NAC652.282. Duties of director: Testing procedures and results.

A director shall ensure that:

     1. The testing systems developed and used for each of the tests performed in the laboratory result in services of high quality for the analytic phase of each test and any activities conducted before and after that phase.

     2. Acceptable levels of analytical performance are established and maintained for each testing system.

     3. The methodology selected for each test yields results of a sufficient quality to provide for the care of patients.

     4. The procedures used for the verification of testing methods are adequate to determine the accuracy, precision and other pertinent characteristics of performance for those methods.

     5. Testing is performed in such a manner as required by federal and state statute and regulation, and any policies and protocols adopted by the laboratory.

     6. The reports of testing results include the pertinent information required to interpret those results.

     7. Programs of quality control and quality assurance are established and maintained to ensure the quality of the laboratory’s services and to identify any failure of quality when it occurs, and that records of such programs are maintained by the laboratory for at least 2 years.

     8. Whenever there is a significant deviation from the laboratory’s established specifications for performance:

     (a) Any necessary remedial action is taken and documented; and

     (b) The results of patients’ tests are not reported until the deviation is corrected.

     (Added to NAC by Bd. of Health, eff. 10-22-93; A by R177-97, 1-30-98)