12VAC5-90 Regulations for Disease Reporting and Control

REGULATIONS

Vol. 26 Iss. 7 - December 07, 2009

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 90

Proposed Regulation

Title of Regulation: 12VAC5-90. Regulations for Disease Reporting and Control (amending 12VAC5-90-10, 12VAC5-90-30, 12VAC5-90-80, 12VAC5-90-90, 12VAC5-90-100, 12VAC5-90-103, 12VAC5-90-107, 12VAC5-90-110, 12VAC5-90-130, 12VAC5-90-140, 12VAC5-90-225, 12VAC5-90-370).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 5, 2010.

Agency Contact: Diane Woolard, Ph.D., Director, Disease Surveillance, Department of Health, 109 Governor St., Richmond, VA 23219, telephone [phone], or email [e-mail].

Basis: Section 32.1-35 of the Code of Virginia directs the Board of Health 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 amendment is necessary to make the regulations comply with changes in the Code of Virginia. The proposed changes improve the ability of the Virginia Department of Health to conduct surveillance and implement disease control for conditions of public health concern, including some that may indicate bioterrorism events. 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 update: (i) language to ensure that it complies with the Code of Virginia and reflects current public health, medical and scientific terminology; (ii) disease reporting requirements, including reportable diseases and those required to report; (iii) language regarding laboratory reporting requirements; (iv) tuberculosis reporting and control requirements and definitions; (v) provisions regarding the reporting of toxic substance-related illness; (vi) requirements related to HIV prenatal testing and gamete donation; (vii) and other disease reporting and control provisions necessary to protect the health of the people of the Commonwealth.

Issues: The proposed changes improve the ability of the Virginia Department of Health to conduct surveillance and implement disease control for conditions of public health concern, including some that may indicate bioterrorism events. The changes will position the agency to better detect and respond to these illnesses to protect the health of the public.

Except as noted below, changes are alterations in language and terminology to reflect current scientific use and to provide clarification. For example, the phrase "interrupt the transmission of disease" is replaced by "reduce the occurrence of disease," names of conditions on the Reportable Disease List are modified to comply with scientific usage, and definitions that were in a subsection are moved to the Definitions section. These changes improve the clarity of the regulations but are not substantive.

Updates to disease reporting requirements include:

1. Conditions requiring rapid communication will be reported "by the most rapid means available," rather than "within 24 hours" to clarify that immediate action is expected for these high priority conditions.

2. The change in terminology from "poliomyelitis" to "poliovirus infection" clarifies that all poliovirus infections are reportable, not only those resulting in paralysis.

3. Toxic Shock Syndrome is removed from the list of reportable conditions, but is added as a reportable Group A Streptococcal infection. Toxic shock may result from streptococcal or staphylococcal organisms. The number of staphylococcal toxic shock syndrome cases has been minimal over the past 10 years (averaging 1.2 cases per year) and clinical management is effective to limit spread. Streptococcal infections are still of public health concern and will remain reportable.

4. Kawasaki syndrome is removed from the list of reportable conditions. The conditional was initially added as a reportable condition due to a national research effort to identify the causal agents. However, no cause has been identified and there is no public health intervention to reduce the occurrence of disease. Over the past five years, an average of 17 Kawasaki cases was reported each year in Virginia.

5. Changes in reporting requirements for laboratory directors pertain to Lyme disease and heavy metals. Lyme disease is added to the list of conditions reportable by laboratories because laboratory findings are essential for identification and confirmation of cases. Because the major reference laboratories currently submit Lyme disease findings, the impact is expected to be minimal. When reporting elevated levels of heavy metal exposure, the amendment proposes requiring laboratories to provide speciation, indicating whether the metal is organic or inorganic, when this information is available. This assists in determining whether public health action is needed to follow up on reports, which applies only to inorganic metals.

6. To comply with changes in § 32.1-37 of the Code of Virginia, new wording is added to specify that persons in charge of a residential or day program, service, or facility licensed or operated by any agency of the Commonwealth must report outbreaks. The change in Code of Virginia, which was made during the 2008 legislative session, addressed a gap in the requirement for persons in charge of schools, child care centers, and summer camps to reports outbreaks. Earlier involvement by public health minimizes the number of individuals who become ill and assists the facility in implementing changes to reduce future outbreaks.

Submission of tuberculosis specimens: To comply with changes in § 32.1-50 of the Code of Virginia, the updated regulations remove the exception that previously allowed a laboratory to submit drug susceptibility findings for tuberculosis specimens in place of a viable sample. Submission of positive cultures for a member of the M. tuberculosis complex to the Division of Consolidated Laboratory Services (DCLS) or other approved laboratory guarantees the availability of drug susceptibility results for public health and treating clinicians. These results are important to ensure the appropriate treatment of individuals impacted by tuberculosis disease. In addition, genetic fingerprinting of the organism by public health laboratories provides insights into disease transmission patterns and identifies points where public health intervention can prevent further transmission.

Submission of specimens for additional confirmation: Laboratories identifying evidence of 14 conditions in addition to tuberculosis have been required to submit specimens to DCLS. In this action the requirement is expanded to include four additional conditions. Two are potential bioterrorism conditions not currently included on the list (brucellosis and Q fever). The third is novel influenza A viruses, which could herald the arrival of a new strain of influenza that could potentially lead to a large-scale epidemic or pandemic. The fourth is vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus. VDH receives less than 24 reports per year of these four conditions combined. Resistance to vancomycin in Staphylococcus aureus is an emerging health concern; however, most preliminary findings of resistance are ruled out with confirmatory testing. The other changes in this section offer clarifications. Typhoid fever is caused by Salmonella typhi, and was intended to be covered in the requirement for evidence identifying salmonellosis, but specific mention of the organism will ensure specimen submission. For E. coli O157, the new requirement specifies that when EIA testing is done without culture, the positive broth may be submitted; previously the regulations referred only to the submission of specimens for further testing. Additional testing performed at the state laboratory for these 17 conditions is essential for identifying and delineating outbreaks. On a national level, the ability to obtain and act on this type of analysis is expected of state health departments.

Isolation and quarantine: Changes to the regulations specify that if the risk of infection or transmission continues at the end of the confinement, new orders may be issued to extend the confinement. The procedures for extending orders protect the individual while minimizing health risks to the public. These changes make isolation and quarantine orders more practical to implement and enforce.

Immunization requirements: The regulations are updated to be in conformance with changes in § 32.1-46 of the Code of Virginia, which updated the immunization requirements for children. Additionally, the immunization requirements for school entry in 12VAC5-110-70 are referenced, rather than repeated. This section makes reference to the changes in immunization requirements in § 32.1-46 and those in 12VAC5-110-70, which is under separate review, but does not modify the requirements themselves nor incur any additional costs. The changes reduce duplication in regulations and eliminate the need to modify both sets of regulations when immunization requirements are updated.

Prenatal testing for HIV infection: The regulations are updated to be in conformance with changes in § 54.1-2403.01 of the Code of Virginia, which was amended in the 2008 Session of the General Assembly, and with current guidelines of the Centers for Disease Control and Prevention (CDC). HIV testing during pregnancy is a standard of medical care, and universal screening with an opt-out provision is supported by the American College of Obstetricians and Gynecologists. The change in regulation language would change HIV testing during pregnancy from opt-in to opt-out, and increase from one to two the number of HIV tests to be performed on pregnant women. This change would potentially benefit women by identifying HIV infection, and benefit their newborns through identifying those who would require HIV preventive treatment. The change would ultimately benefit society by decreasing the number of children with HIV infection. This regulation would bring Virginia in line with CDC guidance as well as the Code of Virginia, which makes prenatal HIV testing a routine opt-out procedure. In guidance released in 2006, the CDC identified states where two HIV tests should be performed during pregnancy, because those states have an elevated incidence of HIV or AIDS among women 15 – 45 years of age. Virginia was one of the identified states, and the Association of Maternal and Child Health Programs, to which the Title V Maternal and Child Health Block Grant recipients belong, recommends that state and national policymakers take steps to implement universal opt-out screening, which includes the second HIV test during the third trimester in the jurisdictions identified by CDC. The only disadvantage to the public or the Commonwealth is the cost of the HIV testing.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health proposes to update the regulations to conform to recent changes in the Code of Virginia, to add to or subtract diseases from the list of reportable diseases, to expand the list of conditions for which laboratories are required to submit specimens, and to clarify some of the current requirements and definitions.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The proposed changes update the regulations to conform to recent changes in the Code of Virginia pertaining to the reporting of outbreaks (§ 32.1-37), prenatal testing for HIV infection (§ 54.1-2403.01), immunization requirements (§ 32.1-46), and tuberculosis reporting and control requirements (§ 32.1-50). While these changes are substantial, no significant economic effect is expected upon promulgation as they have already been in effect under the statute.

