N.J. Admin. Code § 8:65-1.3

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:65-1.3 - Definitions

(a) The following words and terms, as used in this chapter, shall have the meanings that N.J.S.A. 26:5C-1 et seq., establishes, particularly at 26:5C-5:

"Commissioner";

"Department"; and

"HIV infection," as amended and supplemented by the surveillance case definition.

(b) The following words and terms, as used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Adolescent" means a person who is 13 years of age or older and under 18 years of age.

"Adult" means a person who is 18 years of age or older.

"Audit" means the review of health records to determine the type and dates of services related to HIV infection provided by a health care provider, responsible party, or institution, and to verify compliance with this chapter.

"Bio-analytical laboratory director" means a person to whom the State Board of Medical Examiners, within the Division of Consumer Affairs of the New Jersey Department of Law and Public Safety, issues licensure pursuant to the Bio-analytical Laboratory and Laboratory Directors Act (1953), N.J.S.A. 45:9-42 through 42.25.

"Blood bank" means an entity that the Department licenses as a blood bank pursuant to N.J.S.A. 26:2A-1 through 16 and N.J.A.C. 8:8.

"CD4 count or percentage" means a count or percentage of T-lymphocytes containing the CD4+ epitope, determined as a result of lymphocyte phenotyping.

"Centers for Disease Control and Prevention" or "CDC" means the Centers for Disease Control and Prevention of the United States Department of Health and Human Services.

"Clinical laboratory" means:

1. A laboratory that the Department licenses as a clinical laboratory pursuant to the New Jersey Clinical Laboratory Improvement Act, N.J.S.A. 45:9-42.26 through 42.45, excluding a limited purpose laboratory; and

2. A VHA laboratory.

"Clinical laboratory director" means a bio-analytical laboratory director in charge of a clinical laboratory.

"Confirmed case" means a case that is positive for HIV in accordance with the criteria for a confirmed case established in the surveillance case definition, obtained in accordance with the Laboratory Testing Recommendations and the testing algorithm.

"Counseling and testing site" means a facility the Department designates to provide counseling and rapid HIV testing without charge pursuant to the terms and conditions of a Department grant.

"Division" means the Division of HIV, STD, and TB Services for which the contact information is Surveillance Program, Division of HIV, STD, and TB Services, New Jersey Department of Health, PO Box 363, Trenton, NJ 08625-0363, telephone (609) 984-5940.

"Division envelope" means a postage-prepaid envelope that is addressed to the Division and marked "confidential" for use in submission of HIV reports to the Division.

1. Supplies of Division envelopes are available at no charge to health care providers, responsible parties, and clinical laboratories upon telephone request to the Division at (609) 984-5940.

"DNA" means deoxyribonucleic acid.

"Electronic laboratory reporting" means electronic laboratory reporting as N.J.A.C. 8:57 defines that term and in accordance with the electronic laboratory reporting procedures that N.J.A.C. 8:57 establishes.

"Epidemiologic investigation" means the analysis of health records and laboratory test results to confirm cases, evaluate and identify disease progression, confirm treatments and co-morbidities, and ascertain other characteristics of persons exposed to, or living with, HIV infection.

"Federal correctional institution" means a hospital, clinic, laboratory service, or other provider of health care or laboratory services, which is:

1. Operated by, or under the jurisdiction of, the Federal Bureau of Prisons of the United States Department of Justice;

2. Subject to BOP HIV Management Guidance and BOP PS 6190.04; and

3. Located:

i. In New Jersey; or

ii. In any state or territory of the United States providing health care or laboratory services to a New Jersey resident.

"Health benefits plan" means a public or private plan that pays or provides hospital and medical expense benefits for covered services, and is delivered or issued for delivery in this State by or through a carrier, but does not include the following plans, policies, or contracts: Medicaid, Medicare, Medicare Advantage, accident only, credit, disability, long-term care, TRICARE supplement coverage, coverage arising out of a workers' compensation or similar law, automobile medical payment insurance, personal injury protection insurance issued pursuant to N.J.S.A. 39:6A-1 et seq., a dental plan as defined pursuant to N.J.S.A. 26:2S-26, and hospital confinement indemnity coverage.

"Health care facility" means health care facility as N.J.S.A. 26:2H-1 et seq., particularly 26:2H-2, defines that term.

"Health care provider" means a physician, a physician assistant, and/or an advanced practice nurse whom the applicable professional board within the Division of Consumer Affairs of the New Jersey Department of Law and Public Safety licenses, pursuant to Title 45 of the New Jersey Revised Statutes.

