justicedao/ipfs_state_laws huggingface dataset:
333-024-1090 Newborn Screening: Use, Release and Retention of Residual Specimens (1) Residual specimens may be used by the Oregon State Public Health Laboratory for: (a) Quality assurance and method development activities as required to maintain CLIA compliance. (b) Program evaluation and quality improvement. (2) The Oregon State Public Health Laboratory shall only release specimens as follows: (a) To a third-party laboratory to perform some or all testing described in OAR 333-024-1070. (b) If required by a court order. (c) To the parent or legal guardian of the infant, or a third party identified by a parent or legal guardian, with a parent or legal guardian’s written authorization, according to the Oregon State Public Health Laboratory procedure for requesting specimens. (3) Specimens may not be released under subsection (2)(c) of this rule within 30 days of the report of the screening results. (4) Specimens submitted to the Oregon State Public Health Laboratory are retained for 12 months after which the specimen is destroyed using a secure method, except as necessary to comply with section (2) of this rule. The destruction may occur at any time in the month following the specimen’s 12-month retention limit. (5) Specimens retained for longer than 12 months as necessary to comply with section (1) of this rule shall be de-identified by the Oregon State Public Health Laboratory. Statutory/Other Authority: ORS 413.042 & ORS 433.110 - 433.770 (as amended by 2025 OL, Chapter 203) Statutes/Other Implemented: ORS 433.110 - 433.770 (as amended by 2025 OL, Chapter 203) History: PH 22-2025, amend filed 10/30/2025, effective 11/01/2025 PH 77-2024, amend filed 10/29/2024, effective 11/20/2024 PH 24-2019, amend filed 11/18/2019, effective 11/25/2019 PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019
333-024-1100 Newborn Screening: Ordering Specimen Collection Kits and Fees (1) Kits for collecting specimens for newborn screening must be ordered from the Oregon State Public Health Laboratory. (2) Orders must be accompanied by payment for the full amount of the order, based on the fees in section (3) of this rule, or fee exemption request based on section (4) of this rule. Refunds will not be issued for specimens that cannot be used for testing due to an error in the collection or transport of the specimen or incomplete patient information. (3) The fees for newborn screening specimen collection kits include the cost of newborn screening services provided by the Oregon State Public Health Laboratory and are as follows: (a) $100 per one-specimen kit. (b) $175 per two-specimen kit. (c) $175 per three-specimen kit. (4) No Oregon infant shall be denied newborn screening because of the inability of the infant's parent or legal guardian to pay the fee for a test or kit: (a) A practitioner, parent, or legal guardian requesting an exemption from fees shall complete a form, available from the Oregon Health Authority, demonstrating that the individual requesting the exemption is unable to pay the fee. (b) Exemption forms must be received by the Oregon State Public Health Laboratory within 30 calendar days from the day the infant was born. (c) Upon receipt of a form requesting a fee exemption and confirmation through Oregon Health Authority records that exemption criteria are met, the Oregon Health Authority will grant an exemption and will issue a refund check or provide or replace the kit to the payer of record. Statutory/Other Authority: ORS 413.014, 431A.750 & 433.285 Statutes/Other Implemented: ORS 433.285, 433.290 & 433.295 History: PH 77-2024, amend filed 10/29/2024, effective 11/20/2024 PH 167-2022, amend filed 07/31/2022, effective 08/01/2022 PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019
333-024-1110 Newborn Screening: Failure to Comply The Oregon State Public Health Laboratory may refer a hospital, freestanding birthing center or a practitioner to the appropriate licensing entity for failure to comply with these rules. Statutory/Other Authority: ORS 413.014, 431A.750 & 433.285 Statutes/Other Implemented: ORS 433.285, 433.290 & 433.295 History: PH 7-2020, amend filed 01/14/2020, effective 02/01/2020 PH 283-2018, adopt filed 12/20/2018, effective 01/01/2019
