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Updated December 5, 2005
CHAPTER 333 - DIVISION 12
PROCEDURAL RULES
Acquired Immunodeficiency Syndrome
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333-012-0250
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AIDS Drug Assistance Program
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333-012-0260
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Definitions
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333-012-0262
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Scope
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333-012-0264
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Procedures for Determining HIV and Hepatitis B Status of Source Person Following Occupational Exposure to Body Fluids
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333-012-0265
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Informed Consent
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333-012-0266
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Procedures for Soliciting HIV Testing Following Occupational Exposures to Body Fluids
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333-012-0267
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Procedures Following Substantial Exposure of a Patient by a Health Care Worker
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333-012-0268
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Other Procedures to be Followed
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333-012-0269
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Procedures for Mandatory HIV Testing Following Occupational Exposure to Body Fluids
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333-012-0270
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Confidentiality
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CHAPTER 333 - DIVISION 18; Disease Reporting
333-012-0250
AIDS Drug Assistance Program
(1) Purpose. The AIDS Drug Assistance Program (ADAP) provides medications for the treatment of HIV disease. The program is primarily funded through Title II of the Ryan White CARE Act, which provides grants to States and Territories. The Department of Human Service shall administer the federal funds awarded under Title II of the Ryan White Care Act for the State of Oregon.
(2) Services. Program funds may be used to provide access to medication, purchase health insurance for eligible clients and services that enhance access, adherence, and monitoring of drug treatments.
(3) Eligibility: Individuals must provide documentation of a HIV diagnosis and meet income and resource guidelines as set by the Department of Human Services and other criteria as defined in the Ryan White Care Act.
(4) This program shall be in effect as long as authorized funds are available.
(5) The Department of Human Services will periodically re-evaluate its experience with the program in order to fully utilize the funds available.
Stat. Auth.: ORS 431, 432, 433 & 434
Stats. Implemented:
Hist.: HD 14-1987(Temp), f. & ef. 9-30-87; HD 9-1988, f. 5-11-88, cert. ef. 5-12-88; HD 1-1990(Temp), f. & cert. ef. 1-8-90; PH 9-2005, f. 6-15-05, cert. ef. 6-21-05
Acquired Immunodeficiency Syndrome
333-012-0260
Definitions
For purposes of OAR 333-012-0260 through 333-012-0270, the following definitions shall apply:
(1) "AIDS" refers to the acquired immunodeficiency syndrome, which is caused by infection with the human immunodeficiency virus (HIV). An individual is considered to have AIDS only when the consequences of the HIV infection has reached the stage that meets strict clinical criteria published by the United States Public Health Service's Centers for Disease Control and Prevention in the "Morbidity and Mortality Weekly Report", December 18, 1992, Volume 41, Number RR-17, pages 1- 4, which publication is hereby adopted by reference.
(2) "Division" means the Oregon Health Division of the Oregon Department of Human Resources.
(3) "Employer Representative" means a person, representing the employer of the exposed worker, who is responsible for compliance with OR-OSHA regulations (as defined in OAR 333-012-0280(5)).
(4) "Exposed Patient" means a person receiving health care who receives an exposure that may, on evaluation, be determined to have been a substantial exposure from the health care worker administering health care to the patient.
(5) "Exposed Worker" means a worker who experiences a substantial occupational exposure.
(6) "Health Care Representative" means a person with authority to make health care decisions for another person who is incapable of consent to health care.
(7) "HIV Test" means a Food and Drug Administration (FDA) approved test of an individual for the presence of the human immunodeficiency virus (HIV), or for antibodies or antigens that result from HIV infection, or for any other substance specifically associated with HIV infection and not with other diseases or conditions.
(8) A "HIV-Positive Test" means a positive result on the most definitive HIV test procedure used to test a particular individual. In the absence of the recommended confirming tests, this means the result of the initial test done.
(9) "Licensed Health Care Facility" means a facility as defined in ORS 442.015 and a mental health facility, alcohol treatment facility or drug treatment facility licensed or operated under ORS Chapters 426 or 430.
(10) "Licensed Health Care Provider" means a person licensed or certified to provide health care under ORS Chapters 677, 678, 689, 680, 684 or 685 or ORS 823.150, or under comparable statutes of any other state.
(11) "Licensed Physician" means any physician who is licensed by the Board of Medical Examiners for the State of Oregon, State Board of Podiatry Examiners, State Board of Chiropractic Examiners, or Naturopathic Board of Examiners.
(12) "Local Health Department" means the local health department administrator or his/her designated representative.
(13) "Occupational Exposure" means a substantial exposure of a worker during the performance of the worker's occupation.