The board also proposes 1) to remove Toxic Shock Syndrome from the list of reportable conditions, but add it to the list of reportable Group A Streptococcal infections as the number of cases reported have been minimal over the last decade averaging 1.2 cases per year, 2) to remove Kawasaki syndrome from the list of reportable conditions since it was originally added to collect information that may have helped to identify its causes and no cause has been identified as well as there is being no public health intervention to reduce the occurrence of this disease, 3) to add Lyme disease to the list of conditions reportable by laboratories since laboratory findings are essential for identification and confirmation of cases, and 4) to require the laboratories to indicate if available whether the metal is organic or inorganic in cases of elevated levels of heavy metal exposure.

Virginia Department of Health (VDH) does not anticipate any significant economic costs from these changes because Toxic Shock Syndrome and Kawasaki diseases rarely occur, most laboratories are already submitting Lyme disease findings, and the information requested in heavy metal exposure cases is to be submitted only if it is readily available.

The proposed regulations will also expand the list of conditions for which laboratories are required to submit specimens to include two bio terrorism conditions (brucellosis and Q fever), novel influenza viruses, and vancomycin-intermediate or vancomycin-resistant Stphylococcus aureus. Similarly VDH does not expect significant costs as a result of these added conditions as only 24 cases reported for all four conditions combined in year. However, the benefits may be significant in terms of avoided public health costs in case of an epidemic.

Finally, the proposed regulations change the reporting requirement from "within 24 hours" to "will be reported by the most rapid means available" to clarify that immediate action is expected for high priority conditions; clarify the requirements on the list of specimens to be submitted for additional confirmation with regard to Typhoid fever, and E. coli O157; amend the regulation concerning isolation and quarantine to specify that if the risk of infection or transmission continues at the end of the confinement, new orders may be issued to extend the confinement; and clarify numerous definitions. All of the changes under this group are for clarification purposes and are not anticipated to create any significant economic effect.

Businesses and Entities Affected. The requirement to submit additional specimens could affect up to 50 laboratories doing business in Virginia. Insurance companies and health care providers in Virginia are expected to be affected by increased HIV testing.

Localities Particularly Affected. Regulations apply throughout the Commonwealth.

Projected Impact on Employment. No significant effect is expected on employment.

Effects on the Use and Value of Private Property. No significant effect is expected on the use and value of private property.

Small Businesses: Costs and Other Effects. No significant costs and other effects are expected on employment.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No adverse effect is expected on small businesses.

Real Estate Development Costs. No adverse effect is expected on real estate development costs.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The agency concurs substantially with the economic impact analysis submitted by the Department of Planning and Budget.

Summary:

The proposed amendments update the regulation to conform to recent changes in the Code of Virginia, add or remove diseases from the list of reportable diseases, expand the list of conditions for which laboratories are required to submit specimens, and clarify current requirements and definitions.

Part I
Definitions

12VAC5-90-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute care hospital" means a hospital as defined in § 32.1-123 of the Code of Virginia that provides medical treatment for patients having an acute illness or injury or recovering from surgery.

"Adult intensive care unit" means a nursing care area that provides intensive observation, diagnosis, and therapeutic procedures for persons 18 years of age or more who are critically ill. Such units may also provide intensive care to pediatric patients. An intensive care unit excludes nursing areas that provide step-down, intermediate care, or telemetry only.

"Affected area" means any part or the whole of the Commonwealth that, which has been identified as where individuals persons reside, or may be located, who are known to have been exposed to or infected with, or who are reasonably suspected to have been exposed to or infected with, a communicable disease of public health threat reside or may be located. "Affected area" shall include, but not be limited to, cities, counties, towns, and subsections of such areas, public and private property, buildings, and other structures.

"Arboviral infection" means a viral illness that is transmitted by a mosquito, tick, or other arthropod. This includes, but is not limited to, chikungunya, dengue, eastern equine encephalitis (EEE), LaCrosse encephalitis (LAC), St. Louis encephalitis (SLE), and West Nile virus (WNV) infection.

"Board" means the State Board of Health.

"Cancer" means all carcinomas, sarcomas, melanomas, leukemias, and lymphomas excluding localized basal and squamous cell carcinomas of the skin, except for lesions of the mucous membranes.

"Central line-associated bloodstream infection" means a primary bloodstream infection identified by laboratory tests, with or without clinical signs or symptoms, in a patient with a central line device, and meeting the current Centers for Disease Control and Prevention (CDC) surveillance definition for laboratory-confirmed primary bloodstream infection.

"Central line device" means a vascular infusion device that terminates at or close to the heart or in one of the greater vessels. The following are considered great vessels for the purpose of reporting central line infections and counting central line days: aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic veins, internal jugular veins, subclavian veins, external iliac veins, and common femoral veins.

"Child care center" means a child day center, child day center system, child day program, family day home, family day system, or registered family day home as defined by § 63.2-100 of the Code of Virginia, or a similar place providing day care of children by such other name as may be applied.

"Clinic" means any facility, freestanding or associated with a hospital, that provides preventive, diagnostic, therapeutic, rehabilitative, or palliative care or services to outpatients.

"Commissioner" means the State Health Commissioner or his duly designated officer or agent, unless stated in a provision of these regulations that it applies to the State Health Commissioner in his sole discretion.

"Communicable disease" means an illness due to an infectious agent or its toxic products which is transmitted, directly or indirectly, to a susceptible host from an infected person, animal, or arthropod or through the agency of an intermediate host or a vector or through the inanimate environment.

"Communicable disease of public health significance" means an illness caused by a specific or suspected infectious agent that may be transmitted directly or indirectly from one individual to another. This includes but is not limited to infections caused by human immunodeficiency viruses, bloodborne pathogens, and tubercle bacillus. The State Health Commissioner may determine that diseases caused by other pathogens constitute communicable diseases of public health significance.

"Communicable disease of public health threat" means an illness of public health significance, as determined by the State Health Commissioner in accordance with these regulations, caused by a specific or suspected infectious agent that may be reasonably expected or is known to be readily transmitted directly or indirectly from one individual to another and has been found to create a risk of death or significant injury or impairment; this definition shall not, however, be construed to include human immunodeficiency viruses or the tubercle bacilli, unless used as a bioterrorism weapon.

"Companion animal" means any domestic or feral dog, domestic or feral cat, nonhuman primate, guinea pig, hamster, rabbit not raised for human food or fiber, exotic or native animal, reptile, exotic or native bird, or any feral animal or any animal under the care, custody, or ownership of a person or any animal that is bought, sold, traded, or bartered by any person. Agricultural animals, game species, or any animals regulated under federal law as research animals shall not be considered companion animals for the purpose of this regulation.

"Condition" means any adverse health event, such as a disease, an infection, a syndrome, or as indicated by a procedure (including but not limited to the results of a physical exam, laboratory test, or imaging interpretation) suggesting that an exposure of public health importance has occurred.

"Contact" means a person or animal known to have been in such association with an infected person or animal as to have had an opportunity of acquiring the infection.

"Contact services" means a broad array of services that are offered to persons with infectious diseases and their contacts. Contact services include contact tracing, providing information about current infections, developing risk reduction plans to reduce the chances of future infections, and connecting to appropriate medical care and other services.

"Contact tracing" means the process by which an infected person or health department employee notifies others that they may have been exposed to the infected person in a manner known to transmit the infectious agent in question.

"Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy hazardous substances or organisms from a person, surface, or item to the point that such substances or organisms are no longer capable of causing adverse health effects and the surface or item is rendered safe for handling, use, or disposal.

"Department" means the State Department of Health.

"Designee" or "designated officer or agent" means any person, or group of persons, designated by the State Health Commissioner, to act on behalf of the commissioner or the board.

"Ehrlichiosis/anaplasmosis" means human infections caused by Ehrlichia chaffeensis (formerly included in the category "human monocytic ehrlichiosis" or "HME"), Ehrlichia ewingii or Anaplasma phagocytophilum (formerly included in the category "human granulocytic ehrlichiosis" or "HGE").

"Epidemic" means the occurrence in a community or region of cases of an illness clearly in excess of normal expectancy.

"Essential needs" means basic human needs for sustenance including but not limited to food, water, and health care, e.g., medications, therapies, testing, and durable medical equipment.

