justicedao/ipfs_state_laws huggingface dataset:
333-333-8230 Product Tracking — Cultivation Batches (1) Within 72 hours of beginning a production process, a manufacturer must create a cultivation batch that will contain all fruiting bodies and mycelium produced by that production process. (2) A manufacturer must create a batch name for each cultivation batch and record the cultivation batch name and location in the product tracking system with the unique identification number assigned to the cultivation batch. (3) Unique identification numbers must be physically affixed to the cultivation batch or the separated area where the cultivation batch is physically located as required by OAR 333-333-8220. (4) A manufacturer may have an unlimited number of cultivation batches at any one time. Statutory/Other Authority: ORS 475A.235 & ORS 475A.400 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-333-8240 Product Tracking — Inventory Audits (1) The Oregon Health Authority may perform a physical audit of the inventory of any service center, manufacturer or laboratory licensee at the agency’s discretion and with reasonable notice to the licensee. (2) A variance between the physical audit and the inventory reflected in the product tracking system at the time of the audit, which cannot be attributed to normal moisture variation in psilocybin products, is a violation. Statutory/Other Authority: ORS 475A.235 & ORS 475A.400 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-333-8250 Product Tracking - User Requirements (1) A service center, manufacturer or laboratory licensee and any product tracking system user shall enter data into the product tracking system that fully and transparently accounts for all inventory tracking activities. (2) A service center, manufacturer or laboratory licensee is responsible for the accuracy of all information entered into the product tracking system. (3) Each individual who accesses the product tracking system must have log in credentials, which may not be shared or used by any other person. (4) An individual entering data into the psilocybin tracking system may only use their own psilocybin tracking system log in credentials. (5) Every individual who accesses the product tracking system must hold a valid worker permit as required by ORS 475A.480. Statutory/Other Authority: ORS 475A.235 & ORS 475A.400 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-500-0005 Applicability Unless a specific rule provides otherwise, OAR chapter 333, divisions 500 through 535 apply to a hospital classified as general, low occupancy acute care, or psychiatric or mental and do not apply to a hospital classified as a special inpatient care facility. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 17-2012, f. 12-20-12, cert. ef. 1-1-13 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0020 Application for Hospital License (1) An applicant wishing to apply for a license to operate a hospital shall submit an application on a form prescribed by the Oregon Health Authority (Authority) and pay the applicable fee as specified in OAR 333-500-0030. (2) A single hospital license may cover more than one building if the applicant meets the requirements in OAR 333-500-0025. (3) If the applicant is proposing a new hospital the applicant shall also submit evidence of plans review approval as required by OAR chapter 333, division 675. (4) An applicant that has a certificate of accreditation and deemed status for Medicare certification from the Joint Commission or an accrediting organization approved by the Authority shall provide the certificate to the Authority with its license application, and shall include: (a) All Joint Commission or approved accrediting organization survey and inspection reports; and (b) Written evidence of all corrective actions underway, or completed, in response to Joint Commission or approved accrediting organization recommendations, including all progress reports. (5) No license shall be issued for any hospital for which a certificate of need is required, unless a certificate of need has first been issued under ORS 442.315. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.020 History: PH 9-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09 OHD 2-2000, f. & cert. ef. 2-15-00 HD 21-1993, f. & cert. ef. 10-28-93 HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0005 HD 21-1985, f. & cert. ef. 10-4-85 HD 11-1980, f. & cert. ef. 9-10-80, Renumbered from 333-023-0116 HD 11, f. 3-16-72, cert. ef. 4-1-72 HB 222, f. 8-26-69, cert. ef. 8-26-69 HB 183, f. & cert. ef. 5-26-66
333-500-0027 Emergency Medical Services Satellites (1) A facility indorsed as a satellite under a hospital license for the provision of emergency medical services must, in addition to any requirements in OAR 333-500-0025: (a) Operate 24 hours a day, seven days a week, 365 days a year; (b) Comply with the hospital emergency department rule in OAR 333-520-0070; (c) Develop written emergency department policies and procedures for all emergency medical services satellite operations including but not limited to: (A) The type and scope of emergency medical services provided at the satellite; (B) Integration of satellite operations with parent hospital surgical, laboratory, radiology, pharmacy, nutrition, and other departments to ensure timely provision of services; (C) For a patient who cannot be provided the type and level of care needed to complete treatment of the patient’s injury or condition within 24 hours of arrival at the satellite: (i) Transport of the patient to the