"HIV" means the condition identified in the surveillance case definition, designated by the following ICD-10-CM codes:

1. B20 Human immunodeficiency virus (HIV) disease; and

2. Z21 Asymptomatic human immunodeficiency virus (HIV) infection.

"HIV immunoassay" means one of the following laboratory tests:

1. HIV 1 antibody differentiation assay;

2. HIV 2 antibody differentiation assay;

3. HIV-1 Western blot;

4. HIV-2 Western blot; or

5. HIV-1 immunofluorescent assay.

"HIV-related laboratory test" means a test that the HIV Diagnostic Tests LOINC Map lists.

"HIV-related laboratory test result" means the result of an HIV-related laboratory test:

1. That is an HIV immunoassay performed on a specimen taken from an adult or adolescent and having a positive (reactive) or indeterminate result, and the results of all additional HIV immunoassays performed on the same specimen as part of the testing algorithm, regardless of whether the results of the additional HIV immunoassays are positive (reactive), non-reactive (negative for HIV), or indeterminate;

2. That is an HIV immunoassay performed on a specimen taken from a pediatric person, regardless of whether the results are positive (reactive), non-reactive (negative for HIV), or indeterminate;

3. That is an HIV nucleic acid (RNA or DNA) qualitative and quantitative test, including quantitative test types that do not yield a quantitative result;

4. For CD4 counts and/or percentages, unless the test is ordered to assess a condition that is known not to be HIV, such as cancer;

5. For HIV subtype and antiviral resistance, which is to be reported by nucleotide sequence, as determined through genotypic resistance testing;

6. That is a positive or reactive result of an HIV detection culture or a P24 antigen test;

7. That is a positive or reactive result of an HIV-1 or HIV-2 immunoassay test that can detect both HIV antigens and antibodies; and

8. That is a result of an HIV-related laboratory test conducted as part of the testing algorithm, including negative and indeterminate results, when any HIV-related test conducted as part of the testing algorithm contains a positive or reactive result.

"Institution" means any of the following, but does not include a counseling and testing site:

1. A health care facility;

2. A facility under the jurisdiction of the Division of Mental Health and Addiction Services of the Department;

3. A facility under the jurisdiction of the New Jersey:

i. Department of Children and Families;

ii. Department of Corrections;

iii. Department of Human Services;

iv. Juvenile Justice Commission; or

v. Office of the Secretary of Higher Education;

4. A correctional or juvenile detention facility under the jurisdiction of any New Jersey county or municipality;

5. A Federal correctional institution;

6. A VHA medical facility;

7. A VHA laboratory;

8. A blood bank; and

9. A health benefits plan.

"Limited purpose laboratory" means an entity that the Department licenses pursuant to N.J.A.C. 8:44-3.

"Office of Information and Regulatory Affairs" or "OIRA" means an office that is part of the Office of Management and Budget of the Executive Office of the President of the United States for which the contact information is Office of Information and Regulatory Affairs, Regulatory Information Service Center (MVE), General Services Administration, 1800 F Street, NW, Washington, DC 20405, (202) 482-7340, website http://www.reginfo.gov.

"Pediatric" means under 13 years of age and includes perinatal.

"Perinatal" means under 18 months of age.

"Perinatal exposure" means exposure of a perinatal infant to HIV by reason of the infant being born to a woman who has HIV infection at the time of delivery.

"Rapid HIV test" means a test used to screen for HIV infection that detects, in under 30 minutes, the presence, in blood or oral fluid, of HIV:

1. Antibodies; or

2. Antibodies and antigens.

"Responsible party" means the individual having control or supervision of an institution, such as a chief administrator.

"RNA" means ribonucleic acid.

"VHA laboratory" means a pathology and laboratory medicine service that is:

1. Operated by, or under the jurisdiction of, the Veterans Health Administration of the United States Department of Veterans Affairs;

2. Subject to VHA Directives 1131(4) and 1304; and

3. Located:

i. In New Jersey; or

ii. In any state or territory of the United States providing laboratory services to New Jersey residents.

"VHA medical facility" means a hospital, clinic, pathology and laboratory medicine service, or other provider of health care services, that is:

1. Operated by, or under the jurisdiction of, the Veterans Health Administration of the United States Department of Veterans Affairs;

2. Subject to VHA Directives 1131(4) and 1304; and

3. Located:

i. In New Jersey; or

ii. In any state or territory of the United States providing health care or pathology and laboratory medicine services to New Jersey residents.

N.J. Admin. Code § 8:65-1.3

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