Original Notice.

Preproposal statement of inquiry was filed as WSR 98-19-089 on September 23, 1998.

Title of Rule: Chapter 246-100 WAC, HIV surveillance.

Purpose: This rule institutes reporting of asymptomatic HIV infection, contains provisions to safeguard confidentiality, and ensures access to anonymous HIV testing.

Statutory Authority for Adoption: RCW 70.24.125.

Statute Being Implemented: RCW 70.24.125.

Summary: This rule institutes reporting of asymptomatic HIV infection, contains provisions to safeguard confidentiality, and ensures access to anonymous HIV testing.

Reasons Supporting Proposal: Because of the advent of new medical therapies, AIDS case reporting alone does not provide the information that public health officials need in order to understand the course of the HIV/AIDS epidemic in our state, plan and conduct effective HIV prevention programs or efficiently carry out disease control measures.

Name of Agency Personnel Responsible for Drafting: John Peppert, P.O. Box 47840, Olympia, WA 98504-7840, (360) 236-3427; Implementation: Chris Spitters, P.O. Box 47840, Olympia, WA 98504-7844, (360) 236-3416; and Enforcement: Jack Jourden, P.O. Box 47840, Olympia, WA 98504-7844, (360) 236-3466.

Name of Proponent: Washington State Department of Health, governmental.

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

Explanation of Rule, its Purpose, and Anticipated Effects: This rule requires (1) reporting of asymptomatic HIV disease, in addition to the currently reportable symptomatic HIV infection by health care providers and others with a duty to report; (2) laboratories to report certain tests indicative of HIV infection; (3) local and state health officers take measures to protect the confidentiality of those reports; (4) persons considering HIV testing to be notified of testing options and reporting requirements; (5) local health officers to provide reasonable access to anonymous HIV testing; and (6) the state health officer to provide a report on the HIV surveillance system. The purpose of the rule is to provide the information that public health officials need in order to understand the course of the HIV/AIDS epidemic in our state, plan and conduct effective HIV prevention programs or efficiently carry out disease control measures. The anticipated effects include receipt of additional reports by public health officials and better targeting and use of HIV prevention resources. Some persons may be deterred from confidential HIV testing because of the reporting requirements.

Proposal Changes the Following Existing Rules: This rule institutes reporting of asymptomatic HIV infection, contains provisions to safeguard confidentiality, and ensures access to anonymous HIV testing.

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

One way to redress this ignorance is through partner notification (PN), a process through which individuals are notified of their exposure to a sexually transmitted disease, including HIV, and referred for counseling, testing, and appropriate treatment. Trained staff within local health departments perform PN activities. However, early in the HIV/AIDS epidemic the Washington State Department of Health (DOH) made a policy decision against implementing an HIV reporting system.³ The absence of effective treatments along with public concerns about individual privacy, discrimination, and the stigma of being identified as HIV positive contributed to DOH’s decision. The absence of an HIV surveillance system constrained DOH’s efforts towards partner notification, case management, and other medical and social support services.

The introduction of antiretroviral therapies in 1995, including protease inhibitors, changed the AIDS epidemic. The new therapies reduce viral loads and delay the progression to AIDS and death among HIV-infected individuals. As a result, newly diagnosed AIDS cases declined 31% between 1993 and 1996, and deaths declined 28% between 1995 and 1996 in Washington state.⁴ At the same time, the number of persons living with AIDS increased 31% between 1996 (2,697 as of January 1996) and 1998 (3,527 as of January 1999).⁵

The development of effective antiretroviral treatment has rekindled the department’s interest in establishing an HIV surveillance system. Antiretroviral drugs are especially effective at slowing the progression of the disease when given soon after HIV infection.^6,7 Medical authorities advocate treating persons at the earliest stage of infection, i.e., during primary HIV infection.^8,9 Reporting of positive HIV test results would allow DOH to renew PN efforts and, through early intervention, improve the health prospects of those exposed to the disease.

The new therapies have also made AIDS case reporting an unreliable indicator of underlying trends in HIV infection. Twenty-five states with name-based HIV reporting in addition to AIDS surveillance report that declines in AIDS incidence have not been accompanied by comparable declines in HIV incidence.¹⁰ HIV reporting could help DOH and other public health agencies to monitor the scope of the epidemic, guide the allocation of care and prevention resources, and evaluate the effectiveness of alternative prevention and treatment activities.

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 department is 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 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 HIV test results,

b. 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 obtain completed case reports and to store these case reports securely,

d. DOH. The costs of processing and maintaining confidential HIV case reports and of performing surveillance activities for counties with inadequate surveillance capacity, and

e. HIV-Infected Persons. The potential costs of not being tested if the reporting system becomes a deterrent to testing.

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.¹¹

The first step in determining the cost of the proposed regulations to laboratories and providers is to project the annual number of positive HIV test results occurring in Washington state.

1. HIV Assumptions: Incidence, Prevalence, Number of HIV Infections Diagnosed, Number Newly Diagnosed Each Year: The department anticipates that approximately 600 new (incident) infections occur each year in Washington state. This number, derived in 1995, is based on AIDS cases reported nationally, adjusted for the proportion of total United States cases reported among Washington state residents.¹² Prior to 1996 and the introduction of potent antiretroviral therapy, trends among AIDS cases suggested that infections among men who have sex with men (MSM) had begun to decline from late 1980’s levels in Washington state. But current trends in AIDS cases also show an increase in infections among women, injection drug users, and persons exposed through heterosexual contact.^{13, 14} HIV incidence data in states with HIV reporting show that, while the demographic characteristics and risk behaviors of newly infected persons may have changed, overall rates of infection have not declined; therefore, the Washington state rate is assumed to be similar to the rate estimated in 1995.

The department used a formula published by CDC to estimate that approximately 12,000 of Washington citizens currently live with HIV, of whom 3,500 have AIDS (see Table 1 for a county-by-county breakdown).¹⁵ This leaves about 8,500 persons living with HIV but not AIDS. The department projects that about 6,860 infected persons know of their HIV status (see Table 1). This translates to roughly 81% of the infected population—a rate that is higher than CDC’s 67% national estimate. The department arrived at this figure by adjusting each county’s "knowledge of risk" based on risk, gender distribution of cases, and when the HIV epidemic was first identified in the county. Specifically, DOH assumed a high "knowledge of risk" factor in counties with a high proportion of cases among gay and bisexual men. A telephone survey of gay and bisexual men in Seattle found that 82% had been tested for HIV.¹⁶ Reasoning that knowledge of HIV/AIDS and risk factors is similar in other urban areas, DOH presumed that 80-85% of persons living with HIV in urban areas know of their infections. The department also reasoned that people in rural counties and counties with a high proportion of cases among women and persons exposed through heterosexual contact have a lower "knowledge of risk."

The department based the estimates presented in Table 1 on adjusted "knowledge of risk" considerations.

The department based estimates of the annual number of HIV infections diagnosed each year on a survey of laboratories conducting Western Blot (WB) antibody tests - the principal confirmatory test used to diagnose HIV infection. The department projects between 800-900 individuals will have newly diagnosed HIV infections each year. These cases include both incident (new) HIV infections and prevalent (old) infections which, for whatever reason, are being diagnosed for the first time.

Table 1. Estimated number of persons living with AIDS and HIV, persons with diagnosed infections, and persons with newly diagnosed HIV infections

County	Persons Living	Persons Living with	Newly Diagnosed	Persons Living with	Persons Diagnosed
	with AIDS	HIV (includes AIDS)	HIV (WB)	HIV (excludes AIDS)	with HIV (not AIDS)
ADAMS	2	7	0	5	3
ASOTIN	7	24	2	17	12
BENTON-FRANKLIN	39	133	9	94	65
CHELAN/DOUGLAS	10	34	2	24	17
CLALLAM	19	65	5	46	36
COLUMBIA	1	3	0	2	2
COWLITZ	34	116	8	82	65
FERRY	2	7	0	5	4
GRANT	7	24	2	17	11
GRAYS HARBOR	16	54	4	38	30
ISLAND	17	58	4	41	35
JEFFERSON	9	31	2	22	18
KING	2219	7550	532	5331	4400
KITSAP	55	187	13	132	105
KITTITAS	6	20	1	14	10
KLICKITAT	2	7	0	5	4
LEWIS	9	31	2	22	18
LINCOLN	0	12	0	12	4
MASON	40	136	10	96	82
OKANOGAN	10	34	2	24	17
PACIFIC	3	10	1	7	6
PEND OREILLE	4	14	1	10	7
PIERCE	321	1092	77	771	614
SAN JUAN	5	17	1	12	10
SKAGIT	15	51	4	36	29
SNOHOMISH	193	657	46	464	369
SOUTHWEST WA	131	446	31	315	250
SPOKANE	141	480	34	339	259
STEVENS	8	27	2	19	14
THURSTON	58	197	14	139	111
WAHKIAKUM	1	3	0	2	2
WALLA WALLA	24	82	6	58	40
WHATCOM	60	204	14	144	114
WHITMAN	3	10	1	7	6
YAKIMA	56	191	13	135	94
TOTAL	3,527	12,014	842	8,487	6,860

2. Laboratory Costs: Number of Laboratories Reporting, Number of Tests, Time Required for Reporting of Results: According to a recent survey by DOH’s Infectious Disease and Reproductive Health Assessment Unit, twenty-one laboratories perform HIV Western Blot (WB) antibody testing in Washington state. This number excludes public health laboratories, where anonymous HIV testing is conducted for public counseling and testing sites. Of these laboratories, ten also currently conduct CD4 lymphocyte testing and report their AIDS-defining results, by coded patient identifier, to DOH on a monthly or quarterly basis. During the 4th quarter of 1998, these ten laboratories performed 73.5% of all HIV positive WB antibody tests.

