services

NationalAccreditation Board for Hospitals and Healthcare Providers 1

7/29/2019 N A B H.PDF

6/92

51. Contents Page No.

Terms and definitions 1 - 41 Organisation and Management 5-61.1 Legal identity , 51.2 Responsibility 51.3 Ethics in blood bank! blood center 51.4 Management system 51.5 Policies, processes and procedures 6

2 Accommodation and Environment 7-92.1 Space allocation 7

2.1.1 Location and surroundings 72.1.2 Accommodation of blood Qank! blood centre 72.1.3 Processing of blood component from whole blood by a 8blood bank! blood center2.1.4 Plasmapheresis, Plateletpheresis and Leucapheresis 82.1.5 Blood donation camp 8

2.2 Environment Control 92.3 Biological,' Chemical and Radiation Safety 92.4 Internal Communication System 9

3 Personnel 10 - 123.1 Personnel requirement 103.2 Qualification 10

3.2.1 Medical Director/In-Charge/ Medical Officer 103.2.2 Blood bank! blood centre technician(s) 103.2.3 Registered Nurse(s) 103.2.4 Technical Supervisor 11

3.3 Job description/ responsibilities 11. ' 3.4 Responsibilities of Medical Director/In-charge/ Medical Officer, 11Technical Manager and Quality Manager

3.5 Training 113.6 Competence 123.7 Personnel health 123.8 Personnel records 123.9 Confidentiality of information 12

4 Equipment 13 - 144.1 Equipment requirement 134.2 Selection and validation of equipment 134.3 Use of equipment 13 "4.4 Equipment detail record, unique identification 134.5 Programme for calibration and maintenance of equipment 134.6 Equipment for storage of blood and component 144.7 Computer system 144.8 Breakdown of equipment 14

Itj'II

IL


TABLE OF CONTENTS

National Accreditation Board for Hospitals and Healthcare Providers iii

7/29/2019 N A B H.PDF

7/92

5 External services and supplies , 155.1 Policies and procedures for supplier's selection 155.2 Inventory control 155.3 Evaluation of suppliers 15

6 Process Control 16 - 456.1 Policies and validation of processes and procedures 16

6.1.1 Traceability of blood unit anq sample from blood collection 16to issue blood6.1.2 Standard procedure 16a Written procedure 16b New procedures! changes and validation 17

6.2 Donor laboratory 176.2.1 Blood donation 17

6.2.1.1 Donor recruitment 176.2.1.2 Pre-donation counseling 176.2.1.3 Donor registration, consent and s e l ~ c t i o n 18

a Donor registration 18b Consent 18c Criteria for selection of donors 18d Donation interval 18

6.2.1.4 Phlebotomy procedure 19a General 19b Method of preparation of phlebotomy site 19c Equipment and blood bag 19d Anticoagulant solutions 19e Volume 196.2.1.5 Post donation care 206.2.1.6 Adverse donor reaction management 206.2.1.7 Blood donation camp! drives 206.2.1.8 Autologous transfusion procedure 216.2.1.9 Donor notification of abnormal findings, test 21result and counselling

.' a Information of test results 21b Counselling and referral 216.2.1.10 Records of donor and donor's blood! 21components6.2.1.11 Therapeutic plasmapheresis and cy1tapheresis 22

6.2.2 Handling of samples and blood units 236.2.2.1 Samples for laboratory tests 236.2.2.2 Identification and traceability 23

a Blood unit identification 23b Traceability 236.2.2.3 Transportation 24

6.3 Component laboratory 246.3.1 Sterility 246.3.2 Seal 246.3.3 Preparation of components 24a Red blood cells components 24

b Platelet concentrate (random donor platel19ts) 25c Granulocyte concentrate 26d Plasma 26

Standards for Blood Banksl Blood Centres and Transfusion Services

NationalAccreditation Board for Hospitals and Healthcare Providers iv

7/29/2019 N A B H.PDF

8/92

e Single donor cryoprecipitate (cryoprecipitated anti- 26hemophilic factor)f Donor apheresis 266.4 Quarantine and storage 276.4.1 Refrigerator and freezers for storage 276.4.2 Quarantine 286.5 Labelling 306.5.1 Labelling for whole blood/ component 306.5.2 Instructions for transfusion 306.5.3 Special requirements for component label 316.6 Testing of donated blood 316.6.1 Determination of ABO group 316.6.2 Determination of Rh(D) type 316.6.3 Determination of unexpected antibodies 316.6.4 Test for Transfusion Transmitted Infection 326.6.4.1 Screening for HIV antibody 326.6.4.2 Test for Viral Hepatitis 326.6.4.3 Test for Syphilis 326.6.4.4 Test for Malaria '; 326.7 Compatibility testing 326.7.1 Request for blood and its components 326.7.2 Sample receiving, acceptance and preservation 336.7.3 Pre-transfusion testing 336.7.3.1 Testing of recipient blood 336.7.3.2 Repeat testing of donor blood 346.7.4 Issue of blood and its component 346.7.4.1 Issue of blood 346.7.4.2 Re-issue of blood 356.7.4.3 Urgent requirement of blood 356.7.4.4 Selection of blood and components for 35transfusion6.7.4.5 Massive transfusion 366.7.4.6 Neonates , 366.7.5 Records of recipient 366.7.6 Transfusion related advices 376.7.6.1 Informed consent 376.7.6.2 Identification of recipient and donor unit 376.7.6.3 Supervision 376.7.6.4 Administration of blood and blood component 376.7.6.5 Guidelines for transfusion practices 386.7.6.6 Special considerations for use of components 38Red cells transfusion 38Fresh frozen plasma 38Cryoprecipitate 38Single donor plasma 38Platelets and leucocytes 38Irradiation 396.8 Transfusion reaction and evaluation 396.8.1 Error prevention 396.8.2 Immediate complication 406.8.3 Delayed complications 40

6.8.4 Detection, reporting & evaluation of transfusion maction 416.9 Documentation in transfusion service 41


National Accreditation Board for Hospitals and Healthcare Providers v

7/29/2019 N A B H.PDF

9/92

6.10 Histocompatibility testing 416.11 Quality control 42

6.11.1 ABO and anti-D reagents 426.11.2 Reagent red blood cells 426.11.3 Red cell panel 426.11.4 Anti-human globulin reagent 426.11.5 Bovine serum albumin 436.11.6 Enzyme reagents 436.11.7 Hepatitis B antigen, anti-HCV and anti-HIV 1 & 2 test 436.11.8 Test for Syphilis 436.11.9 Normal saline and buffered solutions 436.11.10 Blood component 43

6.12 Proficiency testing programme 446.13 Bio-medical waste disposal and laboratory safety in blood bank! 44blood centre

6.13.1 Protection of blood bank personnel against laboratory 44infection6.13.2 Safety in the laboratory 446.13.3 Disposal of blood and laboratory material 45

7 Identification of Deviations and Adverse Events 467.1 Polices and procedures when non-conformity is detected 467.2 Procedures for release of non-conforming blood component 467.3 Preventing recurrence of non-conformity 46

8 Performance Improvement 478.1 Addressing complaints 478.2 Corrective action 47

8.2.1 Root cause analysis 478.2.2 Implementation and monitoring changes r e s u l t i n ~ 1 from 47corrective action8.2.3 Documentation of corrective action 47

8.3 Preventive action 47.-

9 Document Control 48 -499.1 Procedure for document control and review of documents 489.2 Document required 489.3 Maintenance of documents in computer software 49

10 Record 5010.1 Record identification 5010.2 Quality and technical records 5010.3 Record retaining period 50

11 Internal Audit and Management Review 5111.t Policy for internal audit and management review 5111.2 Procedure of internal audit 5111.3 Procedure of management review 5111.4 Documentation of internal audit and management review 51Annexure A: Requirements for Storage, Transportation and Expiration 52 - 54Annexure B: Requirements for Allogeneic Donor Qualification 55 - 60


National Accreditation Board for Hospitals and Healthcare Providers vi

7/29/2019 N A B H.PDF

10/92

Annexure C: Requirements of Apheresis Donor Qualification 61 - 62Annexure 0: Quality Control 63 -701 Frequency of testing for reagent and solution 632 Quality control of reagent red blood cells 633 Quality control of ABO reagent (anti-A, anti-B, and anti-AB) 634 Acceptable titre and aVidity of ABO reagents 645 Quality acceptable of Rh anti sera (Anti-D) 646 Acceptable titre and avidity of anti-D in anti-Rh (D) reagent 657 Acceptable quality of anti-globulin reagent 658 Quality control of proteases (Enzymes) 669 Quality control of 22% Bovine Serum Albumin (BSA) 6610 Quality control of normal saline 6611 Quality control of distilled water 6712 Quality control of whole blood 6713 Quality control of red cell concentrate (prepared from 450 ml blood) 6714a Quality control of red cell in preservative solution preparod from 67

