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

Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: April 1, 2022.

Agency Contact: Kristin Collins, Policy Analyst, Office of Epidemiology, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7298, or email kristin.collins@vdh.virginia.gov.

Basis: Sections 32.1-12 and 32.1-35 of the Code of Virginia authorize the State Board of Health to promulgate the proposed regulation. Specifically, § 32.1-35 of the Code of Virginia directs the board to promulgate regulations specifying which diseases occurring in the Commonwealth are to be reportable and the method by which they are to be reported.

Purpose: The proposed changes are essential to protect the health and safety of citizens because they will improve the ability of the Virginia Department of Health (VDH) to conduct surveillance and investigations, collect necessary public health information, and continue to implement disease control measures for COVID-19. The changes will position the agency to better detect and respond to these illnesses to protect the health of the public.

Substance: Amendments to current regulations will for COVID-19: (i) require all suspect or confirmed COVID-19 case report forms be submitted electronically to VDH; (ii) clarify that the category laboratory directors includes all entities that hold Clinical Laboratory Improvement Amendments Certificates of Waiver so that entities testing for COVID-19 are required to report to VDH; (iii) require all COVID-19 laboratory reports be submitted electronically to VDH; (iv) add the requirement that patient telephone number, email address, and ethnicity be included in the list of fields that are reported by physicians, laboratory directors, and directors of medical care facilities; and (v) add "coronavirus, severe" to the list of infectious diseases that shall be reported to persons practicing funeral services.

Issues: The primary advantages to the public are the improved ability of the agency to control the risk of disease in the community based on timelier reporting through VDH's online morbidity reporting portal and the improved ability to accurately report COVID-19 data. No disadvantages have been identified.

The primary advantage to the agency is that the proposed changes improve the focus of surveillance and ability of VDH to conduct surveillance and implement disease control for conditions of public health concern in a timely manner. The changes will position the agency to better detect and respond to these illnesses to protect the health of the public. No disadvantages have been identified.

Department of Planning and Budget's Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia (Code) and Executive Order 14 (as amended, July 16, 2018). The analysis presented below represents DPB's best estimate of these economic impacts.¹

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to make permanent a discretionary emergency regulation that would add COVID-19 to the list of reportable diseases.² Specifically, the proposed amendments would (i) specify the patient information to be collected and reported to the Virginia Department of Health (VDH), (ii) require COVID-19 case and laboratory reports to be submitted electronically, (iii) identify all entities (physicians, lab directors, and other non-traditional providers who conduct COVID testing) that are required to report COVID-19, and (iv) add "coronavirus, severe" to the list of infectious diseases that shall be reported to persons practicing funeral services at the time of transferring custody of a dead body.

Background. The Regulations for Disease Reporting and Control provide information about the process and procedures for reporting diseases to VDH, including what diseases must be reported, who must report them, and other details.

The 2020 federal Coronavirus Aid, Relief, and Economic Security (CARES) Act requires that every laboratory that performs a test that is "intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 shall report the results of each such test to the Secretary of Health and Human Services until the end of the Public Health Emergency declaration with respect to COVID-19 or any extension of such declaration.³ Details regarding who had to report testing data to whom, and what information had to be reported, were left to the Secretary's discretion. A federal public health emergency for COVID-19 was first declared on January 31, 2020, and has been renewed every three months since then, most recently on October 18, 2021.⁴

In order to implement these requirements, the Centers for Disease Prevention and Control (CDC) has communicated specific requirements for laboratories, including details regarding who must make reports (what entities are considered "laboratories") and what data elements must be reported.⁵ The CDC requires all COVID-19 testing sites to have a Clinical Laboratory Improvement Amendments (CLIA) certificate and requires every CLIA-certified testing site to report data for all diagnostic and screening testing completed, including molecular, antigen, and antibody testing for each individual tested, within 24 hours of test completion.⁶ These reporting requirements apply to all entities conducting COVID-19 testing; VDH's reporting requirements described below separate reporters into two groups for the purposes of this regulation: (a) physicians and directors of medical care facilities, and (b) directors of laboratories, including other entities that hold CLIA Certificates of Waiver. The CDC has also directed all entities conducting COVID-19 testing to report testing data to state or local public health departments according to state law or policy.

