justicedao/ipfs_state_laws huggingface dataset:
333-077-0230 Violations In addition to non-compliance with any law that governs a birthing center, it is a violation to: (1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Oregon Health Authority (Authority) staff access to the birthing center, its documents or records; (2) Fail to submit a plan of correction or implement an approved plan of correction; (3) Fail to comply with all applicable laws, lawful ordinances and rules relating to safety from fire; (4) Refuse or fail to comply with an order issued by the Authority; (5) Refuse or fail to pay a civil penalty; (6) Fail to comply with rules governing the storage of medical records following the closure of a birthing center; or (7) Knowingly allow a licensed clinical provider to practice outside their scope of practice. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 23-2025, adopt filed 11/03/2025, effective 11/03/2025
333-077-0240 Informal Enforcement (1) If, during an investigation or survey Oregon Health Authority (Authority) staff document violations of birthing center licensing laws, the Authority may issue a statement of deficiencies that cites the law alleged to have been violated and the facts supporting the allegation. (2) Upon receipt of a statement of deficiencies, a birthing center shall be provided an opportunity to dispute the Authority's survey findings but must still comply with sections (3) and (4) of this rule. (a) If a birthing center desires an informal conference to dispute the Authority's survey findings, the birthing center shall advise the Authority in writing within 10 business days after receipt of the statement of deficiencies. The written request must include a detailed explanation of why the birthing center believes the statement of deficiencies is incorrect. (b) A birthing center may not seek a delay of any enforcement action against it on the grounds the informal dispute resolution has not been completed. (c) If a birthing center is successful in demonstrating the deficiencies should not have been cited, the Authority shall reissue the statement of deficiencies, removing such deficiencies and rescinding or modifying any remedies issued for such deficiencies. The reissued statement of deficiencies shall state that it supersedes the previous statement of deficiencies and shall clearly identify the date of the superseded statement of deficiencies. (3) A signed plan of correction must be received by the Authority within 10 business days from the date the statement of deficiencies was mailed to the birthing center. A signed plan of correction will not be used by the Authority as an admission of the violations alleged in the statement of deficiencies. (4) A birthing center shall correct all deficiencies within 60 days from the date of the exit conference, unless an extension of time is requested and granted from the Authority. A request for such an extension shall be submitted in writing and must accompany the plan of correction. (5) The Authority shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Authority, the Authority shall notify the birthing center administrator or the administrator's designee in writing and request that the plan of correction be modified and resubmitted no later than 10 working days from the date the letter of non-acceptance was mailed to the administrator. (6) If the birthing center does not come into compliance by the date of correction reflected on the plan of correction or 60 days from date of the exit conference, whichever is sooner, the Authority may propose to deny, suspend, or revoke the birthing center license, or impose civil penalties in accordance with ORS chapter 183. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025, ORS 441.015 & ORS 441.030 History: PH 23-2025, adopt filed 11/03/2025, effective 11/03/2025
333-077-0250 Formal Enforcement (1) If during an investigation or survey the Oregon Health Authority (Authority) finds substantial failure to comply with birthing center licensing laws, the Authority may issue a Notice of Proposed Nonrenewal, Revocation or Suspension in accordance with ORS 183.411 through 183.470. (2) If the Authority finds a serious danger to public health or safety, it may issue a Notice of Emergency License Suspension under ORS 183.430(2). (3) If the Authority revokes a birthing center license, the final order shall specify when the birthing center may reapply for a license. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025, ORS 183.430, ORS 441.015 & ORS 441.030 History: PH 23-2025, adopt filed 11/03/2025, effective 11/03/2025
333-077-0260 Civil Penalties (1) A licensee that violates a birthing center licensing law, including OAR 333-077-0230 is subject to the imposition of a civil penalty not to exceed $500 per day per violation. (2) In determining the amount of a civil penalty, the Oregon Health Authority (Authority) shall consider whether: (a) The Authority made repeated attempts to obtain compliance; (b) The licensee has a history of noncompliance with birthing center licensing laws; (c) The violation poses a serious risk to the public's health; (d) The licensee gained financially from the noncompliance; and (e) There are mitigating factors, such as a licensee's cooperation with an investigation or actions to come into compliance. (3) The Authority shall document its consideration of the factors in section (2) of this rule. (4) Each day a violation continues is an additional violation. (5) A civil penalty imposed under this rule shall comply with ORS 183.745. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.990 History: PH 23-2025, adopt filed 11/03/2025, effective 11/03/2025