450 ml whole blood (ADSOLI SAGM)14b Quality control of red cell in preservative solution preparEld from 68350 ml whole blood (ADSOLI SAGM)15 Quality control of Leucocytes-poor red cells 6816 Quality control of platelet concentrate prepared from 350/ 450 ml of 68whole blood17 Quality control of platelet concentrate prepared from buffy coat 6918 Quality of platelet concentrate by apheresis 6919 Quality control of Fresh Frozen Plasma (FFP) 6920 Quality control of cryoprecipitate (Factor-VIII) 7021 Quality control of plasma (Frozen) 7022 Quality control of granulocytes 70Annexure E: Records 71 -72Annexure F: Good Manufacturing Practice (GMPs)/ Standard Operating 73 -74Procedures (SOPs)Annexure G: List of Equipments available in Blood Bank! Blood Center 75 -76Annexure H: Calibration Frequency for Equipments 77 -78References 79


NationalAccreditation Board for Hospitals and Healthcare Providers vii

7/29/2019 N A B H.PDF

11/92


NationalAccreditation Board for Hospitals and Healthcare Providers viii

7/29/2019 N A B H.PDF

12/92

tit


TERMS AND DEFINITIONS

For the purpose of this document, the terms and definitions are given as followsAccuracy of measurement: Closeness of the agreement between the result of ameasurement and a true value of the measurand.Agreement: A contract, order, or understanding between two or more parties, such asbetween a facility and one of its customers.Agreement review: Systematic activit ies carried out before finalizing the agreement toensure that requirements are adequately defined, free from ambiguity, documented, andachievable.Apheresis: The process by which blood drawn from a donor, afiter separating plasma orplatelets or leucocytes, is transfused simultaneously into the said donor.Autologous blood: The blood drawn from the ,patient! recipient for re-transfusion into him/her later 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 bankl'-hlood centre: A place or organisation or units or institutions or othersarrangements made by such organisation, unit or institution for canying out all or any of theoperation for collectioll, apheresis, storage, processing and distribution of blood drawn fromdonors and/ or for preparation, storage and distribution of blood components.In-Charge blood bank! blood centre Director: Competent person (s) with responsibility for,and authority over, a blood bank! blood centre.Blood bank! blood centre Management: Person (s) who manage 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 blooddrawn from 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: Fulfillment of requirements. Requirements may be defined by customers,practice standards, regulatory agencies, or law.Corrective action: An activity performed to eliminate the cause of an existing nonconformance, or other undesirable situation in order to prevent recurrence.

NationalAccreditation Board for Hospitals and Healthcare Providers

7/29/2019 N A B H.PDF

13/92


Customerl recipient: The receiver of a product or service. A customer may be internal (Le.,another department within the same organization) or external (Le., another organization).Disaster: An event (internal, local, or national) that can affect th,e blood supply or the safetyof staff, patient! recipients, volunteers, and donors.Document (noun): Written or electronically generated informaltion and work instructions.Examples of documents include quality manuals, procedures, or ;forms.Document (verb): To capture information for use in documents through writing or electronicmedia.Equipment: Adurable item, instrument, or device used in a p r o C E ~ S S or procedure.Event: A generic term used to encompass the terms 'incident', 'error', and 'accident'.Executive management: The highest level personnel within an organization, who haveresponsibility for the operations of the organization and who have the authority to establishor change the organization's quality policy. Executive management may be an individual or agroup of individuals.Incident: An unplanned deviation from a facility's established policy, process or procedure.Label: An inscription affixed to a unit of blood, component, tissue, derivative, or sample foridentification.Labelling: Information that is required or selected to accompany a unit of blood, component,tissue, derivative or sample, which may include content, identification, description ofprocesses, storages requirements, expiration date, cautionary statements or indications foruse.

Non-conformance: Failure to meet requirement.Measurement: Set of operation having the object of determining GI value or a quantity.

Leucapheresis: The process by which the blood drawn from a donor, after leucocyteconcentrate have been separated, is re-transfused simultaneously into the said donor.

2 National Accreditation Board for Hospitals and Healthcare Providers

Organization: An institution, or part thereof that has its own functions and executivemanagement.

Open system: A system, the contents of which are exposed to air and out side elements . during preparation and separation of components.

Maintain: To keep in the current state.Material: A good or supply item used in the manufacturing process. Materials are a type ofinput product. Reagents are a type of material.

Laboratory: Laboratory for the biological, microbiological, immunological, serological,immunohaematological, haematological, or other examination of materials derived from thehuman body for the purpose of providing information for the' diagnosis, prevention, pretransfusion check and treatment of disease in, or assessmen1t of the health of, humanbeings, and which may provide a consultant advisory servicl9 covering all aspects of. -laboratory investigation including the interpretation of results and advice on furtherappropriate investigation.j

7/29/2019 N A B H.PDF

14/92


Policy: A documented general principle that guides present and future decisions.

Product: A tangible result of a process or procedure.

3NationalAccreditation Board for Hospitals and Healthcare Providers

Quality control: Testing routinely performed on materials and equipment to ensure theirproper function.

Quality: Characteristics of a unit of blood, component, tissue, d E ~ r i v a t i v e , sample, criticalmaterial, or service that bear on its ability to meet requirements, including those definedduring agreement review.

Plasmapheresis: The process by which the blood drawn from a donor, after plasma hasbeen separated, is re-transfused during the same sitting into the said donor.Peripheral Blood Stem Cel l (PBSC): The stem cell is the most immature cell in the bonemarrow. Most of the stem cells are found in the bone marrow. There are also a few stem cellin the blood. These are called peripheral blood stem cells.

Proficiency testing: The structured evaluation of laboratory methods that assesses thesuitability of processes, procedures, equipment. materials, and personnel. "

Professional donor: A person who donates blood for a valuable consideration, in cash orkind, from any source, on behalf of the recipient-patienU recipient and includes a 'paid donor'or a 'commercial donor'.

Process Control: The efforts to standardize and control processes in order to producepredictable output.

Primary sample:SpecimenSet of one or more parts initially taken from a systemNote: in some places, the term 'specimen' is used instead of primary sample (or a subsample of it), which is the sample prepared for sending to, or as r e c E ~ i v e d by, the blood bank!blood centre or laboratory and which are intended for examination.>

Plateletpheresis: The process by which the blood drawn from a donor, after plateletconcentrates have been separated, is re-transfused simultaneously iinto the said donor.

Peripheral stem cell collection: It is a procedure that uses cell separator machine(Apheresis) and separates and collects one type. of white blood cells- called a mononuclearcell-from the blood. Except for a small number of red cells, the machine returns all the bloodto the donor/ patienU recipient.

Procedure: A series of tasks usually performed by one person according to instructions.P r ~ c e s s : A set of related tasks and activities that accomplish a work goal.

Pre-donation procedures: It include the mandatory process and activity done beforeproceeding with bleeding the donor.Post donation procedures: All the activities, procedures and instructions carried out afterbleeding the donor.Preventive action: An action taken to reduce the potential for non-conformance or otherundesirable s i t u a t i o n s ~

rII

L

7/29/2019 N A B H.PDF

15/92


Management system: The organizational structure, responsibilities, policies, processes,procedures, and recourses established by executive management to achieve quality.Quantity: Attribute of a phenomenon, body or substanc9 that may be distinguishedqualitatively and determine quantitatively.Quarantine: To isolate nonconforming/ untested blood, compone,nts, tissue, derivatives, ormaterials to prevent their distribution or use.Reference standards: Reference standards define how or within what parameters anactivity shall be performed and are more detailed than management system requirements.Replacement donor: A donor who is a family friend or a relative of the patient! recipient.Sample: One or more parts taken from a system and intended to provide information on thesystem, often to serve as a basis for decision on the system or its production.Supplier: An activity that provides an input material or service.Supplier qualification: An evaluation method designed to ensure that input materials andservices (e.g. material, blood components, tissue and derivativEls, patient! recipient bloodsamples) obtained from a supplier meet specified requirements.Traceability: Property of the result of a measurement or the volume of a standard where byit can be related to stated references, usually national or international standards, through anunbroken chain of comparisons all having stated uncertainties.Transfusion service: A facility that performs ol1e or more of the following activities:compatibility testing, storage, selection, and issuing of blood and components to intendedrecipients. Transfusion services do not necessarily collect blood or process whole blood intocomponents.True positive: A positive result on both the initial test and the confirmatory test.

r

Trueness of measurement: Closeness of agreement between the average value obtained, ..from a large series of result of measurements and a true value.

