PRINTER'S NO. 515
No. 491 Session of 1989
INTRODUCED BY GREENLEAF, SALVATORE, REIBMAN, SHAFFER, HELFRICK,
ANDREZESKI, REGOLI, AFFLERBACH AND DAWIDA, FEBRUARY 10, 1989
REFERRED TO PUBLIC HEALTH AND WELFARE, FEBRUARY 10, 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," providing for testing programs for clinical
8 laboratories.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 Section 1. The act of September 26, 1951 (P.L.1539, No.389),
12 known as The Clinical Laboratory Act, is amended by adding
13 sections to read:
14 Section 11.2. Testing Programs for Clinical Laboratories.--
15 The department shall:
16 1. Require clinical laboratories to submit periodic reports
17 of tests performed and prescribe standards for the examination
18 of specimens, to include determination of the maximum number of
19 specimens an employe of a laboratory may examine on a daily
20 basis.
21 2. Develop a mandatory proficiency testing program for all
1 clinical laboratories, including out-of-State laboratories
2 accepting specimens collected in Pennsylvania, to be
3 administered by the department at least annually.
4 Section 11.3. Quotas Prohibited.--No clinical laboratory
5 operating under this act shall have a quota system for the
6 examination of specimens by any of its technicians or other
7 employes.
8 Section 2. Section 14 of the act, amended December 6, 1972
9 (P.L.1388, No.297), is amended to read:
10 Section 14. Penalty.--Any person [operating] who operates a
11 clinical laboratory without first having obtained a permit from
12 the Department of Health or [violating] who violates the
13 provisions of section 11.3 or 13.1 of [the] this act shall, upon
14 conviction thereof, be sentenced to pay a fine not exceeding
15 five hundred dollars ($500) or to imprisonment not exceeding one
16 (1) year, or both.
17 Section 3. This act shall take effect in 60 days.
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