Title of Regulation: 12VAC5-90. Regulations for Disease Reporting and Control (amending 12VAC5-90-80).

Statutory Authority: § 32.1-35 of the Code of Virginia.

Effective Date: November 14, 2018.

Agency Contact: Tim Powell, Acting Director, Division of Surveillance and Investigation, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7760, or email tim.powell@vdh.virginia.gov.

Summary:

The amendments (i) remove acquired immunodeficiency syndrome and Creutzfeldt-Jakob disease from the reportable disease list; (ii) add infection or colonization with Candida auris and any carbapenemase-producing organism to the reportable disease list; (iii) add the name of the reportable organism next to disease names on the reportable disease list and conditions reportable by laboratory directors; (iv) replace specific laboratory methods from the list of conditions reportable by laboratory directors with a requirement for directors of laboratories to report based on any laboratory method if the method indicates the presence of a reportable organism; (v) update the list of conditions reportable by laboratory directors to reflect current laboratory technology and public health standards, including reporting of all lead blood levels, viral loads for persons who test positive for hepatitis C, liver enzyme results for persons who test positive for hepatitis B, and gram negative diplococci; (vi) remove Creutzfeldt-Jakob disease from the list of conditions reportable by laboratory directors; (vii) reorder subsections E through I; (viii) move certain language from the list of isolates or other specimens that must be submitted to the Division of Consolidated Laboratory Services in 12VAC5-90-90 B to 12VAC5-90-80 D and update it; and (ix) add the names of reportable organisms next to disease names so that the isolate submission list is aligned with the reportable disease list and list of conditions reportable by laboratory directors.

Part III
Reporting of Disease

12VAC5-90-80. Lists of diseases that shall be reported.

A. Reportable disease list. The board declares suspected or confirmed cases of the following named diseases, toxic effects, and conditions to be reportable by the persons enumerated in 12VAC5-90-90. Conditions identified by an asterisk (*) require immediate communication to the local health department by the most rapid means available upon suspicion or confirmation, as defined in subsection C of this section. Other conditions should be reported within three days of suspected or confirmed diagnosis, unless otherwise specified in this section. Neonatal Abstinence Syndrome shall be reported as specified in subsection E of this section.

Acquired immunodeficiency syndrome (AIDS)

Amebiasis (Entamoeba histolytica)

*Anthrax (Bacillus anthracis)

Arboviral infections (e.g., CHIK, dengue, EEE, LAC, SLE, WNV, Zika)

Babesiosis (Babesia spp.)

*Botulism (Clostridium botulinum)

*Brucellosis (Brucella spp.)

Campylobacteriosis (Campylobacter spp.)

Candida auris, infection or colonization

Carbapenemase-producing organism, infection or colonization

Chancroid (Haemophilus ducreyi)

Chickenpox (Varicella) (Varicella virus)

Chlamydia trachomatis infection

*Cholera (Vibrio cholerae O1 or O139)

*Coronavirus infection, severe

Creutzfeldt-Jakob disease if younger than 55 years of age

Cryptosporidiosis (Cryptosporidium spp.)

Cyclosporiasis (Cyclospora spp.)

*Diphtheria (Corynebacterium diphtheriae)

*Disease caused by an agent that may have been used as a weapon

Ehrlichiosis/Anaplasmosis (Ehrlichia spp., Anaplasma phagocytophilum)

Escherichia coli infection, Shiga toxin-producing

Giardiasis (Giardia spp.)

Gonorrhea (Neisseria gonorrhoeae)

Granuloma inguinale (Calymmatobacterium granulomatis)

*Haemophilus influenzae infection, invasive

Hantavirus pulmonary syndrome

Hemolytic uremic syndrome (HUS)

*Hepatitis A

Hepatitis B (acute and chronic)

Hepatitis C (acute and chronic)

Hepatitis, other acute viral

Human immunodeficiency virus (HIV) infection

Influenza, confirmed

*Influenza-associated deaths in children if younger than 18 years of age

Lead, reportable blood levels

Legionellosis (Legionella spp.)

Leprosy (Hansen's disease) (Mycobacterium leprae)

Leptospirosis (Leptospira interrogans)

Listeriosis (Listeria monocytogenes)

Lyme disease (Borrelia spp.)

Lymphogranuloma venereum (Chlamydia trachomatis)

Malaria (Plasmodium spp.)