Subsequently, the Board promulgated emergency regulations to clarify and enforce the CARES Act reporting requirements and to collect necessary information to guide state-level policy making in response to COVID-19.⁷ Specifically, the Board added "Coronavirus, severe" to 12VAC5-90-80 List of diseases that shall be reported and a subsection specifying who would report COVID-19 tests and how. The proposed amendments at this stage largely preserve the changes made at the emergency stage, with the exception of one significant change that is discussed here.

The proposed amendments require physicians and directors of medical care facilities to report COVID-19 testing data when a person who is infected with or is suspected of having COVID-19 is treated or examined, hospitalized, or admitted to an intensive care unit. Physicians and directors of medical care facilities would be required to report "the person's name, telephone number, email address, address, age, date of birth, race, ethnicity, sex, and pregnancy status; name of disease diagnosed or suspected; the medical record number (if applicable); the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made.⁸ The proposed language also specifies that case reports shall be submitted immediately or within 24 hours by entering the information into VDH's online Confidential Morbidity Report portal or via electronic case reporting.⁹

The proposed amendments include analogous reporting requirements for directors of laboratories, including other entities that hold CLIA Certificates of Waiver; while the patient data to be reported is the same as above, labs would also have to report the source of the specimen, the laboratory method and the result. Under the emergency regulation, lab directors were required to report both positive and negative test results; as per the proposed amendments at this stage, lab directors would only have to report positive test results. In practice, this change would only affect lab directors once the federal public health emergency declaration is lifted, since the CARES Act requires that every test be reported to the Secretary of Health and Human Services and VDH will continue to act as a conduit for that information. As for physicians, lab directors would also be required to report tests within 24 hours, either by entering information into VDH's online portals for lab reporting or via electronic lab reporting.¹⁰

Lastly, 12VAC5-90-90 states that, "In accordance with § 32.1-37.1 of the Code of Virginia, any person in charge of a hospital, nursing facility or nursing home, assisted living facility, or correctional facility shall, at the time of transferring custody of any dead body to any person practicing funeral services, notify the person practicing funeral services or his agent if the dead person was known to have had, immediately prior to death, an infectious disease which may be transmitted through exposure to any bodily fluids." COVID-19 was added to the list of infectious diseases subject to this requirement at the emergency stage; this change would be made permanent.

Estimated Benefits and Costs.¹¹ The primary benefits of timely data collection about COVID-19 suspected cases and test results were, and continue to be, the protection of public health. In the initial stages of the COVID-19 pandemic, this included critical decision making regarding the procurement of personal protective equipment for hospital staff and other frontline workers, the procurement and allocation of ventilators and oxygen and other critical supplies, and hiring and staffing decisions for hospitals, nursing homes, emergency rooms, and other providers. Funeral services workers would benefit from the addition of COVID-19 to the list of infectious diseases they are informed of so that they can take adequate precautions.

In addition, collecting information on both positive and negative tests allowed public health experts to calculate and report the percent-positivity rate, which served as a leading indicator of community transmission at the local, regional, and state levels. This information was and continues to be used to guide public health policies such as social distancing, recommendations (and mandates) regarding masking, travel, capacity limits for various businesses, and lockdowns. Thus, in addition to meeting federal requirements, the proposed amendments have benefited and would likely continue to benefit the public, at least as long as the pandemic continues.

