WSR 04-20-067

PROPOSED RULES

STATE BOARD OF HEALTH


[ Filed October 4, 2004, 12:36 p.m. ]

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.]


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

WAC 246-101-101   Notifiable conditions and the health care provider.   This section describes the conditions that Washington's health care providers must notify public health authorities of on a statewide basis. The board finds that the conditions in the table below (Table HC-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions in Washington. Principal health care providers shall notify public health authorities of these conditions as individual case reports using procedures described throughout this chapter. Other health care providers in attendance shall notify public health authorities of the following notifiable conditions, unless the condition notification has already been made. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

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


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


Notifiable Condition Time frame for Notification Notifiable to Local Health Department Notifiable to State Department of Health
Acquired Immunodeficiency Syndrome (AIDS) Within 3 work days
Animal Bites Immediately
Arboviral Disease Within 3 work days
Asthma, occupational Monthly
Birth Defects Autism (((Provisional through August, 2004))) Spectrum Disorders Monthly
Birth Defects Cerebral Palsy (((Provisional through August, 2004))) Monthly
Birth Defects ((Fetal)) Alcohol ((Syndrome/Fetal Alcohol Effects (Provisional through August, 2004))) Related Birth Defects Monthly
Botulism (foodborne, infant, and wound) Immediately
Brucellosis (Brucella species) Immediately
Campylobacteriosis Within 3 work days
Chancroid Within 3 work days
Chlamydia trachomatis infection Within 3 work days
Cholera Immediately
Cryptosporidiosis Within 3 work days
Cyclosporiasis Within 3 work days
Diphtheria Immediately
Disease of suspected bioterrorism origin (including):

Anthrax

Smallpox

Immediately
Disease of suspected foodborne origin (communicable disease clusters only) Immediately
Disease of suspected waterborne origin (communicable disease clusters only) Immediately
((Encephalitis, viral Within 3 work days ))
Enterohemorrhagic E. coli (shiga-like toxin producing infections only) such as E. coli O157:H7 Infection Immediately
Giardiasis Within 3 work days
Gonorrhea Within 3 work days
Granuloma inguinale Within 3 work days
Haemophilus influenzae (invasive disease, children under age 5) Immediately
Hantavirus pulmonary syndrome Within 3 work days
Hemolytic uremic syndrome Immediately
Hepatitis A (acute infection) Immediately
Hepatitis B (acute infection) Within 3 work days
Hepatitis B surface antigen + pregnant women Within 3 work days
Hepatitis B (chronic) Initial diagnosis, and previously unreported prevalent cases (((Provisional through August, 2004))) Monthly
Hepatitis C Acute and chronic (((Provisional through August, 2004))) Monthly
Hepatitis (infectious), unspecified Within 3 work days
Herpes simplex, neonatal and genital (initial infection only) (((Provisional through August, 2004))) Within 3 work days
Human immunodeficiency virus (HIV) infection Within 3 work days
Legionellosis Within 3 work days
Leptospirosis Within 3 work days
Listeriosis Immediately
Lyme Disease Within 3 work days
Lymphogranuloma venereum Within 3 work days
Malaria Within 3 work days
Measles (rubeola) Immediately
Meningococcal disease Immediately
Mumps Within 3 work days
Paralytic shellfish poisoning Immediately
Pertussis Immediately
Pesticide poisoning (hospitalized, fatal, or cluster) Immediately
Pesticide poisoning (all other) Within 3 work days
Plague Immediately
Poliomyelitis Immediately
Psittacosis Within 3 work days
Q Fever Within 3 work days
Rabies (Confirmed Human or Animal) Immediately
Rabies (Including use of post-exposure prophylaxis) Within 3 work days
Relapsing fever (borreliosis) Immediately
Rubella (including congenital rubella syndrome) Immediately
Salmonellosis Immediately
Serious adverse reactions to immunizations Within 3 work days
Shigellosis Immediately
((Streptococcus, Group A, Invasive (Indicated by blood, spinal fluid or other normally sterile site) (Provisional through August, 2004) Within 3 work days ))
Syphilis Within 3 work days
Tetanus Within 3 work days
Trichinosis Within 3 work days
Tuberculosis Immediately
Tularemia Within 3 work days
Typhus Immediately
Vibriosis Within 3 work days
Yellow fever Immediately
Yersiniosis Within 3 work days
Other rare diseases of public health significance Immediately
Unexplained critical illness or death Immediately

[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.]


