Pepper, Hamilton & Scheetz, Fred Speaker, Lewis S. Kunkel, Jr., Thomas B. Schmidt, III, Harrisburg, for appellants.
Jeffrey B. Schwartz, Chief Counsel, Jay Alexander Gold, Asst. Atty. Gen., Harrisburg, for appellees.
Eagen, C. J., and O'Brien, Roberts, Pomeroy, Nix and Manderino, JJ. Pomeroy, J., filed a dissenting opinion in which O'Brien, J., joins.
The question presented in this appeal*fn1 is whether the regulation promulgated by the Pennsylvania Department of Health (Department) subjecting office laboratories of private physicians to regulation under the Clinical Laboratory Act*fn2 (the Act) is a valid exercise of the Department's rule-making power.
The Act provides that "clinical laboratories" are subject to regulation by the Department. Section 2152 of the Act defines a "clinical laboratory" as "any place, establishment or institution organized and operated primarily for the performance of all or any bacteriological, biochemical, microscopical, serological, or parasitological tests."*fn3 On August 16, 1975, the Department promulgated a regulation subjecting clinical laboratories of private physicians to regulation under the Act.*fn4 Appellants,
individual physicians and members of the Pennsylvania Medical Society, brought an action in equity in the Commonwealth Court alleging that the regulation exceeded the Department's rule-making power. Appellants sought injunctive relief and an order rescinding the regulation. The parties agreed that there were no disputed issues of fact and filed cross-motions for summary judgment pursuant to Pa.R.Civ.P. 1035. Because the Commonwealth Court was evenly divided on the issue whether office laboratories of private physicians are subject to regulation under the Act, it held that the issue was "non-justiciable" and dismissed the complaint. The
Commonwealth Court enjoined the enforcement of the regulation pending appeal.*fn5
We hold that the regulation is a valid exercise of the Department's rule-making power. Therefore, we vacate the decree of the Commonwealth Court dismissing the complaint and enter summary judgment in favor of appellees. The injunction is dismissed.
The Clinical Laboratory Act, originally enacted as the Analytical-Biochemical-Biological Laboratory Act*fn6 in 1951, was enacted to ensure that clinical laboratory testing was accurately performed by competently supervised professionals. The preamble to the Act provides:
"Whereas, the health and lives of the citizens of this Commonwealth are endangered by incompetent supervision of clinical laboratory tests; and
"Whereas, a due regard for public health and preservation of human life demands that none but scientists competent and properly qualified by sufficient training in the fundamental sciences and experienced in their applications in the clinical laboratory shall be permitted to supervise the work of such laboratories."*fn7
The Act requires that clinical laboratories obtain permits, operate under a qualified supervisor, and satisfy regulations promulgated by the Department regarding the adequacy of equipment, facilities and laboratory procedures.
Prior to 1972, the Act applied to laboratories within the definition of an "analytical-biochemical-biological laboratory," defined as any "place, establishment or institution organized and operated primarily for the performance of all or any bacteriological, biochemical, microscopical, serological, or parasitological tests."*fn8 Originally, the Act exempted: (1) laboratories maintained and operated by the federal, state, county or municipal government; (2) laboratories maintained and operated for research or teaching purposes; (3) laboratories of private physicians who were licensed to practice in Pennsylvania; (4) hospital laboratories; and (5) laboratories operated in industrial organizations and administered by a duly licensed physician.*fn9 Thus, the broad scope of the exemption suggests that independent commercial laboratories were the primary targets of the original Act.
In 1961, the Act was amended.*fn10 The Department was authorized to adopt rules and regulations for the proper enforcement of the Act regarding:
"(1) Contents of application;
(2) Adequacy of laboratory quarters and equipment;
(3) Means and standards of accuracy of laboratory procedures;
(4) Definition of unethical practice and unethical advertising;
(5) Any other matters it may deem advisable for the protection of the public and for carrying out the provisions and purposes of this act."*fn11
The Department was also empowered to verify the accuracy of the work of each laboratory "using such means and standards as the department shall specify by rule or regulation."*fn12 The 1961 amendments also narrowed the exemption for private physicians. Whereas the Act originally exempted all laboratories operated by a physician licensed to practice in Pennsylvania,*fn13 after the 1961 amendments, only laboratories of private ...