Reagents, procedures or equipment which have been demonstrated to be inadequate for clinical laboratory use as evidenced by reliable data from generally acceptable scientific testing and evaluating sources shall be prohibited for use by clinical laboratories upon specific notification by the Department. Also, reagents, equipment and procedures which do not have substantial proof of efficacy either by trial or extended use experience shall be prohibited for routine use.

Notes of Decisions

Inasmuch as each time it sent in proficiency test results, hospitals had notified Department of Health that it was using a particular type of machine, and inasmuch as the Department had not notified the hospital, under this section, that use of the machine was prohibited, the court could find that the equipment was acceptable. Commonwealth v. O’Hayer, 497 A.2d 649 (Pa. Super. 1985).

Cross References

This section cited in 28 Pa. Code § 5.103 (relating to blood tests for blood alcohol content).