North Carolina Regulations
Department of Health and Human Services/Commission for Public Health
REGISTER SOURCE: Vol. 35, Issue 3, North Carolina Register 2020-08-03 pp.189-192
PUBLICATION DATE: 08/03/2020
ACTION DATE: 06/18/2020
EFFECTIVE DATE: 07/01/2020
PUBLICATION TYPE: Register
REGISTER SOURCE: Cumulative Index 2020-06-29
PUBLICATION DATE: 06/29/2020
ACTION DATE: 06/18/2020
PUBLICATION TYPE: Centralized Repository
REGISTER SOURCE: Vol. 34, Issue 22, North Carolina Register 2020-05-15 pp.2121-2124
PUBLICATION DATE: 05/15/2020
ACTION DATE: 05/15/2020
EFFECTIVE DATE: 04/24/2020
EXPIRATION DATE: 01/19/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 34, Issue 17, North Carolina Register 2020-03-02 pp.1675-1678
PUBLICATION DATE: 03/02/2020
ACTION DATE: 03/02/2020
EFFECTIVE DATE: 02/17/2020
EXPIRATION DATE: 04/17/2020
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 34, Issue 17, North Carolina Register 2020-03-02 pp.1652-1655
PUBLICATION DATE: 03/02/2020
ACTION DATE: 03/02/2020
COMMENT DEADLINE: 05/01/2020
PUBLICATION TYPE: Register
Office of Administrative Hearings 2020-02-13
PUBLICATION DATE: 02/13/2020
ACTION DATE: 02/13/2020
COMMENT DEADLINE: 03/05/2020
PUBLICATION TYPE: Agency

Note from the Codifier: The OAH website includes notices and the text of proposed temporary rules as required by G.S. 150B21.1(a1). Prior to the agency adopting the temporary rule, the agency must hold a public hearing no less than five days after the rule and notice have been published and must accept comments for at least 15 business days. For questions, you may contact the Office of Administrative Hearings at 919.431.3000 or email oah.postmaster@oah.nc.gov.

TITLE 10A - DEPARTMENT OF HEALTH AND HUMAN SERVICES

Notice is hereby given in accordance with G.S. 150B-21.1 that the Commission for Public Health intends to amend the rule cited as 10A NCAC 41A .0101.

Codifier of Rules approved this rule as an emergency rule effective February 5, 2020 and received for publication the following notice and proposed temporary rule on February 5, 2020.

Public Hearing:

Date: February 24, 2020

Time: 2:00 p.m.

Location: Cardinal Conference Room, located at 5605 Six Forks Road, Raleigh, NC 27609

Reason for Proposed Temporary Action: A serious and unforeseen threat to the public health, safety or welfare. A novel Coronavirus (nCoV) was identified as the cause of an emerging infectious disease outbreak in December 2019 in Wuhan, Hubei Province, China. This nCoV causes respiratory illness ranging in severity from milder illness to death. As of February 4, 2020, over 20,500 confirmed cases and 427 deaths had been reported, almost all from China, but also from 25 other countries including the United States. The ongoing outbreak has already surpassed the total number of the previous outbreaks of SARS (Sudden Acute Respiratory Syndrome) and MERS (Middle Eastern Respiratory Syndrome). The first U.S. case was reported in a traveler returning from Wuhan on January 21, 2020 in Washington State. The North Carolina Division of Public Health is working closely with the Centers for Disease Control and Prevention (CDC) to monitor and prepare for possible cases in North Carolina. No vaccine or specific treatment for this infection is available. Rapid implementation of control measures may help limit spread if cases are reported once identified.

It is imperative that public health authorities be rapidly notified when these infections are suspected so that appropriate control measures can be implemented to prevent further spread. Currently, diagnostic testing is only available at CDC through coordination with the State Laboratory for Public Health. Rapid notification of suspected infections will increase the timeliness of testing, case identification, and implementation of control measures to protect the public's health. For this reason, the State Health Director issued a Temporary Order pursuant to G.S. 130A-141.1 requiring immediate reporting of novel coronavirus effective February 3, 2020. An emergency rule was adopted on February 5, 2020 to continue the reporting requirement by rule while temporary and eventually permanent rules are pursued. Immediate adoption of the rule is required due to the serious and unforeseen threat posed by this infectious disease.