*Measles (Rubeola)

*Meningococcal disease (Neisseria meningitidis)

Mumps

Neonatal abstinence syndrome (NAS)

Ophthalmia neonatorum

*Outbreaks, all (including foodborne, healthcare-associated health care-associated, occupational, toxic substance-related, waterborne, and waterborne) any other outbreak)

*Pertussis (Bordetella pertussis)

*Plague (Yersinia pestis)

*Poliovirus infection, including poliomyelitis

*Psittacosis (Chlamydophila psittaci)

*Q fever (Coxiella burnetii)

*Rabies, human and animal

Rabies treatment, post-exposure

*Rubella, including congenital rubella syndrome

Salmonellosis (Salmonella spp.)

Shiga toxin-producing Escherichia coli infection

Shigellosis (Shigella spp.)

*Smallpox (Variola) (Variola virus)

Spotted fever rickettsiosis (Rickettsia spp.)

Staphylococcus aureus infection, vancomycin-intermediate or vancomycin-resistant

Streptococcal disease, Group A, invasive or toxic shock

Streptococcus pneumoniae infection, invasive, in children if younger than five years of age

Syphilis (report *primary and *secondary syphilis by rapid means) (Treponema pallidum) report *congenital, *primary, *secondary, and other

Tetanus (Clostridium tetani)

Toxic substance-related illness

Trichinosis (Trichinellosis) (Trichinella spiralis)

*Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Tuberculosis infection in children younger than four years of age

*Tularemia (Francisella tularensis)

*Typhoid/Paratyphoid fever infection (Salmonella Typhi, Salmonella Paratyphi)

*Unusual occurrence of disease of public health concern

*Vaccinia, disease or adverse event

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

*Vibrio infection *Vibriosis (Vibrio spp.)

*Viral hemorrhagic fever

*Yellow fever

Yersiniosis (Yersinia spp.)

B. Conditions reportable by directors of laboratories. Laboratories shall report all test results indicative of and specific for the diseases, infections, microorganisms, conditions, and toxic effects specified in this subsection for humans. Such tests include microbiological culture, isolation, or identification; assays for specific antibodies; and identification of specific antigens, toxins, or nucleic acid sequences. Additional condition-specific requirements are noted in this subsection and subsection D of this section. Conditions identified by an asterisk (*) require immediate communication to the local health department by the most rapid means available upon suspicion or confirmation, as defined in subsection C of this section. Other conditions should be reported within three days of suspected or confirmed diagnosis.

Amebiasis - by microscopic examination, culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Entamoeba histolytica)

*Anthrax - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Bacillus anthracis)

Arboviral infection, for example, CHIK, dengue, EEE, LAC (also known as California encephalitis), SLE, WNV, or Zika - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

Babesiosis - by culture, antigen detection, nucleic acid detection, microscopic examination, or serologic results consistent with recent infection (Babesia spp.)

*Botulism - by culture, nucleic acid detection, or identification of neurotoxin in a clinical specimen (Clostridium botulinum)

*Brucellosis - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Brucella spp.)

Campylobacteriosis - by culture or culture-independent diagnostic test (CIDT) (i.e., antigen detection or nucleic acid detection). For CIDT, also submit all available culture results (positive or negative) associated with a positive result. (Campylobacter spp.)

Candida auris - Include available antimicrobial susceptibility findings in report.

Carbapenemase-producing organism - Include available antimicrobial susceptibility findings in report.

Chancroid - by culture, antigen detection, or nucleic acid detection (Haemophilus ducreyi)

Chickenpox (Varicella) - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Varicella virus)

Chlamydia trachomatis infection - by culture, antigen detection, nucleic acid detection or, for lymphogranuloma venereum, serologic results consistent with recent infection

*Cholera - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Vibrio cholerae O1 or O139)

*Coronavirus infection, severe - by culture, nucleic acid detection, or serologic results consistent with recent infection (e.g., SARS-CoV, MERS-CoV)

Creutzfeldt-Jakob disease if younger than 55 years of age by histopathology in patients under the age of 55 years

Cryptosporidiosis - by microscopic examination, antigen detection, or nucleic acid detection (Cryptosporidium spp.)

Cyclosporiasis - by microscopic examination or nucleic acid detection (Cyclospora spp.)

*Diphtheria - by culture or histopathology (Corynebacterium diphtheriae)

Ehrlichiosis/Anaplasmosis - by culture, nucleic acid detection, microscopic examination, or serologic results consistent with recent infection (Ehrlichia spp., Anaplasma phagocytophilum)

Escherichia coli infection, Shiga toxin-producing - by culture, Shiga toxin detection (e.g., nucleic acid detection, EIA), or serologic results consistent with recent infection

Giardiasis - by microscopic examination, antigen detection, or nucleic acid detection (Giardia spp.)