Unit: A container of blood or one of its components in a suitable volume of anticoagulantobtained from a collection of blood from one donor.

Verification: Confirmation by examination and provision of objective evidence that speoifiedrequirements has been met.

Uncertainty of measurement: Parameter associated with the result of a measurement thatcharacterised the dispersion of the values that could reasonably be attributed to themeasurement.

4NationalAccreditation Board for Hospitals and Healthcare Providers

.'Voluntary blood donor: A person who voluntarily donates blood after he/ she has beendeclared fit after a medical examination, for donating blood, on fulfil ling the criteria givenhereinafter, without accepting in return any consideration in cash or kind from any source,but does not include a professional or a paid donor.

Validation: Establishing recorded evidence that provides a high degree of assurance that aspecific process will consistently produce an outcome, meeting its predeterminedspecifications and quality attributes.

7/29/2019 N A B H.PDF

16/92


1.3 Ethics in blood bank! blood centre

1.1 Legal identity

5National Accreditation Board for Hospitals and Healthcare Providers

1. ORGANISATION AND MANAGEMENT

1.2.1 An organization chart (organogram) shall be defined.

1.2.3 The responsibilities of personnel working in blood bankl blood centre with aninvolvement or influence on functioning, shall be clearly defined in order to identifyconflict of interest.

1.1 .1 The blood bank! blood centre shall have a valid license from Central DrugsStandard Control Organization (CDSCO) and approved by Drug Controller General(India), central license approving authQrity undei Drug and Cosmetic Rules-1945with further amendments.

\1.2.2 It is the responsibility of management for compliance wi1th these standards andapplicable laws and regulation.

1.1.2 The organisation under which the blood bank! blood centre functions shall belegally identifiable.

1.2 Responsibility

1.3.1 The blood bank! blood centre personnel shall be bound by the ethical code of theirrespective profession, which have to be observed. Personnel responsible for themanagement of blood bank! blood centre should accept that, as with other healthprofessionals, they could have responsibilities over and above the minimumrequired by law.

1.3.3 Blood bank! blood centre shall not engage in practices restricted by law and shoulduphold the reputation of their profession.

1.3.2 A blood bank! blood centre will need to determine acceptable practice that isappropriate for their own situation and incorporate the detail in their quality manual.

1.3.4 Ethics shall underpin all the procedures and process canried out in blood bank!blood centre.

1.4 Management System

1.4.2 Quality policy and objectives of the quality management system shall be definedand issued under the authority of the Directorl In-charge and documented in aquality manual. This policy shall include scope of servicl3s, objective of qualitymanagement system with management commitment to comply with the standardsand local regulations.

1.4.1 The blood bank! blood centre management shall have responsibility for the design,implementation, maintenance and improvement of the quality management system;

7/29/2019 N A B H.PDF

17/92


1.5 Policies, processes and procedures

1.4.5 The quality manual shall be kept up to date under the authority of an individualresponsible for maintaining quality management system.

r

For implementation and maintenance of quality management system, themanagement shall identify a Quality Manager, a Technical Manager and deputies.Roles and responsibilities of Technical Manager and the Quality Manager (howevernamed) shall be defined, including their responsibility for Emsuring compliance withthese standards. These personnel shall have responsibilities and authority tooversee compliance with the requirement of the quality management system.

Director/In-charge blood bank! blood centre shall approve all policies, process andprocedures.

1.5.1 Quali ty and ,operational policies, processes, and prooedures shall be developedand implemented to ensure that the requirements of theSE! Standards are satisfied.All such policies, processes, and procedures shall be recorded and followed.1.5.2

1.4.4 All personnel shall be instructed to familiarize themselves with the qualitymanagement system with use and application of the quality manual and allreferenced documents.

1.4.6

1.4.3 A quality manual shall describe the quality management system covering all theaspects of standards and the structure of the documentation used in the qualitymanagement system. The quality manual shall include or make reference to thesupporting procedures including technical procedures. It shall outline the structureof the documentation in the quality management system.

National Accreditation Board for Hospitals and Healthcare Providers

- - - - ~6

7/29/2019 N A B H.PDF

18/92


2.1.2 Accommodation of blood bank! blood centre

2.1.1 Location and surroundings2.1 Space allocation

The blood components shall be prepared by blood bank! blood centres as a part ofthe blood bank services.

Processing of blood component from whole blood by a blood bank! blood centre

Rooms with adequate area and other specifications for preparing blood componentdepending on quantum of work load (already defined in point no. 2.1.1 and 2.1.2).

The blood bank! blood centre shall be designed for the efficiency of its operation, tooptimise the comfort of its occupants and to minimize the risk of injury andoccupationalJllness. Patient! recipients, employees and visitors shall be protectedfrom recognized hazards.

The blood bank! blood centre shall be located at a place, which shall be away fromopen sewerage, drain, public lavatory or'similar unhygienic surroundings.

A blood bank! blood centre shall have a minimum area of 100 square meters for itsoperations and an additional area of minimum 50 square meters for preparation ofblood components. It shall be consisting of a room each for:a) Registration and medical examination with adequate furniture and facilit ies forregistration and selection of donors,b) Donor motivation areal Counsellor (optional),c) Blood collection (air-conditioned),d) Refreshment-cum-rest-room (air-conditioned),e) Laboratory for blood transmissible disease like hepatitis., syphilis, malaria, HIVantibodies (air-conditioned),f) Blood component preparation. This shall be air-conditioned to maintaintemperature between 20C to 25C, with a provision of quarantine arealequipment,g) Laboratory for blood group serology (air-conditioned),h) Sterilization-cum-washing,i) Store-cum-record room.

- - ~ - - - - - - - - - - - - - - - - - - - - .......

Building: The building (s), used for operation of a blood bank! blood centre andl orpreparation of blood components shall be constructed in such a manner so as topermit.the operation of the blood bank! blood centre and preparation of bloodcomponents under hygienic conditions and shall avoid entry of insects, rodents andflies. It shall be well-lighted, ventilated and screened (meslh) whenever necessary.The walls and floors of the rooms where collection of bloocl or preparation of bloodcomponents or blood products is carried out shall be smooth, washable andcapable of being kept clean. Drains shall be of adequate size and, whereconnected directly to a sewer, shall': be equipped with traps to prevent backsiphonage.

2.1.3

2. ACCOMMODATION AND ENVIRONMENT

,II1i1j

NationalAccreditation Board for Hospitals and Healthcare Providers 7

7/29/2019 N A B H.PDF

19/92


2.1.4 Plasmapheresis Plateletpheresis and LeucapheresisAn area of 10 square meters shall be provided for apheresis in the blood bank!blood centre.

2.1.5 Blood donation campFor holding a blood donation camp. the following requirements shall be fulfil led/complied:PremisesPremises under the blood donation camp shall have sufficient area (permanentlyconstructed or a mobile van) and the location shall be hygienic so as to allowproper operation, maintenance and cleaning.All information regarding the personnel working, equipment used and facilitiesavailable at such a camp shall be well documented and l:lnsuring the following:a. Continuous and uninterrupted e l ~ c t r i c a l supply for equipment used in the camp,b. Adequate lighting for all the required activities,c. Hand-washing facilities for staff,d. Reliable communication system to the central office of the controller/ organiser

of the camp,e. Furniture and equipment arranged within the available space,f. Refreshment facilities for donors and staff,g. Facilities for medical examination of the donors,h. Proper disposal of waste.

,

2.1.10 Blood bank! blood centre shall have adequate back up facility for maintainingelectrical supply round the clock.

2.1.7 Access to and use of areas affecting the quality of the examinations shall becontrolled. Appropriate measures shall be taken to safeguard samples andresources from unauthorized access.

2.1.6 There shall be effective separation between adjacent blood bank! blood centresections in which there are incompatible activities. Measures shall be taken toprevent cross-contamination.

8National Accreditation Boardfor Hospitals and Healthcare Providers

2.1.9 Work areas shall be clean and well maintained (good housekeeping), storageincluding transportation and disposal of dangerous material shall be those specifiedby relevant regulations. Special procedures and training for personnel could benecessary to meet the requirements.

2.1.8 Relevant storage space and condition shall be provided to ensure the continuingintegrity of samples, documents, files, manuals, equipment, reagents, blood bank!blood centre supplies, records and results.

7/29/2019 N A B H.PDF

20/92


2.2 Environment Control

2.4 Internal Communication System

9

The blood bank! blood centre shall have process to mInimIZe and respond toenvironmentally related risks to the health and safety of employees (includingimmunization), donors, volunteers, patient! recipients and visitors. Suitableenvironment and equipment shall be available to maintain safe environment.

C o m m u n i c a t ~ n systems within the blood bank! blood centre shall be thoseappropriate to the size and complexity of the facility for the efficient transfer ofmessages.

