The objective of the Clinical Laboratory Improvement Amendments (CLIA) program is to ensure quality laboratory testing. All laboratories issued a CLIA certificate, and all CLIA-exempt laboratories must comply with the applicable inspection requirements. Failure to comply with the law may lead to the suspension, limitation, and/or revocation of your CLIA certificate and the cancellation of your Medicare Provider Number. It is important to seek out a laboratory consultant to help you with this matter. In the meantime, here is some useful information.
Basic Inspection Requirements
As part of the inspection process, laboratories may be required to allow interviews of all personnel concerning the laboratory's compliance as well as let all personnel be observed when performing a testing process or procedure. They should also give CMS or its representative access to all areas encompassed under the certification, including testing and reporting areas; specimen procurement and processing areas; and storage facilities for supplies, records, reports, and specimen reagents. If asked, the laboratory must provide CMS with copies or exact duplicates of all records and data required.
Note: It is very likely for a laboratory consultant to advise to have all records and data accessible or retrievable within a reasonable amount of time during the inspection. CMS may decide to re-inspect a laboratory at any time to evaluate and make a determination of the laboratory's compliance. Failure to permit an inspection could result in suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment and suspension to revoke the laboratory's CLIA certificate.
Waived and PPM (provider-performed microscopy) Laboratories
Laboratories with a certificate of waiver or certificate for PPM are not subject to biennial inspections, however, CMS may conduct inspections at any time during the laboratory's hours of operation. This is so to determine whether the laboratory is performing tests beyond the scope of its certificate or collect information regarding the appropriateness of tests specified as waived or PPM. In any case, waived and PPM laboratories have to comply with all of the basic inspection requirements.
If you manage or own a laboratory, take into consideration this information. Laboratories are required to comply with law regulations in order to maintain CLIA certification. If you are in need of a laboratory consultant, contact us today to learn more.