New Jersey Administrative Code › Title 8 - HEALTH › Chapter 65 - HIV INFECTION REPORTING › Subchapter 1 - GENERAL PROVISIONS › Section 8:65-1.3 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(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.