CAN CSA-Z900 2 1-2012 Tissues for assisted reproduction (Second Edition).pdf

1、CAN/CSA-Z900.2.1-12A National Standard of CanadaTissues for assisted reproductionLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings t

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20、 Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caCAN/CSA-Z900.2.1-12Tissues for assisted reproductionApproved byStandards Council of CanadaTMA trade-mark of the Canadian Standards Association, operating as “CSA Group”Prepared byISBN 978-1-77139-041-5 2012 CSA GroupAll r

21、ights 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-free 1-800-463-6727 or 416-747-4044.CSA Group prints its publicati

22、ons 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 Canadian Standards Association Tissues for assisted reproductionTechnical Committee on Safety of Cells, Tiss

23、ues, and Organs for Transplantation and Assisted Reproduction viSubcommittee on Reproductive Tissues viiiPreface ix0Introduction11Scope12 Reference publications 33 Definitions and abbreviations 43.1 Definitions 43.2 Abbreviations 94 Establishment requirements 104.1 Establishment identity 104.2 Perso

24、nnel 104.2.1 General 104.2.2 Training 114.2.3 Medical director 114.2.4 Medical consultants and medical director designates 124.3 Quality management 124.3.1 Quality assurance system 124.3.2 Quality control 134.3.3 Process control 134.3.4 Investigations 144.3.5 Internal audits 144.3.6 Personnel traini

25、ng 155 Facilities 165.1 General 165.2 Security 165.3 Equipment 176 Standard operating procedures 186.1 General 186.2 Format 186.3 Content 186.3.1 Facilities, equipment, and personnel 186.3.2 Donor selection 196.3.3 Activities related to reproductive tissues 196.4 Approvals and reviews 196.5 Extra co

26、pies 206.6 Archives 207 Records and tracking 207.1 General 207.2 Donor identification 21CAN/CSA-Z900.2.1-12 Canadian Standards Associationiv December 20127.3 Recordkeeping requirements 217.4 Tracking requirements 228 Infection control and safety 238.1 Safety procedures 238.2 Universal precautions 23

27、8.3 Personnel immunization 249 Disposal of tissues for assisted reproduction 249.1 General 249.2 Documentation 2410 Consent 2410.1 General 2410.2 Predonation counselling 2410.3 Basis of consent 2510.4 Documentation 2611 Compensation 2612 Donor suitability assessment 2612.1 General 2612.1.1 Rationale

28、 2612.1.2 Procedures 2712.1.3 Questionnaires 2712.2 Suitability of donors 2712.2.1 Basis of donor suitability assessment 2712.2.2 Recruitment 2712.2.3 Required elements for donor selection 2712.3 Documentation 2812.3.1 General 2812.3.2 Documentation of donor consent 2813 Donor screening 2913.1 Contr

29、aindications or exclusion criteria 2913.1.1 General 2913.1.2 Anonymous donors 2913.1.3 Exemptions for directed reproductive donors 3013.2 Physical examination 3113.3 Semen evaluation 3113.4 Genetic history and testing 3114 Testing 3214.1 General 3214.2 Infectious disease testing 3214.2.1 General 321

30、4.2.2 Serological Test kits 3314.2.3 Microbiological testing for Chlamydia trachomatis and Neisseria gonorrhoeae 3314.2.4 Test results 3414.2.5 Confirmatory or supplemental tests 3414.2.6 Donor re-entry 3414.2.7 Notification 3514.2.8 Serological testing for infectious diseases Preliminary tests 3514

31、.2.9 Blood typing 35 Canadian Standards Association Tissues for assisted reproductionDecember 2012 v14.2.10 Archived serum samples 3614.3 Other tests 3614.3.1 Microbiological testing 3614.3.2 Repeat serological testing recommended for early detection of infection 3715 Retrieval, preparation, preserv

32、ation, and storage 3715.1 General 3715.2 Reagents and supplies 3715.3 Retrieval 3815.4 Preparation and preservation 3815.5 Pooling 3915.6 Packaging, containers, and storage 3916 Labels, inserts, and accompanying documentation 4116.1 General 4116.2 Exterior packages 4116.3 Documentation 4216.4 Inform

33、ation requirements 4216.5 Donor confidentiality 4317 Quarantine and release 4317.1 General 4317.2 Repeat screening and serological testing prior to distribution 4317.2.1 General 4317.2.2 Quarantine period 4317.2.3 Repeat screening and testing 4317.2.4 Exemptions for surrogate mothers/gestational car

