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 
19collected, separated, labeled, coded, inputted and packaged for

1shipment or transport to a clinical laboratory operating in 
2accordance with the provisions of this act.

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

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

14"Specimen collection." The instruction, acquisition,
15separation, labeling, handling, coding or data entry of any
16material originating from the human body for testing to aid or
17ascertain a person's state of health.

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

20Section 11. Inspection.--The department [may at any time
21visit, enter, examine and inspect the premises occupied,
22maintained and conducted by any laboratory, and may examine all
23matters in relation thereto. Periodically the department shall
24verify the accuracy of the work of each laboratory using such
25means and standards as the department shall specify by rule or
26regulation.] shall have the authority to:

27(1) Investigate the facts submitted in an application for
28permit or renewal of a permit by any person to operate a
29clinical laboratory <-in this Commonwealth and conduct inspections
30as necessary.

1(2) Promulgate regulations for the criteria and manner to
2investigate or inspect a clinical laboratory.

3(3) Maintain access to and enter upon the premises of a
4clinical laboratory to enforce the provisions of this act.

5(4) Exempt or limit out-of-State clinical laboratories from
6the department's inspection process provided the out-of-State
7clinical laboratory:

8(i) is accredited, certified or licensed under the Clinical
9Laboratories Improvement Act of 1967 (Public Law 90-174, 81
10Stat. 533) and, to the extent applicable, by the state that has
11issued a license or permit to operate a clinical laboratory; and

12(ii) provides proof to the department that the clinical
13laboratory applying for a permit or renewal of a permit has met
14the requirements for exemption of the inspection process under
15this section.

16Section 3. Sections 13.1 and 14 of the act, amended or added
17December 6, 1972 (P.L.1388, No.297), are amended to read:

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

1section 13, it shall be unlawful for a person or clinical 
2laboratory regardless of whether the person or clinical 
3laboratory is located in this Commonwealth or maintains a permit 
4issued by the department to:

5(1) Solicit, collect, process, handle, receive, accept,
6deliver or transmit, by mail or otherwise, material originating
7from the human body on behalf of a person or clinical laboratory
8except that this section may not prohibit a clinical laboratory
9from referring a specimen to another clinical laboratory issued
10a license or permit in conformity with the Clinical Laboratories
11Improvement Act of 1967 (Public Law 90-174, 81 Stat. 533) and
12related State laws.

13(2) Pay or receive a commission, bonus, kickback or rebate
14or engage in a split-fee arrangement in any form with a health
15care provider or other provider, either directly or indirectly,
16for patients or their specimens referred to <-a any clinical
17laboratory operating within this Commonwealth <-or testing a
18specimen accepted or collected within this Commonwealth.

19(3) Lease or rent space, shelves or equipment or other
20services within a health care provider's office or other
21provider's office including the leasing or renting of space
22within a part of a health care provider's office for the purpose
23of establishing a collection station.

24(4) Directly or indirectly provide through employees, 
25contractors, an independent staffing company, lease agreement or 
26otherwise, personnel to perform functions or duties in a health 
27care provider's office, or a part of a health care provider's 
28office, for any purpose regardless of whether fair market value 
29is offered or given, including for the collection or handling of 
30specimens, unless the clinical laboratory and the physician's

1office are wholly owned and operated by the same entity.

2(5) Permit the placement of paid or unpaid personnel to
3perform services, including but not limited to specimen
4collection, processing the specimen or packaging or handling
5services or genetic counseling in a health care provider's or
6other provider's office regardless of whether fair market value
7is offered or given.

8(b) This section does not preclude a clinical laboratory
9from owning or investing in a building in which space is leased
10or rented for adequate and fair consideration to health care
11providers or other providers.

12Section 14. Penalty.--(a) Any person operating a clinical
13laboratory without first having obtained a permit from the
14[Department of Health] department or violating the provisions of
15section 13.1 of the act shall, upon conviction thereof, be
16sentenced to pay a fine not exceeding five hundred dollars
17($500) or to imprisonment not exceeding one (1) year, or both.

18(b) <-The In addition to any other penalty that may be imposed
19by the department, the department may assess a civil penalty of
20up to five hundred dollars ($500) per day on a person or
21clinical laboratory that engages in any of the following:

22(1) Violates the provisions of this act or the department's

24(2) Operates a clinical laboratory within this Commonwealth
25without a permit from the department.

26(3) Performs testing without a permit from the department on
27any specimen accepted or collected within this Commonwealth.

28(c) Moneys received from civil penalties imposed by the 
29department on a person or clinical laboratory shall be paid into 
30the State Treasury and shall be credited to the general

1government appropriations of the department for administering 
2and enforcing the provisions of this act.

3Section 4. This act shall take effect immediately.