CMS Issues New Organ Procurement Organization Survey Protocol and Guidance Revisions
The U.S. Centers for Medicare and Medicaid Services (CMS) has published a new survey protocol in Appendix Y of their State Operations Manual (SOM). In addition, revisions were also made to update and clarify interpretive guidance in Appendix Y.
The Organ Procurement Organization (OPO) survey protocol encompasses a full review of all the OPO Conditions for Coverage (CfC) for all recertification surveys. The CMS Regional Office (RO) conducts recertification surveys every four years. The components of the basic survey include pre-purvey preparation, entrance, administrative review, donor record review, personnel record review and interview, review of the quality assessment and performance improvement program, preparation for exit and exit. It can be helpful for organizations to familiarize themselves with the survey process and expectations for demonstrating compliance with CfCs.
In addition to the new survey protocol, CMS has also provided some interpretive guidance revisions for OPOs, including:
- Updating the definition of eligible death to mirror the definition used by the Organ Procurement and Transplantation Network (OPTN) (42 CFR 486.302)
- Revision outcome measure three for contiguous and non-contiguous states so that it must meet the rules and requirements of the OPTN aggregate donor yield measure. (42 CFR 486.318 (a)(3) and 42 CFR 486.318 (b)(3))
- The OPTN aggregate donor yield measure has initial criteria that is used to identify OPOs with lower than expected organ yield, for all organs and for each organ type. (42 CFR 486.318 (a)(3)(i) and 42 CFR 486.318(b)(3)(i))
- The guidance under the requirement for evaluating patients for donation after cardiac death has been rewritten to clarify that an OPO must have written protocols for its collaboration with hospital staff regarding withdrawal of life support for the Donation after Cardiac Death (DCD) donor. There must also be clear directives as to the responsibilities of the hospital staff and the OPO staff in the period of time between extubation and declaration of death. (42 486.344 (f)(1))
- Consistent with OPTN policy, blood type and blood subtype (if used for allocation) and infectious disease testing results should be sent physically with each organ. All other donor information can be accessed electronically by the transplant center. (42 486.346 (b)(1))
Included with today’s notice are example policies that reflect the above updated guidance. A link to the CMS memorandum is also provided. For more resources check out MCN Healthcare’s Leadership Manual!
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