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Oregon Bulletin

May 1, 2012

Oregon Health Authority, Public Health Division, Chapter 333

Rule Caption: Amendment and adoption of rules related to Outpatient Renal Dialysis Facilities (ESRD facilities).

Adm. Order No.: PH 4-2012

Filed with Sec. of State: 3-30-2012

Certified to be Effective: 4-1-12

Notice Publication Date: 1-1-2012

Rules Adopted: 333-700-0004, 333-700-0017, 333-700-0018, 333-700-0019, 333-700-0053, 333-700-0057, 333-700-0061, 333-700-0062, 333-700-0063, 333-700-0064, 333-700-0072, 333-700-0073

Rules Amended: 333-700-0000, 333-700-0005, 333-700-0010, 333-700-0015, 333-700-0020, 333-700-0025, 333-700-0030, 333-700-0035, 333-700-0040, 333-700-0045, 333-700-0050, 333-700-0060, 333-700-0065, 333-700-0075, 333-700-0080, 333-700-0085, 333-700-0090, 333-700-0095, 333-700-0100, 333-700-0105, 333-700-0110, 333-700-0115, 333-700-0120, 333-700-0125, 333-700-0130

Rules Repealed: 333-700-0055, 333-700-0070

Subject: The Oregon Health Authority, Public Health Division is permanently adopting, amending and repealing Oregon Administrative Rules in chapter 333, division 700 relating to Outpatient Renal Dialysis Facilities (ESRD facilities) in response to legislation passed in 2009 (SB 158) and federal rule alignment. The proposed changes will: update the rules to be consistent with Centers for Medicare and Medicaid regulations; provide better organization for the rules; provide clearer wording; provide clearer processes for licensing, handling complaints, investigations, surveys, and discipline; add a mobile dialysis section; add staffing ratio requirements and make housekeeping changes.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-700-0000

Statement of Purpose

The purpose of these rules is to establish the standards for licensure of outpatient renal dialysis facilities.

Stat. Auth.: ORS 441.015, 441.025 & 442.015
Stats. Implemented: ORS 441.015, 441.025 & 442.015
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0004

Referenced Codes and Standards

The codes and standards referenced in these rules shall be considered part of the requirements of these rules to the prescribed extent of each such reference. Where differences occur between provisions of these rules and referenced codes and standards, the provisions of the most restrictive code shall apply.

(1) Association for the Advancement of Medical Instrumentation (AAMI) publication, “Dialysate for Hemodialysis”, AAANSI/AAMI RD 52:2004;

(2) Association for the Advancement of Medical Instrumentation (AAMI) publication, “Reuse of Hemodialyzers”, third edition ANSI/AAMI RD 47/AI:2003;

(3) 2010 Oregon Structural Specialty Code;

(4) 2010 Oregon Mechanical Specialty Code;

(5) 2010 Oregon Energy Efficiency Specialty Code;

(6) 2010 Oregon Electrical Specialty Code;

(7) 2011 Oregon Plumbing Specialty Code;

(8) 2010 Oregon Fire Code;

(9) National Fire Protection Association, NFPA 101 Life Safety Code, 2000 Edition;

(10) National Fire Protection Association, NFPA 99 Standard for Healthcare Facilities, 1999 Edition;

(11) National Fire Protection Association, NFPA 110 Standard for Emergency and Standby Power Systems, 2002 Edition;

(12) National Fire Protection Association, NFPA 90A Standard for Installation of Air-Conditioning and Ventilating Systems, 1996 Edition;

(13) National Fire Protection Association, NFPA 255 Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 Edition;

(14) ASHRAE Standard 170-2008 Ventilation of Health Care Facilities.

Stat. Auth.: ORS 441.015, 441.025 & 441.060
Stats. Implemented: ORS 441.025 & 441.060
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0005

Definitions

As used in OAR chapter 333, division 700, unless the context requires otherwise, the following definitions apply:

(1) “Administrator” means a person designated by the governing body to have overall management of the facility. The administrator enforces the rules and regulations relative to the health care and safety of patients. The administrator plans, organizes, and directs those responsibilities delegated to the administrator by the governing body.

(2) “Agreement”, as used in these rules, means a written document executed between a dialysis facility and another facility in which the other facility agrees to assume responsibility for furnishing specified services to patients and for obtaining reimbursement for those services.

(3) “Arrangement”, as used in these rules, means a written document executed between a dialysis facility and another facility in which the other facility agrees to furnish specified services to patients but the dialysis facility retains responsibility for those services and for obtaining reimbursement for them.

(4) “Assessment” means a complete assessment done by a physician, registered nurse, social worker, or dietitian that is appropriate for the scope of practice for that discipline. Assessment includes:

(a) Systematic and ongoing collection of information to determine an individual’s health status and need for intervention;

(b) Comparison with past information; and

(c) Judgment, evaluation, or conclusion that occurs as a result of subsections (a) and (b) of this section.

(5) “Authentication” means verification that an entry in the patient medical record is genuine.

(6) “Authority” means the Oregon Health Authority.

(7) “Certified Hemodialysis Technician” (CHDT) has the meaning given that term in ORS 688.625.

(8) “CMS” means the Center for Medicare and Medicaid Services.

(9) “Conditions for Coverage” (CfC) means the minimum health and safety standards that providers and suppliers must meet in order to be Medicare and Medicaid certified.

(10) “Dialysis” means a process by which dissolved substances are removed from a patient’s body by diffusion from one fluid compartment to another across a semi-permeable membrane. The two types of dialysis that are currently in common use are hemodialysis and peritoneal dialysis.

(11) “Discharge”, as used in these rules, means the process whereby a patient who was receiving services in a facility is either sent home, transferred to another facility or has died.

(12) “Division” means the Public Health Division of the Oregon Health Authority.

(13) “End-Stage Renal Disease (ESRD)” means that stage of renal impairment that appears irreversible and permanent, and requires a regular course of dialysis or kidney transplantation to maintain life.

(14) “ESRD service” means the type of care or services furnished to a dialysis patient.

(15) “Facility”, as used in these rules, means an outpatient renal dialysis facility.

(16) “Furnishes directly” means the facility provides the service through its own staff and employees, or through individuals who are under direct contract to furnish such services personally for the facility (i.e., not through Agreements” or “arrangements”).

(17) “Furnishes on the premises” means the facility furnishes services on its main premises; or on its other premises that are contiguous with or in immediate proximity to the main premises, and under the direction of the same professional staff and governing body as the main premises.

(18) “Governing body” means the body or person legally responsible for the direction and control of the operation of the facility.

(19) “Governmental unit” means the state, or any county, municipality, or other political subdivision, or any related department, division, board or other agency.

(20) “Health care facility” (HCF) has the meaning given that term in ORS 442.015.

(21) “Health Care Facility Licensing Law” means ORS 441.005 through 441.990 and implementing rules.

(22) “Histocompatibility testing” means laboratory test procedures which determine compatibility between a potential organ donor and a potential organ transplant recipient.

(23) “Hospital” has the meaning given that term in ORS 442.015.

(24) “Licensed” means that the person to whom the term is applied is currently licensed, certified or registered by the proper authority to follow his or her profession or vocation within the State of Oregon, and when applied to a health care facility means that the facility is currently licensed by the Authority.

(25) “Licensed nurse” means a nurse licensed under ORS chapter 678 to practice registered or practical nursing.

(26) “Licensed Practical Nurse” (LPN) means a person licensed under ORS chapter 678 to practice practical nursing.

(27) “Major alteration” means any structural change to the foundation, roof, floor, or exterior or load bearing walls of a building, or the extension of an existing building to increase its floor area. Major alteration also means the extensive alteration of an existing building such as to change its function and purpose, even if the alteration does not include any structural change to the building.

(28) “Network” means Northwest Renal Network (Network 16). The Network is a Quality Improvement Organization under contract to the federal Centers for Medicare and Medicaid Services.

(29) “New Construction” means a new building or an addition to an existing building.

(30) “NFPA” means National Fire Protection Association.

(31) “Outpatient dialysis” means dialysis furnished by a licensed outpatient renal dialysis facility. Outpatient dialysis includes:

(a) Staff-assisted dialysis. Dialysis performed by the staff of the facility;

(b) Self-dialysis. Dialysis performed, with little or no professional assistance, by a dialysis patient who has completed an appropriate course of training;

(c) “Home dialysis” means dialysis performed by an appropriately trained patient or helper at home;

(d) “Self-dialysis and home dialysis training” means a program that trains dialysis patients to perform self-dialysis or home dialysis with little or no professional assistance, and trains other individuals to assist patients in performing self-dialysis or home dialysis.

(32) “Outpatient Mobile dialysis” means hemodialysis treatments provided by qualified personnel in a patient’s home, whether that is a private residence or care facility.

(33) “Organ procurement”, as used in these rules, means the process of acquiring donor kidneys.

(34) “Oregon Sanitary Code” means the Food Sanitation Rules in OAR 333-150.

(35) “Patient audit” means review of the medical record and physical inspection and interview of a patient.

(36) “Patient care staff” as used in these rules means registered nurses, licensed practical nurses, certified hemodialysis technicians, social workers, and dieticians.

(37) “Person” has the meaning given that term in ORS 442.015.

(38) “Physician” means a person licensed under ORS Chapter 677 to practice medicine by the Oregon Medical Board.

(39) “Physician’s Assistant” has the meaning given that term in ORS 677.495.

(40) “Qualified instructor” means a person who is qualified in the field of instruction by education and experience.

(41) “Qualified personnel” means personnel who meet the requirements specified in this section.

(a) “Dietitian” means a person who is a licensed dietitian as specified in ORS 691.435.

(b) “Nurse responsible for nursing service” means a person who is licensed as a registered nurse by the state in which practicing, and

(A) Has at least 12 months of experience in clinical nursing, and an additional 6 months of experience in nursing care of the patient with permanent kidney failure or who is undergoing kidney transplantation including training in and experience with the dialysis process; or

(B) Has 18 months of experience in nursing care of the patient on maintenance dialysis, or in nursing care of the patient with a kidney transplant including training in and experience with the dialysis process.

(c) “Physician-director” or medical director means a physician who:

(A) Is Board-certified in internal medicine or pediatrics by a professional board, and has had at least 12 months of experience or training in the care of patients at dialysis facilities; or

(B) As of April 1, 2012 served for at least 12 months as director of a dialysis or transplantation program.

(d) “Social worker” means a person who:

(A) Has completed a course of study with specialization in clinical practice at, and holds a masters degree from, a graduate school of social work accredited by the Council on Social Work Education; or

(B) Has served for at least two years as a social worker, one year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under paragraph (d)(A) of this definition.

(e) “Transplantation surgeon” means a physician who:

(A) Is board-eligible or board-certified in general surgery or urology by a professional board; and

(B) Has at least 12 months training or experience in the performance of renal transplantation and the care of patients with renal transplants.

(42) “Records” are defined as case histories, clinical records, X-rays, treatment charts, progress reports and other similar written accounts of the patients of any provider.

(43) “Registered Nurse” (RN) means a person licensed under ORS chapter 678 to practice registered nursing.

(44) “Statement of deficiencies” means a document issued by the Division that describes a facility’s deficiencies in complying with health care facility licensing laws or conditions for coverage.

(45) “Survey” means an inspection of a facility to determine the extent to which a facility is in compliance with health facility licensing laws and conditions for coverage.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 442.015
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 11-2011, f. & cert. ef. 10-27-11; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0010

Application for Licensure

(1) An outpatient renal dialysis facility must obtain a license from the Division.

(2) An applicant wishing to apply for a license to operate an outpatient renal dialysis facility shall submit an application on a form prescribed by the Division and pay the applicable fee as specified in OAR 333-700-0015. The application form shall specify such information as required by the Division and must include, but is not limited to, demographic, ownership, and administrative information.

(3) No person or facility 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 facility 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 facility by the Division nor shall any service be offered or provided which is not authorized within the scope of the license issued to such person or facility.

(4) Each application for license renewal shall accurately reflect only the number of stations the facility is then presently capable of operating considering existing equipment and service capability of the facility and the physical requirements as specified within these rules and regulations. The number of stations to be licensed shall not exceed the number of stations reflected in the license to be renewed unless approved by the Division.

(5) Compliance with “Submission of Plans,” OAR 333-700-0065 is also required as a condition of licensure.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.020 & 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0015

Annual License Fee

For outpatient renal dialysis facilities, the annual licensing fee shall be $2,000. Each license shall be issued only for the facility named in the application and shall not be transferable. If the ownership of the agency changes, the new owner shall apply for a license.

Stat. Auth.: ORS 441.015 & 442.025
Stats. Implemented: ORS 441.020 & 442.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0017

Application Review

(1) In reviewing an application for an outpatient renal dialysis facility the Division shall:

(a) Verify compliance with the applicable sections of ORS chapters 441 and 442, and OAR chapter 333, division 700;

(b) Conduct an on-site licensing survey in coordination with the State Fire Marshal’s Office; and

(c) Verify compliance with conditions for coverage if the applicant has requested Medicare or Medicaid certification.

(2) In determining whether to license an outpatient renal dialysis facility, the Division shall consider factors relating to the health and safety of individuals to be cared for at the facility and the ability of the operator of the facility to safely operate the facility, and may not consider whether the facility is or shall be a governmental, charitable or other nonprofit institution or whether it is or shall be an institution for profit.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.022 & 442.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0018

Approval of License Application

(1) The Division shall notify an applicant in writing if a license application is approved, and shall include the license with the appropriate information.

(2) A license shall be issued only for the premises and persons or governmental units named in the application and is not transferable or assignable.

(3) The license shall be conspicuously posted.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0019

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.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0020

Expiration and Renewal of License

Each license to operate an outpatient renal dialysis facility shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application at least 30 days prior to the expiration date upon a form prescribed by the Division as described in OAR 333-700-0010.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0025

Denial or Revocation of a License

(1) A license for any facility may be denied, suspended or revoked by the Division when the Division finds that there has been a substantial failure to comply with the provisions of these rules and of health care facility licensing laws.

(2) A person or persons in charge of a facility shall not permit, aid or abet any illegal act affecting the welfare of the license.

(3) A license shall be denied, suspended or revoked in any case where the State Fire Marshal certifies that there was failure to comply with all applicable laws, lawful ordinances and rules relating to safety from fire.

