Rhode Island

Rhode Island Department of Health, Public Health Division. Clinical Laboratories. 
https://rules.sos.ri.gov/regulations/part/216-60-05-4

Application: CMS-116 Application Form

These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-16.2-5, and are established for the purpose of adopting minimum standards for licensure of clinical laboratories and for the protection of the health, safety and welfare of the public. Prior to issuing a license, the licensing agency shall review the following documents required to be provided by a laboratory prior to licensure:

(1) Laboratory Director: provide documentation of the qualifications of the individual designated as laboratory director and a copy of that individual’s
resume;
(2) Laboratory staff: provide a list of technical personnel that includes qualification designations (MT, MLT, etc); also designate the individuals’
primary special area(s), if the application is for more than one specialty area;
(3) Hours of operation: provide a statement about the laboratory hours of operation;
(4) Laboratory facility: provide floor plans or a description of the facility that supports a statement that the facility is adequate for the scope of services for which licensure is requested;
(5) Equipment: provide a current equipment list representing all of the testing equipment for the specialty area(s) for which licensure is requested;
(6) Summary of tests performed: provide a list of all the tests for which
licensure is requested;
(7) Proficiency testing program: identify the proficiency testing program(s) for each specialty, subspecialty, or analyte for which licensure is requested;
(8) Quality control program: provide information regarding how the daily quality control program is achieved and used to ensure accurate testing;
(9) Quality assurance: provide a description of the laboratory’s quality assurance program or a copy of the quality assurance plan;
(10) Fees: see §§ 4.4(A)(1) and (2) of this Part and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the
Department of Health (Part 10-05-2 of this Title).

Contact Information: Department of Health 3 Capitol Hill Providence, RI 02908

Phone: 401-222-5960

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.