(14) "Person(s)" includes, but is not limited to, any licensed physician; other licensed health care provider; licensed health care facility; mental health facility, alcohol treatment facility, or drug treatment facility not licensed as a licensed health care facility under ORS Chapter 441; clinical laboratory; blood or sperm bank; plasma center; insurer; insurance agent; insurance-support organization as defined in ORS 746.600; government agency; employer; research organization; or agent of any of the foregoing.
(15) "Source Person" means a person whose body fluids were the source of a substantial exposure.
(16) "Substantial Exposure" means contact with blood or blood components, semen, or vaginal/cervical secretions through percutaneous inoculation or contact with an open wound, nonintact skin, or mucous membrane of the exposed person. Substantial exposure includes contact with other body fluids only if they are visibly contaminated with blood. In situations at accident sites and in other uncontrolled environments with poor lighting where it is not possible to evaluate if the fluids were visibly contaminated with blood, contact with fluids that reasonably may have been so contaminated constitutes substantial exposure.
(17) "Worker" means a person who is licensed or certified to provide health care under ORS Chapters 677, 678, 679, 680, 682, 684 or 685, an employee of a health care facility, of a licensed health care provider or of a clinical laboratory, as defined in ORS 438.010(1), a firefighter, a law enforcement officer, as defined in ORS 30.795, a corrections officer or a probation officer.
[Publications: The publication(s) referred to or incorporated by reference in this rule are available from theagency.]
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433-006 & ORS 433.065
Hist.: HD 5-1988, f. 3-15-88, cert. ef. 3-18-88; HD 25-1990, f. & cert. ef. 12-17-90; HD 29-1994, f. & cert. ef. 12-2-94; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0262
Scope
OAR 333-012-0265 and 333-012-0270 pertain to the provisions of ORS 433.045 regarding informed consent for HIV testing and confidentiality of HIV test results. OAR 333-012-0266 through 333-012-0269 pertain to the provisions of ORS 433.065 regarding procedures for testing of source persons involved in the occupational exposure to body fluids, ORS 433.075 regarding content of employer-provided prevention, education and testing programs for human immunodeficiency virus, and ORS 433.080 regarding mandatory testing of source persons to help prevent further spread of HIV from persons exposed to the virus in occupational settings. OAR 333-012-0280 through 333-012-0400 are promulgated under the authority of ORS 431.110(1)(e) and 433.004(1)(d) and regard the prevention of transmission of hepatitis B virus and HIV from an infected health care worker to a patient in an occupational setting.
Stat. Auth.: ORS 431.110(1)(e), ORS 433.004(1)(d) & ORS 433.045 - ORS 433.080
Stats. Implemented:
Hist.: HD 5-1988, f. 3-15-88, cert. ef. 3-18-88; HD 25-1990, f. & cert. ef. 12-17-90; HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0264
Procedures for Determining HIV and Hepatitis B Status of Source Person Following Occupational Exposure to Body Fluids
(1) Any worker who experiences an occupational exposure may make a confidential written report of the incident and request for intervention to the health care provider and/or health care facility primarily responsible for the care of the source person. The employer representative may also make such a report and/or request.
(2) A health care facility shall establish and follow written procedures by which such reports and requests are first presented to the facility by the exposed worker and then, in turn, by the facility to the source person's primary health care provider;
(3) When the care of the source person is not being provided in a health care facility, the exposed worker or their employer representative may make the report and request for intervention directly to the source person's health care provider or if the source person's health care provider is unknown, the local health department (see sections 5(a)-(d) below);
(4) Once the report is received, the health care facility or source person's health care provider shall evaluate the evidence that the exposure was substantial. If the facility or source person's health care provider judge that the exposure was not substantial, the exposed worker may request their own health care provider to evaluate whether or not the exposure was substantial. If the respective health care providers do not agree, the local health department administrator or designee shall decide whether or not the exposure is substantial, upon request. If it is judged to have been a substantial exposure, the source person's health care provider shall notify the exposed worker whether the source person has been tested for HIV or for hepatitis B or C, and, if so, what the test results were, provided that:
(a) The individual whose HIV or hepatitis B or C test information is released is notified in writing of this disclosure; and
(b) The identity of the person tested for HIV or hepatitis B or C is not explicitly disclosed during the notification process. Any individual who has HIV or hepatitis B or C information about another individual pursuant to this subsection shall not disclose the identity of that tested individual, or the results of such a test in a manner which permits identification of that tested individual without that individual's specific written authorization, except as otherwise required or permitted by Oregon law.
(5) The exposed worker or their employer representative may make a written report of the substantial exposure and request for intervention to the local public health department for the jurisdiction in which the exposure occurred, if any of the following circumstances exist:
(a) A specimen is not obtained from the source person within two working days after the written report is received by the source person's health care provider, regardless of the reason;
(b) No health care provider for the source person is known;
(c) The health care provider who has received a report of an occupational exposure and request for intervention finds that the facts stated do not demonstrate that a substantial exposure has occurred;
(6) Under any of these circumstances, the local public health officer will review the facts and decide whether a substantial exposure did in fact occur.
