reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0110 - Institutional Review Boards (IRBs) and Approval for Research

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 192.547
Stats. Implemented: ORS 192.533 &
				  192.547
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0115 - Informed Consent for Non-Exempt Genetic Research

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 192.535 & 192.547
Stats. Implemented: ORS 192.535 &
				  192.547
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0120 - Anonymous, Coded, or Exempt Genetic Research

Current through Register Vol. 63, No. 7, July 1, 2024
(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 IRB with assurances that the criteria in (3) below are
			 met.
(2) Any person proposing to
			 conduct research that is thought to be exempt from review shall obtain an IRB
			 determination that the research is exempt from review under  45 CFR 46.101 (b) or other applicable exemption from the Federal Common Rule.
(3) A human biological sample or clinical
			 individually identifiable health information may be used in anonymous or coded
			 genetic research only if prior to the time the research is conducted:
(a) The subject has granted informed consent
			 for the specific anonymous or coded research project; or
(b) The subject has granted consent for
			 genetic research generally; or
(c)
			 The subject was notified in accordance with OAR
			 333-025-0165  that the individual's sample or information may be used for anonymous or coded
			 research, and before the sample or information was obtained, the subject did
			 not request that the sample or information be withheld from anonymous or coded
			 research; or
(d) The subject was
			 not notified, due to emergency circumstances, in accordance with OAR
			 333-025-0165,
			 that the individual's sample or information may be used for anonymous research
			 or coded research, and the individual died before receiving the notice;
			 or
(e) The subject has granted
			 blanket informed consent and the sample or information was obtained before June
			 25, 2001; or
(f) The subject was
			 deceased when the sample or information was obtained; or
(g) An Institutional Review Board:
(A) Waives or alters the consent requirements
			 pursuant to the Federal Common Rule; and
(B) Waives authorization pursuant to the
			 Federal Privacy Rule.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0125 - IRB Registry

Current through Register Vol. 63, No. 7, July 1, 2024
(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 the 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.
Stat. Auth.: ORS 192.547
Stats. Implemented: ORS
				  192.547
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0130 - Recontact

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0135 - Information Concerning Deceased Individuals

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0140 - Informed Consent Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
(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 other licensed health care providers or facilities, shall obtain
			 informed consent according to ORS 677.097;
(b) Except as provided in OAR
			 333-025-0120,
			 a person conducting research shall obtain informed consent according to the
			 procedure given in OAR
			 333-025-0115;
			 and
(c) If genetic information is
			 collected in connection with an insurance transaction governed by ORS 746.135,
			 informed consent will be conducted in the manner described by the Department of
			 Consumer and Business Services under authority of ORS 746.135(1).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0145 - Retention for the Purpose of Identification of Deceased Individuals

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Stat. Auth.: ORS 192.537 & 192.539
Stats. Implemented: ORS 192.537 &
				  192.539
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0150 - Retention for the Purpose of Testing to Benefit Blood Relatives of Deceased Individuals

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Stat. Auth.: ORS 192.535 & 192.537
Stats. Implemented: ORS 192.535 &
				  192.537
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0155 - Retention for the Purpose of Newborn Screening Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Stat. Auth.: ORS 433.285, 192.535 & 192.537
Stats. Implemented: ORS 192.535 &
				  192.537
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0160 - Disclosure of Genetic Information: Procedure for Authorization of Disclosure by the Tested Individual or the Tested Individual's Representative

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0165 - Provider Notification and Opt Out

Current through Register Vol. 63, No. 7, July 1, 2024
(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 his/her personal
			 representative, in accordance with this rule, that the individual's biological
			 specimen or clinical individually identifiable health information may be used
			 or disclosed for anonymous or coded research; and
(b) Give the individual the opportunity to
			 make an opt-out statement.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 26 - CIVIL PENALTIES RELATED TO REPORTING, INVESTIGATION, AND CONTROL OF DISEASES OF PUBLIC HEALTH CONCERN › Section 333-026-0030 - Civil Penalties for Violations of OAR Chapter 333, Divisions 18 and 19

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0000 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0001 - Compliance with Federal Law