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

WAC 246-101-201   Notifiable conditions and laboratories.   This section describes the conditions about which Washington's laboratories must notify public health authorities of on a statewide basis. The board finds that the conditions in the table below (Table Lab-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions in Washington. The board also finds that submission of specimens for many of these conditions will further prevent the spread of disease. Laboratory directors shall notify public health authorities of positive cultures and preliminary test results as individual case reports and provide specimen submissions using procedures described throughout this chapter. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

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


Table Lab-1 (Conditions Notifiable by Laboratory Directors)


Notifiable Condition Time frame for Notification Notifiable to Local Health Department Notifiable to Department of Health Specimen Submission to Department of Health (Type & Timing)
Arboviral Disease (Isolation; Detection of Viral Nucleic Acid or Antibody) 2 days
Blood Lead Level Elevated Levels 2 Days

Nonelevated Levels Monthly

Botulism (Foodborne) Immediately Serum and Stool - If available, submit suspect foods (2 days)
Botulism (Infant) Immediately Stool (2 days)
Botulism (Wound) Immediately Culture, Serum, Debrided tissue, or Swab sample (2 days)
Brucellosis (Brucella species) 2 days Subcultures (2 days)
CD4+ (T4) lymphocyte counts less than 200 and/or CD4+ (T4) percents less than fourteen percent of total lymphocytes (patients aged thirteen or older) Monthly Only when the local health department is designated by the Department of Health
Chlamydia trachomatis infection 2 days
Cholera Immediately Culture (2 days)
Cryptosporidiosis 2 days
Cyclosporiasis 2 days Specimen (2 days)
Diphtheria 2 days Culture (2 days)
Disease of Suspected Bioterrorism Origin (examples):

Anthrax

Smallpox

Immediately Culture (2 days)
Enterohemorrhagic E. coli (shiga-like toxin producing infections only) such as E. coli O157:H7 Infection 2 days Culture (2 days)
Gonorrhea 2 days
Hepatitis A (IgM positive) 2 days
Hepatitis B (chronic) Initial diagnosis, and previously unreported prevalent cases Monthly
Hepatitis C Acute and chronic Monthly
Human immunodeficiency virus (HIV) infection (including positive Western Blot assays, P24 antigen or viral culture tests) 2 days Only when the local health department is designated by the Department of Health √ (Except King County)
Human immunodeficiency virus (HIV) infection (positive results on HIV nucleic acid tests (RNA or DNA)) Monthly Only when the local health department is designated by the Department of Health √ (Except King County)
Listeriosis 2 days
Measles (rubeola) Immediately Serum (2 days)
Meningococcal disease 2 days Culture (Blood/CSF or other sterile sites) (2 days)
Pertussis 2 days
Plague Immediately Culture or other appropriate clinical material (2 days)
Rabies (human or animal) Immediately √ (Pathology Report Only) Tissue or other appropriate clinical material (Upon request only)
Salmonellosis 2 days Culture (2 days)
Shigellosis 2 days Culture (2 days)
Syphilis Serum (2 days)
Tuberculosis 2 days Culture (2 days)
Tuberculosis (Antibiotic sensitivity for first isolates) 2 days
Tularemia Culture or other appropriate clinical material (2 days)
Other rare diseases of public health significance Immediately

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.]


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

WAC 246-101-301   Notifiable conditions and health care facilities.   This section describes the conditions that Washington's health care facilities must notify public health authorities of on a statewide basis. The board finds that the conditions in the table below (Table HF-1) are notifiable for the prevention and control of communicable and noninfectious diseases and conditions. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction. Health care facilities are required to notify public health authorities of cases that occur in their facilities. Health care facilities may choose to assume the notification for their health care providers for conditions designated in Table HF-1. Health care facilities may not assume the reporting requirements of laboratories that are components of the health care facility. Local health officers may require additional conditions to be notifiable within the local health officer's jurisdiction.

