048-2 Wyo. Code R. § 2-6

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Current through April 27, 2019

Section 2-6 - Issuance of License

(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.

048-2 Wyo. Code R. § 2-6