(4) A license may be suspended or revoked for failure to comply with a Division order arising from a facility’s substantial lack of compliance with the rules or statutes.

(5) A facility license that has been suspended or revoked may be reissued after the Division determines that the facility has satisfactorily complied with the health care facility licensing laws.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025, 441.030 & 441.037
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0030

Discontinuance and Recommencement of Operation of Out?patient Renal Dialysis Facilities

(1) If an outpatient renal dialysis facility wishes to temporarily discontinue operation but retain its license to operate, the facility shall notify the Division of the fact at least 14 days prior to the temporary discontinuance.

(2) An outpatient renal dialysis facility shall notify all patients of facility closure. Such notice shall include a procedure by which individuals may obtain their medical records.

(3) Before any patient is admitted to an outpatient renal dialysis facility that has temporarily discontinued operation, the outpatient renal dialysis facility shall request approval from the Division. The Division may conduct an on-site survey or other review to determine whether the outpatient renal dialysis facility is in compliance with health care facility licensing laws and conditions for coverage, if applicable.

(4) An outpatient renal dialysis facility may not renew operation until it receives approval, in writing, from the Division.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0035

Return of Facility License

(1) If an outpatient renal dialysis facility’s license is suspended, revoked, expires, or if a facility decides to permanently close, the license certificate in the licensee’s possession shall be returned to the Division immediately.

(2) If the outpatient renal dialysis facility is voluntarily permanently closed, the facility 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) An outpatient renal dialysis facility shall notify the Division of a facility’s closure under section (2) of this rule at least 14 days prior to the closure and submit plans for the orderly transfer of the patients and 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.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.030
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0040

Classification

(1) Outpatient Renal Dialysis facilities (also known as End Stage Renal Dialysis facilities) that provides renal dialysis services directly to outpatients.

(2) The classification of each facility shall be so designated on the license.

(3) Health care facilities licensed by the Division shall neither assume a descriptive title or be held out under any descriptive title other than the classification title established by the Division and under which the facility is licensed. This not only applies to the name on the facility but where stationery, advertising and other representations are involved.

(4) No change in the licensed classification of any facility, as set out in this rule, shall be allowed by the Division unless such facility shall file a new application, accompanied by the required license fee, with the Division. If the Division finds that the applicant and facility comply with health care facility (HCF) laws and the regulations of the Division relating to the new classification for which application for licensure is made, the Division shall issue a license for such classification.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.030
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0045

Hearings

Upon written notification by the Division of revocation, suspension or denial to issue or renew a license, a written request by the facility for a hearing in accordance with ORS 183.310 to 183.500 shall be granted by the Division.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 183.413 - 183.500 & 441.037
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0050

Adoption by Reference

All rules, standards and publications referred to in OAR 333-700-0000 through 333-700-0130 are made a part thereof. Copies are available for inspection at the Division during office hours. Where publications are in conflict with the rules, the rules shall govern.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0053

Complaints

(1) Any person may make a complaint verbally or in writing to the Division regarding an allegation against an outpatient renal dialysis facility of a violation of any health care facility licensing law or condition for coverage.

(2) The identity of a person making a complaint shall be kept confidential.

(3) An investigation may be carried out as soon as practicable after the receipt of a complaint in accordance with OAR 333-700-0057.

(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 Division shall refer the matter to that agency.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.057
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0057

Investigations

(1) As soon as practicable after receiving a complaint, taking into consideration the nature of the complaint, Division staff may begin an investigation.

(2) An outpatient renal dialysis facility shall permit Division staff access to the facility during an investigation.

(3) An investigation may include but is not limited to:

(a) Interviews of the complainant, patients of the facility, patient family members, witnesses, facility management and staff;

(b) On-site observations of patients, staff performance, and the physical environment of the facility; and

(c) Review of documents and records.

(4) Except as otherwise specified in 42 CFR 401, Subpart B, information obtained by the Division during an investigation of a complaint or reported violation under this section is confidential and not subject to public disclosure under ORS 192.410 through 192.505. Upon the conclusion of the investigation, the Division may publicly release a report of its findings but may not include information in the report that could be used to identify the complainant or any patient at the health care facility. The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of a health care facility, and may report information obtained during an investigation to a health professional regulatory board as defined in ORS 676.160 as that information pertains to a licensee of the board.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.057
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0060

Surveys

(1) The Division shall, in addition to any investigations conducted under OAR 333-700-0057, conduct at least one on-site licensing survey of each outpatient renal dialysis facility every three years to determine compliance with health care facility licensing laws and at such other times as the Division deems necessary.

(2) In lieu of an on-site inspection required under section (1) of this rule, the Division 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 Division, if:

(A) The certification or accreditation is recognized by the Division as addressing the standards and conditions for coverage requirements of the CMS and other standards set by the Division. Health care facilities must provide the Division with the letter from CMS indicating its deemed status;

(B) The health care facility notifies the Division to participate in any exit interview conducted by the federal agency or accrediting body; and

(C) The health care facility provides copies of all documentation concerning the certification or accreditation requested by the Division.

(3) An outpatient renal dialysis facility shall permit Division staff access to the facility during a survey.

(4) An outpatient renal dialysis facility shall make all requested documents and records available to the surveyor for review and copying.

(5) Entrance conference: The Division’s surveyor shall hold a conference with the person who is in charge of the facility at the time of the survey for the purpose of explaining the nature and scope of the survey.

(6) An on-site survey may include, but not be limited to:

(a) Equipment;

(b) Water treatment and reuse;

(c) Infection control;

(d) Quality assurance/Quality Assessment and Performance Improvement;

(e) Provision for and coordination of treatment;

(f) Staff qualifications;

(g) Facility staffing;

(h) Medical director involvement;

(i) Patients’ rights;

(j) Physical environment;

(k) Emergency management;

(l) Interviews of patients, patient family members, facility management and staff;

(m) On-site observations of patients, staff performance, and the physical environment of the facility;

(n) Review of documents and records; and

(o) Patient audits.

(7) Following a survey, Division staff may conduct an exit conference with the facility administrator or his or her designee. During the exit conference Division staff shall:

(a) Inform the facility representative of the preliminary findings of the survey; and

(b) Give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings.

(8) Following the survey, Division staff shall prepare and provide the facility administrator or his or her designee specific and timely written notice of the findings.

(9) If the findings result in a referral to another regulatory agency, Division staff shall submit the applicable information to that referral agency for its review and determination of appropriate action.

(10) If no deficiencies are found during a survey, the Division shall issue written findings to the facility administrator indicating that fact.

(11) If deficiencies are found, the Division shall take informal or formal enforcement action in compliance with OAR 333-700-0062 or 333-501-0063.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.060
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0061

Violations

In addition to non-compliance with any health care facility licensing law or condition for coverage, it is a violation to:

(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Division staff access to the facility, its documents or records;

(2) Fail to 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 Division;

(5) Refuse or fail to pay a civil penalty; or

(6) Fail to comply with rules governing the storage of medical records following the closure of a facility.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.030
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0062

Informal Enforcement

(1) If, during an investigation or survey Division staff document violations of health care facility licensing laws or conditions for coverage, the Division 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 received by the Division within 10 business days from the date the statement of deficiencies was mailed to the facility. A signed plan of correction may not be used by the Division as an admission of the violations alleged in the statement of deficiencies.

(3) An outpatient renal dialysis facility shall correct all deficiencies within 60 days from the date of the exit conference, unless an extension of time is requested from the Division. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(4) The Division shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Division, the Division shall notify the facility administrator 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.

(5) If the facility 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 Division may propose to deny, suspend, or revoke the facility license, or impose civil penalties.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0063

Formal Enforcement

(1) If, during an investigation or survey Division staff document substantial failure to comply with health care facility licensing laws, conditions for coverage or if a facility fails to pay a civil penalty imposed under ORS 441.170, the Division may issue a Notice of Proposed Suspension or Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470.

(2) The Division may issue a Notice of Imposition of Civil Penalty for violations of health care facility licensing laws.

(3) At any time the Division may issue a Notice of Emergency License Suspension under ORS 183.430(2).

(4) If the Division revokes a facility license, the order shall specify when, if ever, the facility may reapply for a license.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0064

Civil Penalties

(1) A licensee that violates a health care facility licensing law, including OAR 333-700-0061 (Violations), is subject to the imposition of a civil penalty not to exceed $500 per day per violation.

(2) In addition to the penalties under section (2) of this rule, civil penalties may be imposed for violations of ORS 441.030 or 441.015(1).

(3) In determining the amount of a civil penalty the Division shall consider whether:

(a) The Division made repeated attempts to obtain compliance;

(b) The licensee has a history of noncompliance with health care facility 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.

(4) The Division shall document its consideration of the factors in section (3) of this rule.

(5) Each day a violation continues is an additional violation.

(6) A civil penalty imposed under this rule shall comply with ORS 183.745.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.030 & 441.990
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0065

Submission of Plans

(1) An outpatient renal dialysis facility proposing to make alterations 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 Division for preliminary inspection and approval or recommendations with respect to compliance with Division 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 must also be submitted to the local building division having authority for review and approval in accordance with state building codes.

Stat. Auth.: ORS 441.015, 441.025 & 441.060
Stats. Implemented: ORS 441.025 & 441.060
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0072

Waivers

(1) While all outpatient renal dialysis facilities are required to maintain continuous compliance with the Division’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:

(a) Submitted to the Division in writing;

(b) Identify the specific rule for which a waiver is requested;

(c) The special circumstances relied upon to justify the waiver;

(d) Why the facility is unable to be in compliance, the alternatives considered and why the alternatives 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 shall not jeopardize patient health and safety; and

(f) The proposed duration of the waiver.

(2) Upon finding that the facility has satisfied the conditions of this rule, the Division may grant a waiver.

(3) A facility may not implement a waiver until it has received written approval from the Division.

(4) During an emergency the Division may waive a rule that a facility is unable to meet, for reasons beyond the facility’s control. If the Division waives a rule under this section it shall issue an order, in writing, specifying which rules are waived, which facilities are subject to the order, and how long the order shall remain in effect.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0073

Outpatient Mobile Dialysis

(1) A dialysis facility that provides staff assisted hemodialysis in a patient’s home must:

(a) Be licensed as an outpatient renal dialysis facility; and

(b) Have a centralized, secure location, where the patient, water quality, equipment maintenance, quality assurance and other records are available for review by the Division.

(2) A facility must obtain written approval from the Authority prior to implementation of the provision of outpatient mobile dialysis services. The Authority may conduct a survey to determine compliance with this rule.

(3) Hemodialysis treatments must be performed by an individual currently licensed or certified in Oregon as a certified hemodialysis technician, registered nurse or licensed practical nurse who:

(a) Has at least six months of experience in caring for hemodialysis patients; and

(b) Has completed, prior to providing assisted hemodialysis treatments in a patient’s home, a training program and skills checklist specific to care of hemodialysis patients in the patient’s home and management of complications.

(4) The dialysis facility RN responsible for patient care shall ensure that individuals performing hemodialysis in a patient’s home meet the qualifications in section (3) of this rule and shall document such qualifications and provide the documentation to the Division upon request.

(5) The facility must ensure that the water and dialysate testing and other requirements of American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) RD52:2004 are met. In addition, bacteriological and endotoxin testing must be performed on a quarterly or more frequent basis as needed, to ensure that the quality of the water and dialysate meets these AAMI requirements.

(6) The dialysis facility must correct any water and dialysate quality problems for the home hemodialysis patient.

(a) A record of any preventive hemodialysis machine maintenance as required by the manufacturer’s directions for use must be maintained and any breakdowns repaired; and

(b) The facility must arrange for backup dialysis until water quality and mechanical problems are corrected.

(7) If staff assisted outpatient mobile dialysis is provided in a health care facility providing 24/7 onsite nursing services the following additional requirement must be met:

(a) The staffing ratio for staff assisted home dialysis must be one licensed nurse or CHDT per patient unless the following conditions are met:

(A) The patients are located in one room in which they are visible from a central location within that room; and

(B) There is a second staff member, who is a registered nurse, with at least six months dialysis experience.

(b) Should the requirements in paragraphs (a)(A) and (B) of this section be met, the staffing ratio must be dependent on the acuity and needs of the patients as determined by the dialysis facility RN or the patient’s nephrologist. In no case shall the staffing ratio be greater than three patients per one qualified staff member while patients are undergoing hemodialysis treatments.

(c) There must be an agreement between the dialysis facility and the care facility specifying the expectations of each party, to ensure the coordination of individual patient care needs.

(d) Policies and procedures regarding care of the hemodialysis patient must be in place for both the care facility and dialysis facility.

(e) If the staff assisted hemodialysis is performed by a CHDT there must be an RN on duty, and accessible, in the care facility who has documented training in the care of hemodialysis patients including, but not limited to, common ESRD related medications, IV medications commonly given during dialysis, potential complications of hemodialysis, assessment of ESRD patients, and treatment of those complications. This training shall be updated annually.

(f) There must be documentation reflecting that:

(A) On the day of dialysis prior to the initiation of the hemodialysis treatment, the care facility RN has assessed the patient and consulted with the dialysis facility RN; and

(B) The CHDT providing the hemodialysis treatment must consult with the care facility RN before and after the hemodialysis treatment.

(g) The dialysis facility RN must be available at all times for consultation while the patient is undergoing hemodialysis treatment.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0075

Administrative Authority and Management

(1) Every facility shall be organized, equipped, and administered to provide adequate care for each person admitted.

(2) The governing body, the owner, or the person or persons designated by the owner or governing body shall be the authority responsible for the management and control of the facility, and shall not:

(a) Permit, aid or abet the commission of any unlawful act relating to the securing of a license, or the operation of the facility; and

(b) With the exception of abusive or disruptive patients, refuse to admit and treat, on the basis of medical need, alcohol and substance abusers, mentally ill or intellectually disabled patients solely on the basis of their substance abuse or mental illness. Discharge of patients exhibiting violent, threatening, disruptive, or abusive behavior shall be handled as outlined in OAR 333-700-0115(2)(f).