The blood bank! blood centre shall monitor, control and record environmentalconditions, as required by relevant specifications or where they may influence theprocedures and quality of the results. Attention should b43 paid to sterility, dust,electromagnetic interference, radiation, humidity, electrical supply, temperature,sound and vibration levels as appropriate to the technical activities concerned.

The blood bank! blood centre shall have a process for monitoring adherence tobiological, chemical and radiation safety standards and regulation, whereapplicable.


2.3 Biological, Chemical and Radiatio'" Safety

7/29/2019 N A B H.PDF

21/92


3. PERSONNEL

3.1 Personnel RequirementThe blood bank! blood centre shall have a process to ensure the employment of anadequate number of individuals qualified by education, training and/ or experience.

f

3.2 QualificationThe operation of blood bank! blood centre for processing of whole human bloodand/ or components shall be conducted under the active direction and personalsupervision of competent technical staff consisting of at I!ast one person who is fulltime Medical Officer possessing following qualification:

3.2.1 Medical Director/ In-charge/ Medical OfficerMD (Pathology)/ MD/ DNB (Transfusion Medicine)ORDegree in Medicine (M.B.B.S) with Diploma in Clinical Pathology or TransfusionMedicine having adequate knowledge in blood group serology, blood groupmethodology and medical principles involved in the procurement of blood and/ orpreparation of its components.ORDegree in Medicine (M.B.B.S) having experience in blood bank! blood centre forone year during regular services and also has adequate knOWledge and experiencein blood group serology, blood group methodology and ml3dical principles involvedin the procurement of blood and/ or preparation of its components.


3:2.2

3.2.3

Blood bank! blood centre technician(s)Technician shall be full time competent staff possessingDegree in Medical Laboratory'Technology (M.L.T.) with six months experience inthe testing of blood and/ or its component;ORDiploma in Medical Laboratory Technology (M.L.T.) with onl3-year experience in thetesting of blood and/ or its component. .(The degree or diploma being from University/ Institution r!cognized by the CentralGovernment or State Government).

Registered Nurse(s)Registered with statel central nursing council.

10

7/29/2019 N A B H.PDF

22/92


OR

11National Accreditation Board for Hospitals and Heaithcare Providers

Personnel performing critical tasks shall be qualified to perform assigned activitieson the basis of appropriate education, training and! or experience.

3.3 Job description! responsibilitiesCurrent job descriptions shall be maintained and slhall define appropriatequalifications for each job position.

(The degree or diploma being from a University! Institution recognized by theCentral GovernmenU State Government).

Diploma in Medical Laboratory Technol6gy (M.L.T.) with one year experience in thetesting of blood and its components.

3.4 Responsibilities of Medical Director! In-chargle! Medical Officer,Technical Manager and Quality Manager3.4.1 The responsibilities of the blood bank! blood centre Medical Director! In-charge!Medical Officer shall include professional, scientific, consultative or advisoryorganizational, administrative and educational matters. These shall be relevant tothe services offered by the blood bank! blood centre. In case of more than 1

Medical Officers in the blood bank! blood centre, the responsibility shall be definedby the Medical Director! In-charge.3.4.2 Technical Manager shall have overall responsibility for the technical operation andthe provision of resources needed to ensure the required quality of blood bank!blood centre procedures.

3.2.4 Technical Supervisor (where blood components are manufactured) possessingDegree in Medical Laboratory Technology (M.L.T.) with six months experience inthe testing of blood and its components.

3.4.3 Quality Manager with responsibility and authority to oversee compliance with therequirements of the Quality Management system. The Quality Manager shalldirectly report to the Director! In-Charge blood bank! blood center. In a blood bank!blood centre collecting less than 3000 units same person can be designated asTechnical Manager and Quality Manager.

3.5 Training3.5.1 All personnel shall have training specific to quality assurance and qualitymanagement for services offered. >3.5.2 It shall be the responsibility of the management to ensure thorough maintenance ofrecords and other latest techniques used in blood bank! blood centre system thatthe personnel involved in blood bank! blood centre activities for collection, storage,testing and distribution are adequately trained in the cummt good manufacturingpractices! standard operating procedures for the tasks undertaken by eachpersonnel, and receive initial and continuing training relevant to their needs.

7/29/2019 N A B H.PDF

23/92


3.5.3 There shall be a continuing education program available to staff at all levels.3.5.4 Employees shall be trained to prevent adverse incidents and/ or contain the effectsof, and report adverse incidents.

3.6 CompetenceThe competency of each person to perform assignE!d tasks shall be assessedfollowing training and periodically thereafter. Retraining and reassessment shalloccur when necessary.

3.7 Personnel health

3.8 Personnel records

3.9 Confidentiality of informationAll personnel shall maintain confidentiality of information regarding donor/ patient!recipient. Health records of staff shall be kept confidential and in a safe place.

12

A pre-employment medical examination and regular health check up shall beconducted on all the employees. Occupational health hazards are adequatelyaddressed.

Blood bank! blood centre management shall maintain records of the Personalinformation, relevant educational and professional qualification, training andexperience, and competence of all personnel. This information shall be readilyavailable to relevant personnel, and may include:a) Certification or license, if required,b) Reference from previous employment, if possible,c) Job descriptions,d) Records of continuing education and aChievements,e) Provision for untoward incident or accident reports,f) Record of identification of signature and initials,g) Competency evaluation.Other records available to authorized person relatingl to personnel health mayinclude records of exposure to occupational hazards and records of immunizationstatus.


7/29/2019 N A B H.PDF

24/92


4.3 Use of equipment

4. EQUIPMENT

4.2 Selection and validation of equipment

13National Accreditation Board for Hospitals and Healthcare Providers

4.4 Equipment detail record, unique identificationRecords shall be maintained for each item of equipment. These records shallinclude at least the following:a) Identification of the equipment,b) Manufacturer's name, type, identification and serial number or other uniqueidentification,c) Manufacturer's contact person and telephone number,d) Date of receiving and date of putting into a service,e) Current location, where appropriate,f) Condition when received (new, used or reconditioned),g) Manufacturer's instructions, if available, or reference of their retention,h) Equipment performance records that confirm the equipment suitability for use,i) Maintenance carried out and that planned for the future,j) Damage to or malfunction, modification or repair of the Bquipment.These records shall be maintained and shall be readily available for the life span ofthe equipment or for any time period required by lawl regulcltion.

Equipment used in the collection, processing, testing, storage and distribution ofblood and its components shall be maintained in a clean and proper manner and soplaced as to facilitate cleaning and maintenance.

Only authorized personnel shall operate the equipment. UIP-to-date instructions onthe use and maintenance of the equipment (including relevant manuals anddirection for 'Use provided by the manufacturer of the equipment) shall be readilyavailable to personnel.

4.1 Equipment requirementThe blood bank! blood centre shall be furnished with all the equipment that isrequired for the provision of services (including blood collection, componentpreparation, processing, examination and storage). The blood bank! blood centreshall have policies, processes, and' procedures to Emsure that calibration,maintenance, and monitoring of equipment conforms to these blood bank! bloodcentre standards and other specified requirement.

Equipment shall show (upon installation and in routine USE!) capability of achievingthe performance required and shall comply with specifiications relevant to theexaminations concerned.

4.5 Programme for calibration and maintenanceof equipment4.5.1 Blood bank! blood centre management shall establish a programme that regularlymonitors and demonstrates proper calibration and function of instruments, reagentsand analytical system. It shall also have a documented and recorded programme of

7/29/2019 N A B H.PDF

25/92


preventive maintenance, which, at a minimum, follows the manufacturer'srecommendation.4.5.2 The equipment shall be observed, standardized and calibrated regularly onscheduled basis as described in the standard operating procedure manual andshall operate in the manner for which it was designed so as to ensure compliance

with the legal requirement (the equipment) as stated below for blood and itscomponents.4.5.3 Equipment shall be observed, standardized and calibrated with at least theminimum frequencies defined in Annexure H.

4.5.4 The program for calibration of equipment shall be designed and operated so as toensure that calibrations are traceable to international system of units (51). The linkto 51 units may be achieved by reference to national measurement standards.

r

4.6 Equipment fo r storage of blood and component4.6.1 Blood bank! blood centre shall have adequate storage facility corresponding to itsworkload.4.6.2 Storage devices shall have design to ensure that the proper temperature ismaintained.4.6.3 There shalf be a process to monitor the temperature of refrigerator, freezers, andplatelet incubators continuously and to record the temperature at least every 4hours.4.6.4 If blood or components are stored in an open storage area,_ the ambienttemperature shall be maintained at 22C 2C.

