A. The director shall appoint a clinical laboratory licensure advisory committee consisting of members representing a variety of persons affected by this article. The committee shall advise the director regarding the adoption of rules and shall make recommendations regarding interpretive guidelines necessary to properly administer and enforce the provisions of this article. Committee members serve at the pleasure of the director. Committee members are not eligible to receive compensation but are eligible for reimbursement of expenses pursuant to title 38, chapter 4, article 2.

Terms Used In Arizona Laws 36-465

  • Department: means the department of health services. See Arizona Laws 36-451
  • Director: means the director of the department of health services. See Arizona Laws 36-451
  • including: means not limited to and is not a term of exclusion. See Arizona Laws 1-215
  • laboratory: means any facility, agency, institution, medical office, health care institution, building, or place which provides through its ownership or operation facilities for the microbiological, serological, chemical, immunohematological, hematological, cytologic, histologic, radiobioassay, cytogenetic, histocompatibility, pathological, toxicological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of a disease or an impairment or the assessment of human health conditions or to determine the presence, absence or concentration of various substances in the body. See Arizona Laws 36-451
  • License: means a regular license, renewal license or provisional license issued by the department pursuant to this chapter. See Arizona Laws 36-451

B. After consultation with the advisory committee, the director shall adopt rules for clinical laboratories, relating to:

1. Classes and levels of laboratory practice and types and categories of laboratory examinations performed on material taken from the human body.

2. Minimum standards of proficiency testing to ensure valid and accurate laboratory testing.

3. The construction and operation of the laboratory, including plumbing, heating, lighting, ventilation, electrical services and similar conditions to assure that the operation of the laboratory is conducted in a manner which will protect the public health. A rule adopted pursuant to this paragraph shall require that laboratory facilities conform to all state and local building, safety and fire codes and ordinances.

4. The education, training, experience and responsibilities of laboratory directors, supervisors and personnel who perform laboratory examinations and procedures for collecting human specimens or blood.

5. All conditions within the laboratory related to infectious, hazardous and toxic materials.

6. Requirements to adequately assure the validity and reliability of the laboratory examinations and test results.

7. The proper collection, transportation and storage of specimens.

8. Reports, records, equipment and facilities necessary for the proper and effective operation of the laboratory.

9. Persons who may collect and submit human specimens for examination and receive examination results.

10. Additional grounds for denial, suspension and revocation of a license.

11. Exemptions from on-site inspections.

12. Criteria for determining substantial compliance with the provisions of this article and rules adopted pursuant to this article.

C. The department may issue interpretive guidelines on subjects relating to rules adopted pursuant to this article.