(7) Intervention by the local public health department. When the local public health administrator is notified of an occupational exposure, within two working days he or she shall follow the procedures outlined above in sections 4(a) and (b).
(8) Pursuant to ORS 433.065 and 433.006, an exposed worker shall be offered information about HIV and Hepatitis B or C infections, methods of preventing HIV or Hepatitis B or C infections, HIV and Hepatitis B or C tests and assistance in following the procedures outlined above. For employed workers this information and assistance shall be provided by the employer of the worker. Persons who are self-employed may obtain this information and assistance from a representative of the local health department.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433.006 & ORS 433.065
Hist.: HD 29-1994, f. & cert. ef. 12-2-94; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0265
Informed Consent
(1) General scope. Pursuant to ORS 433.045(1), no person shall submit the blood of an individual to an HIV test without first obtaining informed consent or ascertaining that informed consent is obtained. This requirement does not apply to the HIV testing of deceased persons in the anatomical gift setting (ORS 97.265, subsection 4) or the official medical examiner setting or where a clinical laboratory performs an HIV test on a specimen obtained outside of Oregon.
(2) Who may give consent:
(a) Anyone permitted by the laws of Oregon to give consent to medical procedures for a particular individual may give consent for HIV testing of that individual;
(b) A minor under 15 years of age may also give consent.
(3) Statutory exceptions to the requirement of informed consent prior to HIV testing:
(a) Pursuant to ORS 433.055(3), informed consent for an HIV test need not be obtained from an individual if the test is for the purpose of research as authorized by the Division and if the testing is performed in a manner by which the identity of the individual is not known, and may not be retrieved by the researcher;
(b) Pursuant to Section 20(4), Chapter 600, Oregon Laws 1987, informed consent for an HIV test need not be obtained from an individual convicted of sex crimes or drug-related crimes who is tested for HIV infection by the Oregon Department of Corrections after being screened for and found to have evidence for possible exposure to HIV;
(c) Nothing herein is intended to exclude any other exceptions that may arise under Oregon law.
(4) Informed consent for HIV tests ordered by licensed physicians. In obtaining informed consent for an HIV test, a licensed physician shall follow the procedure in ORS 677.097.
(5) Informed consent for HIV tests ordered by other licensed health care providers or persons acting on behalf of licensed health care facilities. In obtaining informed consent for an HIV test, an other licensed health care provider or persons acting on behalf of a licensed health care facility shall use a procedure that is substantially similar to that specified in ORS 677.097.
(6) Informed consent for HIV tests ordered or arranged for by insurers, insurance agents, or insurance support organizations. In obtaining informed consent for an HIV test, an insurer, insurance agent, or insurance support organization as defined in ORS 746.600, or persons acting in behalf thereof, shall comply with the rules of the Insurance Division, OAR 836-050-0200 through 836-050-0255, which contain substantially the same procedures as specified in subsection (7)(a) of this rule.
(7) Informed consent for HIV tests ordered or arranged for by any persons other than those covered in sections (4), (5), and (6) of this rule. Informed consent for HIV tests ordered or arranged for by any persons other than: licensed physicians; other licensed health care providers; persons acting on behalf of licensed health care facilities; or insurers, insurance agents, and insurance-support organizations, as defined in ORS 746.600, shall be obtained as specified in this section:
(a) Procedure for informed consent. Except as provided in subsection (b) of this section, in order to obtain informed consent for an HIV test of an individual, any person subject to section (7) of this rule shall carry out the following procedure:
(A) Provide the individual for his/her retention a copy of the form as specified in Appendix 1;
(B) Orally summarize for the individual the substance of the statement in Appendix 1 and specify alternatives to the HIV test in the particular instance, and if the test information will be disclosed to others, who those others will be;
(C) Explain the risks from having the HIV test. This shall include a description of Oregon law pertaining to the confidentiality of information about an individual having the test and that individual's test results; a statement that there may be circumstances under which disclosure might be permitted or required without consent; and a statement of the potential consequences in regards to insurability, employment, and social discrimination if the HIV test results become known to others;
(D) Inform the individual that he or she has the right to request additional information from a knowledgeable person before giving consent;
(E) Ask the individual to be tested whether he/she has any further questions, and if so, provide the individual a full and complete opportunity to ask those questions and receive answers from a person who is sufficiently knowledgeable to give accurate and complete answers about AIDS, HIV tests and the consequences of being tested or not tested;
(F) Have the individual sign a consent form as specified in Appendix 1, after having had an opportunity to read it;
(G) Maintain the signed form as specified in Appendix 1 for at least seven years.