333-024-2000 Fees for Communicable Disease Tests Performed in the State Laboratory (1)(a) State public health laboratory maximum fees for testing performed are based on the August 2013 Division of Medical Assistance Programs Fee for Service Fee Schedule. (b) The person submitting the specimen shall bear ultimate responsibility for remitting payment of state public health laboratory fees. (2) Notwithstanding the fees charged by the state public health laboratory for testing, the state public health laboratory shall accept payment for testing services from Medicare and Medicaid health plans at the rates established by these programs or plans, including Coordinated Care Organizations (CCOs). (3) A non-profit corporation or state or local governmental organization may apply to the state public health laboratory for a reduction or waiver of test fees stated in subsection (1)(a) of this rule. Reduction or waiver requests must be sent to the director of the state public health laboratory and be accompanied by proof of non-profit status. Requests should include the estimated number and type of tests anticipated per year. The state public health laboratory may, in its discretion, reduce or waive test fees. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.] Statutory/Other Authority: ORS 431A.750 Statutes/Other Implemented: ORS 431A.750 History: PH 16-2020, amend filed 03/26/2020, effective 04/01/2020 PH 10-2020, renumbered from 333-024-0240, filed 01/29/2020, effective 01/29/2020 PH 283-2018, amend filed 12/20/2018, effective 01/01/2019 PH 92-2018, amend filed 02/12/2018, effective 04/01/2018 PH 11-2014, f. 4-15-14, cert. ef. 5-1-14 HB 18-1981(Temp), f. & ef. 9-11-81; HB 3-1982, f. & ef. 2-25-82; HD 12-1982, f. 6-11-82, ef. 7-1-82; HD 27-1982(Temp), f. 12-15-82, ef. 12-16-82; HD 9-1983, f. 6-24-83, ef. 7-1-83; HD 11-1983(Temp), f. & ef. 7-11-83; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 7-1987, f. & ef. 7-15-87; HD 12-1990, f. & cert. ef. 5-22-90; HD 8-1991, f. & cert. ef. 6-19-91; HD 28-1994, f. 10-28-1994, cert. ef. 11-1-94; HD 12-1997, f. 9-26-97, cert. ef. 10-1-97; OHD 3-1998, f. 3-31-98, cert. ef. 4-1-98; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 7, 2014, f. & cert. ef. 1-30-14
333-025-0105 Scope (1) OAR 333-025-0100 to 0165 apply to all genetic research subject to the law of the State of Oregon. (2) All genetic research must comply with the applicable standards set forth in the Federal Common Rule. Additional protections for subjects of research are authorized by ORS 192.531 et seq. and these rules. These rules set state standards that are in addition to, and not intended to alter, any requirements under the Federal Common Rule or the Federal Privacy Rule. Statutory/Other Authority: ORS 192.531–192.549 Statutes/Other Implemented: ORS 192.531–192.549 History: PH 21-2005, f. 12-30-05, cert. ef. 1-1-06 PH 9-2004, f. & cert. ef. 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 OHD 14-2002, f. & cert. ef. 9-27-02
333-025-0110 Institutional Review Boards (IRBs) and Approval for Research (1) An IRB must conform to the organizational and operational standards contained in the Federal Common Rule. (2) All proposed genetic research, including anonymous research, or research otherwise exempt from IRB approval, must first be submitted to an IRB for explicit prior approval or an explicit determination that the research is anonymous or otherwise exempt. (3) A researcher must disclose to the IRB the intended use of human DNA samples, genetic tests or other genetic information for every proposed research project, including anonymous or otherwise exempt research. (4) A researcher must follow the requirements of OAR 333-025-0115 and 333-025-0120 and provide assurances to the IRB that these requirements have been met. Statutory/Other Authority: ORS 192.547 Statutes/Other Implemented: ORS 192.533 & 192.547 History: PH 21-2005, f. 12-30-05, cert. ef. 1-1-06 PH 9-2004, f. & cert. ef 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 OHD 14-2002, f. & cert. ef. 9-27-02
333-025-0115 Informed Consent for Non-Exempt Genetic Research (1) Except as provided in OAR 333-025-0120, a researcher may use an identified human biological sample or genetic information obtained on or after June 25, 2001, for genetic research only with specific informed consent for genetic research. (2) Except as provided in OAR 333-025-0120, a researcher may use an identified human biological sample or genetic information obtained prior to June 25, 2001, for genetic research with blanket informed consent or specific informed consent for genetic research. Statutory/Other Authority: ORS 192.535 & 192.547 Statutes/Other Implemented: ORS 192.535 & 192.547 History: PH 21-2005, f. 12-30-05, cert. ef. 1-1-06 PH 9-2004, f. & cert. ef 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 OHD 14-2002, f. & cert. ef. 9-27-02
