Masland v. Bachman
| Citation | 374 A.2d 517,473 Pa. 280 |
| Parties | David S. MASLAND, M.D., H. Robert Davis, M.D., John J. Hanlon, M.D., and the Pennsylvania Medical Society, Appellants, v. Leonard BACHMAN, M.D. the Secretary of Health of the Commonwealth of Pennsylvania, and the Department of Health of the Commonwealth of Pennsylvania. |
| Decision Date | 03 June 1977 |
| Court | United States State Supreme Court of Pennsylvania |
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.
Before EAGEN, C. J., and O'BRIEN, ROBERTS, POMEROY, NIX and MANDERINO, JJ.
The question presented in this appeal 1 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 2 (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." 3 On August 16, 1975, the Department promulgated a regulation subjecting clinical laboratories of private physicians to regulation under the Act. 4 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 rulemaking 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. 5
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 6 in 1951, was enacted to ensure that clinical laboratory testing was accurately performed by competently supervised professionals. The preamble to the Act provides:
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." 8 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. 9 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. 10 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. " 11
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." 12 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, 13 after the 1961 amendments, only laboratories of private physicians "operated solely in connection with the diagnosis and treatment of his own patients" 14 were exempt.
In 1972, the Legislature amended the Act again, 15 changing its title to the Clinical Laboratory Act. The Legislature retained the preamble and the definition of a "laboratory" from the original Act, but substituted the phrase "clinical laboratory" wherever "analytical-biochemical-biological laboratory" had been used. 16 In addition, the 1972 amendments eliminated the exemptions for the following types of laboratories: (1) laboratories maintained and operated by state, county or municipal governments; (2) office laboratories operated by private physicians solely for the diagnosis and treatment of his or her own patients; (3) hospital laboratories; and (4) industrial laboratories. Following the 1972 amendments, the only remaining exemptions are for laboratories maintained and operated by the federal government and those operated solely for research or teaching purposes. 17
To implement the 1972 amendment, the Department promulgated a regulation which subjected previously exempt clinical laboratories to regulation under the Act. The regulation defines "clinical laboratory" to include "all independent, hospital, industrial, state, county and municipal laboratories and all clinical laboratories operated in private offices and clinics of practitioners of the healing arts." 18 This regulation applies to all laboratories which were previously exempt under the original Act but whose exemption was deleted by the Legislature in 1972.
A. Appellants assert that, by its terms, the Act does not extend its coverage to office laboratories of private physicians. The Act is applicable to "clinical laboratories," defined as "any place, establishment or institution organized and operated primarily for the purpose of . . . tests." Appellants contend that the portion of a physician's office which is set aside for laboratory testing is not a "place" within the meaning of the Act. Rather, they maintain that a physician's entire office is a "place." Since a physician's office is organized primarily for the examination and treatment of patients, they argue that a physician's office laboratory, which is only operated as an incident to that purpose, cannot be regulated under the Act. We do not agree.
The Department interprets the Act to include office laboratories of private physicians as "places" within the meaning of the Act. We find the Department's interpretation to be more reasonable than appellants' interpretation. The use of the word "place," in addition to the words "establishment" or "institution," is consistent with the legislative intent to focus on the primary purpose for which a particular area is used, in addition to the primary purpose of the larger organization or institution of which it may be a part. By its common usage, the word "place" may refer to a particular room or area within a larger building or facility, 19 and certainly could be used to refer to the part of a physician's office set aside for tests. Thus, while the word "place" may not be entirely free from ambiguity, we believe that the Department's interpretation of the Act follows from the natural meaning of the statutory language.
B. An examination of the legislative history of the Act resolves any question of the meaning of the Act in favor of the Department's interpretation. The 1972 amendment, which deleted most of the previous exemptions, including the exemption for office laboratories of private physicians "operated solely for the treatment and diagnosis of . . . (their) patients," evinces a legislative intent to regulate these laboratories.
A change in the language of a statute ordinarily indicates a change in legislative intent. 20 As originally enacted in 1951, the Act exempted all laboratories operated by a physician licensed to practice in Pennsylvania. The Act provided in pertinent part:
"This act shall include nor apply to . . . a laboratory operated by a physician licensed to practice in this Commonwealth." 21
In 1961, the Act was amended to narrow the exemption for laboratories of private physicians. Only laboratories used solely for the treatment and diagnosis of a physician's own patients were exempt from the requirements of the Act. 22 In 1972, the Legislature deleted this specific exemption for laboratories of private physicians and thereby mandated that even office laboratories of private physicians which were used solely for the treatment and diagnosis of the physician's own patients should be subject to regulation. 23
The Legislature's elimination of the exemption for private physicians was part of a...
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