4.7 Computer systemWhen computers or automated examination equipment sire used for the collection,processing, recording, reporting, storage or retrieval of examination date, the bloodbank! blood centre shall ensure that:a) Computer software, including that built into equipment is documented andsuitably validated as adequate for use in the facility,b) Procedures are established and implemented for protecting the integrity of dataat all times,c) Computer and automated equipment are maintained to ensure properfunctioning and provided with environmental and operating conditions

necessary for maintaining the integrity of data,d) . Computer programmes and routines are adequat1ely protected to preventaccess, alternation and destruction by unauthorized pierson.

4.8 Breakdown of equipmentWhenever equipment is found to be defective it shall be taken out of service,clearly labelled and appropriately stored until it is been repaired and shown to becalibrated to meet specified acceptance criteria.


7/29/2019 N A B H.PDF

26/92


5.1 Policies and procedures fo r supplier's selection5.. EXTERNAL SERVICES AND SUPPLIES

15 . NationalAccreditation Board for Hospitals and Healthcare Providers

5.3 Evaluation of suppliersThe blood bank! blood centre shall evaluate suppliers of clritical reagents, suppliesand services that affect the quality of examinations and shall maintain records ofthese evaluations and list of those approved.

5.1.1 Blood bank! blood centre management shall define and document its policies andprocedures for the selection and use of purchased external services, equipmentand consumable supplies that affect the quality of its services. Purchased itemsshall consistently meet the blood bank! blood centre quality requirements. National,regional or local regulations may require record of purchased items. There shall beprocedures and criteria for inspection, acceptance/ rejection, and storage ofconsumable materials.

Each blood collecting container and its satellite container(s), i f any, shall beexamined visually for damage or evidence of contamination prior to its use andimmediately after filling, such examination shall include inspection for breakage ofseals, when there is such indication the container shall not be used or, if detectedafter filling, shall be properly discarded.

5.1.2 Purchased equipment and consumable supplies that affect the quality of theservice shall not be used until they have been verified as complying with standardspecifications or requirements defined for the procedure concerned.5.1.3 All supplies and reagents used in the collection, processing, compatibility testing,storage and distribution of blood and blood components shall be stored at propertemperature in a safe and hygienic pla,?e in a proper manner.5.1.4 All supplies coming in contact with blood and blood components intended fortransfusion shall be sterile, pyrogen-free, and shall not inb:lract with the product insuch a manner as to have an adverse effect upon the s,afety, purity, potency oreffectiveness of the product.5.1.5 Supplies and reagent that do not bear an expiry date shall be stored in a mannerthat the oldest is used first.5.1.6 Supplies. and reagent shall be used in a manner consistent with instructionsprovided by the manufacturer.5.1.7 All final containers and closures of blood and blood components intended for

transfusion shall be clean and free of contaminants.

5.2 Inventory control5.2.1 There shall be an inventory control system for supplies. Appropriate quality records

of external services, supplies and purchased product shall be established andmaintained for period of time as defined in the quality management system.5.2.2 This system should include the recording of lot number of all relevant reagents,control materials and calibrators, the date of receipt in the blood bank! blood centreand the date the material was placed in service. All of theSE! quality records shall beavailable for blood bank! blood centre management review. "

7/29/2019 N A B H.PDF

27/92


6.1 Policies and validation of processes and procedures

6. PROCESS CONTROL

,The blood bank! blood centre shall . have policies and validated processes andprocedures that ensure the quality of the blood, component, derivatives andservices. The blood bank! blood centre shall ensure that these policies, processesand procedures are carried out under controlled conditions.

The blood bank! blood centre shall establish a procedure to identify a recipient of atransfusion of blood from a donor who is subsequently found to have been infectedwith transfusion transmissible infection. In case this happ49ns the blood bank! bloodcentre shall inform the patient! recipient's physician. Appropriate record of suchevents shall be kept. The unused components from this unit shall be discarded.

Note: Some of the following might not be applicable to the scope of all blood banks!blood centers.

The blood bank! blood centre shall ensure that all blood, components, derivativesissued and critical materials used in their processing activities, as well as laboratorysample and donor and patient! recipient records, are identified and traceable.

Traceability of blood unit and sample from blood collection to issue blood

For each critical step in collection, processing, compatibility testing andtransportation of blood, component and derivatives issued, there shall be amechanism to identify who performed the step and when it was performed.

Process or procedure steps

6.1.1

National Accreditation Board for Hospitals and Healthcare PrOYiders

6.1.2 Standard procedureThe blood bank! blood centre shall use procedures including examinationprocedures, which meet the needs of the users of bilood bank! blood centreservices. National guidel ines! manuals and other regulatory directives shall befollowed. In absence of the above preferred procedures that have been publishedin establishedl authoritative textbooks, peer-reviewed text or journals or ininternational guidelines shall be used. If in-house procedures are used, these shallbe appropriately validated for their intended use and fully documented.The blood bank! blood centre shall record the result obtained and the procedureused for the validation in case in-house developed methods are used.a) Written procedure

All procedures shall be documented and be available at the workstation forrelevant staff. Documented procedures and necessary instructions shall peavailable in a language commonly understood by the staff in blood bank! bloodcentre.

16 '

7/29/2019 N A B H.PDF

28/92

7/29/2019 N A B H.PDF

29/92


c) Test carried out on donated blood,d) Confidentiality of test results,e) Need for honest answers in view of window period.6.2.1.3 Donor registration, consent and selection

a) Donor registrationA questionnaire shall be prepared in English and local languages which issimple and easy to understand to pe answered by t h ~ ~ donor.For donors who are illiterate, assistance shall be gliven by donor registrationstaff.Medical officer with minimum MBBS qualification shall be responsible forreviewing the donor's health conditions and physical ~ ~ x a m i n a t i o n of the donor.

r

b) Consent

.'"

18

For detail procedure of apheresis see 6.3.3.1.

Interval between two plateletpheresis shall be 48 hours and not more than twicea week and not to exceed 24 times in a year. The donors shall be testedappropriately to detect thrombocytopenia.

At least 48 hours must elapse after plasmapheresis or cytapheresis (excepterythropheresis) before whole blood is collected from a donor.

For double red cell collection, donor shall have haemoglobin 13.5 g/ dl andweight >65 Kgs. The interval between the two procedures shall be six m o n t h s ~

Demographic details such as name and address of donor, date and time ofdonor selection and donation shall be registered.

Prior to blood donation, the consent of the donor shall be obtained in writingwith donor's signature or thumb impression after the procedure is explained andthe donor is informed regarding testing of blood for all mandatory tests forsafety pf recipients. The donor shall be provided an opportunity to askquestions and refuse consent. After donation, if the donor seeks the status ofTransfusion Transmitted Infection (TTl), the same may be provided with priorconsent.

Apheresis shall be done only after three months of whole blood collection or inan event when red cells are not returned at the end of pheresis.

d) Donation intervalThe interval between two blood donations shall be at lelast three months.

c) Criteria for selection of donorsThe requirements given at Annexure B shall be followed in order to ensure thatthe blood donation will not be detrimental to the donor/ recipients.


I

7/29/2019 N A B H.PDF

30/92

or


Citrate-phosphate-dextrose (CPO) solution: 14 ml solution is required for 100 mlof blood.

Citrate-phosphate-dextrose-adenine (CPOA-1) solution: 14 ml solution isrequired for 100 ml of blood.

19

d) Anticoagulant solutionsThe anticoagulant solution shall be sterile and pyrogen-free. One of thefollOWing solutions shall be used in the indicated volumels.

100 ml SAGM/ AOSOL (for 450ml whole blood) and no ml (for 350ml wholeblood) or any other approved additive solution containiing saline, adenine andglucose (or with mannitol) is added to packed cells a f t l ~ r separation of plasmafor storage.

c) Equipment and blood bagThe blood bags for collection of blood shall be sterile, pyrogen-free anddisposable, with a closed system of collection as per standards provided bynational authority. Multiple interconnected plastic bags shall be used for bloodcomponent preparation (closed system). Venting of any container shall be doneunder laminar airflow bench and such container shall bel used within 24 hours (ifpreserved at 4C for red cells). To avoid venting in case of paediatric use,multiple inter-connected closed containers shall be used.

The blood donor area shall be clear, congenial, comfortable and convenientlyapproachable. As the temperatures vary Widely in different seasons, it ismandatory to have air-conditioned rooms to make the donor comfortable and tominimise chances of donor reaction.b) Method of preparation of phlebotomy siteA strict standardised procedure shall be in use to achieve surgical cleanlinessfor preparing venepuncture site to provide maximum possible assurance ofsterile product.

e) VolumeVolume of blood collected shall be proportionate to the volume of antfcoagulant with 10% variation and shall not exceed 10 ml/ kg body weight.Units of blood where volume collected is out of the permitted limits shall not beused for transfusion. No attempt shall be made to collect blood from such donorduring the same session.