(3) The governing authority shall formulate and implement a written set of bylaws or other appropriate policies and procedures for the operation of the facility. These shall:

(a) State the purpose of the facility;

(b) Specify by title the person who is responsible for the operation and maintenance of the facility, and methods established by the governing body for holding that person responsible;

(c) Provide for at least annual meetings of the governing body; and

(d) Provide a policy and procedure manual that is designed to ensure professional and safe care for patients including, but not limited to:

(A) Admission criteria;

(B) Rights and responsibilities of patients;

(C) Care of patients;

(D) Patient grievance procedures;

(E) Infection control policies;

(F) Personnel qualifications and training requirements;

(G) Consultant qualifications, functions, and responsibilities;

(H) Reprocessing of hemodialyzers;

(I) Emergency management of patients;

(J) Annual reviews of the facilities policies, procedures and operation; and

(K) A facility-wide Quality Assessment and Performance Improvement (QAPI) program to evaluate the provision of patient care. The program shall have a written plan of implementation. Quality data shall be reviewed and analyzed quarterly. The QAPI program shall be reviewed at least annually. It shall be designed to effectively identify and correct problems. Written documentation of QAPI activities shall be available at the facility.

(4) The governing body shall review implementation of these policies at least annually to ensure that the intent of the policies is carried out. These policies shall be developed by the physician responsible for supervising and directing the provision of dialysis services, or the facility’s organized medical staff, with the advice from a group of professional personnel associated with the facility, including, but not limited to, one or more physicians and one or more registered nurses experienced in rendering dialysis care.

(5) An administrator shall be appointed by the governing body, shall be responsible for the management of the facility, and shall assure adherence to facility policies and procedures. The required full time nurse manager may serve as the administrator. Any change in the administrator shall be reported to the Division in writing within 30 days. The administrator must have sufficient experience in the management of dialysis facilities, or appropriate education so as to assure that they are qualified to carry out their responsibilities.

(6) The following documents shall be available at the facility:

(a) Appropriate documents showing control and ownership;

(b) Bylaws, policies and procedures of the governing body;

(c) Minutes of the governing body meetings;

(d) Minutes of the facility’s professional staff meetings;

(e) Reports of inspections, reviews, and corrective actions taken related to licensure;

(f) Minutes of the facility’s quality improvement meetings; and

(g) Contracts and agreements to which the facility is a party.

(7) Medical Staff:

(a) If more than one physician practices at the facility, the physicians shall be organized as a Medical Staff with appropriate bylaws approved by the governing body. The medical staff shall meet at least once a year, and minutes shall be maintained at the facility of such meetings;

(b) The Governing Body shall designate a qualified physician as the physician-director of the facility. The physician-director shall be responsible for the development and implementation of patient care policies and medical staff bylaws, rules, and regulations;

(c) A qualified physician with demonstrated experience in the care of patients receiving dialysis shall be on call and available to patients within a reasonable time frame;

(d) The facility shall require and the medical director shall ensure that any adverse medical patient outcomes are communicated to the patient’s physician, and that the facility takes appropriate corrective action.

(8) Transfer Agreement: Each facility shall have in effect an agreement with one or more hospitals, for the provision of inpatient care or other hospital services. The transfer agreement shall provide the basis for an effective working agreement under which the services of the hospital are promptly available to the facility’s patients as needed. The facility shall have on file documentation of this agreement. There shall be reasonable assurances that:

(a) Transfer of patients must be effected between the hospital and the facility whenever such transfer is deemed medically necessary by the physician, with timely acceptance and admission;

(b) There shall be interchange, within one working day, of medical or other necessary information useful in the medical care of the patient transferred to a hospital, or to another facility; and

(c) Security and accountability are assured for the patient’s personal effects.

(9) The patient care policies shall cover the following:

(a) Scope of services provided by the facility (either directly or under arrangement);

(b) Admission and discharge policies (in relation to both in-facility care and home care);

(c) Medical supervision and physician services;

(d) Patient care plans, frequency of review, and methods of implementation;

(e) Care of patients in medical and other emergencies;

(f) Pharmaceutical services;

(g) Medical records (including those maintained onsite, maintained offsite by the facility, maintained in the patients’ homes);

(h) Administrative records;

(i) Use and maintenance of the physical plant and equipment; and

(j) The provision of home dialysis support services, if offered.

(10) The physician-director of the facility must be designated in writing and must be responsible for the execution of patient care policies. If the responsibility for day-to-day execution of patient care policies has been delegated by a physician-director to a registered nurse, the physician-director shall provide medical guidance in such matters.

(11) The facility policy shall provide that, whenever feasible, hours for dialysis are scheduled for patient convenience and that arrangements are made to accommodate employed patients who wish to be dialyzed during their non-working hours.

(12) The governing body shall adopt policies to ensure there is evaluation of the progress each patient is making toward the goals stated in the patient’s care plan. Such evaluations shall be carried out through regularly scheduled conferences, with participation by the staff involved in the patient’s care.

(13) Medical supervision and emergency coverage: The governing body of the facility shall ensure that the health care of every patient is under the continuing supervision of a physician.

(14) The physician responsible for the patient’s medical supervision shall evaluate the patient’s immediate and long-term needs and shall prescribe a planned regimen of care which covers indicated dialysis and other treatments, services, medications, diet, special procedures recommended for the health and safety of the patient, and plans for continuing care and discharge. Such plans are made with input from other professional personnel involved in the care of the patient. The facility staff must ensure the physician orders are implemented appropriately.

(15) The governing body must ensure that medical care is available for emergencies during the hours the facility is in operation. The facility shall post at the nursing/monitoring station a roster with the names of the physicians to be called and how they can be reached. There shall be a system in place that must direct patients who call during non-operational hours to appropriate assistance.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 441.055
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0080

Quality Assessment and Performance Improvement

(1) The facility shall establish a program to monitor the quality of care given to patients. This program shall document that the facility staff evaluate the provision of care, determine treatment goals, identify opportunities for improvement, develop and implement improvement plans, and evaluate implementation until resolution of a problem is achieved.

(2) The medical director of the facility is responsible for quality monitoring and improvement activities. The Quality Assessment and Performance Improvement (QAPI) team shall consist of a multi-disciplinary team to include representatives of medical staff, administration, nursing, technical, social work and dietary. Meetings of the QAPI team shall be held at least quarterly or more often if needed to resolve a particular issue.

(3) QAPI mechanisms shall include:

(a) An ongoing review of key elements of care using comparative and trend data to include aggregate patient data and to promote the reduction of risks;

(b) Identification of areas where performance measures or outcome data indicate a need for improvement;

(c) Establishment of QAPI committees to identify any variations from desired outcomes; create and implement improvement plans; evaluate the effectiveness of the improvement plan; and

(d) Establishment and monitoring of key quality indicators. For each indicator, the facility shall establish a performance level consistent with current professional knowledge. At a minimum, the following indicators shall be monitored on an ongoing basis:

(A) Water Quality including chemical and bacteriological indicators;

(B) Equipment maintenance and repair;

(C) Reprocessing of dialyzers including performance measures, labeling, disinfection, and pyrogenic reactions;

(D) Infection control including monitoring of staff and patient infections;

(E) Clinical outcomes including laboratory values, dialysis adequacy, hospitalizations, vascular access complications;

(F) Incidents and rate of adverse occurrences (clinical variances) including accidents, medication errors, treatment errors, infiltrations, needle sticks, adverse drug reactions, and other occurrences affecting patients, visitors, or staff;

(G) Mortality including review of each patient death and monitoring of mortality rates and trends;

(H) Complaints and suggestions including those from patients, family and staff; and

(I) Other indicators as required by federal regulations and Network requirements.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0085

Patient Care Plan

(1) Each facility shall maintain a written patient care plan for each patient to ensure that patients receive the appropriate treatment modality and the appropriate care within that modality. Provisions shall be made for the patient, or when appropriate, parent or legal guardian to be involved with the health team in the planning of care and in the development of the care plan. Due consideration shall be given to his/her preferences.

(2) The written patient care plan for each patient of a facility (including home dialysis patients under the supervision of the facility) shall be based upon the nature of the patient’s illness, the treatment prescribed, and an assessment of the patient’s needs.

(3) The patient care plan shall be personalized for the individual, shall reflect the psychological, nutrition, social, and functional needs of the patient, and shall indicate the dialysis and other care required as well as the individualized modifications in approach necessary to achieve the long-term and short-term goals. Any unresolved concerns of the patient and family shall be addressed at the time of each review. Documentation shall reflect that the patient and family has had an opportunity to voice these concerns and the methods utilized to achieve resolution of the concerns.

(4) The plan shall be developed by an interdisciplinary care team consisting of at least the physician responsible for the patient’s dialysis care, a qualified nurse responsible for nursing services, a qualified social worker, and a qualified dietitian.

(5) The care plan for a patient whose medical condition is not stable shall be reviewed at least monthly by the interdisciplinary care team. For an adult patient aged 18 and older whose condition is stable, the care plan shall be reviewed at least annually. For pediatric patients whose conditions are stable, the care plan shall be reviewed monthly for ages 0-11 months, quarterly for ages 1-5 years, and every six months for ages 6-17 years. The care plan shall be revised as necessary to ensure that it provides for the ongoing needs of the patient.

(6) If the patient is transferred to another facility, the care plan shall be sent to the receiving facility at the time the patient is transferred or within one working day of the transfer.

(7) For a home-dialysis patient whose care is under the supervision of the facility, the care plan shall provide for periodic monitoring of the patient’s home adaptation, including provisions for visits to the home by qualified facility personnel to the extent appropriate.

(8) When a dialysis patient uses an anemia management drug in the home, the plan must provide for monitoring home use of the anemia management drug. This monitoring shall include the following:

(a) Review of diet or fluid intake for indiscretions as indicated by hyperkalemia and elevated blood pressure secondary to volume overload;

(b) Review of lab values and medications to ensure adequate management of anemia;

(c) A reevaluation of the dialysis prescription taking into account the patient’s increased appetite and red blood cell volume;

(d) A method for physician follow up on blood tests and a mechanism (such as a patient log) for keeping the physician informed of the results; and

(e) Review of the training of the patient to identify the signs and symptoms of hypotension and hypertension.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0090

Medical Records

(1) The facility shall maintain complete medical records on all patients (including self-dialysis patients within the self-dialysis unit and home dialysis patients whose care is under the supervision of the facility) in accordance with accepted professional standards and practices.

(2) The medical records must be completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information. Each patient’s medical record shall contain sufficient information to identify the patient clearly, to justify the diagnosis and treatment, and to document the results accurately. All medical records shall contain documented evidence of the following:

(a) Assessment of the needs of the patient;

(b) Evidence that the patient was informed of the results of the assessment;

(c) Documentation of any treatment with a reprocessed hemodialyzer (when applicable);

(d) Establishment of an appropriate plan of treatment;

(e) The care and services provided;

(f) Identification and social data;

(g) Signed consent forms:

(A) All consent forms shall document that the information was provided in such a way that acknowledges the patient’s individual language and special needs; and

(B) Except as provided in ORS 109.610(1) and 433.045, a minor 15 years of age or older may consent to hospital care, medical or surgical diagnosis or treatment by a physician, and dental care, without the consent of a parent or guardian.

(h) Documentation of an initial history and physical and an update of the history and physical at least annually or whenever changes occur;

(i) Reports of any pertinent medical, surgical or access procedures which shall be filed in the record within 30 days of the procedure;

(j) Referral information with authentication of diagnosis;

(k) Diagnostic and therapeutic orders. Physician orders must be reviewed and rewritten annually. “Resume previous orders” is not adequate to meet the annual requirement. All verbal orders shall be received by a licensed nurse or physician assistant. Orders relating to social work or nutrition services may be received by the professional responsible for that service. Verbal orders must be countersigned within 45 calendar days by the practitioner giving the order. All patients shall have written orders for length of dialysis treatment, the dialyzer type, the composition of the dialysate, the estimated dry weight, any medications the patient receives at the dialysis facility, the heparinization schedule including the amount of the bolus, maintenance dose and when to discontinue the maintenance dose, and any necessary infection control measures. New orders that include, but are not limited to the above listed items, must be written when a patient returns from an inpatient stay at a hospital;

(l) Progress notes;

(m) Reports of treatments and clinical findings;

(n) Reports of laboratory results, diagnostic tests, and procedures;

(o) Social worker and nutritional assessments: Initial assessments must be completed within 30 days of admission to the facility. Subsequent assessments must be completed annually and updated as necessary; and

(p) A medication list that is updated as needed and reviewed at least quarterly or as changes occur.

(3) The facility shall require and the medical director shall ensure that any adverse medical patient outcomes are communicated to the patient’s physician, and that the facility takes appropriate corrective action.

(4) All entries in the medical record shall be dated and authenticated by the person making the entry.

(5) Protection of medical record information: There must be a plan for the retention, storage, preservation of confidentiality, certification of validity, and where appropriate, destruction of medical records.

(a) The facility must safeguard medical record information against loss, destruction, or unauthorized use. The facility must have written policies and procedures which govern the use and release of information contained in medical records.

(b) Written consent of the patient, or authorized person(s) acting on behalf of the patient, is required for release of information not mandated by federal law or by statute. Medical records are made available under stipulations of confidentiality for inspection by Division staff as required for administration of the dialysis program or authorized agents of the state for the purposes of confirming compliance with these rules.

(c) If a patient is under the age of 15, the patient’s medical records may be released only with the voluntary and informed consent of the patient’s parent or legal guardian. In the case of divorce, unless otherwise ordered by the court, either parent may consent for the minor as provided by ORS 107.154.

(6) Medical records supervisor. A member of the facility’s staff shall be designated to serve as supervisor of medical records services, and ensure that all records are properly documented, completed, and preserved. When necessary, consultation is secured from a qualified medical record practitioner. The functions of the medical records supervisor include, but are not limited to, the following:

(a) Ensuring that the records are documented, completed, and maintained in accordance with accepted professional standards and practices;

(b) Safeguarding the confidentiality of the records in accordance with established policy and legal requirements; and

(c) Ensuring that the records contain pertinent medical information and are filed for easy retrieval.

(7) Completion of medical records and centralization of clinical information: Medical records shall be completed by all members of the dialysis facility staff within 30 days following the patient’s discharge. Current medical records and those of discharged patients shall be completed promptly. All clinical information pertaining to a patient must be centralized in the patient’s medical record. Provisions shall be made for collecting and including in the medical record medical information generated regarding self-dialysis patients. Entries concerning the daily dialysis process must either be completed by staff, or be completed by trained self-dialysis patients, trained home dialysis patients or trained assistants and must be countersigned by staff of the dialysis facility.

