Wyo. Code R. 048-0013-2
Clinical Laboratories, Licensure of
Chapter 2: Licensure
Effective Date: 08/26/1985 to 05/05/2004
Rule Type: Superceded Rules & Regulations
Reference Number: 048.0013.2.08261985
Section 1. License required. 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 111, IV and V following.
Section 2. Qualifications of laboratory directors.
(a) For reference laboratories, the laboratory director shall meet one of the following standards:
(i) A physician certified in anatomical and/or clinical pathology, by the American Board of Pathology or the American Osteopathic board of Pathology;
(ii) A physician certified by the American Board of Pathology, or the American Osteopathic Board of Pathology in at least one of the laboratory specialties;
(iii) A physician or a holder of a doctoral degree from an accredited institution in a chemical, biological, physical, or other laboratory science that is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, or the American Association of Bioanalysts;
(iv) A physician or a holder of a doctoral degree from, an accredited institution in a chemical, biological, physical, or other laboratory science that, subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties in an approved clinical laboratory.
(b) For physician office laboratories, the laboratory director shall be a physician, licensed by the Board of Medical Examiners to practice in Wyoming.
Section 3. Issuance of Certificate of Qualification.
(a) The state agency shall send a qualification form, for a certificate, in care of the laboratory director, to all clinical laboratories known to be operating in the state as of January 1, 1985. After January 1, 1985, an individual shall request, in writing, a qualification form for a certificate from the state agency.
(b) The state agency shall issue a certificate to all individuals meeting the qualifications specified in Section 2 above.
(c) The certificate shall indicate that the individual may direct a reference or physician office laboratory.
(d) The certificate will be valid for one year from the date on which it was issued.
(e) The state agency will automatically renew the Certificate of Qualification on a yearly basis.
(a) A laboratory director certified to direct a reference laboratory may direct no more than two laboratories and concurrently provide provisional directorship for no more than six laboratories.
(b) A laboratory director certified to direct a physician office laboratory may direct one such laboratory.
(a) The state agency shall send an application for license to all laboratories operating in the state as of January 1, 1985.
(b) The owner of the laboratory or his legally authorized representative shall complete the application for license.
(c) After January 1, 1985, 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 $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 $500.00.
(e) For reference laboratories, a certified reference laboratory director that provides provisional directorship may be named as director for licensure purposes. A laboratory requiring this arrangement shall document the visits by the director, and such documentation shall accompany the license application. The state agency shall note the provisional status of the director in these instances.
(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 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 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 30 days, beginning with receipt of the notice, to amend the existing license, re-issue a license or make no change in the existing license. During the 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 tests.
(i) The state agency shall renew a license on a yearly, basis provided:
(i) the appropriate fee is submitted with a completed renewal from; (ii) the laboratory director has a valid Certificate of Qualification
(iii) the laboratory has met the appropriate inspection, and proficiency testing requirements.
(a) All licensed laboratories shall accept only those specimens collected by a physician, laboratory director, dentist, trained personnel under the direction of a physician, laboratory director, dentist, or local, state or federal health authorities.
(b) Examinations of specimens shall be made only at the request of a physician, dentist, or local, state or federal health authorities authorized to use laboratory findings.
(c) Results of a test or tests shall only be reported to the submitter of the specimen or as directed by the submitter. The report shall be written, signed and dated, and shall include the name and address of the laboratory in which the test(s) were actually performed.
(d) All specimens shall be tested on the premises of the laboratory that accepted the specimen unless the specimen was forwarded to an approved reference laboratory.