"Exceptional circumstances" means the presence, as determined by the commissioner in his sole discretion, of one or more factors that may affect the ability of the department to effectively control a communicable disease of public health threat. Factors to be considered include but are not limited to: (i) characteristics or suspected characteristics of the disease-causing organism or suspected disease-causing organism such as virulence, routes of transmission, minimum infectious dose, rapidity of disease spread, the potential for extensive disease spread, and the existence and availability of demonstrated effective treatment; (ii) known or suspected risk factors for infection; (iii) the potential magnitude of the effect of the disease on the health and welfare of the public; and (iv) the extent of voluntary compliance with public health recommendations. The determination of exceptional circumstances by the commissioner may take into account the experience or results of investigation in Virginia, another state, or another country.

"Foodborne outbreak" means two or more cases of a similar illness acquired through the consumption of food contaminated with chemicals or an infectious agent or its toxic products. Such illnesses include but are not limited to heavy metal intoxication, staphylococcal food poisoning, botulism, salmonellosis, shigellosis, Clostridium perfringens food poisoning, hepatitis A, and Escherichia coli O157:H7 infection.

"Healthcare-associated infection" (also known as nosocomial infection) means a localized or systemic condition resulting from an adverse reaction to the presence of an infectious agent or agents or its toxin or toxins that (i) occurs in a patient in a healthcare setting (e.g., a hospital or outpatient clinic), (ii) was not found to be present or incubating at the time of admission unless the infection was related to a previous admission to the same setting, and (iii) if the setting is a hospital, meets the criteria for a specific infection site as defined by CDC.

"Hepatitis C, acute" means the following clinical characteristics are met: (i) discrete onset of symptoms indicative of viral hepatitis and (ii) jaundice or elevated serum aminotransferase levels and the following laboratory criteria are met: (a) serum alanine aminotransferase levels (ALT) greater than 400 IU/L; (b) IgM anti-HAV negative (if done); (c) IgM anti-HBc negative (if done); and (d) hepatitis C virus antibody (anti-HCV) screening test positive with a signal-to-cutoff ratio predictive of a true positive as determined for the particular assay as defined by CDC, HCV antibody positive by immunoblot (RIBA), or HCV RNA positive by nucleic acid test.

"Hepatitis C, chronic" means that the laboratory criteria specified in clauses (b), (c) and (d) listed above for an acute case are met but clinical signs or symptoms of acute viral hepatitis are not present and serum alanine aminotransferase (ALT) levels do not exceed 400 IU/L. This category will include cases that may be acutely infected but not symptomatic.

"Immunization" means a procedure that increases the protective response of an individual's immune system to specified pathogens.

"Independent pathology laboratory" means a nonhospital or a hospital laboratory performing surgical pathology, including fine needle aspiration biopsy and bone marrow specimen examination services, which reports the results of such tests directly to physician offices, without reporting to a hospital or accessioning the information into a hospital tumor registry.

"Individual" means a person or companion animal. When the context requires it, "person or persons" shall be deemed to include any individual.

"Infection" means the entry and multiplication or persistence of a disease-causing organism (prion, virus, bacteria, fungus, parasite, or ectoparasite) in the body of an individual. An infection may be inapparent (i.e., without recognizable signs or symptoms but identifiable by laboratory means) or manifest (clinically apparent).

"Influenza A, novel virus" means infection of a human with an influenza A virus subtype that is different from currently circulating human influenza H1 and H3 viruses. Novel subtypes include H2, H5, H7, and H9 subtypes or influenza H1 and H3 subtypes originating from a nonhuman species.

"Invasive" means the organism is affecting a normally sterile site, including but not limited to blood or cerebrospinal fluid.

"Investigation" means an inquiry into the incidence, prevalence, extent, source, mode of transmission, causation of, and other information pertinent to a disease occurrence.

"Isolation" means the physical separation, including confinement or restriction of movement, of an individual or individuals who are infected with, or are reasonably suspected to be infected with, a communicable disease of public health threat in order to prevent or limit the transmission of the communicable disease of public health threat to uninfected and unexposed individuals.

"Isolation, complete" means the full-time confinement or restriction of movement of an individual or individuals infected with, or reasonably suspected to be infected with, a communicable disease in order to prevent or limit the transmission of the communicable disease to uninfected and unexposed individuals.

"Isolation, modified" means a selective, partial limitation of freedom of movement or actions of an individual or individuals infected with, or reasonably suspected to be infected with, a communicable disease. Modified isolation is designed to meet particular situations and includes but is not limited to the exclusion of children from school, the prohibition or restriction from engaging in a particular occupation or using public or mass transportation, or requirements for the use of devices or procedures intended to limit disease transmission.

"Isolation, protective" means the physical separation of a susceptible individual or individuals not infected with, or not reasonably suspected to be infected with, a communicable disease from an environment where transmission is occurring, or is reasonably suspected to be occurring, in order to prevent the individual or individuals from acquiring the communicable disease.

"Laboratory" as used herein means a clinical laboratory that examines materials derived from the human body for the purpose of providing information on the diagnosis, prevention, or treatment of disease.

"Laboratory director" means any person in charge of supervising a laboratory conducting business in the Commonwealth of Virginia.

"Law-enforcement agency" means any sheriff's office, police department, adult or youth correctional officer, or other agency or department that employs persons who have law-enforcement authority that is under the direction and control of the Commonwealth or any local governing body. "Law-enforcement agency" shall include, by order of the Governor, the Virginia National Guard.

"Lead-elevated blood levels" "Lead, elevated blood levels" means a confirmed blood level greater than or equal to 10 micrograms of lead per deciliter (μg/dL) of whole blood in a child or children 15 years of age and younger, a venous blood lead level greater than or equal to 25 μg/dL in a person older than 15 years of age, or such lower blood lead level as may be recommended for individual intervention by the department or the Centers for Disease Control and Prevention.

"Least restrictive" means the minimal limitation of the freedom of movement and communication of an individual while under an order of isolation or an order of quarantine that also effectively protects unexposed and susceptible individuals from disease transmission.

"Medical care facility" means any hospital or nursing home licensed in the Commonwealth, or any hospital operated by or contracted to operate by an entity of the United States government or the Commonwealth of Virginia.

"Midwife" means any person who is licensed as a nurse midwife by the Virginia Boards of Nursing and Medicine or who possesses a midwife permit issued by the State Health Commissioner is licensed by the Board of Medicine as a certified professional midwife.

"National Healthcare Safety Network (NHSN)" means a surveillance system created by the CDC for accumulating, exchanging, and integrating relevant information on infectious adverse events associated with healthcare delivery.

"Nosocomial outbreak" means any group of illnesses of common etiology occurring in patients of a medical care facility acquired by exposure of those patients to the disease agent while confined in such a facility.

"Nucleic acid detection" means laboratory testing of a clinical specimen to determine the presence of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) specific for an infectious agent using any method, including hybridization, sequencing, or amplification such as polymerase chain reaction.

"Nurse" means any person licensed as a professional nurse or as a licensed practical nurse by the Virginia Board of Nursing.

"Occupational outbreak" means a cluster of illness or disease that is indicative of a work-related exposure. Such conditions include but are not limited to silicosis, asbestosis, byssinosis, pneumoconiosis, and tuberculosis.

"Outbreak" means the occurrence of more cases of a disease than expected.

"Period of communicability" means the time or times during which the etiologic agent may be transferred directly or indirectly from an infected person to another person, or from an infected animal to a person.

"Physician" means any person licensed to practice medicine or osteopathy by the Virginia Board of Medicine.

"Quarantine" means the physical separation, including confinement or restriction of movement, of an individual or individuals who are present within an affected area or who are known to have been exposed, or may reasonably be suspected to have been exposed, to a communicable disease of public health threat and who do not yet show signs or symptoms of infection with the communicable disease of public health threat in order to prevent or limit the transmission of the communicable disease of public health threat to unexposed and uninfected individuals.

"Quarantine, complete" means the full-time confinement or restriction of movement of an individual or individuals who do not have signs or symptoms of infection but may have been exposed, or may reasonably be suspected to have been exposed, to a communicable disease of public health threat in order to prevent the transmission of the communicable disease of public health threat to uninfected individuals.

"Quarantine, modified" means a selective, partial limitation of freedom of movement or actions of an individual or individuals who do not have signs or symptoms of the infection but have been exposed to, or are reasonably suspected to have been exposed to, a communicable disease of public health threat. Modified quarantine may be designed to meet particular situations and includes but is not limited to limiting movement to the home, work, and/or one or more other locations, the prohibition or restriction from using public or mass transportation, or requirements for the use of devices or procedures intended to limit disease transmission.

