The CLIA inspection regulations are found in Subpart Q of the Code of Federal Regulations; this subpart addresses both basic and specific inspection requirements. All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements. CMS's policy for inspections includes an announced initial and biennial recertification inspection and unannounced complaint and follow-up inspections. The process focuses more on outcomes as opposed to processes. CMS's objectives in developing an outcome-oriented survey process were to not only determine the laboratory's regulatory compliance but to assist laboratories in improving patient care by emphasizing those aspects that have a direct impact on the laboratory's overall test performance. CMS promotes the use of an educational survey process.
Basic Inspection Requirements
Laboratories are required to permit CMS or its representatives to conduct an inspection; CLIA-exempt and accredited laboratories must permit validation and complaint inspections. As part of the process, laboratories may be required to:
- Test samples, including proficiency testing, or perform procedures.
- Permit interviews of all personnel concerning the laboratory's compliance.
- Permit personnel to be observed performing all phases of the testing process.
- Permit CMS or its representative access to all areas encompassed under the certification, including (but not limited to):
- Specimen procurement and processing areas
- Storage facilities for specimen reagents, supplies, records and reports
- Testing and reporting areas
- Provide CMS or its representative with copies or exact duplicates of all records and data it requires.
- A laboratory must have all records and data accessible and retrievable within a reasonable amount of time during the inspection. Further, a laboratory must provide (upon request) all information and data necessary for CMS or its representative to make a determination of the laboratory's compliance. CMS or its representative may re-inspect a laboratory at anytime to evaluate the laboratory's ability to provide accurate and reliable test results. CMS or its representative may conduct an inspection when there are complaints alleging non-compliance with the regulations. Failure to permit an inspection of any type results in suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment and suspension or limitation of or action to revoke the laboratory's CLIA certificate.
Waived and PPM Laboratories
While laboratories issued a Certificate of Waiver or Certificate for Provider Performed Microscopy are not subject to biennial inspections, CMS or its representative may conduct inspections at any time during the laboratory's hours of operation to:
- Determine if the laboratory is operated and testing is performed in a manner that does not constitute an imminent and serious risk to public health.
- Evaluate a complaint from the public.
- Determine whether the laboratory is performing tests beyond the scope of the laboratory's certificate.
- Collect information regarding the appropriateness of tests specified as waived or provider performed microscopy.
Waived and PPM laboratories must comply with all of the basic inspection requirements.
Certificate of Compliance
Laboratories issued a registration certificate must permit an initial inspection to assess the laboratory's compliance with the regulations before issuance of a certificate of compliance. These inspections may occur any time during the laboratory's hours of operation and may include review of PPM testing. CMS or its representatives may conduct subsequent inspections on a biennial basis or with such frequency as necessary to ensure compliance. Subsequent inspections are based on compliance history. Laboratories demonstrating CLIA compliance (based on type and number of deficiencies cited previously, proficiency testing performance and number and types of complaints lodged) are given the opportunity to participate in the Alternative Quality Assessment Survey (AQAS), which is a self-survey document. This option is available every other survey cycle (a two year period).
Accredited and CLIA-Exempt Laboratories
CMS or its representative may conduct validation and complaint investigation inspections of any accredited or CLIA-exempt laboratory at any time during its hours of operation. Should an accredited laboratory fail to be in compliance with one or more condition-level requirements, it is subject to a full review by CMS; should a CLIA-exempt laboratory fail to be in compliance with one or more condition-level requirements, it is subject to appropriate enforcement actions under the approved State licensure program.