Current through Register Vol. 63, No. 7, July 1, 2024
(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. A licensed home health agency that is not currently
			 certified by the CMS must ensure that it complies with this rule no later than
			 [insert six months from effective date of rule.]
(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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
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 419B.005; or
(c) "Abuse" as it applies to an "elderly
			 person" or a "person with a disability" as those terms are defined in ORS
			 124.005.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0010 - Application for Licensure and Fees

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0015 - Review of License Application

Current through Register Vol. 63, No. 7, July 1, 2024
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 nursing and at least one of the following other
			 services:
(a) Physical therapy, occupational
			 therapy, speech therapy, medical social services, or home health aide
			 services;
(b) Other therapeutic
			 services such as in-home care services as defined in ORS
			 443.305 or palliative care as defined in ORS
			 413.273 may be provided in addition to a service required under subsection (2)(a).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0017 - Approval of License Application

Current through Register Vol. 63, No. 7, July 1, 2024
(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 license shall be
			 conspicuously posted in an office that is viewable by the public.
(4) A licensed home health agency that also
			 provides personal care services that are necessary to assist an individual's
			 daily needs, but do not include curative or rehabilitative services is not
			 required to be licensed as an in-home care agency. Such agencies shall comply
			 with ORS
			 443.305 through
			 443.355 and OAR 333-536-0000  through 333-536-0125  with the exception of the licensing
			 requirements.
(5) No person or home
			 health agency licensed pursuant to the provisions of ORS chapter 443 and these
			 rules, shall in any manner or by any means assert, represent, offer, provide or
			 imply that such person or agency 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 such person or agency by the Authority nor shall any service be offered or
			 provided which is not authorized within the scope of the license issued to such
			 person or facility.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.015,
				  443.085 &
				  443.090
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0018 - Denial of License Application

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0020 - Expiration and Renewal of License

Current through Register Vol. 63, No. 7, July 1, 2024
(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,
			 accompanied by the required fee, to the Authority not less than 30 days prior
			 to the license expiration date.
(3)
			 The Authority may issue a renewal license contingent upon evidence of the
			 agency's compliance with ORS chapter 443 and these rules; attestation to the
			 delivery of agency services to patient(s) during the last calendar year; and,
			 if requested, receipt of an annual statistical report containing such
			 information as may be prescribed by the Authority.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.015
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0029 - Denial, Suspension, or Revocation of License

Current through Register Vol. 63, No. 7, July 1, 2024
(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 penalty or deny, suspend or revoke an
			 agency license, it shall do so in accordance with ORS
			 183.411 through
			 183.470.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.045
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0033 - Return of Agency License and Agency Closure

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 discontinues operations must:
(a) Inform
			 patients or the patient's representative about the closure at least 14 calendar
			 days prior to closure;
(b) Provide
			 information about how an individual may obtain their clinical
			 records;
(c) Notify the Authority
			 at least 14 calendar days prior to closure and submit plans for the transfer,
			 storage and disposal of clinical records.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0036 - Surveys

Current through Register Vol. 63, No. 7, July 1, 2024
(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 times as the Authority deems necessary.
(2) In lieu of the in-person inspection
			 required by section (1) of this rule, the Authority may accept:
(a) CMS certification by a federal agency or
			 an approved accrediting organization; or
(b) A survey conducted within the previous
			 three years by an accrediting organization approved by the Authority if:
(A) The certification or accreditation is
			 recognized by the Authority as addressing the standards and Condition for
			 Participation requirements of the CMS and other standards set by the
			 Authority;
(B) The agency notifies
			 the Authority to participate in any exit interview conducted by the federal
			 agency or accrediting body; and
(C)
			 The agency provides copies of all documentation concerning the certification or
			 accreditation requested by the Authority including:
(i) Written evidence of all corrective
			 actions underway, or completed, in response to approved accrediting
			 organizations recommendations;
(ii) All progress reports; and
(iii) The letter from CMS indicating the
			 agency's deemed status.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0037 - Complaints

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 complaint and any personally identifiable information, as that is defined in
			 ORS
			 432.005 is confidential and not subject to disclosure under ORS
			 192.311 to
			 192.478.
(3) An investigation may be carried out after
			 receipt of a complaint in accordance with OAR 333-027-0038.
(4) An employee or contract provider with
			 knowledge of a violation of ORS chapter 443 or these rules, shall use the
			 reporting procedures established by the home health agency before notifying the
			 Authority or other state agency of the inappropriate care or violation, unless
			 the employee or contract provider:
(a)
			 Believes a patient's health or safety is in immediate jeopardy; or
(b) Files a complaint in accordance with
			 section (1) of this rule.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0038 - Investigations

