In a CMS notification letter dated August 26, 2008, submitted by Judith Yost, Director, Division of Laboratory Services, the CMS issued a statement on their interpretation of a practice that they considered to meet the definition of PT referral, and urged that any laboratory or individual participating in that practice to cease that practice immediately.
"...CMS has become aware of a few pathologists who, at a certified remote location, examine gynecologic cytology specimens for a main laboratory facility. Their cytology PT is being performed in a similar manner. Specifically, a previously screened and marked PT slide set is sent to the pathologist at a remote location to be evaluated as part of the pathologist’s annual cytology PT. Because this meets the definition of PT referral, CMS has determined that this practice must cease. ..."
- Pathologists who examine slides at a remote location need to make arrangements to take the Cytology PT test at the Main Laboratory.
- A cytotechnologist from the Main Laboratory may travel to the pathologist's location in order to participate in the Cytology PT testing event.
- Any laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certification revoked for at least one year.
- Any laboratory that receives proficiency testing samples from another laboratory for testing must notify CMS of the receipt of those samples.
- In addition, Section 493.1840(a)(8) states “ CMS may initiate adverse action to suspend, limit, or revoke any CLIA certificate if CMS finds that a laboratory’s owner or operator or one of its employees has … within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked. (This provision applies only to the owner or operator, not to all of the laboratory’s employees.)”
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