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


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


Notifiable Condition Time frame for Notification Notifiable to Local Health Department Notifiable to State Department of Health
Acquired Immunodeficiency Syndrome (AIDS) Within 3 work days
Animal Bites Immediately
Arboviral Disease Within 3 work days
Asthma, occupational Monthly
Birth Defects Abdominal Wall Defects (inclusive of gastroschisis and omphalocele) (((Provisional through August, 2004))) Monthly
Birth Defects Autism (((Provisional through August, 2004))) Spectrum Disorders Monthly
Birth Defects Cerebral Palsy (((Provisional through August, 2004))) Monthly
Birth Defects Down Syndrome Monthly
Birth Defects Fetal Alcohol ((Syndrome/Fetal Alcohol Effects (Provisional through August, 2004))) Related Birth Defects Monthly
Birth Defects Hypospadias Monthly
Birth Defects Limb reductions Monthly
Birth Defects Neural Tube Defects (inclusive of anencephaly and spina bifida) Monthly
Birth Defects Oral Clefts (inclusive of cleft lip with/without cleft palate) Monthly
Botulism (foodborne, infant, and wound) Immediately
Brucellosis (Brucella species) Immediately
Cancer (See chapter 246-430 WAC) Monthly
Chancroid Within 3 work days
Chlamydia trachomatis infection Within 3 work days
Cholera Immediately
Cryptosporidiosis Within 3 work days
Cyclosporiasis Within 3 work days
Diphtheria Immediately
Disease of suspected bioterrorism origin (including):

Anthrax

Smallpox

Immediately
Disease of suspected foodborne origin (communicable disease clusters only) Immediately
Disease of suspected waterborne origin (communicable disease clusters only) Immediately
((Encephalitis, viral Within 3 work days ))
Enterohemorrhagic E. coli (shiga-like toxin producing infections only) such as E. coli O157:H7 Infection Immediately
Giardiasis Within 3 work days
Gonorrhea Within 3 work days
Granuloma inguinale Within 3 work days
Gunshot wounds (nonfatal) Monthly
Haemophilus influenzae (invasive disease, children under age 5) Immediately
Hantavirus pulmonary syndrome Within 3 work days
Hemolytic uremic syndrome Immediately
Hepatitis A (acute infection) Immediately
Hepatitis B (acute infection) Within 3 work days
Hepatitis B surface antigen+ pregnant women Within 3 work days
Hepatitis B (chronic) Initial diagnosis, and previously unreported prevalent cases (((Provisional through August, 2004))) Monthly
Hepatitis C Acute and chronic (((Provisional through August, 2004))) Monthly
Hepatitis (infectious), unspecified Within 3 work days
Human immunodeficiency virus (HIV) infection Within 3 work days
Legionellosis Within 3 work days
Leptospirosis Within 3 work days
Listeriosis Immediately
Lyme Disease Within 3 work days
Lymphogranuloma venereum Within 3 work days
Malaria Within 3 work days
Measles (rubeola) Immediately
Meningococcal disease Immediately
Mumps Within 3 work days
Paralytic shellfish poisoning Immediately
Pertussis Immediately
Pesticide poisoning (hospitalized, fatal, or cluster) Immediately
Plague Immediately
Poliomyelitis Immediately
Psittacosis Within 3 work days
Q Fever Within 3 work days
Rabies (Confirmed Human or Animal) Immediately
Rabies (Use of post-exposure prophylaxis) Within 3 work days
Relapsing fever (borreliosis) Immediately
Rubella (including congenital rubella syndrome) Immediately
Salmonellosis Immediately
Serious adverse reactions to immunizations Within 3 work days
Shigellosis Immediately
((Streptococcus, Group A Invasive (Indicated by blood, spinal fluid or other normally sterile site) (Provisional through August, 2004) Within 3 work days ))
Syphilis Within 3 work days
Tetanus Within 3 work days
Trichinosis Within 3 work days
Tuberculosis Immediately
Tularemia Within 3 work days
Typhus Immediately
Vibriosis Within 3 work days
Yellow fever Immediately
Yersiniosis Within 3 work days
Other rare diseases of public health significance Immediately
Unexplained critical illness or death Immediately

[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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