US · guidance
CMS SOM App. X, Tag X-031
§482.80 Condition of Participation: Data Submission, Clinical Experience, and Outcome
Requirements for Initial Approval of Transplant Programs.
Except as specified in paragraph (d) of this section, and §488.61 of this chapter, transplant
programs must meet all data submission, clinical experience, and outcome requirements to
be granted initial approval by CMS.
Guideline §482.80
The Standards of this Condition are evaluated by the surveyor off-site, prior to the survey. The
determination of compliance or non-compliance will be communicated to the program at the
time of the survey. Since the findings for data submission and outcome requirements are based
on data submitted to the OPTN prior to the survey, the program may not submit any additional or
corrected data during the survey to change the compliance determination. Additional guidance
for processing initial surveys can be found in the SOM, Chapter 2.
History
Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
197aebaf4344936ccb91cd7623456b8db441e4a42ea988414bc91c5425c9a877
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