Current through Register Vol. 63, No. 7, July 1, 2024
(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's family members,
			 witnesses, and agency management and staff;
(b) On-site observations of the patient(s),
			 staff performance, patient environment; and
(c) Review of documents and records.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0046 - Geographic Service Area

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A home
			 health agency serves a geographic service area that is equal to or less than 60
			 miles from the physical location of the agency.
(2) A branch office provides services to the
			 parent agency's location within a portion of the area served by the parent
			 agency.
(3) A home health agency
			 that moves its physical location:
(a) Must
			 apply for a new license in accordance with OAR 333-027-0010; and
(b) Ensure that the services it provides to
			 patients is within 60 miles from the new physical location.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0050 - Changes in Services Provided

Current through Register Vol. 63, No. 7, July 1, 2024
(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) Governing body approval of addition of
			 the services and all revisions in agency policies pertaining to the new
			 services;
(b) Governing body
			 approval of the agency's policies and procedures pertaining to the new
			 services; and
(c) Adherence to
			 agency personnel policies and ORS chapter 443 and these rules by all
			 individuals providing services through the agency.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0060 - Administration of Home Health Agency

Current through Register Vol. 63, No. 7, July 1, 2024
(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 administrative and supervisory functions to another
			 agency, individual, or organization.
(2) An agency shall ensure that:
(a) A clinical manager is employed who is
			 responsible for the oversight of all patient care services and personnel and
			 that the clinical manager is available during all operating hours;
(b) A professional policy-making committee is
			 established in accordance with ORS
			 443.065; and
(c) All patient complaints are reviewed
			 including documentation and resolution.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0064 - Criminal Records Check

Current through Register Vol. 63, No. 7, July 1, 2024
(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, including but not
			 limited to discipline by a licensing or certifying agency, or drug or alcohol
			 dependency;
(b) "Fitness
			 determination" means a decision made by an agency pursuant to the policy
			 established in accordance with section (5) of this rule, that a subject
			 individual is or is not fit to hold a position, paid or not paid, have direct
			 access, or otherwise provide services to a patient.
(c) "Subject Individual" (SI) means an
			 individual on whom an agency may conduct a criminal records check and from whom
			 an agency may require fingerprints for the purpose of conducting a national
			 criminal records check, including:
(A) An
			 employee or prospective employee;
(B) A contractor, temporary worker, volunteer
			 or owner of an agency who may have contact with patients or has access to
			 personal information about patients, including but not limited to Social
			 Security numbers, dates of birth, driver license numbers, medical information,
			 personal financial information, or criminal background information;
(C) A prospective contractor, temporary
			 worker, or volunteer or owner who may have contact with patients or has access
			 to personal information about patients, including but not limited to Social
			 Security numbers, dates of birth, driver license numbers, medical information,
			 personal financial information, or criminal background information.
(d) "Vendor" means a researcher or
			 company hired to provide a criminal records check on a subject
			 individual.
(e) "Weighing test"
			 means a process in which an agency considers available information to make a
			 fitness determination when an SI has potentially disqualifying convictions or
			 conditions.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0080 - Advance Directives

Current through Register Vol. 63, No. 7, July 1, 2024
(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 and appointing a health care representative. The policy shall
			 include provisions for the education of agency personnel and the community on
			 issues relating to advance directives.
(2) An agency shall ensure that each patient
			 receives the following information and materials, in written form, without
			 recommendation:
(a) Information on the rights
			 of the individual under Oregon law to make health care decisions, including the
			 right to accept or refuse medical treatment and the right to execute an advance
			 directive or appoint a health care representative;
(b) Information on the policies of the agency
			 with respect to the implementation of the rights of the individual under Oregon
			 law to make health care decisions;
(c) A copy of the advance directive set forth
			 in ORS chapter 127; and
(d) The
			 name of a person who can provide additional information concerning the forms
			 for advance directives or appointing a health care representative.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0110 - Conformance with Physician's or Allowed Practitioner's Orders

