Original Notice.

Preproposal statement of inquiry was filed as WSR 98-09-113 and 98-09-114.

Title of Rule: Notifiable conditions surveillance.

Purpose: Tracking communicable and other diseases is a primary function of public health agencies. This type of data is critical to local health departments in their efforts to control the spread of diseases, such as tuberculosis, measles, hepatitis and HIV/AIDS, just to name a few. This type of data is also critical to national epidemiological efforts conducted by the Centers for Disease Control and Prevention and other public health organizations.

Statutory Authority for Adoption: RCW 43.20.050, 43.70.545, 70.24.125, 70.28.010, 70.104.030.

Statute Being Implemented:

STATUTE BEING IMPLEMENTED	ADOPTING AUTHORITY	APPLICABLE WAC SECTION
RCW 43.20.050 Powers and duties of the State Board of Health -- State public health report -- Delegation of authority -- Enforcement of rules.	State Board of Health	246-100-011, 246-100-016, 246-100-021, 246-100-026, 246-100-031, 246-100-036, 246-100-041, 246-100-042, 246-100-043, 246-100-046, 246-100-071, 246-100-076, 246-100-081, 246-100-086, 246-100-091, 246-100-171, 246-100-176, 246-100-181, 246-100-196, 246-100-201, 246-100-216, 246-100-231, 246-100-236, 246-100-241, 246-101-001, 246-101-005, 246-101-010, 246-101-015, 246-101-101, 246-101-105, 246-101-110, 246-101-115, 246-101-120, 246-101-201, 246-101-205, 246-101-210, 246-101-215, 246-101-220, 246-101-225, 246-101-230, 246-101-301, 246-101-305, 246-101-310, 246-101-315, 246-101-320, 246-101-401, 246-101-405, 246-101-410, 246-101-415, 246-101-420, 246-101-425, 246-101-501, 246-101-505, 246-101-510, 246-101-515, 246-101-520, 246-101-525, 246-101-601, 246-101-605, 246-101-610, 246-101-615, 246-101-620, 246-101-625, 246-101-630, 246-101-635, 246-101-640 246-101-701, 246-101-705, 246-101-710, 246-101-715, 246-101-720, 246-101-725, 246-101-730, 246-420-001, 246-420-010, 246-420-020, 246-420-030, 246-420-040, 246-420-050, and 246-420-060.
RCW 43.70.545 Data collection and reporting rules.	Department of Health	246-100-218, 246-101-115, 246-101-225, 246-101-301, 246-101-305, 246-101-315, 246-101-320, 246-101-605, 246-101-610, 246-101-615, 246-101-620, and 246-101-630.
RCW 70.24.125 Reporting requirements for sexually transmitted diseases -- Rules.	State Board of Health	246-100-076, 246-100-081, 246-100-231, 246-100-236, 246-101-101, 246-101-110, 246-101-115, 246-101-201, 246-101-210, 246-101-215, 246-101-220, 246-101-225, 246-101-301, 246-101-310, 246-101-315, 246-101-510, 246-101-520, 246-101-620, 246-101-630, and 246-101-635.
RCW 70.28.010 Physicians required to report cases.	Board of Health	246-100-076, 246-100-081, 246-100-231, 246-100-236, 246-101-101, 246-101-110, 246-101-115, 246-101-201, 246-101-210, 246-101-215, 246-101-220, 246-101-225, 246-101-301, 246-101-310, 246-101-315, 246-101-510, 246-101-620, and 246-101-635.
RCW 70.104.030 Powers and duties of the Department of Health.	Department of Health	246-100-217, 246-101-001, 246-101-105, 246-101-110, 246-101-115, 246-101-120, 246-101-301, 246-101-305, 246-101-310, 246-101-315, 246-101-320, 246-101-605, 246-101-610, 246-101-615, and 246-101-620.

Summary: Revises and integrates the nine different regulatory structures for notifiable conditions surveillance in a single unified format; updates that list of what conditions are notifiable to public health authorities.

Reasons Supporting Proposal: By revising and integrating the notifiable conditions regulations and list of notifiable conditions, and continuing the development of systems to electronically record and exchange notifiable conditions data, public health authorities will have the necessary information to respond in a more timely manner to health events in the community. Enhanced capacity to respond to public health events should result in economic benefit for the health care system and the community. Future integration of less immediate conditions into the physician-health claims billing system will also help to provide a more complete picture of health threats in the community. The creation of criteria for what would be acceptable from a standard electronic data format as a report to public health authorities will set the standard for future business transactions.

Name of Agency Personnel Responsible for Drafting and Implementation: Greg Smith, P.O. Box 47815, Olympia, WA 98504-7815, (360) 236-3704; and Enforcement: Maxine Hayes, MD, P.O. Box 47890, Olympia, WA 98504-7890, (360) 236-4030.

Name of Proponent: State Department of Health and State Board of Health, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: Revises and integrates all current state regulations regarding disease reporting to public health authorities so: Time frames for notification are streamlined to no more than three per category of reporter; clarifications about who the reporter must notify are included; emergent conditions of public health importance are added, lesser priority conditions are deleted; process for receiving notifications through alternative methods is established; systematic review process established for all newly notifiable conditions is [are] established; and other technical changes in the disease reporting and notification process are accomplished.

Proposal Changes the Following Existing Rules: This proposed regulation revises and integrates the entire notifiable conditions system into one easy to read and use regulation.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

The notifiable conditions system is presently a series of distinct systems built largely to respond to specific situations and diseases. Components included in addition to communicable disease reporting are: Animal bites reporting, blood lead reporting, pesticide poisoning, gunshot wound reporting, birth defects reporting, and cancer reporting. The current reporting systems have nine different timeframes for reporting and eight different reporting processes. In many cases there is confusion among reporters (health care providers, laboratories, hospitals) about which reporting process applies to which condition.

Representatives from Department of Health (DOH), local health departments, the Department of Labor and Industries (L&I), and the medical and the laboratory communities began meeting in late 1997 to assess how to modernize and integrate the notifiable conditions system. Twelve criteria were used to generate a draft list of notifiable conditions: Incidence, morbidity, mortality, communicability, preventability and treatability, need for an immediate public health response, socioeconomic impact, agricultural impact, WHO and CDC interest, public perception, and action to be taken by public health using the data. Efforts were made to minimize the use of the "notifiable conditions" process for collecting data that were otherwise available to public health authorities.

The department held more than one hundred fifty meetings with various groups of affected stakeholders to discuss changes to the list and how, when and where conditions should be reported. The feedback from those meetings clearly called for consolidated time frames for notification, consistent data collection methods and regulatory schemes revision, as was the need to automate and integrate as much of the reporting burden as possible. The regulated community also indicated a desire to streamline and coordinate processes wherever possible and to develop new regulations that were logical, understandable, and easier to use. Finally the regulated community desired a systematic method for evaluating emergent conditions added to the notifiable conditions system before they became permanently notifiable. The SBOH and DOH drew heavily from the public comments when developing the proposed regulations.

Is an SBEIS necessary? Under the Regulatory Fairness Act (chapter 19.85 RCW), a small business economic impact statement (SBEIS) is required whenever a regulation imposes "more than minor" costs on a regulated business. The act defines a business as any "...entity, including a sole proprietorship, corporation, partnership, or other legal entity, that is owned and operated independently from all other businesses, that has the purpose of making a profit...." Thus, the board and department are not required to assess the cost that a rule may impose on a public or nonprofit institution. This exemption is important for this proposed rule since a significant portion of the burden falls on public entities. The board and the department has identified the following types of entities as affected by the proposed rule.

a. Laboratories, the costs of generating and transmitting reports of positive test results,

b. Health care providers, the costs (to physicians, infection control practitioners, other medical care providers) of completing case reports,

c. Local health jurisdictions, the costs of conducting follow-up investigations with providers to complete case reports and to securely store these case reports, and

d. State government, DOH and L&I.

Of these entities, only laboratories and providers meet the definition of a business seeking to make a profit. The "more than minor" thresholds for laboratories and providers are $300 and $240, respectively.¹

1. Assumptions: Annual Incidence of Viral, Enteric, Genetic and Occupational Diseases: The first step in determining the cost of the proposed regulations to laboratories and providers is to project the annual disease incidence occurring in Washington state. The board anticipates approximately four hundred fifty persons will test positive for viral disease, one hundred fifty for food/water-borne disease, six hundred for genetic disorders, and two thousand for occupational illnesses. The board derived this estimate after reviewing available data sources of disease incidence.² The board used the above projections of disease incidence to estimate four types of costs associated with each illness category.

2. Laboratory Costs: Number of Laboratories Reporting, Number of Tests, Time Required for Reporting of Results: Washington state has some two thousand five hundred laboratories performing a wide variety of tests. Some of these laboratories specialize in the performance of specific diagnostic tests while others offer a broader array of diagnostic tests. In 1999, the board prepared a significant analysis for the name-to-code HIV reporting regulation. To estimate laboratory cost of HIV reporting, DOH staff interviewed knowledgeable representatives of nine laboratories. The survey indicated that laboratories use computer programs to identify reportable tests and generate the required notifiable disease reports. Staff involvement is limited to an average of two minutes per test result. Assuming staff costs $20/hour (including overhead and benefits), each report costs laboratories $0.67. The board assumes that laboratory "per report" costs for the proposed rule will be similar to that estimated for the HIV reporting rule.

Viral: The proposed rule would not require laboratories to perform any additional activities when they find a positive viral test result. Therefore, there are no added costs.

Food/Water Borne: The proposed rule would add cryptosporidiosis and cyclosporiasis to the list of reportable conditions for laboratories. Notification of the local health jurisdiction would be required within two days of obtaining a positive test result. In addition, laboratories would need to send a tissue specimen to the state laboratory. Assuming one hundred fifty cases each year, this proposal would add about $100 in paperwork costs. In addition, packaging and delivering cyclospora specimens to the state laboratory would cost about $15. The board and the department estimated the required overall annual laboratory cost associated with food/water borne diseases at $850.³

Genetic: The proposed rule would not increase laboratory costs as they would not be required to perform any additional activities. However, the institution drawing the tissue sample (most likely a hospital) would be required to provide a monthly report to the state Department of Health of all cases of the newly specified genetic diseases. Assuming six hundred cases each year, this proposal would add about $400 to hospital annual paperwork costs.

Occupational: The proposed rule would not increase laboratory costs as they would not be required to perform any additional activities.

Estimating the cost that individual laboratories will face from the proposed regulatory amendments is difficult because of the wide variation in laboratory size. The board does not expect that any laboratory would face cost increases of more than $300. The board's and the department's expectation is grounded in the fact that some two thousand five hundred laboratories operate in Washington state and the total reporting cost of all providers is estimated at less than $2,800. Nevertheless, the board and the department decided it prudent to prepare an SBEIS for this business category just in case some providers may face costs of more than $300.

3. Cost to Providers: Time Required for Completing Case Reports, Number of Reports, Number of Unnecessary Case Report Investigations: To estimate the cost of mandatory provider reporting, SBOH first determined the time it would take providers to complete a patient case report. In the analysis accompanying the recent regulation requiring notification of HIV infection, the board and the department interviewed four AIDS disease investigators at the Seattle-King County Department of Public Health who estimated that a case report could typically be completed in fifteen minutes. Department staff independently came to the same estimate. The board assumes that a report for one of the new notifiable conditions would take a similar amount of time since similar information is required. Based on staff time costs of $20/hour (physicians regularly delegate their reporting authority to a specific office staff member), the provider cost per completed case report is estimated at $5/report.

Viral: The proposed rule would add Hepatitis B surface antigen positivity in pregnant women and Hantavirus pulmonary syndrome to the list of reportable conditions for providers. Notification of the local health jurisdiction would be required within three working days of obtaining a positive test result. Assuming four hundred fifty annual cases, this requirement would impose costs of $2250 on providers.

Food/Water Borne: The proposed rule would require providers to notify the local health jurisdiction of cases of cryptosporidiosis and cyclosporiasis within three working days of obtaining a positive test result. Assuming one hundred fifty annual cases, this requirement would impose costs of $750 on providers.

Genetic: The proposed rule would not require providers to perform any additional activities when they find one of the newly specified genetic diseases. Therefore, there are no added costs.

Occupational: The proposed rule would require providers to report cases of occupational asthma to the Department of Health. Notification would be required on a monthly basis. Assuming two hundred thirty five annual cases, this requirement would impose total annual costs of $1,175 on providers.