333-025-0125 IRB Registry (1) The Oregon Health Authority, Public Health Division shall establish and maintain a registry of IRBs that review research conducted in Oregon or that involves research subjects living in Oregon. (2) By October 1, 2002, each existing IRB must register with Oregon Health Authority, Public Health Division on registration forms provided by the Authority. (3) The Authority will update its registry annually. Each IRB will be required to renew its registration each year, or sooner if there exists material changes in the terms of registration. Statutory/Other Authority: ORS 192.547 Statutes/Other Implemented: ORS 192.547 History: PH 9-2004, f. & cert. ef 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 OHD 14-2002, f. & cert. ef. 9-27-02
333-025-0130 Recontact (1) Recontact of a research subject should not occur unless the subject was informed during the initial consent process that recontact may occur under specified circumstances and with this understanding, the research subject consented to participate in the study. (2) If recontact of subjects is contemplated, the researcher must provide research protocols to the IRB describing the circumstances that might lead to recontact, as well as a plan for managing the process. If a subject declines the possibility of recontact, the researcher may not recontact the subject. (3) Notwithstanding (1) above, in order to consider recontact in a situation where recontact was not contemplated and therefore not addressed in research protocols a researcher must seek approval from the IRB for re-contact and must assure the following conditions exist: (a) The findings are scientifically valid and confirmed; (b) The findings have significant implications for the subject’s or the public’s health; and (c) A course of action to ameliorate or treat the subject’s or the public’s health concerns is readily available. (4) Under conditions described in (3), the researcher shall determine and adhere to the expressed wishes and desires of the research subject in relation to disclosure of genetic information to that individual. (5) When research results are disclosed to a subject, appropriate medical advice and referral must be provided. (6) In all cases, a decision to recontact research subjects must have prior approval of the IRB. Statutory/Other Authority: ORS 192.547 Statutes/Other Implemented: ORS 192.547 History: PH 9-2004, f. & cert. ef 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 OHD 14-2002, f. & cert. ef. 9-27-02
333-025-0135 Information Concerning Deceased Individuals (1) Anyone permitted by Oregon law to dispose of the body of a deceased individual or who is authorized by ORS 146.113 to 146.117 to submit the DNA sample of an unidentified deceased individual to a DNA diagnostic laboratory may obtain or retain genetic information for the purpose of identification of the deceased. After identification, relevant information concerning the death shall be submitted into the permanent medical record of the deceased. (2) A DNA sample of or genetic information about a deceased individual may be used for medical diagnosis of blood relatives of the individual and for no other purpose except as otherwise authorized by law. A request to use a sample or information for such purpose may be made by: (a) A representative designated by the decedent to act on the individual's behalf after death; (b) The closest surviving blood relative of the decedent; or (c) If there is more than one surviving blood relative of the same degree of relationship to the decedent, by the majority of the surviving closest blood relatives of the decedent. (3) A DNA sample sent to a diagnostic laboratory for testing under Section (1) or (2) of this rule must be accompanied by an affidavit stating that the specific purpose for obtaining the DNA sample is to identify the deceased individual or is for medical diagnosis of blood relatives of the decedent, and for no other purpose. (4) A person may use an individual's DNA sample or genetic information that is derived from a biological specimen or clinical individually identifiable health information for anonymous research or coded research, if the individual was deceased when the individual's biological specimen or clinical individually identifiable health information was obtained (OAR 333-025-0120). Statutory/Other Authority: ORS 192.535, 192.537 & 192.539 Statutes/Other Implemented: ORS 192.535, 192.537 & 192.539 History: PH 21-2005, f. 12-30-05, cert. ef. 1-1-06 PH 9-2004, f. & cert. ef. 3-23-04 PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 Renumbered from 333-024-0500 by OHD 14-2002, f. & cert. ef. 9-27-02 HD 1-1997, f. & cert. ef. 1-10-97