To estimate the laboratory cost of name-based HIV reporting, DOH staff interviewed knowledgeable representatives of nine of these laboratories. The representatives predicted the number of HIV antigen (viral load) and reportable CD4 tests performed annually, as well as the time required to report each positive result by name. These laboratories use computer programs to identify reportable tests and generate the required disease reports for DOH. The standard for reporting for other reportable diseases is by name, and with the advent of coded CD4 reporting in 1993, laboratories were required to alter their computer programs to address this anomaly. The proposed amendments would replace reporting by code with name-based reporting, and would thereby simplify and standardize the reporting process.

Results of the survey indicated that laboratories spend an average of two minutes per test result reported. Staff time spent on this effort was calculated at $20/hour (including overhead and benefits). The resultant costs per laboratory for CD4, HIV antibody, and viral load test results are shown in Table 2. The department assumes that the cost to laboratories of the proposed name-to-code conversion system would be similar to this standard name-based model. The proposed rule would require laboratories to report HIV positive test results by name and local health departments to convert the names-to-code. The annual cost to laboratories of a confidential named system of HIV reporting varies between $287 and $6,401 per year. The cost to implement the proposed standards generally exceeds $300 threshold and, therefore, an SBEIS is required.

Table 2. Estimated volume of laboratory reports and costs for named HIV reporting, including AIDS. Assumes the costs to laboratories of a name-to-code conversion system would be similar.

Laboratory	1	2	3	4	5	6	7	8	9
Cost per Reportable CD4 Specimen	$0.67	$0.67	$0.67	$0.67	$0.67	$0.67	$0.67	$0.67	$0.67
Positive CD4 Tests per Year†	622	496	148	254	324	1292	112	1874	784
Cost of Named CD4 Reporting	$417	$332	$99	$170	$217	$866	$75	$1,256	$525
Annual HIV Viral Load Tests	3096	1844	475	480	1188	2250	312	7200	1960
Cost of Named Viral Load Reporting	$2,074	$1,235	$318	$322	$796	$1,508	$209	$4,824	$1,313
Positive WB Tests per Year‡	68	28	4	16	40	80	4	480	48
Cost of Named Western Blot Reporting	$46	$19	$3	$11	$27	$54	$3	$322	$32
Total Cost of all HIV-associated Test Reporting	$2,537	$1,587	$420	$503	$1,040	$2,427	$287	$6,401	$1,871

^† Estimated as annualized average of 1st and 4th quarters of 1997

^‡ Estimated as annualized number of positive Western Blot tests 1st quarter 1998

3. Cost to Providers: Time Required for Completing Case Reports, Number of Reports, Number of Unnecessary Case Report Investigations: The department asked four AIDS disease investigators at the Seattle-King County Department of Public Health and DOH to independently estimate the average length of time it takes a provider to complete a named AIDS case report. Each estimated that a case report could typically be completed in fifteen minutes. The department assumes that a named HIV report would take the same amount of time since similar information is required. Assuming a staff time cost of $20/hour (physicians regularly delegate their reporting authority to office staff), the provider cost per completed case report is estimated at $5/report.¹⁷ The proposed rule would impose three categories of costs on providers: Costs associated with the number of HIV-infected persons identified through Western Blot (WB) testing (i.e., newly diagnosed cases); the number of HIV-infected persons identified through viral load testing; and the self-initiated reporting by providers of patients receiving HIV-related care (i.e., prevalent cases). As illustrated in Table 1, DOH predicts that 842 persons are likely to be newly diagnosed with HIV each year in Washington state.

Table 3 shows the estimated costs of a name-to-code system of HIV reporting for four modeled scenarios. Each model presents a different assumption about the proportion of infected individuals who seek care, the number of incident HIV infections averted through targeted prevention activities, and the proportion of prevalent cases who are in care and who are reported. For example, Model 1 assumes that 80% of cases are in care and 85% of these cases are reported during Year 1 of a name-to-code system of HIV reporting, the cost to providers is estimated to be $29,077. This is a maximum estimate of reported cases, since it reflects a higher proportion of cases who seek care than has been reported nationally,¹⁸ and it reflects a completeness of case reporting similar to that achieved with the implementation of CD4 reporting in Washington state in 1993.

Model 2 assumes that 65% of cases are in care and 65% of these cases are reported during Year 1 of a name-to-code system of HIV reporting, the cost to providers is estimated to be $19,747. This model reflects the national rate of cases who seek care and a relatively high level of case reporting. Model 3 assumes that 46% of cases are in care and 30% of these cases are reported, the cost to providers is estimated to be $9,446. This estimate assumes fewer cases who seek care than current national and state levels and a moderate level of case reporting.

The department finds the levels of case reporting assumed in Models 1, 2, and 3 to be too high. Neither DOH or local health jurisdictions have the staff capacity to handle all these reports in the first year. For this reason, the reporting by laboratories of viral load test results - which will trigger the investigations leading to the majority of reports of prevalent cases - will be phased in as capacity allows. The department does anticipate that 65% of infected individuals will seek care, a level on par with the current proportion.

As a result of these considerations, DOH anticipates that Model 4 gives the most likely estimate of provider costs. Model 4 assumes that 65% of cases are in care and 10-15% of these cases will be reported in Year 1. Under these assumptions, the cost to providers is estimated to be approximately $6,801, or $6,679 when annualized over five years.

Table 3. Estimated provider cost for four models of a name-to-code HIV reporting system

	Model 1	Model 2	Model 3	Model 4
Total Cases Reported
Year 1	5507	3740	1789	1288
Year 2	2335	2516	1658	1256
Year 3	1320	1809	1545	1226
Year 4	995	1400	1448	1197
Year 5	891	1164	1365	1171
Provider Cost per Case Report	$5	$5	$5	$5
Annual Cost of Named HIV/AIDs Reporting
Year 1	$27,535	$18,700	$8,945	$6,440
Year 2	$11,675	$12,580	$8,290	$6,280
Year 3	$6,600	$9,045	$7,725	$6,130
Year 4	$4,975	$7,000	$7,240	$5,985
Year 5	$4,455	$5,820	$6,825	$5,855
Provider Cost per Unnecessary Investigation	$1	$1	$1	$1
Cost of Unnecessary Investigations
Year 1 (7% of Lab Reports)	$1,542	$1,047	$501	$361
Year 2 (9% of Lab Reports)	$841	$906	$597	$452
Year 3 (11% of Lab Reports)	$581	$796	$680	$539
Year 4 (13% of Lab Reports)	$517	$728	$753	$622
Year 5 (15% of Lab Reports)	$535	$698	$819	$703
Provider Cost for Completed Reports and Unnecessary Investigations
Year 1	$29,077	$19,747	$9,446	$6,801
Year 2	$12,516	$13,486	$8,887	$6,732
Year 3	$7,181	$9,841	$8,405	$6,669
Year 4	$5,492	$7,728	$7,993	$6,607
Year 5	$4,990	$6,516	$7,644	$6,558
Annualized Provider Cost for Completed Reports and Unnecessary Investigations	$12,398	$11,781	$8,519	$6,679

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 hundreds of providers operate in Washington state and the total reporting cost of all providers is estimated at about $6,700. However, some providers will face more than $240. For example, an individual practitioner specializing in treating HIV/AIDS patients could have costs substantially higher than $240. On the other hand, reporting costs for a large provider in a rural setting with minimal HIV prevalence will likely be well less than $240 per year. Since some providers will 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. The department looked to its records and determined that thirty-two laboratories conduct HIV/AIDS tests in Washington state.¹⁹ The number of testing personnel at these laboratories ranges from 1 to 297 - eighteen labs have fewer than fifty people and fourteen have over fifty people. Therefore, the proposed rule will clearly affect both large and small laboratories.

With regard to providers, DOH did not find specific information about the employment patterns of providers who would likely be affected by this proposed rule. Nevertheless, DOH is aware that providers span a range of sizes; from individuals in sole practices to large managed care companies. Therefore, DOH believes 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. According to the data available, the one laboratory with fewer than fifty employees would face substantially higher compliance costs than the larger laboratories on a per employee basis than large laboratories. Based on this finding DOH must provide relief for small businesses in this business category, if legal and feasible.

Table 4. Per Employee Laboratory cost of Reporting HIV Positive Test Results

Laboratory	1	2	3	4	5	6	7	8	9
Annual HIV Viral Load Tests	3096	1844	475	480	1188	2250	312	7200	1960
Total Cost of HIV-associated Test Reporting (from Table 2)	$2,537	$1,587	$420	$503	$1,040	$2,427	$287	$6,401	$1,871
Employment	68	53	297	140	87	205	109	16	129
Cost Per Employee	$37.31	$29.94	$1.41	$3.59	$11.95	$11.84	$2.63	$400.06	$14.50

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, DOH considered the cost of reporting relative to the time required to draw and prepare a specimen for an HIV WB test. The WB test has standardized protocols for preparing a specimen.²⁰ Therefore, DOH 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. As Table 4 illustrates, some small providers conduct a high number of tests while some large providers do not. Therefore, including consideration of economics of scale provides no clear direction regarding the relative cost of drawing a specimen at large and small providers. Similarly, DOH reasoned that including consideration of economics of scale provides no clear direction as to whether named reporting is more or less expensive for small providers. Based on this reasoning, DOH concluded that the proposed rule does not impose disproportionate costs on small providers. Therefore, the department is not obligated to provide relief for this category of businesses.

What Regulatory Mitigation is Provided? This assessment found that the proposed rule will impose disproportionately higher costs on small laboratories. Requirements of the Regulatory Fairness Act are very specific in this situation.²¹

"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."

