PRINTER'S NO. 2674
No. 2033 Session of 2003
INTRODUCED BY FRANKEL, BEBKO-JONES, BELFANTI, CORRIGAN, CURRY,
DeLUCA, DeWEESE, FABRIZIO, GOODMAN, GRUCELA, HORSEY, JAMES,
JOSEPHS, KIRKLAND, ROSS, WANSACZ, WASHINGTON AND YOUNGBLOOD,
SEPTEMBER 29, 2003
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE,
SEPTEMBER 29, 2003
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 the use of home tests by
8 physicians.
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 a
13 section to read:
14 Section 11.2. Use of FDA-approved and Clinical Laboratory
15 Improvement Act (CLIA) Waived Point-of-care and At-home Testing
16 Equipment by Physicians.--(a) Notwithstanding any other
17 provision of law, a private physician may utilize in his office
18 laboratory any FDA-approved and CLIA-waived point-of-care
19 testing equipment, including cholesterol profile testing,
1 glucose testing and prothrombin time testing or at-home testing
2 equipment that is available to a patient if all of the following
3 conditions are met:
4 (1) The physician's office laboratory must be licensed by
5 the Bureau of Laboratories and directed by a physician.
6 (2) The personnel of the physician's office laboratory must
7 be trained according to manufacturer's recommendations to use
8 the equipment.
9 (3) The physician's office laboratory may perform testing
10 only on the patients of the physician or those of the practice
11 and may not receive specimens from other offices or
12 laboratories.
13 (4) The physician's office laboratory shall use materials
14 that are in date and are stored and used according to the
15 manufacturer's directions.
16 (5) The physician's office laboratory shall have written
17 procedure manuals or follow supplemental package inserts
18 supplied by the equipment manufacturer.
19 (6) All quality control tests conducted by the physician's
20 office laboratory shall be done in accordance with
21 manufacturer's directions and recorded in a quality control log
22 book.
23 (7) All results of the laboratory tests of a patient shall
24 be entered in the patient's chart.
25 (b) The Bureau of Laboratories may perform an onsite
26 examination of the physician's office laboratory when point-of-
27 care or at-home testing is initiated and every two years
28 thereafter or in lieu of the onsite examination, a self-
29 evaluation questionnaire may be sent to the physician's office
30 laboratory which shall be completed by the physician's office
20030H2033B2674 - 2 -
1 laboratory and returned to the Bureau of Laboratories.
2 Section 2. This act shall take effect in 60 days.
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