(8) Retention and preservation of records: All medical records shall be kept for a period of at least seven years after the date of discharge. Original medical records may be retained on paper, microfilm, electronic, or other media. The medical records of pediatric patients shall be kept at least three years after the age of 18 or for a total of seven years, whichever is longer.

(9) Location and facilities: The facility shall maintain adequate facilities, equipment, and space conveniently located to provide efficient processing of medical records (e.g., reviewing, filing, and prompt retrieval) and statistical medical information (e.g., required abstracts, reports, etc.).

(10) Transfer of medical information: The facility must provide for the exchange of medical and other information necessary or useful in the care and treatment of patients transferred to other medical facilities.

(11) If the facility closes or is purchased, arrangements shall be made for the medical records to be transferred to the patients’ new place of treatment. In the case of expired or no longer treated patients, arrangements must be made to store those records for the required time intervals. The patients’ families and the Division shall be notified of the location of the medical records.

(12) Technical logs must meet the same documentation standards as the medical records, including proper correction of errors. A signature list must be readily available to identify the users of initials.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0095

Medical Director of an Outpatient Renal Dialysis Facility

The Medical Director shall be responsible for oversight of the care provided by the staff of the dialysis facility. Treatment must be provided under the general supervision of a director who is a physician. The physician-director need not devote full time as director but shall be responsible for planning, organizing, conducting, and directing the professional dialysis services and must devote sufficient time to carrying out these responsibilities. The director may also serve as the Chief Executive Officer of the facility.

(1) The director of a dialysis facility must be a qualified physician-director.

(2) The responsibilities of the physician-director include but are not limited to the following:

(a) Assuring the development and implementation of the process of modality selection, i.e., transplantation or dialysis and the setting for dialysis for all patients;

(b) Assuring adequate training of nurses and technicians in dialysis techniques;

(c) Assuring adequate monitoring of the patient and the dialysis process, including, self-dialysis patients;

(d) Assuring periodic assessment of patient performance of dialysis tasks;

(e) Assuring the development and availability of a patient care policy and procedures manual and its implementation. At a minimum, the manual shall describe the following:

(A) Types of dialysis used in the facility and the procedures followed in performance of such dialysis;

(B) Hepatitis prevention and procedures for handling an individual with hepatitis;

(C) Infection control; and

(D) A disaster preparedness plan (e.g., patient emergency, fire, flood);

(f) Assuring that patient teaching materials are available for use by all trainees during the training period and at times other than during the dialysis procedure when self-dialysis training or home dialysis training is offered; and

(g) Assuring that patient outcomes are monitored and evaluated as part of the QAPI process. The Medical Director must assure that a plan is in place for the improvement of patient outcomes. This process shall include a review of any accidents, incidents, or adverse outcomes.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0100

Patient Care Staff

(1) The facility shall maintain a personnel record for each staff member which includes, but is not limited to documentation of the following:

(a) Hire date;

(b) Required current license or certification;

(c) Orientation completed prior to commencement of duties;

(d) Job description;

(e) Employment application;

(f) Annual evaluation(s);

(g) Education and qualifications;

(h) Health status to include at a minimum:

(A) Documentation of compliance with OAR 333-019-0041 for Tuberculosis exposure; and

(B) Documentation of Hepatitis B (HbsAg) testing according to CDC guidelines;

(i) Current CPR certification for direct patient care personnel.

(2) Properly trained personnel must be present in adequate numbers to meet the needs of the patients, including those needs arising from medical and nonmedical emergencies. Employees who have not demonstrated competency as defined by facility policy must not be counted in the staff/patient ratios.

(3) The facility must employ at least one full time qualified registered nurse responsible for nursing service:

(a) This registered nurse may also act as the required full time nurse manager;

(b) There shall be a registered nurse or physician, experienced in rendering ESRD care in the facility to supervise care whenever patients are undergoing dialysis treatments; and

(c) A registered nurse or physician shall be designated as the charge person in each facility to oversee ESRD patient care.

(4) An adequate number of personnel must be present to ensure that the staff/patient ratio is appropriate to the level of dialysis care being provided. The staffing levels must be adjusted based on the individual and aggregate needs of the patients.

(5) At a minimum, the staffing level at a facility shall not exceed four patients receiving hemodialysis treatments per licensed nurse or CHDT providing direct patient care.

(6) During treatment times, there shall be a minimum of one registered nurse (RN) available for every 16 patients. If more than 16 patients are receiving hemodialysis treatments at one time, there shall be an additional registered nurse present. Should the RN to patient ratio exceed 1 to 12, the RN shall not be counted as part of the 1 to 4 direct patient care ratio.

(7) The facility shall have a staffing plan in place that shall allow them to maintain staffing ratios in the event of sick calls, vacations and unscheduled absences.

(8) The facility may continue to operate and treat scheduled patients in the event that circumstances temporarily do not allow these staffing levels to be met if the medical director or designee determines this can be done safely:

(a) These circumstances shall be documented in the records of the facility; and

(b) These circumstances must not occur during more than five percent of the facility’s operating hours in any six month period without approval of a waiver by the Division.

(9) These staffing ratios do not preclude the use of new technology or experimental models. Application for a waiver may be made to the Division by facilities wishing to implement new technology.

(10) The facility shall be responsible for developing and implementing a written facility-wide staffing plan for all patient care staff including registered nurses, licensed practical nurses, hemodialysis technicians, social workers, and dietitians. The facility shall have a process that ensures the consideration of input from patient care staff in the development, implementation, monitoring, evaluation, and modification of the staffing plan. The staffing plan shall include the number, qualifications, and categories of staff needed. The written staffing plan shall be evaluated and monitored for effectiveness, and revised as necessary, as part of the facility’s QAPI process. Written documentation of these QAPI activities shall be maintained.

(a) The written staffing plan shall be based on the care required by aggregate and individual needs of patients. This care shall be the major consideration in determining the number and categories of personnel needed. The written staffing plan shall be based on the specialized qualifications and competencies of the staff. The skill mix and the competency of the staff shall ensure that the needs of the patient are met and shall ensure patient safety.

(b) The written staffing plan shall be consistent with the scopes of practice for RNs, LPNs, hemodialysis technicians, social workers, and dietitians.

(c) The facility shall maintain a list of qualified staff that may be called to provide qualified replacement or additional staff in the event of emergencies, sickness, vacations, vacancies and other absences of staff and that provides a sufficient number of replacement staff for the facility on a regular basis. The list shall be available to the individual responsible for obtaining replacement staff.

(d) The written staffing plan shall establish minimum numbers of personnel (RNs, LPNs, hemodialysis technicians, social workers and dietitians) on specified shifts. The number of personnel on duty shall be sufficient to assure that the needs of each patient are met. In no case shall fewer than one registered nurse and one other staff member be on duty when a patient is undergoing dialysis treatment.

(e) After a facility learns about the need for replacement staff, the facility shall make every reasonable effort to obtain staff for unfilled hours or shifts before requiring a patient care staff member to work overtime. Reasonable effort includes the facility seeking replacement at the time the vacancy is known and contacting all available resources as described in section (2) of this rule. Such efforts shall be documented.

(f) The facility shall have a workable plan in place to deal with both medical and non-medical emergencies.

(g) If the facility offers self-care dialysis training, a qualified licensed nurse must be in charge of such training.

(h) Licensed practical nurses. This chapter does not preclude a licensed practical nurse (LPN) from practicing in accordance with the rules adopted by the Oregon State Board of Nursing. If the LPN is acting in the capacity of a hemodialysis technician, the facility shall ensure that the LPN is functioning within his/her job description and scope of practice.

(11) Employee Orientation and Training: Each facility shall have and execute a written orientation and training program to familiarize each employee with his/her job responsibilities. The facility shall maintain documentation that each staff member has attended the orientation program. Each employee shall be evaluated to assure that he/she possesses at least the minimum competencies required to perform his/her job function.

(a) The facility orientation program for all staff, approved by the medical director shall include at least:

(A) Review of the services provided by the facility;

(B) Review of facility policies and procedures, including general infection control procedures and use of universal precautions;

(C) The facility’s emergency procedures and disaster preparedness plans;

(D) Training in the use of fire extinguishers;

(E) The facility’s Quality Assessment and Performance Improvement Program;

(F) Documentation and records requirements; and

(G) Job descriptions that adequately describe the duties of every position including:

(i) Position;

(ii) Title;

(iii) Scope of authority;

(iv) Specific responsibilities; and

(v) Minimum requirements.

(b) The facility shall conduct and document a training needs assessment to identify training needs specific to care for the dialysis patients, and shall document the provision of such training by a qualified instructor.

(12) Job descriptions shall be given to each employee when assigned to a position or when the job description is revised. A copy of this job description signed by the employee shall be maintained in the employee’s file.

(13) The facility shall also maintain documentation of the satisfactory completion by each staff member of a skills competency checklist.

(14) Trainees must not be counted in staffing ratios until documentation reflects they are qualified to work independently. Patients shall be informed when trainees are participating in their treatment and the trainee shall be supervised at all times.

(15) All staff must maintain required current certification and licensure according to the requirements of their profession.

(16) The physician-director shall be responsible for ensuring that each patient caregiver has completed the appropriate training and orientation, and has demonstrated competence in their roles. This responsibility may be delegated to the facility’s administrative and education staff. There must be documentation to reflect this delegation.

(17) The most recent statement of deficiencies resulting from an inspection by the state agency shall be reviewed with the staff and shall be available in the facility for reference.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0105

Minimal Service Requirements for an Outpatient Renal Dialysis Facility

The facility must provide dialysis services, as well as adequate laboratory, social, and nutritional services to meet the needs of the dialysis patient.

(1) Outpatient Dialysis Services:

(a) Staff-assisted dialysis services. The facility must provide all necessary dialysis services and staff required to perform dialysis.

(b) Self-dialysis services. If the facility offers self-dialysis services, it must provide all medically necessary supplies and equipment and any other service specified in the facility’s patient care policies.

(2) Laboratory Services: The facility must make available laboratory services (other than the specialty of tissue pathology and histocompatibility testing), to meet the needs of the dialysis patient. All laboratory services must be performed by an appropriately certified laboratory in accordance with federal and state regulations. If the facility furnishes its own laboratory services, these services must meet the applicable requirements established in state and federal regulations. If the facility does not provide laboratory services, it must make arrangements to obtain these services from a laboratory certified in the appropriate specialties and subspecialties of service.

(3) Social Services: Social services shall be provided to patients and their families and shall be directed at supporting and maximizing the social functioning and adjustment of the patient. Social services must be furnished by a qualified social worker who has an employment or contractual relationship with the facility. The facility shall provide adequate social work coverage to ensure the needs of the patients are met. The qualified social worker is responsible for:

(a) Conducting psychosocial evaluations;

(b) Participating in team reviews of patient progress;

(c) Recommending changes in treatment based on the patient’s current psychosocial needs;

(d) Providing casework and group work services to patients and their families in dealing with the special problems associated with dialysis; and

(e) Identifying community social agencies and other resources and assisting patients and families to utilize them.

(4)(a) Nutrition Services: Nutrition services shall be provided to the patients and the patient’s caregiver(s) in order to maximize the patient’s nutritional status. Each patient must be evaluated as to his/her nutritional needs by the attending physician and by a qualified dietitian who has an employment or contractual relationship with the facility.

(b) The facility shall provide an adequate amount of dietitian coverage to ensure the needs of the patients are met. The dietitian shall be responsible for:

(A) Conducting nutritional assessments of patients;

(B) Participating in a team process in developing and reviewing patient care plans;

(C) Recommending nutrition therapy with consideration of cultural preferences and changes in treatment based on the patient’s nutritional needs in consultation with the patient’s physician;

(D) Counseling patients, patients’ families and significant others; and monitoring adherence to and response to nutrition therapy;

(E) Referring patients for assistance with nutrition resources such as financial assistance, community resources or in-home assistance; and

(F) Participating in Quality Assessment and Performance Improvement activities.

(5) Self-dialysis Support Services: The facility furnishing self-dialysis training, upon completion of the patient’s training, must furnish (either directly, under agreement or by arrangement with another facility) the following services:

(a) Surveillance of the patient’s home adaptation, including provisions for visits to the home or the facility;

(b) Consultation for the patient with a qualified social worker and a qualified dietitian;

(c) A record-keeping system, which assures continuity of care;

(d) Installation and maintenance of equipment;

(e) Testing and appropriate treatment of the water; and

(f) Ordering of supplies on an ongoing basis.

(6) Participation in Recipient Registry: The facility shall participate in a patient registry program with an Organ Procurement Organization (OPO) designated or redesignated for patients who are awaiting cadaveric donor transplantation.

(7) Home Anemia Management:

(a) Patient Monitoring: The facility, or the physician responsible for all dialysis-related services furnished to the patient, shall monitor the patient. This monitoring shall include:

(A) Reviewing appropriate laboratory values;

(B) Establishing the plan of care and monitoring the progress of the home anemia management therapy;

(C) Determining that the patient or a caregiver who assists the patient in performing self-dialysis meets the following conditions:

(i) Is trained by the facility to inject the anemia management drug;

(ii) Is capable of carrying out the procedure;

(iii) Is capable of reading and understanding the drug labeling; and

(iv) Is trained in, and capable of observing, aseptic techniques.

(D) Determining that the anemia management drug can be stored in the patient’s residence under refrigeration, and that the patient is aware of the potential hazard of a child’s having access to the drug and syringes.

(b) The patient’s physician or facility must:

(A) Develop a protocol that follows the drug label instructions; and

(B) Make the protocol available to the patient to ensure safe and effective home use of the anemia management drug.

(8) Medications:

(a) Medications maintained in the facility shall be properly stored and safeguarded in enclosures of sufficient size that are not accessible to unauthorized persons;

(b) Refrigerators used for storage of medications shall maintain appropriate temperatures for such storage and routine monitoring of these temperatures shall be documented;

(c) Medications not given immediately shall be labeled with the name of the medication, the dosage prepared, the date and time, and the initials of the person preparing the medication. Expired medications must be disposed of appropriately; and

(d) All medications shall be administered by licensed nurses, physician assistants, pharmacists, or physicians. Intravenous normal saline, intravenous heparin, and subcutaneous lidocaine may be administered as part of a routine hemodialysis treatment by dialysis technicians qualified according to Oregon Administrative Rules for Hemodialysis Technicians (OARs 333-275-0001 through 333-275-0180).