To mitigate the impact of this new requirement, DOH will phase in the reporting of HIV antigen (viral load) test results over a 1-3 year period. The schedule for any individual laboratory will depend on its ability to comply with the new regulation. (The department will determine ability to comply using a survey of all laboratories.) The department anticipates that small laboratories will generally have more difficulty reporting viral loading and therefore, quality for the longest phase-in period. Phasing-in the requirement to report HIV antigen tests will provide significant relief to laboratories since as many as 40,000 of these tests are annually performed in Washington state. (By contrast, fewer than 850 positive Western Blot tests are performed annually.)

The department will also work collaboratively with laboratories to identify and implement the most cost-effective means of reporting viral load test results, including the use of electronic media, pre-packaged data entry screens and transmittal software, and encryption software. Individual laboratories will not be required to report the results of viral load tests until there is mutual agreement that this can be accomplished without undue hardship and without compromising the security of the data. The reporting requirement will be enacted on a case-by-case basis as these conditions are satisfied, "upon written request of the state department of health."

Other Requirements: 1. How DOH involved small businesses in the development of the rule:

The department involved small businesses in the development of this proposed rule in several ways. Beginning in 1997, a series of public forums were held across the state to discuss the need for HIV reporting and to receive stakeholder input to help determine the most desirable reporting system. These forums were widely advertised through public announcements in various media and through direct communications with self-identified "interested parties," including the Washington State Medical Association (WSMA), individual physicians, and representatives of clinical laboratories. Physicians and other providers were members of panels who lead these public discussions in King, Yakima, Spokane, and Pierce counties, and representatives of clinical laboratories were in attendance.

At their October 1998 meeting, the State Board of Health (BOH) directed DOH to draft WAC language to require reporting of symptomatic HIV infection. At this meeting, a representative of the WSMA testified in support of a name-based system of HIV reporting. Copies of the rule change drafted by DOH were subsequently circulated to all interested parties and stakeholders, including physicians, representatives of the WSMA, and representatives of clinical laboratories. Their comments were reviewed and incorporated wherever possible. At the November BOH meeting, members of the medical community provided further testimony in favor of these changes.

In December 1998, DOH surveyed representatives of nine clinical laboratories performing HIV tests and five major AIDS medical providers and informed them that there would be at least one more opportunity to give testimony to the BOH. They were also invited to provide comments directly to DOH regarding the proposed WAC changes. In addition, DOH held a public meeting at Sea-Tac to receive comments on the proposed rule changes. This meeting was attended by a representative of the Washington State Laboratory Association.

In early 1999, the BOH gave further direction to DOH to modify its original proposal to include requirements for local health jurisdictions and DOH to convert names to code and destroy patient names within ninety days after receipt of a completed HIV case report. As before, this updated draft of the rule changes was circulated to interested parties and stakeholders, including representatives of the clinical laboratory and provider communities, and their comments were solicited.

2. The industries required to comply with the proposed rule: Two for-profit industries are required to comply with this rule: Laboratories and medical care providers.

¹ Washington State Vital Statistics 1994 & 1995. Published by the Washington State Department of Health, Center for Health Statistics, Olympia, WA.

² CDC. Commonly asked questions about HIV reporting. Update, April 1998.

³ DOH operates a name-based Acquired Immunodeficiency Syndrome (AIDS) surveillance system. AIDS is the end-stage of damage caused by HIV represented by a variety of immunologic and clinical conditions.

⁴ Annual Communicable Disease Report 1997. Published by the Washington State Department of Health, Epidemiology, Health Statistics, and Public Health Laboratories, Seattle, WA.

⁵ Monthly AIDS Surveillance Report, 1/31/99. Published by the Washington State Department of Health, Office of Infectious Disease and Reproductive Health, Olympia, WA.

⁶ Carpenter CC, Fischl MA, Hammer SM, et al. Antiretroviral therapy for HIV infection in 1997: update recommendations of the International AIDS society-USA panel. JAMA 1997;277:1962-1969.

⁷ Ryland LM. Survival among Washington state AIDS cases, 1987-1996. HIV/AIDS Quarterly Epidemiology Report 2nd Quarter, 1998:11-13.

⁸ Havlir DV, Richman DD. Viral dynamics of HIV: complications for drug development and therapeutic strategies. Ann Intern Med 1996;124:984-994.

⁹ Ho DD. Viral counts in HIV infection. Science 1996;272:1124-1125.

¹⁰ CDC. Diagnosis and reporting of HIV and AIDS in states with integrated HIV and AIDS surveillance--United States, January 1994-June 1997. MMWR 1998;47:309-314.

¹¹ 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 - Offices & Clinics of Doctors of Medicine.

¹² HIV/AIDS Estimates and Forecasts. Published by the Washington State Department of Health and the Seattle-King County Department of Public Health, October 1996.

¹³ Ryland LM. AIDS among Washington State residents living outside Seattle-King County. HIV/AIDS Quarterly Epidemiology Report, 3rd Quarter 1998:8-13.

¹⁴ Barkan S. Annual review of the epidemiology of AIDS in King County. HIV/AIDS Quarterly Epidemiology Report, 3rd Quarter 1998:14-21.

¹⁵ CDC. Update: Trends in AIDS incidence—United States, 1996. MMWR 1997;46:861-867.

¹⁶ Campsmith ML, Goldbaum GM, Brackbill RM, et al. HIV testing among men who have sex with men—results of a telephone survey. Prev Med 1997;26:839-844.

¹⁷ A laboratory report may trigger an investigation which reveals that the case has already been reported. Based on DOH’s experience with CD4 T-lymphocyte reporting, the proportion of lab report-triggered investigations which reveal previously reported cases tends to increase over time. Generally, these investigations take less time than new case reports, and this analysis assumes that they will cost the provider $1.

¹⁸ Studies conducted by RAND, the California-based think-tank, suggest that between 46%-65% of persons who are aware of their HIV infections are likely to be seeing a doctor on a regular basis.

¹⁹ This number includes both public and private laboratories.

²⁰ Constantine NT, Callahan J, Watts DM. Retroviral testing: Essentials for quality control and laboratory diagnosis. CRC Press, 1992, Boca Raton.

²¹ RCW 19.85.030(3).

A copy of the statement may be obtained by writing to Michelle Davis, P.O. Box 47890, Olympia, WA 98504-7890, phone (360) 236-4044, fax (360) 596-7424.

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

Hearing Location: DoubleTree Inn, 18740 International Boulevard, Sea-Tac, WA, on July 14, 1999, at 1:00 p.m.

Assistance for Persons with Disabilities: Contact State Board of Health by July 7, 1999, TDD (800) 833-6388, or (360) 548-5275.

Submit Written Comments to: John Peppert, P.O. Box 47840, Olympia, WA 98504-7840, fax (360) 236-3400, by July 7, 1999.

Date of Intended Adoption: July 14, 1999.

May 27, 1999

James W. Robertson

Acting Executive Director

OTS-3077.2

AMENDATORY SECTION(Amending Order 225B, filed 12/23/91, effective 1/23/92)

WAC 246-100-016
Confidentiality.

Identifying information about any individual with a reportable disease or condition pursuant to chapter 246-100 WAC shall be protected by persons with knowledge of such identity.

(1) Health care providers, employees of a health care facility or medical laboratory, and other individuals with knowledge of a person with sexually transmitted disease, 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 establish and implement policies and procedures to maintain confidentiality related to a patient's medical information.

(2) For the purpose of RCW 70.24.105(6), customary methods for exchange of medical information shall be limited as follows:

(a) Health care providers may exchange confidential 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.  Meaning:

(i) The information shared impacts the care or treatment decisions concerning the patient; and

(ii) The health care provider requires the information for the patient's benefit.

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

(c) Health care facility administrators 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:

(i) Medical record or chart audits;

(ii) Peer reviews;

(iii) Quality assurance;

(iv) Utilization review purposes;

(v) Research ((review board reviews)) as authorized under chapters 42.48 and 70.02 RCW;

(vi) Risk management; and

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

(d) Health care facility administrators and health care providers responsible for office management are authorized to permit access to a patient's medical information and medical record by health care facility and 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.

(e) Health care facility administrators are authorized to permit exchange of medical information for training and teaching of health care providers and students when exchange of confidential medical information is necessary for such training and specifically related to the care of the patient.

(3) Health care providers, employees of a health care facility or medical laboratory, and other individuals with knowledge of a person with a reportable disease or condition, other than those specified in subsections (1) and (2) of this section, shall release identifying information only to other individuals responsible for protecting the health and well being of the public through control of communicable and certain other diseases.

(4) Local and state health department personnel shall maintain individual case reports as confidential records consistent with WAC 246-100-091.

(5) Local and state health department personnel shall not disclose identifying information received as a result of WAC 246-100-076 (1)(c)(i) and (xiv) or WAC 246-100-236 (1)(a)(xviii) and (xix) unless:

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

(b) Authorized by written patient consent.

(6) Local and state health department personnel are authorized to use HIV identifying information obtained as a result of WAC 246-100-076 (1)(c)(i) and (xiv) and WAC 246-100-236 (1)(a)(xviii) and (xix) 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.

(7) 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.

(8) State and local health officers shall require and maintain signed confidentiality agreements with all health department employees with access to HIV identifying information. Such 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 agency.

(9) State and 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 authorized representative for review and appropriate action.

(10) The Washington state public health laboratory, 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 identifying information accompanying submitted laboratory specimens as confidential records.

(((6))) (11) Statistical summaries and epidemiologic studies based on individual case reports may be public information provided no individual is identified or identifiable.

[Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-016, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-016, filed 12/27/90, effective 1/31/91.  Statutory Authority: RCW 70.24.105.  90-07-033 (Order 043), § 248-100-016, filed 3/14/90, effective 4/14/90.  Statutory Authority: Chapter 70.24 RCW.  88-21-093 (Order 322), § 248-100-016, filed 10/19/88; 88-17-057 (Order 317), § 248-100-016, filed 8/17/88.  Statutory Authority: RCW 43.20.050.  87-11-047 (Order 302), § 248-100-016, 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

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

(g) 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;

(((g))) (h) 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;

(((h))) (i) Use identifying information on HIV-infected individuals provided according to WAC ((246-100-072)) 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, ((including)) and spouses; ((and

(i))) 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) 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 ((fifteenth)) sixteenth edition ((1990)) 1995 of Control of Communicable Diseases in Man, edited by Abram S. Benenson, published by the American public health association, 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 70.24.022, [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) The state health officer shall have authority to:

(a) Require reporting of cases and suspected cases of disease and conditions in addition to those required in WAC 246-100-076 for a period of time less than thirty-six months when:

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

(ii) Epidemiologic investigation based on reports of cases may contribute to understanding of the disease or condition, and

(iii) 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 reportable.

(b) Require laboratories to submit specimens indicative of infections in addition to those required in WAC 246-100-231 for a period of time less than thirty-six months, provided:

(i) The infection is of public health concern, and

(ii) Written notification is provided to all local health officers and all directors of medical laboratories registered as described in WAC 246-100-221 explaining:

(A) Actions required, and

(B) Reason for the addition.

(((c) Eliminate the requirement for laboratories to report CD4+counts and CD4+ percents as specified in WAC 246-100-236 if state and federal funding of HIV/AIDS-related health services do not depend on numbers of reported AIDS cases or if less than ten percent of cases reported are discovered through laboratory reporting of CD4+ count and CD4+ percent results.))

(2) The state health officer's authorization to require reporting of cases or submission of laboratory specimens, other than those specified in WAC 246-100-076 and 246-100-231, shall expire thirty-six months from the date of written notification of local health officers and laboratory directors unless amended rules are adopted by the state board of health.

(3) The state health officer shall distribute periodic epidemiologic summary reports and an annual review of public health issues to local health officers and local health departments.

[Statutory Authority: Chapter 70.24 RCW.  93-08-036 (Order 354B), § 246-100-041, filed 4/1/93, effective 5/2/93.  Statutory Authority: RCW 43.20.050.  92-02-019 (Order 225B), § 246-100-041, filed 12/23/91, effective 1/23/92; 91-02-051 (Order 124B), recodified as § 246-100-041, filed 12/27/90, effective 1/31/91; 87-11-047 (Order 302), § 248-100-041, filed 5/19/87.]

Within twelve months of the effective date of the HIV infection reporting system established in WAC 246-100-076, the state health officer, in cooperation with local health officers, will report to the board on:

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

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

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

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

[]

(1) A health care provider may consult with the local health officer or an authorized representative about an HIV-infected individual ((without identifying the individual)).

(2) Only under the specific circumstances listed below, a principal health care provider shall report the identity of sex or injection equipment-sharing partners, including spouses, of an HIV-infected individual to the local health officer or an authorized representative:

(a) After being informed of the necessity to notify sex and injection-equipment sharing partners, including spouses, and confirm notification to the health care provider, the HIV-infected individual either refuses or is unable to notify partners that partners:

(i) May have been exposed to and infected with HIV; and

(ii) Should seek HIV-pretest counseling and consider HIV testing; and

(b) The HIV-infected individual neither accepts assistance nor agrees to referral to the local health officer or an authorized representative for assistance in notifying partners.

(3) Only in the specific circumstances listed below, shall a principal health care provider ((shall report the identity of an individual with a positive HIV test result to)) notify the local health officer or an authorized representative to directly contact the HIV-infected person for the purpose of partner notification:

(a) The HIV-infected person agrees to meet with the local health officer or authorized representative; or

(b) The principal health care provider provided pretest counseling as described in WAC 246-100-209(1) before the individual was tested; and

(((b))) (c) The principal health care provider made efforts, but was unable to meet face-to-face with the individual to notify the individual of the HIV-test result and to provide post-test counseling as required in WAC 246-100-209 in order to assure partner notification.

(4) A health care provider shall not disclose the identity of an HIV-infected individual or the identity of sex and injection equipment-sharing partners, including spouses, at risk of HIV infection, except as authorized in RCW 70.24.105, WAC 246-100-072, or 246-100-076.

(5) Local health officers and authorized representatives shall:

(a) Confirm conditions in subsections (2) and (3) of this section were met prior to initiating partner notification or receiving referral of identity of an HIV-infected individual; and

(b) Use identifying information, provided according to this section, on HIV-infected individuals only for contacting the HIV-infected individual to provide post-test counseling or to contact sex and injection equipment-sharing partners, including spouses; and

(c) Destroy documentation of referral information established under this subsection, containing identities and identifying information on the HIV-infected individual and at-risk partners of that individual, immediately after notifying partners or within three months of the date information was received, whichever occurs first.

[Statutory Authority: RCW 70.24.022, [70.24].340 and Public Law 104-146.  97-15-099, § 246-100-072, filed 7/21/97, effective 7/21/97.  Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-072, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-072, filed 12/27/90, effective 1/31/91.  Statutory Authority: Chapter 70.24 RCW.  89-02-008 (Order 324), § 248-100-072, filed 12/27/88.]

(1) The following diseases and conditions shall be reported as individual case reports by health care providers and others with a duty to report to the local health department in accordance with requirements and procedures described throughout chapter 246-100 WAC:

(a) Category A diseases require an immediate report at the time a case is suspected or diagnosed and include:

(i) Anthrax,

(ii) Botulism (including food-borne, infant, and wound),

(iii) Cholera,

(iv) Diphtheria, noncutaneous,

(v) Measles (rubeola),

(vi) Paralytic shellfish poisoning,

(vii) Plague,

(viii) Poliomyelitis, and

(ix) Rabies.

(b) Category B diseases or conditions require a case report within one day of diagnosis and include:

(i) Brucellosis,

(ii) Gastroenteritis of suspected food-borne or waterborne origin,

(iii) Hemophilus influenzae invasive disease (excluding otitis media) in children age five years and under,

(iv) Hepatitis A and B, acute,

(v) Leptospirosis,

(vi) Listeriosis,

(vii) Meningococcal disease,

(viii) Paratyphoid fever (see salmonellosis),

(ix) Pertussis,

(x) Rubella, including congenital,

(xi) Salmonellosis, including paratyphoid fever and typhoid fever,

(xii) Shigellosis,

(xiii) Syphilis--primary, secondary, or congenital (for other, see Category C),

(xiv) Tuberculosis (suspected or diagnosed),

(xv) Typhoid fever, including carrier (see salmonellosis),

(xvi) Unusual communicable disease (see definition WAC 246-100-011).

(c) Category C diseases or conditions require a case report within seven days of diagnosis and include:

(i) Acquired immunodeficiency syndrome (AIDS) ((class IV)) and symptomatic human immunodeficiency virus (HIV((, HTLV III, or LAV))) disease for adults and adolescents (as classified by the Centers for Disease Control, U.S. Public Health Service, Morbidity and Mortality Weekly Report (MMWR), ((May 23, 1986)) December 19, 1992, Volume ((35)) 41, Number ((20)) RR-17), and ((class P-2)) for pediatric HIV ((illness)) cases (as classified by the Centers for Disease Control, U.S. Public Health Service, MMWR, April 24, 1987, Volume 36, Number 15),

(ii) Amebiasis,

(iii) Campylobacteriosis,

(iv) Chancroid,

(v) Chlamydia trachomatis infection,

(vi) Ecoli 0157:H7 infection,

(vii) Encephalitis, viral,

(viii) Giardiasis,

(ix) Gonorrhea,

(x) Granuloma inguinale,

(xi) Herpes simplex, initial genital infection,

(xii) Herpes simplex, neonatal,

(xiii) Hepatitis non-A, non-B, and unspecified,

(xiv) Human immunodeficiency virus (HIV) infection,

(xv) Kawasaki syndrome,

(((xv))) (xvi) Legionellosis,

(((xvi))) (xvii) Leprosy (Hansen's disease),

(((xvii))) (xviii) Lyme disease,

(((xviii))) (xix) Lymphogranuloma venereum,

(((xix))) (xx) Malaria,

(((xx))) (xxi) Mycobacteriosis,

(((xxi))) (xxii) Mumps,

(((xxii))) (xxiii) Nongonococcal urethritis,

(((xxiii))) (xxiv) Pelvic inflammatory disease, acute,

(((xxiv))) (xxv) Pseudomonas folliculitis of suspected waterborne origin,

(((xxv))) (xxvi) Psittacosis,

(((xxvi))) (xxvii) Q fever,

(((xxvii))) (xxviii) Relapsing fever (borreliosis),

(((xxviii))) (xxix) Reye Syndrome,

(((xxix))) (xxx) Rheumatic fever,

(((xxx))) (xxxi) Rocky mountain spotted fever,

(((xxxi))) (xxxii) Syphilis--other (see also Category B),

(((xxxii))) (xxxiii) Tetanus,

(((xxxiii))) (xxxiv) Tick paralysis,

(((xxxiv))) (xxxv) Toxic shock syndrome,

(((xxxv))) (xxxvi) Trichinosis,

(((xxxvi))) (xxxvii) Tularemia,

(((xxxvii))) (xxxviii) Vibriosis,

(((xxxviii))) (xxxix) Yersiniosis, and

(((xxxix))) (xl) Severe adverse reaction to immunization.

