US · guidance
CMS SOM App. C, Tag D2064
§493.831 Standard: Virology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
Interpretive Guidelines §493.831(e)
Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must
enroll and successfully participate in a CMS-approved proficiency testing program for
HPV. Laboratories should refer to Subpart H for further information. For example: A
Cytology laboratory that performs HPV testing must have a CLIA certificate that
includes the subspecialty of Virology.
§493.833 Condition: Diagnostic immunology.
(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The specialty of diagnostic immunology includes for purposes of proficiency testing
the subspecialties of syphilis serology and general immunology.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
ae6b9ebc48e2322fbb29333ccfbb56c2f5caf98fb058959972787abb7a6c9c97
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