The direct costs of the proposed amendments fall on physicians and lab directors who face a significant reporting burden and a binding time constraint. To the extent that this reporting is required by the CARES Act and the Secretary of Health and Human Services, these costs are unavoidable. VDH has attempted to mitigate this burden by providing multiple online portals and secure electronic transmission methods in order to reduce the time and paperwork costs of these requirements. As the pandemic has evolved, the criteria for testing have changed and tests have become more widely available; people may be more likely to get tested in order to travel or attend an event, or to get tested more frequently if they have to be present in-person for work or education. Thus, as the number of negative tests increase in general, percent positivity may not be as informative or useful as it once was. In recognition of these trends, the Board proposes to remove the requirement to report negative COVID-19 tests, which would significantly reduce the reporting burden for labs, including entities with CLIA waivers. At the same time, requiring that positive cases and tests be reported would ensure that new "spikes" or "hotspots" can be identified quickly.

Many of the patient-specific data elements (such as biographical and contact information) that would be required by these proposed changes are already required for other reportable diseases. However, this proposed change is the first time that this regulation has required that the telephone number, email address, and ethnicity be reported. An indirect cost of the proposed amendments, therefore, relates to individuals' data privacy and the risk that one's personal biographical details, contact details, and health information may be accessed by unauthorized persons or entities and/or used for nefarious purposes. Such concerns may discourage individuals from getting tested even when they do exhibit symptoms, which would defeat the purpose of collecting this information. All the patient-related data fields included in the proposed amendments (except e-mail address) are currently required by the CARES Act, so VDH does not have much leeway in amending the scope of data collected.¹² Further, the reported data are transmitted to the CDC and possibly other entities, which amplifies privacy concerns since data sharing increases the risk of a security breach, even if the data are de-identified.

In order to ameliorate these costs in the long run, the Board and VDH could revisit the scope of data collection and the list of data fields once the federal public health emergency is lifted and re-evaluate the proposed requirements. If COVID-19 ends up becoming more common and less dangerous, VDH could consider only requiring physicians to report cases that require hospitalization or admission to intensive care, or only requiring lab reports to include select demographic data but no personally identifiable information.

Businesses and Other Entities Affected. The proposed amendments affect roughly 20,000 physicians, 125 laboratories, 100 hospitals, and 250 nursing homes in Virginia.¹³ There are currently 7,791 entities with CLIA certificates in Virginia (including the 125 laboratories mentioned previously) who are potentially impacted by the proposed amendments.¹⁴ Some of these entities may operate multiple testing locations, such as a school district with one certificate that covers 13 schools.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.¹⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As noted above, the proposal to add new reporting requirements would increase costs for physicians, hospitals, nursing homes, labs and other testing centers. Thus, an adverse impact is indicated.

Small Businesses¹⁶ Affected.¹⁷ To the extent that some of the affected laboratories or nursing homes may be small businesses, the proposed amendments would appear to adversely affect small businesses.

Types and Estimated Number of Small Businesses Affected. The number of small businesses impacted by the proposed amendments is unknown. Some of the affected laboratories or nursing homes may be small businesses and some small businesses (not necessarily connected to health care) may have acquired CLIA Waivers to offer on-site testing for employees or clients. To the extent that offering testing improves employee or client satisfaction for the latter category of small businesses, their costs may be offset by other gains.

Costs and Other Effects. The proposed amendments increase reporting requirements, which requires staff time. An adverse economic impact¹⁸ on laboratories, including entities with CLIA Waivers is indicated because there do not appear to be any offsetting direct benefits to these small businesses.

Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both reduce adverse impact and meet federal requirements and the intended policy goals.

Localities¹⁹ Affected.²⁰ The proposed amendments potentially affect all 132 localities, but localities with greater COVID-19 prevalence may have higher rates of testing; thus, physicians, hospitals, nursing homes, and labs in those localities would be disproportionately affected. The proposed amendments do not introduce costs for local governments. Accordingly, no additional funds would be required. Consequently, no adverse economic impact²¹ is indicated for any particular locality.

Projected Impact on Employment. The proposed amendments do not appear to affect total employment directly. Some hospitals, nursing homes, or labs may have hired additional temporary staff in order to meet the reporting requirements.