333-080-0040 Definitions (1) As used in this section of Oregon Administrative Rules: (a) “Entity” means an individual, corporation, business trust, partnership, limited liability company, association, joint venture or an instrumentality of an entity. (b) “Eye bank” means an entity that is licensed or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage or distribution of human eyes or parts of human eyes. (c) “Health care facility” has the meaning given that term in ORS 442.015. (d) “Organ procurement organization” means an entity designated by the United States Secretary of Health and Human Services as an organ procurement organization. (e) “Tissue bank” means an entity that is licensed or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage or distribution of tissue for transplants. (2) Tissue banks and eye banks must be registered with and regulated by the United States Food and Drug Administration. (3) A health care facility that performs organ transplants must: (a) Be a member of the Organ Procurement and Transplantation Network established by the National Organ Transplant Act of 1984; (b) Be regulated by the United States Department of Health and Human Services; and (c) Use an organ procurement organization to obtain organs for transplants. (4) A health care facility that performs tissue or corneal transplants must obtain the tissue or corneas from a tissue bank or an eye bank that is registered with and regulated by the United States Food and Drug Administration. Statutory/Other Authority: ORS 441.015 Statutes/Other Implemented: ORS 183.745, ORS 441.015, ORS 441.079 & ORS 441.082 History: PH 5-2008, f. 3-7-08, cert. ef. 7-1-08
333-080-0050 Registration and Civil Penalties (1) An organ procurement organization, tissue bank or eye bank may not do business in Oregon unless it has registered with the Oregon Health Authority. Registration with the Authority must be completed within 30 days after the implementation of these rules on July 1, 2008. (a) The Authority shall develop a registration form and the transplant organizations shall, at least 30 days prior to implementation, obtain and mail the required form to the Authority. (2) Each organ procurement organization, tissue bank and eye bank shall provide to the Authority, at least every three years, current documentation of designation, certification and inspection as evidence of compliance with national standards and requirements under federal law. (3) The Authority may impose a civil penalty not to exceed $1,000 against an organ procurement organization, tissue bank or eye bank doing business in this state for failure to: (a) Register with the Authority; (b) Report loss of designation, accreditation or certification within 60 days of the loss; or (c) Supply the Authority with requested current documentation of designation, certification and inspection. (d) For the first violation the civil penalty shall be $250; (e) For the second violation the civil penalty shall be $500; (f) For the third and any subsequent violations, the civil penalty shall be $1000. (4) Civil penalties under this section shall be imposed in the manner provided under ORS 183.745. Statutory/Other Authority: ORS 441.015 Statutes/Other Implemented: ORS 183.745, ORS 441.015, ORS 441.079 & ORS 441.082 History: PH 5-2008, f. 3-7-08, cert. ef. 7-1-08
333-081-0000 Purpose The purpose of these rules is to establish standards for licensure of Nontransplant Anatomical Research Recovery Organizations. Statutory/Other Authority: ORS 438.705-438.720 & 438.994 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0005 Definitions As used in OAR 333-081-0000 through 333-081-0090 the following definitions apply: (1) “Accrediting body” means an entity that is approved by the Public Health Division and meets the requirements of ORS 438.720(2). (2) “Anatomical material” has the meaning given that term in ORS 438.705(1). (3) “Division” means the Public Health Division of the Oregon Health Authority. (4) “Donor” has the meaning given that term in ORS 97.953. (5) “Human Remains” has the meaning given that term in ORS 97.010. (6) “Nontransplant anatomical research recovery organization” or “NARRO” has the meaning given that term in ORS 438.705(3) and is defined as follows: (a) A NARRO means a person that engages in the recovery or distribution of anatomical material from a donor for research or education purposes other than transplanting the anatomical material or therapy. (b) A NARRO does not include: (A) A hospital or other health care facility as those terms are defined in ORS 442.015; (B) A public corporation as defined in ORS 353.010; (C) A public or private institution of higher education; or (D) A clinical laboratory, as defined in ORS 438.010, that is: (i) Licensed under ORS 438.010 to 438.510; and (ii) Owned or controlled by, or under common ownership with, a hospital described in paragraph (A) of this subsection. (7) “Survey” means an inspection of the premises or records of either an applicant for licensure as a NARRO or of a licensed NARRO in order to determine the extent to which that entity is in compliance with ORS 438.710 and 438.715 and these rules. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0010 Application for Licensure (1) Persons meeting the definition of a NARRO as set out in ORS 438.705(3) and OAR 333-081-0005(5) may not act as a NARRO or hold themselves out as a NARRO unless licensed as such by the Division. (2) An applicant wishing to apply for a license to operate a NARRO shall submit an application on the most current form prescribed by the Division and pay the application fee specified in OAR 333-081-0035. (3) An applicant that has obtained accreditation from an accrediting body approved by the Division shall provide proof of accreditation to the Division with its license application and shall include: (a) All of the approved accrediting body survey and inspection reports; and (b) Written evidence of all corrective actions underway or completed in response to the approved accrediting body recommendations including progress reports. (4) If any of the information delineated in a NARRO’s most recent application changes at a time other than the annual renewal date, it must submit a revised application to the Division within 30 calendar days of the change. (5) Notwithstanding section (4) of this rule, a NARRO must submit a revised application to the Division 30 calendar days prior to any of the following changes: (a) Change in ownership or management, acquisition by or of, or merger with another NARRO; (b) Change in facilities because of expansion, relocation, renovations or structural changes that affect NARRO operations; and (c) Change in the scope of operations of the NARRO. (6) In order to allow the Division to determine whether any of the changes reported in accordance with section (4) or (5) of this rule may affect NARRO compliance with NARRO licensing laws and rules, the Division may request NARRO documents, records or other materials for review or it may conduct an on-site inspection. (7) If a NARRO loses accreditation, it shall immediately notify the Division and surrender its license in accordance with OAR 333-081-0045. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0015 Review of License Application (1) Following receipt of a completed application and the required fee, the Division must conduct a survey in accordance with OAR 333-081-0050 to determine whether the NARRO is in compliance with ORS 438.710 & 438.715 and these rules. (2) In lieu of conducting a survey, the Division may accept proof of accreditation by an accrediting body approved by the Division. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0020 Approval of License Application (1) The Division must notify an applicant in writing if a license application is approved and must include a copy of the license. (2) The Division will issue a license only for the premises and person(s) named in the application and it may not be transferred or assigned. (3) A licensed NARRO must post the license in a conspicuous location where it is viewable by the public. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0025 Denial of License Application If the Division intends to deny a license application, it shall issue a Notice of Proposed Denial of License Application in accordance with ORS 183.411 through 183.470. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0030 Expiration and Renewal of License (1) An initial or renewed license expires two years after the date of issuance or renewal. (2) If the ownership of a NARRO changes, a new license is required. (3) If renewal or a new license is sought because of a change of ownership, the licensee shall make application at least 45 days prior to the change of ownership using a form prescribed by the Division. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0035 Fees (1) The fee for an initial or renewed NARRO license is $1,750. (2) All application fees are non-refundable. Statutory/Other Authority: ORS 438.710 Statutes/Other Implemented: ORS 438.710 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0040 Denial, Suspension or Revocation of License (1) A license for a NARRO may be denied, suspended or revoked by the Division if a licensed NARRO has failed to comply with Oregon Laws 2013, chapter 356, sections 2 and 3, OAR 333-081-0080 or for violations of laws, regulations or administrative rules that governs how it obtains, processes and distributes donor material. (2) If the Division intends to suspend or revoke a NARRO license, it shall do so in accordance with ORS 183.411 through 183.470. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0045 Return of License Each license certificate in the licensee's possession shall be returned to the Division immediately upon the suspension or revocation of the license, failure to renew the license by the date of expiration, loss of accreditation or if operation is discontinued by the voluntary action of the licensee. Statutory/Other Authority: ORS 438.705-438.720 & 438.994 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0050 Surveys (1) The Division must, in addition to any investigations conducted pursuant to OAR 333-081-0065, conduct at least one survey of each NARRO prior to licensure and once every two years thereafter as a requirement of licensing and at such other times as the Division deems necessary. (2) In lieu of an on-site inspection required by section (1) of this rule, the Division may accept proof of accreditation by an accrediting body approved by the Division if the NARRO: (a) Gives the Division sufficient advance notice to allow the Division to participate in any exit interviews conducted by the accrediting body; and (b) Provides the Division with copies of all documentation concerning the accreditation that it requests. (3) A NARRO must permit Division staff access to its premises during a survey. (4) A survey may include, but is not limited to: (a) Interviews of NARRO management and staff; (b) On-site observations of the NARRO premises, staff performance and activities; and (c) Review of documents, records and other materials required to be kept by OAR 333-081-0070. (5) A NARRO shall make all requested documents and records available to the surveyor for review and copying. (6) Following a survey, Division staff may conduct an exit conference with a NARRO agency owner, administrator, or designee. During an exit conference, Division staff must: (a) Inform the NARRO owner, administrator or designee of the preliminary findings of the inspection; and (b) Give the owner, administrator or designee a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings. (7) Following a survey, Division staff must prepare and provide the NARRO owner or administrator specific and timely written notice of the findings. (8) If no deficiencies are found during a survey, the Division must issue written findings to the NARRO owner or administrator indicating that fact. (9) Upon conclusion of a survey the Division must, upon request, publicly release the written documents described in sections (7) and (8) of this rule in accordance with the Oregon Public Records Act. (10) If deficiencies are found, the Division must take informal or formal enforcement action in accordance with OAR 333-081-0085 and 333-081-0090. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0055 Approval of Accrediting Bodies (1) If the Division finds that an accrediting body has the necessary qualifications to certify that state licensing standards have been met, the Division will accept accreditation from the accrediting body in accordance with the requirements of OAR 333-081-0050(2). (2) In order to allow the Division to make the finding set forth in section (1) of this rule, the accrediting body must request approval in writing using the most recent approval form provided by the Division and shall provide, at a minimum: (a) Documentation of program policies and procedures that show that its accreditation process at least meets the requirements set out in Oregon Laws 2013, chapter 356, section 4(2) and these rules; (b) Documentation evidencing that the accrediting body has the resources and expertise to successfully carry out the accreditation process; and (c) An attestation that it, or any of its owners or employees, does not have a direct or indirect financial interest in any of the NARROs that it seeks to accredit. Statutory/Other Authority: ORS 438.720 Statutes/Other Implemented: ORS 438.720 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0060 Complaints (1) Any person may make a complaint to the Division regarding an allegation as to violations of Oregon Laws 2013, chapter 356, sections 2 and 3 or these rules. (2) Upon conclusion of an investigation, the Division shall, upon request, publicly release a report of its findings in accordance with the Oregon Public Records Act. The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of a NARRO. (3) If a complaint involves an allegation of criminal conduct or an allegation that is within the jurisdiction of another local, state, or federal agency, the Division shall refer the matter to that agency. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14
333-081-0065 Investigations (1) As soon as practicable after receiving a complaint, taking into consideration the nature of the complaint, Division staff must begin an investigation. (2) An investigation may include but is not limited to: (a) Interviews of the complainant, persons identified by the complainant as having knowledge of the facts alleged in the complaint, NARRO management and staff, and other persons having knowledge of the practices of the NARRO; and (b) On-site observations of staff performance and of the physical environment of the NARRO facility; and (c) Review of documents, records and other materials. (3) A NARRO must permit Division staff access to its premises during an investigation. Statutory/Other Authority: ORS 438.710 & 438.720 Statutes/Other Implemented: ORS 438.705-438.720 & 438.994 History: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14