Title of Regulation: 12VAC5-90. Regulations for Disease Reporting and Control (amending 12VAC5-90-10, 12VAC5-90-370).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 1, 2011.

Agency Contact: Diane Woolard, PhD, Director, Disease Surveillance, Department of Health, 109 Governor Sreet, Richmond, VA 23219, telephone (804) 864-8124, or email diane.woolard@vdh.virginia.gov.

Basis: Section 32.1-35.1 of the Code of Virginia requires acute care hospitals to report infection information to the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN) and for the State Board of Health to define infections to be reported and the patient populations to be included.

Purpose: The proposed regulatory action identifies additional measures related to healthcare-associated infections that acute care hospitals must report to the CDC and the Virginia Department of Health (VDH). The amendment to the Regulations for Disease Reporting and Control is proposed in response to increased interest in measuring and improving patient safety in hospitals and reducing the occurrence of healthcare-associated infections.

Substance: The proposed amendment to 12VAC5-90-370 moves the definitions to 12VAC5-90-10 and adds reporting requirements for hospitals. The specific proposed additional reporting requirements are:

1. Central line-associated bloodstream infections in one adult inpatient medical ward and one adult inpatient surgical ward. Wards selected should be those with the longest length of stay during the previous calendar year, excluding cardiology, obstetrics, psychiatry, hospice, and step-down units. Data shall include the number of central-line days in each population at risk.

2. Clostridium difficile infection, laboratory-identified events on inpatient units facility-wide, with the exceptions recommended by CDC protocol. Data shall include patient days.

3. Acute care hospitals shall report to the VDH quarterly, within one month of the close of the calendar year quarter, aggregate counts of the Surgical Care Improvement Project (SCIP) Core Measures pertaining to the following surgical procedures: hip arthroplasty, knee arthroplasty, and coronary artery bypass graft. Data shall be collected in accordance with the Specification Manual for National Hospital Inpatient Quality Measures and shall include counts of the patient population and the applicable SCIP measures for each of the three surgical procedures. SCIP measures track compliance with procedures that have been shown to reduce the risk of infection following surgeries.

Issues: As evidenced by a national movement, the public is very interested in increased reporting of healthcare-associated infections and other measures of the quality of medical care. The advantage to the citizens is that more information would be available about hospital quality. The disadvantage to the regulated community (hospitals) is the increased workload that would be created.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health proposes to require hospitals to report three additional measures associated with healthcare associated infections.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs. Detailed analysis of the benefits and costs can be found in the next section.

Estimated Economic Impact. Section 32.1-35.1 of the Code of Virginia mandates that the acute care hospitals report nosocomial (healthcare-associated) infections to the Centers for Disease Control and Preventions National Healthcare Safety Network and release their infection data to the State Board of Health which in turn may release the data to the public. The legislative mandate requires the Board to determine the types of infections to be reported and the patient populations to be included. As a result, the Board started requiring, in 2008, acute care hospitals to report central line-associated blood stream infections in adult intensive care units.

With this action, the Board proposes to require hospitals to report quarterly three additional measures associated with healthcare associated infections. These measures are central line-associated blood stream infections in two wards outside of intensive care units, Clostridium difficile infections that meet the Centers for Disease Control and Prevention definition of a laboratory-identified event, and surgical care improvement process measures pertaining to hip arthroplasty, knee arthroplasty, and coronary artery bypass graft surgeries.

According to the Centers for Disease Control and Prevention, National Healthcare Safety Network (NHSN) evolved from the National Nosocomial Infection System, which was developed in the early 1970s to track healthcare-associated infections and has been a voluntary reporting system. The proposed regulations will require Virginia acute care hospitals to report additional measures to the already existing NHSN system and allow the Virginia Department of Health (VDH) to retrieve reported information.

According to VDH, of the approximately 90 hospitals that will start reporting the additional three measures, about 75% was already collecting data on central line-associated blood stream infections outside of intensive care units and about 93% was already collecting data on Clostridium difficile infections in some manner. All are required to collect data on surgical care improvement process measures pertaining to hip arthroplasty, knee arthroplasty, and coronary artery bypass graft surgeries and report it to the Centers for Medicare and Medicaid Services.