Effects on the Use and Value of Private Property. The proposed new reporting requirements for private hospitals, nursing homes, and laboratories, including entities with CLIA waivers moderately increase their costs. However, given the role played by such organizations in responding to the COVID-19 pandemic and the public health benefits of the data collected, it would be unlikely to reduce the value of these firms. Some laboratories may have expanded the scale of their operations and become more valuable if they were able to hire personnel and use technology to more efficiently meet the reporting requirements while also performing more tests. The proposed amendments do not affect real estate development costs.

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¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²See https://townhall.virginia.gov/l/ViewStage.cfm?stageid=9040 for the Emergency/NOIRA stage, which became effective on January 20, 2021 and expires on July 19, 2022.

³See https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf, Sec. 18115(a). The Act became effective March 27, 2020.

⁴See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. As of this writing, there is no indication as to when the emergency declaration will stop being renewed.

⁵See https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html.

⁶See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/cliabrochure.pdf. Anyone who performs testing of human specimens for the diagnosis, prevention or treatment of disease or health problems must apply for a CLIA certificate. This includes physicians who operate their own in-office laboratories and medical care facilities. There are 4 types of CLIA certificates: Certificate of Waiver, Provider Performed Microscopy, Compliance, and Accreditation. CLIA Certificate of Waiver holders may now include various entities that have started conducting some types of COVID tests, such as school districts, employers, sports teams, etc. Thus, "labs" and "directors of laboratories" are broad classifications in the context of CARES Act reporting requirements and this regulation.

⁷See https://townhall.virginia.gov/l/ViewStage.cfm?stageid=9040. Although the emergency regulation became effective January 20, 2021, VDH reported that they had begun collecting COVID-19 data in March 2020, as required by the CARES Act. The emergency regulation expires on July 19, 2022.

⁸Details regarding data elements appear in a new section 80-90 I., titled COVID-19 (SARS-CoV-2), to specify that they are only required for COVID-19. VDH has clarified that physicians would not be required to report patients' other diagnosed or suspected health conditions, nor be required to submit information on any lab tests that are not COVID-19 tests.

⁹The proposed amendments include hyperlinks to these online portals. The emergency language requires physicians and directors of medical care facilities to report hospitalizations and intensive care unit admissions through the Emergency Department Care Coordination program. That requirement would be removed at this stage. Separately, VDH also created a point-of-care reporting portal in September 2020 due to the high volume of point-of-care tests that were being conducted for COVID-19 to make reporting easier. (https://apps.vdh.virginia.gov/pocreporting/login/login.aspx)

¹⁰This deviates from the emergency stage, which allowed the use of paper Epi-1 forms or the laboratory's own forms if it contained the required information, and computer generated reports containing the required information.

¹¹The Economic Impact Analysis compares the proposed regulation to the regulation in the Virginia Administrative Code. The emergency regulation is: 1) not in the Virginia Administrative Code (see http://law.lis.virginia.gov/admincode) and 2) temporary. Thus, the Economic Impact Analysis assesses the impact of changing the permanent regulations. Consequently, to the extent that the proposed text matches the emergency text, some of the benefits and costs described here have likely already accrued.

¹²See https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf from https://www.hhs.gov/coronavirus/testing/covid-19-diagnostic-data-reporting/index.html. The list of data fields on pages 2-4 contains all the data fields required by VDH in the proposed text, except the patient's email address. Individuals may choose not to disclose biographical or contact information when getting tested. Although testing sites are required to make every effort to collect this information, if individuals choose not to disclose certain information the testing site would still be able to submit incomplete records to VDH.

¹³Agency Background Document, page 5: https://townhall.virginia.gov/l/GetFile.cfm?File=58\5581\9399\AgencyStatement_VDH_9399_v1.pdf.

¹⁴VDH reported that in federal fiscal years 2020 and 2021, 1,429 new CLIA Certificates of Waiver were created for testing entities in Virginia. Not all of these were testing for COVID-19, but a large majority were. Further, there is no federal requirement for facilities with CLIA certificates to notify VDH or CLIA if they have added a test as long as the test of the same complexity and specialty of their certificate; thus all 7,791 entities with current certificates may be affected.

