WSR 97-04-041
PERMANENT RULES
DEPARTMENT OF HEALTH
(State Board of Health)
[Filed January 31, 1997, 9:35 a.m.]
Date of Adoption: December 11, 1996.
Purpose: WAC 246-100-207 (3)(a) has been identified as being in conflict with RCW 70.24.325, both of which regulate HIV testing for insurance purposes. The WAC inappropriately limits regulation to only the testing of "blood." The RCW applies to HIV testing performed on any specimen.
Citation of Existing Rules Affected by this Order: Amending WAC 246-100-207.
Statutory Authority for Adoption: RCW 70.24.380.
Adopted under notice filed as WSR 96-22-070 on November 4, 1996.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, amended 0, repealed 0; Federal Rules or Standards: New 0, amended 0, repealed 0; or Recently Enacted State Statutes: New 0, amended 0, repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, amended 0, repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, amended 1, repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, amended 0, repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, amended 0, repealed 0; Pilot Rule Making: New 0, amended 0, repealed 0; or Other Alternative Rule Making: New 0, amended 0, repealed 0.
Effective Date of Rule: Thirty-one days after filing.
January 27, 1996 [1997]
Sylvia Beck
Executive Director
State Board of Health
AMENDATORY SECTION (Amending Order 225B, filed 12/23/91, effective
1/23/92)
WAC 246-100-207 Human immunodeficiency virus (HIV) testing--Ordering--Laboratory screening--Interpretation--Reporting. (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) 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) 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.
(3) 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 ((drawing blood)) 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) Requirements under subsection (3)(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 local health department for interpretation and post-test counseling.
(4) 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) 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 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.
(c) Such information consists of relevant, pertinent facts
communicated in such a way that it will be readily understood by the
recipient.
[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.]