(2) Any cluster or pattern of cases, suspected cases, deaths, or increased incidence of any disease or condition beyond that expected in a given period which may indicate an outbreak, epidemic, or related public health hazard shall be reported immediately by telephone to the local health officer.  Such patterns include, but are not limited to, suspected or confirmed outbreaks of food borne or waterborne disease, chickenpox, influenza, viral meningitis, nosocomial infection suspected due to contaminated products or devices, or environmentally related disease.

(3) A health care provider conducting a clinical HIV research project shall be required to 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 section.

(4) In implementing the reporting requirements in subsection (1)(c)(i) and (xiv), the department of health will seek the input of local health departments, HIV-infected persons, and community organizations serving persons with HIV infection or AIDS.

(5) Effective September 1, 1999, health care providers are required to report to the local health department all cases of HIV infection consistent with the provisions of chapter 246-100 WAC, provided the HIV-infected person receives health care or treatment services on or after September 1, 1999, regardless of the date of initial diagnosis. 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.

(6) When providing technical assistance to a local health department, authorized representatives of the state health department may temporarily and subject to the time limitations in WAC 246-100-036 (2)(j) 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 246-100-036 (2)(j); and

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

(7) Diagnosed cases of symptomatic HIV infection, including AIDS, as defined in this section remain a reportable condition, by name, regardless of the date of diagnosis.

(8) Local health officers may require reporting of additional diseases and conditions.

[Statutory Authority: RCW 70.28.032.  96-23-064, § 246-100-076, filed 11/20/96, effective 12/21/96.  Statutory Authority: Chapter 70.24 RCW.  93-08-036 (Order 354B), § 246-100-076, filed 4/1/93, effective 5/2/93.  Statutory Authority: RCW 43.20.050.  92-02-019 (Order 225B), § 246-100-076, filed 12/23/91, effective 1/23/92; 91-02-051 (Order 124B), recodified as § 246-100-076, filed 12/27/90, effective 1/31/91; 87-11-047 (Order 302), § 248-100-076, filed 5/19/87.]

(1) Definitions.

(a) "Anonymous HIV testing" means that the name or identity of the individual tested for HIV will not be recorded or linked to the HIV test result. However, once the individual testing positive receives HIV health care or treatment services, reporting of the identity of the individual to the state or local public health officer is required.

(b) "Behaviors presenting imminent danger to public health (BPID)" means the following activities, under conditions specified below, performed by an individual with a laboratory confirmed HIV infection:

(i) Anal or vaginal intercourse without a latex condom; or

(ii) Shared use of blood-contaminated injection equipment;

(iii) Donating or selling HIV-infected blood, blood products, or semen; and

(iv) Under the following specified conditions:

(A) The infected individual received post-test counseling as described in WAC 246-100-209 prior to repeating activities in subsection (1)(((a))) (b)(i) and (ii) of this section; and

(B) The infected individual did not inform the persons, with whom activities described in subsection (1)(((a))) (b)(i) and (ii) of this section occurred, of his or her infectious status.

(((b))) (c) "Behaviors presenting possible risk" means:

(i) Actual actions resulting in "exposure presenting a possible risk" limited to:

(A) Anal, oral, or vaginal intercourse excluding conjugal visits; or

(B) Physical assault; or

(C) Sharing of injection equipment or sharp implements; or

(D) Throwing or smearing of blood, semen, or vaginal fluids; or

(ii) Threatened action if:

(A) The threatening individual states he or she is infected with HIV; and

(B) The threatened behavior is listed in subsection (1)(b)(i)(A), (B), (C), and (D) of this section; and

(C) The threatened behavior could result in "exposure presenting a possible risk."

(((c))) (d) "Conduct endangering public health" means:

(i) Anal, oral, or vaginal intercourse for all sexually transmitted diseases;

(ii) For HIV and Hepatitis B:

(A) Anal, oral, or vaginal intercourse; and/or

(B) Sharing of injection equipment; and/or

(C) Donating or selling blood, blood products, body tissues, or semen; and

(iii) Activities described in subsection (1)(d)(i) and (ii) of this section resulting in introduction of blood, semen, and/or vaginal fluids to:

(A) Mucous membranes;

(B) Eyes;

(C) Open cuts, wounds, lesions; or

(D) Interruption of epidermis.

(((d))) (e) "Confidential HIV testing" means that the name or identity of the individual tested for HIV will be recorded and linked to the HIV test result, and that the name of the individual testing positive for HIV will be reported to the state or local health officer in a private manner.

(f) "Exposure presenting possible risk" means one or more of the following:

(i) Introduction of blood, semen, or vaginal fluids into:

(A) A body orifice or a mucous membrane;

(B) The eye; or

(C) An open cut, wound, lesion, or other interruption of the epidermis.

(ii) A needle puncture or penetrating wound resulting in exposure to blood, semen, and/or vaginal fluids.

(((e))) (g) "Reasonably believed" or "reason to believe," in reference to a sexually transmitted disease, means a health officer's belief which:

(i) For the purpose of investigating the source and spread of disease, is based upon a credible report from an identifiable individual indicating another person is likely to have a sexually transmitted disease (STD) or to have been exposed to a STD; and

(ii) For the purpose of issuing a written order for an individual to submit to examination, counseling, or treatment is based upon:

(A) Laboratory test results confirming or suggestive of a STD; or

(B) A health care provider's direct observation of clinical signs confirming an individual has or is likely to have a STD; or

(C) Obtaining information directly from an individual infected with a STD about the identity of his or her sexual or needle-sharing contacts when:

(I) Contact with the infected individual occurred during a period when the disease may have been infectious; and

(II) The contact was sufficient to transmit the disease; and

(III) The infected individual is, in the health officer's judgment, credible and believable.

(((f))) (h) "Substantial exposure" means physical contact resulting in exposure presenting possible risk, limited to:

(i) A physical assault upon the exposed person involving blood or semen;

(ii) Intentional, unauthorized, nonconsensual use of needles or sharp implements to inject or mutilate the exposed person;

(iii) An accidental parenteral or mucous membrane or nonintact skin exposure to blood, semen, or vaginal fluids.

(2) Health care providers shall:

(a) Report each case of sexually transmitted disease as required in chapter 246-100 WAC, and

(b) Instruct each patient regarding:

(i) Communicability of the disease, and

(ii) Requirements to refrain from acts that may transmit the disease to another.

(c) Ensure completion of a prenatal serologic test for syphilis in each pregnant woman pursuant to RCW 70.24.090 including:

(i) Submission of a blood sample for syphilis to a laboratory approved to perform prenatal serologic tests for syphilis, as required in RCW 70.24.090, at the time of the first prenatal visit, and

(ii) Decide whether or not to omit the serologic test for syphilis if the test was performed elsewhere during the current pregnancy.

(3) Laboratories, health care providers, and other persons shall deny issuance of a certificate or statement implying an individual is free from sexually transmitted disease.

(4) Local health officers, health care providers, and others, in addition to requirements in chapter 246-100 WAC, shall comply with the provisions in chapter 70.24 RCW.

(5) Prevention of ophthalmia neonatorum.

(a) Health care providers diagnosing or caring for a patient with gonococcal or chlamydial ophthalmia neonatorum shall report the case to the local health officer or local health department in accordance with the provisions of this chapter.

(b) The principal health care provider attending or assisting in the birth of any infant or caring for an infant after birth, shall ensure instillation of a department-approved prophylactic ophthalmic agent into the conjunctival sacs of the infant within the time frame established by the department in policy statement of ophthalmia agents approved for the prevention of ophthalmia neonatorum in the newborn, issued June 19, 1981.

(6) State and local health officers or their authorized representatives shall:

(a) Have authority to conduct or cause to be conducted an interview and investigation of persons infected or reasonably believed to be infected with a sexually transmitted disease; and

(b) Use procedures and measures described in WAC 246-100-036(4) in conducting investigations.

(7) State and local health officers and their authorized representatives shall have authority to:

(a) Issue written orders for medical examination, testing, and/or counseling under chapter 70.24 RCW, only after:

(i) All other efforts to protect public health have failed, including reasonable efforts to obtain the voluntary cooperation of the person to be affected by the order; and

(ii) Having sufficient evidence to "reasonably believe" the individual to be affected by the order:

(A) Has a sexually transmitted disease; and

(B) Is engaging in "conduct endangering public health"; and

(iii) Investigating and confirming the existence of "conduct endangering public health" by:

(A) Interviewing sources to assess their credibility and accuracy; and

(B) Interviewing the person to be affected by the order; and

(iv) Including in a written order all information required in RCW 70.24.024.

(b) Issue written orders for treatment under RCW 70.24.022 only after laboratory test results, or direct observation of clinical signs or assessment of clinical data by a physician, confirm the individual has, or is likely to have, a sexually transmitted disease;

(c) Issue written orders to cease and desist from specified activities, under RCW 70.24.024 only after:

(i) Determining the person to be affected by the order is engaging in "conduct endangering public health"; and

(ii) Laboratory test results, or direct observation of clinical signs or assessment of clinical data by a physician, confirm the individual has, or is likely to have, a sexually transmitted disease; and

(iii) Exhausting procedures described in subsection (7)(a) of this section; and

(iv) Enlisting, if appropriate, court enforcement of the orders described in subsections (7)(a) and (b) of this section; and

(d) Seek court orders for detainment under RCW 70.24.034, only for persons infected with HIV and only after:

(i) Exhausting procedures described in subsection (7)(a), (b), and (c) of this section; and

(ii) Enlisting, if appropriate, court enforcement of orders to cease and desist; and

(iii) Having sufficient evidence to "reasonably believe" the person is engaging in "behaviors presenting an imminent danger to public health."

(8) Conditions for detainment of individuals infected with sexually transmitted disease.

