2010 Wyoming Statutes
Title 33 - Professions And Occupations
Chapter 34 - Licensing Of Clinical Laboratories And Blood Banks

CHAPTER 34 - LICENSING OF CLINICAL LABORATORIES AND BLOODBANKS

 

33-34-101. Definitions.

 

 

(a) As used in this act:

 

(i) "Blood bank" means a facility for the collection, processing or storage of human blood or blood derivatives, but shall not include such a facility located in a memorial, district or private hospital;

 

(ii) "Clinical laboratory" means any facility for the microbiological, serological, chemical, hematological, biophysical, cytological or pathological examination of materials derived from the human body for the purpose of obtaining information for the diagnosis, prevention or treatment of disease or the assessment of medical condition;

 

(iii) "Laboratory director" means the person who is responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting of findings of tests;

 

(iv) "Laboratory reference system" means a system of periodic testing of methods, procedures and materials of clinical laboratories and blood banks, including without limitation the distribution of manuals of approved methods, inspection of facilities, cooperative research and periodic submission of test specimens for examination;

 

(v) "State agency" means the Wyoming department of health;

 

(vi) "This act" means W.S. 33-34-101 through 33-34-109.

 

33-34-102. Required license and certification.

 

 

(a) On and after July 1, 1978, no person shall own or operate a clinical laboratory or blood bank for the purpose of soliciting or accepting a specimen for laboratory examination, or collecting, processing or storing human blood or blood derivatives unless a valid laboratory license therefor has been issued. A license shall be issued authorizing the performance of one (1) or more laboratory procedures, or one (1) or more categories of such procedures. A separate license is required for each facility at which laboratory tests are performed or at which a blood bank is operated.

 

(b) No person shall function as a laboratory director unless he has been certified by the state agency.

 

33-34-103. Issuance of certificates of qualification.

 

 

(a) The state agency shall prescribe minimum qualifications for laboratory directors in microbiology, serology, chemistry, hematology, biophysics, cytology or pathology.

 

(b) The state agency shall issue a certificate of qualification to any person who meets the minimum qualifications and demonstrates that he possesses the character, training and ability relating directly to the capacity to administer properly the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting of test findings.

 

(c) Application for a certificate of qualification shall be made on forms provided by the state agency. It shall specify the procedures or categories of procedures for which the certificate is sought and such other pertinent and qualifying information as the state agency needs to carry out the requirements of this act.

 

(d) The certificate is valid for a period of one (1) year from the date of its issuance and may be renewed each year thereafter.

 

(e) Notwithstanding the provisions of this section, the state agency may issue a temporary certificate of qualification pending the issuance of a regular certificate. A temporary certificate is valid for ninety (90) days from the date of its issuance.

 

33-34-104. Issuance of laboratory license.

 

 

(a) Application for a laboratory license shall be made by the owner of the laboratory or his legally authorized representative upon forms provided by the state agency. The application shall contain the name of the owner, the name of the laboratory director, the laboratory procedures or categories of procedures for which the laboratory license is sought, the location and physical description of the facility at which tests are to be performed or at which a blood bank is to be operated, and such other pertinent and qualifying information as the state agency needs to carry out the requirements of this act.

 

(b) A license shall not be issued unless a valid certificate of qualification in the procedures for which the license is sought has been issued to the laboratory director, and unless the state agency finds that the laboratory is competently staffed, properly equipped and the laboratory will be operated in the manner required by this act.

 

(c) If the owner of the laboratory is not the laboratory director, or if two (2) or more owners are codirectors of the laboratory, the license shall be issued jointly to the owner and the laboratory director or to the codirector owners, and they are jointly and severally responsible to the state agency for the maintenance and conduct of the laboratory and for any violations of this act or the rules and regulations promulgated hereunder.

 

(d) A license is valid for the calendar year for which it is issued. The initial application for a license shall be accompanied by a fee of one hundred dollars ($100.00) for each category but not to exceed five hundred dollars ($500.00) maximum for each laboratory. All fees collected by the state agency shall be deposited in the state general fund.

 

(e) The license shall specify the names of the owner and the director of the laboratory, the laboratory procedures or categories of procedures authorized and the location at which the procedures may be performed. The license and the certificate of qualification shall be displayed at all times in a prominent place in the laboratory.

 

(f) A license is automatically void if there is a change in the laboratory director. A license is automatically void thirty (30) days following a change in the ownership or location of the laboratory. An application for a new license may be made prior to any change in the laboratory director, ownership or location, or prior to the expiration of the thirty (30) day period, in order to permit the uninterrupted operation of the laboratory.

 

33-34-105. Duties and powers of state agency.

 

 

(a) The state agency may inquire into the operation of laboratories and may conduct periodic inspections of facilities, methods, procedures, materials, staff and equipment.

 

(b) The state agency may require laboratories to submit, in a form prescribed by the state agency, periodic reports of tests performed and such other pertinent and qualifying information as the state agency may need to carry out the provisions of this act. The state agency may also require laboratories to submit lists of medical technologists who are employed to perform laboratory procedures and to notify the state agency of any changes in such personnel.

