Original Notice.

     Preproposal statement of inquiry was filed as WSR 04-12-119.

     Title of Rule and Other Identifying Information: WAC 246-101-015, 246-101-101, 246-101-201 and 246-101-301, notifiable conditions. The State Board of Health (SBOH) last updated the notifiable conditions chapter in 2000 adding eight "provisionally notifiable" conditions. These eight conditions include: Autism, Birth defects--Abdominal wall defects, Cerebral palsy, Fetal alcohol syndrome/fetal alcohol effects, Hepatitis B (chronic), Hepatitis C (acute and chronic), Herpes simplex (initial genital infection only), and Group A Streptococcus (invasive disease only) which are provisionally notifiable through August 2004. Provisionally notifiable conditions are conditions placed on the notifiable conditions list for four years in order for the Department of Health (DOH) to collect sufficient data and determine if conditions should be made permanently notifiable.

     Additionally, the proposed rule will require laboratories to report cases of Hepatitis B (chronic), Hepatitis C (acute and chronic), and add the national case definitions for human disease caused by insect bites Arthropod Borne virus or arboviral diseases. This includes viral encephalitis (inflammation of the brain) only and removes viral encephalitis from the notifiable conditions list.

     Finally, the last proposed change includes an update in terminology based on recommendations from the maternal and child health section of DOH. The terms Birth defects -- Autism and Birth defects -- Fetal alcohol syndrome/fetal alcohol effects will be updated to Birth defects -- Autism spectrum disorders and Birth defects -- Alcohol related birth defects.

     The change to a permanently notifiable status requires health care providers, health care facilities, and laboratories to report the aforementioned conditions and diagnoses to public health officials.

     Hearing Location(s): Kelso Red Lion Hotel, 510 Kelso Drive, Kelso, WA 98626, on November 10, 2004, at 1:30 p.m.

     Date of Intended Adoption: November 10, 2004.

     Submit Written Comments to: Jovi Swanson, 101 Israel Road, Tumwater, WA 98501, website http://www3.doh.wa.gov/policyreview/, fax (360) 586-7424, by November 1, 2004.

     Assistance for Persons with Disabilities: Contact Jovi Swanson by November 1, 2004, TTY (800) 833-6388 or (360) 236-4028.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposal is to ensure continued reporting of specific conditions and diagnoses by health care providers, laboratories, and facilities to public health officials. The proposal amends WAC 246-101-015, 246-101-101, 246-101-201, and 246-101-301 by striking the provisional status for the eight provisionally notifiable conditions, making seven of the conditions permanently notifiable, moving Hepatitis B and Hepatitis C from a voluntary reporting status to a mandatory reporting status for laboratories, adding the new national case definitions endorsed by the Centers for Disease Control and Prevention Arboviral Disease and eliminating the term viral encephalitis, and updating the terminology within birth defects.

     Reasons Supporting Proposal: Notifiable conditions reporting provides the information necessary for public health officials to track communicable diseases and other conditions. The data collected in notifiable conditions reporting are critical to local health departments and the Department of Health to protect the public health by tracking communicable diseases and other conditions. Public health professionals use these data to treat persons already ill, provide preventative therapies, and to assess broader patterns of disease, historical trends, and geographic clustering.

     Statutory Authority for Adoption: RCW 43.20.050 and 70.24.125.

     Statute Being Implemented: RCW 43.20.050 and 70.24.125.

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

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

     Name of Agency Personnel Responsible for Drafting: Jovi Swanson, 101 Israel Road, Tumwater, WA 98501, (360) 236-4028; Implementation and Enforcement: Maria Courogen, 7211 Cleanwater Lane, Building 14, Olympia, WA 98504-7833, (360) 236-3458; Wendy Krier, 7211 Cleanwater Lane, Building 14, Olympia, WA 98504-7833, (360) 236-3440; Mira Leslie, 1610 N.E. 150th Street, MSTP K-19, Shoreline, WA 98155-7224, (206) 361-2930; and Riley Peters, 7171 Cleanwater Lane, Building 10, Tumwater, WA 98504-7835, (360) 236-2323.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.030 an agency shall prepare a small business economic impact statement whenever a regulation imposes more than minor costs. The current proposed rule does not impose more than minor costs on small businesses.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Jovi Swanson, Department of Health, 101 Israel Road, Town Center 1, Tumwater, WA 98501, phone (360) 236-4028, fax (360) 586-7424, e-mail jovi.swanson@doh.wa.gov.

September 30, 2004

Craig McLaughlin

Acting Executive Director

OTS-7516.5

AMENDATORY SECTION(Amending WSR 00-23-120, filed 11/22/00, effective 12/23/00)

WAC 246-101-015   Provisional condition notification.   This section describes how conditions can become notifiable; what period of time conditions are provisionally notifiable; what analyses must be accomplished during provisional notification status; the transition of provisionally notifiable conditions to permanent notification or deletion of notification requirements. The department's goal for provisionally notifiable conditions is to collect enough information to determine whether requiring notification improves public health.

     (1) The state health officer may:

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

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

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

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

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

     (A) Additional reporting requirements; and

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

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

     (i) The infection is of public health concern;

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

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

     (A) Actions required; and

     (B) Reason for the addition.

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

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

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

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

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

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

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

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

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

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

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

     (3) Based upon the evaluation in subsection (2) of this section, the board will assess results of the evaluation after the particular condition is notifiable or the requirement for laboratories to submit specimens indicative of infections has been in place for no longer than forty months. The board will determine based upon the results of the evaluation whether the provisionally notifiable condition or the requirement for laboratories to submit specimens indicative of infections should be:

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

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

     (c) Deleted from the notifiable conditions system.

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

     (a) Autism (through August, 2004);

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

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

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

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

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

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

     (h) Birth defects - Abdominal wall defects (through August, 2004).

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

[Statutory Authority: RCW 43.20.050. 00-23-120, § 246-101-015, filed 11/22/00, effective 12/23/00.]

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

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

[Statutory Authority: RCW 43.20.050, 70.24.125 and 70.28.010. 00-23-120, § 246-101-101, filed 11/22/00, effective 12/23/00.]

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

Table Lab-1 (Conditions Notifiable by Laboratory Directors)

     Additional notifications that are requested but not mandatory include:

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

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

[Statutory Authority: RCW 43.20.050, 70.24.125 and 70.28.010. 00-23-120, § 246-101-201, filed 11/22/00, effective 12/23/00.]

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

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

[Statutory Authority: RCW 43.20.050, 43.70.545, 70.24.125, 70.28.010 and 70.104.030. 00-23-120, § 246-101-301, filed 11/22/00, effective 12/23/00.]

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