Oregon Administrative Code

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…

333-025-0100 Definitions As used in these rules: (1) "Anonymous research" means scientific or medical genetic research conducted in such a manner that any DNA sample or genetic information used in the research is unidentified. "Anonymous research" does not include research conduc…

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 au…

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 fr…

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…

333-025-0120 Anonymous, Coded, or Exempt Genetic Research (1) Any person proposing to conduct genetic research that is thought to be anonymous shall obtain from an IRB, prior to conducting such research, a determination that the research is anonymous. The person shall furnish the…

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 …

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 …

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 laborator…

333-025-0140 Informed Consent Procedures for Obtaining Genetic Information (1) Unless exempted by ORS 192.535(1)(a)–(f), all persons collecting genetic information must conform to standards of informed consent as follows: (a) Physicians licensed under ORS Chapter 677, and any oth…

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…

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 indiv…

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 Auth…

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 accor…

333-025-0165 Disclosure of Genetic Information: Provider Notification and Opt Out (1) A direct provider that is a covered entity and who obtains a biological specimen or clinical individually identifiable health information from an individual must: (a) Notify the individual or hi…

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 reportab…

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 11/24/20…

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, adopt…

333-027-0005 Definitions The following definitions shall apply in OAR 333-027-0000 through 333-027-0190: (1) "Abuse" means: (a) "Abuse" as it applies to an "adult" as those terms are defined in ORS 430.735; (b) "Abuse" as it applies to a "child" as those terms are defined in ORS …

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 lice…

333-027-0015 Review of License Application In reviewing an application for a home health agency license, the Authority shall: (1) Confirm receipt of required fee and determine the application is complete; (2) Verify that the agency is primarily engaged in providing skilled nursin…

333-027-0017 Approval of License Application (1) The Authority shall notify an applicant in writing if a license application is approved. (2) A license shall be issued only for the agency and person(s) named in the application and may not be transferred or assigned. (3) The licen…

333-027-0018 Denial of License Application If the Authority intends to deny a license application, it shall issue a Notice of Intent to Deny in accordance with ORS 183.411 through 183.470. Statutory/Other Authority: ORS 443.085 Statutes/Other Implemented: ORS 443.045 History: PH …

333-027-0020 Expiration and Renewal of License (1) Each license to operate a home health agency shall expire on December 31 of each calendar year following the date of issue. (2) An agency shall submit a completed application for renewal on a form prescribed by the Authority, acc…

333-027-0029 Denial, Suspension, or Revocation of License (1) The Authority may impose a civil penalty or deny, suspend or revoke an agency's license for failure to comply with ORS 443.004, 443.014 through 443.095 or these rules. (2) If the Authority intends to impose a civil pen…

333-027-0033 Return of Agency License and Agency Closure (1) If an agency license is suspended, revoked, or if the facility decides to discontinue operations, the license certificate in the licensee’s possession shall be returned to the Authority immediately. (2) An agency that d…

333-027-0036 Surveys (1) The Authority shall, in addition to any investigations conducted pursuant to OAR 333-027-0038, conduct at least one in-person inspection of each agency prior to licensure and once every three years thereafter as requirement of licensing and at such other …

333-027-0037 Complaints (1) Any person may make a complaint verbally or in writing to the Authority regarding an allegation as to the care or services provided by a home health agency or violations of home health agency laws or regulations. (2) The identity of a person making a c…

333-027-0038 Investigations (1) An unannounced complaint investigation will be carried out as soon as practicable of the receipt of the complaint and may include, but is not limited to: (a) Interviews of the complainant, caregivers, patients, a patient’s representative, a patient…

333-027-0046 Geographic Service Area (1) As used in this rule, "underserved area or population" means an area in which residents have a shortage of available home health services or a group of persons who face economic, racial, cultural, linguistic, religious, sexual orientation,…

333-027-0050 Changes in Services Provided (1) An agency must obtain written approval from the Authority prior to the implementation of the provision of additional services. When an agency applies for approval of additional services, the agency must provide evidence of: (a) Govern…

