CAN CSA-Z900 2 3-2012 Perfusable organs for transplantation (Second Edition).pdf

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1、CAN/CSA-Z900.2.3-12A National Standard of CanadaPerfusable organs for transplantationLegal 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 brin

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18、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 remains the responsibility of

19、 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 Standard of CanadaPublished in D

20、ecember 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-Z900.2.3-12Perfusable organs for transplantationPrepared byISBN 978-1-77139-009-5 2012 CSA Gr

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

22、ublications 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 2012 CSA Group Perfusable organs for transplantationTechnical Committee on Safety of Cells, Tissues,

23、 and Organs for Transplantation, and Assisted Reproduction viiSubcommittee on Perfusable Organs ixPreface x1Scope12 Reference publications 23 Definitions and abbreviations 23.1 Definitions 23.2 Abbreviations 34 Establishment requirements 34.1 Establishment identity 34.1.1 General 34.1.2 Organ donati

24、on organization 34.1.3 Transplant programs 34.1.4 Histocompatibility laboratory 34.2 Personnel 44.2.1 General 44.2.2 Training 44.2.3 Medical director or director 44.2.4 Transplant physicians and surgeons 44.2.5 Donor coordinator 54.2.6 Recipient coordinator 64.3 Quality management 75 Facilities 75.1

25、 General 75.1.1 Application 75.1.2 Organ donation organization 75.1.3 Transplant program 75.2 Security 75.3 Equipment 85.3.1 General 85.3.2 Refrigerators and freezers 85.4 Communication 85.5 Inpatient facilities 85.6 Outpatient facilities 86 Standard operating procedures 87 Records and tracking 97.1

26、 General 97.2 Donor identification 97.2.1 General 97.2.2 Donor information 97.3 Recordkeeping 9CAN/CSA-Z900.2.3-12 2012 CSA Groupiv December 20127.3.1 General 97.3.2 Documentation 97.3.3 Mandatory information 97.3.4 Donor chart 107.3.5 Recipient records 107.4 Tracking 107.4.1 General 107.4.2 Registr

27、ation of transplantation information 117.4.3 Transmission 118 Infection control and safety 119 Disposal of organs 119.1 General 119.2 Human remains 119.3 Documentation 1110 Consent 1110.1 General 1110.2 Predonation counselling 1210.3 Basis of consent 1210.4 Medical examiner and coroner cases 1210.5

28、Living donors 1211 Compensation 1312 Donor suitability assessment 1312.1 General 1312.2 Suitability of donors 1312.2.1 General 1312.2.2 History 1312.2.3 Assessment of living donors 1412.3 Documentation 1513 Donor screening 1513.1 Contraindications or exclusion criteria 1513.1.1 General 1513.1.2 Addi

29、tional criteria 1513.1.3 Exceptional distribution 1613.2 Physical examination 1613.2.1 General 1613.2.2 Clinical procedures 1613.2.3 Documentation 1613.2.4 Intraoperative assessment 1613.3 Release 1614 Testing 1714.1 General 1714.2 Laboratory testing 1714.2.1 Infectious disease testing 1714.2.2 Bloo

30、d tests 1714.2.3 Confirmatory or supplemental tests 1714.2.4 Donor re-entry 1714.2.5 Notification 17 2012 CSA Group Perfusable organs for transplantationDecember 2012 v14.2.6 Minimum testing for infectious diseases 1714.2.7 Blood typing 1814.2.8 Plasma dilution 1814.2.9 Archived samples 1814.3 Other

31、 testing 1914.3.1 Histocompatibility laboratory 1914.3.2 Additional testing for specific types of organ donation 1915 Retrieval, processing, preservation, and storage 2015.1 General 2015.2 Reagents and supplies 2015.3 Retrieval 2015.3.1 General 2015.3.2 Organ donation organization 2015.3.3 Donor con

32、sideration 2115.3.4 Neurological determination of death 2115.3.5 Cardiocirculatory death 2115.3.6 Donor team transportation 2215.3.7 Transplant surgeons 2215.3.8 Living donor operation and post-operative management 2215.4 Processing and preservation 2215.5 Pooling 2315.6 Packaging and storage 2315.7

