Wyoming

Wyoming Department of Health, Public Health Division. Clinical Laboratories. 
https://rules.wyo.gov/Search.aspx

(1) WY Rules and Regulations 048.0013.1-6

Formerly cited as WY ADC HLTH CL

Application: Forms CMS-116 Application

Complete a CLIA Application, in its entirety and mail to: Healthcare Licensing and Surveys, Hathaway Building, Suite 510, 2300 Capitol Avenue, Cheyenne, WY 82002

All clinical laboratories in Wyoming Shall have a valid license issued by the state agency. In order to receive a license, a laboratory shall have a director certified by the state agency, and meet the appropriate inspection and proficiency testing requirements as specified in Chapters III, IV, and V following.

The owner(s) or director-owner shall request, in writing, an application for license from the state agency.

(d) The license application shall be accompanied by the appropriate license fee.

(i) The fee shall be one hundred dollars ($100.00) for each category of tests.

(ii) Test categories are: microbiology, serology, chemistry, hematology, biophysics, cytology, and pathology.

(iii) The license fee for any laboratory shall not exceed five hundred dollars ($500.00)

(a) The license application shall require: (i) The name, address, and phone number of the laboratory; (ii) The name and address of the owner; (iii) The name and Certificate of Qualification; number of the director; (iv) A list of the laboratory tests performed; (v) A list of personnel that perform the laboratory tests; (vi) Documentation of participation in the appropriate proficiency testing program. (vii) For reference laboratories, CLIA license number, Medicare provider number, documentation of accreditation from JCAHO or CAP, and a copy of the most recent inspection report.

(b) The license shall be issued: (i) To the owner if he is the director of the laboratory or; (ii) Jointly to the owner and director of the laboratory or; (iii) Jointly to co-owners and directors of the laboratory.

(c) The license shall specify the owner, the laboratory director, laboratory classification, location of the laboratory, and the laboratory procedures or categories of procedures authorized.

(d) The license shall be valid for the calendar year in which it was issued.

(e) A license shall automatically be voided if there is a change in the laboratory director.

(f) A license shall automatically be voided thirty (30) days following a change in ownership or location.

(g) Application for a new license may be made prior to any change in the laboratory director, ownership, or location of the laboratory or within the thirty (30) day expiration period noted in (f) above.

(h) A laboratory shall notify the state agency, in writing, if the laboratory intends to offer a new test or tests for which it has not been licensed, during the license year. The state agency shall have thirty (30) days beginning with receipt of the notice to amend the existing license, reissue a license, or make no change in the existing license. During the thirty (30) day period, the state agency may, depending on the nature of the test(s) being considered, determine by inspection, check testing or both, that the laboratory can satisfactorily perform the new test(s).

(i) The state agency shall renew a license on a yearly basis provided: (i) The appropriate fee is submitted with a completed renewal form; (ii) The laboratory director has a valid Certificate of Qualification; (iii) The laboratory has met the appropriate inspection and proficiency testing requirements.

CLIA payments may be sent to:

CLIA Laboratory Program
PO Box 3056
Portland, OR 97208-3056

Or to pay your CLIA fees online please click here 

New CLIA Fees Effective January 27, 2024 click here for information

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.