(b) Exemptions from use of the form as specified in Appendix 1:
(A) Blood banks, plasma centers, and sperm banks may apply to the administrator of the Division for exemption from mandatory use of a form as specified in Appendix 1. In order to be eligible for such exemption, the blood bank, plasma center, or sperm bank must use a form or forms having a content substantially similar to that specified in Appendix 1. Approval of exemption by the administrator shall be in writing and shall be effective as to the form or forms approved for use under the application. The application must be in writing, dated and signed by the executive officer of the blood bank, plasma center, or sperm bank, and include a copy of the form or forms for which exemption is requested;
(B) If exemption is granted, all procedures specified in paragraphs (7)(a)(B) - (G) of this rule shall be applied in using the approved form adopted by the blood bank, plasma center, or sperm bank.
[ED. NOTE: The Appendix referenced in this rule is not printed in the OAR Compilation. Copies are available from theagency.]
Stat. Auth.: ORS 433
Stats. Implemented:
Hist.: HD 5-1988, f. 3-15-88, cert. ef. 3-18-88; HD 29-1994, f. & cert. ef. 12-2-94
333-012-0266
Procedures for Soliciting HIV Testing Following Occupational Exposures to Body Fluids
(1) Pursuant to ORS 433.065, concerning who may request that testing be done and the procedures to be followed in obtaining test results:
(1) Procedures described under Section 333-012-0264 should be followed. If it is judged that the exposure was substantial, the source person's health care provider or local health department shall approach the source person or the source person's health care representative and solicit consent to testing. This rule applies both to exposed workers who are employed by the facility and to exposed workers whose substantial exposure occurs during preadmission care of source persons transported to that facility;
(2) When the source person is deceased, a request for consent to testing under this section shall be made to the person having the right to control the remains of the decedent, as specified in ORS 97.130. When a source person is unable to give consent as determined by the health care provider, anyone permitted by the laws of Oregon to give consent to medical procedures for a particular individual may give consent for HIV testing of that individual. If, within reasonable effort, such a person cannot be found, consent may be given by two physicians lisenced to practive medicine in the state of Oregon.
(3) The fact that a request for consent to a test was made, the date of the request, and whether or not the source person or the source person's health care representative consented to be tested shall be recorded in writing and signed by the health care provider or local public health administrator or designee requesting consent. This record shall immediately be made available to the exposed worker.
(4) If consent for testing is given, the HIV test results may be released to the exposed worker provided that :
(a) The individual whose HIV test results are released is notified in writing of this disclosure; and
(b) The identity of the person tested for HIV is not explicitly disclosed during the notification process. Any individual who has HIV information about another individual pursuant to this subsection shall not disclose the identity of that tested individual, or the results of such a test in a manner which permits identification of that tested individual without that individual's specific written authorization, except as otherwise required or permitted by Oregon law.
(5) If consent for HIV testing is refused, see section 333-012-0269 for procedures for mandatory HIV testing.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433.006 & ORS 433.065
Hist.: HD 25-1990, f. & cert. ef. 12-17-90; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0267
Procedures Following Substantial Exposure of a Patient by a Health Care Worker
(1) Any worker who has been the source of a substantial exposure to a patient while administering health care to that patient shall cause that exposure to be reported in writing to the exposed patient and to the worker's employer or health care facility where the exposure occurred within two days of the incident. Upon request by the health care worker or health care facility, the local health department shall provide assistance in making this notification to the exposed patient. The report shall advise the exposed patient if the worker will consent to an HIV test if it is requested. If the worker does not consent, the report will indicate that the exposed patient may request, with the assistance of the local public health department, the worker to consent to an HIV test. If two days have passed after a substantial exposure and a witness to the incident has reason to believe the patient has not been notified of the substantial exposure, the witness shall, if a worker, and may, if not a worker, notify either the health care worker's employer or the local health department and provide details of the incident.
(2) An exposed patient who has received a report of an exposure under section (1) of this rule may make a written request for intervention to the local public health administrator. Upon receipt of the report, the local health department administrator or designee shall, within two working days, request the health care worker to consent to testing. The fact that a request for consent to a test or tests was made, the date of the request and whether or not the source person consented to be tested shall be recorded in writing and signed by the local public health administrator or designee requesting the consent. The record shall immediately be made available to the exposed patient.
(3) Pursuant to ORS 433.065, a patient who has experienced a substantial exposure by a person providing them health care shall be offered information about HIV infection, methods of preventing HIV infection, and HIV tests. This information will be provided by the patient's primary care provider. Upon request by the patient's health care provider, the local health department administrator or designee shall provide assistance in providing this information to the exposed patient.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433.006 & ORS 433.065
Hist.: HD 25-1990, f. & cert. ef. 12-17-90; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0268
Other Procedures to be Followed
(1) When an HIV test is performed pursuant to OAR 333-012-0269, the blood specimen must be drawn by a licensed physician or another licensed health care provider under the supervision of a licensed physician or licensed nurse practitioner. The test(s) must be performed in a licensed clinical laboratory, which will report the results only to an authorized person pursuant to ORS 438.430. Once received from the laboratory, test results shall be reported confidentially both to the source person and to the person who suffered the substantial exposure giving rise to the test.
