STATE BOARD OF HEALTH
[Filed July 2, 2018, 1:26 p.m.]
Title of Rule and Other Identifying Information: WAC 246-100-011 Definitions, 246-100-207 Human immunodeficiency virus (HIV) testing—Ordering—Laboratory screening—Interpretation—Reporting, and 246-100-208 Counseling standard—AIDS counseling. Amending various sections within Title 246 WAC to reflect the repeal of consent and opt-out options specific to HIV testing.
Hearing Location(s): On August 8, 2018, at 1:30 p.m., at the John A. Cherberg Building, Senate Hearing Room 3 (SHR3), 304 15th Avenue S.W., Olympia, WA 98501.
Date of Intended Adoption: August 8, 2018.
Submit Written Comments to: Caitlin Lang, P.O. Box 47990, Olympia, WA 98504-7990, email https://fortress.wa.gov/doh/policyreview, fax 360-236-4088, by July 31, 2018.
Assistance for Persons with Disabilities: Contact Caitlin Lang, phone 360-628-7342, TTY 360-833-6388 or 711, email email@example.com, by July 25, 2018.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The legislature passed SB 6580 (chapter 158, Laws of 2018), which requires any and all barriers to HIV testing be removed. The purpose of this proposal is to update three state board of health rule sections that contain consent and opt-out options specific to HIV testing to assure alignment with newly revised state law. As a result of the rule change, HIV testing will be subject to the same notification and consent requirements that apply to any other medical test.
Reasons Supporting Proposal: The proposal is necessary to make state board of health rules consistent with requirement changes pursuant to SB 6580 (chapter 158, Laws of 2018). The rule change normalizes HIV and treats it like any other medical testing.
Statutory Authority for Adoption: RCW 70.24.380
Statute Being Implemented: SB 6580 (chapter 158, Laws of 2018).
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington state board of health, governmental.
Name of Agency Personnel Responsible for Drafting: Caitlin Lang, 101 Israel Road S.E., Tumwater, WA 98504-7990, 360-628-7342; Implementation and Enforcement: Claudia Catastini, 310 Israel Road S.E., Tumwater, WA 98504-7838, 360-236-3458.
A school district fiscal impact statement is not required under RCW 28A.305.135
A cost-benefit analysis is not required under RCW 34.05.328
. RCW 34.05.328
(5)(b)(v) exempts rules the content of which is explicitly and specifically dictated by statute.
This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:
Is exempt under RCW 19.85.025
(3) as the rule content is explicitly and specifically dictated by statute.
June 29, 2018
Michelle A. Davis
AMENDATORY SECTION(Amending WSR 14-08-046, filed 3/27/14, effective 4/27/14)
The ((following)) definitions ((shall)) in this section apply ((in the interpretation and enforcement of)) throughout chapter 246-100 WAC unless the context clearly requires otherwise:
(1) "Acquired immunodeficiency syndrome (AIDS)" means illness, disease, or conditions defined and described by the Centers for Disease Control, U.S. Public Health Service, Morbidity and Mortality Weekly Report (MMWR), ((December 18, 1992)) April 11, 2014, Volume ((41)) 63, Number ((RR-17)) RR-03. A copy of this publication is available for review at the department and at each local health department.
(2) "AIDS counseling" means counseling directed toward:
(a) Increasing the individual's understanding of acquired immunodeficiency syndrome; and
(b) Assessing the individual's risk of HIV acquisition and transmission; and
(c) Affecting the individual's behavior in ways to reduce the risk of acquiring and transmitting HIV infection.
(3) "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.
(4) "Board" means the Washington state board of health.
(5) "Case" means a person, alive or dead, having been diagnosed to have a particular disease or condition by a health care provider with diagnosis based on clinical or laboratory criteria or both.
(6) "Child day care facility" means an agency regularly providing care for a group of children for less than twenty-four hours a day and subject to licensing under chapter 74.15
(7) "Communicable disease" means an illness caused by an infectious agent which can be transmitted from one person, animal, or object to another person by direct or indirect means including transmission via an intermediate host or vector, food, water, or air.
(8) "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.
(9) "Contaminated" or "contamination" means containing or having contact with infectious agents or chemical or radiological materials that pose an immediate threat to present or future public health.
(10) "Contamination control measures" means the management of persons, animals, goods, and facilities that are contaminated, or suspected to be contaminated, in a manner to avoid human exposure to the contaminant, prevent the contaminant from spreading, and/or effect decontamination.
(11) "Department" means the Washington state department of health.
(12) "Detention" or "detainment" means physical restriction of activities of an individual by confinement for the purpose of controlling or preventing a serious and imminent threat to public health and may include physical plant, facilities, equipment, and/or personnel to physically restrict activities of the individual to accomplish such purposes.
(13) "Disease control measures" means the management of persons, animals, goods, and facilities that are infected with, suspected to be infected with, exposed to, or suspected to be exposed to an infectious agent in a manner to prevent transmission of the infectious agent to humans.