"Reportable disease" means an illness due to a specific toxic substance, occupational exposure, or infectious agent, which affects a susceptible individual, either directly, as from an infected animal or person, or indirectly through an intermediate host, vector, or the environment, as determined by the board.

"SARS" means severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV) disease.

"School" means (i) any public school from kindergarten through grade 12 operated under the authority of any locality within the Commonwealth; (ii) any private or parochial school that offers instruction at any level or grade from kindergarten through grade 12; (iii) any private or parochial nursery school or preschool, or any private or parochial child care center licensed by the Commonwealth; and (iv) any preschool handicap classes or Head Start classes.

"Serology" means the testing of blood, serum, or other body fluids for the presence of antibodies or other markers of an infection or disease process.

"Surveillance" means the ongoing systematic collection, analysis, and interpretation of outcome-specific data for use in the planning, implementation, and evaluation of public health practice. A surveillance system includes the functional capacity for data analysis as well as the timely dissemination of these data to persons who can undertake effective prevention and control activities.

"Susceptible individual" means a person or animal who is vulnerable to or potentially able to contract a disease or condition. Factors that affect an individual's susceptibility include but are not limited to physical characteristics, genetics, previous or chronic exposures, chronic conditions or infections, immunization history, or use of medications.

"Toxic substance" means any substance, including any raw materials, intermediate products, catalysts, final products, or by-products of any manufacturing operation conducted in a commercial establishment, that has the capacity, through its physical, chemical or biological properties, to pose a substantial risk of death or impairment either immediately or over time, to the normal functions of humans, aquatic organisms, or any other animal but not including any pharmaceutical preparation which deliberately or inadvertently is consumed in such a way as to result in a drug overdose.

"Tubercle bacilli" means disease-causing organisms belonging to the Mycobacterium tuberculosis complex and includes Mycobacterium tuberculosis, Mycobacterium bovis, and Mycobacterium africanum or other members as may be established by the commissioner.

"Tuberculin skin test (TST)" means a test for demonstrating infection with tubercle bacilli, performed according to the Mantoux method, in which 0.1 ml of 5 TU strength tuberculin purified protein derivative (PPD) is injected intradermally on the volar surface of the arm. Any reaction is observed 48-72 hours after placement and palpable induration is measured across the diameter transverse to the long axis of the arm. The measurement of the indurated area is recorded in millimeters and the significance of the measured induration is based on existing national and department guidelines.

"Tuberculosis" means a disease caused by tubercle bacilli.

"Tuberculosis, active disease" (also "active tuberculosis disease" and "active TB disease"), as defined by § 32.1-49.1 of the Code of Virginia, means a disease caused by an airborne microorganism and characterized by the presence of either (i) a specimen of sputum or other bodily fluid or tissue that has been found to contain tubercle bacilli as evidenced by culture or nucleic acid amplification, including preliminary identification by rapid methodologies; (ii) a specimen of sputum or other bodily fluid or tissue that is suspected to contain tubercle bacilli as evidenced by smear, and where sufficient clinical and radiographic evidence of active tuberculosis disease is present as determined by a physician licensed to practice medicine in Virginia; or (iii) sufficient clinical and radiographic evidence of active tuberculosis disease as determined by the commissioner is present, but a specimen of sputum or other bodily fluid or tissue containing, or suspected of containing, tubercle bacilli is unobtainable.

"Tuberculosis infection in children age less than 4 years" means a significant reaction resulting from a tuberculin skin test (TST) or other approved test for latent infection without clinical or radiographic evidence of active tuberculosis disease, in children from birth up to their fourth birthday.

"Vaccinia, disease or adverse event" means vaccinia infection or serious or unexpected events in persons who received the smallpox vaccine or their contacts, including but not limited to bacterial infections, eczema vaccinatum, erythema multiforme, generalized vaccinia, progressive vaccinia, inadvertent inoculation, post-vaccinial encephalopathy or encephalomyelitis, ocular vaccinia, and fetal vaccinia.

"Waterborne outbreak" means two or more cases of a similar illness acquired through the ingestion of or other exposure to water contaminated with chemicals or an infectious agent or its toxic products. Such illnesses include but are not limited to giardiasis, viral gastroenteritis, cryptosporidiosis, hepatitis A, cholera, and shigellosis. A single case of laboratory-confirmed primary amebic meningoencephalitis or of waterborne chemical poisoning is considered an outbreak.

12VAC5-90-30. Purpose.

This chapter is designed to provide for the uniform reporting of diseases of public health importance occurring within the Commonwealth in order that appropriate control measures may be instituted to interrupt the transmission reduce the occurrence of disease.

Part III
Reporting of Disease

12VAC5-90-80. Reportable disease list.

A. 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 rapid immediate communication to the local health department within 24 hours of 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.

Acquired immunodeficiency syndrome (AIDS)

Amebiasis

*Anthrax

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

*Botulism

*Brucellosis

Campylobacteriosis

Chancroid

Chickenpox (Varicella)

Chlamydia trachomatis infection

*Cholera

Creutzfeldt-Jakob disease if <55 years of age

Cryptosporidiosis

Cyclosporiasis

*Diphtheria

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

Ehrlichiosis Ehrlichiosis/Anaplasmosis

Escherichia coli infection, Shiga toxin-producing

Giardiasis

Gonorrhea

Granuloma inguinale

*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

*Influenza-associated deaths in children <18 years of age

Kawasaki syndrome

Lead-elevated blood levels Lead, elevated blood levels

Legionellosis

Leprosy (Hansen's (Hansen disease)

Listeriosis

Lyme disease

Lymphogranuloma venereum

Malaria

*Measles (Rubeola)

*Meningococcal disease

*Monkeypox

Mumps

Ophthalmia neonatorum

*Outbreaks, all (including but not limited to foodborne, nosocomial, healthcare-associated, occupational, toxic substance-related, and waterborne)

*Pertussis

*Plague

*Poliomyelitis *Poliovirus infection, including poliomyelitis

*Psittacosis

*Q fever

*Rabies, human and animal

Rabies treatment, post-exposure

Rocky Mountain spotted fever

*Rubella, including congenital rubella syndrome

Salmonellosis

*Severe acute respiratory syndrome (SARS)

Shigellosis

*Smallpox (Variola)

Streptococcal disease, Group A, invasive or toxic shock

Streptococcus pneumoniae infection, invasive, in children <5 years of age

Syphilis (report *primary and *secondary syphilis by rapid means)

Tetanus

Toxic shock syndrome

Toxic substance-related illness

Trichinosis (Trichinellosis)

*Tuberculosis, active disease

Tuberculosis infection in children <4 years of age

*Tularemia

*Typhoid *Typhoid/paratyphoid fever

*Unusual occurrence of disease of public health concern

*Vaccinia, disease or adverse event

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

*Vibrio infection

*Viral hemorrhagic fever

*Yellow fever

Yersiniosis

B. Conditions reportable by directors of laboratories.

Conditions identified by an asterisk (*) require rapid immediate communication to the local health department within 24 hours of 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

*Anthrax—by culture, antigen detection or nucleic acid detection

Arboviral infection—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

*Botulism—by culture or identification of toxin in a clinical specimen

*Brucellosis—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

Campylobacteriosis—by culture

Chancroid—by culture, antigen detection, or nucleic acid detection

Chickenpox (varicella)—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

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

*Cholera—by culture or serologic results consistent with recent infection

Creutzfeldt-Jakob disease if <55 years of age - presumptive diagnosis - by histopathology in patients under the age of 55 years

Cryptosporidiosis—by microscopic examination, antigen detection, or nucleic acid detection

Cyclosporiasis—by microscopic examination or nucleic acid detection

*Diphtheria—by culture

Ehrlichiosis—by Ehrlichiosis/Anaplasmosis—by culture, nucleic acid detection, or serologic results consistent with recent infection

Escherichia coli infection, Shiga toxin-producing—by culture of E. coli O157 or other Shiga toxin-producing E. coli, Shiga toxin detection (e.g., by EIA), or nucleic acid detection

Giardiasis—by microscopic examination or antigen detection

Gonorrhea—by microscopic examination of a urethral smear specimen (males only), culture, antigen detection, or nucleic acid detection

*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 or IgM antibodies

Hepatitis C (acute and chronic)—by hepatitis C virus antibody (anti-HCV) screening test positive with a signal-to-cutoff ratio predictive of a true positive as determined for the particular assay as defined by CDC, HCV antibody positive by immunoblot (RIBA), or HCV RNA positive by nucleic acid test. For all hepatitis C patients, also report available results of serum alanine aminotransferase (ALT), anti-HAV IgM, anti-HBc IgM, and HBsAg