(2) Except as provided in ORS 433.080, the informed consent provisions of OAR 333-012-0265 and the confidentiality provisions of OAR 333-012-0270 shall apply to HIV testing pursuant to OAR 333-012-0267 and 333-012-0269.
(3) Pursuant to ORS 433.075(4), where an employer provides a program of prevention, education and testing for HIV exposures for its employees, the program will be considered to be approved by the Oregon Health Division if the employee to be tested receives counseling regarding infection control, uniform body fluids precautions, sexual/needle-sharing abstinence and safer sex practices including advice about precautionary measures to be taken with partners at risk of exposure to HIV while test results are pending. The Oregon Health Division will make the educational materials needed for such a program available at cost to any employer who requests such materials in writing. Laboratories used for testing services must comply with College of American Pathologists or U.S. Centers for Disease Control proficiency standards on a regular basis. If an employer does not have a testing program in place, the employer shall notify the exposed worker of a health care provider who will perform testing, or an exposed worker may seek medical treatment from a health care provider of his or her choice.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433.006 & ORS 433.065
Hist.: HD 25-1990, f. & cert. ef. 12-17-90; HD 29-1994, f. & cert. ef. 12-2-94; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0269
Procedures for Mandatory HIV Testing Following Occupational Exposure to Body Fluids
(1) The provisions of ORS 433.080, which describe the legal petition process for mandatory testing of a source person, may be invoked only if the petitioner:
(a) Has received a substantial exposure, and at the time of exposure either was an exposed worker or was a patient exposed to a health care worker during the provision of health care services;
(b) Has followed the procedures for soliciting voluntary HIV testing following occupational exposures to body fluids as outlined in OAR 333-012-0266;
(3) Provides written documentation from a licensed health care provider that the petitioner meets the above criteria (subsections (a) and (b)). Once this documentation is received, mandatory testing must be done within three weeks following the petition, if, on adjudication, it is found that the petitioner's claim has merit.
(2) The exposed worker/patient must agree to undergo HIV testing in order to activate the mandatory provisions of ORS 433.080. Written certification from a health care provider that such a test specimen has been submitted must be provided at the time the petition is filed to request a court order for mandatory testing of the source person.
(3) The mandatory provisions of ORS 433.080 shall only be activated if decisions regarding a specific medical intervention, such as post-exposure prophylaxis, will be significantly influenced based on the results of the test.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented: ORS 433.006 & ORS 433.065
Hist.: HD 25-1990, f. & cert. ef. 12-17-90; HD 7-1997, f. & cert. ef. 6-26-97
333-012-0270
Confidentiality
(1) General. Pursuant to ORS 433.045(3), no person shall disclose or be compelled to disclose the identity of any individual upon whom an HIV test is performed, or the results of such a test in a manner which permits identification of the subject of the test, except as required or permitted by the law of this state or any rule, or as authorized by the individual whose blood is tested.
(2) Disclosure to or for tested individual. HIV test results may be disclosed to the tested individual. HIV test results may be disclosed to the person ordering the test and to any other individual authorized by the laws of Oregon to give consent to medical procedures for the individual.
(3) Medical records. When a licensed physician, other licensed health care provider, or licensed health care facility obtains an HIV test of an individual, the test result and documentation of informed consent may be entered into the routine medical record of that individual maintained by that licensed physician, other licensed health care provider, or licensed health care facility. The information in the record may be seen by, or shared orally with, persons who must review the record for the purpose of delivering health care to the individual or for routine administrative procedures. When necessary, the record may be photocopied and the copies distributed to persons to facilitate the delivery of health care to the individual and for administrative purposes. Those with such access to the medical record may not disclose the identity of the tested individual, or the results of such a test, in a manner which permits identification of the tested individual without that individual's specific written authorization, except as required or permitted by Oregon law.
(4) HIV test results may be disclosed to licensed physicians or other licensed health care providers providing care to the tested individual when knowledge of the test results is specifically needed to provide optimal emergency diagnosis and/or treatment to the individual and the individual is unable to authorize such disclosure.
(5) A physician may notify an individual who has had a substantial exposure to another individual whether that individual has been HIV tested, and, if so, what the test results were, provided that:
(a) The individual whose HIV test information released is notified in writing of this disclosure; and
(b) The identity of the HIV tested person is not explicitly disclosed during the notification process. Any individual who has HIV test information about another individual pursuant to this subsection shall not disclose the identity of that tested individual, or the results of such a test in a manner which permits identification of that tested individual without that individual's specific written authorization, except as required or permitted by Oregon law.
