Original jurisdiction in case of David S. Masland, M.D.; H. Robert Davis, M.D.; John J. Hanlon, M.D.; and the Pennsylvania Medical Society v. Leonard Bachman, M.D., the Secretary of Health of the Commonwealth of Pennsylvania, and the Department of Health of the Commonwealth of Pennsylvania.
Lewis S. Kunkel, Jr., with him Fred Speaker, Thomas B. Schmidt, III, and Pepper, Hamilton & Scheetz, for plaintiffs.
Jay Alexander Gold, Assistant Attorney General, with him Jennifer A. Stiller, Assistant Attorney General, Jeffrey B. Schwartz, Chief Counsel, and Robert P. Kane, Attorney General, for defendants.
Judges Crumlish, Jr., Kramer, Wilkinson, Jr., Mencer, Rogers and Blatt. President Judge Bowman did not participate. Opinion by Judge Rogers. Judges Wilkinson and Blatt concur in this Opinion.
[ 25 Pa. Commw. Page 437]
The Analytical-Biochemical-Biological Laboratory Act, Act of September 26, 1951, P.L. 1539, as amended, 35 P.S. § 2151 et seq., subjected to State regulation by the Department of Health of:
"[a]ny place, establishment or institution organized and operated primarily for the performance of all or any bacteriological, biochemical, microscopical, serological, or parasitological tests by the practical application of one or more of the fundamental sciences to material originating from the human body, by the use of specialized apparatus, equipment and methods, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health.
"The term 'Department' means the Department of Health." Section 2, 35 P.S. § 2152.
Section 13, 35 P.S. § 2163, exempted from the operation of the Act a number of specified kinds of laboratories, including "a laboratory operated by a physician licensed to practice in this Commonwealth, provided such laboratory is operated solely in connection with the diagnosis and treatment of his own patients."
[ 25 Pa. Commw. Page 438]
The Analytical-Biochemical-Biological Laboratory Act was extensively amended by the Act of December 6, 1972, P.L. 1388, 35 P.S. § 2151 et seq. (Supp. 1975-1976). The name was changed to The Clinical Laboratory Act. A number of the exemptions provided in the earlier version of the Act were dropped in the amended version, including the exemption of laboratories of licensed physicians operated solely in connection with the diagnosis and treatment of patients.*fn1 However, the term Clinical Laboratory was defined in the amended version by words identical to those used to define Analytical-Biochemical-Biological Laboratory in the original.
By amendment to the original form of the Act made in 1962*fn2 and untouched by the 1972 amendments, the Department of Health was empowered to adopt rules and regulations "for the proper enforcement of the Act with regard to . . . other matters it may deem advisable for the protection of the public and for carrying out the provisions and purposes of this Act."
[ 25 Pa. Commw. Page 2129]
The subject of this lawsuit in our original jurisdiction is the following proposed regulations of the Department of Health, published at Vol. 5, Number 35, ...