Human immunodeficiency virus infection—by culture, antigen detection, nucleic acid detection, or detection of antibody confirmed with a supplemental test. For HIV-infected patients, report all results of CD4 and HIV viral load tests

Influenza—by culture, antigen detection by direct fluorescent antibody (DFA), or nucleic acid detection

Lead-elevated Lead, elevated blood levels—by blood lead level greater than or equal to 10 μg/dL in children ages 0-15 years, or greater than or equal to 25 μg/dL in persons older than 15 years of age

Legionellosis—by culture, antigen detection (including urinary antigen), nucleic acid detection, or serologic results consistent with recent infection

Listeriosis—by culture

Lyme disease—by culture, antigen detection, or detection of antibody confirmed with a supplemental test

Malaria—by microscopic examination, antigen detection, or nucleic acid detection

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

*Meningococcal disease—by culture or antigen detection from a normally sterile site

*Monkeypox—by culture or nucleic acid detection

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;

3. Drug susceptibility test results for M. tuberculosis.

*Pertussis—by culture, antigen detection, or nucleic acid detection

*Plague—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

*Poliomyelitis—by *Poliovirus infection—by culture

*Psittacosis—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

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

*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

Rocky Mountain spotted fever—by culture, antigen detection (including immunohistochemical staining), nucleic acid detection, or serologic results consistent with recent infection

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

Salmonellosis—by culture

*Severe acute respiratory syndrome—by culture, nucleic acid detection, or serologic results consistent with recent infection

Shigellosis—by culture

*Smallpox (variola)—by culture or nucleic acid detection

Staphylococcus aureus infection, resistant, as defined below.

1. Methicillin-resistant - by antimicrobial susceptibility testing of a Staphylococcus aureus isolate, with a susceptibility result indicating methicillin resistance, cultured from a normally sterile site

2. 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

Streptococcal disease, Group A, invasive—by invasive or toxic shock—by culture from a normally sterile site

Streptococcus pneumoniae infection, invasive, in children <5 years of age—by culture from a normally sterile site in a child under the age of five years

*Syphilis—by microscopic examination (including dark field), antigen detection (including direct fluorescent antibody), or serology by either treponemal or nontreponemal methods

Toxic substance-related illness—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

*Tularemia—by culture, antigen detection, nucleic acid detection, or serologic results consistent with recent infection

*Typhoid *Typhoid/paratyphoid fever—by culture

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

*Vibrio infection—by culture

*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

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, require immediate identification and control. Reporting of persons confirmed or suspected of having these diseases, listed below, shall be made within 24 hours immediately by the most rapid means available, preferably that of telecommunication (e.g., telephone, telephone transmitted facsimile, pagers, etc.) to the local health director or other professional employee of the department. (These same diseases are also identified by an asterisk (*) in subsection A and subsection B, where applicable, of this section.)

Anthrax

Botulism

Brucellosis

Cholera

Diphtheria

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

Haemophilus influenzae infection, invasive

Hepatitis A

Influenza Influenza-associated deaths in children <18 years of age

Influenza A, novel virus

Measles (Rubeola)

Meningococcal disease

Monkeypox

Outbreaks, all

Pertussis

Plague

Poliomyelitis Poliovirus infection, including poliomyelitis

Psittacosis

Q fever

Rabies, human and animal

Rubella, including congenital rubella syndrome

Severe acute respiratory syndrome (SARS)

Smallpox (Variola)

Syphilis, primary and secondary

Tuberculosis, active disease

Tularemia

Typhoid Typhoid/paratyphoid fever

Unusual occurrence of disease of public health concern

Vaccinia, disease or adverse event

Vibrio infection

Viral hemorrhagic fever

Yellow Fever 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 by rapid communication as in subsection C of this section.

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

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 by the most rapid means available. 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.

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; 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 to be provided by the department (Form Epi-1), a computer generated printout containing the data items requested on Form Epi-1, or a Centers for Disease Control and Prevention (CDC) surveillance form that provides the same information and shall be made within three days of the suspicion or confirmation of disease unless the disease in question requires rapid reporting under 12VAC5-90-80 C. Reporting may be done by means of secure electronic transmission upon agreement of the physician and the department.

Pursuant to § 32.1-49.1 of the Code of Virginia, additional elements are required to be reported for individuals with confirmed or suspected active tuberculosis disease. Refer to Part X for details on these requirements.

B. Directors of laboratories. Any person who is in charge of a laboratory conducting business in the Commonwealth 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) 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 and medical facility for whom 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 by an asterisk shall be reported within 24 hours by the most rapid means available, 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. 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 anthrax, cholera, diphtheria, E. coli O157 infection, invasive H. influenzae infection, listeriosis, meningococcal disease, pertussis, plague, poliomyelitis, salmonellosis, shigellosis, invasive Group A streptococcal disease, yersiniosis, and other diseases as may be requested by the health department, shall notify the health department of the positive culture and submit the initial isolate to the Virginia Division of Consolidated Laboratory Services (DCLS). Stool specimens that test positive for Shiga toxin shall be submitted to DCLS for organism identification. A laboratory identifying Mycobacterium tuberculosis complex (see 12VAC5-90-225) shall submit a representative and viable sample of the initial culture to DCLS or other laboratory designated by the board to receive such specimen. any of the following conditions shall notify the health department of the positive culture and submit the initial isolate to the Virginia Division of Consolidated Laboratory Services (DCLS). All specimens must be identified with the patient and physician information required in this subsection.

Anthrax

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 broth cultures to DCLS 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 DCLS or other laboratory designated by the board to receive such specimen.)

Typhoid fever

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

Yersiniosis

Other diseases as may be requested by the health department

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

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; the date of admission; hospital chart 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 unless the disease in question requires rapid reporting under 12VAC5-90-80 C and shall be made on Form Epi-1, a computer generated printout containing the data items requested on Form Epi-1, or a Centers for Disease Control and Prevention (CDC) 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, 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, 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 children persons who have common symptoms suggesting an epidemic or outbreak situation. Such persons may notify the local health department of report additional information, including individual cases of communicable diseases that occur in their facilities. 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 telecommunication 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 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.

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:

Creutzfeldt-Jakob disease

Human immunodeficiency virus infection

Hepatitis B

Hepatitis C

Monkeypox

Rabies

Smallpox

Syphilis, infectious

Tuberculosis, active disease

Vaccinia, disease or adverse event

Viral hemorrhagic fever

G. Employees, applicants, and persons in charge of food establishments. 12VAC5-421-80 of the Food Regulations requires a food employee or applicant to notify the person in charge of the food establishment when diagnosed with certain diseases that are transmissible through food. 12VAC5-421-120 requires the person in charge of the food establishment to notify the health department. Refer to the appropriate sections of the Virginia Administrative Code for further guidance and clarification regarding these reporting requirements.

Part IV
Control of Disease

12VAC5-90-100. Methods.

The board and commissioner shall use appropriate disease control measures to manage the diseases listed in 12VAC5-90-80 A, including but not limited to those described in the "Methods of Control" sections of the 18th Edition of the Control of Communicable Diseases Manual (2004) published by the American Public Health Association. The board and commissioner reserve the right to use any legal means to control any disease which is a threat to the public health.

When notified about a disease specified in 12VAC5-90-80, the local health director or his designee shall have the authority and responsibility to perform contact tracing/contact services for HIV infection, infectious syphilis, and active tuberculosis disease and may perform contact tracing services for the other diseases if deemed necessary to protect the public health. All contacts of HIV infection shall be afforded the opportunity for appropriate counseling, testing, and individual face-to-face disclosure of their test results. In no case shall names of informants or infected individuals be revealed to contacts by the health department. All information obtained shall be kept strictly confidential.

The local health director or his designee shall review reports of diseases received from his jurisdiction and follow up such reports, when indicated, with an appropriate investigation in order to evaluate the severity of the problem. The local health director or his designee may recommend to any individual or group of individuals appropriate public health control measures, including but not limited to quarantine, isolation, immunization, decontamination, or treatment. He shall determine in consultation with the Office of Epidemiology and the commissioner if further investigation is required and if one or more forms of quarantine and/or isolation will be necessary.

Complete isolation shall apply to situations where an individual is infected with a communicable disease of public health significance (including but not limited to active tuberculosis disease or HIV infection) and is engaging in behavior that places others at risk for infection with the communicable disease of public health significance, in accordance with the provisions of Article 3.01 (§ 32.1-48.02 et seq.) of the Code of Virginia.