(6) Reporting HIV test results to public health authorities. Reporting the identity and test result of an individual with a HIV-positive test result to the local health department or Division on a death certificate, or as required or permitted by OAR 333-018-0000 through 333-018-0030 is not a breach of confidentiality.
(7) In the anatomical gift setting, the identity of an HIV tested deceased individual and that individual's HIV test results may be released to a licensed physicians, other licensed health care providers, or licensed health care facilities to the minimum extent necessary to prevent contaminated anatomical parts from being transplanted into other individuals.
(8) Disclosure with authorization. Possession of HIV test information does not confer the right to disclose this information to others, except as permitted by Oregon law:
(a) HIV test results and the identity of the tested individual may be released to any other party only with the specific written authorization of the tested individual. This includes authorization for release of information to third-party payors. General consent for release of medical records is not sufficient. If, in the judgement of the attending licensed physician and one other licensed physician, the patient is incapable of making health care decisions, then anyone permitted by the laws of Oregon to give consent to medical procedures for a particular individual may give consent for release of HIV test results of that individual. The authorization for release of HIV test information must specifically include:
(A) The statement that HIV test information may be released;
(B) The specific purpose for which the information may be released;
(C) Those to whom the information may be released;
(D) The specific time period during which the release may occur;
(E) The date of the authorization, and the signature of the individual giving authorization.
(b) If a clinical laboratory is instructed, by the person ordering the test, to bill a third party payor for an HIV test of an individual, the laboratory may presume that consent for such billing has been obtained from the tested individual. The laboratory may, therefore, bill third party payors, which billing may disclose the administration of an HIV test, in accordance with the instructions of the person ordering the test, without directly obtaining the consent of individual whose specimen is being tested to the disclosure to such third party payors.
(9) Re-disclosure without authorization:
(a) All written HIV test information released with authorization of the tested individual must be labelled with a statement which substantially says "This information may not be disclosed to any one without the specific written authorization of the individual";
(b) Any person that has received HIV test information about an individual shall not further disclose that information without the specific written authorization of the individual, except in compliance with these rules.
Stat. Auth.: ORS 433.045 - ORS 433.080
Stats. Implemented:
Hist.: HD 5-1988, f. 3-15-88, cert. ef. 3-18-88; HD 6-1990(Temp), f. 2-22-90, cert. ef. 3-1-90; HD 25-1990, f. & cert. ef. 12-17-90; HD 16-1991, f. & cert. ef. 10-10-91; HD 29-1994, f. & cert. ef. 12-2-94
Infected Health Care Providers
333-012-0280
Definitions
For the purpose of OAR 333-012-0280 through 333-012-0400, the following definitions apply. Other definitions pertaining to these rules are listed in OAR 333-012-0260:
(1) "Health Care Provider" as defined in OAR 333-017-0000(25) means a person who has direct or supervisory responsibility for the delivery of health care or medical services. This shall include, but not be limited to: Licensed physicians, nurse practitioners, physician assistants, nurses, dentists, medical examiners, and administrators, superintendents and managers of clinics, health care facilities as defined in ORS 442.015(13) and licensed laboratories.
(2) "Reviewable Health Care Provider" means a health care provider who routinely performs or participates in the performance of surgical, obstetric, or dental procedures that:
(a) Pose a significant risk of a bleeding injury to the arm or hand of the health care provider; and
(b) Are of a nature that reasonably could result in the patient having an exposure to the health care provider's blood in a manner capable of effectively transmitting HIV or hepatitis B virus (HBV), for example, due to the inability of the health care provider to withdraw the injured limb. Examples of procedures that do not carry this significant risk include, but are not limited to: oral, rectal, or vaginal examinations; phlebotomy; administering intramuscular, intradermal, or subcutaneous injections; needle biopsies, need aspirations, and lumbar punctures; cutdown and angiographic procedures; excision of epidermal or dermal lesions; suturing of superficial lacerations; endoscopy; placing and maintaining peripheral and central intravascular lines, nasogastric tubes, rectal tubes, and urinary catheters; or acupuncture.
(3) "HBsAg" means the surface antigen of the hepatitis B virus.
(4) "HBeAg" means the "e" antigen of the hepatitis B virus.
(5) "OR-OSHA" means the Oregon Occupational Safety and Health Division of the Oregon Department of Consumer and Business Services.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93; HD 29-1994, f. & cert. ef. 12-2-94
333-012-0290
Preamble
(1) The purpose of OAR 333-012-0280 through 333-012-0400 is to prevent the transmission of hepatitis B virus and human immunodeficiency virus to patients from infected health care providers. The Division declares that strict adherence to proper infection control procedures by all health care providers is the primary way to prevent such transmission. The Division recognizes that when proper infection control procedures are used, the risk of transmission of HIV or hepatitis B virus from reviewable health care providers to their patients is negligible.