Comment Procedures: Comments from the public shall be directed to: Virginia Niehaus, 1931 Mail Service Center, Raleigh, NC 27699-1931, phone (919)707-5006, email cphcomment@lists.ncmail.net. The comment period begins February 5, 2020 and ends March 5, 2020.

Public Hearing:

Date: February 24, 2020

Time: 2:00 p.m.

Location: Cardinal Conference Room, located at 5605 Six Forks Road, Raleigh, NC 27609

CHAPTER 41 - EPIDEMIOLOGY HEALTH

SUBCHAPTER 41A - COMMUNICABLE DISEASE CONTROL

SECTION .0100 - COMMUNICABLE DISEASE CONTROL

10A NCAC 41A .0101 REPORTABLE DISEASES AND CONDITIONS

(a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within the time period specified after the disease or condition is reasonably suspected to exist:

(1) acquired immune deficiency syndrome (AIDS) - 24 hours;

(2) anthrax - immediately;

(3) botulism - immediately;

(4) brucellosis - 7 days;

(5) campylobacter infection - 24 hours;

(6) Candida auris - 24 hours;

(7) Carbapenem-Resistant Enterobacteriaceae (CRE) - 24 hours;

(8) chancroid - 24 hours;

(9) chikungunya virus infection - 24 hours;

(10) chlamydial infection (laboratory confirmed) - 7 days;

(11) cholera - 24 hours;

(12) Creutzfeldt-Jakob disease - 7 days;

(13) cryptosporidiosis - 24 hours;

(14) cyclosporiasis - 24 hours;

(15) dengue - 7 days;

(16) diphtheria - 24 hours;

(17) Escherichia coli, shiga toxin-producing - 24 hours;

(18) ehrlichiosis - 7 days;

(19) encephalitis, arboviral - 7 days;

(20) foodborne disease, including Clostridium perfringens, staphylococcal, Bacillus cereus, and other and unknown causes - 24 hours;

(21) gonorrhea - 24 hours;

(22) granuloma inguinale - 24 hours;

(23) Haemophilus influenzae, invasive disease - 24 hours;

(24) Hantavirus infection - 7 days;

(25) Hemolytic-uremic syndrome - 24 hours;

(26) Hemorrhagic fever virus infection - immediately;

(27) hepatitis A - 24 hours;

(28) hepatitis B - 24 hours;

(29) hepatitis B carriage - 7 days;

(30) hepatitis C, acute - 7 days;

(31) human immunodeficiency virus (HIV) infection confirmed - 24 hours;

(32) influenza virus infection causing death - 24 hours;

(33) legionellosis - 7 days;

(34) leprosy - 7 days;

(35) leptospirosis - 7 days;

(36) listeriosis - 24 hours;

(37) Lyme disease - 7 days;

(38) Lymphogranuloma venereum - 7 days;

(39) malaria - 7 days;

(40) measles (rubeola) - 24 hours;

(41) meningitis, pneumococcal - 7 days;

(42) meningococcal disease - 24 hours;

(43) Middle East respiratory syndrome (MERS) - 24 hours;

(44) monkeypox - 24 hours;

(45) mumps - 7 days;

(46) nongonococcal urethritis - 7 days;

(47) novel coronavirus infection - immediately;

(48)(47) novel influenza virus infection - immediately;

(49)(48) plague - immediately;

(50)(49) paralytic poliomyelitis - 24 hours;

(51)(50) pelvic inflammatory disease - 7 days;

(52)(51) psittacosis - 7 days;

(53)(52) Q fever - 7 days;

(54)(53) rabies, human - 24 hours;