33、 Disposition of donors body 2415.8 Medical examiner and coroner cases 2416 Labels, inserts, and accompanying documentation 2416.1 General 2416.2 Documentation 2416.3 Information requirements 2416.3.1 General 2416.3.2 Labels 2416.3.3 Inserts 2516.3.4 Donor confidentiality 2516.3.5 Verification of pac

34、kaging, labels, and package inserts 2516.3.6 Documentation for future tracking 2517 Quarantine and release 2517.1 General 2517.2 Living donor quarantine 2518 Distribution 2618.1 General 2618.2 Transportation 2618.3 Organ allocation, offering, and acceptance 2618.3.1 Organ allocation 2618.3.2 Organ o

35、ffering 2718.3.3 Acceptance of organ offering 2718.4 Receiver of organs 2818.4.1 General 2818.4.2 Release to an organ donation organization 2818.4.3 Release to a transplant program 2818.5 Recipient consideration 2918.5.1 Referral of potential recipient 29CAN/CSA-Z900.2.3-12 2012 CSA Groupvi December

36、 201218.5.2 Assessment of potential recipient 2918.5.3 Listing of future recipients 2918.5.4 Recipient notification/preparation 3018.6 Organ assessment and transplantation 3018.7 Exceptional distribution 3118.8 Organs for medical research 3219 Error, accident, and adverse reaction investigation and

37、recall 3219.1 General 3219.2 Investigation, notification, and reporting 3219.3 Recall 3320 Continuous improvement 33Tables1 Mandatory information to be maintained and collected by the organ donation organization 332 Mandatory information to be maintained and collected by the transplant program 34 20

38、12 CSA Group Perfusable organs for transplantationDecember 2012 viiTechnical 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, OntarioVi

39、ce-ChairH. Messner The Princess Margaret 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 Cen

40、tre, Montral, QubecRepresenting the 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 Qu

41、een Elizabeth II Health Sciences Centre,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 I

42、nfectious Disease Canada (AMMI)M. Larivire Transplant Qubec, Montral, QubecCAN/CSA-Z900.2.3-12 2012 CSA Groupviii December 2012A. Leader Ottawa Fertility Centre, Ottawa, OntarioR. Lundrigan Kidney Foundation of Canada,Spaniards Bay, Newfoundland and LabradorConsumer RepresentativeAssociateG. Nayeri

43、Health Canada, 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. Re

44、nnie University of Alberta Hospital, Edmonton, AlbertaLiaison representing the CSA TC Z252 and the Canadian Advisory Committee to ISO/TC 212AssociateG. Rocha GRMC Vision Centre, Brandon, ManitobaK. Young Canadian Blood Services, Edmonton, AlbertaJ. Kraegel CSA Group,Mississauga, OntarioProject Manag

45、er 2012 CSA Group Perfusable organs for transplantationDecember 2012 ixSubcommittee on Perfusable OrgansK. Peltekian Queen Elizabeth II Health Sciences Centre,Halifax, Nova ScotiaChairF. Agbanyo Health Canada, Centre for Blood and Tissues Evaluation,Ottawa, OntarioC. Beninger Southern Alberta Organ

46、and Tissue Program,Calgary, AlbertaRepresenting the Canadian Society of TransplantationM.P. Carrier Transplant Qubec,Montral, QubecP. Chaudhury McGill University Health Centre, Montreal, QubecRepresenting the Canadian Society for TransplantationJ. Drew London Health Sciences Centre,London, OntarioL.

47、A. Gillham-Eisen Health Canada, Office of Policy and International Collaboration,Ottawa, OntarioJ. Hanright Trillium Gift of Life Network, Toronto, OntarioR. Lundrigan Kidney Foundation of Canada,Spaniards Bay, Newfoundland and LabradorConsumer RepresentativeJ. Preiksaitis University of Alberta Hosp

48、ital,Edmonton, OntarioL. Rehel Transplant Qubec,Montral, QubecK. Young Canadian Blood Services, Edmonton, AlbertaJ. Kraegel CSA Group,Mississauga, OntarioProject ManagerCAN/CSA-Z900.2.3-12 2012 CSA Groupx December 2012PrefaceThis is the second edition of CAN/CSA-Z900.2.3, Perfusable organs for trans

49、plantation. 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. It was developed from work initiated by Health Canadas Expert Working Group on Safety of Organs and Tissues for Transplantation. This Stand