(a) A local health officer may notify the state health officer if he or she determines:

(i) The criteria for "behaviors presenting imminent danger to public health (BPID)" are met by an individual; and

(ii) Such individual fails to comply with a cease and desist order affirmed or issued by a court.

(b) A local or state health officer may request the prosecuting attorney to file an action in superior court to detain an individual specified in subsection (8)(a) of this section.

(c) The requesting local or state health officer or authorized representative shall:

(i) Notify the department prior to recommending the detainment setting where the individualized counseling and education plan may be carried out consistent with subsections (8)(d), (e), and (f) of this section;

(ii) Make a recommendation to the court for placement of such individual consistent with subsections (8)(d) and (f) of this section; and

(iii) Provide to the court an individualized plan for education and counseling consistent with subsection (8)(e) of this section.

(d) State board of health requirements for detainment of individuals demonstrating BPID:

(i) Sufficient number of staff, caregivers, and/or family members to:

(A) Provide round-the-clock supervision, safety of detainee, and security; and

(B) Limit and restrict activities to prevent BPID; and

(C) Make available any medical, psychological, or nursing care when needed; and

(D) Provide access to AIDS education and counseling; and

(E) Immediately notify the local or state health officer of unauthorized absence or elopement; and

(ii) Sufficient equipment and facilities to provide:

(A) Meals and nourishment to meet nutritional needs; and

(B) A sanitary toilet and lavatory; and

(C) A bathing facility; and

(D) Bed and clean bedding appropriate to size of detainee; and

(E) A safe detention setting appropriate to chronological and developmental age of detainee; and

(F) A private sleeping room; and

(G) Prevention of sexual exploitation.

(iii) Sufficient access to services and programs directed toward cessation of BPID and providing:

(A) Linguistically, socially, culturally, and developmentally appropriate ongoing AIDS education and counseling; and

(B) Psychological and psychiatric evaluation and counseling; and

(C) Implementation of court-ordered plan for individualized counseling and education consistent with subsection (8)(e) of this section.

(iv) If required, provide access to isolation and/or restraint in accordance with restraint and seclusion rules in WAC 275-55-263 (2)(c);

(v) Maintain a safe, secure environment free from harassment, physical danger, and sexual exploitation.

(e) Washington state board of health standards for an individualized counseling and education plan for a detainee include:

(i) Consideration of detainee's personal and environmental characteristics, culture, social group, developmental age, and language;

(ii) Identification of habitual and addictive behavior and relapse pattern;

(iii) Identification of unique risk factors and possible cross-addiction leading to behavior presenting imminent danger to public health;

(iv) Identification of obstacles to behavior change and determination of specific objectives for desired behavior;

(v) Provision of information about acquisition and transmission of HIV infection;

(vi) Teaching and training of individual coping skills to prevent relapse to BPID;

(vii) Specific counseling for chemical dependency, if required;

(viii) Identification of and assistance with access to community resources, including social services and self-help groups appropriate to provide ongoing support and maintenance of behavior change; and

(ix) Designation of a person primarily responsible for counseling and/or education who:

(A) Completed pretest and post-test counselor training approved by the office on AIDS; and

(B) Received training, as approved by the office on AIDS, focused on facilitating behavior change related to preventing BPID; and

(C) Has a post-graduate degree in social work, psychology, counseling, psychosocial nursing, or other allied profession; and

(D) Completed at least one year clinical experience after post-graduate education with a primary focus on individualized behavior change; and

(E) Is a certified counselor under chapter 18.19 RCW.

(x) Designation and provision of a qualified counselor under WAC 275-19-145 when the detainee is assessed to have a drug or alcohol problem.

(f) The state board of health designates the following settings appropriate for detainment provided a setting meets requirements in subsection (8)(d)(i), (ii), (iii), (iv), and (v) of this section:

(i) Homes, care facilities, or treatment institutions operated or contracted by the department;

(ii) Private homes, as recommended by the local or state health officer;

(iii) Boarding homes licensed under chapter 18.20 RCW;

(iv) Nursing homes licensed under chapter 18.51 RCW;

(v) Facilities licensed under chapter 71.12 RCW, including:

(A) Psychiatric hospitals, per chapter 246-322 WAC;

(B) Alcoholism treatment centers if certified for substance use under chapter 275-19 WAC;

(C) Adult residential rehabilitation centers, per chapter 246-325 WAC;

(D) Private adult treatment homes, per chapter 246-325 WAC;

(E) Residential treatment facilities for psychiatrically impaired children and youth, per chapter 246-323 WAC;

(vi) A hospital licensed under chapter 70.41 RCW.

(9) Jail administrators may order pretest counseling, post-test counseling, and HIV testing of persons detained in jail according to RCW 70.24.360 only under the following conditions:

(a) The jail administrator documents and reports to the local health officer, within seven days after the incident, any incident perceived to be actual or threatened "behaviors presenting possible risk"; and

(b) The local health officer:

(i) Determines the documented behavior or behaviors meet the criteria established in the definition of "behaviors presenting a possible risk"; and

(ii) Interviews the detained individual to evaluate the factual basis for alleged actual or threatened behavior; and

(iii) Makes a fact determination, based upon the documented behavior, the interview with the detained individual, and/or independent investigation, that sufficient factual evidence exists to support the allegation of actual or threatened "behaviors presenting possible risk"; and

(iv) Arranges for testing of the individual who is the source of the behavior to occur within seven days of the request from the jail administrator; and

(v) Reviews with the detained individual who is the source of the behavior the documentation of the actual or threatened behavior to try to assure understanding of the basis for HIV testing; and

(vi) Provides written approval of the jail administrator's order prior to HIV testing in accordance with subsection (7)(a)(i) of this section.

(c) The jail administrator maintains HIV test results and identity of the tested individual as a confidential, nondisclosable record, as provided in RCW 70.24.105.

(10) When an individual experiences a substantial exposure to another individual's body fluids and requests HIV testing of that other individual, the state and local health officers have authority to order pretest counseling, HIV testing, and post-test counseling of that other individual providing:

(a) The alleged exposure occurred when the individual was employed or acting as an authorized volunteer in one of the following employment categories:

(i) Law enforcement officer;

(ii) Firefighter;

(iii) Health care provider;

(iv) Staff of health care facilities;

(v) Funeral director;

(vi) Embalmer; and

(b) The alleged substantial exposure occurred on the job; and

(c) The request to the health officer for testing and counseling of the individual was made within seven days of the occurrence of the alleged exposure; and

(d) The local health officer:

(i) Determines that the alleged exposure meets the criteria established in the definition of "substantial exposure"; and

(ii) Ensures that pretest counseling of the individual to be tested, or a legal representative, occurs; and

(iii) Arranges for testing of the individual who is the source of the exposure to occur within seven days of the request from the person exposed; and

(e) The exposed individual agrees to be tested for HIV if such testing is determined appropriate by the health officer; and

(f) Records on HIV testing ordered by a health officer are maintained only by the ordering health officer.

(11) For the purpose of RCW 49.60.172 concerning the absence of HIV infection as a bona fide occupational qualification only, "significant risk" means a job qualification which requires person-to-person contact likely to result in direct introduction of blood into the eye, an open cut or wound, or other interruption of the epidermis, when:

(a) No adequate barrier protection is practical; and

(b) Determined only on case-by-case basis consistent with RCW 49.60.180.

[Statutory Authority: RCW 70.24.022, [70.24].340 and Public Law 104-146.  97-15-099, § 246-100-206, filed 7/21/97, effective 7/21/97.  Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-206, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-206, filed 12/27/90, effective 1/31/91.  Statutory Authority: Chapter 70.24 RCW.  89-07-095 (Order 325), § 248-100-206, filed 3/22/89; 88-21-093 (Order 322), § 248-100-206, filed 10/19/88; 88-17-056 (Order 316), § 248-100-206, filed 8/17/88.  Statutory Authority: RCW 43.20.050.  87-11-047 (Order 302), § 248-100-206, filed 5/19/87.]

(1) Any person ordering or prescribing an HIV test for another, except for seroprevalent studies under chapter 70.24 RCW or provided under subsections (2) and (3) of this section, shall:

(a) Provide or refer for pretest counseling described under WAC 246-100-209;

(b) Obtain or ensure informed specific consent of the individual to be tested separate from other consents prior to ordering or prescribing an HIV test, unless excepted under provisions in chapter 70.24 RCW; ((and))

(c) Inform, orally or in writing, the individual to be tested of the availability of anonymous HIV testing and of the differences between "anonymous HIV testing" and "confidential HIV testing"; and

(d) Provide or refer for post-test counseling described under WAC 246-100-209 if HIV test is positive for or suggestive of HIV infection.

(2) Any person authorized to order or prescribe an HIV test for another may offer anonymous HIV testing without restriction.

(3) Blood banks, tissue banks, and others collecting or processing blood, sperm, tissues, or organs for transfusion/transplanting shall:

(a) Obtain or ensure informed specific consent of the individual prior to ordering or prescribing an HIV test, unless excepted under provisions in chapter 70.24 RCW;

(b) Explain that the reason for HIV testing is to prevent contamination of the blood supply, tissue, or organ bank donations; ((and))

(c) At the time of notification regarding a positive HIV test, provide or ensure at least one individual counseling session; and

(d) Inform the individual that the name of the individual testing positive for HIV infection will be confidentially reported to the state or local health officer.

(((3))) (4) Persons subject to regulation under Title 48 RCW and requesting an insured, subscriber, or potential insured or subscriber to furnish the results of an HIV test for underwriting purposes, as a condition for obtaining or renewing coverage under an insurance contract, health care service contract, or health maintenance organization agreement shall:

(a) Before obtaining a specimen to perform an HIV test, provide written information to the individual tested explaining:

(i) What an HIV test is;

(ii) Behaviors placing a person at risk for HIV infection;

(iii) The purpose of HIV testing in this setting is to determine eligibility for coverage;

(iv) The potential risks of HIV testing; and

(v) Where to obtain HIV pretest counseling.

