Proficiency testing (PT) requirements are defined by CLIA, state regulations, and accreditation agencies. These requirements apply to all test methods. As per CLIA, all non-waived testing requires PT for each specialty, subspecialty, and analyte or test method. Federal guidelines (CLIA) do not require PT for waived tests. State regulations and regulatory agencies may have requirements above what CLIA requires. Any facility that performs CLIA-waived testing may choose to perform PT on waived methods. Good laboratory practice may include PT for all methods. The facility must enroll in a Health and Human Services (HHS)-approved PT program (refer to the link below). The facility must remain with the selected agency for a minimum enrollment period of one year before changing agencies.
If a commercial program is not available for an analyte, a separate commercial provider may be used for the test method(s) or analyte(s). Another option is to incorporate an alternate form of PT, such as split sample testing, which must be performed at least twice per year. Multiple identical instruments must either have PT performed on each instrument or split sample testing performed to confirm compliance for each instrument in use.
The laboratory will allow results to be released to CLIA for all analytes and events. All records must be maintained for at least two years and accessible to inspectors at the time of the survey.