Gonorrhea - by microscopic examination of a urethral smear (males only) or endocervical smear (females only), culture, antigen detection, or nucleic acid detection. (Neisseria gonorrhoeae) - Include available antimicrobial susceptibility findings in report.

*Haemophilus influenzae infection, invasive - by culture, antigen detection, or nucleic acid detection from a normally sterile site

Hantavirus pulmonary syndrome - by antigen detection (immunohistochemistry), nucleic acid detection, or serologic results consistent with recent infection

*Hepatitis A - by detection of IgM antibodies

Hepatitis B (acute and chronic) - by detection of HBsAg, HBeAg, or IgM antibodies or nucleic acid detection. For any reportable hepatitis finding, submit All hepatitis B patients, also report available results of serum alanine aminotransferase (ALT) and all available results from the hepatitis panel.

Hepatitis C (acute and chronic) - by hepatitis C virus antibody (anti-HCV) positive, HCV antigen positive, or HCV RNA positive by nucleic acid test. For all hepatitis C patients with any positive HCV test, also report all results of HCV viral load tests, including undetectable viral loads and report available results of serum alanine aminotransferase (ALT) and all available results from the hepatitis panel.

Hepatitis, other acute viral - any Any finding indicative of acute infection with hepatitis D, E, or other cause of viral hepatitis. For any reportable hepatitis finding, submit all available results from the hepatitis panel.

Human immunodeficiency virus (HIV) infection - by culture, antigen detection, nucleic acid detection, or detection of antibody. For HIV-infected patients, report all results of CD4 and HIV viral load tests, including undetectable viral loads. For HIV-infected patients, report all HIV genetic nucleotide sequence data associated with HIV drug resistance tests by electronic submission. For children younger than three years of age, report all tests regardless of the test findings (e.g., negative or positive).

Influenza, confirmed - by By culture, antigen detection by direct fluorescent antibody (DFA), or nucleic acid detection.

Lead, reportable blood levels - by any detectable blood lead level in children ages 0-15 years or levels greater than or equal to five µg/dL in persons older than 15 years of age All lead results from tests of venous or capillary blood performed by a laboratory certified by the Centers for Medicare and Medicaid Services in accordance with 42 USC § 263a, the Clinical Laboratory Improvement Amendment of 1988 (CLIA-certified).

Legionellosis - by culture, antigen detection (including urinary antigen), nucleic acid detection, or serologic results consistent with recent infection (Legionella spp.)

Leptospirosis - by culture, microscopic examination by dark field microscopy, nucleic acid detection, or serologic results consistent with recent infection (Leptospira interrogans)

Listeriosis - by culture from a normally sterile site. If associated with miscarriage or stillbirth, by culture from placental or fetal tissue (Listeria monocytogenes), invasive or if associated with miscarriage or stillbirth from placental or fetal tissue

Lyme disease - by culture, antigen detection, or detection of antibody confirmed with a supplemental test (Borrelia spp.)

Malaria - by microscopic examination, antigen detection, or nucleic acid detection (Plasmodium spp.)

*Measles (Rubeola) - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

*Meningococcal disease - by culture, nucleic acid detection, or antigen detection from a normally sterile site (Neisseria meningitidis), invasive - Include identification of gram-negative diplococci.

Mumps - by culture, nucleic acid detection, or serologic results consistent with recent infection

*Mycobacterial diseases - (See 12VAC5-90-225 B) Report any of the following:

1. Acid fast bacilli by microscopic examination;

2. Mycobacterial identification - preliminary and final identification by culture or nucleic acid detection M. tuberculosis complex or any other mycobacteria;

3. Drug Antimicrobial susceptibility test results for M. tuberculosis complex.

*Pertussis - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Bordetella pertussis)

*Plague - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Yersinia pestis)

*Poliovirus infection - by culture

*Psittacosis - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Chlamydophila psittaci)

*Q fever - by culture, antigen detection, nucleic acid detection, immunohistochemical methods, or serologic results consistent with recent infection (Coxiella burnetii)

*Rabies, human and animal - by culture, antigen detection by direct fluorescent antibody test, nucleic acid detection, or, for humans only, serologic results consistent with recent infection

*Rubella - by culture, nucleic acid detection, or serologic results consistent with recent infection

Salmonellosis - by culture, antigen detection, or nucleic acid detection (Salmonella spp.)

