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 
17otherwise:

18"Accept." The act of receiving specimens that are properly 
19collected, separated, labeled, coded, inputted and packaged for 
20shipment or transport to a clinical laboratory operating in
 

1accordance with the provisions of this act.

2"Clinical Laboratory." [means any] Any place, establishment
3or institution organized and operated primarily for the
4performance of all or any bacteriological, biochemical,
5microscopical, serological, or parasitological tests by the
6practical application of one or more of the fundamental sciences
7to material originating from the human body, by the use of
8specialized apparatus, equipment and methods, for the purpose of
9obtaining scientific data which may be used as an aid to
10ascertain the state of health.

11[The term] "Department." [means the] The Department of
12Health[.] of the Commonwealth.

13"Specimen collection." The instruction, acquisition,
14separation, labeling, handling, coding or data entry of any
15material originating from the human body for testing to aid or
16ascertain a person's state of health.

17Section 2. Section 11 of the act, amended August 4, 1961
18(P.L.920, No.400), is amended to read:

19Section 11. Inspection.--The department [may at any time
20visit, enter, examine and inspect the premises occupied,
21maintained and conducted by any laboratory, and may examine all
22matters in relation thereto. Periodically the department shall
23verify the accuracy of the work of each laboratory using such
24means and standards as the department shall specify by rule or
25regulation.] shall have the authority to:

26(1) Investigate the facts submitted in an application for
27permit or renewal of a permit by any person to operate a
28clinical laboratory in this Commonwealth and conduct inspections
29as necessary.

30(2) Promulgate regulations for the criteria and manner to

1investigate or inspect a clinical laboratory.

2(3) Maintain access to and enter upon the premises of a
3clinical laboratory to enforce the provisions of this act.

4(4) Exempt or limit out-of-State clinical laboratories from
5the department's inspection process provided the out-of-State
6clinical laboratory:

7(i) is accredited, certified or licensed under the Clinical
8Laboratories Improvement Act of 1967 (Public Law 90-174, 81
9Stat. 533) and, to the extent applicable, by the state that has
10issued a license or permit to operate a clinical laboratory; and

11(ii) provides proof to the department that the clinical
12laboratory applying for a permit or renewal of a permit has met
13the requirements for exemption of the inspection process under
14this section.

15Section 3. Sections 13.1 and 14 of the act, amended or added
16December 6, 1972 (P.L.1388, No.297), are amended to read:

17Section 13.1. Unlawful Conduct.--[It shall be unlawful for
18any person to solicit, receive, accept, deliver or transmit, by
19mail or otherwise, material originating from the human body on
20behalf of any person operating a laboratory not in possession of
21a permit under this act regardless of whether such laboratory is
22located in this Commonwealth. The provisions of this section
23shall not apply to transactions with any person operating a
24laboratory located in another state, which laboratory has been
25issued a license or permit in conformity with the "Clinical
26Laboratories Improvement Act of 1967," and related statutes.
27Neither shall this section apply to transactions with
28laboratories operated in this State which are exempt from the
29permit requirements of this act.] (a) Except as provided in 
30section 13, it shall be unlawful for a person or clinical
 

1laboratory regardless of whether the person or clinical 
2laboratory is located in this Commonwealth or maintains a permit 
3issued by the department to:

4(1) Solicit, collect, process, handle, receive, accept,
5deliver or transmit, by mail or otherwise, material originating
6from the human body on behalf of a person or clinical laboratory
7except that this section may not prohibit a clinical laboratory
8from referring a specimen to another clinical laboratory issued
9a license or permit in conformity with the Clinical Laboratories
10Improvement Act of 1967 (Public Law 90-174, 81 Stat. 533) and
11related State laws.

12(2) Pay or receive a commission, bonus, kickback or rebate
13or engage in a split-fee arrangement in any form with a health
14care provider or other provider, either directly or indirectly,
15for patients referred to a clinical laboratory operating within
16this Commonwealth.

17(3) Lease or rent space, shelves or equipment or other
18services within a health care provider's office or other
19provider's office including the leasing or renting of space
20within a part of a health care provider's office for the purpose
21of establishing a collection station.

22(4) Directly or indirectly provide through employees, 
23contractors, an independent staffing company, lease agreement or 
24otherwise, personnel to perform functions or duties in a health 
25care provider's office, or a part of a health care provider's 
26office, for any purpose regardless of whether fair market value 
27is offered or given, including for the collection or handling of 
28specimens, unless the clinical laboratory and the physician's 
29office are wholly owned and operated by the same entity.

30(5) Permit the placement of paid or unpaid personnel to

1perform services, including but not limited to specimen
2collection, processing the specimen or packaging or handling
3services or genetic counseling in a health care provider's or
4other provider's office regardless of whether fair market value
5is offered or given.

6(b) This section does not preclude a clinical laboratory
7from owning or investing in a building in which space is leased
8or rented for adequate and fair consideration to health care
9providers or other providers.

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

16(b) The department may assess a civil penalty of up to five
17hundred dollars ($500) per day on a person or clinical
18laboratory that engages in any of the following:

19(1) Violates the provisions of this act or the department's
20regulations.

21(2) Operates a clinical laboratory within this Commonwealth
22without a permit from the department.

23(3) Performs testing without a permit from the department on
24any specimen accepted or collected within this Commonwealth.

25(c) Moneys received from civil penalties imposed by the 
26department on a person or clinical laboratory shall be paid into 
27the State Treasury and shall be credited to the general 
28government appropriations of the department for administering 
29and enforcing the provisions of this act.

30Section 4. This act shall take effect immediately.