CAN CSA-Z900 1-2012 Cells tissues and organs for transplantation General requirements (Second Edition Update 1 April 2013).pdf

1、CAN/CSA-Z900.1-12A National Standard of CanadaCells, tissues, and organs for transplantation: General requirementsUPDATED APRIL 2013Legal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the

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18、rds as National Standards 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 importa

19、ntto note that it remains 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

20、Group”National Standard 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-Z900.1-12Cells, tissues, and organs for transp

21、lantation: General requirementsPrepared byISBN 978-1-55491-819-5 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 On

22、line Store at shop.csa.ca or call toll-free 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.December 2012 iiiContents 20

23、12 CSA Group Cells, tissues, and organs for transplantation: General requirementsTechnical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction viPreface viii1Scope 12 Reference publications 23 Definitions and abbreviations 43.1 Definitions 43.2 Abbreviatio

24、ns 84 Establishment requirements 94.1 Establishment identity 94.2 Personnel 94.2.1 General 94.2.2 Training 104.2.3 Medical and scientific directors 104.3 Quality management 114.3.1 Quality assurance system 114.3.2 Quality control 124.3.3 Process control 124.3.4 Audits 134.3.5 Investigations 134.3.6

25、Personnel training 145 Facilities 145.1 General 145.2 Security 155.3 Equipment 156 Standard operating procedures 166.1 General 166.2 Format 166.3 Content 176.3.1 Facilities, equipment, and personnel 176.3.2 Donor selection 176.3.3 Activities related to cells, tissues, and organs 176.4 Approvals and

26、reviews 186.5 Extra copies 186.6 Archives 187 Records and tracking 187.1 General 187.2 Donor identification 197.3 Recordkeeping 197.4 Tracking 208 Infection control and safety 218.1 Safety procedures 21CAN/CSA-Z900.1-12 2012 CSA Groupiv December 20128.2 Universal precautions 218.3 Personnel immuniza

27、tion 219 Disposal of cells, tissues, and organs 229.1 General 229.2 Human remains 229.3 Documentation 2210 Consent 2210.1 General 2210.2 Predonation counselling 2210.3 Basis of consent 2210.3.1 General 2210.3.2 Information 2210.3.3 Documentation 2310.4 Medical examiner and coroner cases 2311 Compens

28、ation 2312 Donor suitability assessment 2312.1 General 2312.2 Suitability of donors 2312.3 Documentation 2412.4 Documentation of donor consent 2413 Donor screening 2413.1 Contraindications or exclusion criteria 2413.2 Physical examination 2514 Testing 2514.1 General 2514.2 Laboratory testing 2614.2.

29、1 Infectious disease testing 2614.2.2 Blood tests 2614.2.3 Confirmatory or supplemental tests 2614.2.4 Donor re-entry 2714.2.5 Notification 2714.2.6 Minimum testing for infectious diseases 2714.2.7 Blood typing 2814.2.8 Plasma dilution 2814.2.9 Archived samples 2814.3 Other testing 2815 Retrieval, p

30、reparation, preservation, and storage 2815.1 General 2815.2 Reagents and supplies 2915.3 Retrieval 2915.4 Preparation and preservation 2915.5 Pooling 3015.6 Packaging and storage 3016 Labels, inserts, and accompanying documentation 3116.1 General 3116.2 Documentation 31 2012 CSA Group Cells, tissues

31、, and organs for transplantation: General requirementsDecember 2012 v16.3 Information requirements 3216.3.1 General 3216.3.2 Donor confidentiality 3216.3.3 Autologous donations 3216.3.4 Labelling for exceptional distribution 3217 Quarantine and release 3217.1 General 3217.2 Living donor quarantine 3

32、318 Distribution 3318.1 General 3318.2 Transportation 3318.3 Receiver of cells, tissues, and organs 3418.4 Exceptional distribution 3518.5 Release of cells, tissues, and organs not intended for transplantation 3519 Error, accident, and adverse reaction investigation and reporting 3619.1 General 3619

33、.2 Investigation, notification, and reporting 3619.3 Recall 3820 Continuous improvement 38AnnexesA (informative) Developmental background and history of the CSA general requirements standard andits subsets 40B (informative) Ethics: Cells, tissues, and organs for transplantation 43C (normative) Label

34、ling requirements 49D Placeholder 58E (normative) Factors and behaviours associated with a higher risk of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) 59F (informative) Bibliography 61CAN/CSA-Z900.1-12 2012 CSA Groupvi December 2012Technical Committee on S

35、afety 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 Margaret Hospital, Toronto, OntarioVice-ChairC. Beninger Sou

36、thern Alberta Organ and Tissue Program,Calgary, AlbertaRepresenting the Canadian Society of TransplantationJ. Biemans Canadian Blood Services,Ottawa, OntarioAssociateP. Chaudhury McGill University Health Centre, Montral, QubecRepresenting the Canadian Society of TransplantationAssociateM. Fortin Hpi

37、tal 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 Centre,Halifax, Nova ScotiaJ. Hanright Trillium Gift of Life N

38、etwork, 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 CSA Group Cells, tissues, and organs for transplantation:

39、General requirementsDecember 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 Canada, Health Products and Food Branch

40、,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 of Alberta Hospital, Edmonton, A

41、lbertaLiaison 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-Z900.1-12 2012 CSA Groupviii December

42、2012PrefaceThis is the second edition of CAN/CSA-Z900.1, Cells, tissues, and organs for transplantation: General requirements. It supersedes the first edition published in in 2003. This Standard and its subset standards (which contain requirements for specific types of cells, tissues, and organs) ar

43、e part of a series of management system standards and were developed from the work initiated by Health Canadas Expert Working Group on Safety of Organs and Tissues for Transplantation. See Annex A. The principle of equal consideration of cells, tissues, and organs used for transplantation has been f

44、undamental to the development of this Standard and its specific subsets, i.e., members of the Technical Committee with expertise in tissues, perfusable organs, ocular tissues, and lymphohematopoietic cells have an equal say in the development of the Standards. This Standard is a dynamic document, an

45、d while it is intended to reflect current scientific knowledge, it does not obviate the need for users to be aware of state-of-the-art developments. Establishments are encouraged to submit suggestions for changes to this Standard during its lifetime as needed, e.g., to reflect scientific advances or

46、 to respond to emerging diseases.Ethical considerations associated with the transplantation of cells, tissues, and organs are outlined in Annex B. It is acknowledged that donated cells, tissues, and organs are made available by individuals as an altruistic contribution to society.This Standard was p

47、repared by the Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as

48、 a National Standard of Canada by the Standards Council of Canada.Notes: (1) Use of the singular does not exclude the plural (and vice 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 respo

49、nsibility of the users of the Standard to judge its suitability for their particular purpose.(3) This Standard was developed by consensus, 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