¹⁵Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

¹⁶Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

¹⁷If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to Code § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

¹⁸Adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.

¹⁹"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

²⁰§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

²¹Adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health (VDH) agrees with the findings of the economic impact analysis (EIA), with two caveats.

The EIA prepared by the Department of Planning and Budget for the proposed stage amendment to the Disease Reporting and Control Regulations, (12VAC5-90) states that "the Board proposes to remove the requirement to report negative COVID-19 tests." This statement is true; however, VDH would like to clarify that this continues to be a federal reporting requirement in the CARES Act and all laboratories, including those with Clinical Laboratory Improvement Amendments waivers, will be required to continue reporting negative COVID-19 test results until the federal requirement is removed

Further, the EIA indicates that an "indirect cost of the proposed amendments, therefore, relates to individuals" data privacy and the risk that one's personal biographical details, contact details, and health information may be accessed by unauthorized persons or entities and/or used for nefarious purpose." Data reported to VDH related to this action are required to be kept confidential per §§ 32.1-36, 32.-38, and 32.1-41of the Code of Virginia. Further, all of VDH's data systems are compliant with Commonwealth of Virginia security standards. With these controls in place, risk addressed here is extremely minimal.

Summary:

The proposed amendments add to the reporting requirements for physicians and directors of medical care facilities for COVID-19 to (i) require physicians and directors of medical care facilities to report suspected or confirmed COVID-19 cases and COVID-19 hospitalizations and intensive care unit admissions to the Virginia Department of Health (VDH) through participation in the Emergency Department Care Coordination Program; (ii) require all suspected or confirmed COVID-19 case report forms be submitted electronically to VDH; (iii) clarify that the category "laboratory directors" includes pharmacies that hold Clinical Laboratory Improvement Amendments Certificates of Waiver so that pharmacies testing for COVID-19 are required to report to VDH; (iv) require laboratory directors report both positive and negative COVID-19 test results; (v) require patient telephone number, email address, and ethnicity be included in the list of fields that are reported by physicians, laboratory directors, and directors of medical care facilities; and (vi) add "coronavirus, severe" to the list of infectious diseases that shall be reported to persons practicing funeral services.

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. COVID-19 (SARS-CoV-2) shall be reported as specified in subsection I of the section.

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 virus)

Chlamydia trachomatis infection

*Cholera (Vibrio cholerae O1 or O139)

*Coronavirus infection, severe

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)

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 if younger than 18 years of age

Lead, 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, health care-associated, occupational, toxic substance-related, waterborne, and 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 virus)

Spotted fever rickettsiosis (Rickettsia spp.)

Streptococcal disease, Group A, invasive or toxic shock

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

Syphilis (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

*Tularemia (Francisella tularensis)

*Typhoid/Paratyphoid 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

*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 (Entamoeba histolytica)

*Anthrax (Bacillus anthracis)

Arboviral infection, for example, CHIK, dengue, EEE, LAC, SLE, WNV, or Zika

Babesiosis (Babesia spp.)

*Botulism (Clostridium botulinum)

*Brucellosis (Brucella spp.)

Campylobacteriosis (Campylobacter spp.)

Candida auris - Include available antimicrobial susceptibility findings in report.

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

Chancroid (Haemophilus ducreyi)

Chickenpox (Varicella virus)

Chlamydia trachomatis infection

*Cholera (Vibrio cholerae O1 or O139)

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

Cryptosporidiosis (Cryptosporidium spp.)

Cyclosporiasis (Cyclospora spp.)

*Diphtheria (Corynebacterium diphtheriae)

Ehrlichiosis/Anaplasmosis (Ehrlichia spp., Anaplasma phagocytophilum)

Giardiasis (Giardia spp.)