Estimating the cost to individual providers is very difficult because of the significant variation in provider size and the communities they serve. On average this proposed rule would cost providers well less than $240 since many of providers operate in Washington state and the total reporting cost of all providers is estimated at about $4,200. Nevertheless, the board thinks that some providers may face costs of more than $240. For example, an individual practitioner specializing in treating infectious diseases could have costs higher than $240. On the other hand, reporting costs for a large provider in a rural setting will likely be well less than $240 per year. Since some providers may face more than $240 an SBEIS is required for this business category.

Does the proposed rule affect both large and small businesses? With certain restrictions the act requires the government agencies to provide regulatory relief whenever a rule imposes a disproportionate cost burden on small businesses. The act defines a small business as one that employs less than fifty individuals. As part of the rule-making analysis prepared for the board's 1999 HIV name-to-code reporting regulation, the department investigated employment at thirty two laboratories in Washington state.⁴ The number of testing personnel at these laboratories ranges from one to two hundred ninety-seven -- eighteen labs have fewer than fifty people and fourteen have over fifty people. Based on these employment numbers, the board determined that the proposed rule might very well affect both large and small laboratories.

With regard to providers, the board and the department did not find specific information about the employment patterns of providers who would likely be affected by this proposed rule. Nevertheless, the board and the department are aware that providers span a range of sizes; from individuals in sole practices to large managed care companies. Therefore, the board and the department believe it reasonable to assume that the proposed rule will affect both large and small providers.

Does the proposed rule impose disproportionate cost on small businesses? The act provides specific direction to agencies on how to determine if a proposed regulation imposes disproportionate costs on small business (RCW 19.85.040(1)).

"To determine whether the proposed rule will have a disproportionate impact on small businesses, the impact statement must compare the cost of compliance for small business with the cost of compliance for the 10% of businesses that are the largest businesses required to comply with the proposed rules using one or more of the following as a basis for comparing costs:

a) Cost per employee;

b) Cost per hour of labor; or

c) Cost per one hundred dollars of sales."

On a cost per employee basis, the proposed regulation would affect small laboratories significantly more than large laboratories if there were sizable fixed costs for the reporting of notifiable conditions. However, the board and the department believe it more likely that the costs associated with reporting are variable (proportional to hours of labor required for reporting). As such, the board and the department expect that there would not be a difference in per employee costs. Nevertheless, given the possibility that laboratories with fewer than fifty employees would face higher per employee compliance costs than the larger laboratories, the board and the department think it prudent to provide relief for small businesses in this business category.

The board and the department finds that on a cost per hour of labor basis, the proposed rule would not impose a disproportionate cost impact on small providers. To make this finding, the board and the department considered the cost of reporting relative to the time required to draw and prepare a tissue specimen. Most tests have standardized protocols for preparing a specimen.⁵ Therefore, the board and the department presumed that the time to draw and prepare the specimen would be similar at large and small institutions. Consideration of economics of scale (i.e., efficiency gains resulting from drawing many samples) does not change this presumption. Therefore, the board and the department concluded that the proposed rule does not impose disproportionate costs on small providers, and that mitigation is not required.

What Regulatory Mitigation is Provided? This assessment found that the proposed rule could impose disproportionately higher costs on small laboratories. Requirements of the Regulatory Fairness Act are very specific in this situation.⁶

"Based upon the extent of the disproportionate impact on small business... the agency shall, where legal and feasible in meeting the stated objectives of the statutes upon which the rule is based, reduce the costs imposed by the rule on small businesses. Methods to reduce the costs on small businesses may include:

a) Reducing, modifying, or eliminating substantive regulatory requirements;

b) Simplifying, reducing, or eliminating recordkeeping and reporting requirements;

c) Reducing the frequency of inspections;

d) Delaying compliance timetables;

e) Reducing or modifying fine schedules for noncompliance; or

f) Any other mitigation techniques."

The board and the department do not expect any laboratories to have difficulty complying with the notification requirements in the proposed regulatory amendments. The department based this expectation on a survey in which no individual laboratory indicated any difficulty with this provision. In addition, the board and the department expect that smaller, less sophisticated labs would not have the ability to do many of the tests. Lack of equipment, lack of mediums for growing cultures and lack of technical proficiency are likely to cause smaller less sophisticated labs to send their samples to a reference laboratory (possibly the PHL, possibly a major private lab) instead of doing the tests in-house.

Nevertheless, to account for the possibility that some laboratories might face disproportionate costs, the board and the department will phase in the reporting of cryptosporidiosis and cyclosporiasis for any laboratory that requests a delay in implementation. The board and the department anticipate that small laboratories will generally be more likely to request an extended phase-in period. Phasing-in the requirement to report cryptosporidiosis and cyclosporiasis tests and serving as an available referral laboratory would provide significant relief to small laboratories.

The board and the department are also working collaboratively with laboratories to identify and implement the most cost-effective means of reporting test results, including the use of electronic media, prepackaged data entry screens or use of data generated by an individual laboratory's clinical laboratory information management system, transmittal software, and encryption software. Individual laboratories will not be required to report the results of cryptosporidiosis and cyclosporiasis tests until a mutually agreed upon time if the laboratory requests additional time to meet the reporting requirement. The reporting requirement will be enacted on a case-by-case basis in these situations.

Other Requirements:

1. How DOH involved small businesses in the development of the rule: The department conducted a survey of all licensed laboratories in September 1998 in an attempt to ascertain what if any difficulties or concerns laboratories may have with these proposed changes in the laboratory notification requirements.

The department also has solicited input directly from health care providers and laboratorians in local and professional forums, and has been working cooperatively with the Washington State Medical Association (Medical Practice Subcommittee and Specialty Committee), Washington State Hospital Association, the DOH-Clinical Laboratory Advisory Committee, and the Washington State Association of Local Public Health Officials as leaders and representatives of various entities required [to] take actions under the proposed regulations.

2. The industries required to comply with the proposed rule: Two for-profit industries are required to comply with this rule: Laboratories and health care providers (including individual providers and hospitals).

3. Will the proposed rule cause any industry to lose business? The proposed rule will not cause any industry to lose business. Laboratories are in the business of performing diagnostic tests. They have for many years been integral to notification processes about the results of those tests with public health authorities. Health care providers are in the business of treating illness and maintaining wellness of their patients. Changes to these regulations are designed to reflect the most critical public health priorities – those conditions where public health must assist the health care provider by assisting in an intervention. These interventions prevent further transmission of communicable diseases, assure that appropriate and available treatment is obtained for patients that are already affected by a notifiable condition, and that information about disease and condition outbreaks provides a basis of information to prevent future outbreaks.

¹ Washington State Department of Community, Trade and Economic Development, "Facilitating Regulatory Fairness, A Resource Guide to Implementation for Rule Writers," January, 1995. The cost threshold for laboratories was from SIC code 807 - Medical & Dental Laboratories, the cost threshold for providers was from SIC code 801 - Office & Clinics of Doctors of Medicine.

² To approximate the number of illnesses, the board extrapolated known national incidence data to the Washington population, estimated Washington prevalence from state prevalence rates from states where prevalence is known, and applied estimates of prevalence based on data from recent outbreaks.

³ The actual cost of sending tissue samples to the state laboratory is likely to be less than estimated here. Commercial and LHJ laboratories forward many of tissue samples to the state laboratory as the state laboratory serves as a reference laboratory for private clinical laboratories. Commercial and LHJ laboratories submit samples when they do not have the equipment or other technology to perform the particular diagnostic test adequately. Thus, the proposed regulation would only affect those samples that would not have been sent without the mandate.

⁴ This number includes both public and private laboratories.

⁵ Constantine NT, Callahan J, Watts DM. Retroviral testing: Essentials for quality control and laboratory diagnosis. CRC Press, 1992, Boca Raton.

⁶ RCW 19.85.030(3).

A copy of the statement may be obtained by writing to Greg Smith, Washington State Department of Health, P.O. Box 47815, Olympia, WA 98504-7815, phone (360) 236-3704.

RCW 34.05.328 applies to this rule adoption. Under the provisions of RCW 70.24.080, 70.24.084, and 70.05.100 violation of any lawful rule adopted by the board may subject the violator to criminal or monetary penalties.

Hearing Location: Room 316, South Campus Center, University of Washington, Seattle, Washington, on July 12, 2000, at 9:00 a.m.

Assistance for Persons with Disabilities: Contact Heather Boe, (360) 236-4104, by July 5, 2000, TDD (800) 833-6388, or (360) 548-5275.

Submit Written Comments to: Greg Smith, fax (360) 236-4088, by July 12, 2000.

Date of Intended Adoption: September 1, 2000.

June 6, 2000

Nancy Ellison

for Mary C. Selecky

Secretary, Department of Health

June 6, 2000

Dennis Braddock

Chair, State Board of Health

OTS-4107.1

AMENDATORY SECTION(Amending WSR 97-15-099, filed 7/21/97, effective 7/21/97)

WAC 246-100-011
Definitions.

The following definitions shall apply in the interpretation and enforcement of chapter 246-100 WAC:

(1) "Acquired immunodeficiency syndrome (AIDS)" means illness, disease, or conditions defined and described by the Centers for Disease Control, U.S. Public Health Service, Morbidity and Mortality Weekly Report (MMWR), December 18, 1992, Volume 41, Number RR-17. A copy of this publication is available for review at the department and at each local health department.

(2) "AIDS counseling" means counseling directed toward:

(a) Increasing the individual's understanding of acquired immunodeficiency syndrome; and

(b) Assessing the individual's risk of HIV acquisition and transmission; and

(c) Affecting the individual's behavior in ways to reduce the risk of acquiring and transmitting HIV infection.

(3) "Board" means the Washington state board of health.

(4) (("Carrier" means a person harboring a specific infectious agent and serving as a potential source of infection to others, but who may or may not have signs and/or symptoms of the disease.

(5))) "Case" means a person, alive or dead, having been diagnosed to have a particular disease or condition by a health care provider with diagnosis based on clinical or laboratory criteria or both.

(((6) "Category A disease or condition" means a reportable disease or condition of urgent public health importance, a case or suspected case of which must be reported to the local or state health officer immediately at the time of diagnosis or suspected diagnosis.

(7) "Category B disease or condition" means a reportable disease or condition of public health importance, a case of which must be reported to the local health officer no later than the next working day following date of diagnosis.

(8) "Category C disease or condition" means a reportable disease or condition of public health importance, a case of which must be reported to the local health officer within seven days of diagnosis.

(9))) (5) "Child day care facility" means an agency regularly providing care for a group of children for less than twenty-four hours a day and subject to licensing under chapter 74.15 RCW.

(((10))) (6) "Communicable disease" means an illness caused by an infectious agent which can be transmitted from one person, animal, or object to another person by direct or indirect means including transmission via an intermediate host or vector, food, water, or air.

(((11) "Contact" means a person exposed to an infected person, animal, or contaminated environment which might provide an opportunity to acquire the infection.

(12))) (7) "Department" means the Washington state department of ((social and)) health ((services)).

(((13))) (8) "Detention" or "detainment" means physical restriction of activities of an individual by confinement, consistent with WAC 246-100-206(8), for the purpose of monitoring and eliminating behaviors presenting imminent danger to public health and may include physical plant, facilities, equipment, and/or personnel to physically restrict activities of the individual to accomplish such purposes.

(((14) "Food handler" means any person preparing, processing, handling, or serving food or beverages for people other than members of his or her household.

(15) "Food service establishment" means any establishment where food or beverages are prepared for sale or service on the premises or elsewhere, and any other establishment or operation where food is served or provided for the public with or without charge.

(16))) (9) "Health care facility" means:

(a) Any facility or institution licensed under chapter 18.20 RCW, boarding home, chapter 18.46 RCW, ((maternity homes)) birthing centers, chapter 18.51 RCW, nursing homes, chapter 70.41 RCW, hospitals, or chapter 71.12 RCW, private establishments, clinics, or other settings where one or more health care providers practice; and

(b) In reference to a sexually transmitted disease, other settings as defined in chapter 70.24 RCW.

(((17))) (10) "Health care provider" means any person having direct or supervisory responsibility for the delivery of health care ((or medical care)) who is:

(a) Licensed or certified in this state under Title 18 RCW; or

(b) Is military personnel providing health care within the state regardless of licensure.

