CAN CSA-Z900 2 2-2012 Tissues for transplantation (Second Edition Update No 1 November 2013).pdf

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1、CAN/CSA-Z900.2.2-12A National Standard of CanadaTissues 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 brings togethe

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14、ch patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA Group for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:sLOADTHISDOCUMENTON

15、TOACOMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$(ii) Clostridium; and(iii) Streptococcus pyogenes (group A strep.); and(b) for skin tissue:(i) Staphylococcus aureus;(ii) Streptococcus pyogenes (group A strep.);(iii) Enterococcus sp.;(iv) gram negat

16、ive bacilli;(v) Clostridium; and(vi) fungi (yeasts, moulds).14.3.2.3 Blood cultures14.3.2.3.1 The results of any blood cultures performed shall be documented in the donor record and the medical director shall assess the suitability of the donation. 14.3.2.3.2 The protocol for blood cultures shall be

17、 documented in the SOP manual.14.3.2.4 Transplantation prior to receipt of culture resultsIn situations where tissue transplantation is performed for medical reasons before culture results are available (e.g., fresh osteochondral allografts, which, because of tissue viability issues, must be transpl

18、anted promptly), the culture results shall be forwarded to the transplanting physician as soon as they become available and these results shall be documented in the donor record.The tissue bank shall document the established protocol in its SOPs.14.3.2.5 Evaluation of data14.3.2.5.1 The medical dire

19、ctor or designate shall review the results of all cultures for each tissue. Evaluation of the safety of that tissue shall be determined before the tissue is released for transplantation. The medical director or designate shall document the suitability of a tissue donor before tissues are released. 1

20、4.3.2.5.2 Tissues failing to meet the suitability criteria outlined in the SOP manual shall not be used.14.3.2.5.3 The criteria used for evaluating culture results shall be documented in the SOP manual.9(Replaces p. 9, December 2012)CAN/CSA-Z900.2.2-12 2012 CSA GroupNovember 201314.3.2.6 Repeated mi

21、crobial testing 14.3.2.6.1 For each preparation step in which tissue is unwrapped and rewrapped, a bacteriological culture shall be taken to rule out contamination during the procedure, unless the tissue is processed using a validated sterilization method. Any occurrence of contamination shall be do

22、cumented in the donor record.14.3.2.6.2 The protocol for microbial testing shall be documented in the SOP manual.14.3.2.7 Bacteriological quality control testing prior to release for transplant14.3.2.7.1 Representative microbiological cultures shall be obtained for all tissues to be released for hum

23、an transplantation, unless the release is based on sterilization parameters having been met in accordance with a validated process. The results of aerobic and anaerobic cultures shall be documented in the donor record.14.3.2.7.2 The medical director or designate shall evaluate the data specified in

24、Clause 14.3.2.7.1 before tissue is released for transplantation.14.3.2.7.3 If final culture results are positive, the tissue shall be discarded, except for skin tissue where the culture results identify normal skin flora. 14.3.2.8 Bacteriological testing at time of transplantation14.3.2.8.1 In the a

25、bsence of a bioburden reduction protocol (as defined by the tissue bank), swab cultures or sterile biopsies of each tissue shall be taken immediately upon unwrapping the tissue in the operating room at the time of transplantation. Where cultures are performed, aerobic and anaerobic culture results s

26、hall be forwarded for placement in the recipients medical record. If positive culture results are obtained, these shall be forwarded to the source establishment.14.3.2.8.2 The protocol for bacteriological testing at the time of transplantation shall be documented in the SOP manual.15 Retrieval, prep

27、aration, preservation, and storage15.1 GeneralThe requirements specified in Clause 15.1 of CAN/CSA-Z900.1 shall apply in this Standard.15.2 Reagents and suppliesThe requirements specified in Clause 15.2 of CAN/CSA-Z900.1 shall apply in this Standard.(Replaces p. 10, December 2012)10Standards Update

28、ServiceCAN/CSA-Z900.2.2-12December 2012Title:Tissues for transplantationPagination:24 pages (viii preliminary and 16 text), each dated December 2012To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to r

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44、rpose.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 December 2012 by CSA GroupA not-for-profit private sector or

45、ganization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caCAN/CSA-Z900.2.2-12Tissues for transplantationPrepared byISBN 978-1-77139-008-8 2012 CSA GroupAll rights reserved. No part of this publication may be reproduced

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47、nsumer fibre, is EcoLogo and Processed Chlorine Free certified, and was manufactured using biogas energy.December 2012 iiiContents 2012 CSA Group Tissues for transplantationTechnical Committee on Safety of Cells, Tissues, and Organs for Transplantation, and Assisted Reproduction vSubcommittee on Tis

48、sues viiPreface viii1Scope12 Reference publications 23 Definitions and abbreviations 23.1 Definitions 23.2 Abbreviations 34 Establishment requirements 34.1 Establishment identity 34.2 Personnel 34.2.1 General 34.2.2 Medical director 34.3 Quality management 35 Facilities 36 Standard operating procedu

49、res 36.1 General 36.2 Format 36.3 Content 36.4 Approvals and reviews 46.5 Extra copies 46.6 Archives 47 Records and tracking 47.1 General 47.2 Donor identification 47.3 Recordkeeping requirements 47.4 Tracking requirements 48 Infection control and safety 49 Disposal of tissues 410 Consent 510.1 General 510.2 Predonation counselling 510.3 Basis of consent 511 Compensation 512 Donor suitability a