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For Release:
October 19, 2009

Heather Howard

For Further Information Contact:
Office of Communications
(609) 984-7160

Department of Health and Senior Services Proposes a New Rule at N.J.A.C. 8:44-2.14, Clinical Laboratory Services, Operation of Clinical Laboratories, Collection Stations and Patient Service Centers


The Division of Public Health and Environmental Laboratories, Clinical Laboratory and Improvement Services, of the Department of Health and Senior Services is proposing rulemaking to adopt a new rule at N.J.A.C. 8:44-2.14, which would prohibit a clinical laboratory from reimbursing a physician in exchange for operating a collection station in the physician’s office.  The proposed rulemaking would also set standards for patient service centers/collection stations that serve the general public.


       Over the past several years, it has been brought to the attention of the Department that the increasing competition for business among clinical laboratories has resulted in some laboratories offering to pay physicians, under the guise of rent, to operate collection stations within the offices used by the physicians for the practice of medicine.  The Department believes that the payment of rent by a laboratory to a physician to operate a collection station in the physician’s office creates a potential conflict of interest between the physician and the laboratory, and constitutes an incentive to the physician to refer specimens to the laboratory in violation of N.J.S.A. 45:9-42.42d, prohibited activities.  This statute provides that a clinical laboratory shall not either personally, or through an agent, solicit referral of specimens to his or any other clinical laboratory, or contract to perform clinical laboratory examinations of specimens in a manner which offers or implies an offer of rebates to a person or persons submitting specimens, or fee-splitting inducements, participation in any fee-splitting arrangements or other unearned remuneration.


       The proposal continues to permit clinical laboratories to operate collection stations licensed by the Department in physician offices, but prohibits the payment of rent or other direct or indirect payments, or performing or offering other goods and services by the clinical laboratory to the physician.  The proposal would prohibit laboratory staff from performing services normally provided by physician office staff, and would prohibit laboratory staff from being jointly employed or retained as independent contractors by the physician. Except as necessary for the reporting of  test results, the laboratory would be prohibited from providing office supplies, equipment, waste disposal services, test kits for the physicians own use, electronic medical records or other goods and services to the physician. 


        The proposed rulemaking would provide that a patient service center/collection station that is intended to serve the general public shall not be operated in a physician’s office.  In addition, the proposal requires that a patient service center/collection station intended to serve the general public shall be:


·         Open to, and serve the general public, and shall not be restricted to serving the patients of one or more specific medical practices;

·         Located in a free-standing building or occupy a space in a public access building;

·         Accessed directly through an exterior building entrance or from a public access foyer or hallway that clearly identifies the name of the laboratory, and not accessed though a physician’s office;

·         Identified to the general public by clearly visible signage on the exterior of the building and listed in the building’s on-site directory, with advertisements and other public notices by the laboratory listing the address and telephone number of the patient services center;

·         Self-contained with regard to all aspects of the operations including the waiting room    , reception area, phlebotomy rooms, restroom facilities and specimen and supply storage.  The patient service center may share a common waiting area used by all tenants of a building or floor of a building so long as two or more of the tenants renting separate office spaces are not physicians or healthcare providers.



       The proposal appears in the October 19, 2009 issue of the New Jersey Register.  LexisNexis® provides free on-line public access to the New Jersey Administrative Code and the New Jersey Register at


       A public hearing on the proposed new rules will be held on November 9, 2009, between 1:00 P.M. and 3:00 P.M. at the New Jersey Department of Health and Senior Services, First Floor Auditorium, Health and Agriculture Building, 369 South Warren Street (at Market Street), Trenton, New Jersey 08608.  Persons wishing to comment on the proposal at the public hearing who wish to be placed on the list of speakers are requested to telephone Ms. Mary Marks at (609) 984-7923 by November 2, 2009, and bring a written copy of their remarks for submission to the public record.


       The public has until December 18, 2009 to comment on the proposal.  Persons wishing to comment on the proposal must submit their comments in writing to Ruth Charbonneau, Director, Office of Legal and Regulatory Affairs, New Jersey Department of Health and Senior Services, PO Box 360, Trenton, NJ 08625-0360.  Written comments on the proposal must be postmarked on or before December 18, 2009, which is the close of the 60-day public comment period.

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