ESSENTIAL 2 Maps to TR 4.2 100% of OPO Category I and II employees undergo BBP training annually The survey team will review OPO safety records for evidence of OPO Category I and II employees BBP education for each of the three years involving the accreditation cycle. The survey team shall use a minimum 10% sampling of employee safety records to validate training. ESSENTIAL 3 Maps to QI 1.2 The OPO Quality Plan is reviewed by the OPO board annually. The survey team will review OPO board (advisory OR governing) records for evidence of the OPO Quality Plan's review for each of the three years involving the accreditation cycle. ESSENTIAL 4 Maps to CL 3.2 100% of OPO donor records sampled contain evidence of authorization for organs recovered The survey team will review OPO donor records for evidence of OPO documentation of authorization for each of the three years involving the accreditation cycle. The survey team shall use the minimum sampling method used for routine donor record review. ESSENTIAL 5 Maps to CL 2.2 100% of OPO donor records sampled contain evidence of patient death declaration prior to beginning organ recovery surgery The survey team will review OPO donor records for evidence of the donor hospital's documentation of patient death for each of the three years involving the accreditation cycle. The survey team shall use the minimum sampling method used for routine donor record review. ESSENTIAL 6 Maps to CL 4.D.2.1 100% of donor records sampled contain evidence of completed infectious disease testing The survey team will review OPO donor records for evidence of OPO documentation of donor infectious disease for each of the three years involving the accreditation cycle. The survey team shall use the minimum sampling method used for routine donor record review. STANDARD INTERPRETIVE GUIDELINES ADMINISTRATION STANDARD AS 1 GOVERNING AND ADVISORY BODY An organized governing and advisory board must be established. The surveying team should determine that the OPO has a governing and advisory board.
investigator (PI) has education and experience within the area of research as stated in the study design. Evidence that the project has been subjected to ethical oversight either by an Institutional Review Board (IRB) if appropriate (i.e. living subjects involved in the research) or an OPO ethical oversight process. Ethical oversight will also demonstrate donor and recipient confidentiality of protected health information. Evidence that priority is reserved for organs and tissues (if applicable to the research request) to be transplanted or used for medical therapy before being designated for research purposes. an IRB or OPO ethical oversight board, or equivalent, Evidence that the PI has a process for maintaining the security of files, and/or human materials, provided by the OPO for the proposed research, and that the protected health information of the donor and any involved recipients will remain confidential, and That the OPO communicates to the PI that the first priority for the deceased donor, and organs and/or tissues, are to provide transplants and transplant therapy before being designated for research purposes. RS 1.3 Minimum information disclosed by each PI: The OPO shall obtain minimum information from each PI who is approved for a deceased donor research intervention to include: PI’s full name, all applicable sponsors of the research intervention, PI contact information, details of the intervention, full title of the protocol, an objective method for determining the protocol end date (i.e. specific month, day and year; number of specimens, etc.). The survey team will review OPO approved research protocols involving deceased donors over the OPO three year accreditation period and verify the PI’s full name, all applicable sponsors of the research intervention, PI contact information, details of the intervention, title of the protocol, an objective method for determining the protocol end date. RS 1.4 RESEARCH INTERVENTION COMMUNICATIONS: RS 1.4.1 The OPO must have a policy and procedure for systematically The survey team will ask the OPO what authorization is required by the state’s UAGA