(b) Obtain informed specific written consent for an HIV test.  The written informed consent shall include:

(i) An explanation of confidential treatment of test result reports limited to persons involved in handling or determining applications for coverage or claims for the applicant or claimant; and

(ii) That the name of the individual testing positive for HIV infection will be confidentially reported to the state or local health officer; and

(iii) Requirements under subsection (((3))) (4)(c) of this section.

(c) Establish procedures to inform an applicant of the following:

(i) Post-test counseling specified under WAC 246-100-209(4) is required if an HIV test is positive or indeterminate;

(ii) Post-test counseling is done at the time any positive or indeterminate HIV test result is given to the tested individual;

(iii) The applicant is required to designate a health care provider or health care agency to whom positive or indeterminate HIV test results are to be provided for interpretation and post-test counseling; and

(iv) When an individual applicant does not identify a designated health care provider or health care agency and the applicant's HIV test results are positive or indeterminate, the insurer, health care service contractor, or health maintenance organization shall provide the test results to the state or local health department for interpretation and post-test counseling.

(((4))) (5) Laboratories and other places where HIV testing is performed shall demonstrate complete and satisfactory participation in an HIV proficiency testing program approved by the Department Laboratory Quality Assurance Section, Mailstop K17-9, 1610 N.E. 150th, Seattle, Washington 98155.

(((5))) (6) The department laboratory quality assurance section shall accept substitutions for EIA screening only as approved by the United States Food and Drug Administration (FDA) and a published list or other written FDA communication.

(((6) Medical laboratories testing for the presence of HIV shall:

(a) Send an HIV test prevalence results report by telephone or in writing to the department office on AIDS (Mailstop K17-9, 1610 N.E. 150th, Seattle, Washington 98155), quarterly or more often; and

(b) Include in the report:

(i) Number of samples tested;

(ii) Number of samples repeatedly reactive by enzyme immuno assay (EIA);

(iii) Number of samples tested by western blot assay (WBA) or other confirmatory test as approved by department office on AIDS;

(iv) Number of positive test results by WBA or other confirmatory test as approved by department office on AIDS;

(v) Number of specimens tested by viral culture; and

(vi) Number of positive test results from viral cultures.))

(7) Persons informing a tested individual of positive laboratory test results indicating HIV infection shall do so only when:

(a) HIV is isolated by viral culture technique; or

(b) HIV nucleic acid (RNA or DNA) is detected; or

(c) HIV is detected through a P24 antigen (neutralizable) test; or

(d) HIV antibodies are identified by a sequence of tests which are reactive and include:

(i) A repeatedly reactive screening test such as the enzyme immunoassay (EIA); and

(ii) An additional, more specific, assay such as a positive western blot assay (WBA) or other tests as ((defined and described in the AIDS office manual, April, 1988, Department of Health, Office on AIDS, P.O. Box 47840, Olympia, Washington 98504-7840)) approved by the United States Food and Drug Administration (FDA) in a published list or other written FDA communication.

(((c))) (e) Such information consists of relevant, pertinent facts communicated in such a way that it will be readily understood by the recipient.

[Statutory Authority: RCW 70.24.380.  97-04-041, § 246-100-207, filed 1/31/97, effective 3/3/97.  Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-207, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-207, filed 12/27/90, effective 1/31/91.  Statutory Authority: Chapter 70.24 RCW and RCW 70.24.130.  89-20-006 (Order 334), § 248-100-207, filed 9/22/89, effective 10/23/89.  Statutory Authority: Chapter 70.24 RCW.  89-14-003 (Order 329), § 248-100-207, filed 6/22/89; 88-17-058 (Order 318), § 248-100-207, filed 8/17/88.]

(1) Principal health care providers shall counsel or ensure AIDS counseling for:

(a) Each pregnant woman; and

(b) Each patient seeking treatment of a sexually transmitted disease.

(2) Drug treatment programs under chapter 70.96A RCW shall provide or ensure provision of AIDS counseling for each person in a drug treatment program.

(3) Health care providers, persons, and organizations providing AIDS counseling shall:

(a) Assess the behaviors of each individual counseled for risk of acquiring and transmitting human immunodeficiency virus (HIV);

(b) Maintain a nonjudgmental environment during counseling which:

(i) Considers the individual's particular circumstances; and

(ii) Is culturally, socially, linguistically, and developmentally appropriate to the individual being counseled.

(c) Focus counseling on behaviors increasing the risk of HIV acquisition and transmission;

(d) Provide or ensure provision of personalized risk reduction education to individuals who:

(i) Are men who had sex with other men at any time since 1977;

(ii) Used intravenous substances at any time since 1977;

(iii) Engaged in sex for money or drugs at any time since 1977;

(iv) Have had sexual and/or injection equipment-sharing contact with persons listed in subsection (3)(d)(i), (ii), and (iii) of this section;

(v) Have been exposed to or known to have had a sexually transmitted disease at any time since 1977;

(vi) Are at increased risk of HIV infection by definition of United States Public Health Service, Centers for Disease Control;

(vii) Are enrolled in a drug treatment program under chapter 69.54 RCW; or

(viii) Received multiple transfusions of blood, plasma, or blood products from 1977 to 1985.

(e) Encourage individuals assessed to be at other than virtually no risk of HIV infection to:

(i) Receive AIDS risk reduction counseling;

(ii) Consider information about the nature, purpose, and potential ramifications of HIV testing;

(iii) Receive pretest counseling;

(iv) Consider confidential or anonymous voluntary HIV testing if appropriate((;)) and understand the differences between "anonymous HIV testing" and "confidential HIV testing"; and

(v) "Virtually no risk of HIV infection" means persons with medical histories absent of and reporting none of the following factors:

(A) Transfusion with blood or blood products at any time since 1977;

(B) Residence at any time in countries where HIV is considered endemic since 1977;

(C) Unprotected sex between men at any time since 1977;

(D) Use of intravenous substances at any time since 1977, especially when sharing injection equipment;

(E) Engagement in sex for money or drugs at any time since 1977;

(F) Sexual and/or injection equipment-sharing contacts at any time since 1977 with persons listed in subsection (3)(e)(((iii))) (v)(C), (D), and (E) of this section;

(G) Exposure to a sexually transmitted disease; and

(H) Increased risk of HIV infection by definition of United States Public Health Service, Centers for Disease Control.

(4) Persons and organizations providing AIDS counseling may provide additional or more comprehensive counseling than required in this section.

[Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-208, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-208, filed 12/27/90, effective 1/31/91.  Statutory Authority: Chapter 70.24 RCW.  88-17-058 (Order 318), § 248-100-208, filed 8/17/88.]

(1) Health care providers and other persons providing pretest counseling shall:

(a) Assess the individual's risk of acquiring and transmitting HIV by evaluating information about the individual's possible risk-behaviors;

(b) Provide at least one individual counseling session prior to HIV testing;

(c) Inform in writing or orally any individual planning to be tested for HIV that:

(i) Anonymous HIV testing is available through the local health department, home testing kits, or may be available through other community sources, and explain the differences between "anonymous HIV testing" and "confidential HIV testing"; and

(ii) If the test result is positive, ((the tested individual needs to notify)) sex and injection equipment-sharing partners ((that partners)), including spouses must be notified that they:

(A) May have been exposed to and infected with HIV; and

(B) Should seek HIV pretest counseling and consider HIV testing; and

(((ii) Unless HIV testing is anonymous,)) (iii) The principal health care provider is required to refer identities of at-risk partners to the local health officer or authorized representative if:

(A) The HIV-infected individual either refuses or is unable to notify partners of exposure, possible infection, and need for pretest counseling and HIV testing; or

(B) The HIV-infected individual neither accepts assistance nor agrees to referral to the local health officer or an authorized representative for assistance in notifying partners; and

(((iii))) (iv) Unless HIV testing is anonymous, the principal health care provider is required to confidentially refer the ((identify)) identity of the individual testing positive to the local health officer or an authorized representative ((if the principal health care provider made efforts, but was unable to meet face-to-face with the individual to:

(A) Notify the individual of the HIV test result; and

(B) Provide post-test counseling, as required in this section, to assure partner notification)).

(2) When an individual is assessed by a counselor or health care provider as "virtually no risk of HIV infection," as defined in WAC 246-100-208 (3)(e)(v) a counselor or the health care provider shall, in addition to subsection (1)(a) of this section:

(a) Maintain a nonjudgmental environment during counseling which:

(i) Considers the individual's particular circumstances; and

(ii) Is culturally, socially, linguistically, and developmentally appropriate to the individual being counseled.

(b) Explain the nature, purpose, value, and reason for the HIV tests;

(c) In writing or orally, inform the individual to be tested that anonymous HIV testing is available through the local health department, home testing kits, or may be available through other community sources, and explain the differences between "anonymous HIV testing" and "confidential HIV testing";

(d) Explain the possible effect of HIV testing and a positive HIV test result related to employment, insurance, housing, and other potential legal, social, and personal consequences;

(((d))) (e) Develop and maintain a system of referral and make referrals that:

(i) Are accessible and confidential for those counseled;

(ii) Are acceptable to and supportive of those counseled;

(iii) Provide assistance to those counseled in maintaining risk reduction behaviors.

(((e))) (f) Provide at least one individual counseling session at the time HIV test results are disclosed to individuals testing positive; and

(((f))) (g) Maintain disclosure and confidentiality requirements in WAC 246-100-016.

