Sponsored by:

Assemblywoman  ANGELICA M. JIMENEZ

District 32 (Bergen and Hudson)


District 30 (Monmouth and Ocean)


Co-Sponsored by:

Senator Rice






     Requires clinical laboratory that provides services for accountable care organization to establish clinical laboratory testing advisory board.



     As reported by the Assembly Health and Senior Services Committee with technical review.


An Act concerning clinical laboratories and amending and supplementing P.L.1975, c.166.


     Be It Enacted by the Senate and General Assembly of the State of New Jersey:


     1.    Section 2 of P.L.1975, c.166 (C.45:9-42.27) is amended to read as follows:

     2.    As used in [this act] P.L.1975, c.166 (C.45:9-42.26 et seq.) and (P.L.   , c.     ) (C.     ) (pending before the Legislature as this bill):

     [a.] "Clinical laboratory" means any facility used for the performance of chemical, bacteriologic, virologic, parasitologic, serologic, hematologic, immunohematologic, biophysical, cytologic, or other examinations of materials derived from the human body for the purpose of yielding information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition.  Anatomic pathology is not considered to be within the scope of this definition.  Any facility used for the collection, processing, and transmission of specimens to another facility for the performance of clinical tests falls within the purview of [this act] P.L.1975, c.166 (C.45:9-42.26 et seq.).

     [b.] "Department" means the [State] Department of Health.

     [c.] "Commissioner" means the [State] Commissioner of Health or [his] the commissioner’s duly authorized agent.

     [d.] "Clinical laboratory owner" means a person or agency in whom is vested the rights of control, possession, and dominion of a clinical laboratory and for the purposes of [this act] P.L.1975, c.166 (C.45:9-42.26 et seq.) shall include a county, municipality, or any other owner of an institution operating a clinical laboratory.

     [e.] "Clinical laboratory director" means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including, but not limited to, supervision of procedures for testing and reporting of results.  Nothing in [this act] P.L.1975, c.166 (C.45:9-42.26 et seq.) shall be deemed to exempt the director of a clinical laboratory from the licensure requirements of  P.L.1953, c.420 (C.45:9-42.1 et seq.), where [such] those requirements would otherwise be applicable.

     [f.] "Clinical laboratory evaluation program"  means a program of evaluating the proficiency of clinical laboratories by the department.

     “Clinical laboratory testing” means testing performed by a clinical laboratory pursuant to P.L.1975, c.166 (C.45:9-42.26 et seq.) or otherwise subject to 42 U.S.C. s.263a.

     [g.] "Anatomic pathology" means the gross or microscopic examination of tissues by a physician specifically trained to interpret and diagnose disease by [such] means of that examination.

     [h.] "Person" means any individual, partnership, limited partnership, corporation, or other legal entity.

(cf: P.L.1975, c.166, s.2)


     2.    (New section)  a.  A clinical laboratory licensed pursuant to P.L.1975, c.166 (C.45:9-42.26 et seq.), which is providing services for an entity that is operating as an accountable care organization in accordance with any applicable requirements of State and federal law, shall be required to establish a clinical laboratory testing advisory board for the purposes of subsection b. of this section.

     b.    The clinical laboratory testing advisory board shall be authorized to consider and make recommendations to the governing board of the accountable care organization for the adoption of guidelines or protocols concerning:

     (1)   clinical laboratory testing that is utilized for diagnostic purposes or disease management, including guidelines or protocols designed to ensure the appropriateness of testing; and

     (2)   pathologist consultation on episodes of care.

     c.     The composition of the clinical laboratory testing advisory board shall be determined by the accountable care organization, except that the clinical laboratory testing advisory board shall include among its members at least one physician who is legally affiliated with the accountable care organization and is a clinical laboratory director of a clinical laboratory that is providing services for the accountable care organization.

     d.    The provisions of this act shall not be construed to require that the governing board of an accountable care organization adopt a clinical laboratory testing guideline or protocol recommended by a clinical laboratory testing advisory board pursuant to subsection b. of this section.


     3.    This act shall take effect on the first day of the fourth month next following the date of enactment.