Modified isolation shall apply to situations in which the local health director determines that modifications of activity are necessary to prevent disease transmission. Such situations shall include but are not limited to the temporary exclusion of a child with a communicable disease from school, or the temporary prohibition or restriction of any individual or individuals with a communicable disease from engaging in activities that may pose a risk to the health of others, such as using public transportation or performing an occupation such as foodhandling or providing healthcare the temporary exclusion of an individual with a communicable disease from food handling or patient care, the temporary prohibition or restriction of an individual with a communicable disease from using public transportation, the requirement that a person with a communicable disease use certain personal protective equipment, or restrictions of other activities that may pose a risk to the health of others.

Protective isolation shall apply to situations such as the exclusion, under § 32.1-47 of the Code of Virginia, of any unimmunized child from a school in which an outbreak, potential epidemic, or epidemic of a vaccine preventable disease has been identified.

To the extent permitted by the Code of Virginia, the local health director may be authorized as the commissioner's designee to implement the forms of isolation described in this section. When these forms of isolation are deemed to be insufficient, the local health director may use the provisions of Article 3.01 (§ 32.1-48.01 et seq.) of the Code of Virginia for the control of communicable diseases of public health significance or, in consultation with the Office of Epidemiology, shall provide sufficient information to enable the commissioner to prepare an order or orders of isolation and/or quarantine under Article 3.02 (§ 32.1-48.05 et seq.) of the Code of Virginia for the control of communicable diseases of public health threat.

12VAC5-90-103. Isolation for communicable disease of public health threat.

A. Application. The commissioner, in his sole discretion, may invoke the provisions of Article 3.02 (§ 32.1-48.05 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia and may declare the isolation of any individual or individuals upon a determination that:

1. Such individual or individuals are known to have been infected with or are reasonably suspected to have been infected with a communicable disease of public health threat;

2. Exceptional circumstances render the procedures of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia to be insufficient, or the individual or individuals have failed or refused to comply voluntarily with the control measures directed by the commissioner in response to a communicable disease of public health threat; and

3. Isolation is the necessary means to contain a communicable disease of public health threat, to ensure that such isolated individual or individuals receive appropriate medical treatment subject to the provisions of § 32.1-44 of the Code of Virginia, or to protect health care providers and others who may come into contact with such infected individual or individuals.

The commissioner, in his sole discretion, may also order the isolation of an affected area if, in addition to the above, the Governor has declared a state of emergency for such affected area of the Commonwealth.

B. Documentation. For isolation for a communicable disease of public health threat, information about the infection or suspected infection, the individual, individuals, and/or affected area, and the nature or suspected nature of the exposure shall be duly recorded by the local health department in consultation with the Office of Epidemiology. This information shall be sufficient to enable documenting a record of findings and to enable the commissioner to prepare the order of isolation, including the information required in § 32.1-48.12 of the Code of Virginia. In addition, sufficient information on individuals shall be maintained by the local health department to enable appropriate follow-up of individuals for health status evaluation and treatment as well as compliance with the order of isolation.

The commissioner shall ensure that the protected health information of any individual or individuals subject to the order of isolation is disclosed only in compliance with state and federal law.

C. Means of isolation. The local health department shall assess the situation, and in consultation with the Office of Epidemiology, identify the least restrictive means of isolation that effectively protects unexposed and susceptible individuals. The place of isolation selected shall allow the most freedom of movement and communication with family members and other contacts without allowing disease transmission to other individuals and shall allow the appropriate level of medical care needed by isolated individuals to the extent practicable. The commissioner, in his sole discretion, may order the isolated individual or individuals to remain in their residences when possible, to remain in another place where they are present, or to report to a place or places designated by the commissioner for the duration of their isolation.

The commissioner's order of isolation shall be for a duration consistent with the known period of communicability of the communicable disease of public health threat or, if the course of the disease is unknown or uncertain, for a period anticipated as being consistent with the period of communicability of other similar infectious agents. In the situation where an area is under isolation, the duration of isolation shall take into account the transmission characteristics and known or suspected period of communicability.

D. Delivery. The local health department shall deliver the order of isolation, or ensure its delivery by an appropriate party such as a law-enforcement officer or health department employee, to the affected individual or individuals in person to the extent practicable. If, in the opinion of the commissioner, the scope of the notification would exceed the capacity of the local health department to ensure individual notification in a timely manner, then print, radio, television, Internet, and/or other available means shall be used to inform those affected.

E. Enforcement. Upon finding that there is probable cause to believe that any individual or individuals who are subject to an order of isolation may fail or refuse to comply with such order, the commissioner in his sole discretion may issue an emergency detention order requiring include in the order a requirement that such individual or individuals are to be taken immediately into custody by law-enforcement agencies and detained for the duration of the order of isolation or until the commissioner determines that the risk of noncompliance is no longer present. For any individual or individuals identified as, or for whom probable cause exists that he may be, in violation of any order of isolation, or for whom probable cause exists that he may fail or refuse to comply with any such order, the enforcement authority directed by the commissioner to law-enforcement agencies shall include but need not be limited to the power to detain or arrest.

Any individual or individuals so detained shall be held in the least restrictive environment that can provide any required health care or other services for such individual. The commissioner shall ensure that law-enforcement personnel responsible for enforcing an order or orders of isolation are informed of appropriate measures to take to protect themselves from contracting the disease of public health threat.

F. Health status monitoring. The local health department shall monitor the health of those under isolation either by regular telephone calls, visits, self-reports, or by reports of caregivers or healthcare providers or by other means.

G. Essential needs. Upon issuance of an order of isolation to an individual or individuals by the commissioner, the local health department shall manage the isolation, in conjunction with local emergency management resources, such that individual essential needs can be met to the extent practicable. Upon issuance of an order of isolation by the commissioner to for an affected area, existing emergency protocols pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44 of the Code of Virginia shall be utilized for mobilizing appropriate resources to ensure essential needs are met.

H. Appeals. Any individual or individuals subject to an order of isolation or a court-ordered confirmation or extension of any such order may file an appeal of the order of isolation in accordance with the provisions of § 32.1-48.13 of the Code of Virginia. An appeal shall not stay any order of isolation.

I. Release from isolation. Once the commissioner determines that an individual or individuals no longer pose a threat to the public health, the order of isolation has expired, or the order of isolation has been vacated by the court, the individual or individuals under the order of isolation shall be released immediately. If the risk of an infected individual transmitting the communicable disease of public health threat to other individuals continues to exist, an order of isolation may be developed to extend the restriction prior to release from isolation.

J. Affected area. If the criteria in subsection A of this section are met and an area is known or suspected to have been affected, then the commissioner shall notify the Governor of the situation and the need to order isolation for the affected area during the known or suspected time of exposure. In order for an affected area to be isolated, the Governor must declare a state of emergency for the affected area.

If an order of isolation is issued for an affected area during the known or suspected time of exposure, the commissioner shall cause the order of isolation to be communicated to the individuals residing or located in the affected area. The use of multiple forms of communication, including but not limited to radio, television, internet, and/or other available means, may be required in order to reach the individuals who were in the affected area during the known or suspected time of exposure.

The provisions for documentation, means of isolation, enforcement, health status monitoring, essential needs, and release from isolation/quarantine isolation described above will apply to the isolation of affected areas. Appropriate management of a disease of public health threat for an affected area may require the coordinated use of local, regional, state, and national resources. In specifying one or more affected areas to be placed under isolation, the objective will be to protect as many people as possible using the least restrictive means. As a result, defining the precise boundaries and time frame of the exposure may not be possible, or may change as additional information becomes available. When this occurs, the commissioner shall ensure that the description of the affected area is in congruence with the Governor's declaration of emergency and shall ensure that the latest information is communicated to those in or exposed to the affected area.

12VAC5-90-107. Quarantine.

A. Application. The commissioner, in his sole discretion, may invoke the provisions of Article 3.02 (§ 32.1-48.05 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia and may order a complete or modified quarantine of any individual or individuals upon a determination that:

1. Such individual or individuals are known to have been exposed to or are reasonably suspected to have been exposed to a communicable disease of public health threat;

2. Exceptional circumstances render the procedures of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia to be insufficient, or the individual or individuals have failed or refused to comply voluntarily with the control measures directed by the commissioner in response to a communicable disease of public health threat; and

3. Quarantine is the necessary means to contain a communicable disease of public health threat to which an individual or individuals have been or may have been exposed and thus may become infected.

The commissioner, in his sole discretion, may also order the quarantine of an affected area if, in addition to the above, the Governor has declared a state of emergency for such affected area of the Commonwealth.