34、riers for directed reproductive donation 4417.2.5 Orphaned embryos 4417.3 Release of reproductive tissues 4417.3.1 Medical director review of donor suitability 4417.3.2 Technical review for safety and quality 4417.3.3 Computer release of reproductive tissue donations 4517.3.4 Release under exception

35、al distribution 4517.3.5 Release of reproductive tissues processed prior to the publication date of this Standard 4518 Distribution 4618.1 General 4618.2 Transportation 4718.3 Receiver of reproductive tissues 4718.4 Exceptional distribution 4818.5 Release of reproductive tissues not intended for use

36、 in an AHR procedure 4819 Adverse event monitoring and recalls 4919.1 General 4919.2 Investigation, notification, and reporting 4919.3 Recall and stop distribution 51CAN/CSA-Z900.2.1-12 2012 CSA Groupvi December 2012Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and

37、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 Southern Alberta Organ and Tissue Program,Calgary, AlbertaRepres

38、enting the Canadian Society of TransplantationJ. Biemans Canadian Blood Services, Ottawa, OntarioAssociateP. Chaudhury McGill University Health Centre, Montreal, QubecRepresenting the Canadian Society of TransplantationAssociateM. Fortin Hpital Notre Dame du Centre Hospitalier Universit de Montral,M

39、ontral, QubecRepresenting BioethicistsL.A. Gilham-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 Network, Toronto, OntarioY. Jalbert Ministre de la Sant et d

40、es Services Sociaux (MSSS),Qubec, QubecD. Kumar University of Alberta, Edmonton, AlbertaRepresenting the Association of Medical Microbiology and Infections Disease Canada (AMMI)M. Larivire Qubec-Transplant, Montral, Qubec 2012 CSA Group Tissues for assisted reproductionDecember 2012 viiA. Leader Ott

41、awa Fertility Centre, Ottawa, OntarioR. Lundrigan Kidney Foundation of Canada, Spaniards Bay, Newfoundland and LabradorConsumer representativeAssociateG. Nayeri Health Canada, Health Products and Food Branch,Ottawa, OntarioK. Peltekian Queen Elizabeth II Health Sciences Centre,Halifax, Nova ScotiaAs

42、sociateK. Reinhard Health Canada,Assisted Human Reproduction Implementation Office,Ottawa, OntarioAssociateS. Rmy Hma-Qubec, Saint-Laurent, QubecAssociateR. Rennie University of Alberta Hospital, Edmonton, AlbertaLiaison representing the CSA TC Z252 and the Canadian Advisory Committee to ISO/TC 212A

43、ssociateG. Rocha GRMC Vision Centre, Brandon, ManitobaK. Young Canadian Blood Services, Edmonton, AlbertaJ. Kraegel CSA Group,Mississauga, OntarioProject ManagerCAN/CSA-Z900.2.1-12 2012 CSA Groupviii December 2012Subcommittee on Reproductive TissuesA. Leader Ottawa Fertility Centre,Ottawa, Ontario C

44、hairF. Agbanyo Health Canada,Centre for Blood and Tissues Evaluation,Ottawa, OntarioH. Brooks Outreach Health Services Inc.,Newmarket, OntarioC. Greene Regional Fertility Program,Calgary, AlbertaM. Gysler The Credit Valley Hospital,Mississauga, OntarioS. Hamilton ISIS Regional Fertility Centre,Missi

45、ssauga, OntarioM.C. Lveill Ottawa Fertility Centre,Ottawa, OntarioD. Mortimer Oozoa Biomedical,West Vancouver, British ColumbiaH. Quesnel Health Canada,Ottawa, OntarioK. Reinhard Health Canada,Assisted Human Reproduction Implementation Office,Ottawa, OntarioI. Ryll Edmonton, AlbertaConsumer represen

46、tativeJ. Kraegel CSA Group,Mississauga, Ontario Project Manager 2012 CSA Group Tissues for assisted reproductionDecember 2012 ixPrefaceThis is the second edition of CAN/CSA-Z900.2.1, Tissues for assisted reproduction. It supersedes the first edition, published in 2003. The previous edition of this S

47、tandard was directly linked to CAN/CSA-Z900.1, in that it contained only the reproductive tissue-specific requirements and referred to CAN/CSA-Z900.1 for all other requirements. The current edition is a stand-alone document in which the relevant content from CAN/CSA-Z900.1 has been incorporated, and

48、 adapted as necessary, to apply to reproductive tissues.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; it was developed from work initiated by Health Canadas Expert Working Group on S

49、afety of Organs and Tissues for Transplantation.This Standard is a dynamic document, and 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.This Standard was prepared by the Subcommittee on Reproductive Tissues, under the jurisdiction of the Technical Committee on Safety of Cell