PRINTER'S NO. 430
No. 390 Session of 1989
INTRODUCED BY GLADECK, VEON, DAVIES, McHALE, TRELLO, MAIALE,
NAHILL, MORRIS, E. Z. TAYLOR, DeLUCA, SERAFINI, RITTER,
SAURMAN, HECKLER, CORNELL, J. L. WRIGHT, FARMER, LAUGHLIN,
ROBINSON, BUNT, LASHINGER, FOX, CORRIGAN AND REBER,
FEBRUARY 13, 1989
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, FEBRUARY 13, 1989
AN ACT
1 Amending the act of September 26, 1951 (P.L.1539, No.389),
2 entitled, as amended, "An act defining clinical laboratory;
3 regulating the operation of the same; requiring such
4 laboratories to obtain permits, and to be operated under the
5 direct supervision of qualified persons; imposing certain
6 duties upon the Department of Health; and providing
7 penalties," further providing for the inspection of
8 laboratories and for the regulatory powers of the Department
9 of Health.
10 The General Assembly of the Commonwealth of Pennsylvania
11 hereby enacts as follows:
12 Section 1. Sections 11 and 11.1 of the act of September 26,
13 1951 (P.L.1539, No.389), known as The Clinical Laboratory Act,
14 amended or added August 4, 1961 (P.L.920, No.400), are amended
15 to read:
16 Section 11. Inspection.--The department may at any time
17 visit, enter, examine and inspect the premises occupied,
18 maintained and conducted by any laboratory, and may examine all
19 matters in relation thereto. Periodically, and at least once
20 annually, the department shall verify the accuracy of the work
1 of each laboratory using such means and standards as the
2 department shall specify by rule or regulation.
3 Section 11.1. Rules and Regulations.--The Department of
4 Health shall have the power, and its duty shall be, to adopt
5 rules and regulations for the proper enforcement of this act
6 with regard to the following:
7 (1) Contents of application;
8 (2) Adequacy of laboratory quarters and equipment;
9 (3) Means and standards of accuracy of laboratory
10 procedures, including, but not limited to, limits on the number
11 of slides examined by cytotechnologists per day;
12 (4) Definition of unethical practice and unethical
13 advertising;
14 (5) Any other matters it may deem advisable for the
15 protection of the public and for carrying out the provisions and
16 purposes of this act.
17 Section 2. This act shall take effect in 60 days.
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