parent hospital for continuing care using appropriate transportation and personnel; or (ii) Transfer to another receiving hospital with capability and capacity. (d) Coordinate with: (A) Any 9-1-1 jurisdiction within the 9-1-1 service area as those terms are defined in ORS 403.105 to ensure, to the greatest extent possible, that only patients who can receive an appropriate level of care at the satellite are transported to the satellite to limit the need for multiple emergency transports; and (B) Ambulance services within the ambulance service area as those terms are defined in OAR 333-250-0205 to ensure, to the greatest extent possible, that only patients who can receive an appropriate level of care at the satellite are transported to the satellite to limit the need for multiple emergency transports; and (e) On a quarterly basis, report to the Oregon Health Authority (Authority), for each patient evaluated or treated at the satellite, a basic emergency medical services data set including but not limited to: (A) Unique patient ID; (B) Gender; (C) Ethnicity; (D) Race; (E) Year of birth; (F) Date and time of patient presentation to satellite; (G) Chief complaint; (H) Diagnosis; (I) Discharge disposition; (J) Date and time of patient discharge; (K) Transport mode to and from the facility, including ambulance service provider, if applicable; and (L) Facility transferred to, if applicable. (2) A facility indorsed as a satellite under a hospital license for the provision of emergency medical services may not: (a) Be located: (A) In a county with three or more hospitals with an emergency department; or (B) In a city with a hospital with an emergency department. (b) Receive a trauma center categorization by the Authority; (c) Keep a patient for more than 24 hours; or (d) Provide inpatient care. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.020 History: PH 11-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 37-2023, minor correction filed 09/08/2023, effective 09/08/2023 PH 11-2015, f. & cert. ef. 8-13-15 PH 7-2015(Temp), f. & cert. ef. 3-24-15 thru 9-19-15
333-500-0030 Annual License Fee/Late Fee (1) The annual license fee for a hospital is as specified in ORS 441.020. (2) If a hospital license covers a satellite or mobile satellite approved by the Oregon Health Authority (Authority) under OAR 333-500-0025, the applicable license fee shall be the sum of the license fees which would be applicable if each location or unit was separately licensed. (3) The Authority may charge a reduced hospital fee or hospital satellite fee if the Authority determines that charging the standard fee constitutes a significant financial burden. (4) A hospital that fails to submit its license renewal application and fee before December 1 of each year shall be charged a late fee of $1,250. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.020 History: PH 24-2025, amend filed 12/18/2025, effective 12/23/2025 PH 12-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09 OHD 12-2001, f. & cert. ef. 6-12-01 OHD 2-2000, f. & cert. ef. 2-15-00 HD 21-1993, f. & cert. ef. 10-28-93 HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0010 HD 10-1988, f. & cert. ef. 5-27-88 HD 23-1987 (Temp), f. 11-27-87, cert. ef. 10-15-87 thru 4-15-88 HD 4-1984, f. & cert. ef. 2-16-84, Renumbered from 333-023-0117 HD 22-1982(Temp), f. & cert. ef. 11-9-82 HD 11-1980, f. & cert. ef. 9-1-80 HD 3-1979 f. & cert. ef. 2-26-79 HD 15-1978(Temp), f. 11-17-78, cert. ef. 1-1-79 HD 147, f. & cert. ef. 12-2-77 HD 143(Temp), f. & cert. ef. 8-4-77 HD 11, f. 3-16-72, cert. ef. 4-1-72
333-500-0034 Application Review (1) In reviewing an application for a new hospital, the Oregon Health Authority (Authority) shall: (a) Verify compliance with the applicable sections of ORS chapters 441 and 476, and OAR 333-500 through 535, 675, and chapter 837; (b) Determine whether a certificate of need is required and was obtained; (c) Conduct an in-person licensing survey in coordination with the State Fire Marshal’s Office; and (d) Verify compliance with conditions of participation if the applicant has requested Medicare or Medicaid certification. (2) In determining whether to license a hospital the Authority shall consider factors relating to the health and safety of individuals to be cared for at the hospital and the ability of the operator of the hospital to safely operate the facility, and may not consider whether the hospital is or shall be a governmental, charitable or other nonprofit institution or whether it is or shall be an institution for profit. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.022 & 441.025 History: PH 15-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 2-2024, amend filed 01/29/2024, effective 01/29/2024 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0036 Approval of License Application (1) The Oregon Health Authority (Authority) shall notify an applicant in writing if a license application is approved, and shall include the license with the appropriate classification. (2) A license shall be issued only for the premises and persons or governmental units named in the application and it is not transferable or assignable. (3) The license shall be conspicuously posted in an area where patients are admitted. (4) No hospital licensed pursuant to the provisions of ORS chapter 441 shall in any manner or by any means assert, represent, offer, provide or imply that such person or hospital is or may render care or services other than that which is permitted by or which is within the scope of the license issued to the hospital by the Authority nor shall any service be offered or provided which is not authorized within the scope of the license issued to the hospital. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 16-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0038 Denial of License Application If the Oregon Health Authority 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 441.025 Statutes/Other Implemented: ORS 441.037 History: PH 17-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 17-2012, f. 12-20-12, cert. ef. 1-1-13 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0040 Expiration and Renewal of License (1) Each license to operate a hospital shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application and pay the appropriate fee at least 30 days prior to the expiration date upon a form prescribed by the Oregon Health Authority (Authority). (2) For emergency preparedness planning and licensing purposes, a licensee shall provide, in its application for license renewal: (a) The number of beds currently in use or capable of being used; (b) The total number of beds that could be used with only minor alterations, taking into consideration existing equipment, the ancillary service capability of the facility, and the physical environment required by OAR 333-500 through 535, as applicable; and (c) The number of beds to be licensed. (3) A single hospital license may cover more than one location if the licensee meets the requirements in OAR 333-500-0025. (4) An applicant that has a certificate of accreditation and deemed status for Medicare certification from the Joint Commission or an accrediting organization approved by the Authority shall provide the certificate to the Authority with its renewal application, and shall include: (a) All Joint Commission or approved accrediting organization survey and inspection reports; and (b) Written evidence of all corrective actions underway, or completed, in response to Joint Commission or approved accrediting organization recommendations, including all progress reports. (5) If an applicant wishes to renew its license and increase the number of beds licensed from the previous licensing year, the applicant shall include: (a) Evidence of plans review approval as required by OAR 333-535 and 675 as applicable; and (b) Evidence that a certificate of need was obtained, or is not required. (6) The Authority may not renew a license for any hospital if a certificate of need is required and has not been obtained pursuant to ORS 442.315. (7) If the Authority intends to deny a license renewal application, it shall issue of Notice of Proposed Denial of License Renewal Application in accordance with ORS 183.411 through 183.470. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 18-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09 HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0015 HD 11-1980, f. & cert. ef. 9-2-80, Renumbered from 333-023-0118 HD 4-1978, f. & cert. ef. 3-31-78 HD 150(Temp), f. & cert. ef. 12-15-77 HD 11, f. 3-16-72, cert. ef. 4-1-72 HB 183, f. & cert. ef. 5-26-66
333-500-0045 Submission of Plans (1) A hospital proposing to make alterations or additions to an existing facility or to construct a new facility shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Oregon Health Authority (Authority) for preliminary inspection and approval or recommendations with respect to compliance with Authority rules and compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified. (2) Submissions shall comply with OAR chapter 333, division 675. Plans should also be submitted to the local building division having authority for review and approval in accordance with state building codes. Statutory/Other Authority: ORS 441.025 & ORS 441.060 Statutes/Other Implemented: ORS 441.025 & ORS 441.060 History: PH 19-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 7-2016, f. & cert. ef. 2-24-16 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0055 Discontinuance and Recommencement of Operation of Hospitals (1) If a hospital wishes to temporarily discontinue operation but retain its license to operate, the hospital shall notify the Oregon Health Authority (Authority) of the fact at least 14 days prior to the temporary discontinuance. (2) A hospital shall issue a multimedia press release within 24 hours of the temporary discontinuance, notifying the public of hospital closure. Such notice shall include a procedure by which individuals may obtain their medical records. (3) Before any patient is admitted to a hospital that has temporarily discontinued operation, the hospital shall request that the Authority conduct an in-person survey to determine whether the hospital is in compliance with health facility licensing laws and conditions of participation, if applicable. (4) A hospital may not renew operation until it receives approval, in writing, from the Authority. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 20-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 2-2024, amend filed 01/29/2024, effective 01/29/2024 PH 11-2009, f. & cert. ef. 10-1-09 HD 21-1993, f. & cert. ef. 10-28-93 HD 1-1989, f. & cert. ef. 1-10-89 HD 20-1988(Temp), f. & cert. ef. 7-29-88