(((18))) (11) "HIV testing" means conducting a laboratory test or sequence of tests to detect the human immunodeficiency virus (HIV) or antibodies to HIV performed in accordance with requirements to WAC 246-100-207.      To assure that the protection, including but not limited to, pre- and post-test counseling, consent, and confidentiality afforded to HIV testing as described in chapter 246-100 WAC also applies to the enumeration of CD4+(T4) lymphocyte counts (CD4+ counts) and CD4+ (T4) percents of total lymphocytes (CD4+ percents) when used to diagnose HIV infection, CD4+ counts and CD4+ percents will be presumed HIV testing except when shown by clear and convincing evidence to be for use in the following circumstances:

(a) Monitoring previously diagnosed infection with HIV;

(b) Monitoring organ or bone marrow transplants;

(c) Monitoring chemotherapy;

(d) Medical research; or

(e) Diagnosis or monitoring of congenital immunodeficiency states or autoimmune states not related to HIV.

The burden of proving the existence of one or more of the circumstances identified in (a) through (e) of this subsection shall be on the person asserting such existence.

(((19) "Infection control measures" means the management of infected persons, persons suspected to be infected, and others in such a manner as to prevent transmission of the infectious agent.

(20))) (12) "Isolation" means the separation or restriction of activities of infected persons, or of persons suspected to be infected, from other persons to prevent transmission of the infectious agent.

(((21) "Laboratory director" means the director or manager, by whatever title known, having the administrative responsibility in any medical laboratory.

(22))) (13) "Local health department" means the city, town, county, or district agency providing public health services to persons within the area, as provided in chapter 70.05 RCW and chapter 70.08 RCW.

(((23))) (14) "Local health officer" means the individual having been appointed under chapter 70.05 RCW as the health officer for the local health department, or having been appointed under chapter 70.08 RCW as the director of public health of a combined city-county health department.

(((24) "Medical laboratory" means any facility analyzing specimens of original material from the human body for purposes of patient care.

(25))) (15) "Nosocomial infection" means an infection acquired in a hospital or other health care facility.

(((26))) (16) "Outbreak" means the occurrence of cases of a disease or condition in any area over a given period of time in excess of the expected number of cases.

(((27))) (17) "Post-test counseling" means counseling after the HIV test when results are provided and directed toward:

(a) Increasing the individual's understanding of human immunodeficiency virus (HIV) infection;

(b) Affecting the individual's behavior in ways to reduce the risk of acquiring and transmitting HIV infection;

(c) Encouraging the individual testing positive to notify persons with whom there has been contact capable of spreading HIV;

(d) Assessing emotional impact of HIV test results; and

(e) Appropriate referral for other community support services.

(((28))) (18) "Pretest counseling" means counseling provided prior to HIV testing and aimed at:

(a) Helping an individual to understand:

(i) Ways to reduce the risk of human immunodeficiency virus (HIV) transmission;

(ii) The nature, purpose, and potential ramifications of HIV testing;

(iii) The significance of the results of HIV testing; and

(iv) The dangers of HIV infection; and

(b) Assessing the individual's ability to cope with the results of HIV testing.

(((29))) (19) "Principal health care provider" means the attending physician or other health care provider recognized as primarily responsible for diagnosis and treatment of a patient or, in the absence of such, the health care provider initiating diagnostic testing or therapy for a patient.

(((30))) (20) "Quarantine" means the separation or restriction on activities of a person having been exposed to or infected with an infectious agent, to prevent disease transmission.

(((31) "Reportable disease or condition" means a disease or condition of public health importance, a case of which, and for certain diseases, a suspected case of which, must be brought to the attention of the local health officer.

(32))) (21) "School" means a facility for programs of education as defined in RCW 28A.210.070 (preschool and kindergarten through grade twelve).

(((33))) (22) "Sexually transmitted disease (STD)" means a bacterial, viral, fungal, or parasitic disease or condition which is usually transmitted through sexual contact, including:

(a) Acute pelvic inflammatory disease;

(b) Chancroid;

(c) Chlamydia trachomatis infection;

(d) Genital and neonatal herpes simplex;

(e) Genital human papilloma virus infection;

(f) Gonorrhea;

(g) Granuloma inguinale;

(h) Hepatitis B infection;

(i) Human immunodeficiency virus infection (HIV) and acquired immunodeficiency syndrome (AIDS);

(j) Lymphogranuloma venereum;

(k) Nongonococcal urethritis (NGU); and

(l) Syphilis.

(((34))) (23) "Spouse" means any individual who is the marriage partner of an HIV-infected individual, or who has been the marriage partner of the HIV-infected individual within the ten-year period prior to the diagnosis of HIV-infection, and evidence exists of possible exposure to HIV.

(((35))) (24) "State health officer" means the person designated by the secretary of the department to serve as statewide health officer, or, in the absence of such designation, the person having primary responsibility for public health matters in the state.

(((36))) (25) "Suspected case" means a person whose diagnosis is thought likely to be a particular disease or condition with suspected diagnosis based on signs and symptoms, laboratory evidence, or both.

(((37) "Unusual communicable disease" means a communicable disease which is not commonly seen in the state of Washington but which is of general public health concern including, but not limited to, Lassa fever, smallpox, typhus, and yellow fever.

(38))) (26) "Veterinarian" means an individual licensed under provisions of chapter 18.92 RCW, veterinary medicine, surgery, and dentistry and practicing animal health care.

[Statutory Authority: RCW 70.24.022, [70.24].340 and Public Law 104-146.      97-15-099, § 246-100-011, filed 7/21/97, effective 7/21/97.      Statutory Authority: Chapter 70.24 RCW.      93-08-036 (Order 354B), § 246-100-011, filed 4/1/93, effective 5/2/93.      Statutory Authority: RCW 43.20.050 and 70.24.130.      92-02-019 (Order 225B), § 246-100-011, filed 12/23/91, effective 1/23/92.      Statutory Authority: RCW 43.20.050.      91-02-051 (Order 124B), recodified as § 246-100-011, filed 12/27/90, effective 1/31/91.      Statutory Authority: Chapter 70.24 RCW.      89-07-095 (Order 325), § 248-100-011, filed 3/22/89; 88-17-057 (Order 317), § 248-100-011, filed 8/17/88.      Statutory Authority: RCW 43.20.050.      88-07-063 (Order 308), § 248-100-011, filed 3/16/88; 87-11-047 (Order 302), § 248-100-011, filed 5/19/87.]

Every health care provider, as defined in chapter 246-100 WAC, shall:

(1) Provide adequate, understandable instruction in control measures designed to prevent the spread of disease to:

(a) Each patient with a communicable disease under his or her care((,)); and

(b) ((Family of a patient with a communicable disease,

(c) Contacts and)) Others as appropriate to prevent spread of disease.

(2) ((Ensure notification of the local health officer or local health department regarding:

(a) Cases of reportable diseases and conditions.      See WAC 246-100-071, 246-100-076, and 246-100-081;

(b) Outbreaks or suspected outbreaks of disease.      See WAC 246-100-071, 246-100-076, and 246-100-081;

(c) Known barriers which might impede or prevent compliance with orders for infection control or quarantine; and

(d) Name, address, and other pertinent information for any case or carrier refusing to comply with prescribed infection control measures.

(3))) Cooperate with public health authorities during investigation of:

(a) Circumstances of a case or suspected case of a ((reportable disease or)) notifiable condition or other communicable disease((,)); and

(b) An outbreak or suspected outbreak of illness.

Comply with requirements in WAC 246-100-206, 246-100-211, and ((246-100-217)) chapter 246-101 WAC.

(3) Use protocols established in Communicable Diseases Manual, seventeenth edition, James Chin, MD, MPH, editor, 2000, when treating wounds caused by animal bites. A copy of this publication is available for review at the department and at each local health department.

[Statutory Authority: RCW 43.20.050, 70.24.130 and 70.104.055.      92-02-019 (Order 225B), § 246-100-021, filed 12/23/91, effective 1/23/92.      Statutory Authority: RCW 43.20.050.      91-02-051 (Order 124B), recodified as § 246-100-021, filed 12/27/90, effective 1/31/91.      Statutory Authority: Chapter 70.104 RCW.      90-10-036 (Order 049), § 248-100-021, filed 4/26/90, effective 5/27/90.      Statutory Authority: RCW 43.20.050.      87-11-047 (Order 302), § 248-100-021, filed 5/19/87.]

(1) The local health officer shall review and determine appropriate action for:

(((a) Each reported case or suspected case of a reportable disease or condition;

(b) Any disease or condition considered a threat to public health;

(c) Each reported outbreak or suspected outbreak of disease, requesting assistance from the department in carrying out investigations when necessary; and

(d))) Instituting disease prevention and infection control, isolation, detention, and quarantine measures necessary to prevent the spread of communicable disease, invoking the power of the courts to enforce these measures when necessary.

(2) Local health officers shall:

(a) ((Submit reports to the state health officer as required in chapter 246-100 WAC;

(b) Establish a system at the local health department for maintaining confidentiality of written records and written and telephoned disease case reports consistent with WAC 246-100-016;

(c))) Notify health care providers within the health district regarding requirements in this chapter;

(((d) Distribute appropriate report forms to persons responsible for reporting;

(e) Notify the principal health care provider:

(i) If possible, prior to initiating a case investigation by the local health department; and

(ii) For HIV infection, not contact the HIV-infected person directly without considering the recommendations of the principal health care provider on the necessity and best means for conducting the case investigation, unless:

(A) The principal health care provider cannot be identified; or

(B) Reasonable efforts to reach the principal health care provider over a two-week period of time have failed;

(f))) (b) Ensure anonymous HIV testing is reasonably available;

(((g))) (c) Make HIV testing, AIDS counseling, and pretest and post-test counseling, as defined in this chapter, available for voluntary, mandatory, and anonymous testing and counseling as required by RCW 70.24.400;

(((h))) (d) Make information on anonymous HIV testing, AIDS counseling, and pretest and post-test counseling, as described under WAC 246-100-208 and 246-100-209, available;

(((i))) (e) Use identifying information on HIV-infected individuals provided according to chapter 246-101 WAC ((246-100-076 and 246-100-236)) only:

(i) For purposes of contacting the HIV-positive individual to provide test results and post-test counseling; or

(ii) To contact persons who have experienced substantial exposure, including sex and injection equipment-sharing partners, and spouses; or

(iii) To link with other name-based public health disease registries when doing so will improve ability to provide needed care services and counseling and disease prevention; and

(((j) Destroy case report identifying information on asymptomatic HIV-infected individuals received as a result of WAC 246-100-076 within three months of receiving a complete case report;

(k))) (f) Destroy documentation of referral information established in WAC 246-100-072 and this subsection containing identities and identifying information on HIV-infected individuals and at-risk partners of those individuals immediately after notifying partners or within three months, whichever occurs first.

(3) ((Each local health officer has the authority to:

(a) Carry out additional steps determined to be necessary to verify a diagnosis reported by a health care provider;

(b) Require any person suspected of having a reportable disease or condition to submit to examinations required to determine the presence of the disease or condition; and

(c) Investigate any case or suspected case of a reportable disease or condition or other illness, communicable or otherwise, if deemed necessary.

(4))) Local health officers shall conduct investigations and institute control measures consistent with those indicated in the ((sixteenth)) seventeenth edition ((1995)), 2000, of ((Control of)) Communicable Diseases Manual, ((edited by Abram S. Benenson, published by the American public health association)) James Chin, MD, MPH, editor, except:

(a) When superseded by more up-to-date measures, or

(b) When other measures are more specifically related to Washington state.

[Statutory Authority: RCW 70.24.125. and 70.24.130.      99-17-077, § 246-100-036, filed 8/13/99, effective 9/1/99.      Statutory Authority: RCW 70.24.022, [70.24].340 and Public Law 104-146.      97-15-099, § 246-100-036, filed 7/21/97, effective 7/21/97.      Statutory Authority: RCW 43.20.050 and 70.24.130.      92-02-019 (Order 225B), § 246-100-036, filed 12/23/91, effective 1/23/92.      Statutory Authority: RCW 43.20.050.      91-02-051 (Order 124B), recodified as § 246-100-036, filed 12/27/90, effective 1/31/91.      Statutory Authority: Chapter 70.24 RCW.      89-02-008 (Order 324), § 248-100-036, filed 12/27/88.      Statutory Authority: RCW 43.20.050.      88-07-063 (Order 308), § 248-100-036, filed 3/16/88.]

