North Carolina Regulations
Department of Health and Human Services/Commission for Public Health
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TITLE 10A - DEPARTMENT OF HEALTH AND HUMAN SERVICES

Rule-making Agency: Commission for Public Health

Rule Citation: 10A NCAC 41A .0101

Effective Date: April 24, 2020

Date Approved by the Rules Review Commission: April 16, 2020

Reason for Action: A novel Coronavirus was identified as the cause of an emerging infectious disease outbreak in December 2019 in Wuhan, Hubei Province, China. This novel Coronavirus causes respiratory illness ranging in severity from mild illness to death. As of March 23, 2020, over 340,000 confirmed cases and 15,000 deaths had been reported from 173 countries, including the United States. The first U.S. case was reported in a traveler returning from Wuhan on January 21, 2020 in Washington State. As of March 23, over 30,000 cases had been reported in the U.S., and over 260 cases had been reported in North Carolina. The North Carolina Division of Public Health is working closely with the Centers for Disease Control and Prevention (CDC) to monitor and respond to this pandemic in North Carolina. No vaccine or specific treatment for this infection is available. It is imperative that public health authorities be rapidly notified when infections of novel coronavirus or deaths caused by novel coronavirus are suspected so that appropriate control and mitigation measures can be quickly implemented to prevent further spread. Rapid notification of suspected infections and deaths will increase the timeliness of testing, case identification, and implementation of control and mitigation measures to protect the public's health. For this reason, pursuant to G.S. 130A-141.1, the State Health Director issued a Temporary Order requiring immediate reporting of novel coronavirus infections effective February 3, 2020 and another Temporary Order requiring reporting of deaths due to novel coronavirus infection within 24 hours effective March 23, 2020. This temporary rule is needed to continue these reporting requirements while a permanent amendment is pursued. Immediate adoption of this temporary rule is required due to the serious and unforeseen threat posed by this infectious disease.

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 causing death - 24 hours;

(48) novel coronavirus infection - immediately;

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

(48)(50) plague - immediately;

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

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

(51)(53) psittacosis - 7 days;

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

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

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

(55)(57) rubella - 24 hours;

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

(57)(59) salmonellosis - 24 hours;

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

(59)(61) shigellosis - 24 hours;

(60)(62) smallpox - immediately;

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

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

(63)(65) syphilis - 24 hours;

(64)(66) tetanus - 7 days;

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

(66)(68) trichinosis - 7 days;

(67)(69) tuberculosis - 24 hours;

(68)(70) tularemia - immediately;

(69)(71) typhoid - 24 hours;

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

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

(72)(74) vaccinia - 24 hours;

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

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

(75)(77) 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.

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

Amended Eff. October 1, 1994; February 1, 1990;

Temporary Amendment Eff. July 1, 1997;

Amended Eff. August 1, 1998;

Temporary Amendment Eff. February 13, 2003; October 1, 2002; February 18, 2002; June 1, 2001;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. November 1, 2003; May 16, 2003;

Amended Eff. January 1, 2005; April 1, 2004;

Temporary Amendment Eff. June 1, 2006;

Amended Eff. April 1, 2008; November 1, 2007; October 1, 2006;

Temporary Amendment Eff. January 1, 2010;

Temporary Amendment Expired September 11, 2011;

Amended Eff. July 1, 2013;

Temporary Amendment Eff. December 2, 2014;

Amended Eff. October 1, 2015;

Emergency Amendment Eff. March 1, 2016;

Temporary Amendment Eff. July 1, 2016;

Amended Eff. January 1, 2018; October 1, 2016;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 9, 2018;

Amended Eff. October 1, 2018;

Emergency Amendment Eff. February 17, 2020;

Temporary Amendment Eff. April 24, 2020.