Gonorrhea (Neisseria gonorrhoeae) - Include available antimicrobial susceptibility findings in report.

*Haemophilus influenzae infection, invasive

Hantavirus pulmonary syndrome

*Hepatitis A

Hepatitis B (acute and chronic) - For 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) - For all 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 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 - 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 culture, antigen detection by direct fluorescent antibody (DFA), or nucleic acid detection.

Lead, blood levels - 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 (Legionella spp.)

Leptospirosis (Leptospira interrogans)

Listeriosis (Listeria monocytogenes), invasive or if associated with miscarriage or stillbirth from placental or fetal tissue

Lyme disease (Borrelia spp.)

Malaria (Plasmodium spp.)

*Measles (Rubeola)

*Meningococcal disease (Neisseria meningitidis), invasive - Include identification of gram-negative diplococci.

Mumps

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

1. Acid fast bacilli;

2. M. tuberculosis complex or any other mycobacteria;

3. Antimicrobial susceptibility results for M. tuberculosis complex.

*Pertussis (Bordetella pertussis)

*Plague (Yersinia pestis)

*Poliovirus infection

*Psittacosis (Chlamydophila psittaci)

*Q fever (Coxiella burnetii)

*Rabies, human and animal

*Rubella

Salmonellosis (Salmonella spp.)

Shiga toxin-producing Escherichia coli infection

Shigellosis (Shigella spp.)

*Smallpox (Variola virus)

Spotted fever rickettsiosis (Rickettsia spp.)

Streptococcal disease, Group A, invasive or toxic shock

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

*Syphilis (Treponema pallidum)

Toxic substance-related illness - By blood or urine laboratory findings above the normal range, including 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) (Trichinella spiralis)

Tuberculosis infection

*Tularemia (Francisella tularensis)

*Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi A, Salmonella Paratyphi B, Salmonella Paratyphi C)

*Vaccinia, disease or adverse event

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

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

*Viral hemorrhagic fever

*Yellow fever

Yersiniosis (Yersinia spp.)

C. Reportable diseases requiring rapid communication. Certain of the diseases in the list of reportable diseases because of their extremely contagious nature, potential for greater harm, or 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 if younger than 18 years of age

Influenza A, novel virus

Measles (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 virus)

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

Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Tularemia (Francisella tularensis)

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

Unusual occurrence of disease of public health concern

Vaccinia, disease or adverse event

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. 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.

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.

I. COVID-19 (SARS-CoV-2). COVID-19 shall be reported by physicians and directors of medical care facilities when a person who is infected with or who is suspected of having COVID-19 is treated or examined, hospitalized, or admitted into the intensive care unit. Physicians and directors of medical care facilities shall report that person's name, telephone number, email address, address, age, date of birth, race, ethnicity, sex, and pregnancy status; name of disease diagnosed or suspected; the medical record number (if applicable); the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made. Case reports shall be submitted immediately or within 24 hours by entering the information into the Department of Health online Confidential Morbidity Report portal at http://www.vdh.virginia.gov/clinicians or via electronic case reporting (https://www.vdh.virginia.gov/meaningful-use/meaningful-use-submissions-of-electronic-case-reports/).

Positive SARS-CoV-2 tests shall be reported by directors of laboratories, including other entities that hold Clinical Laboratory Improvement Amendments Certificates of Waiver. Each report shall give the source of the specimen and the laboratory method and result; the name, telephone number, email address, address, age, date of birth, race, ethnicity, sex, and pregnancy status (if known) of the person from whom the specimen was obtained; and the name, address, and telephone number of the physician at whose request and medical facility at which the examination was made. Reports shall be submitted immediately or within 24 hours to the department. Reports shall be made by entering information into the department's available portal for laboratory reporting at http://www.vdh.virginia.gov/clinicians or via electronic laboratory reporting at http://www.vdh.virginia.gov/meaningful-use/submissionofreportablelabresults.

12VAC5-90-90. Those required to report.