(55)(54) Rocky Mountain spotted fever - 7 days;

(56)(55) rubella - 24 hours;

(57)(56) rubella congenital syndrome - 7 days;

(58)(57) salmonellosis - 24 hours;

(59)(58) severe acute respiratory syndrome (SARS) - 24 hours;

(60)(59) shigellosis - 24 hours;

(61)(60) smallpox - immediately;

(62)(61) Staphylococcus aureus with reduced susceptibility to vancomycin - 24 hours;

(63)(62) streptococcal infection, Group A, invasive disease - 7 days;

(64)(63) syphilis - 24 hours;

(65)(64) tetanus - 7 days;

(66)(65) toxic shock syndrome - 7 days;

(67)(66) trichinosis - 7 days;

(68)(67) tuberculosis - 24 hours;

(69)(68) tularemia - immediately;

(70)(69) typhoid - 24 hours;

(71)(70) typhoid carriage (Salmonella typhi) - 7 days;

(72)(71) typhus, epidemic (louse-borne) - 7 days;

(73)(72) vaccinia - 24 hours;

(74)(73) vibrio infection (other than cholera) - 24 hours;

(75)(74) whooping cough - 24 hours; and

(76)(75) yellow fever - 7 days.

(b) For purposes of reporting, "confirmed human immunodeficiency virus (HIV) infection" is defined as a positive virus culture, repeatedly reactive EIA antibody test confirmed by western blot or indirect immunofluorescent antibody test, positive nucleic acid detection (NAT) test, or other confirmed testing method approved by the Director of the State Public Health Laboratory conducted on or after February 1, 1990. In selecting additional tests for approval, the Director of the State Public Health Laboratory shall consider whether such tests have been approved by the federal Food and Drug Administration, recommended by the federal Centers for Disease Control and Prevention, and endorsed by the Association of Public Health Laboratories.

(c) In addition to the laboratory reports for Mycobacterium tuberculosis, Neisseria gonorrhoeae, and syphilis specified in G.S. 130A-139, laboratories shall report using electronic laboratory reporting (ELR), secure telecommunication, or paper reports.

(1) Isolation or other specific identification of the following organisms or their products from human clinical specimens:

(A) Any hantavirus or hemorrhagic fever virus.

(B) Arthropod-borne virus (any type).

(C) Bacillus anthracis, the cause of anthrax.

(D) Bordetella pertussis, the cause of whooping cough (pertussis).

(E) Borrelia burgdorferi, the cause of Lyme disease (confirmed tests).

(F) Brucella spp., the causes of brucellosis.

(G) Campylobacter spp., the causes of campylobacteriosis.

(H) Candida auris.

(I) Carbapenem-Resistant Enterobacteriaceae (CRE).

(J) Chlamydia trachomatis, the cause of genital chlamydial infection, conjunctivitis (adult and newborn) and pneumonia of newborns.

(K) Clostridium botulinum, a cause of botulism.

(L) Clostridium tetani, the cause of tetanus.

(M) Coronavirus, novel human strain.

(N)(M) Corynebacterium diphtheriae, the cause of diphtheria.

(O)(N) Coxiella burnetii, the cause of Q fever.

(P)(O) Cryptosporidium parvum, the cause of human cryptosporidiosis.

(Q)(P) Cyclospora cayetanesis, the cause of cyclosporiasis.

(R)(Q) Ehrlichia spp., the causes of ehrlichiosis.

(S)(R) Shiga toxin-producing Escherichia coli, a cause of hemorrhagic colitis, hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura.

(T)(S) Francisella tularensis, the cause of tularemia.

(U)(T) Hepatitis B virus or any component thereof, such as hepatitis B surface antigen.

(V)(U) Human Immunodeficiency Virus, the cause of AIDS.

(W)(V) Legionella spp., the causes of legionellosis.

(X)(W) Leptospira spp., the causes of leptospirosis.

(Y)(X) Listeria monocytogenes, the cause of listeriosis.

