CMS SOM App. C, Tag D6116

(b)(3) Enrollment and participation in an HHS approved proficiency testing

program commensurate with the services offered;

Interpretive Guidelines §493.1451(b)(3)

Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must

enroll and successfully participate in a CMS-approved proficiency testing program for

HPV beginning in 2008. Laboratories should refer to Subpart H for further information.

The laboratory’s CLIA certificate must include the subspecialty of Virology. The

laboratory must also be in compliance with all the CLIA regulations governing the

preanalytic, analytic, and postanalytic phases of testing including proficiency testing and

personnel requirements.