(1) Definitions specific to this section:

(a) "Breeder" means a person or persons propagating birds for purpose of sale, trade, gift, or display;

(b) "Displayer" means a person, owner, or entity other than a public or private zoological park showing, exhibiting, or allowing a person or persons to handle or access a bird in a place open to the public or in a health care facility;

(c) "Leg band" means a smooth plastic or metal cylinder, either open (seamed) or closed (seamless), designed to be used to encircle a leg of a bird including permanent inscription of identification indicating:

(i) Code for individual bird, and

(ii) Code for breeder source except when open bands identify vendor rather than breeder.

(d) "Psittacine bird" or "bird" means all birds commonly known as:

(i) Parrots,

(ii) Macaws,

(iii) Cockatoos,

(iv) Lovebirds,

(v) Parakeets, and

(vi) All other birds of the order psittaciformes.

(e) "Vendor" means a person or entity selling, trading, or giving a bird to another person or entity.

(2) A person selling, trading, or otherwise transferring a bird shall identify each bird by:

(a) A coded and closed (seamless) leg band;

(b) A United States department of agriculture open (seamed) leg band; or

(c) An open (seamed) leg band only in cases where an original and closed (seamless) leg band was lost or required replacement due to injury or potential injury to the bird.

(3) A vendor transferring a bird to other than the general public shall maintain a record of transfer including acquisition, sales, and trade of a bird, for at least one year and including:

(a) Date of transaction;

(b) Name and address of the recipient and source;

(c) Number and type, including the common name of the bird transferred; and

(d) Leg band codes, including breeder or vendor and individual bird codes, omitting individual bird code only upon initial transfer of a bird propagated by the breeder.

(4) A vendor transferring a bird to the general public shall provide each buyer or recipient with:

(a) A sales slip or written document including all information required in subsection (3)(a), (b), (c), and (d) of this section; and

(b) A written warning or caution notice including:

(i) Information about possible human infection or disease caused by birds, especially psittacosis, parrot fever, and ornithosis;

(ii) Signs of infection or a sick bird including:

(A) Nasal discharge,

(B) Sneezing,

(C) Coughing,

(D) Ruffled feathers,

(E) Lethargy, and

(F) Diarrhea.

(iii) Signs and symptoms of an illness in a human including, but not limited to:

(A) Chills,

(B) Fever,

(C) Headache,

(D) Cough, and

(E) Muscle aches.

(iv) Information that nasal discharge and droppings of an infected or sick bird may cause illness in humans; and

(v) Advice to consult veterinarian or health care provider, as appropriate, if signs or symptoms occur.

(5) A vendor shall post a readable sign in a public area with a warning described in subsection (4)(b) of this section.

(6) When investigation of a human case of psittacosis indicates probable infection from a bird, the local health officer shall:

(a) Order collection of blood or other appropriate samples from the suspect bird or birds for appropriate laboratory tests to rule out disease; or

(b) Use protocols established in Communicable Diseases ((in Man)) Manual, ((15th)) seventeenth edition, ((Abram S. Benenson)) James Chin, MD, MPH, editor, ((1990)) 2000. A copy of this publication is available for review at the department and at each local health department; and

(c) Have authority to enforce requirements of this section on a nonpsittacine bird or birds when:

(i) There is suspected exposure to an infected bird, or

(ii) There is evidence a bird caused a disease.

(7) When a local health officer orders a quarantine of a bird or birds, the vendor shall:

(a) Cooperate with the local health officer, and

(b) Assume costs associated with action.

(8) Upon confirmation of psittacosis, vendors shall follow directions issued by the local health officer to:

(a) Place the birds under antibiotic treatment with environmental cleaning and sanitizing; or

(b) Destroy all birds on the premises followed by environmental cleaning and sanitizing; and

(c) Assume costs associated with psittacosis prevention and control action ordered by local and state health officer;

(d) Prohibit sale or addition of birds to inventory; and

(e) Prevent contact of any bird with the public.

(9) A person exhibiting or displaying a bird or birds in a place or area used or occupied by the public shall exhibit the bird or birds in a manner preventing human exposure to the birds and bird discharges except:

(a) In single-purpose pet shops and aviaries, and

(b) At bird shows if:

(i) A room containing a bird or birds is separated from other areas and activities, and

(ii) The room entrance has a sign warning a person about potential exposure to psittacosis.

(10) Shipment and embargo of birds.

(a) Any person or entity receiving a psittacine bird or birds from points outside Washington state shall:

(i) Comply with Title 9 CFR, parts 92.3 and 92.8(b);

(ii) Refuse receipt of any bird originating from premises where psittacosis infection is suspected or known; and

(iii) Refuse receipt of any bird from a premise quarantined for psittacosis.

(b) The state health officer is authorized to:

(i) Order placement and removal of an embargo upon shipment of a live bird or birds into Washington state, and

(ii) Order any action necessary to control an outbreak or potential outbreak of psittacosis in Washington state.

[Statutory Authority: RCW 43.20.050.      92-02-019 (Order 225B), § 246-100-201, filed 12/23/91, effective 1/23/92; 91-02-051 (Order 124B), recodified as § 246-100-201, filed 12/27/90, effective 1/31/91; 88-07-063 (Order 308), § 248-100-201, filed 3/16/88.]

     The following sections of the Washington Administrative Code are repealed:

WAC 246-100-016	Confidentiality.
WAC 246-100-026	Responsibilities and duties -- Veterinarians.
WAC 246-100-031	Responsibilities and duties -- Laboratory directors.
WAC 246-100-041	Responsibilities and duties -- State health officer.
WAC 246-100-042	Reporting of blood lead levels.
WAC 246-100-043	Surveillance report to the board -- State health officer.
WAC 246-100-046	Responsibilities and duties -- Cases, suspected cases, carriers, contacts, and others.
WAC 246-100-071	Responsibility for reporting to and cooperating with the local health department.
WAC 246-100-076	Reportable diseases and conditions.
WAC 246-100-081	Reports -- Content -- Time -- Hospital monthly report permitted for certain diseases.
WAC 246-100-086	Reporting diseases and conditions directly to department.
WAC 246-100-091	Handling of reports by local health department -- Handling of reports by department.
WAC 246-100-171	Special settings -- Food service establishments.
WAC 246-100-176	Special settings -- Schools.
WAC 246-100-181	Special settings -- Child day care facilities.
WAC 246-100-196	Animal bites -- Report to local health department.
WAC 246-100-216	Special diseases -- Surveillance for influenza.
WAC 246-100-217	Special condition -- Pesticide poisoning.
WAC 246-100-218	Special condition -- Gunshot wounds.
WAC 246-100-231	Duties of laboratories -- Submission of specimens by laboratories.
WAC 246-100-236	Duties of laboratories -- Reporting of laboratory results indicative of certain reportable diseases.
WAC 246-100-241	Duties of laboratories -- Duty to cooperate with local health departments and the department.

OTS-4106.1

REPEALER
     The following chapter of the Washington Administrative Code is repealed:

WAC 246-420-001	Purpose.
WAC 246-420-010	Definitions.
WAC 246-420-020	General requirements.
WAC 246-420-030	Information -- Content of reports.
WAC 246-420-040	Information to parents.
WAC 246-420-050	Confidentiality of reports -- Access to information -- Use of information.
WAC 246-420-060	Information on public and private services for handicapped.

OTS-4105.1

WAC 246-101-005, 246-101-010, and 246-101-015 are applicable throughout this chapter.

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The purpose of notifiable conditions reporting is to provide the information necessary for public health officials to protect the public's health by tracking communicable diseases and other conditions. These data are critical to local health departments and the departments of health and labor and industries in their efforts to prevent and control the spread of diseases and other conditions. Public health officials take steps to protect the public, based on these notifications. Treating persons already ill, providing preventive therapies for individuals who came into contact with infectious agents, investigating and halting outbreaks, and removing harmful health exposures are key ways public health officials protect the public. Public health workers also use these data to assess broader patterns, including historical trends and geographic clustering. By analyzing the broader picture, officials are able to take appropriate actions, including outbreak investigation, redirection of program activities, or policy development.

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The following definitions apply in the interpretation and enforcement of this chapter:

(1) "Blood lead level" means a measurement of lead content in whole blood.

(2) "Board" means the Washington state board of health.

(3) "Carrier" means a person harboring a specific infectious agent and serving as a potential source of infection to others.

(4) "Case" means a person, alive or dead, diagnosed with a particular disease or condition by a health care provider with diagnosis based on clinical or laboratory criteria or both.

(5) "Child day care facility" means an agency regularly providing care for a group of children for less than twenty-four hours a day and subject to licensing under chapter 74.15 RCW.

(6) "Condition notifiable within three work days" means a notifiable condition that must be reported to the local health officer or department within three working days following date of diagnosis. For example, if a condition notifiable within three work days is diagnosed on a Friday afternoon, the report must be submitted by the following Wednesday.

(7) "Communicable disease" means a disease caused by an infectious agent which can be transmitted from one person, animal, or object to another person by direct or indirect means including transmission via an intermediate host or vector, food, water, or air.

(8) "Communicable disease cluster" means two or more cases of a confirmed or suspected communicable disease with a suspected common source diagnosed or exposed within a twenty-four hour period.

(9) "Contact" means a person exposed to an infected person, animal, or contaminated environment that may lead to infection.

(10) "Department" means the Washington state department of health.

(11) "Disease of suspected bioterrorism origin" means a disease caused by viruses, bacteria, fungi, or toxins from living organisms that are used to produce death or disease in humans, animals, or plants. Many of these diseases may have nonspecific presenting symptoms. The following situations could represent a possible bioterrorism event and should be reported immediately to the local health department:

(a) A single diagnosed or strongly suspected case of disease caused by an uncommon agent or a potential agent of bioterrorism occurring in a patient with no known risk factors;

(b) A cluster of patients presenting with a similar syndrome that includes unusual disease characteristics or unusually high morbidity or mortality without obvious etiology; or

(c) Unexplained increase in a common syndrome above seasonally expected levels.

(12) "Elevated blood lead level" means blood lead levels equal to or greater than 25 micrograms per deciliter for persons aged fifteen years or older, or equal to or greater than 10 micrograms per deciliter in children less than fifteen years of age.

(13) "Food service establishment" means a place, location, operation, site, or facility where food is manufactured, prepared, processed, packaged, dispensed, distributed, sold, served, or offered to the consumer regardless of whether or not compensation for food occurs.

(14) "Health care facility" means:

(a) Any facility or institution licensed under chapter 18.20 RCW, Boarding homes; chapter 18.46 RCW, Birthing centers; chapter 18.51 RCW, Nursing homes; chapter 70.41 RCW, Hospitals; chapter 70.128 RCW, Adult family homes; or chapter 71.12 RCW, Private establishments;

(b) Clinics, or other settings where one or more health care providers practice; and

(c) In reference to a sexually transmitted disease, other settings as defined in chapter 70.24 RCW.

(15) "Health care provider" means any person having direct or supervisory responsibility for the delivery of health care who is:

(a) Licensed or certified in this state under Title 18 RCW; or

(b) Military personnel providing health care within the state regardless of licensure.

(16) "Health care services to the patient" means treatment, consultation, or intervention for patient care.

(17) "Health carrier" means a disability insurer regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, or a health maintenance organization as defined in RCW 48.46.020.

(18) "HIV testing" means conducting a laboratory test or sequence of tests to detect the human immunodeficiency virus (HIV) or antibodies to HIV performed in accordance with requirements to WAC 246-100-207. To assure that the protection, including, but not limited to, pre- and post-test counseling, consent, and confidentiality afforded to HIV testing as described in chapter 246-100 WAC also applies to the enumeration of CD4+(T4) lymphocyte counts (CD4+ counts) and CD4+ (T4) percents of total lymphocytes (CD4+ percents) when used to diagnose HIV infection, CD4+ counts and CD4+ percents will be presumed HIV testing except when shown by clear and convincing evidence to be for use in the following circumstances:

(a) Monitoring previously diagnosed infection with HIV;

(b) Monitoring organ or bone marrow transplants;

(c) Monitoring chemotherapy;

(d) Medical research; or

(e) Diagnosis or monitoring of congenital immunodeficiency states or autoimmune states not related to HIV.

The burden of proving the existence of one or more of the circumstances identified in (a) through (e) of this subsection shall be on the person asserting the existence.

