T56CH23
Title 56 > T56CH23
Sections (4)
56-2301
TITLE 56 PUBLIC ASSISTANCE AND WELFARE CHAPTER 23 QUALITY ASSURANCE FOR CLINICAL LABORATORIES 56-2301. short title. This chapter shall be known and may be cited as the Quality Assurance for Clinical Laboratories. History: [56-2301, added 2025, ch. 84, sec. 14, p. 398.]
56-2302
TITLE 56 PUBLIC ASSISTANCE AND WELFARE CHAPTER 23 QUALITY ASSURANCE FOR CLINICAL LABORATORIES 56-2302. registration requirements. (1) A clinical laboratory shall register with the department of health and welfare on a department form prior to accepting specimens for testing. (2) Registered clinical laboratories shall submit a completed registration form every two (2) years and indicate any changes in laboratory operations. (3) To be registered, a clinical laboratory shall submit evidence of certification from one (1) of the following: (a) The centers for medicare and medicaid services (CMS) clinical laboratory improvement amendments certification program; (b) An agency approved by CMS as an accreditation program; or (c) Other certification programs approved by the department of health and welfare. (4) The following laboratories and facilities are excluded from compliance with this chapter: (a) Teaching, research, forensic, and pre-employment drug screening laboratories, if test results are not used for diagnosis or treatment; (b) Prosthetic dental laboratories; and (c) Facilities performing skin testing solely for the detection of allergies and sensitivities. History: [56-2302, added 2025, ch. 84, sec. 14, p. 398.]
56-2303
TITLE 56 PUBLIC ASSISTANCE AND WELFARE CHAPTER 23 QUALITY ASSURANCE FOR CLINICAL LABORATORIES 56-2303. department inspections. Qualified representatives of the department of health and welfare are authorized to inspect any registered clinical laboratory to determine the adequacy of the supervision, staffing, and quality assurance program. History: [56-2303, added 2025, ch. 84, sec. 14, p. 399.]
56-2304
TITLE 56 PUBLIC ASSISTANCE AND WELFARE CHAPTER 23 QUALITY ASSURANCE FOR CLINICAL LABORATORIES 56-2304. general requirements. (1) A clinical laboratory shall have adequate space, equipment, and supplies to perform the services offered by the laboratory with accuracy, precision, and safety. (2) Practitioners legally authorized to diagnose, treat, and prescribe are authorized to order both waived and nonwaived tests and receive results. Laboratory directors are authorized to order the waived tests listed on an approved registration form and receive results. (3) Clinical laboratories shall satisfactorily participate in proficiency testing programs approved by the department of health and welfare and ensure all proficiency testing results are available to the department. (4) Clinical laboratories shall: (a) Identify the person responsible for performing a procedure; (b) Maintain testing records for at least two (2) years and ensure that test reports are readily accessible upon request; and (c) Identify specimens referred to other certified laboratories and identify the reference laboratory by name and address. History: [56-2304, added 2025, ch. 84, sec. 14, p. 399.]