A. Physicians. Each physician who treats or examines any person who is suffering from or who is suspected of having a reportable disease or condition shall report that person's name, address, age, date of birth, race, sex, and pregnancy status for females; name of disease diagnosed or suspected; the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made, except that influenza should be reported by number of cases only (and type of influenza, if available). Reports are to be made to the local health department serving the jurisdiction where the physician practices. A physician may designate someone to report on his behalf, but the physician remains responsible for ensuring that the appropriate report is made. Any physician, designee, or organization making such report as authorized herein shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

Such reports shall be made on a Form Epi-1, a computer generated printout containing the data items requested on Form Epi-1, or a CDC or VDH surveillance form that provides the same information and shall be made within three days of the suspicion or confirmation of disease except that those identified in 12VAC5-90-80 C shall be reported immediately by the most rapid means available, preferably by telephone, to the local health department serving the jurisdiction in which the facility is located. Reporting may be done by means of secure electronic transmission upon agreement of the physician and the department.

Additional elements are required to be reported for individuals with confirmed or suspected active tuberculosis disease. Refer to Part X (12VAC5-90-225 et seq.) for details on these requirements.

B. Directors of laboratories. Laboratory directors shall report any laboratory examination of any clinical specimen, whether performed in-house or referred to an out-of-state laboratory, which yields evidence, by the laboratory method(s) method indicated or any other confirmatory test, of a disease listed in 12VAC5-90-80 B.

Each report shall give the source of the specimen and the laboratory method and result; the name, address, age, date of birth, race, sex, and pregnancy status for females (if known) of the person from whom the specimen was obtained; and the name, address, and telephone number of the physician at whose request and medical facility at which the examination was made. When the influenza virus is isolated, the type should be reported, if available. Reports shall be made within three days of identification of evidence of disease, except that those identified in 12VAC5-90-80 C shall be reported immediately by the most rapid means available, preferably by telephone, to the local health department serving the jurisdiction in which the laboratory is located. Reports shall be made on Form Epi-1 or on the laboratory's own form if it includes the required information. Computer generated reports containing the required information may be submitted. Reporting may be done by means of secure electronic transmission upon agreement of the laboratory director and the department. Reports of HIV genetic nucleotide sequence data associated with HIV drug resistance tests must be submitted electronically. Any person making such report as authorized herein shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

A laboratory identifying evidence of any of the following conditions shall notify the local health department of the positive culture or other positive test result within the timeframes specified in 12VAC5-90-80 and submit the initial isolate or other initial specimen to the Division of Consolidated Laboratory Services within seven days of identification. All specimens must be identified with the patient and physician information required in this subsection.

Anthrax

Botulism

Brucellosis

Cholera

Diphtheria

E. coli infection, Shiga toxin-producing. (Laboratories that use a Shiga toxin EIA methodology 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.)

Haemophilus influenzae infection, invasive

Influenza A, novel virus

Listeriosis

Meningococcal disease

Pertussis

Plague

Poliovirus infection

Q fever

Salmonellosis

Shigellosis

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

Typhoid/Paratyphoid fever

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

Vibrio infection, including infections due to Photobacterium damselae and Grimontia hollisae

Yersiniosis

Other diseases as may be requested by the health department

When a clinical specimen yields evidence indicating the presence of a select agent or toxin as defined by federal regulations in 42 CFR Part 73, the person in charge of the laboratory shall contact the Division of Consolidated Laboratory Services and arrange to forward an isolate for confirmation. If a select agent or toxin has been confirmed in a clinical specimen, the laboratory director shall consult with Division of Consolidated Laboratory Services or CDC regarding isolate transport or destruction.

Laboratories operating within a medical care facility shall be considered to be in compliance with the requirement to notify the local health department when the director of that medical care facility assumes the reporting responsibility; however, laboratories are still required to submit isolates to the Division of Consolidated Laboratory Services or other designated laboratory as noted in this subsection.