(19) "Immediately notifiable condition" means a notifiable condition of urgent public health importance, a case or suspected case of which must be reported to the local health officer or the department immediately at the time of diagnosis or suspected diagnosis.

(20) "Infection control measures" means the management of infected persons, or of a person suspected to be infected, and others in a manner to prevent transmission of the infectious agent.

(21) "Institutional review board" means any board, committee, or other group formally designated by an institution, or authorized under federal or state law, to review, approve the initiation of, or conduct periodic review of research programs to assure the protection of the rights and welfare of human research subjects as defined in RCW 70.02.010.

(22) "Isolation" means the separation or restriction of activities of infected individuals, or of persons suspected to be infected, from other persons to prevent transmission of the infectious agent.

(23) "Laboratory" means any facility licensed as a medical test site under chapter 70.42 RCW.

(24) "Laboratory director" means the director or manager, by whatever title known, having the administrative responsibility in any licensed medical test site.

(25) "Local health department" means the city, town, county, or district agency providing public health services to persons within the area, established under chapters 70.05, 70.08, and 70.46 RCW.

(26) "Local health officer" means the individual having been appointed under chapter 70.05 RCW as the health officer for the local health department, or having been appointed under chapter 70.08 RCW as the director of public health of a combined city-county health department.

(27) "Member of the general public" means any person present within the boundary of the state of Washington.

(28) "Monthly notifiable condition" means a notifiable condition which must be reported to the local health officer or department within one month of diagnosis.

(29) "Nosocomial infection" means an infection acquired in a hospital or other health care facility.

(30) "Notifiable condition" means a disease or condition of public health importance, a case of which, and for certain diseases, a suspected case of which, must be brought to the attention of the local health officer or the state health officer.

(31) "Other rare diseases of public health significance" means a disease or condition, of general public health concern, which is occasionally or not ordinarily seen in the state of Washington including, but not limited to, viral hemorrhagic fevers, Rocky Mountain Spotted fever, and other tick borne diseases. This also includes a communicable disease that would be of general public concern if detected in Washington.

(32) "Outbreak" means the occurrence of cases of a disease or condition in any area over a given period of time in excess of the expected number of cases.

(33) "Patient" means a case, suspected case, or contact.

(34) "Pesticide poisoning" means the disturbance of function, damage to structure, or illness in humans resulting from the inhalation, absorption, ingestion of, or contact with any pesticide.

(35) "Principal health care provider" means the attending health care provider recognized as primarily responsible for diagnosis or treatment of a patient, or in the absence of such, the health care provider initiating diagnostic testing or treatment for the patient.

(36) "Public health authorities" means local health departments, the state health department, and the department of labor and industries personnel charged with administering provisions of this chapter.

(37) "Quarantine" means the separation or restriction on activities of an individual having been exposed to or infected with an infectious agent, to prevent disease transmission.

(38) "School" means a facility for programs of education as defined in RCW 28A.210.070 (preschool and kindergarten through grade twelve).

(39) "Sexually transmitted disease (STD)" means a bacterial, viral, fungal, or parasitic disease or condition which is usually transmitted through sexual contact, including:

(a) Acute pelvic inflammatory disease;

(b) Chancroid;

(c) Chlamydia trachomatis infection;

(d) Genital and neonatal Herpes simplex;

(e) Genital human papilloma virus infection;

(f) Gonorrhea;

(g) Granuloma inguinale;

(h) Hepatitis B infection;

(i) Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS);

(j) Lymphogranuloma venereum;

(k) Nongonococcal urethritis (NGU); and

(l) Syphilis.

(40) "State health officer" means the person designated by the secretary of the department to serve as state-wide health officer, or, in the absence of this designation, the person having primary responsibility for public health matters in the state.

(41) "Suspected case" means a person whose diagnosis is thought likely to be a particular disease or condition with suspected diagnosis based on signs and symptoms, laboratory evidence, or both.

(42) "Third-party payor" means an insurer regulated under Title 48 RCW authorized to transact business in this state or other jurisdiction, including a health care service contractor, and health maintenance organization; or an employee welfare benefit plan; or a state or federal health benefit program as defined in RCW 70.02.010.

(43) "Unexplained critical illness or death" means cases of illness or death with infectious hallmarks but no known etiology, in previously healthy persons one to forty-nine years of age excluding those with chronic medical conditions (e.g., malignancy, diabetes, AIDS, cirrhosis).

(44) "Veterinarian" means an individual licensed under provisions of chapter 18.92 RCW, Veterinary medicine, surgery, and dentistry and practicing animal health care.

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This section describes how conditions can become notifiable; what period of time conditions are provisionally notifiable; what analyses must be accomplished during provisional notification status; the transition of provisionally notifiable conditions to permanent notification or deletion of notification requirements. The department's goal for provisionally notifiable conditions is to collect enough information to determine whether requiring notification improves public health.

(1) The state health officer may:

(a) Request reporting of cases and suspected cases of disease and conditions in addition to those required in Tables HC-1, Lab-1, and HF-1 on a provisional basis for a period of time less than forty-eight months when:

(i) The disease or condition is newly recognized or recently acknowledged as a public health concern;

(ii) Epidemiological investigation based on notification of cases may contribute to understanding of the disease or condition;

(iii) There is reason to expect that the information acquired through notification will assist the state and/or local health department to design or implement intervention strategies that will result in an improvement in public health; and

(iv) Written notification is provided to all local health officers regarding:

(A) Additional reporting requirements; and

(B) Rationale or justification for specifying the disease or condition as notifiable.

(b) Request laboratories to submit specimens indicative of infections in addition to those required in Table Lab-1 on a provisional basis for a period of time less than forty-eight months, if:

(i) The infection is of public health concern;

(ii) The department has a plan for using data gathered from the specimens; and

(iii) Written notification is provided to all local health officers and all laboratory directors explaining:

(A) Actions required; and

(B) Reason for the addition.

(2) Within forty months of the state health officer's designation of a condition as provisionally notifiable in subsection (1) of this section, or requests for laboratories to submit specimens indicative of infections in subsection (2) of this section, the department will conduct an evaluation for the notification requirement that:

(a) Estimates the societal cost resulting from the provisionally notifiable condition;

(i) Determine the prevalence of the provisional notifiable condition; and

(ii) Identify the quantifiable costs resulting from the provisionally notifiable condition; and

(iii) Discuss the qualitative costs resulting from the provisionally notifiable condition.

(b) Describes how the information was used and how it will continue to be used to design and implement intervention strategies aimed at combating the provisionally notifiable condition;

(c) Verifies the effectiveness of previous intervention strategies at reducing the incidence, morbidity, or mortality of the provisional notifiable condition;

(d) Identifies the quantitative and qualitative costs of the provisional notification requirement;

(e) Compares the costs of the provisional notification requirement with the estimated cost savings resulting from the intervention based on the information provided through the provisional notification requirement;

(f) Describes the effectiveness and utility of using the notifiable conditions process as a mechanism to collect these data; and

(g) Describes that a less burdensome data collection system (example: biennial surveys) would not provide the information needed to effectively establish and maintain the intervention strategies.

(3) Based upon the evaluation in subsection (2) of this section, the board will assess results of the evaluation after the particular condition is notifiable or the requirement for laboratories to submit specimens indicative of infections has been in place for forty months. The board will determine based upon the results of the evaluation whether the provisionally notifiable condition or the requirement for laboratories to submit specimens indicative of infections should be:

(a) Permanently notifiable in the same manner as the provisional notification requirement;

(b) Permanently notifiable in a manner that would use the evaluation results to redesign the notification requirements; or

(c) Deleted from the notifiable conditions system.

(4) The following conditions are provisionally notifiable through the date indicated:

(a) Autism (through August, 2004);

(b) Cerebral palsy (through August, 2004);

(c) Fetal alcohol syndrome/Fetal alcohol effects (through August, 2004);

(d) Hepatitis B, chronic - Initial diagnosis, and previously unreported prevalent cases (through August, 2004);

(e) Hepatitis C - Initial diagnosis, and previously unreported prevalent cases (through August, 2004);

(f) Herpes simplex (initial genital infection, only) (through August, 2004); and

(g) Streptococcus, Group A (invasive disease only - indicated by blood, spinal fluid or other normally sterile site) (through August, 2004).

(5) The department shall have the authority to declare an emergency and institute notification requirements under the provisions of RCW 34.05.350.

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This section describes the conditions that Washington's health care providers must notify public health authorities of on a state-wide basis. The board finds that the conditions in the table below (Table HC-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions in Washington. Principal health care providers shall notify public health authorities of these conditions as individual case reports using procedures described throughout this chapter. Other health care providers in attendance shall notify public health authorities of the following notifiable conditions, unless the condition notification has already been made. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

WAC 246-101-105, 246-101-110, 246-101-115, and 246-101-120 also include requirements for how notifications shall be made, when they shall be made, the content of these notifications, and how information regarding notifiable conditions cases must be handled and may be disclosed.

Table HC-1 (Conditions Notifiable by Health Care Providers)

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Health care providers shall:

(1) Notify the local health department where the patient resides (in the event that patient residence cannot be determined, notify the local health department where the health care providers practice) regarding:

(a) Cases or suspected cases of notifiable conditions specified as notifiable to local health departments in Table HC-1;

(b) Cases of conditions designated as notifiable by the local health officer within that health officer's jurisdiction;

(c) Outbreaks or suspected outbreaks of disease. These patterns include, but are not limited to, suspected or confirmed outbreaks of chickenpox, influenza, viral meningitis, nosocomial infection suspected due to contaminated food products or devices, or environmentally related disease;

(d) Known barriers which might impede or prevent compliance with orders for infection control or quarantine; and

(e) Name, address, and other pertinent information for any case, suspected case or carrier refusing to comply with prescribed infection control measures.

(2) Notify the department of health of conditions designated as notifiable to the local health department when:

(a) A local health department is closed or representatives of the local health department are unavailable at the time a case or suspected case of an immediately notifiable condition occurs;

(b) A local health department is closed or representatives of the local health department are unavailable at the time an outbreak or suspected outbreak of communicable disease occurs.

(3) Notify the department of pesticide poisoning that is fatal, causes hospitalization or occurs in a cluster.

(4) Notify the department as specified in Table HC-1 regarding cases of notifiable conditions specified as notifiable to the department.

(5) Assure that positive cultures and preliminary test results for notifiable conditions of specimens referred to laboratories outside of Washington for testing are correctly notified to the local health department of the patient's residence or the department as specified in Table Lab-1. This requirement can be satisfied by:

(a) Arranging for the referral laboratory to notify either the local health department, the department, or both; or

(b) Forwarding the notification of the test result from the referral laboratory to the local health department, the department, or both.

(6) Cooperate with public health authorities during investigation of:

(a) Circumstances of a case or suspected case of a notifiable condition or other communicable disease; and

(b) An outbreak or suspected outbreak of disease.

(7) Provide adequate and understandable instruction in disease control measures to each patient who has been diagnosed with a case of a communicable disease, and to contacts who may have been exposed to the disease.

(8) Maintain responsibility for deciding date of discharge for hospitalized tuberculosis patients.

(9) Notify the local health officer of intended discharge of tuberculosis patients in order to assure appropriate outpatient arrangements are arranged.

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(1) Conditions designated as:

(a) Immediately notifiable must be reported by telephone or by secure facsimile copy of a written case report to the local health officer or the department as specified in Table HC-1;

(b) Notifiable within three working days must be reported by written case report or secure facsimile copy to the local health officer or department as specified in Table HC-1; and

(c) Notifiable on a monthly basis must be reported by written case report or secure facsimile copy to the local health officer or the department as specified in Table HC-1.

(2) The local health officer may authorize notifications by telephone or secure electronic transmission for cases and suspected cases of notifiable conditions specified as notifiable to local health departments.

(3) The state health officer may authorize notifications by telephone or secure electronic transmission for cases and suspected cases of notifiable conditions specified as notifiable to the department.

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(1) For each condition listed in Table HC-1, health care providers must provide the following information for each case or suspected case:

(a) Name;

(b) Address;

(c) Telephone number;

(d) Date of birth;

(e) Sex;

(f) Diagnosis or suspected diagnosis of disease or condition;

(g) Pertinent laboratory data, if available;

(h) Name and address or telephone number of the principal health care provider;

(i) Name and address or telephone number of the person providing the report; and

(j) Other information as the department may require on forms generated by the department.