333-025-0145 Retention of Genetic Information for the Purpose of Identification of Deceased Individuals (1) Any person who is permitted by Oregon law to dispose of the body of a deceased individual, or anyone who is authorized by ORS 146.113–117 may retain the genetic information obtained from an unidentified deceased individual’s DNA sample without specific authorization for the purpose of identification of the deceased individual. (2) Upon identification of the deceased individual, persons so authorized in Section (1) shall convey the deceased individual’s genetic information to his/her permanent medical record. Statutory/Other Authority: ORS 192.537 & 192.539 Statutes/Other Implemented: ORS 192.537 & 192.539 History: Renumbered from 333-024-0520 by PH 9-2004, f. & cert. ef 3-23-04 Renumbered from 333-024-0520 by PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 Renumbered from 333-024-0520 by OHD 14-2002, f. & cert. ef. 9-27-02 HD 1-1997, f. & cert. ef. 1-10-97
333-025-0150 Retention of Genetic Information for the Purpose of Testing to Benefit Blood Relatives of Deceased Individuals Any person may retain the genetic information of a deceased individual indefinitely for the sole purpose of benefiting blood relatives of the deceased individual without specific authorization. Statutory/Other Authority: ORS 192.535 & 192.537 Statutes/Other Implemented: ORS 192.535 & 192.537 History: Renumbered from 333-024-0530 by PH 9-2004, f. & cert. ef 3-23-04 Renumbered from 333-024-0530 by PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 Renumbered from 333-024-0530 by OHD 14-2002, f. & cert. ef. 9-27-02 HD 1-1997, f. & cert. ef. 1-10-97
333-025-0155 Retention of Genetic Information for the Purpose of Newborn Screening Procedures The Oregon Health Authority may retain the blood samples of newborns collected for the control of metabolic diseases, as provided in ORS 433.285, for up to one year. Statutory/Other Authority: ORS 433.285, 192.535 & 192.537 Statutes/Other Implemented: ORS 192.535 & 192.537 History: Renumbered from 333-024-0540 by PH 9-2004, f. & cert. ef 3-23-04 Renumbered from 333-024-0540 by PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 Renumbered from 333-024-0540 by OHD 14-2002, f. & cert. ef. 9-27-02 HD 1-1997, f. & cert. ef. 1-10-97
333-025-0160 Disclosure of Genetic Information: Procedure for Authorization of Disclosure by the Tested Individual or the Tested Individual's Representative Except as provided in ORS 192.539, and except for research disclosures authorized by an Institutional Review Board in accordance with these rules, any person shall be required to obtain specific authorization from the individual on whose sample a genetic test was conducted, or an individual's representative, to disclose genetic information, by completing the consent form specified in ORS 192.566, or a form that is substantively similar and by using the following procedure: (1) Request that the tested individual, or his/her representative, read, sign and date the prescribed consent form; and (2) Read, sign, and date the prescribed consent form on behalf of the individual or organization requesting the release of genetic information; and (3) Provide the tested individual, or his/her representative, with a copy of the completed consent form for his/her personal records. Statutory/Other Authority: ORS 192.539 Statutes/Other Implemented: ORS 192.539 History: PH 265-2018, minor correction filed 11/28/2018, effective 11/28/2018 PH 21-2005, f. 12-30-05, cert. ef. 1-1-06 Renumbered from 333-024-0550 by PH 9-2004, f. & cert. ef 3-23-04 Renumbered from 333-024-0550 by PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04 Renumbered from 333-024-0550 by OHD 14-2002, f. & cert. ef. 9-27-02 HD 1-1997, f. & cert. ef. 1-10-97
333-026-0030 Civil Penalties for Violations of OAR Chapter 333, Divisions 18 and 19 (1) A civil penalty may be imposed against a person or entity for a violation of any provision in OAR chapter 333, division 18 or 19, including but not limited to: (a) Failing to report a reportable disease in accordance with OAR chapter 333, division 18; (b) Reporting to work in a communicable stage of any restrictable disease in violation of OAR 333-019-0010 or 333-019-0046; (c) Permitting a child to attend school in violation of OAR 333-019-0010; (d) Failing to immunize an animal against rabies in accordance with OAR 333-019-0017; (e) Failing to license a dog in accordance with OAR 333-019-0019; (f) Failing to euthanize an animal in accordance with OAR 333-019-0024 or 333-019-0027; (g) Euthanizing an animal or destroying the head of a mammal that has bitten a person without authorization under OAR 333-019-0024 from the local public health authority; and (h) Failing to confine an animal in accordance with OAR 333-019-0027. (2) Prior to issuing a notice of imposition of civil penalty, the Oregon Health Authority or the local public health authority shall send a written warning letter advising the person or entity that they are not in compliance with a rule in OAR chapter 333, division 18 or 19 and that continued