(14) "Health care facility" means:
(a) Any facility or institution licensed under chapter 18.20
RCW, assisted living facilities, chapter 18.46
RCW, birthing centers, chapter 18.51
RCW, nursing homes, chapter 70.41
RCW, hospitals, or chapter 71.12
RCW, private establishments, clinics, or other settings where one or more health care providers practice; and
(b) In reference to a sexually transmitted disease, other settings as defined in chapter 70.24
(15) "Health care provider" means any person having direct or supervisory responsibility for the delivery of health care who is:
(a) Licensed or certified in this state under Title 18
(b) Is military personnel providing health care within the state regardless of licensure.
(16) "HIV testing" means conducting a laboratory test or sequence of tests to detect the human immunodeficiency virus (HIV) or antibodies to HIV performed in accordance with requirements to WAC 246-100-207. To assure that the protection, including but not limited to, pre- and post-test counseling, ((consent,)) and confidentiality afforded to HIV testing as described in chapter 246-100 WAC also applies to the enumeration of CD4 + (T4) lymphocyte counts (CD4 + counts) and CD4 + (T4) percents of total lymphocytes (CD4 + percents) when used to diagnose HIV infection, CD4 + counts and CD4 + percents will be presumed HIV testing except when shown by clear and convincing evidence to be for use in the following circumstances:
(a) Monitoring previously diagnosed infection with HIV;
(b) Monitoring organ or bone marrow transplants;
(c) Monitoring chemotherapy;
(d) Medical research; or
(e) Diagnosis or monitoring of congenital immunodeficiency states or autoimmune states not related to HIV.
The burden of proving the existence of one or more of the circumstances identified in (a) through (e) of this subsection shall be on the person asserting such existence.
(17) "Infectious agent" means an organism such as a virus, rickettsia, bacteria, fungus, protozoan, or helminth that is capable of producing infection or infectious disease.
(18) "Isolation" means the separation, for the period of communicability or contamination, of infected or contaminated persons or animals from others in such places and under such conditions as to prevent or limit the direct or indirect transmission of the infectious agent or contaminant from those infected or contaminated to those who are susceptible or who may spread the agent or contaminant to others.
(19) "Local health department" means the city, town, county, or district agency providing public health services to persons within the area, as provided in chapter 70.05
RCW and chapter 70.08
(20) "Local health officer" means the individual having been appointed under chapter 70.05
RCW as the health officer for the local health department, or having been appointed under chapter 70.08
RCW as the director of public health of a combined city-county health department, or his or her delegee appointed by the local board of health.
(21) "Nosocomial infection" means an infection acquired in a hospital or other health care facility.
(22) "Outbreak" means the occurrence of cases of a disease or condition in any area over a given period of time in excess of the expected number of cases.
(23) "Post-test counseling" means counseling after the HIV test when results are provided and directed toward:
(a) Increasing the individual's understanding of human immunodeficiency virus (HIV) infection;
(b) Affecting the individual's behavior in ways to reduce the risk of acquiring and transmitting HIV infection;
(c) Encouraging the individual testing positive to notify persons with whom there has been contact capable of spreading HIV;
(d) Assessing emotional impact of HIV test results; and
(e) Appropriate referral for other community support services.
(24) "Pretest counseling" means counseling provided prior to HIV testing and aimed at:
(a) Helping an individual to understand:
(i) Ways to reduce the risk of human immunodeficiency virus (HIV) transmission;
(ii) The nature, purpose, and potential ramifications of HIV testing;
(iii) The significance of the results of HIV testing; and
(iv) The dangers of HIV infection; and
(b) Assessing the individual's ability to cope with the results of HIV testing.
(25) "Principal health care provider" means the attending physician or other health care provider recognized as primarily responsible for diagnosis and treatment of a patient or, in the absence of such, the health care provider initiating diagnostic testing or therapy for a patient.
(26) "Quarantine" means the limitation of freedom of movement of such well persons or domestic animals as have been exposed to, or are suspected to have been exposed to, an infectious agent, for a period of time not longer than the longest usual incubation period of the infectious agent, in such manner as to prevent effective contact with those not so exposed.
(27) "School" means a facility for programs of education as defined in RCW 28A.210.070
(preschool and kindergarten through grade twelve).
(28) "Sexually transmitted disease (STD)" means a bacterial, viral, fungal, or parasitic disease or condition which is usually transmitted through sexual contact, including:
(a) Acute pelvic inflammatory disease;
(c) Chlamydia trachomatis infection;
(d) Genital and neonatal herpes simplex;
(e) Genital human papilloma virus infection;
(g) Granuloma inguinale;
(h) Hepatitis B infection;
(i) Human immunodeficiency virus infection (HIV) and acquired immunodeficiency syndrome (AIDS);
(j) Lymphogranuloma venereum;
(k) Nongonococcal urethritis (NGU); and
(29) "Spouse" means any individual who is the marriage partner of an HIV-infected individual, or who has been the marriage partner of the HIV-infected individual within the ten-year period prior to the diagnosis of HIV-infection, and evidence exists of possible exposure to HIV.
(30) "State health officer" means the person designated by the secretary of the department to serve as statewide health officer, or, in the absence of such designation, the person having primary responsibility for public health matters in the state.