B. Documentation. For quarantine for a communicable disease of public health threat, information about the infection or suspected infection; the individual, individuals, and/or affected area; and the nature or suspected nature of the exposure shall be duly recorded by the local health department, in consultation with the Office of Epidemiology. This information shall be sufficient to enable documenting a record of findings and enable the commissioner to prepare a written order of quarantine, including the information required in § 32.1-48.09 of the Code of Virginia. In addition, sufficient information on individuals shall be maintained by the local health department to enable appropriate follow-up of individuals for health status evaluation and treatment as well as compliance with the order of quarantine.

The commissioner shall ensure that the protected health information of any individual or individuals subject to the order of quarantine is disclosed only in compliance with state and federal law.

C. Means of quarantine. The local health department shall assess the situation, and in consultation with the Office of Epidemiology, shall recommend to the commissioner the least restrictive means of quarantine that effectively protects unexposed and susceptible individuals. The place of quarantine selected shall allow the most freedom of movement and communication with family members and other contacts without allowing disease transmission to others.

The commissioner, in his sole discretion, may order the quarantined individual or individuals to remain in their residences when possible, to remain in another place where they are present, or to report to a place or places designated by the commissioner for the duration of their quarantine.

The commissioner's order of quarantine shall be for a duration consistent with the known incubation period of the communicable disease of public health threat or, if the incubation period is unknown or uncertain, for a period anticipated as being consistent with the incubation period for other similar infectious agents. In the situation where an area is under quarantine, the duration of quarantine shall take into account the transmission characteristics and known or suspected incubation period.

D. Delivery. The local health department shall deliver the order of quarantine, or ensure its delivery by an appropriate party such as a law-enforcement officer or health department employee, to the affected individual or individuals in person to the extent practicable. If, in the opinion of the commissioner, the scope of the notification would exceed the capacity of the local health department to ensure notification in a timely manner, then print, radio, television, Internet, and/or other available means shall be used to inform those affected.

E. Enforcement. Upon finding that there is probable cause to believe that any individual or individuals who are subject to an order of quarantine may fail or refuse to comply with such order, the commissioner in his sole discretion may issue an emergency detention order requiring include in the order a requirement that such individual or individuals are to be taken immediately into custody by law-enforcement agencies and detained for the duration of the order of quarantine or until the commissioner determines that the risk of and from noncompliance is no longer present. For any individual or individuals identified as, or for whom probable cause exists that he may be, in violation of any order of quarantine, or for whom probable cause exists that he may fail or refuse to comply with any such order, the enforcement authority directed by the commissioner to law-enforcement agencies shall include but need not be limited to the power to detain or arrest.

Any individual or individuals so detained shall be held in the least restrictive environment that can provide any required health care or other services for such individual. The commissioner shall ensure that law-enforcement personnel responsible for enforcing an order or orders of quarantine are informed of appropriate measures to take to protect themselves from contracting the disease of public health threat.

F. Health status monitoring. The local health department shall monitor the health of those under quarantine either by regular telephone calls, visits, self-reports, or by reports of caregivers or healthcare providers or by other means. If an individual or individuals develop symptoms compatible with the communicable disease of public health threat, then 12VAC5-90-103 would apply to the individual or individuals.

G. Essential needs. Upon issuance of an order of quarantine to an individual or individuals by the commissioner, the local health department shall manage the quarantine, in conjunction with local emergency management resources, such that individual essential needs can be met to the extent practicable. Upon issuance of an order of quarantine by the commissioner to for an affected area, existing emergency protocols pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44 of the Code of Virginia shall be utilized for mobilizing appropriate resources to ensure essential needs are met.

H. Appeals. Any individual or individuals subject to an order of quarantine or a court-ordered confirmation or extension of any such order may file an appeal of the order of quarantine in accordance with the provisions of § 32.1-48.10 of the Code of Virginia. An appeal shall not stay any order of quarantine.

I. Release from quarantine. Once the commissioner determines that an individual or individuals are determined to no longer be at risk of becoming infected and pose no risk of transmitting the communicable disease of public health threat to other individuals, the order of quarantine has expired, or the order of quarantine has been vacated by the court, the individuals under the order of quarantine shall be released immediately. If the risk of an individual becoming infected and transmitting the communicable disease of public health threat to other individuals continues to exist, an order of quarantine may be developed to extend the restriction prior to release from quarantine.

J. Affected area. If the criteria in subsection A of this section are met and an area is known or suspected to have been affected, then the commissioner shall notify the Governor of the situation and the need to order quarantine for the affected area. In order for an affected area to be quarantined, the Governor must declare a state of emergency for the affected area.

If an order of quarantine is issued for an affected area, the commissioner shall cause the order of quarantine to be communicated to the individuals residing or located in the affected area. The use of multiple forms of communication, including but not limited to radio, television, Internet, and/or other available means, may be required in order to reach the individuals who were in the affected area during the known or suspected time of exposure.

The provisions for documentation, means of isolation quarantine, enforcement, health status monitoring, essential needs, and release from quarantine described above will apply to the quarantine of affected areas. Appropriate management of a disease of public health threat for an affected area may require the coordinated use of local, regional, state, and national resources. In specifying one or more affected areas to be placed under quarantine, the objective will be to protect as many people as possible using the least restrictive means. As a result, defining the precise boundaries and time frame of the exposure may not be possible, or may change as additional information becomes available. When this occurs, the commissioner shall ensure that the description of the affected area is in congruence with the Governor's declaration of emergency and shall ensure that the latest information is communicated to those in or exposed to the affected area.

Part V
Immunization of Children Persons Less Than 18 Years of Age

12VAC5-90-110. Dosage and age requirements for immunizations; obtaining immunizations.

A. Every child person in Virginia less than 18 years of age shall be immunized against the following diseases by receiving the specified number of doses of vaccine by the specified ages, unless replaced by a revised schedule of the U.S. Public Health Service: in accordance with the most recent Immunization Schedule developed and published by the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). Requirements for school and day care attendance are addressed in 12VAC5-110.

1. Diphtheria, Tetanus, and Pertussis Vaccine—three doses by one year of age of toxoids of diphtheria and tetanus, combined with pertussis vaccine with the remaining two doses administered in accordance with the most recent schedule of the American Academy of Pediatrics or the U.S. Public Health Service.

2. Poliomyelitis Vaccine, trivalent type—three doses of inactivated poliomyelitis vaccine, preferably by one year of age and no later than 18 months of age. Attenuated (live virus) oral polio vaccine may be used if the attending physician feels it is clinically appropriate for a given patient.

3. Measles (Rubeola) Vaccine—one dose of further attenuated (live virus) measles vaccine between 12-15 months of age and no later than two years of age. A second dose shall also be required at the time of initial entry to school. For those children who did not receive a second dose at initial school entry, a second dose shall be required at the time of entry to grade six.

4. Rubella Vaccine—one dose of attenuated (live virus) rubella vaccine between 12-15 months of age and no later than two years of age.

5. Mumps Vaccine—one dose of attenuated (live virus) mumps vaccine between 12-15 months of age and no later than two years of age.

6. Haemophilus influenzae type b (Hib) Vaccine—a maximum of four doses of Hib vaccine for children up to 30 months of age as appropriate for the child's age and in accordance with current recommendations of either the American Academy of Pediatrics or the U.S. Public Health Service.

7. Hepatitis B Vaccine—three doses by 12 months of age and no later than 18 months of age. For children not receiving three doses by 18 months of age, three doses will be required at initial school entry for all children born on or after January 1, 1994. Since July 1 2001, all children who have not received a complete series of hepatitis B vaccine are required to receive such immunization prior to entering the sixth grade.

8. Varicella (Chickenpox) Vaccine—one dose of varicella vaccine between 12-18 months of age. For those children who did not receive a dose of vaccine between 12-18 months of age, a dose will be required at initial school entry.

B. The required immunizations may be obtained from a physician licensed to practice medicine or from the local health department.

Part VI
Venereal Disease

12VAC5-90-130. Prenatal testing.

