Pennsylvania Clinical Laboratory Requirements

Pennsylvania licenses clinical laboratories under its own Clinical Laboratory Act — and since Act 122 of 2013, that includes out-of-state labs testing specimens from Pennsylvania residents. A CLIA certificate alone is not enough.

State agency

Pennsylvania Department of Health, Bureau of Laboratories, Division of Laboratory Improvement — the office that issues clinical laboratory permits (110 Pickering Way, Exton, PA 19341; (610) 280-3464).

License types

In-state clinical laboratory permit — for laboratories located in Pennsylvania.
Out-of-state clinical laboratory permit — separate application for laboratories outside Pennsylvania that test specimens originating in the Commonwealth.
Exceptions — no permit is required for ambulance services performing glucose testing only, plasma centers, or home health and home hospice services performing testing for home use only.

How to apply

Submit the Pennsylvania Clinical Laboratory Permit Application (in-state or out-of-state version) together with the federal CMS-116, proof of the laboratory director's doctoral degree, and director qualification documentation (board certifications, CME credits, experience). Laboratories performing toxicology, blood lead, or erythrocyte protoporphyrin testing need additional approval from the Division of Chemistry and Toxicology and must enroll in the Pennsylvania Toxicology Proficiency Testing Program. Allow a minimum of four weeks for processing. Testing may begin once certificates are received from both CMS and the Pennsylvania Department of Health.

Forms

Application forms — all state forms are listed under Applications and Forms on the Division of Laboratory Improvement page.

In-state clinical laboratory permit application (PDF) — includes the application checklist ($100 fee, director documentation, 4-week processing).
Out-of-state clinical laboratory permit application — separate application for labs testing Pennsylvania specimens; download from the Division's Applications and Forms section.
Change of Status Form — report ownership, director, location, and test-menu changes; download from the Division's Applications and Forms section.
Laboratory Directors Attestation Statement (PDF) — the director's signed attestation of responsibilities.
Form CMS-116 — CLIA Application for Certification (PDF) — filed with the state application.
Application process and demo-change instructions (PDF) — the Division's own walkthrough of the application packet.

Inspection preparedness — have these ready before the surveyors arrive:

Form CMS-116 — CLIA Application for Certification (PDF) — surveyors verify the specialties, sites, and director on file match current operations.
Form CMS-209 — Laboratory Personnel Report (PDF) — current personnel roster; surveyors require it up to date.
Updated Lab Test Menu — the lab's controlled test menu listing every test by specialty; surveyors cross-check it against the certificate.
Understanding Clinical Laboratory Regulations in Pennsylvania (PDF) — the Department's plain-language overview of what labs must meet; use it as a readiness baseline.
Bureau proficiency testing program — Pennsylvania's CMS-approved PT programs (blood lead, alcohol); enrollment is mandatory for those analytes.
CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines.

Fees

The in-state application carries a $100 application fee (check or money order payable to the Pennsylvania Department of Health). Check the current out-of-state application and the Department's fee information for any additional fees.

Personnel requirements

Pennsylvania reviews the laboratory director's qualifications at application — doctoral degree, board certifications, director-specific CME, and experience — under standards the Department publishes in its director interpretive guidance. Testing personnel must meet CLIA personnel standards.

Inspection

The Division of Laboratory Improvement conducts on-site inspections. Laboratories seeking toxicology licensure complete prelicensure proficiency testing before an on-site survey is scheduled.

Renewal and changes

Permits must be renewed on schedule; report changes in status — ownership, director, location, test menu — to the Department using its Change of Status Form so the permit record stays current.

How Pennsylvania differs from federal CLIA

A Pennsylvania clinical laboratory permit is required in addition to the CLIA certificate.
Since Act 122 of 2013, out-of-state labs need a Pennsylvania permit to test specimens from Pennsylvania residents.
The director's qualifications (doctoral degree, boards, CME) are reviewed as part of the permit application.
Toxicology and blood lead testing carry their own prelicensure proficiency testing requirement.
Both the CMS certificate and the Pennsylvania permit must be in hand before testing begins.

Official links

Last verified: October 2026