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
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
REGISTER SOURCE: 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 notices published in this Section of the NC Register include the text of proposed rules. The agency must accept comments on the proposed rule(s) for at least 60 days from the publication date, or until the public hearing, or a later date if specified in the notice by the agency. If the agency adopts a rule that differs substantially from a prior published notice, the agency must publish the text of the proposed different rule and accept comment on the proposed different rule for 60 days.

Statutory reference: G.S. 150B-21.2.

TITLE 10A - DEPARTMENT OF HEALTH AND HUMAN SERVICES

Notice is hereby given in accordance with G.S. 150B-21.2 that the Commission for Public Health intends to amend the rule cited as 10A NCAC 41A .0101.

Link to agency website pursuant to G.S. 150B-19.1(c): https://cph.publichealth.nc.gov/

Proposed Effective Date: July 1, 2020

Public Hearing:

Date: April 13, 2020

Time: 10:00 a.m.

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

Reason for Proposed Action: The surveillance and control of communicable diseases and conditions is an important part of protecting the public's health. The proposed rule amends the communicable diseases and conditions reporting requirements to: (1) Add Acute Flaccid Myelitis, Babesiosis, Varicella, and Interferon Gamma Release Assay testing;

(2) re-list Zika; and

(3) make technical changes related to nomenclature, timing of reporting, and scientific progress in laboratory testing and reporting. In addition, the text in italics adding a reporting requirement for novel coronavirus was adopted by the Commission for Public Health under emergency procedures on February 5, 2020 and effective on February 17, 2020 as well as proposed under temporary procedures.

Comments may be submitted to: Virginia Niehaus, CPH Rulemaking Coordinator, 1931 Mail Service Center, Raleigh, NC 27699-1931; phone (919) 707-5006; email cphcomment@lists.ncmail.net

Comment period ends: May 1, 2020

Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission after the adoption of the Rule. If the Rules Review Commission receives written and signed objections after the adoption of the Rule in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.

Fiscal impact. Does any rule or combination of rules in this notice create an economic impact? Check all that apply.

¿ State funds affected

¿ Local funds affected

¿ Substantial economic impact (≥= $1,000,000)

¿ Approved by OSBM

¿ No fiscal note required

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) acute flaccid myelitis - 7 days;

(3) anaplasmosis - 7 days;

(4)(2) anthrax - immediately;

(5) arboviral infection, neuroinvasive - 7 days;

(6) babesiosis - 7 days;

(7)(3) botulism - immediately;

(8)(4) brucellosis - 7 days;

(9)(5) campylobacter infection - 24 hours;

(10)(6) Candida auris - 24 hours;

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

(12)(8) chancroid - 24 hours;

(13)(9) chikungunya virus infection - 24 hours;

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

(15)(11) cholera - 24 hours;

(16)(12) Creutzfeldt-Jakob disease - 7 days;

(17)(13) cryptosporidiosis - 24 hours;

(18)(14) cyclosporiasis - 24 hours;

(19)(15) dengue - 7 days;

(20)(16) diphtheria - 24 hours;

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

(22)(18) ehrlichiosis - 7 days;

(19) encephalitis, arboviral - 7 days;

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

(24)(21) gonorrhea - 24 hours;

(25)(22) granuloma inguinale - 24 hours;

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

(27)(24) Hantavirus infection - 7 days;

(28)(25) Hemolytic-uremic syndrome - 24 hours;

(29)(26) Hemorrhagic fever virus infection - immediately;

(30)(27) hepatitis A - 24 hours;

(31)(28) hepatitis B - 24 hours;

(32)(29) hepatitis B carriage - 7 days;

(33)(30) hepatitis C, acute - 7 days;

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

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

(36)(33) legionellosis - 7 days;

(37)(34) leprosy - 7 days;

(38)(35) leptospirosis - 7 days;

(39)(36) listeriosis - 24 hours;

(40)(37) Lyme disease - 7 days;

(41)(38) Lymphogranuloma venereum - 7 days;

(42)(39) malaria - 7 days;

(43)(40) measles (rubeola) - immediately;24 hours;

(44)(41) meningitis, pneumococcal - 7 days;

(45)(42) meningococcal disease - 24 hours;

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

(47)(44) monkeypox - 24 hours;

(48)(45) mumps - 7 days;

(49)(46) nongonococcal urethritis - 7 days;

(50) novel coronavirus infection - immediately;

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

(52)(48) plague - immediately;

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

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

(55)(51) psittacosis - 7 days;

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

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

(54) Rocky Mountain spotted fever - 7 days;

(58)(55) rubella - 24 hours;

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

(60)(57) salmonellosis - 24 hours;

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

(62)(59) shigellosis - 24 hours;

(63)(60) smallpox - immediately;

(64) spotted fever rickettsiosis - 7 days;

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

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

(67)(63) syphilis - 24 hours;

(68)(64) tetanus - 7 days;

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

(70)(66) trichinosis - 7 days;

(71)(67) tuberculosis - 24 hours;

(72)(68) tularemia - immediately;

(73)(69) typhoid - 24 hours;

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

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

(76)(72) vaccinia - 24 hours;

(77) varicella - 24 hours;

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

(79)(74) whooping cough - 24 hours;

and

(80)(75) yellow fever - 7 days;days.and

(81) zika virus - 24 hours.

(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) Anaplasma spp, the causes of anaplasmosis.

(B) Any hantavirus or hemorrhagic fever virus.

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

(D) Babesia spp., the cause of babesiosis.

(E)(C) Bacillus anthracis, the cause of anthrax.

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

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

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

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

(J)(H) Candida auris.

(K)(I) Carbapenem-Resistant Enterobacteriaceae (CRE).

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

(M)(K) Clostridium botulinum, a cause of botulism.

(N)(L) Clostridium tetani, the cause of tetanus.

(O) Coronavirus, novel human strain.

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

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

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

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

(T) Dengue virus.

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

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

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

(X) Hepatitis A virus.

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

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

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

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

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

(DD) Measles virus.

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

(FF)(Z) Monkeypox.

(GG) Mumps virus.

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

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

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

(KK)(DD) Rabies virus.

(LL)(EE) Rickettsia spp.,rickettsii, the cause of Rocky Mountain spotted fever rickettsiosis.fever.

(MM)(FF) Rubella virus.

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

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

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

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

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

(SS)(LL) Vaccinia virus.

(TT) Varicella virus.

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

(VV)(NN) Yellow fever virus.

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

(XX) Zika virus.

(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 virusviruses associated with neuroinvasive disease.meningitis or encephalitis in a human.

(ii) Anaplasma spp., the cause of anaplasmosis.

(iii)(ii) Any hantavirus or hemorrhagic fever virus.

(iv)(iii) Chlamydia psittaci, the cause of psittacosis.

(v) Chikungunya virus.

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

(vii)(v) Dengue virus.

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

(ix)(vii) Measles (rubeola) virus.

(x)(viii) Mumps virus.

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

(xii)(x) Rubella virus.

(xiii) Varicella virus.

(xiv)(xi) Yellow fever virus.

(B) The presence of IgM serum antibodies to:

(i) Any arthropod-borne virus associated with neuroinvasive disease.

(ii) Chikungunya virus.

(iii)(i) Chlamydia psittaci.

(iv) Dengue virus.

(v)(ii) Hepatitis A virus.

(vi)(iii) Hepatitis B virus core antigen.

(vii) Mumps virus.

(viii)(iv) Rubella virus.

(ix)(v) Rubeola (measles) virus.

(x)(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).

(3) All test results for Interferon Gamma Release Assays.

(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.