Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Pennsylvania
- The Bureau's guidance for all permitted labs lists a director acceptable to the Department, a general supervisor present during testing, written procedures, QC records traceable to patients and approved proficiency testing; a director or location change must be reported immediately.
- Act 122 bars clinical labs from placing staff in, or renting space in, a practitioner's office to collect specimens, unless the practitioner owns the lab.
- Pennsylvania has over 9,000 permitted clinical laboratories.
Does Pennsylvania require a state lab license on top of CLIA?
No clinical laboratory may operate in Pennsylvania without a Department of Health permit, applied for by the lab director. A practitioner's office is outside the permit only if it performs nothing beyond a short list of tests, so an office running rapid strep, flu or A1c tests needs a permit along with its CLIA certificate.
- Clinical laboratory permit
- Issued by Pennsylvania Department of Health, Bureau of Laboratories, Division of Laboratory Improvement
- Reaches labs doing only waived tests
Citation: 35 P.S. 2151 et seq.; 28 Pa. Code 5.1, 5.11
Who is exempt in Pennsylvania?
A licensed practitioner's office or clinic is not a clinical laboratory if it performs only urine dipstick or tablet tests, urine sediment, pregnancy tests, red and white cell counts, sedimentation rate, Gram stain, primary culturing for referral, qualitative stool chemistry, pinworm or Trichomonas tests.
Citation: 28 Pa. Code 5.1
What does Pennsylvania charge?
- Waived: $25 filing fee, then $100 per approved category per year, $500 maximum (as of October 2026)
- PPM: $25 filing fee, then $100 per approved category per year, $500 maximum (as of October 2026)
Citation: 28 Pa. Code 5.11(b), (h)
How often does a Pennsylvania lab registration renew?
- Renews every year
- Due Permits run to August 15 each year; the annual fee is billed by the Department, and permit invoices are sent electronically from 2026.
Do labs in other states need a Pennsylvania license to test its specimens?
Since Act 122 of 2013, any lab in or out of Pennsylvania that tests specimens collected in Pennsylvania needs a Pennsylvania permit. Out-of-state labs use a separate application with a $100 fee; the Department may limit their inspection if they hold CLIA and home-state approval.
Citation: 35 P.S. 2151 et seq. (Act 122 of 2013)
Does Pennsylvania add a form to the CMS-116?
The Pennsylvania permit is a separate application to the Bureau of Laboratories, filed by the director, alongside the CMS-116; the Department also posts a Clinical Laboratory Directors Attestation Statement.
Where does a Pennsylvania CMS-116 go?
- Pennsylvania Department of Health, Bureau of Laboratories
- Email: RA-DHPACLIA@pa.gov
- Phone: (610) 280-3464
Opening a testing site in Pennsylvania?
We prepare the CMS-116 and any Pennsylvania filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.
Sources
- stateAgency (CMS list updated May 2026)
- exemptions
- stateLicense, fees, renewal.due, outOfStateLabs
- stateLicense.agency, renewal.due (electronic invoices from 2026), supplement (permit application, directors attestation), notes (over 9,000 labs)
- stateLicense (permit required for physician office labs), notes (requirements for all labs; REV 10/2025)
- outOfStateLabs (Act 122, Q3, Q8, Q9), renewal.due (August 15), notes (office placement ban, Q4 to Q6)
- outOfStateLabs ($100 application fee)