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

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

2、r volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer

3、and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its n

4、on-infringement of any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicable statute,

5、 rule, or regulation. IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO S

6、PECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCU

7、MENT, EVEN IF CSA GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to render professional or other services for or on behalf of any person or entity or to perform any duty owed b

8、y any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the info

9、rmation contained in this document. CSA Group is a private not-for-profit company that publishes voluntary standards and related documents. CSA Group has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes. Intellectual property r

10、ights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and al

11、l inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect

12、 CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights in this document.Patent

13、rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any su

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

29、egister for updates to this publication is 2421688.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.Canadian Standards Association (operatingas “CSA Grou

30、p”), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certificat

31、ion activities. CSA Group standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial,

32、and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSA Groups standards development by volunteering their time and skills to Comm

33、ittee work and supporting CSA Groups objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSA Groups total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSA

34、 Groups standards development activities. CSA Group offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, CSA Group regularly and continually audits and inspects products that bear th

35、e CSA Group Mark. In addition to its head office and laboratory complex in Toronto, CSA Group has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, CSA Group has developed the necessary expertise to meet its corporate mission:

36、CSA Group is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further information on

37、 CSA Group services, write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherdevelopment and improveme

38、nt of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the consumer, facilitating domesti

39、cand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or reviewed by an accredited Standards Development Organization (SDO) and approved by the SCC according to the requirements of CAN-P-2. Approval does

40、not refer to the technical content of the standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of general interests, producer

41、s, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the national interest.Those who have a need to apply standards areencouraged to

42、use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200O

43、ttawa, 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 the users to judge its suitability for their particular pu

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

46、 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 publications on Rolland Enviro100, which contains 100%recycled post-co

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