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Organ Transplant Interpretive Guidelines Update

MCN Question of the Week

Organ Transplant Interpretive Guidelines Update

Question:

Where can I find CMS’ update for the Organ Transplant Interpretive Guidelines?

Answer:

CMS published an advance copy of the Interpretive Guidelines for the Organ Transplant Conditions of Participation (CoPs) at 42 Code of Federal Regulations (CFR) § 482.68 through 482.104 on March 11, 2016.

CMS updated the Organ Transplant Interpretive Guidelines to incorporate previously-published changes, clarify certain areas, and address feedback received based on previously-released drafts. These Interpretive Guidelines supersede all previous versions and will be published in a new Appendix X of the State Operations Manual (SOM). The update was effective immediately.

The Interpretive Guidelines have additions, substantial clarifications and deletions in several areas, including but not limited to the following:

  • Abbreviations were added.
  • Definitions for the phases of transplant and living donor care were added.
  • X011: Guidelines regarding notification to CMS were updated and examples of the required information were added.
  • X013: Removed, as the requirement to notify CMS of a decrease in the number of transplants and potential non-compliance was removed, and other changes were made as needed to conform with amendments to the regulations that became effective on July 11, 2014.
  • X021: Clarification was provided on the relationship of the pediatric to adult programs.
  • X072: Removed, as the requirement for blood type (ABO) verification prior to organ recovery was removed to conform with amendments to the regulations that became effective on July 16, 2012.
  • X073 and X074: A verification requirement prior to administration of anesthesia to a living donor was added to X074, consistent with United Network for Organ Sharing/Organ Procurement and Transplantation Network (UNOS/OPTN) policy.
  • X082, X090 and X091: The phases of transplant and living donation were added and the language was clarified.
  • X092 and X093: The Social Work requirements and examples were clarified.
  • X099 through X104: Previously published content, “Five Aspects of Transplant Quality Assessment and Performance Improvement (QAPI),” was added to the guidelines for clarification, and the examples were updated.

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