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0110

Infection Control

(1) There shall be written policies and procedures in effect for the prevention and control of hepatitis and other infections. These policies must include, but are not limited to:

(a) Appropriate procedures for surveillance and reporting of infections;

(b) Housekeeping;

(c) Handling and disposal of waste and contaminants;

(d) Sterilization and disinfection, including the sterilization and maintenance of equipment where dialysis supplies are reused; and

(e) The rinsing, cleaning, disinfection, preparation and storage of reused items which conform to requirements for reuse.

(2) Dialysis facilities shall follow the Centers for Disease Control and Prevention (CDC) recommendations for preventing transmission of infections. This includes the use of long-sleeved gowns that are impervious to the passage of fluids during procedures at high risk for blood or other bodily fluid contamination (e.g. initiation and termination of dialysis and reuse procedures).

(3) The medical director shall designate a committee or individual qualified in surveillance, prevention and control of nosocomial infections to be responsible for the direction, provision, and quality of infection prevention and control services. The medical director shall be responsible for ensuring the facility maintains a record of all infections, their incidence, treatment, and outcome.

(4) Facilities shall follow the tuberculosis screening requirements for employees outlined in OAR 333-019-0010 and 333-019-0041.

(5) Blood spills shall be cleaned immediately or as soon as is practical with an appropriate chemical disinfectant.

(6) The facility shall employ appropriate techniques to prevent cross-contamination between the unit and adjacent hospital or public areas including, but not limited to: food service areas; laundry; disposal of solid waste and blood-contaminated equipment; and disposal of contaminants into sewage systems. Waste storage and disposal shall be carried out in accordance with applicable local laws and accepted public health procedures. The written patient care policies shall specify the functions to be carried out by facility personnel and by the self-dialysis patients with respect to contamination prevention. Where dialysis supplies are reused, records shall be maintained that can be used to demonstrate whether established procedures covering the rinsing, cleaning, disinfection, preparation and storage of reused items, conform to requirements for reuse.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0115

Patients’ Rights, Responsibilities and Family Education

(1) The governing body of the facility shall adopt written policies regarding the rights and responsibilities of patients and, through the chief executive officer, shall be responsible for development of, and adherence to, procedures implementing such policies.

(2) These policies and procedures shall be made available to patients and any guardians, next of kin, the Division, and to the public. The staff of the facility must be trained in and involved in the execution of such policies and procedures. The patients’ rights policies and procedures must ensure all patients in the facility:

(a) Are informed of these rights and responsibilities, and of all rules and regulations governing patient conduct and responsibilities;

(b) Are informed of services available in the facility and of related charges;

(c) Are informed by a physician of their medical conditions unless medically contraindicated (as documented in their medical records);

(d) Are afforded the opportunity to participate in the planning of their medical care (either through direct involvement or if the patient chooses, through family or a representative);

(e) Are afforded the opportunity to refuse to participate in experimental research;

(f) Are transferred or discharged only for medical reasons, for their own welfare or that of other patients or for nonpayment of fees. Patients discharged for these reasons shall be given a written notice prior to transfer or discharge. A patient exhibiting violent, abusive, or threatening behavior may be discharged immediately if necessary to protect themselves, other patients, or employees. A written notice shall be given to these patients within ten days of transfer or discharge;

(g) Are informed about the effects and potential hazards of receiving dialysis and related treatments;

(h) Are treated with consideration, respect and full recognition of their individual and their personal needs, including maintenance of confidentiality;

(i) Are informed regarding the facility’s reuse of dialysis supplies, including hemodialyzers. If printed materials such as brochures are utilized to describe a facility and its services, they must contain a statement with respect to reuse. Patients have the right to refuse the use of reprocessed dialyzers; and

(j) Are informed of all choices of dialysis treatment including peritoneal, self-care, home dialysis, in-center dialysis, no treatment, hospice, and transplantation. If the patient is not considered to be a candidate for transplantation, this information shall be made available to the patient or his/her family member in writing and include the reason(s).

(3) The facility shall have written documentation from the patient that he/she has had his/her rights and responsibilities explained.

(4) The facility shall provide the patient and his/her family with the opportunity for education including, but not limited to the following topics:

(a) Physical orientation of the dialysis center;

(b) Policy for scheduling patient treatment times;

(c) Policies on violent or disruptive behavior;

(d) Duties of members of the dialysis team;

(e) Team member qualifications and duties;

(f) Boundary issues between staff and patient;

(g) Importance of dialysis adequacy and lab values;

(h) Dietary needs and fluid balance;

(i) Medications;

(j) Benefits of exercise;

(k) Disaster planning for situations in which the facility is unable to operate;

(l) Infection control procedures;

(m) Water purification;

(n) Handling of hazardous substances;

(o) Quality control process;

(p) Medical records including contents and confidentiality issues; and

(q) The right of patients and families to request private conversations with a member(s) of the multidisciplinary team at a time of their convenience.

(5) Grievance mechanism: The facility must inform patients (or their representatives) of the facility’s grievance process and the procedures for appeal. All patients are encouraged and assisted to understand and exercise their rights. Grievances and recommended changes in policies and services may be addressed to facility staff, administration, the Network, and agencies or regulatory bodies with jurisdiction over the facility, through any representative of the patient’s choice, without restraint or interference, and without fear of discrimination or reprisal.

(6) The facility’s grievance process must:

(a) Include a record of each grievance made by a patient, his/her representative or family member;

(b) Include documentation of the facility’s investigation of each grievance, including the resolution;

(c) Include the method and phone number for submitting grievances that cannot be resolved at the facility level (e.g. administration, the Network, and the Division);

(d) Include evidence that the person expressing the grievance is notified in writing of the outcome of the grievance investigation; and

(e) Include evidence the facility has responded to the grievance within 30 days.

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0120

Physical Environment

(1) The physical environment in which dialysis services are furnished must afford a functional, clean, sanitary, safe, and comfortable setting for patients, staff, and the public.

(2) The physical structure in which dialysis services are furnished must be constructed, equipped, and maintained to ensure the safety of patients, staff, and the public.

(3) All electrical and other equipment used in the facility must be maintained free of defects that could be a potential hazard to patients or personnel. There must be an established program of preventive maintenance of equipment used in dialysis and related procedures in the facility. Facilities shall follow the manufacturers’ recommendations for preventive maintenance for all equipment.

(4) The areas used by patients shall be maintained in good repair and kept free of hazards such as those created by damaged or defective parts of the building.

(5) The facility must be able to demonstrate that water and equipment used for dialysis meets the water and dialysate quality standards and equipment requirements found in the Association for the Advancement of Medical Instrumentation (AAMI) publication, “Dialysate for hemodialysis,” ANSI/AAMI RD52:2004 which is incorporated by reference.

(6) Any adverse results identified by the water quality monitoring system shall be addressed and corrected immediately. Documentation of these corrections shall be maintained in a designated area for review.

(7) Testing of the water in dialysis facilities must comply with the requirements of Table 1 of this rule.

(8) Treatment areas shall be designed and equipped to provide adequate and safe dialysis therapy, as well as privacy and comfort for patients. The space for treating each patient must be sufficient to accommodate medically needed emergency equipment and personnel to treat the patient in the event of an emergency. There must be sufficient space in the facility for safe storage of dialysis supplies.

(9) Chronic dialysis patients shall be dialyzed in chairs that can be reclined so that the patient’s head is lower than his/her feet, except when the patient is dialyzed in a hospital bed.

(10) There shall be a nursing/monitoring station from which all patients receiving dialysis can be continuously monitored during the course of treatment.

(11) Heating and ventilation systems shall be capable of maintaining adequate and comfortable temperatures.

(12) Each facility utilizing a central-batch delivery system must provide, either on the premises or through affiliation agreement or arrangement sufficient individual delivery systems for the treatment of any patient requiring special dialysis solutions.

(13) Emergency preparedness:

(a) The health care facility shall develop, maintain, update, train, and exercise an emergency plan for the protection of all individuals in the event of an emergency, in accordance with the regulations as specified in Oregon Fire Code (Oregon Administrative Rules chapter 837, division 40).

(b) The health care facility shall conduct at least two drills every year that document and demonstrate that employees have practiced their specific duties and assignments, as outlined in the emergency preparedness plan.

(c) The emergency plan shall include the contact information for local emergency management. Each facility shall have documentation that the local emergency management office has been contacted and that the facility has a list of local hazards identified in the county hazard vulnerability analysis.

(d) The emergency plan shall address all local hazards that have been identified by local emergency management and may include, but is not limited to, the following:

(A) Chemical emergencies;

(B) Dam failure;

(C) Earthquake;

(D) Fire;

(E) Flood;

(F) Hazardous material;

(G) Heat;

(H) High wind/Tornado;

(I) Landslide;

(J) Nuclear power plant emergency;

(K) Pandemic,

(L) Terrorism,

(M) Thunderstorms; or

(N) Tsunamis (for coastal areas only).

(e) The emergency plan shall address the availability of sufficient supplies for staff and patients to shelter in place or at an agreed upon alternative location for a minimum of two days, in coordination with local emergency management, under the following conditions:

(A) Extended power outage;

(B) No running water;

(C) Replacement of food or supplies is unavailable;

(D) Staff members do not report to work as scheduled; and

(E) The patient is unable to return to pre-treatment shelter.

(f) The emergency plan shall address evacuation, including:

(A) Identification of individual positions’ duties while vacating the building, transporting, and housing residents;

(B) Method and source of transportation;

(C) Planned relocation sites;

(D) Method by which each patient shall be identified by name and facility of origin by people unknown to them;

(E) Method for tracking and reporting the physical location of specific patients until a different entity resumes responsibility for the patient; and

(F) Notification to the Division about the status of the evacuation.

(g) The emergency plan shall address the clinical and medical needs of the patients, including provisions to provide:

(A) Storage of and continued access to medical records necessary to obtain care and treatment of patients, and the use of paper forms to be used for the transfer of care or to maintain care on-site when electronic systems are not available;

(B) Continued access to pharmaceuticals, medical supplies and equipment, even during and after an evacuation; and

(C) Alternative staffing plans to meet the needs of the patients when scheduled staff members are unavailable. Alternative staffing plans may include, but is not limited to, on-call staff, the use of travelers, the use of management staff, or the use of other emergency personnel.

(h) The emergency plan shall be made available as requested by the Division and during licensing and certification surveys. Each plan shall be re-evaluated and revised as necessary or when there is a significant change in the facility or population of the health care facility.

(i) The facility shall have a posted plan for evacuation of patients, staff and visitors in the case of fire or other emergencies.

(j) Participation of staff and patients in fire drills shall be documented. Timing of drills shall be rotated throughout the year to include all shifts. If procedural problems are identified through these drills, records shall show that corrective action has been implemented. Fire drills shall be completed at least every six months.

(k) There shall be documentation that employees have received initial and ongoing training in the use of fire extinguishers. Documentation shall include verification that fire extinguishers are checked at least every month to assure they are operational.

(l) The staff must be familiar with the use of all equipment and procedures to handle medical and non-medical emergencies.

(m) Patients shall be informed of their roles in medical and non-medical emergencies. Patients must be fully informed regarding what to do, where to go, and who to contact if a medical or non-medical emergency occurs.

(n) The facility must have a backup water treatment plan that can be demonstrated to meet Association for the Advancement of Medical Instrumentation (AAMI) standards.

[ED. NOTE: Tables & Publications referenced are available from the agency.]

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 13-2008, f. & cert. ef. 8-15-08; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0125

Reuse of Hemodialyzers and other Dialysis Supplies

If the facility reuses hemodialyzers, the facility shall conform to the following:

(1) Meet the requirements of AAMI published in “Reuse of Hemodialyzers,” third edition, ANSI/AAMI RD47:2002 and RD47:2002/A1:2003 which is incorporated by reference;

(2) Procedure for chemical germicides: To prevent any risk of dialyzer membrane leaks due to the combined action of different chemical germicides, dialyzers shall only be exposed to one chemical germicide during the reprocessing procedure. If a dialyzer is exposed to a second germicide, the dialyzer must be discarded;

(3) Surveillance of patient reactions: In order to detect bacteremia and to maintain patient safety when unexplained events occur, the facility:

(a) Shall take appropriate blood cultures at the time of a febrile response in a patient; and

(b) If pyrogenic reactions, bacteremia, or unexplained reactions associated with ineffective reprocessing are identified, the reuse of hemodialyzers in that setting shall be terminated and the facility shall not continue reuse until the entire reprocessing system has been evaluated;

(4) Transducer filters: To control the spread of hepatitis, transducer filters shall be changed after each dialysis treatment and shall not be reused; and

(5) Bloodlines: If the facility reuses bloodlines, it shall:

(a) Limit the reuse of bloodlines to the same patient;

(b) Not reuse bloodlines labeled for “single use only”;

(c) Reuse only bloodlines for which the manufacturer’s protocol for reuse has been accepted by the Food and Drug Administration (FDA) pursuant to the premarket notification (section 510(k)) provision of the Food, Drug, and Cosmetic Act; and

(d) Follow the FDA-accepted manufacturer’s protocol for reuse of that bloodline.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 441.015 & 441.025
Stats. Implemented: ORS 441.025 & 442.015
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12

333-700-0130

Dialysis Facilities Construction Requirements

These rules apply to outpatient renal dialysis facilities licensed by the State of Oregon.

(1) Applicability. OAR 333-700-0130 shall apply to:

(a) An outpatient renal dialysis facility not licensed on April 1, 2012; or

(b) A major alteration to an outpatient renal dialysis facility for which plans were not submitted to the Division on or before April 1, 2012; provided, however, that OAR 333-700-0130 shall apply only to the major alteration and shall not apply to any other area of the outpatient renal dialysis facility.

(2) All new construction and alterations must comply with Oregon Structural Specialty Code.