Also, according to a survey conducted by the Centers for Disease Control and Prevention 98% of the Virginia hospitals surveyed reported to use the NHSN definition for the central line-associated blood stream infections outside of intensive care units and 71% of the Virginia hospitals surveyed reported to use the NHSN definition for Clostridium difficile infections. Moreover, 19% of the Virginia hospitals surveyed reported they enter central line-associated blood stream infections outside of intensive care data into NHSN system and 10% of the Virginia hospitals surveyed reported they enter Clostridium difficile infections data into NHSN system.

In short, while reporting of additional three measures are expected to add to the hospitals compliance costs, these costs are somewhat mitigated because some hospitals already collect some data using the same definitions as proposed and report these measures to the NHSN system. According to a survey conducted by VDH, for reporting of central line-associated blood stream infections outside of intensive care units, 25% of the hospitals surveyed did not anticipate any additional hours, 31% anticipated 1-5 additional hours, 19% anticipated 6-10 additional hours, 15% anticipated 11-20 additional hours, 10% anticipated more than 20 additional hours would be needed. Similarly, for reporting of Clostridium difficile infections, 9% of the hospitals surveyed did not anticipate any additional hours, 28% anticipated 1-5 additional hours, 40% anticipated 6-10 additional hours, 14% anticipated 11-20 additional hours, 9% anticipated more than 20 additional hours would be needed.

In addition, reporting of three additional measures is expected to demand more administrative resources from VDH. VDH believes that the current staffing level made possible by the temporary federal stimulus funding would be able to absorb the increased workload in terms of the retrieval of data reported to NHSN and dissemination of the same data to public if requested. While the verification of data could be costly, VDH does not plan to conduct data validation of the accuracy of the data reported.

On the other hand, the proposed regulations are expected to help reduce the number of healthcare related infections at the hospitals. The proposed regulations also benefit the public by enabling them to make informed healthcare choices by providing information that can be used as a proxy for hospital quality.

However, in the absence of data validation, it is unclear how the proposed reporting requirements could be effectively enforced. Also, due to litigation concerns, hospitals already have strong incentives to minimize the number of infections occurring at their facilities. Given already existing strong incentives to minimize infections, it is unclear whether reporting would be an effective way to reduce infections at the margin. Furthermore, because the proposed requirements do not channel additional resources to existing infection control programs the benefits are expected to be small. In fact, the introduction of the additional measures that must be reported may actually divert staff resources from infection control activities to reporting activities at the hospitals.

Businesses and Entities Affected. The proposed regulations will require 90 acute care hospitals to report healthcare-associated infection data to the Board.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposed regulations are expected to increase the labor demand by hospitals and by VDH in order to report and retrieve healthcare-associated infection data.

Effects on the Use and Value of Private Property. The proposed regulations are expected to create non-negligible compliance costs on hospitals which would have a negative impact on the asset value of hospitals. Also, infection data will be available to the public. Depending on whether the infection data is favorable or not, some hospitals may see a decrease or increase in the demand for the healthcare services they are offering.

Small Businesses: Costs and Other Effects. According to VDH, of the 90 hospitals, 47 have fewer than 200 beds and could be considered as small businesses. The costs and other effects discussed above are the same for the small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There is no known less costly alternative method for reporting of the proposed three additional healthcare infection measures.

Real Estate Development Costs. The proposed regulations are not expected to have any significant effect 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 107 (09). 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 Virginia Department of Health concurs with the Economic Impact Analysis conducted by the Department of Planning and Budget relative to the proposed changes to the Regulations for Disease Reporting and Control in the action entitled Expanded Requirements for Reporting Healthcare-Associated Infections.

Summary:

The proposed amendments will require hospitals to report three additional measures for healthcare-associated infections: (i) central line-associated bloodstream infections outside of intensive care units; (ii) Clostridium difficile infections that meet the Centers for Disease Control and Prevention's definition of a laboratory-identified event; and (iii) surgical care improvement process measures pertaining to hip arthroplasty, knee arthroplasty, and coronary artery bypass graft surgeries.