6.2.1.4 Phlebotomy procedurea) Blood shall be collected only by a licensed blood bank! blood centre. Bloodshall be drawn from the donor by a qualified physician or under his/ hersupervision by nurse/ technician trained in the procedure. A physician shall bepresent on the premises when the blood is being collected. Blood shall becollected by single venipuncture and flow of blood shall be continuous.

7/29/2019 N A B H.PDF

31/92


Extracorporeal blood volume shall not exceed 15% of the donor's estimatedblood volume.6.2.1.5 Post donation care

Donor shall be given advice regarding post-phlebotomy Ciare and cautioned for thepossible adverse reactions. This shall also be displayed in the blood collection/observation room.

6.2.1.6 Adverse donor reaction managementNecessary drugs and equipment shall be available for treatment of donor reaction,if any. Donor blood collection staff shall be trained in identification andmanagement of donor reactions like:Syncope (fainting or vasovagal syndrome)Tetany (twitching or Muscular spasm)Nausea and vomitingHematomaConvulsionsCardiac problems

6.2.1.7 Blood donation campI drivesOutdoors blood donation campsBlood donation camps shall be organised only by blood bank! blood centresauthorised by SBTC (State Blood Transfusion Council) to augment blood stocks.Donor organiser/ medical social worker of the blood bank! blood centre shallcontact offices, institutions, industries, social and religious organisations,educational institute to collect need based units of blood from targeted group ofdonors located at a particular venue at regular intervals.

The outdoor camps shall be organised in an environment that is conducive andcomfortable. The area shall be cleaned before and after the blood collection.

Adequate publicity and Information Education and Communication (IEC) materialshall be made available to the organisations.The number of blood units collected shall commensurate with the actualrequirement of blood units rather than by social or emotional pressures.

20

Blood bank! blood centre shall maintain quality at each step from donorrecruitment, selection and collection to the final product. The method of bloodcollection and management of donor reaction shall be th,e same as at blood bank! .'"'blood centre.

Authorized person from blood bank! blood centre shall inspect the donation siteprior to the day of blood collection to ensure availability of all facilities asprescribed.

Blood and its components could contain infectious agents and shall be handledwith precautions.


7/29/2019 N A B H.PDF

32/92


Large Camps

6.2.1.8 Autologous transfusion procedure

21

b) Counselling and referralFor ensuring blood safety, the blood bankJ blood centre!s shall provide pre andpost donation counselling services.All blood bankJ blood centres shall train their donor organisers! medical officersto undertake counselling in the absence of a donor counsellor.

Quality measures, pre-donation counselling and transportation procedures shall notbe compromised.

The blood bankJ blood centre doing autologous transfusion shall have the definedprocesses and procedures including predeposit criteria for autologous donation,testing of units, labelling required, pretransfusion testing, perioperative proceduresand post operative procedures.

For TIl other than HIV, the donor shall be referred for follow up to concernedspeciality for further management.

Donors who are HIV sero-reactive shall be referred to a voluntary counsellingand testing centre (VCTC) for post donation confirmation and counselling ormay be provided with the facilities for the confirmation cmd counselling at bloodbankJ blood centre.

The large camps organised on a day shall be planned as per criteria laid down bythe Drug and Cosmetics Act or any other directive from national! state authority.

Demographic details of donor Identification number Donor selection record Medical History Physical examination


6.2.1.9 Donor notification of abnormal findings, test results and counsellinga) Information of test results

The medical officer of blood bankJ blood centre shall inform the donor aboutany sera-reactive result of TIl with prior written consent as per existingregulations.

6.2.1.10 Records of donor and donor's blood! componentsFollowing Donor Records shall be maintained:

7/29/2019 N A B H.PDF

33/92


Donor deferral recordsDonors' blood collection record Date of collection Batch number and bag manufacturer's name Segment number on the donor tubing Particulars of donor Identification number Amount of blood collected Time and duration of collection, whenever appropriate Signature of phlebotomist and medical officerDonor reactions - Statement of donation reaction when occurred needs to bementioned along with the description, management detai ls and action taken forprevention in future.Blood components records Identification number Name and volume of component prepared Date, time and mode of preparation Disposition recordRecord 9fprocessing ofdonor's blood ABO and Rh (D) type Antibody screening and identif ication Anti-HIV 1 & 2, Anti-HeV, HBsAg, VORL test and its interpretation Test for absence for malaria parasitesDocumentation of details of grouping shall be done indicating reaction results,batch number and manufacturer's name of reagents in use, details of reagent redcells in use.Documentation of all infectious disease tests shall be done, including ELISAprintouts showing results and interpretation as well as batch number, expiry dateand manufacturer's name of the kit in use.All rapid tests! spot tests shall be interpreted, p n ~ f e r a b l y by two competentindividuals, and recorded.Quality control records shall be maintained indicating testing of components,reagents and equipment.Records of apheresis procedures shall be maintained.

f

Records of all blood discarded shall be maintained.6.2.1.11 Therapeutic plasmapheresis and cytapheresis

Therapeutic plasmapheresis! cytapheresis shall be done only at the written requestof the patient! recipient's physician preferably in the blood bank! blood centre or ir{the ward depending on patient! recipient's clinical condition.

National Accreditation Board for Hospitals and Healthcare Providers 22

7/29/2019 N A B H.PDF

34/92


b) Traceability

Therapeutic Phlebotomy

23

Each container of blood! blood components! pilot tubes shall be identified by anumeric or alphanumeric number at the time of collection of blood, so that it can betraced back to the donor and also to the recipient. The segment number printed onthe integral donor tubing shall be recorded.a) Blood unit identification

A numeric or alphanumeric system shall be used, that will make it possible totrace any unit of blood or component from source to final destination andrecheck records applying to the specific unit.

The blood bank! blood centre shall ensure that all blood, components preparedin their premises, as well as laboratory samples Glnd donor and patient!recipient records, are identified and traceable to donor and recipients.

No identification mark of donor should be written 011 the label. In case oftransfer of blood unit to blood storage centre, original label with the sameidentification shall be retained. '

The numeric and alphanumeric identification on label shall be provided by thecollecting facility to each unit of blood! its components. This number shall bedocumented for traceability. Any advanced technology for identification such asbarcode system is preferable.

The integral donor tubing of plastic bag shall be filled wIth anticoagulated bloodusing appropriate method and sealed in such a manner that it will be available withsegment numbers for traceability for subsequent compatibility tests.

Therapeutic phlebotomy shall be done only on the request of the patient! recipient'sphysician. The blood bank! blood centre doctor must decide whether to accept theresponsibility of the patient! recipient. The blood collected in such circumstanceshall not be used for transfusion.

Informed consent of the patient! recipient shall be taken in the language he! sheunderstands.

Records of patient! recipient's identification, diagnosis, therapeutic procedures,haemapheresis method, volume of blood removed and returned, time taken, natureand volume of replacement fluids, and adverse reaction if any and medicationadministered, shall be maintained.

Provision for emergency care shall be aVailable.


6.2.2.2 Identification and traceability

6.2.2 Handling of samples and blood units6.2.2.1 Samples for laboratory tests

The blood samples in the pilot tubes (plain and with anticoagulant) shall becollected at the time of collection of blood by the same person. They shall bemarked before collection to be identified with the unit of blood.

7/29/2019 N A B H.PDF

35/92


6.3.2 Seal

6.2.2.3 Transportation

The temperature during transport shall be monitored.

Blood bags that allow transfer of component without bneakage of the seal (closedsystem) shall be used. The seal will not be considered broken if a sterileconnecting device is used.

Whole blood and red cell concentrate, shall be transported in a manner that shallmaintain a temperature of 4 - BOC 2C. PlateleU granulocyte concentrates arestored and transported at 22C :t 2C. Components stored frozen shall betransported in a manner to maintain them frozen. When these are issued fortransfusion, these shall be thawed at 37C prior to issue.

Component LaboratorySterilityThe sterility of all components shall; be maintained during processing by the use ofaseptic methods and sterile pyrogen-free disposable b a ~ l s and solutions.

Immediately after collection, the blood shall be placed alt 4 - BOC 2C except if it isused for component preparation which can be store'd at 22C 2C until theplatelets are separated.

6.36.3.1

Once the frozen components are thawed, these shall be transfused as soon aspossible and positively within 6 hours.At the time of preparation of the final components the integrally connected tubingshall be filled with aliquots of the component and sealed in such a manner that itshall be available for subsequent compatibility and assay testing, if needed.

