PT Participation and Testing Requirements

6048 - PT Participation and Testing Requirements (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A laboratory must meet the CLIA regulatory requirements for enrollment, participation, and testing as specified in Subpart H at 42 CFR 493.801. The SA, adhering to the time frames and guidelines in Appendix C of the SOM, reviews all related documentation. If failure to meet the specific requirements of 42 CFR Part 493 Subpart H is identified by the SA, appropriate actions may be initiated and sent to CMS for review and concurrence. If the SA identifies any information on survey or by any other means that indicates the possibility that any PT sample has been referred to another laboratory for testing prior to an event cut-off date, CMS must be notified immediately. CMS will instruct and advise the SA surveyor of the appropriate actions the surveyor must take. The SA may contact CMS with any questions. All documentation to support the finding of any PT referral is forwarded to CMS who will recommend appropriate sanctions in accordance with Subpart R. (See section 6061.)