Conducting Surveys of Laboratories with a Certificate of

6140.4 - Conducting Surveys of Laboratories with a Certificate of Waiver (CoW) or a Certificate for PPM Procedures (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) As provided at 42 CFR §493.1775 of Subpart Q Inspection, a laboratory that has been issued a CoW or a PPM certificate is not subject to biennial inspections. However, a survey may be conducted as specified in Subpart Q (i.e., randomly) during its hours of operation on authorization by CMS for any or all of the following to: • Determine if the laboratory is testing outside its certificate; • Collect information regarding the appropriateness of tests specified as waived or PPM; • Investigate a complaint from the public; and • Determine if the laboratory is operating and if testing is performed in a manner that does not constitute an imminent and serious risk to public health. Please note that in those instances in which you are performing a survey on a laboratory with a certificate for PPM procedures, the appropriate requirements in 42 CFR Part 493 Subparts H, J, K, M and Q will apply. Furthermore, regardless of the certificate held, in instances in which a survey is occurring in a laboratory with a Certificate of Compliance or a Certificate of Accreditation, which has conducted PPM procedures, that PPM testing may be included in the sample for the patient testing review portion of the survey.