Shiga toxin-producing Escherichia coli infection

Shigellosis - by culture, antigen detection, or nucleic acid detection (Shigella spp.)

*Smallpox (Variola) - by culture or nucleic acid detection (Variola virus)

Spotted fever rickettsiosis - by culture, antigen detection (including immunohistochemical staining), nucleic acid detection, or serologic results consistent with recent infection (Rickettsia spp.)

Staphylococcus aureus infection, resistant, specifically:

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection - by antimicrobial susceptibility testing of a Staphylococcus aureus isolate, with a vancomycin susceptibility result of intermediate or resistant, cultured from a clinical specimen. Include available antimicrobial susceptibility findings in report.

Streptococcal disease, Group A, invasive or toxic shock - for invasive disease, by culture from a normally sterile site; for streptococcal toxic shock, by culture from any body site

Streptococcus pneumoniae infection, invasive, in children if younger than five years of age - by culture from a normally sterile site in a child under the age of five years

*Syphilis - by darkfield microscopy, antigen detection, nucleic acid detection, or serology by either treponemal or nontreponemal methods (Treponema pallidum)

Toxic substance-related illness - by By blood or urine laboratory findings above the normal range, including but not limited to heavy metals, pesticides, and industrial-type solvents and gases. When applicable and available, report speciation of metals when blood or urine levels are elevated in order to differentiate the chemical species (elemental, organic, or inorganic).

Trichinosis (Trichinellosis) - by microscopic examination of a muscle biopsy or serologic results consistent with recent infection (Trichinella spiralis)

Tuberculosis infection

*Tularemia - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection (Francisella tularensis)

*Typhoid/Paratyphoid fever infection - by culture, antigen detection, or nucleic acid detection (Salmonella Typhi, Salmonella Paratyphi A, Salmonella Paratyphi B, Salmonella Paratyphi C)

*Vaccinia, disease or adverse event - by culture or nucleic acid detection

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection - Include available antimicrobial susceptibility findings in report.

*Vibrio infection - isolation of any species of the family Vibrionaceae (other than toxigenic Vibrio cholera O1 or O139, which are reportable as cholera) from a clinical specimen by culture, antigen detection, or nucleic acid detection *Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae), other than toxigenic Vibrio cholera O1 or O139, which are reportable as cholera

*Viral hemorrhagic fever - by culture, antigen detection (including immunohistochemical staining), nucleic acid detection, or serologic results consistent with recent infection

*Yellow fever - by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

Yersiniosis - by culture, nucleic acid detection, or serologic results consistent with recent infection (Yersinia spp.)

C. Reportable diseases requiring rapid communication. Certain of the diseases in the list of reportable diseases, because of their extremely contagious nature or their, potential for greater harm, or both, availability of a specific intervention that must be administered in a timely manner require immediate identification and control. Reporting of persons confirmed or suspected of having these diseases, listed in this subsection, shall be made immediately by the most rapid means available, preferably by telephone to the local health department. (These same diseases are also identified by an asterisk (*) in subsections A and B, where applicable, of this section.)

Anthrax (Bacillus anthracis)

Botulism (Clostridium botulinum)

Brucellosis (Brucella spp.)

Cholera (Vibrio cholerae O1 or O139)

Coronavirus infection, severe

Diphtheria (Corynebacterium diphtheriae)

Disease caused by an agent that may have been used as a weapon

Haemophilus influenzae infection, invasive

Hepatitis A

Influenza-associated deaths in children if younger than 18 years of age

Influenza A, novel virus

Measles (Rubeola) (Rubeola virus)

Meningococcal disease (Neisseria meningitidis)

Outbreaks, all

Pertussis (Bordetella pertussis)

Plague (Yersinia pestis)

Poliovirus infection, including poliomyelitis

Psittacosis (Chlamydophila psittaci)

Q fever (Coxiella burnetii)

Rabies, human and animal

Rubella, including congenital rubella syndrome

Smallpox (Variola) (Variola virus)

Syphilis, congenital, primary, and secondary (Treponema pallidum)

Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Tularemia (Francisella tularensis)

Typhoid/Paratyphoid fever infection (Salmonella Typhi, Salmonella Paratyphi (all types))

Unusual occurrence of disease of public health concern

Vaccinia, disease or adverse event

Vibrio infection Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae), other than toxigenic Vibrio cholerae O1 or O139, which are reportable as cholera

Viral hemorrhagic fever

Yellow fever

D. Toxic substance-related illnesses. All toxic substance-related illnesses, including pesticide and heavy metal poisoning or illness resulting from exposure to an occupational dust or fiber or radioactive substance, shall be reported.