C. Persons in charge of a medical care facility. Any person in charge of a medical care facility shall make a report to the local health department serving the jurisdiction where the facility is located of the occurrence in or admission to the facility of a patient with a reportable disease listed in 12VAC5-90-80 A unless he has evidence that the occurrence has been reported by a physician. Any person making such report as authorized herein shall be immune from liability as provided by § 32.1-38 of the Code of Virginia. The requirement to report shall include all inpatient, outpatient, and emergency care departments within the medical care facility. Such report shall contain the patient's name, address, age, date of birth, race, sex, and pregnancy status for females; name of disease being reported; available laboratory tests and results; the date of admission; hospital chart medical record number; date expired (when applicable); and attending physician. Influenza should be reported by number of cases only (and type of influenza, if available). Reports shall be made within three days of the suspicion or confirmation of disease except that those identified in 12VAC5-90-80 C shall be reported immediately by the most rapid means available, preferably by telephone, to the local health department serving the jurisdiction in which the facility is located. Reports shall be made on Form Epi-1, a computer generated printout containing the data items requested on Form Epi-1, or a CDC or VDH surveillance form that provides the same information. Reporting may be done by means of secure electronic transmission upon agreement of the medical care facility and the department.

A person in charge of a medical care facility may assume the reporting responsibility on behalf of the director of the laboratory operating within the facility.

D. Persons in charge of a residential or day program, service, or facility licensed or operated by any agency of the Commonwealth, or a school, child care center, or summer camp. Any person in charge of a residential or day program, service, or facility licensed or operated by any agency of the Commonwealth, or a school, child care center, or summer camp as defined in § 35.1-1 of the Code of Virginia shall report immediately to the local health department the presence or suspected presence in his program, service, facility, school, child care center, or summer camp of persons who have common symptoms suggesting an outbreak situation. Such persons may report additional information, including identifying and contact information for individuals with communicable diseases of public health concern or individuals who are involved in outbreaks that occur in their facilities, as necessary to facilitate public health investigation and disease control. Any person so reporting shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

E. Local health directors. The local health director shall forward any report of a disease or report of evidence of a disease which has been made on a resident of his jurisdiction to the Office of Epidemiology within three days of receipt. This report shall be submitted immediately by the most rapid means available if the disease is one requiring rapid communication, as required in 12VAC5-90-80 C. All such rapid reporting shall be confirmed in writing and submitted to the Office of Epidemiology, by either a paper report or entry into a shared secure electronic disease surveillance system, within three days. Furthermore, the local health director shall immediately forward to the appropriate local health director any disease reports on individuals residing in the latter's jurisdiction or to the Office of Epidemiology on individuals residing outside Virginia. The Office of Epidemiology shall be responsible for notifying other state health departments of reported illnesses in their residents and for notifying CDC as necessary and appropriate.

F. Persons in charge of hospitals, nursing facilities or nursing homes, assisted living facilities, and correctional facilities. In accordance with § 32.1-37.1 of the Code of Virginia, any person in charge of a hospital, nursing facility or nursing home, assisted living facility, or correctional facility shall, at the time of transferring custody of any dead body to any person practicing funeral services, notify the person practicing funeral services or his agent if the dead person was known to have had, immediately prior to death, an infectious disease which may be transmitted through exposure to any bodily fluids. These include any of the following infectious diseases:

Coronavirus, severe

Creutzfeldt-Jakob disease

Human immunodeficiency virus infection

Hepatitis B

Hepatitis C

Rabies

Smallpox

Syphilis, infectious

Tuberculosis, active disease

Vaccinia, disease or adverse event

Viral hemorrhagic fever

G. Employees, conditional employees, and persons in charge of food establishments. 12VAC5-421-80 of the Food Regulations requires a food employee or conditional employee to notify the person in charge of the food establishment when diagnosed with certain diseases that are transmissible through food and requires the person in charge of the food establishment to notify the regulatory authority. Refer to 12VAC5-421-80 for further guidance and clarification regarding these reporting requirements.