Haw. Code R. § 11-110.1-14 - Licensed clinical laboratory; proficiency testing and quality assessment programs

(a) Licensed clinical laboratories shall demonstrate to the department proficiency in the performance of the tests offered by the clinical laboratory through state approved proficiency testing programs. The cost of proficiency testing programs shall be borne by the licensed laboratory. All licensed clinical laboratories are required to demonstrate and maintain proficiency in each of the specialties or subspecialties for which it is licensed.

(b) Each licensed clinical laboratory shall maintain a properly documented quality assessment program that is acceptable to the department. The quality assessment program shall be designed to assure, on a continuous basis, the reliability of all laboratory results. All facilities, equipment, and instruments shall have inherent capabilities consistent with the services offered and shall be maintained in good operating condition.

(c) Each licensed clinical laboratory shall maintain a written preventive maintenance program which details periodic inspection for proper operation of each piece of equipment and instrument, a written program for validation and calibration of equipment, a dependable reagent and glassware evaluation system, and a continuous surveillance of results. Appropriate records showing the dates of inspections, validation, evaluation, and significant actions taken in response to revealed defects, shall be maintained.

(d) Current manuals of methods and technical procedures shall be maintained by the laboratory and shall be made available to clinical laboratory personnel and, for inspection, to representatives of the department.

Notes

Haw. Code R. § 11-110.1-14

[Eff JUL 05 2007] (Auth: HRS § 321-11) (Imp: HRS § 321-11)