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Pennsylvania CLIA Regulations

The Clinical Laboratory Improvement Amendments regulations require that laboratories performing tests on humans are certified and meet the requirements of the Pennsylvania Department of Health. To get certification contact the Bureau of Laboratories in Pennsylvania, which is charged with the responsibility of recommending certification of clinical laboratories under the CLIA regulations.

  1. Permits

    • Under the Pennsylvania Laboratory Act (enacted under CLIA regulations), a permit is needed to operate a clinical laboratory in the state of Pennsylvania. An application for a permit must include the name of the director of the laboratory and personnel employed in the laboratory, the name and physical address of the laboratory, details of the laboratory equipment that will be used for procedures, tests that will be conducted, and the internal and external quality control systems.

    Participation Qualifications

    • Before qualifying to run a laboratory involved in testing human specimens in Pennsylvania, the CLIA certificate and CLIA identification number must be provided along with a list of CLIA certified diagnostic procedures to be performed by the laboratory and the fees to be charged.

    Responsibilities of Provider

    • Any changes in the type of the CLIA certificate, laboratory procedures and fees and the date the changes were effected must be reported to the public health department in the state of Pennsylvania by the laboratory service provider. Federal and state officials must be allowed to perform onsite reviews of the laboratory to verify the information supplied about its operations. During the review process, federal officials will access laboratory manuals and records to verify that the services being offered by the laboratory comply with federal and state laws and regulations.

    Payment for Laboratory Services

    • The laboratory performing a test receives the payment for that particular service. If the lab is not certified by CLIA to perform the laboratory procedure, payment will not be made by the medical assistance department even if the procedure of the Bureau of Provider Relations Department was followed. To bill laboratory procedures to the department, write a request and provide your name, medical assistance identification number, name of the person who received the procedure and case number. In addition, state the date that the request was made and sign the request.

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