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" means a person 18 years of age or more.

"Affected area" means any part or the whole of the Commonwealth that has been identified as where individuals 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.

"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's (CDC) surveillance definition for laboratory-confirmed primary bloodstream infection in the NHSN Patient Safety Component Manual, Key Terms (June 2010).

"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.

"Clostridium difficile infection, laboratory-identified event" means laboratory testing on unformed stool that yields a positive result for Clostridium difficile toxin A or B or a toxin-producing Clostridium difficile organism detected in the stool sample by culture or other laboratory means, with duplicate reports on a patient ruled out according to CDC definitions in the NHSN Patient Safety Component Manual, MDRO and CDAD Module (June 2010).

"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 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.

"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" 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 a healthcare setting; and (iii) if applicable, meets the criteria for a specific infection site as defined by CDC in the NHSN Patient Safety Component Manual, Key Terms (June 2010).

"Healthcare-associated outbreak" means any group of illnesses of common etiology occurring in patients of a healthcare setting acquired by exposure of those patients to the disease agent while in such a facility.

"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).

"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" 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.

"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.

"Surgical Care Improvement Project (SCIP)" means a national quality initiative supported by The Joint Commission, the Centers for Medicare and Medicaid Services, and other partners in healthcare that is designed to improve surgical care in hospitals.

"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.

Part XIII
Report Reporting 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 enter data on the following healthcare-associated infection infections in the specified patient population: into CDC's National Healthcare Safety Network according to CDC protocols in the NHSN Patient Safety Component Manual Modules: Identifying HAIs (November 2009), Device-associated Module CLABSI Events (June 2010), MDRO and CDAD Module (June 2010), and CDC Locations and Descriptions (July 2010). Acute care hospitals shall ensure that accurate and complete data are entered at least quarterly within one month of the close of the calendar year quarter and shall authorize the department to have access to hospital-specific data contained in the NHSN database.

central 1. 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. Central line-associated bloodstream infections outside intensive care, including in one adult inpatient medical ward and one adult inpatient surgical ward. Wards selected should be those with the longest length of stay during the previous calendar year, excluding cardiology, obstetrics, psychiatry, hospice, and step-down units. Data shall include the number of central-line days in each population at risk.

3. Clostridium difficile infection, laboratory-identified events on inpatient units, with the exceptions recommended by CDC protocol in the NHSN Patient Safety Component Manual, MDRO and CDAD Module (June 2010). Data shall be collected year-round at the overall facility-wide level. Data shall include patient 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 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.

B. Reportable process measures. Acute care hospitals shall report to the department quarterly, within one month of the close of the calendar year quarter, aggregate counts of the Surgical Care Improvement Project (SCIP) Core Measures pertaining to the following surgical procedures: hip arthroplasty, knee arthroplasty, and coronary artery bypass graft. Data shall be collected in accordance with the Specification Manual for National Hospital Inpatient Quality Measures (Version 3.3) and shall include counts of the patient population and the applicable SCIP measures for each of the above designated surgical procedures. Reports shall be submitted to the department's Division of Surveillance and Investigation.

C. 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.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-90)

Control of Communicable Diseases Manual, 18th 19th Edition, 2008, American Public Health Association, 2004.

National Healthcare Safety Network Patient Safety Component Manual, Centers for Disease Control and Prevention:

Key Terms, June 2010.

Multidrug-Resistant Organism & Clostridium difficile-Associated Disease (MDRO/CDAD) Module (MDRO and CDAD Module), June 2010.

Identifying Healthcare-associated Infections (HAI) in NHSN (Identifying HAIs), November 2009.

Central Line-Associated Bloodstream Infection (CLABSI) Event (Device-associated Module CLABSI), June 2010.

CDC Locations and Descriptions, July 2010.

Specification Manual for National Hospital Inpatient Quality Measures, Version 3.3, 04-01-11 (2Q11) through 12-31-11 (4Q11), Centers for Medicare & Medicaid Services and The Joint Commission.