CAN CSA-Z900 2 5-2012 Lymphohematopoietic cells for transplantation (Second Edition Update No 1 April 2013).pdf

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1、CAN/CSA-Z900.2.5-12A National Standard of CanadaLymphohematopoietic cells for transplantationUPDATED APRIL 2013Legal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of

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18、ards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it rem

19、ains the responsibility of the users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”Approved byStandards Council of CanadaTMA trade-mark of the Canadian Standards Association, operating as “CSA Group”National Standa

20、rd of CanadaPublished in December 2012 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caCAN/CSA-Z900.2.5-12Lymphohematopoietic cells for transplantationPrepared by

21、ISBN 978-1-55491-940-6 2012 CSA Group. Updated April 2013.All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.100%To purchase standards and related publications, visit our Online Store at shop.csa.ca or call toll-fre

22、e 1-800-463-6727 or 416-747-4044.CSA Group prints its publications on Rolland Enviro100, which contains 100% recycled post-consumer fibre, is EcoLogo and Processed Chlorine Free certified, and was manufactured using biogas energy. 2012 CSA Group Lymphohematopoietic cells for transplantationDecember

23、2012ContentsTechnical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction viSubcommittee on Lymphohematopoietic Cells viiiPreface ix0Introduction 11Scope 12 Reference publications 23 Definitions and abbreviations 33.1 Definitions 33.2 Abbreviations 44 Esta

24、blishment requirements 54.1 Establishment identity 54.2 Personnel 54.2.1 General 54.2.2 Training 74.2.3 Medical director 84.3 Quality management 94.3.1 General 94.3.2 Clinical transplant program 104.3.3 Collection facility 104.3.4 Cell processing facility 105 Facilities 105.1 General 105.2 Security

25、105.3 Equipment 105.4 Additional requirements 115.4.1 Clinical program 115.4.2 Collection facility 115.4.3 Cell processing facility 126 Standard operating procedures 126.1 General 126.2 Format 126.3 Content 126.3.1 General 126.3.2 Clinical transplant program 137 Records and tracking 137.1 General 13

26、7.2 Donor identification 137.3 Recordkeeping 137.3.1 General 137.3.2 Clinical program 13iiiCAN/CSA-Z900.2.5-12 2012 CSA Groupiv December 20127.3.3 Collection facility 147.3.4 Cell processing facility 147.4 Tracking 148 Infection control and safety 149 Disposal of lymphohematopoietic cells 1510 Conse

27、nt 1510.1 General 1510.2 Predonation counselling 1610.3 Basis of consent 1611 Compensation 1712 Donor suitability assessment 1712.1 General 1712.2 Suitability of donors 1712.2.1 All donors (allogeneic and autologous) 1712.2.2 Allogeneic donors 1712.2.3 Autologous donors 1912.2.4 Special consideratio

28、ns 2012.3 Documentation 2113 Donor screening 2113.1 Contraindications or exclusion criteria 2113.2 Physical examination 2213.3 Autologous cord blood donors 2214 Testing 2214.1 General 2214.2 Laboratory testing 2314.2.1 General 2314.2.2 Notification 2314.2.3 Minimum testing for infectious diseases 23

29、14.2.4 Plasma dilution 2314.2.5 Archived samples 2315 Collection, processing, preservation, and storage 2315.1 General 2315.2 Reagents and supplies 2315.3 Collection 2415.4 Processing and preservation 2515.5 Pooling 2515.6 Packaging material and storage 2516 Labels, package inserts, and accompanying

30、 documentation 2516.1 General 2516.2 Documentation 2616.3 Information requirements 2616.3.1 General 2616.3.2 Confidentiality 2616.3.3 Labelling at the end of collection 26 2012 CSA Group Lymphohematopoietic cells for transplantationDecember 2012 v17 Quarantine and release 2618 Distribution 2718.1 Ge

31、neral 2718.2 Transportation 2718.3 Receiver of lymphohematopoietic cells 2718.4 Exceptional distribution 2719 Error, accident, and adverse reaction investigation and reporting 2819.1 General 2819.2 Investigation, notification, and reporting 2819.3 Recall 2820 Continuous improvement 28CAN/CSA-Z900.2.

