1Amending the act of September 26, 1951 (P.L.1539, No.389),
2entitled, as amended, "An act defining clinical laboratory;
3regulating the operation of the same; requiring such
4laboratories to obtain permits, and to be operated under the
5direct supervision of qualified persons; imposing certain
6duties upon the Department of Health; and providing
7penalties," further providing for definitions, for
8inspection, for unlawful conduct and for penalty.

9The General Assembly of the Commonwealth of Pennsylvania
10hereby enacts as follows:

11Section 1. Section 2 of the act of September 26, 1951
12(P.L.1539, No.389), known as The Clinical Laboratory Act,
13amended December 6, 1972 (P.L.1388, No.297), is amended to read:

14Section 2. Definitions.--The [term] following words and 
15phrases when used in this act shall have the meanings given to 
16them in this section unless the context clearly indicates 

18"Accept." The act of receiving specimens that are properly

1collected, separated, labeled, coded, inputted and packaged for 
2shipment or transport to a clinical laboratory operating in 
3accordance with the provisions of this act.

4"Clinical Laboratory." [means any] Any place, establishment
5or institution organized and operated primarily for the
6performance of all or any bacteriological, biochemical,
7microscopical, serological, or parasitological tests by the
8practical application of one or more of the fundamental sciences
9to material originating from the human body, by the use of
10specialized apparatus, equipment and methods, for the purpose of
11obtaining scientific data which may be used as an aid to
12ascertain the state of health.

13[The term] "Department." [means the] The Department of
14Health[.] of the Commonwealth.

<-15"Health care practitioner." As defined in section 103 of the 
16act of July 19, 1979 (P.L.130, No.48), known as the "Health Care 
17Facilities Act."

18"Health care provider." As defined in section 103 of the act
19of July 19, 1979 (P.L.130, No.48), known as the "Health Care
20Facilities Act."

21"Specimen collection." The instruction, acquisition,
22separation, labeling, handling, coding or data entry of any
23material originating from the human body for testing to aid or
24ascertain a person's state of health.

25Section 2. Section 11 of the act, amended August 4, 1961
26(P.L.920, No.400), is amended to read:

27Section 11. Inspection.--The department [may at any time
28visit, enter, examine and inspect the premises occupied,
29maintained and conducted by any laboratory, and may examine all
30matters in relation thereto. Periodically the department shall

1verify the accuracy of the work of each laboratory using such
2means and standards as the department shall specify by rule or
3regulation.] shall have the authority to:

4(1) Investigate the facts submitted in an application for
5permit or renewal of a permit by any person to operate a
6clinical laboratory and conduct inspections as necessary.

7(2) Promulgate regulations for the criteria and manner to
8investigate or inspect a clinical laboratory.

9(3) Maintain access to and enter upon the premises of a
10clinical laboratory to enforce the provisions of this act.

11(4) Exempt or limit out-of-State clinical laboratories from
12the department's inspection process provided the out-of-State
13clinical laboratory:

14(i) is <-accredited, certified or licensed under the Clinical
15Laboratories Improvement Act of 1967 (Public Law 90-174, 81
16Stat. 533) <-certified or accredited under section 353 of the
17Public Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) and,
18to the extent applicable, by the state that has issued a license
19or permit to operate a clinical laboratory; and

20(ii) provides proof to the department that the clinical
21laboratory applying for a permit or renewal of a permit has met
22the requirements for exemption of the inspection process under
23this section.

24Section 3. Sections 13.1 and 14 of the act, amended or added
25December 6, 1972 (P.L.1388, No.297), are amended to read:

26Section 13.1. Unlawful Conduct.--[It shall be unlawful for
27any person to solicit, receive, accept, deliver or transmit, by
28mail or otherwise, material originating from the human body on
29behalf of any person operating a laboratory not in possession of
30a permit under this act regardless of whether such laboratory is

