Rhode Island Clinical Laboratory Requirements

Rhode Island is the smallest of the six states with its own out-of-state laboratory licensure rule, but the rule is just as binding: any out-of-state lab testing specimens collected in Rhode Island must hold a Rhode Island license.

State agency

Rhode Island Department of Health, the licensing agency for clinical laboratories and stations under R.I. Gen. Laws § 23-16.2 and regulation 216-RICR-60-05-4.

License types

  • Clinical laboratory license — by specialty and subspecialty (microbiology, chemistry, hematology, immunohematology, pathology, diagnostic immunology, and others).
  • Clinical laboratory station license — for collection stations.
  • Out-of-state license — any out-of-state laboratory performing tests on specimens collected in Rhode Island must be licensed under Rhode Island's requirements. Before issuing the license, the agency reviews the lab's documentation: federal certification in the specialties sought, and/or a home-state license in good standing where the home state's laws are deemed equivalent to or stricter than Rhode Island's, as determined by the Director of Health. The Director may also grant immediate licensure to an out-of-state, CLIA-certified lab asked to perform a service no Rhode Island–licensed lab offers.

How to apply

File the Department's Application for Clinical Laboratory with: laboratory director information and qualifications, the federal CLIA provider number, identification of proficiency testing programs by specialty, a description of the daily quality control program, a copy of the current quality assurance plan, and — for out-of-state labs — evidence of good standing (home-state license and/or CLIA certificate).

Forms

Application forms

  • Application for Clinical Laboratory — Rhode Island issues the application through its licensing office; there is no public download on the Department's site. Request it from the RI Department of Health, Office of Facilities Regulation (the regulation requires applications on agency-furnished forms — 216-RICR-60-05-4 §4.4).
  • Form CMS-116 — CLIA Application for Certification (PDF) — your CLIA provider number goes on the state application.

Inspection preparedness — have these ready before the surveyors arrive:

Fees

Fees are calculated from the specialties and subspecialties selected on the application; check the Department's current fee schedule before filing.

Personnel requirements

Rhode Island sets a floor: personnel who perform clinical laboratory tests must, at minimum, have successfully completed a nationally recognized certification examination. Separately, clinical laboratory science practitioners — technologists, technicians, cytotechnologists, and other specialties — are licensed under the Clinical Laboratory Science Practice Act (R.I. Gen. Laws § 23-16.3), which sets education, training, and experience standards by role.

Inspection

The licensing agency makes inspections and investigations as it deems necessary under state law, and laboratories receive prompt notice of any deficiencies recorded.

Renewal and changes

Licenses must be renewed on schedule; report changes to the Department so the license record stays current.

How Rhode Island differs from federal CLIA

  • A Rhode Island license is required in addition to the CLIA certificate.
  • Out-of-state labs need Rhode Island licensure to test specimens collected in Rhode Island — with a reciprocity-style review of the home state's standards.
  • Personnel performing testing must hold, at minimum, a nationally recognized certification, and practitioner-level roles carry state licenses.
  • License fees are tied to the specialties and subspecialties on the application.

Official links

Last verified: October 2026