Clinical Laboratories

Revision Date: 
Saturday, September 21, 2019

Agency Contact Information

Arizona Department of Health Services- Laboratory Licensure & Certification

Authority

Regulations and licensing requirements for clinical laboratories were established in 1969.

Current statutory authority is found at A.R.S. §§36-451 through 36-479.

Function

A clinical laboratory is a facility, institution, medical office, health care institution or place which provides examination of materials derived from the human body in order to diagnose, prevent or treat a disease or assess a condition to determine presence or concentration of various substances in the body. A clinical laboratory does not include a law enforcement crime lab. A.R.S. §36-451.

An accredited lab is one that has received federal accreditation and meets the standards of the federal Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-518).

Clinical labs are required to have a license to operate in the state. In order to obtain a license, a person must submit an application and meet requirements outlined in statute and administrative rule. The Director of the Arizona Department of Health Services administers and enforces provisions relating to licensing and regulating clinical labs. The Director is required to adopt administrative rules outlining lab practices, proficiency standards, lab construction, operating standards, training and education for personnel, and handling specimens. The Director is authorized to deny, suspend or revoke a license; take disciplinary action; conduct hearings and investigations; assess penalties and apply for an injunction.

History

Laws 1969, Chapter 109 established licensing and regulations for clinical laboratories, authorized the State Department of Health to administer the law, establish fees, adopt administrative rules, inspect clinical laboratory premises and operations, deny or revoke a license, conduct investigations, and render decisions. The measure established penalties and provided for judicial review of final decisions. The legislative intent clause stated “…the purpose of the act is to provide for the better protection of public health through the development, establishment, and enforcement of standards for the licensure of clinical laboratories, by providing qualifications for the directors of such clinical laboratories, and by insuring that the tests performed by the clinical laboratories are performed with a high degree of scientific and professional competency.”

Laws 1973, Chapter 158 established the Department of Health Services and transferred the powers and duties of the State Department of Health to the new agency. The new agency also assumed responsibility for several separate agencies. The measure included transition provisions and an effective date of no later than July 1, 1974. The purpose statement explained the new department would provide an integration of health services, reduce duplication, and provide a means to allow those with health problems to find a solution in a single department’s coordinated service. The statement continued, saying: “The legislature intends that the Department of Health Services established by this act shall be able to provide or promote….compliance with standards in licensing of health facilities.” Section 1, Purpose.

Laws 1974, Chapter 30 eliminated the requirement that the Clinical Laboratories division be self-supporting.

Laws 1978, Chapter 103 authorized emergency paramedics and medical technicians to collect specimens or human blood if the person: 1) is working under the direction of a licensed physician, and 2) has written approval of the Director.

Laws 1990, Chapter 190 made a number of changes to clinical laboratory statutes regarding licensing, fees, violations, disciplinary actions and civil penalties. The measure also established the Clinical Laboratory Licensure Advisory Committee, outlined its responsibilities, and created the Clinical Laboratory Licensure Revolving Fund. The Fund consisted of gifts, grants, donations and fees from workshops, conferences and seminars. Fund monies were to be used to support the administration of clinical lab statutory requirements, including sponsoring workshops, conferences and seminars. In addition, the measure required the Director to complete licensing of all clinical laboratories, not otherwise exempted from licensure, no later than July 1, 1992.

Laws 2004, Chapter 49 established the seven-member Advisory Committee on Clinical Laboratories to advise the Director on developing a list of direct access tests and the use and renewal of standing orders. Direct access tests are tests that may be obtained without a physician referral. These provisions were modified in 2015.

Laws 2011, Chapter 268 was a lengthy measure outlining disclosure guidelines for certain medical records or information, including disclosure and confidentiality for clinical laboratory test results.

Laws 2015, Chapter 222 allowed a person to obtain any laboratory test from a clinical laboratory without a healthcare provider’s request or written authorization. The measure also modified the responsibilities of the Advisory Committee on Clinical Laboratories by removing the requirements to: 1) provide advice on developing a list of direct access tests, and 2) making that list available to the public.

Laws 2019, Chapter 195 adds a section providing for temporary licensure of health professions. ADHS is the licensing agency for certain health professions including radiologic technologists; clinical laboratories; midwives; and hearing dispensers, audiologists and speech-language pathologists. The new section 32-3124.A states in part: “A health profession regulatory board in this state may issue a temporary license to allow an applicant who is not a licensee to practice…”. The section sets specific requirements and authorizes the adoption of rules to carry out the new provisions. The new section 32-3124.I states: “This section applies to a health profession regulatory board to the extent that this section does not conflict with the board’s current statutory authority relating to temporary licensure.” https://www.azleg.gov/legtext/54Leg/1R/laws/0195.pdf

Laws 2019, Chapter 227 classifies the unauthorized practice of a health profession as a Class 5 felony. It requires regulatory boards to investigate complaints and authorizes them to issue cease and desist orders or refer complaints to the county attorney or attorney general for prosecution.

Sources

  • Arizona Revised Statutes §§36-451 through 36-479
  • Arizona Administrative Code §§R9-14-101 et seq.
  • Session Laws
    • Laws 1969, Chapter 109
    • Laws 1973, Chapter 158
    • Laws 1974, Chapter 30
    • Laws 1978, Chapter 103
    • Laws 1990, Chapter 190
    • Laws 2004, Chapter 49
    • Laws 2011, Chapter 268
    • Laws 2015, Chapter 222
    • Laws 2019, Chapter 195 and Chapter 227

Related Collections at Arizona State Archives

Record Group 050 – Arizona Department of Health Services