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Home » US Law » 2022 West Virginia Code » Chapter 16. Public Health » Article 5J. Clinical Laboratories Quality Assurance Act

§16-5J-1. Legislative Findings

The Legislature finds that the diagnosis and treatment of human affliction is or may be largely determined by the results of laboratory testing and that inaccurate laboratory test results endanger the health and lives of the citizens of West Virginia. A due respect for the citizenry of the state requires that all such testing be […]

§16-5J-10. Licensure of Technicians; Fee; Rules and Regulations

(a) The director of the department of health shall promulgate rules and regulations for the licensure and certification of lab technicians and lab technologists. All such persons being so employed on the effective date of this article shall be automatically certified and exempt from this requirement: Provided, That any technologist and technician who is certified […]

§16-5J-2. Definition

The term "clinical laboratory" means any facility or place, however named, for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, crytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the […]

§16-5J-3. Rules; Recognized External Standards

The director of the department of health shall promulgate, pursuant to chapter twenty-nine-a of this code, rules required to implement this article, and such rules shall specifically address, among other things, training, education and experience requirements. The standards to be adopted by the department of health shall be equal to or higher than such standards […]

§16-5J-4. Powers and Duties

In addition to promulgating rules specified in section three of this article, the director of the department of health, with the advice of the advisory board created in section five of this article, has the power to: (a) Adopt rules for clinical laboratory licensure; (b) Establish rules for continued evaluation of laboratory testing, such rules […]

§16-5J-6. Hearing and Judicial Review

If a license is withheld, suspended or revoked, the laboratory is entitled to a hearing before representatives of the department of health within sixty days of the withholding, suspension or revocation decision. Such laboratory may be represented at the hearing by counsel and may present evidence in its defense. The final order of the director […]

§16-5J-7. Exemptions

This article does not include or apply to any laboratory or laboratories maintained and operated by the federal government or to any laboratory or laboratories maintained and operated purely for research or teaching purposes nor to any laboratory operated by a primary health care center having tax exempt status and receiving contributions which are deductible […]

§16-5J-8. Unlawful Conduct; Penalties

It is a misdemeanor for any person to solicit, receive, accept, deliver or transmit, by mail or otherwise, material originating from the human body on behalf of any person operating a laboratory not in possession of a license under this article regardless of whether such laboratory is located in this state and, upon conviction thereof, […]

§16-5J-9. Interpretation of Article; Severability

The provisions of this article are severable and if any of its provisions shall be held unconstitutional, the decision of the court shall not affect or impair any of the remaining provisions of this article. It is hereby declared to be the legislative intent that this article would have been adopted had such unconstitutional provisions […]