Every physician attending a pregnant patient during gestation shall examine and test such patient for syphilis, and hepatitis B surface antigen (HBsAg), and any other sexually transmitted disease as clinically indicated within 15 days after beginning such attendance. A second prenatal test for syphilis and HBsAg shall be conducted at the beginning of the third trimester (28 weeks) for patients who are at higher risk for these diseases. Persons at higher risk for syphilis include those who have had multiple sexual partners within the previous year and, those with any prior history of a sexually transmitted disease, and those living in communities and populations in which the prevalence of syphilis is high. Persons at higher risk for hepatitis B virus infection include injecting drug users and those with personal contact with a hepatitis B patient, multiple sexual partners, and/or occupational exposure to blood. If the patient first seeks care during the third trimester, only one test shall be required. As a routine component of prenatal care, every licensed practitioner who renders prenatal care, including any holder of a multistate licensure privilege to practice nursing, regardless of the site of such practice, shall advise every pregnant patient of the value of testing for human immunodeficiency virus (HIV) infection and shall request of each pregnant patient consent to such testing inform every pregnant patient that human immunodeficiency virus (HIV) screening is recommended for all pregnant patients and that she will receive an HIV test as part of the routine panel of prenatal tests unless she declines (opt-out screening). The practitioner shall offer the pregnant patient oral or written information that includes an explanation of HIV infection, a description of interventions that can reduce HIV transmission from mother to infant, and the meaning of positive and negative test results. The confidentiality provisions of § 32.1-36.1 of the Code of Virginia, the informed consent stipulations, and the test result disclosure conditions, and appropriate counseling requirements of § 32.1-37.2 of the Code of Virginia shall apply to any HIV testing conducted pursuant to this section. The Centers for Disease Control and Prevention (CDC) recommends a second HIV test for patients who receive health care in jurisdictions with elevated incidence of HIV or AIDS among women aged 15 through 45 years, which includes Virginia. Practitioners should offer a second HIV test during the third trimester to all pregnant patients. Practitioners shall counsel all pregnant patients with HIV-positive test results about the dangers to the fetus and the advisability of receiving treatment in accordance with the then current Centers for Disease Control and Prevention CDC recommendations for HIV-positive pregnant patients. Any pregnant patient shall have the right to refuse consent to testing for HIV infection and any recommended treatment. Documentation of such refusal shall be maintained in the patient's medical record. Every physician should also examine and test a pregnant patient for any sexually transmitted disease as clinically indicated.

Part VII
Prevention of Blindness from Ophthalmia Neonatorum

12VAC5-90-140. Procedure for preventing ophthalmia neonatorum.

The physician, nurse or midwife in charge of the infant's care after delivery of a baby shall install ensure that one of the following is administered in each eye of that newborn baby as soon as possible after birth one of the following: (i) two drops of a 1.0% silver nitrate solution; (ii) two drops of a 1.0% tetracycline ophthalmic solution; (iii) one quarter inch or an excessive amount a 1-cm ribbon of 1.0% tetracycline ophthalmic ointment; or (iv) one quarter inch or an excessive amount (iii) a 1-cm ribbon of 0.5% erythromycin ophthalmic ointment. This treatment shall be recorded in the medical record of the infant.

Part X
Tuberculosis Control

12VAC5-90-225. Additional data to be reported related to persons with active tuberculosis disease (confirmed or suspected).

A. Physicians and directors of medical care facilities are required to submit all of the following:

1. An initial report to be completed when there are reasonable grounds to suspect that a person has active TB disease, but no later than when antituberculosis drug therapy is initiated. The reports must include the following: the affected person's name; age; date of birth; gender; address; pertinent clinical, radiographic, microbiologic and pathologic reports, whether pending or final; such other information as may be needed to locate the patient for follow-up; and name, address, and telephone number of the treating physician.

2. A secondary report to be completed simultaneously or within one to two weeks following the initial report. The report must include: the date and results of tuberculin skin test (TST); the date and results of the initial and any follow-up chest radiographs; the dates and results of bacteriologic or pathologic testing, the antituberculosis drug regimen, including names of the drugs, dosages and frequencies of administration, and start date; the date and results of drug susceptibility testing; HIV status; contact screening information; and name, address, and telephone number of treating physician.

3. Subsequent reports are to be made when updated information is available. Subsequent reports are required when: clinical status changes, the treatment regimen changes; treatment ceases for any reason; or there are any updates to laboratory results, treatment adherence, name, address, and telephone number of current provider, patient location or contact information, or other additional clinical information.

4. Physicians and/or directors of medical care facilities responsible for the care of a patient with active tuberculosis disease are required to develop and maintain a written treatment plan. This plan must be in place no later than the time when antituberculosis drug therapy is initiated. Patient adherence to this treatment plan must be documented. The treatment plan and adherence record are subject to review by the local health director or his designee at any time during the course of treatment.

5. The treatment plan for the following categories of patients must be submitted to the local health director or his designee for approval no later than the time when antituberculosis drug therapy is started or modified:

a. For individuals who are inpatients or incarcerated, the responsible provider or facility must submit the treatment plan for approval prior to discharge or transfer.

b. Individuals, whether inpatient, incarcerated, or outpatient, who also have one of the following conditions:

(1) HIV infection.

(2) Known or suspected active TB disease resistant to rifampin, rifabutin, rifapentine or other rifamycin with or without resistance to any other drug.

(3) A history of prior treated or untreated active TB disease, or a history of relapsed active TB disease.

(4) A demonstrated history of nonadherence to any medical treatment regimen.

B. Laboratories are required to submit the following:

1. Results of smears that are positive for acid fast bacilli.

2. Results of cultures positive for any member of the M. Mycobacterium tuberculosis complex (i.e., M. tuberculosis, M. bovis, M. africanum) or any other mycobacteria.

3. Results of rapid methodologies, including acid hybridization or nucleic acid amplification, which are indicative of M. tuberculosis complex or any other mycobacteria.

4. In order to ensure susceptibility testing, laboratories Results of tests for antimicrobial susceptibility performed on cultures positive for tubercle bacilli.

5. Laboratories, whether testing is done in-house or referred to an out-of-state laboratory, shall submit a representative and viable sample of the initial culture positive for any member of the M. tuberculosis complex to the Virginia Division of Consolidated Laboratory Services or other laboratory designated by the board to receive such specimen. This requirement may be fulfilled by the submission of a report of antimicrobial drug susceptibility testing performed on the specimen. The intention to file a written report in lieu of sample submission shall be communicated by the laboratory at the time the finding of a positive culture is initially communicated.

5. Laboratories that submit a written susceptibility report in lieu of sample submission are still strongly encouraged to submit a viable, representative sample for each patient in whom one or more cultures are positive for any member of the M. tuberculosis complex for additional testing, if needed.

Part XIII
Report of Healthcare-Associated Infections

12VAC5-90-370. Reporting of healthcare-associated infections.

A. Definitions. The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Acute care hospital" means a hospital as defined in § 32.1-123 of the Code of Virginia that provides medical treatment for patients having an acute illness or injury or recovering from surgery.

"Adult" means a person 18 years of age or more.

"Central line-associated bloodstream infection" means a primary bloodstream infection identified by laboratory tests, with or without clinical signs or symptoms, in a patient with a central line device, and meeting the current Centers for Disease Control and Prevention (CDC) surveillance definition for laboratory-confirmed primary bloodstream infection.

"Central line device" means a vascular infusion device that terminates at or close to the heart or in one of the greater vessels. The following are considered great vessels for the purpose of reporting central line infections and counting central line days: aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic veins, internal jugular veins, subclavian veins, external iliac veins, and common femoral veins.

"Healthcare-associated infection" (or nosocomial infection) means a localized or systemic condition resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s) that (i) occurs in a patient in a healthcare setting (e.g., a hospital or outpatient clinic), (ii) was not found to be present or incubating at the time of admission unless the infection was related to a previous admission to the same setting, and (iii) if the setting is a hospital, meets the criteria for a specific infection site as defined by CDC.

"National Healthcare Safety Network" (NHSN) means a surveillance system created by the CDC for accumulating, exchanging and integrating relevant information on infectious adverse events associated with healthcare delivery.

B. A. Reportable infections and method and timing of reporting.

1. Acute care hospitals shall collect data on the following healthcare-associated infection in the specified patient population: central line-associated bloodstream infections in adult intensive care units, including the number of central-line days in each population at risk, expressed per 1,000 catheter-days.

2. All acute care hospitals with adult intensive care units shall (i) participate in CDC's National Healthcare Safety Network by July 1, 2008, (ii) submit data on the above named infection to the NHSN according to CDC protocols and ensure that all data from July 1, 2008, to December 31, 2008, are entered into the NHSN by January 31, 2009, and (iii) enter data ensure accurate and complete data are available quarterly thereafter according to a schedule established by the department.

3. All acute care hospitals reporting the information noted above shall authorize the department to have access to hospital-specific data contained in the NHSN database.

C. B. Liability protection and data release. Any person making such report as authorized herein shall be immune from liability as provided by § 32.1-38 of the Code of Virginia. Infection rate data may be released to the public by the department upon request. Data shall be aggregated to ensure that no individual patient may be identified.

VA.R. Doc. No. R09-1657; Filed November 17, 2009, 9:57 a.m.