24

Red blood cell concentrate shall be prepared from the whole blood collected inplastic bags, preferably in double or multiple plastic bag system. Plasma isseparated from red blood cells following either centrifugation or undisturbedsedimentation at any time before the expiry date of blood. If closed system is inuse, the expiry date of red cells shall be the same as whole blood. Thehematocrit of packed cells shall be adjusted so that it iis not more than 70%.

If the seal is broken during processing, components stored between 4C 2Cmust be transfused within 24 hours and component stored between 22C 2Cshall be transfused as early as possible and not beyond 15 hours.


6.3.3 Preparation of componentsa) Red Blood Cells Components

Red blood cells

7/29/2019 N A B H.PDF

36/92

Washed red cells


25

Red bio09 cells shall be ordinarily frozen within 6 days of collection of bloodand can be kept frozen up to 10 years.

The method of preparation, storage, thawing and washing shall ensure arecovery of at least 80% of original red cells depending on the procedure inuse.

There shall be no grossly visible platelet aggregat!s during the storage.Swirling phenomenon shall be checked before issue.

Continuous gentle agitation (60-70 oscillations per min) using horizontalagitator or a rotator with 5-10 cycles! minute shall be maintained throughout thestorage period varying from 3 to 5 days depending on the nature of plastic ofthe bag in use considering day of blood collection as day zero.

Platelets shall be s u ~ p e n d e d in approximately 50 ml of plasma and stored at22C 2C under agitation. The pH at storage temperature shall not be lowerthan 6.0 at the end of storage period.

Platelets concentrate shall be separated from whole blood within 6 hours ofcollection by centrifugation at 22C 2 c using e i t h l ~ r platelet rich plasma(PRP) or buffy coat (BC) method, which is validated.

Leucocyte depleted red blood cells

Red blood cells shall be washed with normal saline by automatic cell washer ormanually by centrifugation. The cells shall be washed 2-3 times with normalsaline by centrifuging at 4C 2C. A laminar bench that is validated yearlyshall be used. Closed system of washing is r e c o m m e n d l ~ d .

Leucocyte depleted red blood cells concentrate shall bel prepared by a methodknown to reduce leucocytes in the final component to Iless than 5 x 106 whenintended to prevent febrile reactions.Frozen and deglycerolised red blood cell concentrateRed cells shall be stored frozen continuously at low temperature of -BOCto -196C in the presence of cryoprotective agent. The red cells shall bewashed to remove the cryoprotective agent prior to transfusion.

The concentrate prepared shall not be contaminated with red cells. The degreeof reddish tinge of the concentrate indicates red cell contamination. The unitscontaminated with red cells shall be used as group speci,fic. If the contaminationof RBCs is more than 5 ml the unit shall be issued after cross match.

b) Platelets concentrate (random donor platelets)Platelets concentrate shall be prepared by centrifugation of single unit of wholeblood collected with a smooth venipuncture and a continuous flow of blood.


II' ~j,1,I

7/29/2019 N A B H.PDF

37/92


c) Granulocyte concentrateUnit of granulocytes prepared by use of cell separator shall have 1 x 1010leucocytes and shall be kept at 22C 2C for a maximum period of 24 hours.

d) PlasmaSingle donorplasmaPlasma shall be separated from 'whole blood at any time up to 5 days after theexpiry of the whole blood. The plasma separated after 5 days of expiry dateshall be used only for fractionation.Fresh frozen plasmaFresh plasma shall be separated from the whole blood and frozen solid at _BOC or blast freezer not later than 6 hours of collection. Further storage shallbe done at -300C or lower. Prior to infusion the f r o z l ~ n plasma shall be thawedrapidly at 30 - 37C in a water bath with shaker. Once thawed it shall be usedwithin 6 hours, when kept at rooml ambient temperature, or within 24 hourswhen kept at 4C 2C.Cryo poor plasma or Factor VIII deficient PlasmaThis is,plasma from which cryoprecipitate has been removed. It shall be storedat -30C or lower and once thawed shall be used within 6 hours.

e) Single donor cryoprecipitate (cryoprecipitated anti-hemophilic factor)For preparation of cryoprecipitate the plasma shall b E separated within 6 hoursof collection and frozen hard at -BOC and then can be preserved at -3 00 C orlower and when needed thawed at 4C in cirCUlating water bath or in 4C ColdRooml Blood bank refrigerator.Thawed plasma shall be immediately centrifuged and separated from the coldinsoluble material under sterile conditions.The cryoprecipitate (cold insoluble material) shall be frozen within 1 hour andshall be kept at -30C or lower up to 1 year from thl3 date of donation. Oncethawed, it should be used within 6 hours.

f) Donor apheresisThis procedure shall be carried out only in a blood bank! blood centre licensedfo r this purpose.

There shall be provision for emergency medical care, in the event of anyadverse reaction to the donor.

A medical officer trained in apheresis technique shall be responsible for theprocedure.The staff working on the cell separator shall be trained in apheresis procedureand shall work directly under the supervision of the medical officer.


- - - - - ~ - - - -

7/29/2019 N A B H.PDF

38/92

7/29/2019 N A B H.PDF

39/92


6.4.2

All reagents shall be stored in refrigerators with thermograph or temperaturemonitor in the specific laboratories.Blood bank! blood centre refrigerator! walk-in-cooler shall have inside temperatureof 4C 2C and shall have a system to monitor temperature continuously or atleast the temperature shall be recorded every 4 hours. An alarm system and aprovision for alternate power supply shall be available.Deep freezer shall have inside tempe'rature of -30C or -BOC having temperatureindicator! recording facility with alarm system and provision for alternate powersupply.Platelet incubator with agitator shall have inside temperature of 22C 2C havingtemperature indicator! recording facility with alarm system and provision foralternate power supply. The equipment shall keep the platelet units in continuousgentle agitation.Adequate alternate storage facility and written display of instructions to maintainthe blood and components in the event of failure of power or equipment shall beprovided in the area of prevention. The alarm of all storage equipment shall signalin an area that has adequate personnel coverage round the clock to ensureimmediate corrective action.QuarantineThe whole blood or components shall not be issued for transfusion, till themandatory test are completed and reported as non-reactive. In order to ensure thisprocedure, the untested blood shall be kept in q u a r a n t i n E ~ storage. The units whichtest reactive in any test shall be segregated immediately and kept in separatequarantine area till sent for disposal as per Bio Medical Waste (BMW) rules.Refrigerator or freezers in which blood and blood components are stored forquarantine shall be appropriately labelled.Storage and Expiration (see also AnnexureA)Whole bloodWhole blood shall be stored at 4C 2C in plastic blood bags.Whole blood collected in anticoagulant citrate-phosphatie-dextrose solution (CPO)shall have an expiry date, not exceeding 21 days after phlebotomy. Whole bloodcollected in anticoagulant citrate-phosphate-dextrose with adenine (CPOA-1) shallhave an expiry date not exceeding 35 days after phlebotomy.Red Blood Cell ComponentsRed blood cellsRed blood cells that are separated in a closed system shall have the same eXpirydate as the whole blood from which they are prepared. The time of removal ofplasma is not relevant to the expiry date of red cell concentrates. However, if an '"open system is used, the expiry date shall be 24 hours after separation. Red cellconcentrate shall be stored at 4C 2C.


7/29/2019 N A B H.PDF

40/92


Plasma

Frozen red cells

29

Platelet concentrate

Leucocytes depleted red blood cellsLeucocytes depleted red blood cells shall be stored at 4C 2C. It shall have thesame expiry date as whole blood from ",hich it has been pmpared, if closed systemis used. In case of open system, the expiry shall be within 24 hours.

The platelet concentrate shall be stored at 22C 2C with continuous gentle flatbed agi tation'(60 - 70 strokesl min) or a rotator (5 - 10 cycles! min.) maintainedthroughout the storage period. The expiry date of platelet concentrate prepared inclosed system shall be 3 day after the collection of original blood. The expiry datemay be extended to 5 days when special plastic bags or anticoagulants are in use.

Single donor plasmaSingle donor plasma separated during shelf life shall be stored for 1 year at -30C,or lower and used as plasma for transfusion.

Granulocyte concentrateThe storage temperature for leucocyte concentrate is 2:2C 2C. It shall betransfused as soon as possible and not later than 24 hours of phlebotomy.

CPDA-1 Red cells containing additive solutions shall be stored up to 42 days withday of collection considered as day zero. At midnight (12 '0 ' clock) the day iscompleted.

The expiry date for glycerolized (low or high) frozen red cells is 10 years and shallbe stored between -SOC and -196C.Washed and deglycerolised red cellsWashed red blood cells and deglycerolised red blood cells shall be stored at4C 2C and shall be transfused as soon as possible and within 24 hours afterprocessing.

Cryo poor plasma (normal human plasma) shall be stored at -3QoC or below andshall be stored no longer than 5 years from the date of collection.