Current through Register Vol. 63, No. 7, July 1, 2024
(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 law.
(2) The
			 nurse or therapist who receives a verbal order shall immediately record the
			 order and transmit it to the physician or allowed practitioner within 72
			 hours.
(3) The physician's or
			 allowed practitioner's countersignature shall be obtained within 30 calendar
			 days of the verbal order.
(4)
			 Agency professional personnel shall check all medicines that a patient may be
			 taking to identify possible ineffective drug therapy, adverse reactions,
			 significant side effects, drug allergies, and contraindicated
			 medication.
(5) Agency professional
			 personnel shall promptly report any problems to the patient's physician or
			 allowed practitioner.
(6) Only
			 medications and treatments that must be administered to the patient by agency
			 personnel need to be on a written order form from the physician or allowed
			 practitioner.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.075  & 443.085
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0130 - Nursing Services

Current through Register Vol. 63, No. 7, July 1, 2024
(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 care provided by
			 the home health aide service. The registered nurse shall be readily available
			 to the home health aide by telephone at all hours services are
			 provided.
(3) A home health aide
			 must have the following minimum qualifications:
(a) An Oregon Certified Nursing Assistant
			 (CNA) certification and inclusion on the Oregon State Board of Nursing OBRA
			 Federal CNA Registry; and
(b)
			 Successful completion of a competency evaluation program.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0140 - Therapeutic Services

Current through Register Vol. 63, No. 7, July 1, 2024
(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) Occupational therapy services;
(d) Speech therapy services;
(e) Medical social services;
(f) Home health aide services; or
(g) Medical supplies, other than drugs and
			 biologicals, and medical devices;
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0150 - Clinical Records

Current through Register Vol. 63, No. 7, July 1, 2024
(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 date of the
			 patient's last discharge from the agency.
(3) If an agency changes ownership, the
			 agency shall retain all clinical records in original or digital form and it
			 shall be the responsibility of the successor agency to protect and maintain
			 these records.
(4) In the event of
			 dissolution of an agency, the agency administrator shall notify the Authority
			 where the clinical records will be stored in accordance with OAR
			 333-027-0033.
(5) The agency shall
			 retain non-medical records according to the policy of the individual
			 agency.
(6) An agency shall comply
			 with ORS
			 192.553 through
			 192.581,
			 which governs the use and disclosure of patient's protected health
			 information.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.065  & 443.085
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0155 - Infection Prevention and Control

Current through Register Vol. 63, No. 7, July 1, 2024
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;
(2) Appropriate disposal of sharp instruments
			 in accordance with OAR 333-056-0050;
(3) Development of policies and procedures
			 that include, at a minimum:
(a) Standard
			 precautions such as hand hygiene, respiratory hygiene and cough etiquette, and
			 personal protective equipment;
(b)
			 Availability of personal protective equipment and other equipment necessary to
			 implement plan of care; and
(c)
			 Exposure to bloodborne pathogens such as Hepatitis B and HIV and other
			 potentially infectious agents.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0160 - Quality Assessment and Performance Improvement

Current through Register Vol. 63, No. 7, July 1, 2024
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
				quality assessment and performance improvement activities shall be recorded at
				least quarterly.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.085
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0170 - Waivers

Current through Register Vol. 63, No. 7, July 1, 2024
(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 pilot projects or research. A request for a waiver from a rule
			 must:
(a) Be submitted to the Authority in
			 writing;
(b) Identify the specific
			 rule for which a waiver is requested;
(c) Identify the special circumstances relied
			 upon to justify the waiver;
(d)
			 Explain why the agency is unable to be in compliance, what alternatives were
			 considered, if any, and why alternatives (including compliance) were not
			 selected;
(e) Demonstrate 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 will
			 not jeopardize patient health and safety; and
(f) Include the proposed duration of the
			 waiver.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0175 - Violations

