N.J. Admin. Code § 8:65-2.5

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

Section 8:65-2.5 - Clinical laboratories to report HIV-related laboratory test results

(a) A clinical laboratory director shall report to the Division the accession number, the CLIA code, and the following sections of the ACRF, in accordance with (b) below, within five working days of obtaining an HIV-related laboratory test result performed on a specimen taken from an adult or adolescent person who is receiving health care in, or is a resident of, the State:

1. The section labeled "Patient Identification";

2. The section labeled "Facility Providing Information";

3. The section labeled "Patient Demographics"; and

4. The section labeled "Laboratory Data."

(b) A clinical laboratory director shall report to the Department the accession number, the CLIA code, and the following sections of the PCRF, in accordance with this subsection, within five working days of obtaining an HIV-related laboratory test result performed on a specimen taken from a pediatric person who is receiving health care in, or is a resident of, the State:

1. The section labeled "Patient Identification";

2. The section labeled "Facility Providing Information";

3. The section labeled "Patient Demographics"; and

4. The section labeled "Laboratory Data."

(c) The Department establishes and maintains a form of "Confidential Laboratory Report" that captures the sections of the ACRF and the PCRF that clinical laboratories are to report pursuant to (a) and (b) above, and makes this form available on the Department's forms page at http://www.nj.gov/health/forms or upon request to the Division.

(d) A clinical laboratory director shall comply with (a) and (b) above, in the following order of preference, by:

1. Electronic laboratory reporting;

2. Secure email to episervices@doh.nj.gov;

3. Secure electronic facsimile (e-fax) to (609) 984-2455, subject to (b) above;

4. Submitting a completed form of ACRF or PCRF, as applicable, or Confidential Laboratory Report, to the Division by postal mail marked "confidential," preferably using a Division envelope; or

5. Submitting by use of a Secure File Transfer Protocol (SFTP) through the website at http://njgov.moveitcloud.com/.

i. Entities electing to submit through SFTP should submit an email to episervices@doh.nj.gov to obtain access credentials.

(e) A clinical laboratory director and a clinical laboratory shall not transmit reports, and shall ensure that reports are not submitted by e-fax pursuant to (d)2 above, unless the sending entity does so using processes and equipment that are compliant with the Data Security Guidelines.

(f) If a clinical laboratory sends or "refers" a specimen (a referring clinical laboratory) to another clinical laboratory (a reference laboratory) to perform an HIV-related laboratory test, the referring clinical laboratory and the laboratory director thereof remain responsible to report, and to ensure the complete reporting, to the Division in accordance with this section, of HIV-related laboratory test results that the reference laboratory obtains, regardless of whether the Department has independent jurisdiction over the reference laboratory.

(g) Subject to (h) below, the Department may take enforcement action pursuant to N.J.A.C. 8:65-3against a clinical laboratory and/or a clinical laboratory director that fails to comply with this section.

(h) The Department will refrain from enforcement action against clinical laboratories and clinical laboratory directors that fail to comply with this section if the clinical laboratory and the clinical laboratory director timely submit to the Division, and/or ensure the timely submission to the Division of, the sections listed at (a) and (b) above of an ACRF or a PCRF, as applicable, as to which all fields that the ACRF Technical Guidance or the PCRF and PHER Technical Guidance, as applicable, identifies as "required," are fully completed.

N.J. Admin. Code § 8:65-2.5

Adopted by 54 N.J.R. 1408(a), effective 7/18/2022