If such illness is verified or suspected and presents an emergency or a serious threat to public health or safety, the report of such illness shall be made immediately by the most rapid means available, preferably by telephone.

E. Outbreaks. The occurrence of outbreaks or clusters of any illness that may represent a group expression of an illness that may be of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone.

F. Unusual or ill-defined diseases or emerging or reemerging pathogens. Unusual or emerging conditions of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone. In addition, the commissioner or his designee may establish surveillance systems for diseases or conditions that are not on the list of reportable diseases. Such surveillance may be established to identify cases (delineate the magnitude of the situation), to identify the mode of transmission and risk factors for the disease, and to identify and implement appropriate action to protect public health. Any person reporting information at the request of the department for special surveillance or other epidemiological studies shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

D. Submission of initial isolate or other specimen for further public health testing. A laboratory identifying evidence of any of the conditions in this subsection shall notify the local health department of the positive culture or other positive test result within the timeframes specified in subsection B of this section and submit the initial isolate (preferred) or other initial specimen to the Division of Consolidated Laboratory Services or other public health laboratory where specified in this subsection within seven days of identification. All specimens must be identified with the patient and physician information required in 12VAC5-90-90 B.

Anthrax (Bacillus anthracis)

Botulism (Clostridium botulinum)

Brucellosis (Brucella sp.)

Candida auris

Candida haemulonii

Carbapenem-resistant Enterobacteriaceae

Carbapenem-resistant Pseudomonas aeruginosa

Cholera (Vibrio cholerae O1 or O139)

Coronavirus infection, severe (e.g., SARS-CoV, MERS-CoV)

Diphtheria (Corynebacterium diphtheriae)

Haemophilus influenzae infection, invasive

Influenza, unsubtypeable

Listeriosis (Listeria monocytogenes)

Meningococcal disease (Neisseria meningitidis)

Plague (Yersinia pestis)

Poliovirus infection

Q fever (Coxiella burnetii)

Salmonellosis (Salmonella spp.)

Shiga toxin-producing E. coli infection (Laboratories that identify a Shiga toxin but do not perform simultaneous culture for Shiga toxin-producing E. coli should forward all positive stool specimens or positive enrichment broths to the Division of Consolidated Laboratory Services for confirmation and further characterization.)

Shigellosis (Shigella spp.)

Streptococcal disease, Group A, invasive

Tuberculosis (A laboratory identifying Mycobacterium tuberculosis complex (see 12VAC5-90-225) shall submit a representative and viable sample of the initial culture to the Division of Consolidated Laboratory Services or other laboratory designated by the board to receive such specimen.)

Tularemia (Francisella tularensis)

Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi (all types))

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae)

Yersiniosis (Yersinia spp.)

Other diseases as may be requested by the health department.

G. E. Neonatal abstinence syndrome. Neonatal abstinence syndrome shall be reported by physicians and directors of medical care facilities when a newborn has been diagnosed with neonatal abstinence syndrome, a condition characterized by clinical signs of withdrawal from exposure to prescribed or illicit drugs. Reports shall be submitted within one month of diagnosis by entering the information into the Department of Health's online Confidential Morbidity Report portal (http://www.vdh.virginia.gov/clinicians).

F. Outbreaks. The occurrence of outbreaks or clusters of any illness that may represent a group expression of an illness that may be of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone.

G. Toxic substance-related illnesses. All toxic substance-related illnesses, including pesticide and heavy metal poisoning or illness resulting from exposure to an occupational dust or fiber or radioactive substance, shall be reported.

If such illness is verified or suspected and presents an emergency or a serious threat to public health or safety, the report of such illness shall be made immediately by the most rapid means available, preferably by telephone.

H. Unusual occurrence of disease of public health concern. Unusual or emerging conditions of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone. In addition, the commissioner or the commissioner's designee may establish surveillance systems for diseases or conditions that are not on the list of reportable diseases. Such surveillance may be established to identify cases (delineate the magnitude of the situation), to identify the mode of transmission and risk factors for the disease, and to identify and implement appropriate action to protect public health. Any person reporting information at the request of the department for special surveillance or other epidemiological studies shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.