(3) Minimum facility standards are as follows:

(a) Facility Location & Accessibility:

(A) The facility shall be located to allow for prompt access by ambulances and by buses, including wheelchair-lift equipped type, without the need for patients to traverse across vehicular pathways and parking areas, or the project sponsor shall present an alternate plan showing that patient safety shall not be compromised;

(B) The dialysis unit shall be located in a separate building or section of a building free of traffic by non-related persons;

(C) Accessible parking shall be provided for patients and visitors, constructed to comply with the Oregon Structural Specialty Code, as enforced by the Oregon Building Codes Division and local jurisdictions having authority;

(D) Building access and all patient use areas shall be designed and constructed in accordance with chapter 11 of the Oregon Structural Specialty Code for accessibility at the time of original licensure as enforced by the Oregon Building Codes Division or local jurisdictions having authority; and

(E) Corridors, doorways, and stairways serving the unit shall be sized to allow at least one exit route for emergency transport of a patient by an Emergency Medical Services (EMS) type of stretcher to an ambulance.

(b) Treatment Areas:

(A) Dialysis stations must meet the following minimum criteria:

(i) Individual patient treatment areas shall contain at least 80 sq. ft. 4’-0” minimum shall be available at the foot of the recliner.

(ii) Hand washing stations, readily available for staff use, shall be provided within the treatment area. One hand washing station shall be provided for each four patients minimum, located with appropriate spacing to facilitate washing of hands between patient contact.

(B) Patient care staff station(s) shall be located within the dialysis treatment area and designed to provide visual observation of all patients.

(C) Provide an Isolation Room (to prevent contact transmission of the infectious material) meeting the following minimum criteria:

(i) Shall provide a door and walls that go to the floor, but not necessarily the ceiling, and allow for visual monitoring of the patient;

(ii) Shall accommodate only one patient; and

(iii) Shall contain a hand washing station located in each patient room.

(4) Patient Support: The following shall be provided:

(a) Waiting space with a seating capacity minimum of one seat or wheelchair for each two patient stations;

(b) An Americans with Disabilities Act (ADA) accessible patient toilet, convenient to the waiting room, with emergency nurse call annunciated to the patient care staff station;

(c) Dedicated space for patient scale; and

(d) Dedicated space for wheelchair storage.

(5) General Support Areas: The following shall be provided:

(a) Clean supply room with space for bulk storage of necessary supplies. If preparation of patient care supplies happens within the room, then the clean room must contain a hand wash sink and work counter;

(b) Soiled holding room or area for medical waste. A work counter and hand washing station shall be provided. A flush rim clinical sink with rinsing device is also required when peritoneal dialysis is performed;

(c) If a dedicated medical waste room or area is provided in addition to the soiled holding area, a hand washing station is not required at the medical waste area;

(d) Secure medications storage, meeting Board of Pharmacy rules with dedicated refrigerator and a hand washing station;

(e) Emergency cart/equipment storage located close to the patient treatment area, readily accessible by staff, and not located in the exit path;

(f) Access to a janitor closet with floor sink or service sink and space for supplies within or close to the unit;

(g) Equipment maintenance and storage space for equipment servicing and storage. Equipment space allocated for bio-medical interventions shall not be in proximity to patients while they are undergoing dialysis;

(h) When dialyzer reprocessing is practiced, space for reuse equipment, work counter and hand washing station. Additional sinks shall be provided as defined by the facility’s reprocessing program;

(i) Solution mixing/preparation area for central concentrate delivery system or individual preparation, sized to meet facility needs;

(j) Dedicated space for central or individual water treatment equipment with waste drain sized to meet equipment requirements;

(k) Separate staff toilet, including hand washing station within or near the treatment area;

(l) If a home training program is included, the following shall be provided: separate, 120 square foot, training room(s) each with a hand washing station, counter and separate drain for fluid disposal. At least one convenient program office and general support spaces shall be provided to meet program needs. An emergency nurse call, annunciated at the patient care staff station, or the home training office, shall be provided in each training room.

(m) Staff office; and

(n) Consultation space available for private conferences with patients and family.

(6) Finishes:

(a) Wall materials in all patient treatment areas shall be cleanable;

(b) Water treatment area walls and floors shall be designed and constructed to prevent water from migrating to other areas during normal operating circumstances; and

(c) All soiled utility, medical waste storage, and janitor closet flooring shall be seamless with an integral coved wall base.

(7) Maintenance and Housekeeping:

(a) All building components and equipment shall be maintained in good repair and free from obvious hazards to patients and staff; and

(b) All dialysis equipment shall be maintained in accordance with manufacturers’ recommendations, and each dialysis machine shall be cleaned in accordance with written policies and procedures after each use.

(8) Mechanical and Plumbing:

(a) All heating, ventilation and cooling systems shall comply with the Oregon Mechanical Specialty Code as enforced by the Oregon Building Codes Division or local jurisdiction having authority and shall be maintained in full compliance;

(b) Hot water used for hand washing shall have a water temperature of a minimum of 105 degrees and a maximum of 120 degrees Fahrenheit;

(c) All water treatment and dialysate concentrate equipment and distribution systems shall be in compliance with Association for the Advancement of Medical Instrumentation (AAMI) standards (RD52) at all times. Floor drain(s) shall be provided in these area(s);

(A) No dead end loops or unused branches are allowed in the purified water distribution system;

(B) Product water distribution system shall be constructed of materials that do not contribute chemicals, such as aluminum, copper, lead, and zinc or bacterial contaminants to the purified water.

(C) When used, storage tanks shall have a conical or bowl shaped base and shall drain from the lowest point of the base.

(d) If piped-in oxygen or vacuum systems are included, they shall be installed in accord with National Fire Protection Association (NFPA) 99, chapter 4 and the Oregon Plumbing Specialty Code;

(e) Dialyzer reuse space, if provided, shall not recirculate air, and shall be provided with an exhaust to the outside as required for the reprocessing methods utilized;

(f) To minimize discomfort to patients, whose sensitivity to drafts and temperature change may be accentuated by their physical condition, heating, cooling and ventilation systems in facilities licensed after July 1, 2003, shall be designed to minimize airflow and temperature change at treatment stations; and

(g) In facilities licensed after July 1, 2003, lavatories and sinks intended for hand washing shall be trimmed with fittings operable without use of the hands. Wrist blade controls are not considered to be operable without the use of hands.

(9) Electrical:

(a) All electrical installations shall comply with the Oregon Electrical Specialty Code as enforced by the Oregon Building Codes Division or local authority having jurisdiction and shall be maintained in full compliance.

(b) Emergency power for evacuation lighting, the fire alarm system and the dedicated receptacle for the emergency cart, shall be provided. Lighting levels shall be five foot candles minimum at patient stations, staff support stations and paths of egress for a minimum of 1-1/2 hours.

(c) In facilities initially licensed or constructed after July 1, 2003, provisions shall be made to allow connection to an alternate power source. The point of connection shall be immediately accessible to the exterior. The alternate power source shall provide on-going power for lighting required in subsection (9)(b) of this rule, and continued provision of dialysis services;

(d) A ground fault interrupter (GFI) shall be provided independently for each dialysis machine; and

(e) Hospital grade electrical outlets shall be provided serving all dialysis equipment connections.

(10) Structural, Fire & Life Safety and Maintenance:

(a) All facilities constructed after May 6, 2005, shall be constructed to meet the requirements as defined by the Oregon Structural Specialty Code as enforced by the Oregon Building Codes Division or local authority having jurisdiction and shall be maintained in full compliance.

(b) Dialysis facilities shall be located on the ground floor, unless they are considered an Institutional, I-2, occupancy class per the Oregon Structural Specialty Code and, if certified by Centers for Medicare and Medicaid, an Ambulatory Health Care Occupancy per the National Fire Protection Association Life Safety code 101.

(c) Emergency power supply and exit illumination shall be provided in accordance with Section 407.10 of the Oregon Structural Specialty Code.

(d) Existing licensed dialysis facilities classified as a B occupancy and legally constructed and operating prior to the adoption of these rules shall be permitted to continue to operate as pre-existing non-conforming facilities subject to the following provisions:

(A) Facilities shall have a smoke detection system;

(B) Type 2A:10B:C fire extinguishers shall be installed in locations readily accessible to staff. At least one fire extinguisher shall be provided for each eight patient stations;

(C) The facility shall meet the exiting requirements of chapter 10 of the Oregon Structural Specialty Code and, if certified by Centers for Medicare and Medicaid Services exiting requirements of chapter 5 of the NFPA 101 Life Safety Code;

(D) Minimum egress requirements shall include:

(i) Door latching that is classified as simple hardware;

(ii) Exit signs from all common locations of the facility;

(iii) Exit illumination with an alternate power source; and

(iv) The means of egress shall be free of obstructions.

(E) Floor surfaces shall be relatively level and free of tripping hazards;

(F) Buildings shall be maintained in good condition with sound structural integrity; and

(G) Facilities shall be in compliance with local codes, laws and ordinances.

(e) All interior and exterior materials and surfaces (e.g. floors, walls, roofs, ceilings, windows and furnishings) and all equipment necessary for the health, safety and comfort of patients shall be kept clean and in good repair.

Stat. Auth.: ORS 441.015, 441.025 & 441.060
Stats. Implemented: ORS 441.025 & 441.060
Hist.: PH 7-2003, f. & cert. ef. 6-6-03; PH 13-2005, f. 8-10-05, cert. ef. 8-15-05; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12


 

Rule Caption: Amendments to Special Health Care Facilities, ambulatory surgical center physical environment rules.

Adm. Order No.: PH 5-2012

Filed with Sec. of State: 3-30-2012

Certified to be Effective: 4-1-12

Notice Publication Date: 1-1-2012

Rules Adopted: 333-076-0001

Rules Amended: 333-076-0185

Subject: The Oregon Health Authority, Public Health Division, Facilities Planning and Safety program is permanently amending Oregon Administrative Rules in chapter 333, division 76 pertaining to the physical environment of ambulatory surgical centers. Due to technological advances in surgery procedures and changes in the types of services provided in outpatient settings the current rules have become antiquated and require updating. The changes proposed will align the rules under which Oregon’s ambulatory surgical centers are licensed by, with national healthcare design and construction industry standards. Tables referenced in OAR 333-076-0185 are also being permanently amended and adopted.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-076-0001

Referenced Codes and Standards

The codes and standards referenced in these rules shall be considered part of the requirements of these rules to the prescribed extent of each such reference. Where differences occur between provisions of these rules and referenced codes and standards, the provisions of the most restrictive code shall apply.

(1) 2010 Oregon Structural Specialty Code (OSSC);

(2) 2010 Oregon Mechanical Specialty Code;

(3) 2010 Oregon Energy Efficiency Specialty Code;

(4) 2010 Oregon Electrical Specialty Code (OESC);

(5) 2011 Oregon Plumbing Specialty Code;

(6) 2010 Oregon Fire Code (OFC);

(7) National Fire Protection Association, NFPA 101 Life Safety Code, 2000 Edition;

(8) National Fire Protection Association, NFPA 99 Standard for Healthcare Facilities, 1999 Edition;

(9) National Fire Protection Association, NFPA 110 Standard for Emergency and Standby Power Systems, 2002 Edition;

(10) National Fire Protection Association, NFPA 90A Standard for Installation of Air-Conditioning and Ventilating Systems, 1996 Edition;

(11) National Fire Protection Association, NFPA 255 Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 Edition;

(12) National Fire Protection Association, NFPA 801 Standard for Fire Protection for Facilities Handling Radioactive Materials, 1998 Edition OSHA and radiology;

(13) Illuminating Engineering Society, IES RP 28, 2007 Edition;

(14) Illuminating Engineering Society, IES RP 29, 2006 Edition with Errata;

(15) American National Standards Institute/American Society of Sanitary Engineering, ANSI/ASSE 6000, 2004 edition;

(16) ASHRAE Standard 170-2008 Ventilation of Health Care Facilities;

(17) Underwriters Laboratories, Inc.; UL 1069 Hospital Signaling and Nurse Call Equipment, 7th edition, revised January 22, 2009;

(18) National Fire Protection Association, NFPA 13, Standard for Installation of Sprinkler Systems, 1999 Edition;

(19) National Fire Protection Association, NFPA 72, Standard for Installation of Sprinkler Systems, 1999 Edition.

Stat. Auth.: ORS 441.025 & 441.060
Stats. Implemented: ORS 441.025 & 441.060
Hist.: PH 5-2012, f. 3-30-12, cert. ef. 4-1-12

333-076-0185

Physical Environment

(1) Applicability. OAR 333-076-0185 shall apply to:

(a) An ambulatory surgical center not licensed on April 1, 2012; or

(b) A major alteration to an ambulatory surgical center for which plans were not submitted to the Division on or before April 1, 2012; provided, however, that OAR 333-076-0185 shall apply only to the major alteration and shall not apply to any other area of the ambulatory surgical center.

(2) For the purpose of this rule the following definitions apply:

(a) “Major alteration” means any structural change to the foundation, floor, roof, or exterior or load bearing wall of a building, or the extension of an existing building to increase its floor area, where such structural change or extension affects patient care or safety. “Major alteration” also means the modification of an existing building that results in a change in use, even if the modification does not include any structural change to the building, where such modification affects patient care or safety. “Major alteration” does not include cosmetic upgrades to the interior or exterior of an existing building, including but not limited to changes to wall finishes, floor coverings and casework.

(b) “Change in use” means altering the purpose of an existing room. “Change in use” does not include the sale of an ASC if the new owner provides services in the same class of operating rooms pursuant to section (15) of this rule.

(3) Notification of Alteration: If an ASC proposes any of the following alterations the ASC must notify the Division. The Division shall determine, on a case-by-case basis, whether such alterations constitute a “change in use”. If an alteration affects patient care, patient safety, is a change of use, or includes any of the following, the alteration is subject to this rule:

(a) Addition of surgical services, to the extent the additional surgical services can not be performed in the class of operating rooms existing in the ASC pursuant to section (15) of this rule;

(b) Replacement of equipment in the ASC that is permanently connected to major building components, such as: power, heating, ventilation, air conditioning, plumbing or medical gas; and

(c) Addition of doors to pre-operative holding areas or post-anesthesia care units.

(4) Functional Program.

(a) An ASC shall provide a description of its functional program when plans are submitted for review, along with additional requirements found in OAR 333-675-0000.