333-027-0060 Administration of Home Health Agency (1) An agency shall clearly set forth in writing the organization, services provided, administrative control, and lines of authority for the delegation of responsibility to the patient care level. An agency shall not delegate admi…

333-027-0064 Criminal Records Check (1) For the purposes of this rule, the following definitions apply: (a) "Disqualifying condition" means a non-criminal personal history issue that makes an individual unsuitable for employment, contracting or volunteering for an agency, includi…

333-027-0080 Advance Directives (1) An agency shall maintain written policies and procedures, applicable to any person 18 years of age or older, or to any adult as defined under ORS 127.505, who is receiving health care by, or through, the agency relating to advance directives an…

333-027-0110 Conformance with Physician's or Allowed Practitioner’s Orders (1) Agency personnel shall administer drugs and treatments only as ordered by the patient's physician or allowed practitioner in accordance with 42 CFR 484.60 or by other providers as authorized by Oregon …

333-027-0115 Personnel Safety Program Requirements (1) As used in this rule: (a) "Hazards" means potentially unsafe or dangerous conditions in or around the home health care setting, including but not limited to the presence of uncontrolled animals, persistent or periodic presenc…

333-027-0125 Potential Threat or Disruptive Behavior Flagging Systems (1) As used in this rule: (a) "Authorized staff" means the personnel who are responsible for creating and tracking electronic health record flags. (b) "Disruptive behavior" includes physically aggressive, haras…

333-027-0130 Nursing Services (1) The agency shall provide skilled nursing service by or under the supervision of a registered nurse in accordance with agency policies and the plan of care. (2) The registered nurse is responsible for supervising for quality and appropriateness of…

333-027-0140 Therapeutic Services (1) Pursuant to ORS 443.075, an agency must have an order for a plan of care from a physician or allowed practitioner for at least one of the following services and supplies for each patient: (a) Skilled nursing; (b) Physical therapy services; (c…

333-027-0150 Clinical Records (1) An agency shall maintain, for each patient, a clinical record that covers the service(s) the agency provides directly, or through contract with another agency. (2) An agency shall keep all clinical records for a period of seven years after the da…

333-027-0155 Infection Prevention and Control An agency shall develop an infection control program to prevent and control infections and communicable diseases. The program shall include at a minimum: (1) A tuberculosis infection control plan in accordance with OAR 333-019-0041; (…

333-027-0160 Quality Assessment and Performance Improvement An agency must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished to a patient. Written documentation of q…

333-027-0170 Waivers (1) While all agencies are required to maintain continuous compliance with these rules, these requirements do not prohibit the use of alternative concepts, methods, procedures, techniques, equipment, facilities, personnel qualifications or the conducting of p…

333-027-0175 Violations In addition to non-compliance with any law that governs a home health agency, it is a violation to: (1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Authority staff access to the agency, its documents …

333-027-0180 Informal Enforcement (1) If during an investigation or survey Authority staff document violations of home health licensing rules or laws, the Authority may issue a statement of deficiencies that cites the law alleged to have been violated and the facts supporting the…

333-027-0185 Formal Enforcement (1) If during an investigation or survey Authority staff document a substantial failure to comply with home health licensing laws or rules, or if an agency fails to pay a civil penalty imposed under ORS 443.045 and these rules, the Authority may is…

333-027-0190 Civil Penalties (1) An agency that violates home health licensing laws or rules, an administrative order, or settlement agreement is subject to the imposition of a civil penalty not to exceed $1,000 per violation and may not total more than $2,000. (2) In determining…

333-028-0200 School-Based Health Center Program: Purpose The school-based health center (SBHC) program supports communities in promoting the health and well-being of the school-age population through the evidence-based best practice within a public health framework. These rules (…

333-028-0210 School-Based Health Center Program: Definitions (1) “Authority” means the Oregon Health Authority. (2) “Certification year” means a one-year period beginning on July 1 and ending on June 30. (3) “Electronic health record (EHR)” means an electronic record of an indivi…

333-028-0220 School-Based Health Center Program: School-Based Health Center Program: Certification Requirements In order to be certified as a SBHC, a SBHC must meet all requirements for certification in the following sections of the SBHC Standards for Certification, Version 4, in…