A01119
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
712
Session of
2023
INTRODUCED BY BROWN, PENNYCUICK, CULVER, BOSCOLA, DUSH,
BREWSTER, SCHWANK AND J. WARD, MAY 26, 2023
REFERRED TO HEALTH AND HUMAN SERVICES, MAY 26, 2023
AN ACT
Amending the act of September 26, 1951 (P.L.1539, No.389),
entitled "An act defining clinical laboratory; regulating the
operation of the same; requiring such laboratories to obtain
permits, and to be operated under the direct supervision of
qualified persons; imposing certain duties upon the
Department of Health; and providing penalties," further
providing for definitions and for exemptions and providing
for advertisements for laboratory tests and for source plasma
donation center; and abrogating a regulation.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The act of September 26, 1951 (P.L.1539, No.389),
known as The Clinical Laboratory Act, is amended by adding a
section to read:
Section 1. Section 2 of the act of September 26, 1951
(P.L.1539, No.389), known as The Clinical Laboratory Act, is
amended by adding definitions to read:
Section 2. Definitions.--The following words and phrases
when used in this act shall have the meanings given to them in
this section unless the context clearly indicates otherwise:
* * *
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
"Plasma." The fluid portion of human blood.
"Plasmapheresis." A procedure in which, during a single
visit to a facility, blood is removed from an individual, the
source plasma is separated from the formed elements and at least
the red blood cells are returned to the donor.
"Source Plasma Donation Center." A facility where plasma is
collected by plasmapheresis and used as source material for
further manufacturing use. The term shall not include single-
donor plasma products intended for intravenous use.
* * *
Section 2. Section 13 of the act is amended to read:
Section 13. Exemptions.--This act shall not include nor
apply to any laboratory or laboratories maintained and operated
by the Federal government; nor to any laboratory or laboratories
maintained and operated purely for research or teaching
purposes; nor to any source plasma donation center.
Section 3. The act is amended by adding sections to read:
Section 13.3. Advertisements for Laboratory Tests.--(a) A
clinical laboratory certified under 42 U.S.C. § 263a (relating
to certification of laboratories) and a clinical laboratory
operating under this act may directly or indirectly advertise or
solicit business for diagnostic laboratory testing if all of the
following apply:
(1) For diagnostic testing, the testing is ordered by a
health care practitioner licensed in this Commonwealth or
another person otherwise authorized by the laws of this
Commonwealth to order the test.
(2) The testing is performed by the clinical laboratory.
(3) The clinical laboratory is a covered entity or a
business associate of a covered entity for the purpose of
A01119 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
compliance with the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936)
and the Health Information Technology for Economic and Clinical
Health Act (Public Law 111-5, 123 Stat. 226-279 and 467-496).
(4) The clinical laboratory does not make a claim about the
reliability and validity of the testing that is inconsistent
with the testing proficiency standards under 42 U.S.C. § 263a.
(5) The clinical laboratory discloses that the diagnostic
laboratory test or procedure may or may not be covered by health
insurance.
(b) The department may prohibit the use of a clinical
laboratory's advertisement or solicitation of business for
diagnostic laboratory testing under subsection (a) or impose a
penalty authorized under section 14(b) if the department
determines any of the following:
(1) The diagnostic laboratory testing poses a public threat.
(2) The diagnostic laboratory testing is not in compliance
with this section.
(c) As used in this section, the following words and phrases
shall have the meanings given to them in this subsection unless
the context clearly indicates otherwise:
"Business associate." As defined in 45 CFR 160.103 (relating
to definitions).
"Covered entity." As defined in 45 CFR 160.103.
"Diagnostic laboratory testing." The term includes genetic
testing or procedures for the purpose of screening, diagnosing,
managing or treating a physical or mental condition or disease.
Testing or procedures performed for the purpose of screening,
diagnosing, predisposing, managing or treating a physical or
mental condition or disease. The term shall include germline
A01119 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
genetic and genomic testing.
Section 13.4. Source Plasma Donation Center.--
Notwithstanding any other law, a source plasma donation center
may collect source plasma through plasmapheresis if the source
plasma donation center complies with Federal requirements
governing the collection of source plasma and operation of a
clinical laboratory, including laws governing donor screening
and monitoring, staff qualifications, responsibilities,
supervision, training and duties, in a source plasma donation
center and clinical laboratory.
Section 2 4. The regulations at 28 Pa. Code § 5.73 are
abrogated.
Section 3 5. This act shall take effect immediately.
A01119 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13