(2) In the event that an HIV-infected health care provider demonstrates symptoms of cognitive, emotional, behavioral or neurologic impairment, he or she should be treated like any other distressed and/or impaired health care provider, following the standards of the appropriate professional licensing board.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0300
Infection Control
(1) All health care providers and health care facilities shall strictly adhere to the infection control requirements of OAR 333- 017-0005(1) and applicable sections of the OSHA rules, "Occupational Exposure to Bloodborne Pathogens" (OAR 437-002 - 1910.1030). This includes the proper use of hand washing, protective barriers, and care in the use and sterilization or disposal of needles and other sharp instruments as described in the U.S. Public Health Service's Centers for Disease Control and Prevention recommendations found in "Recommendations for Prevention of HIV Transmission in Health Care Settings", Morbidity and Mortality Weekly Report 1987; 36 (supplement number 2S); 1-18S and "Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health Care Settings", Morbidity and Mortality Weekly Report 1988; 37:377-82, 387-88.
(2) Any health care provider who observes that another health care provider or health care facility is not practicing current infection control standards shall seek correction of that problem through procedures appropriate to the setting. Such procedures may include, for example, discussing the needed corrective actions directly with the health care provider, reporting the breaches of infection control practice to the health care facility's infection control committee, or other actions/reporting as recommended by the infection control committee or required by other regulations.
[Publications: The publication(s) referred to or incorporated by reference in this rule are available from theagency.]
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0310
Infection Control Training
(1) All health care providers and health care facilities shall adhere to the infection control training requirements of the OSHA rules, "Occupational Exposure to Bloodborne Pathogens" (OAR 437-002 – 1910.1030). These include employers ensuring that all employees with potential occupational exposures to bloodborne pathogens participate in a training program at the time of initial assignment to the tasks where occupational exposure may take place and at least annually thereafter.
(2) Any institution in Oregon providing professional training leading to a degree or certificate as a health care provider shall provide formal training in infection control procedures as a prerequisite for graduation.
[Publications: The publication(s) referred to or incorporated by reference in this rule are available from the agency.]
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0320
HIV and Hepatitis B Testing of Health Care Providers
(1) HIV testing and hepatitis B testing of health care providers is not required by the Division.
(2) All reviewable health care providers are encouraged to voluntarily undergo testing for HIV infection. Any reviewable health care provider is encouraged to either:
(a) Demonstrate serologic evidence of immunity to the hepatitis B virus from vaccination; or
(b) To know his or her HBsAg status and, if that status is positive, is encouraged to know his or her HBeAg status.
(3) The provisions of section (2) of this rule shall not be deemed to authorize any health care provider, health care facility, clinical laboratory, blood or sperm bank, insurer, insurance agent, insurance-support organization as defined in ORS 746.600, government agency, employer, research organization or agent of any of them to require HIV testing of any health care provider as a condition of practice. Nor shall such provisions be deemed to create a legal standard of care for reviewable health care providers.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0330
Hepatitis B Immunization
Every reviewable health care provider, whether or not directly subject to regulation by OR-OSHA, is encouraged to determine whether he or she has serologic evidence of immunity to hepatitis B or to obtain complete hepatitis B immunization.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0340
Process for Initiating Review of the Professional Practice of a Reviewable Health Care Provider with a HIV-Positive Test or a Positive Test for HBsAg and HBeAg
(1) Any reviewable health care provider who learns that he or she has a HIV-positive test or a positive test for both HBsAg and HBeAg is encouraged to refrain from participating in the performance of procedures outlined in OAR 333-012-0280(2) until he or she ensures that his or her HIV and/or HBsAg/HBeAg infection status is reported to either:
(a) The Division for the purpose of undergoing a review of his or her professional practice as described in OAR 333-012-0350; or
(b) His or her own institution of employment for the purpose of undergoing a review of his or her professional practice, if such a process exists.
(2) Reports to the Division should be made directly to the State Epidemiologist, the Deputy State Epidemiologist, or the State Health Officer.
(3) Health care providers who are uncertain as to whether or not they are reviewable may seek anonymous guidance from the Division.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93; HD 29-1994, f. & cert. 12-2-94
333-012-0350
Division Response to the Report of a Reviewable Health Care Provider with a HIV-Positive Test or Positive Tests for HBsAg and HBeAg
The following procedures shall be undertaken by the Division at the request of a reviewable health care provider with a positive test for HIV or positive tests for HBsAg and HBeAg:
(1) The Division shall interview the reviewable health care provider and his or her personal licensed physician or primary health care provider within two weeks of receipt of the report to determine:
(a) The date of the initial positive test result;
(b) An estimated date of initial infection, if available from clinical and exposure history information;
(c) The reviewable health care provider's current medical status with special emphasis on presence or absence of exudative lesions or weeping dermatitis, pulmonary tuberculosis, and cognitive, emotional, behavioral or neurologic impairment; and
(d) Whether the reviewable health care provider complies with standard infection control procedures and whether he or she has a history of incidents in which there was a substantial likelihood that a patient received a substantial exposure to the reviewable health care provider's blood;
(e) Pursuant to ORS 433.008 and 433.045, confidentiality of the reviewable health care provider's HIV or HBsAg/HBeAg status shall be maintained during this investigation.