Fresh-frozen plasma and cryoprecipitateThese components shall be stored at -30C or below and slhall be stored no longerthan 12 months. If fresh frozen plasma (FFP) remains unused at the end of 1 yearat -30C, it may be labelled as 'plasma' and shall be used upto 5 years.Expiry date of any component shall be calculated by considering the day ofcollection as day zero.


7/29/2019 N A B H.PDF

41/92

7/29/2019 N A B H.PDF

42/92

7/29/2019 N A B H.PDF

43/92


6.6.4.4 Test for Malaria

6.6.4 Test for Transfusion Transmitted Infection

"32

All blood units shall be tested for malaria parasites using a validated method orsensitive antigen test.

a) Recipient's name,b) Age, Sex, ward and bed number,c) Blood group of recipient if done earlier (for error pnBvention),d) Name of the head of treating unit,e) Amount of blood! component needed,f) Date and time of blood! component requirement,g) Routine! emergency,h) Diagnosis,i) Reason for transfusion, hemoglobin! platelet count,j) History of previous transfusion,k) Obstetric history in the case of female patient! recipient,I) Name of the hospital! hospital registration number,m) Signature of the medical officer,n) Name and signature of the phlebotomist collecting patient! recipient's sample.

Request form for whole blood or components accompanied by the recipient's bloodsamples shall be legible and shall have the following information:

6.6.4.1 Screening for HIV antibodyAll blood units collected shall be tested for HIV 1 and 2 antibodies using ELISA!rapid tests by a validated method. Any alternative tec:hnology with similar or highersensitivity may be used.

Blood samples in pilot tubes taken at the time of collection shall be tested for allrequired mandatory tests under regulation. The whole blood or components fromany unit that tests positive shall be discarded.

Any other test in addition to above being carried out in a blood bank! blood centreshall use validated methods and fulfill all regulatory reiquirements.Note: Test results to be signed by a second trainod person before release ofresults.

National Accreditation Board for HosfJitals and Healthcare Providers

6.6.4.2 Test for Viral HepatitisA test for hepatitis B (HBsAg) and hepatitis C (anti-HCV) by ELISA! rapid test by avalidated method shall be done on each unit of blood. Any technology with similaror higher sensitivity may be used to improve blood safety.

6.6.4.3 Test for SyphilisEach donation of whole blood shall be subjected to serological test for syphilis byVORL or RPR or TPHA or ELISA method.

6.7 Compatibility Testing6.7.1 Request for blood and its components

7/29/2019 N A B H.PDF

44/92

7/29/2019 N A B H.PDF

45/92


Crossmatch

6.7.4.1 Issue of blood

34

The cross matching report shall have patient! recipie!nt's first name with surname,age, sex, identification number, ward, bed number, and ABO and Rh(O) type.

Each unit of blood shall be visually inspected before issue. It shall not be issued ifthere is any evidence of leakage, hemolysis or suspicion of microbial contaminationsuch as unusual turbidity, or change of colour.

A portion of the integral tube with at least one numbered segment shall remainattached with the blood bag being issued.

Interpretation.of cross matching report and the name of the person performing thetest and issuing the blood shall be recorded.

The report shall have donor unit identification number, ABO and Rh (0) type andexpiry date of the blood.

If clinically significant antibody(ies) are not detected during the antibody screeningtest and if there is no record of previous alloantibodies and no history of transfusionof pregnancy within the past three months, then an antiglobulin cross-match is notrequired. An immediate spin must be performed.

Blood shall be issued by the blood bank! blood centre along with the blood crossmatching report.

Minor cross matching using donor serum or plasma and recipient's cells shall notbe necessary as tests for complete and incomplete unexpected antibodies in donorsample'are mandatory.

If clinically significant antibody(ies) is! are detected in recipient, blood lackingcorresponding antigens on cells shall be crossmatched or by trial method theblood, which is compatible, shall be issued. In certain clinical conditions, whereautoantibodies are present, the least incompatible unit shall be issued with warningto clinicians.

A sample of donor cells from a segment attached to the bag and recipient serum orplasma shall be crossmatched. The method used shall demonstrate ABOincompatibility and clinically significant unexpected complete and! or incompleteantibodies and shall include an antiglobulin test.

A label or a tag with patient! recipient's name, hospital name, identification number,.blood unit number assigned by the collecting! intermediary facility and interpretationof the cross matching test, shall also be attached to the blood bag container beforeit is issued from the blood bank! blood centre.


6.7.4 Issue of blood and its component

6.7.3.2 Repeat testing of donor bloodThe blood bank! blood centre performing cross matching shall confirm ABO andRh (0 ) group of all blood units using a sample o b t a i m ~ d from an attached segment.

7/29/2019 N A B H.PDF

46/92


Platelets concentrate

6.7.4.2 Re-issue of blood

35

Platelet concentrates shall be ABO and Rh (0) type specific or compatible with therecipient blood. In case of shortage platelets concentrate of any ABO/ Rh groupshall be used provided there is no visual red cell contamination of the plateletconcentrate. In case of apheresis platelets, plasma shall be reduced when plasma

Single donor plasma or fresh frozen plasma shall be ABO type specific/ compatiblewith recipient's red blood cells. For cryoprecipitate ABO/ Rh !;Jrouping is not must. '

If clinically significant unexpected antibodies are detected in recipient, whole bloodor red blood cells component, which do not have corresponding antigens and arecompatible shall be transfused. On reasonable qualifying circumstance indicated bythe clinician, a least incompatible unit shall be issued with instruction to clinician totransfuse under constant observation.Single donorplasma and fresh frozen plasma

It is recommended that blood once issued shall not be talken back by the bloodbank! blood centre if the cold chain is broken.

The donor tag or label on the blood container and the cross match report form shallindicate that compatibility testing has not been completed at the time of issue.

Recipient shall receive ABO type specific compatible whole blood or red blood cellcomponents. In the absence of ABO type specific blood, group 0 packed red cellsshall be transfused. Rh(O) negative recipient shall receive Rh(O) negative wholeblood or red blood cell components except for reasonable qualifying circumstanceswhen Rh positive may be issued only when Rh antibodies are absent and with dueconsent of treating physician. Rh(O) positive recipient can receive either Rh(O)positive or negative whole blood or red blood cell components.

Blood or blood components shall be issued before completion of routine crossmatching tests, in case where delay in woviding blood rna)' jeopardize the patienUrecipient's life, on receipt of a signed written request of the treating physicianstating that the clinical condition of the patienU recipient is sufficiently urgent torequire the issuance of blood before completing ABO and Rh(O) tests andcompatibility testing. Records of such requests shall be retained for 5 years.

However, standard compatibility test shall be completed promptly. If discrepancy inthe result is noted, the concerned clinician shall be informed immediately.

Recipient whose ABO and Rh(O) type has been determined shall receive ABO andRh(O) specific blood group whole blood or red cells before the tests forcompatibility have been completed.

Under such circumstances, recipients whose ABO and Rh(O) type is not knownshall receive red cells of group 0 Rh(O) negative if available, otherwise 0 Rh(O)positive blood shall be used.


6.7.4.3 Urgent requirement of blood

6.7.4.4 Selection of blood and components for transfusionWhole blood, red cell component

7/29/2019 N A B H.PDF

47/92


incompatible concentrate is in use (e.g. use of '0 ' group to 'B' group patienVrecipient).Granulocyte concentrateleucocyte concentrate shall beABO and Rh(O) type specific or compatible with therecipient blood.

6.7.4.5 Massive transfusionWhen an amount of blood equal to or greater than recipient's total blood volume istransfused within 24 hours, a fresh blood sample shall be used after active bleedingis controlled for cross-match at the time of subsequent transfusion of blood.Component therapy shall be actively considered in these cases.

6.7.4.6 NeonatesFor ABO grouping of neonates only cell grouping with anti-A, anti-B and anti-ABsera shall be required.Serum of the mother shall be tested for unexpected antibody(ies).In the management of haemolytic disease of the newborn it is preferable to usemother's serum for the cross matching. In absence of mother's serum, child'sserum s h ~ 1 I be used for compatibility testing.Neonatal recipient shall not be transfused with whole bloodl plasmal componentcontaining clinically significant antibodies.For exchange transfusion or in hypoxic condition, it is reGommended that the bloodis screened for haemoglobin S if possible.Paediatric blood collection bags are available and are pn:lferable for use.MUltiple blood bags shall be used to make one aliquot for adult and one forpaediatric transfusion.Blood preferably within 72 hours of collection, but not exceeding 5 days, shall beused for exchange transfusion.

6.7.5 Records of recipient Blood requisition form with full particulars of recipient and identificationnumber. Results ofABO and Rh (D) tests and their int

Documents

N A B H.PDF