(2) The local health officer or state health officer may require other information of epidemiological or public health value.

(3) The department may exempt health care providers from reporting responsibilities under this chapter for conditions notifiable within three work days and monthly notifiable conditions if:

(a) A standard electronic data interchange occurs between the health carrier or third-party payor, or the health information clearinghouse and the data interchange consists of a standard electronic claims form approved for use by regulation of the United States Department of Health and Human Services;

(b) The department has developed the capacity to receive copies of the standard electronic claims form;

(c) The health care provider has arranged for the health carrier or third-party payor, or the health information clearinghouse to deliver a copy of the standard electronic claims form to the department;

(d) The information for each case or suspected case includes substantially the same information described in subsection (1) of this section; and

(e) The information is received by the department within time periods specified in WAC 246-101-110.

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(1) All records and specimens containing or accompanied by patient identifying information are confidential.

(2) Health care providers who know of a person with a notifiable condition, other than a sexually transmitted disease, shall release identifying information only to other individuals responsible for protecting the health and well-being of the public through control of disease.

(3) Health care providers with knowledge of a person with sexually transmitted disease, and following the basic principles of health care providers, which respect the human dignity and confidentiality of patients:

(a) May disclose identity of a person or release identifying information only as specified in RCW 70.24.105; and

(b) Shall under RCW 70.24.105(6), use only the following customary methods for exchange of medical information:

(i) Health care providers may exchange medical information related to HIV testing, HIV test results, and confirmed HIV or confirmed STD diagnosis and treatment in order to provide health care services to the patient. This means that information shared impacts the care or treatment decisions concerning the patient; and the health care provider requires the information for the patient's benefit.

(ii) Health care providers responsible for office management are authorized to permit access to a patient's medical information and medical record by medical staff or office staff to carry out duties required for care and treatment of a patient and the management of medical information and the patient's medical record.

(c) Health care providers conducting a clinical HIV research project shall report the identity of an individual participating in the project unless:

(i) The project has been approved by an institutional review board; and

(ii) The project has a system in place to remind referring health care providers of their reporting obligations under this chapter.

(4) Health care providers shall establish and implement policies and procedures to maintain confidentiality related to a patient's medical information.

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This section describes the conditions about which Washington's laboratories must notify public health authorities of on a state-wide basis. The board finds that the conditions in the table below (Table Lab-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions in Washington. The board also finds that submission of specimens for many of these conditions will further prevent the spread of disease. Laboratory directors shall notify public health authorities of positive cultures and preliminary test results as individual case reports and provide specimen submissions using procedures described throughout this chapter. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

WAC 246-101-205, 246-101-210, 246-101-215, 246-101-220, 246-101-225, and 246-101-230 also include requirements for how notifications and specimen submissions are made, when they are made, the content of these notifications and specimen submissions, and how information regarding notifiable conditions cases must be handled and may be disclosed.

Table Lab-1 (Conditions Notifiable by Laboratory Directors)

Additional notifications that are requested but not mandatory include:

(1) Laboratory directors may notify either local health departments or the department or both of other laboratory results including hepatitis B and hepatitis C through cooperative agreement.

(2) Laboratory directors may submit malaria cultures to the state public health laboratories.

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Laboratory directors shall:

(1) Notify the local health department where the patient resides (in the event that patient residence cannot be determined, notify the local health department where the laboratory is located) regarding:

(a) Positive cultures and preliminary test results of notifiable conditions specified as notifiable to the local health department in Table Lab-1.

(b) Positive cultures and preliminary test results of conditions specified as notifiable by the local health officer within that health officer's jurisdiction.

(2) If the laboratory is unable to determine the local health department of the patient's residence, the laboratory director shall notify the local health department in which the health care provider that ordered the laboratory test is located.

(3) Notify the department of health of conditions designated as notifiable to the local health department when:

(a) A local health department is closed or representatives of the local health department are unavailable at the time a positive culture or preliminary test results of an immediately notifiable condition occurs;

(b) A local health department is closed or representatives of the local health department are unavailable at the time an outbreak or suspected outbreak of communicable disease occurs.

(4) Notify the department of positive cultures and preliminary test results for conditions designated notifiable to the department in Table Lab-1.

(5) Notify the department of nonelevated blood lead levels on a monthly basis.

(6) Submit specimens for conditions noted in Table Lab-1 to the Washington state public health laboratories or other laboratory designated by the state health officer for diagnosis, confirmation, storage, or further testing.

(7) Ensure that positive cultures and preliminary test results for notifiable conditions of specimens referred to other laboratories for testing are correctly notified to the correct local health department or the department. This requirement can be satisfied by:

(a) Arranging for the referral laboratory to notify either the local health department, the department, or both; or

(b) Forwarding the notification of the test result from the referral laboratory to the local health department, the department, or both.

(8) Cooperate with public health authorities during investigation of:

(a) Circumstances of a case or suspected case of a notifiable condition or other communicable disease; and

(b) An outbreak or suspected outbreak of disease.

(9) Laboratory directors may designate responsibility for working and cooperating with public health authorities to certain employees as long as designated employees are:

(a) Readily available; and

(b) Able to provide requested information in a timely manner.

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Required laboratory specimen submissions as outlined in Table Lab-1 shall be forwarded within two days. Laboratories shall follow the procedures below in submitting specimens:

(1) Laboratories located in King County shall forward required specimen submissions (except tuberculosis cultures) to:

Public Health Seattle and King County - Laboratory

325 9th Avenue

Box 359973

Seattle, WA 98104-2499

(2) Laboratories located in King County shall forward required tuberculosis cultures to:

Washington State Public Health Laboratories

Washington State Department of Health

1610 NE 150th Street

Seattle, WA 98155

(3) Laboratories located outside of King County shall forward all required specimen submissions to:

Washington State Public Health Laboratories

Washington State Department of Health

1610 NE 150th Street

Seattle, WA 98155

(4) The state health officer may designate additional laboratories as public health referral laboratories.

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For each condition listed in Table Lab-1, laboratory directors must provide the following information with each specimen submission:

(1) Type of specimen tested;

(2) Name of reporting laboratory;

(3) Telephone number of reporting laboratory;

(4) Date specimen collected;

(5) Requesting health care provider's name;

(6) Requesting health care provider's phone number or address, or both;

(7) Test result;

(8) Name of patient (if available), or patient identifier otherwise;

(9) Sex of patient (if available);

(10) Date of birth of patient (if available);

(11) Address of patient (if available);

(12) Telephone number of patient (if available);

(13) Other information of epidemiological value (if available).

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(1) Conditions designated as:

(a) Notifiable within two days must be reported by written case report or secure facsimile copy to the local health officer or the department as specified in Table Lab-1 within two working days; and

(b) Notifiable on a monthly basis must be reported by written case report or secure facsimile copy to the local health officer or the department as specified in Table Lab-1.

(2) The local health officer may authorize notifications by telephone or secure electronic transmission for cases and suspected cases of notifiable conditions specified as notifiable to local health departments.

(3) The state health officer may authorize notifications by telephone or secure electronic transmission for cases and suspected cases of notifiable conditions specified as notifiable to the department.

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(1) For each condition listed in Table Lab-1, laboratory directors must provide the following information for each positive culture or suggestive test result:

(a) Type of specimen tested;

(b) Name of reporting laboratory;

(c) Telephone number of reporting laboratory;

(d) Date specimen collected;

(e) Date specimen received by reporting laboratory;

(f) Requesting health care provider's name;

(g) Requesting health care provider's phone number or address, or both;

(h) Test result;

(i) Name of patient (if available), or patient identifier otherwise;

(j) Sex of patient (if available);

(k) Date of birth or age of patient (if available); and

(l) Other information of epidemiological value (if available).

(2) Local health officers and the state health officer may require laboratory directors to report other information of epidemiological or public health value.

(3) The department may exempt health care providers from reporting responsibilities under this chapter for conditions notifiable within three work days and monthly notifiable conditions if:

(a) A standard electronic data interchange occurs between the health carrier or third-party payor or the health information clearinghouse and the data interchange consists of a standard electronic claims form approved for use by regulation of the United States Department of Health and Human Services;

(b) The department has developed the capacity to receive copies of the standard electronic claims form;

(c) The health care provider has arranged for the health carrier or third-party payor or the health information clearinghouse to deliver a copy of the standard electronic claims form to the department;

(d) The information for each case or suspected case includes substantially the same information described in subsection (1) of this section; and

(e) The information is received by the department within time periods specified in WAC 246-101-220.

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(1) All records and specimens containing or accompanied by patient identifying information are confidential. The Washington state public health laboratories, other laboratories approved as public health referral laboratories, and any persons, institutions, or facilities submitting specimens or records containing patient-identifying information shall maintain the confidentiality of identifying information accompanying submitted laboratory specimens.

(2) Laboratory directors shall establish and implement policies and procedures to maintain confidentiality related to a patient's medical information.

(3) Laboratory directors and personnel working in laboratories who know of a person with a notifiable condition, other than a sexually transmitted disease, shall release identifying information only to other individuals responsible for protecting the health and well-being of the public through control of disease.

(4) Laboratory directors and personnel working in laboratories with knowledge of a person with sexually transmitted disease, and following the basic principles of health care providers, which respect the human dignity and confidentiality of patients:

(a) May disclose identity of a person or release identifying information only as specified in RCW 70.24.105; and

(b) Shall under RCW 70.24.105(6), use only the following customary methods for exchange of medical information:

(i) Laboratory directors and personnel working in laboratories may exchange medical information related to HIV testing, HIV test results, and confirmed HIV or confirmed STD diagnosis and treatment in order to provide health care services to the patient. This means that information shared impacts the care or treatment decisions concerning the patient; and the laboratory director or personnel working in the laboratory requires the information for the patient's benefit.

(ii) Laboratory directors are authorized to permit access to a patient's medical information and medical record by laboratory staff or office staff to carry out duties required for care and treatment of a patient and the management of medical information and the patient's medical record.

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This section describes the conditions that Washington's health care facilities must notify public health authorities of on a state-wide basis. The board finds that the conditions in the table below (Table HF-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction. Health care facilities are required to notify public health authorities of cases that occur in their facilities. Health care facilities may choose to assume the notification for their health care providers for conditions designated in Table HF-1. Health care facilities may not assume the reporting requirements of laboratories that are components of the health care facility. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

WAC sections 246-101-305, 246-101-310, 246-101-315, and 246-101-320 also include requirements for how notifications shall be made, when they are made, the content of these notifications, and how information regarding notifiable conditions cases must be handled and may be disclosed.

Table HF-1 (Conditions Notifiable by Health Care Facilities)

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Health care facilities shall:

(1) Notify the local health department where the patient resides (in the event that patient residence cannot be determined, notify the local health department where the health care facility is located) regarding:

(a) Cases of notifiable conditions specified as notifiable to the local health department in Table HF-1 that occur or are treated in the health care facility.

(b) Cases of conditions specified as notifiable by the local health officer within that health officer's jurisdiction that occur or are treated in the health care facility.

(c) Suspected cases of notifiable conditions for conditions that are designated immediately notifiable that occur or are treated in the health care facility.

(d) Outbreaks or suspected outbreaks of disease that occur or are treated in the health care facility. These patterns include, but are not limited to, suspected or confirmed outbreaks of chickenpox, influenza, viral meningitis, nosocomial infection suspected due to contaminated products or devices, or environmentally related disease. Reports of outbreaks and suspected outbreaks of disease are to be made to the local health officer.

(e) Known barriers which might impede or prevent compliance with orders for infection control or quarantine; and

(f) Name, address, and other pertinent information for any case, suspected case or carrier refusing to comply with prescribed infection control measures.

(2) Notify the department of health of conditions designated as notifiable to the local health department when:

(a) A local health department is closed or representatives of the local health department are unavailable at the time a case or suspected case of an immediately notifiable condition occurs;

(b) A local health department is closed or representatives of the local health department are unavailable at the time an outbreak or suspected outbreak of communicable disease occurs.

(3) Notify the department as specified in Table HF-1 regarding cases of notifiable conditions specified as notifiable to the department.

(4) Notify the department of cancer incidence as required by chapter 246-430 WAC.