noncompliance may result in the issuance of a notice of imposition of civil penalty. A person or entity's assertion that they did not receive the warning letter is not a defense to a notice of imposition of civil penalty. (3) Civil penalties shall be imposed as follows: (a) First violation: $100; (b) Second violation: $200; (c) Third or subsequent violation: $500. (4) Each day a person or entity is out of compliance with a provision of OAR chapter 333, division 18 or 19 will be considered a new violation. (5) A civil penalty may not exceed $500 a day per violation. (6) A notice of imposition of civil penalty shall comply with ORS 183.745. Statutory/Other Authority: ORS 431A.010 Statutes/Other Implemented: ORS 431A.010 & 433.040 History: PH 203-2022, minor correction filed 11/15/2022, effective 11/15/2022 PH 5-2010, f. & cert. ef. 3-11-10
333-027-0000 Purpose The purpose of these rules is to establish the standards for licensure of home health agencies. Statutory/Other Authority: ORS 443.085 Statutes/Other Implemented: ORS 443.014 - 443.090 History: PH 85-2021, minor correction filed 11/24/2021, effective 11/24/2021 PH 7-2012, f. 3-30-12, cert. ef. 4-1-12 OHD 13-1998, f. & cert. ef. 11-6-98 HD 22-1988, f. & cert. ef. 9-16-88 HD 19-1987, f. 11-10-87, ef. 12-1-87
333-027-0001 Compliance with Federal Law (1) Every home health agency subject to ORS 443.014 to 443.105 must comply with the Conditions of Participation governing home health agencies prescribed by the Centers for Medicare and Medicaid Services (CMS), under 42 CFR Part 484, adopted by reference. (2) Although a naturopathic physician may prescribe services and supplies under a plan of care pursuant to ORS 443.065, those services and supplies ordered by the naturopathic physician are not eligible for reimbursement by CMS. (3) In addition to the requirements of 42 CFR Part 484, home health agencies licensed in Oregon must also comply with the rules in OAR 333-027-0000 through 333-027-0190. Statutory/Other Authority: ORS 443.085 Statutes/Other Implemented: ORS 443.014 - 443.090 History: PH 16-2026, amend filed 01/29/2026, effective 02/01/2026 PH 3-2022, adopt filed 01/11/2022, effective 01/13/2022
333-027-0010 Application for Licensure and Fees (1) An agency that establishes, purports to manage or operate as a home health agency must be licensed by the Authority and comply with ORS 443.014–443.095 and these rules. (2) An applicant wishing to apply for a new or renewal license to operate a home health agency shall submit an application on a form prescribed by the Authority and pay the applicable fee as specified in ORS 443.035. (3) The owner or administrator must submit background information to the Authority, in accordance with OAR 333-027-0064 for the purposes of conducting a criminal records check. If a nationwide criminal records check is determined necessary by the Authority, the cost for the nationwide check shall be the responsibility of the agency and shall not exceed the cost charged to the Authority. (4) An agency must inform the Authority in writing of any changes in ownership, organizational structure, or other information delineated in the agency's most recent application within 30 days of the change. (a) If the ownership of an agency changes, other than at the time of the annual renewal, the agency shall submit a change of ownership form along with the applicable fee specified in ORS 443.035. (b) If an agency moves 30 miles or more from its current physical location, the agency must apply for a new license. (c) Failure to notify the Authority may result in denial or revocation of a license. (5) A branch office is overseen by the parent agency and therefore need not independently comply with the licensure requirements specified in these rules. (a) A parent agency must provide supervision and administrative control of any branch office. (b) The Authority shall determine on a case-by-case basis exceptions to the 60 mile travel distance from the parent agency requirement for a branch office as defined in OAR 333-027-0005. (6) A hospital may provide home health services without maintaining a separate governing body and administrative services so long as the services provided meet the requirements of ORS 443.014 through 443.095 and the hospital pays the home health licensing fee under ORS 443.035. (7) License fees will not be prorated and are non-refundable. Statutory/Other Authority: ORS 443.085 Statutes/Other Implemented: ORS 443.015, ORS 443.065 & ORS 443.025 History: PH 3-2022, amend filed 01/11/2022, effective 01/13/2022 PH 7-2012, f. 3-30-12, cert. ef. 4-1-12 OHD 9-2002, f. & cert. ef. 7-2-02 OHD 13-1998, f. & cert. ef. 11-6-98 HD 19-1987, f. 11-10-87, ef. 12-1-87 HD 151, f. & ef. 12-30-77