Health, Department of

Clinical Laboratories, Licensure of

Chapter 5: Level 3 Laboratories

Effective Date: 05/05/2004 to Current

Rule Type: Current Rules & Regulations

Reference Number: 048.0013.5.05052004

RULES AND REGULATIONS FOR

LICENSURE OF CLINICAL LABORATORIES

CHAPTER V

LEVEL III LABORATORIES

Section 1. Description.

Level III laboratories perform any tests that are not listed for Level I and II laboratories. They may perform any or all of those tests listed for Level I and II laboratories.

Section 2. Standards of Licensure for Reference Laboratories.

(a) Reference laboratories that are licensed under CLIA, certified for Medicare, accredited by JCAHO or CAP, shall be deemed to have met the licensure requirements of this act, except as noted below. The state agency reserves the right to inspect these laboratories, if it deems necessary, and shall give a (thirty) 30 day notice prior to such inspection.

(b) Reference laboratories that are not licensed, certified, or accredited as in (a) above shall be inspected at least once every two (2) years by the state agency. Such inspection shall meet or exceed the Medicare standards for independent laboratories. The state agency shall give thirty (30) day notice prior to inspection.

(c) All reference laboratories shall satisfactorily participate in a state approved proficiency testing program and shall forward a copy of the proficiency testing result report(s) to the state agency. Satisfactory performance shall be based on the criteria of acceptable performance established by the provider of the materials. If such information is unavailable, the following criteria shall be used:

(i) For all test categories except immunohematology, the laboratory shall achieve a grade of seventy-five percent (75%) or better;

(ii) For immunohematology, a score of ninety percent (90%) or better shall be achieved;

(iii) Grades shall be determined by agreement with the reference results given by the provider of the materials, with allowance for deviation from the mean, where such consideration is applicable.

(d) All reference laboratories shall have a minimum of one (1) qualified supervisor, as specified in Chapter II, Section 2, and have a sufficient number of qualified personnel for the volume and diversity of tests performed.

(e) Qualified supervisor(s) shall be under the direction of the director and shall supervise technical personnel, reporting, and performing tests requiring special scientific services. In the absence of the director or where provisional directorship is provided, the supervisors shall be responsible for the proper performance of all laboratory procedures and reporting. A laboratory director may be a supervisor.

Section 3. Standards for Licensure of Physician Office Laboratories.

(a) All physician office laboratories shall be inspected at least once every year. Such inspection shall meet or exceed the Medicare standards for record keeping and quality control that can be applied to physician office laboratories.

(b) All physician office laboratories shall satisfactorily participate in a state approved proficiency testing program and shall forward a copy of the proficiency testing result report(s) to the state agency. Satisfactory participation shall be based on the same criteria noted in Section 2 (c) of this Chapter.