(2) The Division shall convene an expert panel within two weeks of completion of the investigation to make recommendations regarding the reviewable health care provider's continued practice.
(3) The identity of the reviewable health care provider will not be revealed to the expert panel, unless the reviewable health care provider consents to this disclosure.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93; HD 29-1994, f. & cert. ef. 12-2-94
333-012-0360
Composition of the Expert Panel and Its Responsibilities
(1) The expert panel shall include: An infectious disease specialist, with expertise in the epidemiology of HIV and hepatitis B infections, who is not involved in the care of the reviewable health care provider; a health professional with expertise in the procedures performed by the reviewable health care provider; a representative of the Division; and others at the discretion of the Division. With the consent of the reviewable health care provider, the reviewable health care provider's personal licensed physician or primary health care provider shall also be offered a position on the panel. The reviewable health care provider shall have the right to review the composition of the panel.
(2) The expert panel shall consider all information obtained by the Division's investigation and may request further information of the Division or the reviewable health care provider as needed.
(3) The expert panel shall make recommendations to the Division regarding the reviewable health care provider's further practice. The panel will focus on the reviewable health care provider's ability to comply with infection control procedures and his or her ability to provide competent care. Restrictions in future practice will be recommended only if there are medical impairments, infection control breaches, or scientific evidence to indicate that, in the Division's judgment, the reviewable health care provider's current practice activities pose a significant risk of transmission to the patient. Job modifications, limitations, or other restrictions are warranted only if there is clear evidence that the reviewable health care provider's current practice activities pose a significant risk of transmitting infection to patients. If restrictions are recommended, the panel will recommend the least restrictive alternative. If warranted, the panel may recommend one or more of the following:
(a) Additional infection control procedures;
(b) Restrictions on specific procedures;
(c) Monitoring of the reviewable health care provider's practice for compliance with the recommendations of the expert panel;
(d) Medical monitoring (both content and frequency) of the reviewable health care provider; and
(e) Frequency with which the panel should reconvene to reconsider its recommendations in light of the changing medical condition of the reviewable health care provider.
(4) The expert panel shall furnish the reviewable health care provider with a draft of its recommendations and an opportunity for comment. Before finalizing its recommendations to the Division, the expert panel shall take into account any comments received from the reviewable health care provider or the provider's representative.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93; HD 29-1994, f. & cert. ef. 12-2-94
333-012-0370
Division Recommendations to Reviewable Health Care Provider
The Division shall consider the specific recommendations of the expert panel and comments, if any, of the reviewable health care provider or the provider's representative, and shall prepare written recommendations to the reviewable health care provider. These written recommendations shall be presented to the reviewable health care provider within one week after completion of the panel's recommendations.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0380
Notification of the Appropriate Licensing Board
If the Division has reason to believe that the reviewable health care provider poses a significant risk of transmission of HIV or hepatitis B virus to the patient, whether or not an HIV-infected or HBsAg/HBeAg-positive reviewable health care provider has been reported to the Division and has consented to voluntary review as outlined above, the Division may notify the appropriate licensing board, and shall inform the reviewable health care provider, in writing, of this notification.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0390
Notification and Counseling of Some or All Past or Present Patients of the Reviewable Health Care Provider
Notification of patients as to their possible exposure to HIV or hepatitis B shall not occur except in any of the following circumstances:
(1) HIV or hepatitis B transmission from reviewable health care provider to at least one of his or her patients has occurred;
(2) The patient to be notified has had a substantial exposure to the reviewable health care provider's blood or body fluids; or
(3) The reviewable health care provider has had significant violations of infection control practices that were standard at the time of the patient contact and which resulted in a significant risk of a substantial exposure to the patient being notified;
(4) The identity of the HIV-infected health care provider shall not be explicitly disclosed during the notification process.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
333-012-0400
Confidentiality
The report of a reviewable health care provider, the Division's investigation, the deliberations and recommendations of the expert panel, and the Division's recommendations pursuant to these rules shall be held in the strictest confidence under ORS 433.008 and 433.045, except as outlined in OAR 333-012-0380 and 333-012-0390.
Stat. Auth.: ORS 431.110(1)(e) & ORS 433.004(1)(d)
Stats. Implemented:
Hist.: HD 18-1993, f. 10-26-93, cert. ef. 10-28-93
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