(31) "Suspected case" or "suspected to be infected" means the local health officer, in his or her professional judgment, reasonably believes that infection with a particular infectious agent is likely based on signs and symptoms, laboratory evidence, or contact with an infected individual, animal, or contaminated environment.
(32) "Veterinarian" means an individual licensed under provisions of chapter 18.92
RCW, veterinary medicine, surgery, and dentistry and practicing animal health care.
AMENDATORY SECTION(Amending WSR 13-03-110, filed 1/17/13, effective 2/17/13)
WAC 246-100-207Human immunodeficiency virus (HIV) testing—Ordering—Laboratory screening—Interpretation—Reporting.
(1) Except for persons conducting seroprevalent studies under chapter 70.24
RCW, or ordering or prescribing an HIV test for another individual under subsections (4) and (5) of this section or under WAC 246-100-208(1), any person ordering or prescribing an HIV test for another individual, shall((:
(a) Obtain the consent of the individual, separately or as part of the consent for a battery of other routine tests provided that the individual is specifically informed verbally or in writing that a test for HIV is included; and
(b) Offer the individual an opportunity to ask questions and decline testing; and
(c))), if the HIV test is positive for or suggestive of HIV infection, provide the name of the individual and locating information to the local health officer for follow-up ((to provide)) and post-test counseling as required by WAC 246-100-209.
(2) The local and state health officer or authorized representative shall periodically make efforts to inform providers in their respective jurisdiction about the September 2006 Centers for Disease Control and Prevention "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Healthcare Settings."
(3) Health care providers may obtain a sample brochure about the September 2006 Centers for Disease Control and Prevention "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Healthcare Settings" by contacting the department's HIV prevention program at P.O. Box 47840, Olympia, WA 98504.
(4) Any person authorized to order or prescribe an HIV test for another individual may offer anonymous HIV testing without restriction.
(5) 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)) donations are tested to prevent contamination of the blood supply, tissue, or organ bank donations;
(((c))) (b) At the time of notification regarding a positive HIV test, provide or ensure at least one individual counseling session; and
(((d))) (c) 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.
(6) 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) At the time of notification regarding a positive HIV test, provide or ensure at least one individual counseling session.
(c) Establish procedures to inform an applicant of the following:
(i) Post-test counseling specified under WAC 246-100-209 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.
(7) Laboratories and other places where HIV testing is performed must demonstrate compliance with all of the requirements in the Medical test site rules, chapter 246-338 WAC.
(8) The department laboratory quality assurance section shall accept substitutions for enzyme immunoassay (EIA) screening only as approved by the United States Food and Drug Administration (FDA) and a published list or other written FDA communication.
(9) Persons informing a tested individual of positive laboratory test results indicating HIV infection shall do so only when:
(a) The test or sequence of tests has been approved by the FDA or the Federal Centers for Disease Control and Prevention as a confirmed positive test result; and
(b) Such information consists of relevant facts communicated in such a way that it will be readily understood by the recipient.
(10) Persons may inform a tested individual of the unconfirmed reactive results of an FDA-approved rapid HIV test provided the test result is interpreted as preliminarily positive for HIV antibodies, and the tested individual is informed that:
(a) Further testing is necessary to confirm the reactive screening test result;
(b) The meaning of reactive screening test result is explained in simple terms, avoiding technical jargon;
(c) The importance of confirmatory testing is emphasized and a return visit for confirmatory test results is scheduled; and
(d) The importance of taking precautions to prevent transmitting infection to others while awaiting results of confirmatory testing is stressed.
AMENDATORY SECTION(Amending WSR 10-01-082, filed 12/15/09, effective 1/15/10)
WAC 246-100-208Counseling standard—AIDS counseling.
(1) Principal health care providers providing care to a pregnant woman who intends to continue the pregnancy and is not seeking care to terminate the pregnancy or as a result of a terminated pregnancy shall:
(a) Provide or ensure the provision of AIDS counseling as defined in WAC 246-100-011(2);
(b) ((When ordering or prescribing an HIV test, obtain the informed consent of the pregnant woman for confidential human immunodeficiency virus (HIV) testing, separately or as part of the consent for a battery of other routine tests provided that the pregnant woman is specifically informed verbally or in writing that a test for HIV is included;
(c) Offer the pregnant woman an opportunity to ask questions and decline testing;
(d) Order or prescribe HIV testing if the pregnant woman consents;
(e) If the pregnant woman refuses to consent, discuss and address her reasons for refusal and document in the medical record both her refusal and the provision of education on the benefits of HIV testing; and
(f))) If an HIV test is positive for or suggestive of HIV infection, provide the follow-up and reporting as required by WAC 246-100-209.
(2) ((Health care providers may obtain a sample brochure addressing the elements of subsection (1) of this section by contacting the department of health's HIV prevention program at P.O. Box 47840, Olympia, WA 98504-7840.
(3))) Principal health care providers shall counsel or ensure AIDS counseling as defined in WAC 246-100-011(2) and offer and encourage HIV testing for each patient seeking treatment of a sexually transmitted disease.
Drug treatment programs under chapter 70.96A
RCW shall provide or ensure provision of AIDS counseling as defined in WAC 246-100-011(2) for each person in a drug treatment program.