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.]