333-500-0060 Return of Hospital License and Hospital Closure (1) If a hospital’s license is suspended, revoked, expires, or if a hospital decides to permanently close, the license certificate in the licensee’s possession shall be returned to the Oregon Health Authority (Authority) immediately. (2) If the hospital is voluntarily permanently closed, the hospital shall issue a multimedia press release within 24 hours, notifying the public of facility closure. Such notice shall include a procedure by which individuals may obtain their medical records. (3) A hospital shall notify the Authority of a hospital’s closure under section (2) of this rule at least 14 days prior to the closure and submit a plan for the storage and disposal of medical records. Medical records not claimed that are more than seven years old from the last date of discharge may be destroyed. Medical records not claimed that are less than seven years old from the last date of discharge shall be stored until they are more than seven years old from the last date of discharge. Medical records may be thinned to include only the admission/discharge sheet (face sheet), discharge summary, history and physical, operative report(s), pathology report(s), and X-ray report(s). Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 21-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 11-2009, f. & cert. ef. 10-1-09 HD 21-1993, f. & cert. ef. 10-28-93 HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0025 HD 11-1980, f. & cert. ef. 9-10-80, Renumbered from 333-023-0122 HD 11, f. 3-16-72, cert. ef. 4-1-72 HB 183, f. & cert. ef. 5-26-66
333-500-0065 Waivers (1) While all hospitals are required to maintain continuous compliance with the Oregon Health Authority (Authority)’s rules, these requirements do not prohibit the use of alternative concepts, methods, procedures, techniques, equipment, facilities, personnel qualifications or the conducting of pilot projects or research. A request for a waiver from a rule must be submitted to the Authority in writing and include the following information: (a) Identification of the specific rule for which a waiver is requested; (b) The special circumstances relied upon to justify the waiver; (c) What alternatives were considered, if any, and why alternatives (including compliance) were not selected; (d) Information demonstrating that the proposed waiver is desirable to maintain or improve the health and safety of the patients, to meet the individual and aggregate needs of patients, and shall not jeopardize patient health and safety; (e) For an initial waiver request received on or after January 1, 2024 or any request received on or after January 1, 2024 to renew a waiver, a description of the following: (A) Possible impacts that the proposed waiver may have on persons from different backgrounds and cultures, including but not limited to individuals of color, individuals with disabilities, individuals with limited English proficiency, people or households with lower incomes, and individuals who identify as lesbian, gay, bisexual, transgender, queer, two-spirit, intersex, asexual, nonbinary, or another minority gender identity or another sexual orientation; (B) How the impact was determined; and (C) Proposed steps to mitigate the impact on disproportionately affected populations; and (f) The proposed duration of the waiver. (2) Upon finding that the hospital has satisfied the conditions of this rule, the Authority may grant a waiver. (3) A hospital may not implement a waiver until it has received written approval from the Authority. (4) During an emergency the Authority may waive a rule that a hospital is unable to meet, for reasons beyond the hospital’s control. If the Authority waives a rule under this section it shall issue an order, in writing, specifying which rules are waived, which hospitals are subject to the order, and how long the order shall remain in effect. (5) A hospital seeking a waiver from a physical environment requirement under OAR chapter 333, division 535 must submit the information specified under subsections (1)(a) through (d) and (1)(f) of this rule. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 22-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 2-2024, amend filed 01/29/2024, effective 01/29/2024 PH 26-2010, f. 12-14-10, cert. ef. 12-15-10 PH 11-2009, f. & cert. ef. 10-1-09
333-500-0090 Adoption by Reference All rules, standards and publications referred to in OAR 333-500 through 535 are incorporated by reference. Copies are available for inspection in the Oregon Health Authority during office hours. Where publications are in conflict with the rules, the rules shall govern. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 23-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 11-2009, f. & cert. ef. 10-1-09 HD 21-1993, f. & cert. ef. 10-28-93 HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0040 HD 11-1980, f. & cert. ef. 9-10-80, Renumbered from 333-023-0119
333-501-0005 Complaints (1) Any person may make a complaint verbally or in writing to the Oregon Health Authority (Authority) regarding an allegation against a hospital of a violation of any health care facility licensing law or condition of participation. (2) The identity of a person making a complaint will be kept confidential. (3) An investigation will be carried out as soon as practicable after the receipt of a complaint in accordance with OAR 333-501-0010. (4) If the complaint involves an allegation of criminal conduct or an allegation that is within the jurisdiction of another local, state, or federal agency, the Authority will refer the matter to that agency. Statutory/Other Authority: ORS 441.025 Statutes/Other Implemented: ORS 441.044 History: PH 24-2024, minor correction filed 04/04/2024, effective 04/04/2024 PH 8-2023, minor correction filed 02/07/2023, effective 02/07/2023 PH 11-2009, f. & cert. ef. 10-1-09