1. (1) A clinical laboratory shall register with the department of health and welfare on a department form prior to accepting specimens for testing.
2. (2) Registered clinical laboratories shall submit a completed registration form every two (2) years and indicate any changes in laboratory operations.

3. (3) To be registered, a clinical laboratory shall submit evidence of certification from one (1) of the following:

   1. (a) The centers for medicare and medicaid services (CMS) clinical laboratory improvement amendments certification program;
   2. (b) An agency approved by CMS as an accreditation program; or
   3. (c) Other certification programs approved by the department of health and welfare.

4. (4) The following laboratories and facilities are excluded from compliance with this chapter:

   1. (a) Teaching, research, forensic, and pre-employment drug screening laboratories, if test results are not used for diagnosis or treatment;
   2. (b) Prosthetic dental laboratories; and
   3. (c) Facilities performing skin testing solely for the detection of allergies and sensitivities.

[56-2302, added 2025, ch. 84, sec. 14, p. 398.]