(5) Ensure that positive cultures and preliminary test results for notifiable conditions of specimens referred to laboratories outside of Washington for testing are correctly notified to the correct local health department as specified in Table Lab-1. This requirement can be satisfied by:

(a) Arranging for the referral laboratory to notify either the local health department, the department, or both; or

(b) Receiving the test result from the referral laboratory, and forwarding the notification to the local health department, the department, or both.

(6) Cooperate with public health authorities during investigation of:

(a) Circumstances of a case or suspected case of a notifiable condition or other communicable disease; and

(b) An outbreak or suspected outbreak of disease.

(7) Provide adequate and understandable instruction in disease control measures to each patient who has been diagnosed with a case of a communicable disease, and to contacts who may have been exposed to the disease.

(8) Maintain an infection control program as described in WAC 246-320-265.

(9) Health care facilities may assume the burden of notification for health care providers practicing within the health care facility where more than one health care provider is in attendance for a patient with a notifiable condition.

(10) Health care facilities may not assume the burden of notification for laboratories within the health care facility. Laboratories within a health care facility must submit specimens to the Washington state public health laboratories and notify public health authorities of notifiable conditions as specified in Table Lab-1.

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(1) Conditions designated as:

(a) Immediately notifiable must be reported by telephone or by secure facsimile copy of a written case report to the local health officer or the department as specified in Table HF-1;

(b) Notifiable within three working days must be reported by written case report or secure facsimile copy to the local health officer or department as specified in Table HF-1; and

(c) Notifiable on a monthly basis must be reported by written case report or secure facsimile copy to the local health officer or the department as specified in Table HF-1.

(2) The local health officer may authorize notifications by telephone or secure electronic transmission for cases and suspect cases of notifiable conditions specified as notifiable to local health departments.

(3) The state health officer may authorize notifications by telephone or secure electronic transmission for cases and suspected cases of notifiable conditions specified as notifiable to the department.

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(1) For each condition listed in Table HF-1, health care facilities must provide the following information for each case or suspected case:

(a) Name;

(b) Address;

(c) Telephone number;

(d) Date of birth;

(e) Sex;

(f) Diagnosis or suspected diagnosis of disease or condition;

(g) Pertinent laboratory data (if available);

(h) Name and address or telephone number of the principal health care provider;

(i) Name and address or telephone number of the person providing the report; and

(j) Other information as the department may require on forms generated by the department.

(2) The local health officer or state health officer may require other information of epidemiological or public health value.

(3) The department may exempt health care facilities from reporting responsibilities under this chapter for conditions notifiable within three work days and monthly notifiable conditions if:

(a) A standard electronic data interchange occurs between the health carrier or third-party payor or the health information clearinghouse, and the data interchange consists of a standard electronic claims form approved for use by regulation of the United States Department of Health and Human Services;

(b) The department has developed the capacity to receive copies of the standard electronic claims form;

(c) The health care facility has arranged for the health carrier or third-party payor or the health information clearinghouse to deliver a copy of the standard electronic claims form to the department;

(d) The information for each case or suspected case includes substantially the same information described in subsection (1) of this section; and

(e) The information is received by the department within time periods specified in WAC 246-101-310.

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(1) All records and specimens containing or accompanied by patient identifying information are confidential.

(2) Personnel in health care facilities who know of a person with a notifiable condition, other than a sexually transmitted disease, shall release identifying information only to other individuals responsible for protecting the health and well-being of the public through control of disease.

(3) Personnel in health care facilities with knowledge of a person with sexually transmitted disease, and following the basic principles of health care providers, which respect the human dignity and confidentiality of patients:

(a) May disclose identity of a person or release identifying information only as specified in RCW 70.24.105; and

(b) Shall under RCW 70.24.105(6), use only the following customary methods for exchange of medical information:

(i) Health care providers may exchange medical information related to HIV testing, HIV test results, and confirmed HIV or confirmed STD diagnosis and treatment in order to provide health care services to the patient.

(ii) This means that information shared impacts the care or treatment decisions concerning the patient; and the health care provider requires the information for the patient's benefit.

(4) Personnel responsible for health care facility management are authorized to permit access to medical information as necessary to fulfill professional duties. Health care facility administrators shall advise those persons permitted access under this section of the requirement to maintain confidentiality of such information as defined under this section and chapter 70.24 RCW. Professional duties means the following or functionally similar activities:

(a) Medical record or chart audits;

(b) Peer reviews;

(c) Quality assurance;

(d) Utilization review purposes;

(e) Research as authorized under chapters 42.48 and 70.02 RCW;

(f) Risk management; and

(g) Reviews required under federal or state law or rules.

(5) Personnel responsible for health care facility management are authorized to permit access to a patient's medical information and medical record by medical staff or health care facility staff to carry out duties required for care and treatment of a patient and the management of medical information and the patient's medical record.

(6) Health care facilities conducting a clinical HIV research project shall report the identity of an individual participating in the project unless:

(a) The project has been approved by an institutional review board; and

(b) The project has a system in place to remind referring health care providers of their reporting obligations under this chapter.

(7) Health care facilities shall establish and implement policies and procedures to maintain confidentiality related to a patient's medical information.

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WAC 246-101-405, 246-101-410, 246-101-415, 246-101-420, and 246-101-425 describe the responsibilities and duties of veterinarians, food service establishments, child day care centers, schools, and the general public regarding notifiable conditions and their obligations to cooperate with public health authorities during the investigation of cases, suspected cases, outbreaks and suspected outbreaks.

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Veterinarians shall:

(1) Notify the local health officer of any suspected case or suspected outbreak of any disease listed in Table HC-1 that is transmissible from animals to humans. Examples of these zoonotic diseases include:

(a) Anthrax;

(b) Brucellosis;

(c) Encephalitis, viral;

(d) Plague;

(e) Rabies;

(f) Psittacosis;

(g) Tuberculosis; and

(h) Tularemia.

(2) Cooperate with public health authorities in the investigation of cases and suspected cases, or outbreaks and suspected outbreaks of zoonotic disease.

(3) Cooperate with public health authorities in the implementation of infection control measures including isolation and quarantine.

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The person in charge of a food service establishment shall:

(1) Notify the local health department of potential foodborne disease as required in WAC 246-215-260.

(2) Cooperate with public health authorities in the investigation of cases and suspected cases, or outbreaks and suspected outbreaks of foodborne or waterborne disease. This includes the release of the name and other pertinent information about food handlers diagnosed with a communicable disease as it relates to a foodborne or waterborne disease investigation.

(3) Not release information about food handlers with a communicable disease to other employees or the general public.

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Child day care facilities shall:

(1) Notify the local health department of cases or suspected cases, or outbreaks and suspected outbreaks of notifiable conditions that may be associated with the child day care facility.

(2) Consult with a health care provider or the local health department for information about the control and prevention of infectious or communicable disease, as necessary.

(3) Cooperate with public health authorities in the investigation of cases and suspected cases, or outbreaks and suspected outbreaks of disease that may be associated with the child day care facility.

(4) Child day care facilities shall establish and implement policies and procedures to maintain confidentiality related to medical information in their possession.

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Schools shall:

(1) Notify the local health department of cases or suspected cases, or outbreaks and suspected outbreaks of disease that may be associated with the school.

(2) Cooperate with the local health department in monitoring influenza.

(3) Consult with a health care provider or the local health department for information about the control and prevention of infectious or communicable disease, as necessary.

(4) Cooperate with public health authorities in the investigation of cases and suspected cases, or outbreaks and suspected outbreaks of disease that may be associated with the school.

(5) Personnel in schools who know of a person with a notifiable condition shall release identifying information only to other individuals responsible for protecting the health and well-being of the public through control of disease.

(6) Schools shall establish and implement policies and procedures to maintain confidentiality related to medical information in their possession.

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(1) Members of the general public shall:

(a) Cooperate with public health authorities in the investigation of cases and suspected cases, or outbreaks and suspected outbreaks of notifiable conditions or other communicable diseases; and

(b) Cooperate with the implementation of infection control measures, including isolation and quarantine.

(2) Members of the general public may notify the local health department of any case or suspected case, or outbreak or potential outbreak of communicable disease.

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This section describes the authorities and responsibilities of local health officers and local health departments in collecting, analyzing, investigating and transmitting case information from notifiable conditions case reports.

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Local health officers or the local health department shall:

(1) Review and determine appropriate action for:

(a) Each reported case or suspected case of a notifiable condition;

(b) Any disease or condition considered a threat to public health;

(c) Each reported outbreak or suspected outbreak of disease, requesting assistance from the department in carrying out investigations when necessary; and

(d) Instituting disease prevention and infection control, isolation, detention, and quarantine measures necessary to prevent the spread of communicable disease, invoking the power of the courts to enforce these measures when necessary.

(2) Establish a system at the local health department for maintaining confidentiality of written records and written and telephoned notifiable conditions case reports;

(3) Notify health care providers, laboratories, and health care facilities within the jurisdiction of the health department of requirements in this chapter;

(4) Notify the department of cases of any condition notifiable to the local health department (except animal bites) upon completion of the case investigation;

(5) Distribute appropriate notification forms to persons responsible for reporting;

(6) Notify the principal health care provider:

(a) If possible, prior to initiating a case investigation by the local health department; and

(b) For HIV infection, not contact the HIV-infected person directly without considering the recommendations of the principal health care provider on the necessity and best means for conducting the case investigation, unless:

(i) The principal health care provider cannot be identified; or

(ii) Reasonable efforts to reach the principal health care provider over a two-week period of time have failed;

(7) Allow laboratories to contact the health care provider ordering the diagnostic test before initiating patient contact if requested and the delay is unlikely to jeopardize public health;

(8) Conduct investigations and institute control measures consistent with those indicated in the seventeenth edition, 2000 of Control of Communicable Diseases Manual, edited by James Chin, published by the American Public Health Association (copy is available for review at the department and at each local health department), except:

(a) When superseded by more up-to-date measures; or

(b) When other measures are more specifically related to Washington state;

(9) The local health department may receive data through any cooperative relationship negotiated by the local health department and any health care provider, laboratory, or health care facility;

(10) Each local health officer has the authority to:

(a) Carry out additional steps determined to be necessary to verify a diagnosis reported by a health care provider;

(b) Require any person suspected of having a reportable disease or condition to submit to examinations required to determine the presence of the disease or condition;

(c) Investigate any case or suspected case of a reportable disease or condition or other illness, communicable or otherwise, if deemed necessary;

(d) Require the notification of additional conditions of public health importance occurring within the jurisdiction of the local health officer.

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Local health departments shall:

(1) Notify the department immediately by telephone or secure electronic data transmission of any notification of a case or suspected case of:

(a) Botulism;

(b) Cholera;

(c) Disease of suspected bioterrorism origin (examples: Anthrax, plague, smallpox);

(d) Hemolytic uremic syndrome;

(e) Measles;

(f) Paralytic shellfish poisoning;

(g) Poliomyelitis; and

(h) Unexplained critical illness or death.

(2) Immediate notifications of cases and suspected cases must include:

(a) Name;

(b) Condition; and

(c) Onset date.

(3) Notify the department immediately by telephone or secure electronic data transmission of any notification of an outbreak or suspected outbreak of foodborne or waterborne or other communicable disease.

(4) For outbreaks or suspected outbreaks of foodborne or waterborne disease, notifications must include:

(a) Organism or suspected organism;

(b) Source or suspected source; and

(c) Number of persons affected.

(5) Submit a written case report either on a form provided by the department or in a format approved by the department for each case of any condition notifiable to the local health department, except animal bites, within seven days of completing the case investigation. The department may waive this requirement if telephone or secure electronic data transmission provided pertinent information.

(6) Local health officials will report asymptomatic HIV infection cases to the department according to a standard code developed by the department.

(7) For any case not immediately notifiable to the department forward pertinent information collected on the case investigation for each case of any condition notifiable to the local health department to the department if the case investigation is not complete within twenty-one days of notification, including:

(a) Name;

(b) Condition or suspected condition;

(c) Source or suspected source; and

(d) Onset date.

(8) Submit a written report on forms provided by the department or in a format approved by the department for an outbreak of any notifiable condition within seven days of completing the investigation. The department may waive this requirement if telephone or secure electronic data transmission provided pertinent information.