1located in this Commonwealth. The provisions of this section
2shall not apply to transactions with any person operating a
3laboratory located in another state, which laboratory has been
4issued a license or permit in conformity with the "Clinical
5Laboratories Improvement Act of 1967," and related statutes.
6Neither shall this section apply to transactions with
7laboratories operated in this State which are exempt from the
8permit requirements of this act.] (a) Except as provided in 
9section 13, it shall be unlawful for a person or clinical 
10laboratory regardless of whether the person or clinical 
11laboratory is located in this Commonwealth <-or maintains a permit 
12issued by the department to:

13(1) Solicit, collect, process, handle, receive, accept,
14deliver or transmit, by mail or otherwise, material originating
15from the human body on behalf of a person or clinical laboratory
16except that this section may not prohibit a clinical laboratory
17from referring a specimen to another clinical laboratory issued
18a license or permit in conformity with the Clinical Laboratories
19Improvement Act of 1967 (Public Law 90-174, 81 Stat. 533) and
20related State laws. <-to solicit, collect, process, handle,
21receive, accept, deliver or transmit, by mail or otherwise,
22material originating from the human body on behalf of a person
23or clinical laboratory not in possession of a permit under this
24act, except that this section may not prohibit a clinical
25laboratory holding a permit from the department from referring a
26specimen to another clinical laboratory holding a permit from
27the department or to a clinical laboratory issued a certificate
28or accreditation in conformity with section 353 of the Public
29Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) and related
30State laws.

1(b) It shall be unlawful for a person or clinical laboratory
2regardless of whether the person or clinical laboratory is
3located in this Commonwealth or maintains a permit issued by the
4department to:

<-5(2) (1) Pay or receive a commission, bonus, kickback or
6rebate or engage in a split-fee arrangement in any form with a
7health care provider or <-other provider health care practitioner,
8either directly or indirectly, for patients or their specimens
9referred to any clinical laboratory operating within this
10Commonwealth or testing a specimen accepted or collected within
11this Commonwealth.

<-12(3) (2) Lease or rent space, shelves or equipment or other
13services within a health care provider's office or <-other
14provider's <-health care practitioner's office including the
15leasing or renting of space within a part of a health care
16provider's <-or health care practitioner's office for the purpose
17of establishing a collection station.

<-18(4) (3) Directly or indirectly provide through employees, 
19contractors, an independent staffing company, lease agreement or 
20otherwise, personnel to perform functions or duties in a health 
21care provider's <-office, or a part of a health care provider's 
22office <-or health care practitioner's office, for any purpose 
23regardless of whether fair market value is offered or given, 
24including for the collection or handling of specimens, unless 
25the clinical laboratory and the physician's <-health care 
26provider's office are wholly owned and operated by the same 

<-28(5) (4) Permit the placement of paid or unpaid personnel to
29perform services, including but not limited to specimen
30collection, processing the specimen or packaging or handling

1services or genetic counseling in a health care provider's or
<-2other provider's or health care practitioner's office regardless
3of whether fair market value is offered or given.

<-4(b) (c) This section does not preclude a clinical laboratory
5from owning or investing in a building in which space is leased
6or rented for adequate and fair consideration to health care
7providers or <-other providers health care practitioners.

8Section 14. Penalty.--(a) Any person operating a clinical
9laboratory without first having obtained a permit from the
10[Department of Health] department or violating the provisions of
11section 13.1 of the act shall, upon conviction thereof, be
12sentenced to pay a fine not exceeding five hundred dollars
13($500) or to imprisonment not exceeding one (1) year, or both.

14(b) In addition to any other penalty that may be imposed by
15the department, the department may assess a civil penalty of up
16to five hundred dollars ($500) per day on a person or clinical
17laboratory that engages in any of the following:

18(1) Violates the provisions of this act or the department's

20(2) Operates a clinical laboratory within this Commonwealth
21without a permit from the department.

22(3) Performs testing without a permit from the department on
23any specimen accepted or collected within this Commonwealth.

24(c) Moneys received from civil penalties imposed by the 
25department on a person or clinical laboratory shall be paid into 
26the State Treasury and shall be credited to the general 
27government appropriations of the department for administering 
28and enforcing the provisions of this act.

29Section 4. This act shall take effect immediately.