32、5-12 2012 CSA Groupvi December 2012Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted ReproductionM. Germain Hma-Qubec,Sainte-Foy, QubecChairF. Agbanyo Health Canada, Centre for Blood and Tissues Evaluation,Ottawa, OntarioVice-ChairH. Messner The Princess Ma

33、rgaret Hospital, Toronto, OntarioVice-ChairC. Beninger Southern Alberta Organ and Tissue Program,Calgary, AlbertaRepresenting the Canadian Society of TransplantationJ. Biemans Canadian Blood Services,Ottawa, OntarioAssociateP. Chaudhury McGill University Health Centre,Montreal, QubecRepresenting the

34、 Canadian Society of TransplantationAssociateM. Fortin Hpital Notre Dame du Centre Hospitalier Universit de Montral,Montral, QubecRepresenting BioethicistsL.A. Gillham-Eisen Health Canada,Office of Policy and International Collaboration,Ottawa, OntarioM. Gross Queen Elizabeth II Health Sciences Cent

35、re,Halifax, Nova ScotiaJ. Hanright Trillium Gift of Life Network,Toronto, OntarioY. Jalbert Ministre de la Sant et des Services Sociaux (MSSS),Qubec, QubecD. Kumar University of Alberta, Edmonton, AlbertaRepresenting the Association of Medical Microbiology and Infectious Disease Canada (AMMI) 2012 C

36、SA Group Lymphohematopoietic cells for transplantationDecember 2012 viiM. Larivire Transplant Qubec, Montral, QubecA. Leader Ottawa Fertility Centre, Ottawa, OntarioR. Lundrigan Kidney Foundation of Canada,Spaniards Bay, Newfoundland and LabradorConsumer RepresentativeAssociateG. Nayeri Health Canad

37、a,Health Products and Food Branch,Ottawa, OntarioK. Peltekian Queen Elizabeth II Health Sciences Centre,Halifax, Nova ScotiaAssociateK. Reinhard Health Canada,Assisted Human Reproduction Implementation Office,Ottawa, OntarioAssociateS. Rmy Hma-Qubec, Saint-Laurent, QubecAssociateR. Rennie University

38、 of Alberta Hospital, Edmonton, AlbertaLiaison representing the CSA TC Z252 and the Canadian Advisory Committee to ISO/TC212AssociateG. Rocha GRMC Vision Centre, Brandon, ManitobaK. Young Canadian Blood Services, Edmonton, AlbertaJ. Kraegel CSA Group,Mississauga, OntarioProject ManagerCAN/CSA-Z900.2

39、.5-12 2012 CSA GroupDecember 2012Subcommittee on Lymphohematopoietic CellsH. Messner The Princess Margaret Hospital,Toronto, OntarioRepresenting CBMTGChairF. Agbanyo Health Canada, Centre for Blood and Tissues Evaluation,Ottawa, OntarioE. Brindle Insception Biosciences,Mississauga, OntarioM. Champag

40、ne Hpital de Verdun,Verdun, QubecL.A. Gillham-Eisen Health Canada, Office of Policy and International CollaborationOttawa, OntarioA. Lebrun Hma-Qubec,St-Laurent, QubecL. Martin Canadian Blood Services,Ottawa, OntarioS. McDiarmid The Ottawa Hospital,Ottawa, OntarioS. Smith Canadian Blood Services,Hal

41、ifax, Nova ScotiaD. Wall University of Manitoba/Cancer Care Manitoba,Winnipeg, ManitobaJ. Kraegel CSA Group,Mississauga, OntarioProject Managerviii 2012 CSA Group Lymphohematopoietic cells for transplantationDecember 2012 ixPrefaceThis is the second edition of CAN/CSA-Z900.2.5, Lymphohematopoietic c

42、ells for transplantation. It supersedes the first edition published in 2003.This Standard is part of a series of management system standards related to the safety of cells, tissues, and organs for transplantation and assisted reproduction. This Standard was developed from work initiated by Health Ca

43、nadas Expert Working Group on Safety of Organs and Tissues for Transplantation.CSA Group gratefully acknowledges the International Netcord Foundation and the Foundation for the Accreditation of Cellular Therapy (FACT) for providing copyright permission to use the NetCord-FACT International Standards

44、 for Cord Blood Collection, Banking and Release for Administration in developing this Standard. This Standard was prepared by the Subcommittee on Lymphohematopoietic Cells, under the jurisdiction of the Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Repr

45、oduction and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.Notes: (1) Use of the singular does not exclude the plural (and vice

46、 versa) when the sense allows.(2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.(3) This Standard was developed by consen

47、sus, which is defined by CSA Policy governing standardization Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included in the Technical

48、Committee list and yet not be in full agreement with all clauses of this Standard.(4) To submit a request for interpretation of this Standard, please send the following information to inquiriescsagroup.org and include “Request for interpretation” in the subject line:(a) define the problem, making re

49、ference to the specific clause, and, where appropriate, include an illustrative sketch;(b) provide an explanation of circumstances surrounding the actual field condition; and(c) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and gu