 

(c) The state agency shall operate and approve laboratory reference systems and prescribe standards for the examination of specimens. As part of the laboratory reference systems, the state agency may require laboratories to analyze test samples submitted by the state agency or an approved system and report the results to the state agency. The rules and regulations of the state agency shall prescribe the manner in which analyses of samples are performed and reports thereon submitted. Such analyses and reports may be considered by the state agency in proceedings under W.S. 33-34-108.

 

(d) The state agency shall adopt rules and regulations to implement the provisions of this act. Where feasible such rules and regulations shall equal or exceed minimum standards for laboratory certification contained in federal rules and regulations promulgated pursuant to the Clinical Laboratories Improvement Act of 1967 (Public Law 90-174) or subsequent federal clinical laboratory acts. However, where feasible and consistent with the above, any clinical laboratory which is located in the office of a physician who only performs tests in the treatment of his own patients and accepts no referral specimens, may be excluded from the licensing requirements of this act. The rules and regulations prescribed and adopted may not be implemented until submitted to the Wyoming legislature for review and approval under procedures as the legislature may prescribe.

 

(e) The state agency may employ inspectors, investigators, assistants and other employees necessary to carry out the provisions of this act, fix their compensation within limits provided by law and prescribe their duties. Qualifications for laboratory inspectors shall be the same as the qualifications established for supervisors pursuant to subsection (f) of this section.

 

(f) The state agency may establish qualifications for supervisor and technical personnel employed in laboratories with the advice and assistance of the advisory committee authorized under W.S. 33-34-106.

 

33-34-106. Advisory committee.

 

 

(a) The state agency shall appoint an advisory committee to advise the state agency concerning implementation and administration of this act. The advisory committee shall consist of seven (7) members, including one (1) pathologist actively engaged in the direction of a laboratory, a medical doctor actively engaged in the practice of medicine, an active hospital administrator, an active laboratory technologist, a professional medical laboratorian from the state public health laboratory, a representative of third party insurance carriers, and a representative consumer of medical care. Appointments will be made from a list of not less than two (2) names submitted by appropriate professional and consumer organizations in this state.

 

(b) Members of the advisory committee shall be reimbursed for expenses incurred in attending committee meetings in the same manner and amount as state employees.

 

33-34-107. Acceptance, collection, identification and examination of specimens.

 

 

(a) A clinical laboratory shall examine human specimens only at the request of a licensed physician, dentist or other person authorized by law to use the findings of laboratory examinations.

 

(b) The results of a test shall only be reported to or as directed by the person who requested it. The reports shall include the name of the director and the name and address of the clinical laboratory in which the test was actually performed.

 

(c) All specimens accepted by a clinical laboratory shall be tested on the premises unless forwarded to another properly licensed clinical laboratory. Any tests made outside Wyoming must be made by a laboratory having a valid federal interstate license.

 

(d) Only a licensed physician or an authorized person may collect specimens.

 

33-34-108. Enforcement.

 

(a) A laboratory license or certificate of qualification may be revoked, suspended, limited or annulled, or the holder thereof may be censured, reprimanded or otherwise disciplined by the state agency on proof that the license or certificate holder or any person in his employ:

 

(i) Is guilty of misrepresentation in obtaining the license or certificate or in the operation of the laboratory;

 

(ii) Knowingly accepts or permits to be accepted a specimen or assignment for laboratory examination from, or renders a report to, a person not authorized by law to submit such assignment or specimen, or receive the report;

 

(iii) Engages or attempts to engage in, or represents himself as entitled to perform any laboratory procedure or category of procedures not authorized in the permit or certificate;

 

(iv) Renders a report on laboratory work actually performed in another laboratory without acknowledging that fact;

 

(v) Demonstrates incompetence or shows consistent errors in performance of laboratory examinations or procedures;

 

(vi) Fails to file any report required by the provisions of this act or the rules and regulations promulgated hereunder; or

 

(vii) Violates or aids in the violation of any provision of this act, the rules and regulations promulgated hereunder, or the state sanitary code.

 

(b) Proceedings under this section may be initiated by a qualified inspector by filing written charges with the state agency.

 

(c) No license or certificate shall be revoked, suspended, limited or annulled without a hearing before the state agency.

 

(d) Any action of the state agency taken pursuant to or under this act is reviewable as provided by state law.

 

(e) Notwithstanding subsections (d) and (e) of this section, upon receipt from the department of family services of a certified copy of an order from a court to withhold, suspend or otherwise restrict a license issued by the board, the board shall notify the party named in the court order of the withholding, suspension or restriction of the license in accordance with the terms of the court order. No appeal under the Wyoming Administrative Procedure Act shall be allowed for a license withheld, suspended or restricted under this subsection.

 

33-34-109. Penalties.

 

 

(a) Any person who violates the provisions of this act is guilty of a misdemeanor, and upon conviction may be punished by imprisonment for not more than six (6) months, or by a fine of not more than seven hundred fifty dollars ($750.00), or both.

 

(b) Any person convicted of a second or subsequent violation of this act may be punished by both a fine and imprisonment.