Change to Standards at D5.400 Time Limits for Tissue Recovery
March 18, 2010
The Board of Governors has approved a recommendation from the Standards Committee to revise language used in Standard D5.400, Time Limits for Tissue Recovery. This change was made to clarify the original intent of the standard. This change was supported by the Tissue-Transmitted Diseases Advisory Group (TTDAG) and the Physicians' Council. The proposal to revise Standard D5.400 was presented and favorably discussed at a well-attended meeting of the Council of Accredited Tissue Banks.
The intent of this standard is to require documentation to support prescribed time limits. If time requirements for cooling of the donor's body cannot be supported by information from relevant records or attending personnel, then you must assume a worse-case scenario: that the body was not cooled during the time in question. Discussions noted that it cannot be assumed that when a body is subjected to some cooling, that the body stays cooled when removed from that environment (and is no longer subjected to cooling). The purpose of the standard is to impose time limitations and body cooling guidelines in an effort to retard microbial proliferation. There is agreement that the total time the body was not refrigerated should be considered when qualifying a deceased donor for suitability. Thus, "consecutive" is now changed to "cumulative" where it appears in this standard.
All tissue banks are advised to review protocols and recovery-related forms to ensure that adequate documentation is provided for time periods of body cooling and time periods when the body is not cooled. You should adopt these changes within six months, on or before September 2, 2010.
Contact Scott Brubaker if you have any questions.