(b) The functional program describes in detail the purpose of the project, department relationships and flow of patients, staff, visitors and supplies as applicable, size and function of each space, description of those services necessary for the complete operation of the ASC, type of anesthesia used, average recovery time, special design feature(s), occupant load, numbers of staff and patients, visitors and vendors, issue of privacy/confidentiality for patients, level of medical gas system per NFPA 99, and type of central electrical system.

(5) Location. Building entrances used to reach outpatient services shall be at grade level, clearly marked, and located so patients need not go through other activity areas. Travel patterns shall preclude unrelated traffic within the unit.

(6) Mixed Uses. An ASC is a distinct entity and must be separate and distinguishable from any other health care facility or office-based physician practice, but the ASC may share a reception area, waiting room and public toilet rooms with the other health care facility or office-based physician practice. Medicare-certified ASCs are subject to specific requirements related to sharing spaces with another health care facility or office-based physician practice. An ASC that is Medicare-certified must be distinct from any other health care facility or office-based physician practice as required in 42 CFR 416.2 and 42 CFR 416.44(a)(2) and (b).

(7) Conformance to Building and Fire and Life Safety Codes. ASCs shall conform to the editions of the Oregon State Building Code, as defined in ORS 455.010(8), under which they were constructed. ASCs to be certified for Medicare reimbursement shall meet standards of the National Fire Protection Association (NFPA) #101 and #99 Codes.

(8) Administrative and Public Areas. An ASC shall have:

(a) An entrance sheltered from inclement weather and accessible to the disabled. If a separate door is provided for the discharge of patients, it must be sheltered from inclement weather and shall be accessible to the disabled;

(b) A reception counter or desk;

(c) Toilet(s) for public use conveniently accessible from the waiting area without passing through patient care or staff work areas or suites;

(d) Telephone access for local phone calls for patients;

(e) Conveniently accessible drinking water;

(f) Conveniently accessible wheelchair storage;

(g) Space(s) for private interviews relating to financing and credit discussions;

(h) Space for business transactions, records storage and administrative and professional staff to work, including but not limited to space designated for computers, printers, fax machines, and copiers if required by the functional program;

(i) Secure and safe storage for medical records of all media type, located to maintain the confidentiality of records and either restricted to staff movement or remote from treatment and public areas. Space required shall be defined by the functional program;

(j) Special storage for staff personal effects with locking drawers or cabinets; and

(k) General storage for supplies and equipment as identified in the functional program.

(9) Environmental Services Room (Housekeeping Closet). An ASC shall have an environmental services room that contains a floor receptor or service sink and storage space for housekeeping supplies and equipment, and that is at least 16 square feet.

(10) Layout. An ASC shall provide three areas – unrestricted, semi-restricted, and restricted – that are defined by the physical activities performed in each area.

(a) Unrestricted area. For the purpose of this rule, unrestricted areas shall include a central control point established to monitor the entrance of patients, personnel, and materials into the restricted areas. (Street clothes are permitted in this area, and traffic is not limited.)

(b) Semi-restricted area. For the purpose of this rule, semi-restricted areas shall include the peripheral support areas of the surgical suite, where traffic is limited to authorized personnel and patients, and where personnel are required to wear surgical attire and hair coverings. A semi-restricted area includes but is not limited to:

(A) Storage areas for clean and sterile supplies;

(B) Work areas for storage and processing of instruments;

(C) Corridors leading to the restricted areas of the surgical suite; and

(D) Scrub sink areas.

(c) Restricted area. For the purpose of this rule, restricted areas are areas where surgical attire and hair coverings are required, and where masks are required due to the presence of open sterile supplies or scrubbed people. A restricted area includes but is not limited to:

(A) Operating and other procedure rooms; and

(B) The clean core (if required by the functional program).

(d) Signs shall be provided at all entrances to restricted areas indicating surgical attire required.

(11) Special Patient Care Rooms. In ASCs with a functional program that includes treatment of patients with known infectious disease or populations with known compromised or suppressed immune systems, the need for and number of airborne infection isolation rooms and protective environment rooms shall be determined by an infection control risk assessment (ICRA).

(a) Airborne Infection Isolation (AII) Room. For the purpose of this rule, Airborne Infection Isolation refers to the isolation of patients infected with organisms spread by airborne droplet nuclei and shall have:

(A) Only one bed and a hand-washing station (placement of an additional hand-washing station outside the room entrance shall be permitted);

(B) An area for gowning and storage of clean and soiled materials located either directly outside or inside the entry door to the patient room;

(C) A separate room with a toilet and hand-washing station;

(D) Perimeter walls, a ceiling, and floor, including penetrations, that are sealed tightly so that air does not infiltrate the environment from the outside or from other spaces;

(E) Self-closing devices on all room exit doors;

(F) Doors with edge seals;

(G) Window treatments and privacy curtains:

(i) Window treatments and privacy curtains shall be smooth-surfaced, easy-to-clean, wipeable, and non-pleated;

(ii) Fabric drapes and curtains shall not be used for window treatments;

(iii) Use of fabric privacy curtains shall be permitted if they are washable. A wipeable fabric with a smooth surface is preferable.

(b) Anteroom. An anteroom to a patient isolation room is not required; however, if an anteroom is part of the design concept, it shall meet the following requirements:

(A) Space for persons to don personal protective equipment before entering the patient room; and

(B) Doors with self-closing devices.

(c) Protective Environment (PE) Rooms. For the purpose of this rule, Protective Environment Room refers to a patient room that is designed to protect a high risk, immunocompromised patient from human and environmental airborne pathogens.

(A) When determined by an Infection Control Risk Assessment (ICRA) and the functional program, special design considerations and ventilation shall be required to ensure the protection of patients who are highly susceptible to infection; and

(B) The room(s) shall meet the requirements of subsection (11)(a) except for paragraph (C).

(12) Non-invasive Procedure & Consultation Room. A non-invasive procedure and consultation room is not a “procedure room” for purposes of ORS 441.020. A non-invasive procedure and consultation room shall have:

(a) A minimum clear floor area of 120 square feet with a minimum room dimension of 10 feet;

(b) A room arrangement that permits a minimum clear dimension of 3 feet at each side and at the foot of the bed;

(c) A hand-washing station;

(d) A counter or shelf space for writing or electronic documentation; and

(e) Visual and acoustical privacy for private medical consultations and confidential communication with patients and their families/legal guardians.

(13) Sterilization Facilities: An ASC shall have space and a system for sterilizing equipment and supplies either on-site or off-site. If located on site, sterilization facilities shall be located in a semi-restricted area and shall include a separate area for cleaning and decontamination of instruments prior to sterilization. Sterilization facilities shall include, but are not limited to, a high-speed sterilizer or other sterilizing equipment for immediate or emergency use, as required by the functional program.

(a) When sterilization is provided off-site, a room for the adequate handling (receiving and distribution) and on-site storage of sterile supplies, that meet paragraph (13)(c)(C) of this rule shall be provided.

(b) Provisions shall be made for sanitizing clean and soiled carts or vehicles consistent with the needs of the particular transportation system.

(c) An on-site processing facility shall include:

(A) A decontamination room for the exclusive use of the surgical suite. If the room has a door or pass through opening for decontaminated instruments between the decontamination room and a clean workroom it shall have a self closing door, but it may not have a direct connection with an operating room. A decontamination room shall include:

(i) A flushing-rim clinical sink or equivalent flush-rim fixture unless the decontamination room is used only for temporary holding of soiled material;

(ii) A hand-washing station; and

(iii) A work counter unless the decontamination room is used only for temporary holding of soiled material.

(B) A clean assembly/workroom that is physically separated from soiled work areas that has adequate space for the designated number of work areas as defined in the functional program as well as space for storage of clean supplies, sterilizer carriages (if used), and instrumentation. Access to this area shall be restricted. A clean/assembly workroom shall contain:

(i) A hand-washing station;

(ii) Workspace; and

(iii) Equipment for terminal sterilizing of medical and surgical equipment and supplies.

(C) Storage for sterile supplies and packs, including provisions for ventilation, humidity, and temperature control.

(i) The sterile supply storage area shall have a floor area as required per the functional program.

(ii) As described in paragraph (13)(c)(B) of this rule, location of the sterile supply storage in an area within the clean assembly/workroom shall be permitted if it is a permanently designated area.

(14) Linen Services. Designated space in the post-anesthesia recovery area(s) shall be provided for clean and soiled linen.

(a) On-site Processing Area. If the functional program requires linen to be processed on site, the area shall:

(A) Be large enough to accommodate a washer, a dryer, and any plumbing equipment needed to meet the temperature requirements of 160 degrees;

(B) Be divided into distinct soiled (sort and wash) and clean (dry and fold) areas;

(C) Have storage for laundry supplies and clean linen; and

(D) Have a hand-washing station within 10 feet without passing through a door.

(b) Off-site Laundry Service Areas. If the functional program requires linen to be processed off site, the area within the ASC shall have a:

(A) Soiled linen holding area or designated and dedicated area for a soiled laundry cart; and

(B) Clean linen storage area that protects linen from soil or damage.

(15) Operating Rooms. The size and location of the operating rooms shall depend on the level of care and equipment specified in the functional program.

(a) Class A Operating Room. For the purpose of this rule, a Class A operating room is for surgery and other procedures that require minimal sedation including but not limited to minor surgical procedures performed under topical and local infiltration blocks with or without oral or intramuscular preoperative sedation. A surgical procedure performed in a Class A operating room could also be performed in a Class B or C operating room.

(A) Space requirements. Class A operating rooms shall have a minimum clear floor area of 150 square feet within a minimum clear dimension of 12 feet.

(B) Clearances. There shall be a minimum clear distance of 3 feet 6 inches at each side, the head, and the foot of the operating table.

(C) Location. Class A operating rooms may be accessed from the semi-restricted corridors of the surgical suite or from an unrestricted corridor adjacent to the surgical suite.

(b) Class B Operating Room. For the purposes of this rule a Class B operating room is for surgery and other procedures that require conscious sedation. A procedure performed in a Class B operating room could also be performed in a Class C operating room.

(A) Space requirements. Class B operating rooms shall have a minimum clear floor area of 250 square feet with a minimum clear dimension of 15 feet.

(B) Clearances. Room arrangement shall permit a minimum clear dimension of 3 feet 6 inches at each side, the head, and the foot of the operating table.

(C) Location. Class B operating rooms shall be accessed from the semi-restricted corridors of the surgical suite.

(c) Class C Operating Room. For the purpose of this rule a Class C operating room is for surgery and procedures that require general anesthesia or deep sedation.

(A) Space requirements. Class C operating rooms shall have a minimum clear floor area of 400 square feet and a minimum clear dimension of 18 feet.

(B) Clearances. Room arrangement shall permit a minimum clear dimension of 4 feet at each side, the head, and the foot of the operating table.

(C) Location. Class C operating rooms shall be accessed from the semi-restricted corridors of the surgical suite.

(d) Each operating room shall have access to at least one medical image viewer located as required by the functional program.

(e) All operating rooms shall be equipped with an emergency communication system designed and installed to effectively summon additional qualified staff support with no more than push activation of an emergency call switch.

(f) An operating room is considered a procedure room for the purposes of determining the appropriate fee under ORS 441.020.

(16) Pre-operative Support Areas.

(a) Location. Pre-operative holding areas shall be under direct visual control of the nursing staff. Pre-operative holding can be shared with post-operative if the functional program defines patient management.

(A) For a Class A operating room the minimum number of patient stations within the pre-operative holding areas is as follows:

(i) At least one patient station if the operating room is accessed from the semi-restricted area.

(ii) None if the operating room is accessed from an unrestricted area and the functional program allows for pre-operative care to be carried out in the operating room.

(B) For a Class B operating room, at least one patient station within the pre-operative holding areas is required. A patient station may consist of a bed, chair or stretcher.

(C) For Class C operating room, at least one patient station per Class C operating room is required.

(D) In an ASC with Class B and Class C operating rooms, area shall be provided to accommodate stretcher and chair space.

(b) Area. Each pre-operative holding area shall provide a minimum clear floor area of 80 square feet for each patient station.

(c) Clearances. Each pre-operative holding area shall have a minimum clear dimension of 5 feet between patient and 4 feet between patient and adjacent walls (at the stretcher’s or chair’s side and foot).

(d) Patient privacy. Provisions such as cubicle curtains shall be made for patient privacy.

(e) Hand-washing station. Hands-free or wrist blade-operable controls shall be available, with at least one station for every six positions or fewer and for each major fraction thereof. Hand-washing stations shall be uniformly distributed to provide convenient access from each patient position. Travel distance to a hand-washing station shall not exceed 20 feet, and shall be located without passing through a door. Travel distances shall be calculated from the foot of the patient station to the hand-washing station.

(f) Documentation space. A counter, table, area for a desk, or storage for a movable table shall be provided.

(g) Change Area. A separate area(s) shall be provided for outpatients to change from street clothing to hospital gowns and prepare for surgery. If the ASC has four or fewer operating rooms, the change area can also be a holding area(s). The change area shall include the following:

(A) Lockers, or acceptable provisions made for securing patients’ personal effects; and

(B) Toilet(s). The patient toilet room(s) shall be separate from public use toilet(s) and located to permit access from pre- and post-operative holding areas.

(17) Recovery Areas.

(a) When determining the number of recovery positions required, an ASC shall take into consideration the types of surgery and procedures performed in the ASC, the types of anesthesia used, average recovery periods, and anticipated staffing levels.

(b) Recovery areas shall be accessible directly from the semi-restricted area. If pre-operative holding areas, Phase 2 areas and recovery areas are required per the functional program, these spaces may be shared if the number of patient positions meet the most restrictive requirements of both pre and post operative areas.

(c) Nurse Control Station. The nurse control station shall have direct sightline to patients in acute recovery stations.

(d) If pediatric surgery is practiced, the functional program and physical environment design shall address the following:

(A) Locations of pediatric recovery stations;

(B) Space for parents;

(C) Sound attenuation; and

(D) Proximity of patient stations to a nursing station.

(e)(A) Post-anesthesia recovery positions. Room(s) for post-anesthesia recovery in an ASC shall be provided in accordance with the functional program;

(B) Number. A minimum of one recovery station per operating room shall be provided. A recovery area analysis shall determine the need for additional recovery stations. In the absence of a recovery area analysis approved by the Division, the minimum number of post-anesthesia recovery positions shall be as follows:

(i) Three recovery positions for each Class C operating room;

(ii) Two recovery positions for each Class B operating room;

(iii) One recovery position for each Class A operating room.

