36-451
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36-451. Definitions In this chapter, unless the context otherwise requires: 1. "Accredited laboratory" means a laboratory which has received accreditation from an accreditation program approved by the secretary of the United States department of health and human services to meet standards of the federal clinical laboratory improvement amendments of 1988 (P.L. 100-518). 2. "Approved proficiency testing program" means a proficiency testing program which is approved and conducted by an accredited body approved by the secretary of the United States department of health and human services to meet the standards of the federal clinical laboratory improvement amendments of 1988 (P.L. 100-518). 3. "Certified laboratory" means a laboratory certified by the United States department of health and human services. 4. "Clinical laboratory" or "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. Clinical laboratory does not include law enforcement crime laboratories. 5. "Department" means the department of health services. 6. "Director" means the director of the department of health services. 7. "Federally licensed laboratory" means a laboratory licensed pursuant to the United States clinical laboratory improvement amendments of 1988 (P.L. 100-518). 8. "Governing authority" means the individual, agency, group or corporation that is appointed, elected or otherwise designated and that has the ultimate responsibility and authority for the conduct of the health care institution. 9. "Health care institution" has the same meaning as prescribed in section 36-401. 10. "License" means a regular license, renewal license or provisional license issued by the department pursuant to this chapter. 11. "Person" means any individual, firm, partnership, association or corporation, whether or not organized for profit, or any other form of business enterprise. |