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(1) Local health officers or local health departments shall establish and maintain confidentiality procedures related to employee handling of all reports of cases and suspected cases, prohibiting disclosure of report information identifying an individual case or suspected cases except:

(a) To employees of the local health department, or other official agencies needing to know for the purpose of administering public health laws and these regulations;

(b) To health care providers, specific designees of health care facilities, laboratory directors, and others for the purpose of collecting additional information about a case or suspected case as required for disease prevention and control;

(2) Local health officers shall require and maintain signed confidentiality agreements with all health department employees with access to identifying information related to a case or suspected case of a person diagnosed with a notifiable condition. The agreements will be renewed at least annually and will include reference to criminal and civil penalties for violation of chapters 70.02 and 70.24 RCW and other administrative actions that may be taken by the local health department.

(3) Local health departments may release statistical summaries and epidemiological studies based on individual case reports if no individual is identified or identifiable.

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(1) The local health officer and local health department personnel shall maintain individual case reports for AIDS and HIV as confidential records consistent with the requirements of this section. The local health officer and local health department personnel shall:

(a) Use identifying information on HIV-infected individuals only:

(i) For purposes of contacting the HIV-positive individual to provide test results and post-test counseling; or

(ii) To contact persons who have experienced substantial exposure, including sex and injection equipment-sharing partners, and spouses; or

(iii) To link with other name-based public health disease registries when doing so will improve ability to provide needed care services and counseling and disease prevention.

(b) Destroy case report identifying information on asymptomatic HIV-infected individuals received as a result of this chapter within three months of receiving a complete case report.

(c) Destroy documentation of referral information established in WAC 246-100-072 and this subsection containing identities and identifying information on HIV-infected individuals and at-risk partners of those individuals immediately after notifying partners or within three months, whichever occurs first.

(d) Not disclose identifying information received as a result of this chapter unless:

(i) Explicitly and specifically required to do so by state or federal law; or

(ii) Authorized by written patient consent.

(2) Local health department personnel are authorized to use HIV identifying information obtained as a result of this chapter only for the following purposes:

(a) Notification of persons with substantial exposure, including sexual or syringe-sharing partners;

(b) Referral of the infected individual to social and health services; and

(c) Linkage to other public health data bases, provided that the identity or identifying information on the HIV-infected person is not disclosed outside of the health department.

(3) Public health data bases do not include health professions licensing records, certifications or registries, teacher certification lists, other employment rolls or registries, or data bases maintained by law enforcement officials.

(4) Local health officials will report asymptomatic HIV infection cases to the state health department according to a standard code developed by the state health department.

(5) Local health officers shall require and maintain signed confidentiality agreements with all health department employees with access to HIV identifying information. These agreements will be renewed at least annually and include reference to criminal and civil penalties for violation of chapter 70.24 RCW and other administrative actions that may be taken by the department.

(6) Local health officers shall investigate potential breaches of the confidentiality of HIV identifying information by health department employees. All breaches of confidentiality shall be reported to the state health officer or their designee for review and appropriate action.

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Local health departments shall:

(1) Maintain a surveillance system for influenza during the appropriate season which may include:

(a) Monitoring of excess school absenteeism;

(b) Sample check with health care providers, clinics, nursing homes, and hospitals regarding influenza-like illnesses; and

(c) Monitoring of workplace absenteeism and other mechanisms.

(2) Encourage submission of appropriate clinical specimens from a sample of patients with influenza-like illness to the Washington state public health laboratories or other laboratory approved by the state health officer.

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This section describes the authorities and responsibilities of the department of health in collecting, analyzing, investigation and transmitting case information from notifiable conditions case reports.

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The department shall:

(1) Provide consultation and technical assistance to local health departments and the department of labor and industries investigating notifiable conditions reports upon request.

(2) Provide consultation and technical assistance to health care providers, laboratories, health care facilities, and others required to make notifications to public health authorities of notifiable conditions upon request.

(3) Develop and distribute forms for the submission of notifiable conditions data to local health departments, health care providers, laboratories, health care facilities, and others required to make notifications to public health authorities of notifiable conditions.

(4) Maintain a twenty-four hour department telephone number for reporting notifiable conditions. That telephone number is (206) 361-2904.

(5) Develop routine data dissemination mechanisms that describe and analyze notifiable conditions case investigations and data. These may include annual and monthly reports and other mechanisms for data dissemination as developed by the department.

(6) Conduct investigations and institute control measures consistent with those indicated in the seventeenth edition, 2000 of Control of Communicable Diseases Manual, edited by James Chin, published by the American Public Health Association (copy is available for review at the department and at each local health department), except:

(a) When superseded by more up-to-date measures; or

(b) When other measures are more specifically related to Washington state.

(7) Document the known environmental, human, and or other variables associated with a case or suspected case of pesticide poisoning.

(8) Report the results of the pesticide investigation to the principal health care provider named in the case report form and to the local health officer in whose jurisdiction the exposure has occurred.

(9) The department may receive data for notifiable conditions or other diseases and conditions through any cooperative relationship negotiated by the department and any health care provider, laboratory, or health care facility.

(10) The department may consolidate reporting for notifiable conditions from any health care provider, laboratory, or health care facility, and relieve that health care provider, laboratory, or health care facility from reporting directly to each local health department, if the department can provide the report to the local health department within the same time as the local health department would have otherwise received it.

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(1) The state health officer or designee shall establish and maintain confidentiality procedures related to employee handling of all reports of cases and suspected cases, prohibiting disclosure of report information identifying an individual case or suspected cases except:

(a) To employees of the local health department, or other official agencies needing to know for the purpose of administering public health laws and these regulations.

(b) To health care providers, specific designees of health care facilities, laboratory directors, and others for the purpose of collecting additional information about a case or suspected case as required for disease prevention and control.

(2) The department shall require and maintain signed confidentiality agreements with all department employees, contractors, and others with access to identifying information related to a case or suspected case of a person diagnosed with a notifiable condition. These agreements will be renewed at least annually and include reference to criminal and civil penalties for violation of chapters 70.02 and 70.24 RCW and other administrative actions that may be taken by the department.

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The department shall:

(1) Distribute periodic epidemiological summary reports and an annual review of public health issues to local health officers and local health departments.

(2) Make available any data or other documentation in its possession for notifiable conditions reported directly to the department to local health officers or their designees upon execution of a data sharing agreement within two days of request.

(3) Distribute case reports for notifiable conditions designated as notifiable to the local health department received through standard electronic data interchange as described in WAC 246-101-115 and 246-101-315 immediately.

(4) Periodically distribute statistical summaries and epidemiological studies based on individual case reports if no individual is identified or identifiable.

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The department shall:

(1) Make notifiable conditions reports where the department of labor and industries has a lead role in conducting the case investigation available within twenty-four hours of receipt by the department.

(2) Make other data necessary to conduct case investigations or epidemiological summaries available within two days of a request from the department of labor and industries.

(3) Execute a data sharing agreement with the department of labor and industries prior to implementation of this chapter.

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Unless otherwise prohibited by law, the department shall make available any data in its possession in sharing data as described in WAC 246-101-615, 246-101-620, and 246-101-625.

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The department shall:

(1) Maintain a surveillance system for monitoring antibiotic resistant disease that may include:

(a) Development of a sentinel network of laboratories to provide information regarding antibiotic resistant disease; and

(b) Sample checks with health care providers, clinics, and hospitals regarding antibiotic resistant disease.

(2) Encourage submission of appropriate clinical specimens from a sample of patients with antibiotic resistant disease to the Washington state public health laboratories or other laboratory approved by the state health officer.

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The following provisions apply for the use of AIDS and HIV notifiable conditions case reports and data:

(1) Department personnel shall not disclose identifying information received as a result of receiving information regarding a notifiable conditions report of a case of AIDS or HIV unless:

(a) Explicitly and specifically required to do so by state or federal law; or

(b) Authorized by written patient consent.

(2) Department personnel are authorized to use HIV identifying information received as a result of receiving information regarding a notifiable conditions report of a case of AIDS or HIV only for the following purposes:

(a) Notification of persons with substantial exposure, including sexual or syringe-sharing partners;

(b) Referral of the infected individual to social and health services; and

(c) Linkage to other public health data bases, provided that the identity or identifying information on the HIV-infected person is not disclosed outside of the health department.

(3) For the purposes of this chapter, public health data bases do not include health professions licensing records, certifications or registries, teacher certification lists, other employment rolls or registries, or data bases maintained by law enforcement officials.

(4) The state health officer shall require and maintain signed confidentiality agreements with all department employees with access to HIV identifying information. These agreements will be renewed at least annually and include reference to criminal and civil penalties for violation of chapter 70.24 RCW and other administrative actions that may be taken by the department.

(5) The state health officer shall investigate potential breaches of the confidentiality of HIV identifying information by department employees. All breaches of confidentiality shall be reported to the state health officer or their authorized representative for review and appropriate action.

(6) When providing technical assistance to a local health department, authorized representatives of the department may temporarily and subject to the time limitations in WAC 246-101-525(2) receive the names of reportable cases of asymptomatic HIV infection for the purpose of HIV surveillance, partner notification, or special studies. Upon completion of the activities by representatives of the state health department, named information will be:

(a) Provided to the local health department subject to the provisions of WAC 246-101-525(2); and

(b) Converted to code and maintained as code only until the person is diagnosed with AIDS.

(7) Within twelve months of the effective date of the HIV infection notification system (by September 1, 2000), established in this chapter, the state health officer, in cooperation with local health officers, will report to the board on:

(a) The ability of the reporting system to meet surveillance performance standards established by the federal Centers for Disease Control and Prevention;

(b) The cost of the reporting system for state and local health departments;

(c) The reporting system's effect on disease control activities; and

(d) The impact of HIV reporting on HIV testing among persons at increased risk of HIV infection.

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The department shall enter into a data sharing agreement with the office of the superintendent of public instruction to access data from data bases maintained by the superintendent containing student health information for the purpose of identifying cases of autism or other conditions of public health interest.

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This section describes the authorities and responsibilities of the department of labor and industries in collecting, analyzing, investigating and transmitting case information from notifiable conditions case reports.

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(1) The department of labor and industries shall:

(a) Provide consultation and technical assistance to local health departments and the department investigating notifiable conditions reports;

(b) Provide consultation and technical assistance to health care providers, laboratories, health care facilities, and others required to make notifications to public health authorities of notifiable conditions upon request;

(c) Provide technical assistance to businesses and labor organizations for understanding the use of notifiable conditions data collected and analyzed by the department of labor and industries; and

(d) Develop routine data dissemination mechanisms that describe and analyze notifiable conditions case investigations and data. These may include annual and monthly reports and other mechanisms for data dissemination as developed by the department of labor and industries.

(2) The department of labor and industries may receive data through any cooperative relationship negotiated by the department of labor and industries and any health care provider, laboratory, or health care facility.

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(1) The department of labor and industries shall establish and maintain confidentiality procedures related to employee handling of all reports of cases and suspected cases, prohibiting disclosure of report information identifying an individual case or suspected cases except:

(a) To employees of the local health department, the department, or other official agencies needing to know for the purpose of administering public health laws and these regulations; and

(b) To health care providers, specific designees of health care facilities, laboratory directors, and others for the purpose of collecting additional information about a case or suspected case as required for occupational condition prevention and control.

(2) The department of labor and industries shall require and maintain signed confidentiality agreements with all employees, contractors, and others with access to identifying information related to a case or suspected case of a person diagnosed with a notifiable condition. Such agreements will be renewed at least annually and include reference to criminal and civil penalties for violation of chapter 70.02 RCW, other chapters of pertinent state law, and other administrative actions that may be taken by the department of labor and industries.

(3) The department of labor and industries may release statistical summaries and epidemiological studies based on individual case reports if no individual is identified or identifiable.

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The department of labor and industries shall:

(1) Distribute periodic epidemiological summary reports and an annual review of public health issues to local health officers and local health departments.

(2) Make available case investigation documentation for notifiable conditions reported directly to the department to local health officers or their designees upon execution of a data sharing agreement.

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The department of labor and industries shall make data and other pertinent information described in WAC 246-101-715 available to local health departments within two days of a request.

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The department of labor and industries shall:

(1) Make other data necessary to conduct case investigations or epidemiological summaries available within two days of a request from the department.

(2) Execute a data sharing agreement with the department prior to implementation of this chapter.

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The department of labor and industries shall maintain a surveillance system for monitoring hospitalized burns that may include:

(1) Development of a sentinel network of burn treatment centers and hospitals to provide information regarding hospitalized burns; and

(2) Sample checks with health care providers, clinics, and hospitals regarding hospitalized burns.

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