(Z)(Y) Middle East respiratory syndrome virus.

(AA)(Z) Monkeypox.

(BB)(AA) Mycobacterium leprae, the cause of leprosy.

(CC)(BB) Plasmodium falciparum, P. malariae, P. ovale, and P. vivax, the causes of malaria in humans.

(DD)(CC) Poliovirus (any), the cause of poliomyelitis.

(EE)(DD) Rabies virus.

(FF)(EE) Rickettsia rickettsii, the cause of Rocky Mountain spotted fever.

(GG)(FF) Rubella virus.

(HH)(GG) Salmonella spp., the causes of salmonellosis.

(II)(HH) Shigella spp., the causes of shigellosis.

(JJ)(II) Smallpox virus, the cause of smallpox.

(KK)(JJ) Staphylococcus aureus with reduced susceptibility to vanomycin.

(LL)(KK) Trichinella spiralis, the cause of trichinosis.

(MM)(LL) Vaccinia virus.

(NN)(MM) Vibrio spp., the causes of cholera and other vibrioses.

(OO)(NN) Yellow fever virus.

(PP)(OO) Yersinia pestis, the cause of plague.

(2) Isolation or other specific identification of the following organisms from normally sterile human body sites:

(A) Group A Streptococcus pyogenes (group A streptococci).

(B) Haemophilus influenzae, serotype b.

(C) Neisseria meningitidis, the cause of meningococcal disease.

(3) Positive serologic test results, as specified, for the following infections:

(A) Fourfold or greater changes or equivalent changes in serum antibody titers to:

(i) Any arthropod-borne viruses associated with meningitis or encephalitis in a human.

(ii) Any hantavirus or hemorrhagic fever virus.

(iii) Chlamydia psittaci, the cause of psittacosis.

(iv) Coxiella burnetii, the cause of Q fever.

(v) Dengue virus.

(vi) Ehrlichia spp., the causes of ehrlichiosis.

(vii) Measles (rubeola) virus.

(viii) Mumps virus.

(ix) Rickettsia rickettsii, the cause of Rocky Mountain spotted fever.

(x) Rubella virus.

(xi) Yellow fever virus.

(B) The presence of IgM serum antibodies to:

(i) Chlamydia psittaci.

(ii) Hepatitis A virus.

(iii) Hepatitis B virus core antigen.

(iv) Rubella virus.

(v) Rubeola (measles) virus.

(vi) Yellow fever virus.

(4) Laboratory results from tests to determine the absolute and relative counts for the T-helper (CD4) subset of lymphocytes and all results from tests to determine HIV viral load.

(5) Identification of CRE from a clinical specimen associated with either infection or colonization, including all susceptibility results and all phenotypic or molecular test results.

(d) Laboratories utilizing electronic laboratory reporting (ELR) shall report in addition to those listed under Paragraph (c) of this Rule:

(1) All positive laboratory results from tests used to diagnosis chronic Hepatitis C Infection, including the following:

(A) Hepatitis C virus antibody tests (including the test specific signal to cut-off (s/c) ratio);

(B) Hepatitis C nucleic acid tests;

(C) Hepatitis C antigen(s) tests; and

(D) Hepatitis C genotypic tests.

(2) All HIV genotypic test results, including when available:

(A) The entire nucleotide sequence; or

(B) The pol region sequence (including all regions: protease (PR)/reverse transcriptase (RT) and integrase (INI) genes, if available).

(e) For the purposes of reporting, Carbapenem-Resistant Enterobacteriaceae (CRE) are defined as:

(1) Enterobacter spp, E.coli or Klebsiella spp positive for a known carbapenemase resistance mechanism or positive on a phenotypic test for carbapenemase production; or

(2) Enterobacter spp, E.coli or Klebsiella spp resistant to any carbapenem in the absence of carbapenemase resistance mechanism testing or phenotypic testing for carbapenemase production.

Authority G.S. 130A-134; 130A-135; 130A-139; 130A-141.