(3) If the individual is assessed by a health care provider to be other than "virtually no risk of HIV infection," as defined in WAC 246-100-208 (3)(e)(v), the person providing pretest counseling shall maintain requirements in subsection (1) and (2) of this section and:

(a) Focus counseling on behaviors increasing the risk of HIV acquisition and transmission;

(b) Provide personalized risk reduction education to individuals who:

(i) Are men engaging in unprotected intercourse with other men at any time since 1977;

(ii) Used intravenous substances at any time since 1977, especially those sharing injection equipment;

(iii) Engaged in sex for money or drugs at any time since 1977;

(iv) Have had sexual and/or injection equipment-sharing contacts at any time since 1977 with persons listed in subsection (3)(b)(i), (ii), and (iii) of this section;

(v) Have been exposed to or diagnosed with a sexually transmitted disease;

(vi) Are at increased risk of HIV infection by definition of United States Public Health Services, Centers for Disease Control;

(vii) Are required by RCW 70.24.095 and 70.24.340 to receive HIV counseling and testing.

(c) Inform any individual planning to be tested for HIV of the need to notify sexual and injection equipment-sharing partners, including spouses, if test results are positive;

(d) Advise individuals listed in subsection (3)(b)(i), (ii), and (iii) of this section not to donate or sell blood, blood products, semen, organs, or other body tissues; and

(e) Emphasize or reemphasize the following counseling messages:

(i) The following will eliminate or decrease the risk of HIV infection:

(A) Sexual abstinence;

(B) A mutually monogamous relationship between uninfected people; and

(C) Following safer sex guidelines.

(ii) Do not share intravenous drugs and injection equipment;

(iii) Do not engage in behaviors in which blood, vaginal fluid, or semen is exchanged;

(iv) Condoms, even if used properly, do not supply absolute protection from HIV infection;

(v) Condoms may reduce risk of HIV infection if the condom is:

(A) Latex and used with a water-based lubricant rather than an oil-based lubricant, if a lubricant is used;

(B) Used in conjunction with spermicide during vaginal or anal intercourse; and

(C) Worn from start to finish of vaginal, oral, and anal intercourse.

(vi) Dental dams may reduce risk of HIV infection if the dental dam is:

(A) Latex; and

(B) Used from start to finish of oral intercourse.

(vii) The sexual behaviors having highest risk for HIV infection are those involving the exchange of blood or semen, especially receptive anal and vaginal intercourse;

(viii) Anal intercourse may increase the risk of condom failure and HIV infection;

(ix) Infected women should postpone pregnancy until more is known about how to prevent prenatal and perinatal transmission of HIV infection;

(x) Sexual negotiation skills can be learned to enhance risk reduction; and

(xi) Other sexually transmitted diseases, especially those causing genital ulcers, may increase the risk of acquiring or transmitting HIV infection.

(f) Make those counseled aware HIV retesting at a later date may be necessary or recommended.

(4) Persons providing post-test counseling shall:

(a) Follow requirements in subsection (1) of this section;

(b) Provide at least one individual counseling session at the time HIV test results are disclosed for individuals:

(i) Testing positive for HIV; or

(ii) Reporting practice of behaviors listed in (3)(b)(i), (ii), and (iii) of this section.

(c) If the individual being counseled tested positive for HIV infection:

(i) Unless testing was anonymous, remind the individual that the identity of the individual testing positive for HIV infection will be confidentially reported to the state or local health officer;

(ii) Provide assistance to persons in notifying partners, including spouses, and confirm those partners including spouses have been notified; and/or

(((ii) Offer)) (iii) Seek agreement to refer the name of the individual((s)) to the local health officer ((as necessary)) for assistance in notifying partners; and/or

(((iii))) (iv) Offer to refer partners for counseling and testing; and

(((iv))) (v) Develop or adopt a system to avoid documenting the names of referred partners in the permanent record of the individual being counseled; and

(((v))) (vi) Offer referral for alcohol and drug and mental health counseling, including suicide prevention, if appropriate; and

(((vi))) (vii) Provide or refer for medical evaluation and antiretroviral treatment; and

(viii) Refer for tuberculosis screening.

[Statutory Authority: RCW 70.24.022, [70.24].340 and Public Law 104-146.  97-15-099, § 246-100-209, filed 7/21/97, effective 7/21/97.  Statutory Authority: RCW 43.20.050 and 70.24.130.  92-02-019 (Order 225B), § 246-100-209, filed 12/23/91, effective 1/23/92.  Statutory Authority: RCW 43.20.050.  91-02-051 (Order 124B), recodified as § 246-100-209, filed 12/27/90, effective 1/31/91.  Statutory Authority: Chapter 70.24 RCW.  89-02-008 (Order 324), § 248-100-209, filed 12/27/88; 88-17-058 (Order 318), § 248-100-209, filed 8/17/88.]

(1) By December 31, 1987, medical laboratories which perform testing or are responsible for referring the specimen to an out-of-state laboratory for testing shall:

(a) Report each positive culture or other suggestive test results to the local health officer by phone, written report, or submission of specimen within two working days, unless specified otherwise, for:

(i) Anthrax (Bacillus anthracis),

(ii) Botulism (Clostridium botulinum),

(iii) Cholera (Vibrio cholerae),

(iv) Diphtheria (Corynebacterium diphtheriae) - toxigenic strains,

(v) Gonorrhea (Neisseria gonorrhoeae) (report within seven days),

(vi) Measles (rubeola) (measles virus),

(vii) Plague (Yersinia pestis),

(viii) Rabies (rabies virus),

(ix) Brucellosis (Brucella species),

(x) Leptospirosis (Leptospira interrogans),

(xi) Listeria infection of blood or spinal fluid (Listeria monocytogenes),

(xii) Meningococcal infection of blood or spinal fluid (N. meningitidis),

(xiii) Pertussis (Bordetella pertussis),

(xiv) Salmonellosis (Salmonella species),

(xv) Shigellosis (Shigella species), and

(xvi) Hepatitis A (positive anti-HAV IgM),

(xvii) Mycobacteriosis,

(xviii) Human immunodeficiency virus (HIV), including positive Western Blot assays, P24 antigen or viral culture tests,

(xix) CD4+(T4) lymphocyte counts less than 200 and/or CD4+(T4) percents less than fourteen percent of total lymphocytes, for patients aged thirteen or older, or positive results on HIV nucleic acid tests (RNA or DNA), (report monthly or quarterly).

(b) For the diseases and conditions listed in (a)(i) through (xvii) of this subsection, send a copy of the state form accompanying specimen submitted as required in WAC 246-100-231 or identifying information including:

(i) Type of specimen tested (e.g., serum or sputum),

(ii) Test result,

(iii) Name of reporting laboratory,

(iv) Date of report,

(v) Name of requesting health care provider or health care facility, and

(vi) Name of patient.

(c) After September 1, 1999, for the diseases and conditions listed in (a)(xviii) and (xix) of this subsection, upon written request of the state department of health, send to the state or local health department identifying information including:

(i) Type of specimen tested (e.g., serum),

(ii) Test result,

(iii) Name of reporting laboratory,

(iv) Date of report,

(v) Name of requesting health care provider or health care facility,

(vi) Name of patient, if submitted by the health care provider, or other patient identifier if the name is not submitted by the health care provider, and

(vii) Patient date of birth and gender, if submitted by the health care provider.

(2) By December 31, 1987, medical laboratories shall report positive cultures or other suggestive test results for chlamydial infection (chlamydia trachomatis) to local health departments monthly including either:

(a) Identifying information specified in subsection (1)(b)(i-vi) of this section, or

(b) Aggregate numbers of positive tests including age, sex, and site of infection when known.

(3) Medical laboratories shall label or stamp reports appropriately with information indicating "reportable disease" and the telephone number of the local health department, if such labels or stamps are provided by the local health department.

(4) State and local health officers and health departments receiving reports from medical laboratories shall:

(a) Allow time for the laboratory to notify the principal health care provider prior to contact if:

(i) Delay is unlikely to jeopardize public health, and

(ii) The laboratory requests a delay.

(b) Try to contact the principal health care provider and discuss circumstances prior to contact of a patient when possible.

(((5) By June 1995, medical laboratories performing CD4+(T4) tests or sending specimens for CD4 testing out-of-state shall submit to the state HIV/AIDS office monthly or quarterly reports on the enumeration of CD4+ (T4) lymphocyte counts (CD4+counts) and CD4+(T4) percents of total lymphocytes (CD4+percents) for specimens submitted after January 1, 1995, of patients aged thirteen or older with CD4+ counts less than two hundred or CD4+percents less than fourteen.  Laboratories may, but are not required to, exclude information concerning specimens which are unrelated to HIV infection or performed in conjunction with medical research, but otherwise shall report the following information:

(a) Patient-specific identifier or anonymous code or, if authorized by the patient, the patient's name submitted to the laboratory; and

(b) Name of the patient's health care provider; and

(c) Address of patient's health care provider; and

(d) CD4+ count (and CD4+ percent if available); and

(e) Date of CD4+ count or CD4+ percent.)) (c) Comply with the requirements of WAC 246-100-036(2).

[Statutory Authority: RCW 70.24.130.  95-13-037, § 246-100-236, filed 6/14/95, effective 7/15/95.  Statutory Authority: Chapter 70.24 RCW.  93-08-036 (Order 354B), § 246-100-236, filed 4/1/93, effective 5/2/93.  Statutory Authority: RCW 43.20.050.  92-02-019 (Order 225B), § 246-100-236, filed 12/23/91, effective 1/23/92; 91-02-051 (Order 124B), recodified as § 246-100-236, filed 12/27/90, effective 1/31/91; 88-07-063 (Order 308), § 248-100-236, filed 3/16/88; 87-11-047 (Order 302), § 248-100-236, filed 5/19/87.]

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