Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter G - Standards and Certification |
Part 493 - Laboratory Requirements |
Subpart I - Proficiency Testing Programs for Nonwaived Testing |
§ 493.905 - Nonapproved proficiency testing programs.
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§ 493.905 Nonapproved proficiency testing programs.
Link to an amendment published at 87 FR 41233, July 11, 2022Cross Reference
and the program(a) Effect on approval status. If a proficiency testing program is determined by HHS to fail to meet any criteria contained in §§ 493.901 through 493.959 for approval of the proficiency testing program, CMS will notify the program
enrolledof its withdrawal of approval. Approval of the PT program remains in effect for 60 days from the date of notification. The proficiency testing program must notify all of its participating laboratories
nonapproval and the reasons for nonapprovalof the
the notification.withdrawal of approval within 30 days from the date of
notification. CMS may disapprove any proficiency testing program that provides false or misleading information with respect to any information that is necessary to meet any criteria contained in §§ 493.901 through 493.959 for approval of the proficiency testing program.
(b) Request for reconsideration. Any proficiency testing program that is dissatisfied with a determination to disapprove the program may request that CMS reconsider the determination, in accordance with subpart D of part 488.
[87 FR 41233, July 11, 2022]