Current through Register Vol. 63, No. 7, July 1, 2024
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 or records;
(2) Fail to implement an approved plan of
			 correction;
(3) Refuse or fail to
			 comply with an order issued by the Authority;
(4) Refuse or fail to pay a civil
			 penalty;
(5) Fail to comply with
			 rules governing the storage of records following the closure of an
			 agency;
(6) Fail to report
			 suspected abuse of elderly persons as defined in ORS
			 124.050;
(7) Fail to return a license as provided in
			 OAR 333-027-0033; or
(8) Operate
			 without a license.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.045  & 443.085
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0180 - Informal Enforcement

Current through Register Vol. 63, No. 7, July 1, 2024
(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 allegation.
(2) A
			 signed plan of correction must be mailed to the Authority within 10 business
			 days from the date the statement of deficiencies was received by the agency. A
			 signed plan of correction will not be used by the Authority as an admission of
			 the violations alleged in the statement of deficiencies.
(3) An agency shall correct all deficiencies
			 within 60 days from the date of the exit conference, unless an extension of
			 time is requested from the Authority. A request for such an extension shall be
			 submitted in writing and must accompany the plan of correction.
(4) 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 agency owner in
			 writing or by telephone:
(a) Identifying which
			 provisions in the plan the Authority finds unacceptable;
(b) Citing the reasons the Authority finds
			 them unacceptable; and
(c)
			 Requesting that the plan of correction be modified and resubmitted no later
			 than 10 working days from the date the letter of non-acceptance was received by
			 the owner.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0185 - Formal Enforcement

Current through Register Vol. 63, No. 7, July 1, 2024
(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 issue a Notice of Proposed Suspension or
			 Notice of Proposed Revocation in accordance with 183.411 through
			 183.470.
(2) The Authority may
			 issue a Notice of Imposition of Civil Penalty for violations of home health
			 licensing laws.
(3) At any time the
			 Authority may issue a Notice of Emergency License Suspension under ORS
			 183.430.
(4) If the Authority revokes an agency
			 license, the order shall specify when, if ever, the agency may reapply for a
			 license.
(5) The Authority may
			 reinstate an agency license that has been suspended after the Authority
			 determines that compliance with these rules have been achieved.
Statutory/Other Authority: ORS
				  443.085
Statutes/Other Implemented: ORS
				  443.045  & 443.085
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 27 - HOME HEALTH AGENCIES › Section 333-027-0190 - Civil Penalties

Current through Register Vol. 63, No. 7, July 1, 2024
(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 the amount of a civil
			 penalty, the Authority shall consider whether:
(a) The Authority made repeated attempts to
			 obtain compliance;
(b) The licensee
			 has a history of non-compliance with home health licensing laws and
			 rules;
(c) The violation poses a
			 serious risk to the public's health; and
(d) There are mitigating factors, such as a
			 licensee's cooperation with an investigation or actions to come into
			 compliance.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 28 - SCHOOL-BASED HEALTH PROGRAMS › Section 333-028-0200 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
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 (OAR
				333-028-0200  through
				333-028-0250) establish the procedure and criteria the Oregon Health Authority shall use to
				certify, suspend and decertify SBHCs. Certification of a SBHC by the SBHC state
				program is voluntary; an operating clinic is free to choose not to participate
				in certification and still operate. Only certified SBHCs are eligible for
				funding from the Oregon Health Authority.
Stat. Auth.: 2013 OL Ch. 683
Stats. Implemented: 2013 OL Ch. 683 & ORS
				  413.225
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 28 - SCHOOL-BASED HEALTH PROGRAMS › Section 333-028-0210 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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 individual's health-related information that conforms
			 to nationally recognized interoperability standards and that can be created,
			 managed and consulted by authorized clinicians and staff across more than one
			 health care provider.
(4)
			 "Electronic medical record (EMR)" means a digital version of a paper chart that
			 contains all of the patient's medical history from one practice. An EMR is
			 mostly used by providers for diagnosis and treatment.
(5) "Program" means the Oregon Health
			 Authority, Public Health Division, school-based health center program.
(6) "School-based health center"
			 (SBHC) has the meaning given the term in ORS 413.225.
(7) "SBHC system" is one or more SBHCs that
			 operate under the same sponsoring agency.
(8) "Sponsoring agency" is an entity that
			 provides the following services for a SBHC or contracts with another entity to
			 provide one or more of the following:
(a)
			 Funding;
(b) Staffing;
(c) Medical oversight;
(d) Liability insurance; and
(e) Billing support.