WSR 05-03-055

PERMANENT RULES

STATE BOARD OF HEALTH


[ Filed January 11, 2005, 4:48 p.m. , effective February 11, 2005 ]


     

     Purpose: This rule change will assure continued reporting of specific conditions and diagnoses by health care providers laboratories, and facilities to public health officials. This adoption moves seven conditions from a provisionally notifiable status to permanently notifiable status; moves Hepatitis B and Hepatitis C from a voluntary reporting status to a mandatory reporting status for laboratories; and adds a new national case definition for arboviral disease, to ensure consistency with CDC case definitions.

     Citation of Existing Rules Affected by this Order: Amending WAC 246-101-015, 246-101-101, 246-101-201, and 246-101-301.

     Statutory Authority for Adoption: RCW 43.20.050, 70.24.125.

      Adopted under notice filed as WSR 04-20-067 on October 4, 2004.

     Changes Other than Editing from Proposed to Adopted Version: There are two minor changes between the proposed rule and the adopted rule. In WAC 246-101-201, regarding Hepatitis B virus, the adopted rule does not include "(Chronic) -- initial diagnosis and previously unreported prevalent cases." In WAC 246-101-201, regarding Hepatitis C, the adopted rule does not include the phrase "Acute and Chronic." The board removed this language based on public comment -- this terminology is based on clinical history information, which laboratories do not have. The change will assure that local health departments receive consistent reporting on all Hepatitis B and C cases from laboratories.

     A final cost-benefit analysis is available by contacting Michelle Davis, P.O. Box 47890, Olympia, WA 98504-7890, phone (360) 236-4044, fax (360) 586-7424, e-mail michelle.davis@doh.wa.gov.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 4, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 4, Repealed 0.

     Date Adopted: November 10, 2004.

Craig McLaughlin

Executive Director

OTS-7516.6


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 Monthly √
Hepatitis C 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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