N.J. Admin. Code § 8:44-2.14

Current through Register Vol. 56, No. 9, May 6, 2024

Section 8:44-2.14 - Collection stations and patient service centers

(a) A clinical laboratory that operates a collection station in a physician's office, also known as in-office phlebotomy, shall be limited to collecting specimens from patients of the medical practice in which the collection station is located, and shall comply with the following provisions:

1. The collection station shall be licensed under this chapter and the license shall be prominently displayed in the collection station area;

2. No reimbursement, fees or any other type of direct or indirect payment shall be made to the physician including, but not limited to, payment of rent or other consideration for the space used for the collection station;

3. Laboratory staff in the collection station shall perform no services for the physician that are normally the responsibility of the physician's office staff, such as taking patient vital signs or other nursing functions, drawing specimens or performing testing for the physician office laboratory or performing clerical services;

4. Laboratory staff in the collection station shall not be shared with, jointly employed or retained as independent contractors by the physician or persons affiliated with the office where the collection station is located;

5. Except as necessary for the reporting of test results, the laboratory shall not provide office supplies, equipment, waste disposal services, test kits for the physician's own use, electronic medical records systems or other goods or services to the physician; and

6. A copy of the signed lease or agreement shall be made available to the Department upon request.

(b) A patient service center/collection station intended to serve the general public shall not be operated within a physician's office and shall be:

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

2. Located in a free standing building or occupy a space in a public access building;

3. Accessed directly through an exterior building entrance or from a public access foyer or hallway that clearly identifies the name of the laboratory and the days and hours of operation.

i. Access shall not be through a physician's office;

4. Identified to the public by clearly visible signage on the exterior of the building and listed in the building's on-site directory.

i. Advertisements and other public notices by the laboratory shall list the address and telephone number of the patient service center;

5. 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 areas; except that the patient service center may share a common waiting area that is used by all the tenants of a building or a floor of the building, provided that two or more tenants renting separate office spaces are not referring physicians or healthcare providers; and

6. A copy of the signed written lease shall be made available to the Department upon request.

(c) The provisions of (a) and (b) above shall not be interpreted as prohibiting a laboratory from operating a patient service center in rented space in a professional building, which may be owned by a physician or group of physicians provided that the conditions of this section are met.

(d) Notwithstanding (a), (b), and (c) above, during the period of the COVID-19 Public Health Emergency, clinical laboratories may open collection stations without applying for a collection station license under the following conditions:

1. The parent clinical laboratory for the collection station is licensed by the New Jersey Department of Health's Clinical Laboratory Improvement Services;

2. The temporary collection station is only used to collect specimens for COVID-19 testing; and

3. The clinical laboratory notifies the Department when it opens a temporary COVID-19 collection station by emailing Patricia Jackman at patricia.jackman@doh.nj.gov and provides the following information:

i. The name of the parent clinical laboratory;

ii. The address where the temporary collection station is located; and

iii. A contact phone number and email for a representative from the parent clinical laboratory.

(e) Temporary collection stations meeting the requirements of (d) above, are exempt from complying with the requirements of (b)2, 3, 4, 5, and 6 above.

(f) This temporary waiver/modification is effective only during the period of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103. This temporary rule waiver/modification shall expire 45 days after the Public Health Emergency has ended. Upon the expiration of this temporary rule waiver/modification, all collection stations will need to comply with the licensure requirements set forth in this section.

N.J. Admin. Code § 8:44-2.14

Modified by Executive Order No. 103(2020) 52 N.J.R. 1487(a), effective 6/5/2020