(f) Area. When a patient cubicle is used for each patient care station, a minimum clear floor area of 80 square feet shall be provided. Space shall also be provided for additional equipment described in the functional program.

(g) Clearances. Each post-anesthesia recovery area shall provide a minimum clear dimension of 5 feet between patient stretchers or beds, 4 feet between patient stretchers or beds and adjacent walls (at the stretcher’s sides and foot), and at least 3 feet from the foot of the stretcher or bed to the closed cubicle curtain.

(h) Patient privacy. Provisions for patient privacy such as cubicle curtains shall be made.

(i) Hand-washing station. Hands-free or wrist blade-operable controls shall be available, with at least one station for every six positions or fewer and for each major fraction thereof. Hand-washing stations shall be uniformly distributed to provide convenient access from each patient position. Travel distance to a hand-washing station shall not exceed 20 feet, and shall be located without passing through a door. Travel distances shall be calculated from the foot of the patient station to the hand-washing station.

(j) Patient toilet room(s). In an ASC with three or more operating rooms, a dedicated patient toilet room shall be provided in the recovery area.

(k) Support areas for post-anesthesia recovery rooms. If the post-anesthesia recovery room(s) is located immediately adjacent to the surgical suite, sharing of these support areas shall be permitted;

(A) Supply storage. Storage space shall be determined by the functional program, however, at least 15 cubic feet needs to be provided.

(B) Receptacles for soiled linen and waste holding shall be provided and meet the requirements of NFPA 101, 20.7.5.5.

(C) Documentation space. A counter, table, area for a desk, or storage for a movable table shall be provided.

(D) Drug distribution station. Each recovery area shall have a drug distribution station that includes:

(i) An area for the storage and preparation of medications administered to patients;

(ii) A refrigerator for pharmaceuticals and double-locked storage for controlled substances if required by the functional program; and

(iii) Convenient access to a hand-washing station without passing through a door.

(E) Nourishment facilities within a recovery area shall have:

(i) A sink, work counter, refrigerator, storage cabinets, and equipment for serving nourishment as required by the functional program; and

(ii) A hand-washing station that is located in the nourishment area or adjacent to the nourishment area.

(18) Phase 2 Recovery.

(a) A Phase 2 recovery area shall be provided if required by the functional program.

(b) Location of the Phase 2 recovery area within the post-anesthesia recovery area shall be permitted, but the Phase 2 area shall be an identifiably separate and distinct part of the post-anesthesia recovery area. Phase 2 recovery stations can be shared with recovery stations if the functional program defines patient management.

(c) Area. When a patient cubicle is used for each patient care station, the design shall provide a minimum of 50 square feet for each patient in a lounge chair with space for additional equipment described in the functional program.

(d) Clearances.

(A) The design shall provide a minimum clear dimension of 4 feet between the sides of adjacent lounge chairs and between the foot of the lounge chairs and the nearest obstruction.

(B) When permanent partitions (full or partial height or width) are used to partially define the patient care station (rather than cubicle curtains), a minimum clear dimension of 3 feet shall be provided on the side of the lounge chair.

(e) Patient privacy. Provisions for patient visual privacy such as cubicle curtains shall be made.

(f) Hand-washing station. Hands-free or wrist blade-operable controls shall be available, with at least one station for every six positions or fewer and for each major fraction thereof. Hand-washing stations shall be uniformly distributed to provide convenient access from each patient position. Travel distance to a hand-washing station shall not exceed 20 feet, and shall be located without passing through a door. Travel distances shall be calculated from the foot of the patient station to the hand-washing station;

(g) Patient toilet room(s). In an ASC with two or fewer operating rooms, a patient toilet room shall be provided in or adjacent to the Phase 2 recovery area. In an ASC with three or more operating rooms, a patient toilet room shall be provided in the Phase 2 recovery area.

(h) Support areas for Phase 2 recovery (if provided) shall provide the following:

(A) Clear sightlines and easy access from the post-anesthesia recovery area to the nurse control station;

(B) Storage space for supplies and equipment;

(C) Documentation space. A counter, table, area for a desk, or storage for a movable table; and

(D) Space for family members.

(19) Support for the Surgical Service Areas: The following shall be provided in the surgical service areas:

(a) Visual surveillance by nursing staff of all traffic entering the semi-restricted corridor (the passage used to access operating rooms and ancillary semi-restricted areas) per the functional program;

(b) Medication storage. Drug storage shall be provided. A refrigerator for pharmaceuticals and double-locked storage for controlled substances shall be provided if required by the functional program;

(c) Scrub facilities. With the exception of ASCs providing exclusively gastrointestinal endoscopy services, an ASC shall have a scrub station(s) trimmed with foot, knee, or electronic controls. Single-lever wrist blades shall not be permitted. Scrub station(s) shall be provided at the entrance to each operating room. A scrub station may serve two operating rooms if it is located on the same wall, and between the two entrances. Scrub stations shall be arranged to minimize splatter on nearby personnel or supply carts. A dedicated hand wash station with hands-free controls shall be provided in each room used for gastrointestinal endoscopy services.

(d) Equipment and supply storage. Equipment storage room(s) shall be provided for equipment and supplies used in the surgical service areas. The combined area of equipment and clean clinical supply storage room(s) shall have a minimum floor area of 50 square feet for each operating room(s) up to two and an additional 25 square feet per additional operating room. Equipment storage room(s) shall be located within the semi-restricted area;

(e) Anesthesia supply storage. An area shall be provided for storing anesthesia equipment and supplies, as defined by the functional program. This space shall be located within the semi-restricted area;

(f) Medical gas storage. An area shall be provided for the storage of medical gas(es) used in the ASC, including adequate space for reserve cylinders. Such space shall meet National Fire Protection Association 99 standards;

(g) Stretcher storage area. In an ASC that provides Class B and C operating rooms, a stretcher storage area for at least one stretcher shall be provided. This storage area shall be convenient for use and located outside the required width of the exit access corridor;

(h) Staff lounge and toilet facilities. Staff lounge toilet facilities shall be provided in an ASC with three or more operating rooms. The toilet room shall be near the recovery area;

(i) Staff lockers. Appropriate change area(s) shall be provided for male and female staff working within the surgical suite (a unisex locker area with one or more private changing rooms shall be permitted.) For an ASC that provides services in Class B and C operating rooms, this area(s) shall be designed to effect a one-way traffic pattern so that personnel entering from outside the surgical suite can change and move directly into the suite’s semi-restricted corridor. As least one staff shower shall be provided that is conveniently accessible to the surgical suite and recovery areas;

(j) Environmental services room (housekeeping closet). An environmental services room shall be provided exclusively for the surgical suite. This room shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment and shall be at least 16 square feet;

(k) Emergency equipment/supply storage. Provisions shall be made for access to and use of emergency resuscitation equipment and supplies (crash cart(s) and anesthesia carts) within 60 feet and at least one per floor of patient care areas;

(l) Fluid waste disposal. Fluid waste disposal facilities shall be provided and shall be located so that they are convenient to the operating rooms and recovery areas. A clinical sink or equivalent equipment in a soiled workroom shall meet this requirement in the operating room area, and a toilet equipped with a bedpan-cleaning device or a separate clinical sink shall meet the requirement in the recovery area.

(20) Details and Finishes:

(a) Corridor width. Public corridors shall have a minimum width of 5 feet, except that corridors connecting the operating room section and the post anesthesia care unit and at least one ambulance transfer exit, where patients are transported on stretchers or beds, shall have a minimum width of 6 feet. The semi-restricted corridor shall have a minimum width of 8 feet in areas used to transport patients on gurneys between pre-operative, procedure, and post-anesthesia recovery areas. Passages and corridors used exclusively for staff access shall be a minimum of 3 feet 8 inches in clear width. Items such as provisions for drinking water, telephone booths, vending machines, etc., shall not restrict corridor traffic or reduce the corridor width below the required minimum. In-corridor storage or parking space for portable equipment shall not overlap required corridor widths. Width shall also meet OFC 1018.2.

(b) Doors and door hardware. The minimum door width for patient use shall be 3 feet. Door openings requiring gurney/stretcher access shall have a minimum clear width of 3 feet 8 inches;

(c) Hand-washing stations. Hand sanitation dispensers shall be provided in addition to hand-washing stations. The number and location of both hand-washing stations and hand sanitation dispensers shall be determined by ICRA;

(A) Hand-washing stations used by medical and nursing staff, patients, and food handlers shall be trimmed with valves that can be operated without hands. Single-lever or wrist blade devices shall be permitted. Sensor-regulated water fixtures shall meet user need for temperature and length of time the water flows. Electronic faucets shall be capable of functioning during loss of normal power. Knee control, foot pedal, electronic or other devices that allow operation without use of the hands are acceptable.

(B) Sinks in hand-washing stations shall be designed with deep basins to prevent splashing to areas where direct patient care is provided, particularly those surfaces where sterile procedures are performed and medications are prepared.

(C) The area of the basin shall not be less than 144 square inches with a minimum 9 inch width or length.

(d) Clinical sinks.

(A) Handles on clinical sinks shall be at least 6 inches long.

(B) Clinical sinks shall have an integral trap wherein the upper portion of the water trap provides a visible seal.

(e) Provisions for hand drying shall be required at all hand-washing stations except scrub sinks.

(A) Hand-washing stations shall include a hand-drying device that does not require hands to contact the dispenser.

(B) If provided, hand towels shall be directly accessible to sinks.

(f) Cleansing agents. Hand-washing stations shall include liquid or foam soap dispensers.

(g) Toilet rooms for patient use in surgery and recovery areas shall be equipped with doors and hardware that permit access from the outside in emergencies. When such rooms have only one opening, the doors shall open outward or be otherwise designed to open without pressing against a patient who may have collapsed within the room.

(h) Radiation protection requirements for X-ray and gamma ray installations shall conform with National Council on Radiation Protection and Measurements (NCRP) reports 102, 147, and 151 and all applicable state requirements. Testing is to be coordinated with the Division’s Radiation Protection Services program to prevent duplication of test observations or construction inspections. Provision shall be made for testing completed installations before use. All defects shall be corrected before approval.

(i) The minimum ceiling height of an ASC shall be 7 feet 10 inches, with the following exceptions:

(A) Ceiling height in corridors, storage rooms, toilet rooms, and other minor rooms shall not be less than 7 feet 8 inches;

(B) Radiographic and other rooms containing ceiling-mounted equipment shall have ceilings of sufficient height to accommodate the equipment and fixtures; and

(C) Boiler rooms shall have ceiling clearances not less than 2 feet 6 inches above the main boiler header and connecting pipe.

(j) Ceilings. Ceiling finishes shall be appropriate for the areas in which they are located and shall be as follows:

(A) Semi-restricted areas.

(i) Ceiling finishes in semi-restricted areas such as clean corridors, central sterile supply spaces, specialized radiographic rooms, and Class A operating rooms shall be smooth, scrubbable, nonabsorptive, nonperforated, capable of withstanding cleaning with chemicals, and without crevices that can harbor mold and bacteria growth.

(ii) Perforated, tegular, serrated, or highly textured tiles shall not be used.

(B) Restricted areas.

(i) Ceilings in restricted areas such as operating rooms shall be monolithic, scrubbable, and capable of withstanding chemicals. Cracks or perforations in these ceilings are not allowed.

(ii) All access openings in ceilings in restricted areas shall be gasketed.

(C) Mechanical and electrical rooms. Suspended ceilings may be omitted in mechanical and electrical rooms/spaces unless required for fire safety purposes.

(k) Floor finishes shall be appropriate for the areas in which they are located and shall:

(A) Be easy to maintain, readily cleanable and appropriately wear-resistant;

(B) In all areas such as clean corridors, central sterile supply spaces, specialized radiographic rooms, and Class A operating rooms, be washable, smooth and able to withstand chemical cleaning;

(C) In areas such as operating rooms, environmental services rooms, and soiled holding or utility rooms, be scrubbable, able to withstand chemical cleaning, and monolithic, with an integral base of at least 6 inches;

(D) In clinical areas, be constructed of materials that allow the easy movement of all required wheeled equipment;

(E) Provide smooth transitions between different flooring materials;

(F) Allow for ease of ambulation and self-propulsion. Carpet and carpet with padding in patient areas shall be glued down or stretched taut and free of loose edges or wrinkles that might create hazards or interfere with the operation of lifts, wheelchairs, walkers, wheeled carts, or patients utilizing orthotic devices;

(G) In all areas subject to wet cleaning methods, not be physically affected by germicidal or other types of cleaning solutions;

(H) Be slip-resistant for flooring surfaces in wet areas (e.g., kitchens, showers and baths), ramps, entries from exterior to interior space, and areas that include water for patient services; and

(I) Joints for flooring openings for pipes, ducts, and conduits shall be tightly sealed to minimize entry of pests. Joints of structural elements shall be similarly sealed.

(l) Wall finishes shall be cleanable and washable. In the vicinity of plumbing fixtures, wall finishes shall be smooth and moisture resistant.

(A) Wall finishes in areas such as clean corridors, central sterile supply spaces, specialized radiographic rooms, and minor surgical procedure rooms shall be washable, smooth, and able to withstand chemical cleaning.

(B) Wall finishes in areas such as operating rooms, delivery rooms, and trauma rooms shall be scrubbable, able to withstand chemical cleaning, and monolithic.

(C) Wall finish treatments shall not create ledges or crevices that can harbor dust and dirt.

(D) Wall surfaces in wet areas (e.g. environmental services rooms) shall be monolithic and all seams shall be covered or sealed.

(E) Wall bases in areas routinely subjected to wet cleaning shall be monolithic and coved with the floor, tightly sealed to the wall, and constructed without voids.

(F) Wall areas penetrated by pipes, ducts, and conduits shall be tightly sealed to minimize the entry of rodents and insects. Joints of structural elements shall be similarly sealed.

(G) Sharp, protruding corners shall be avoided.

(H) Wall protection devices and corner guards shall be durable and scrubbable.

(21) Elevators. Electric or hydraulic elevators are required if the ASC has patient spaces located on other than the grade-level entrance floor. The elevator shall be sized to accept a gurney or stretcher plus an attendant.

(a) Dimensions. Cars shall have a minimum inside floor dimension of not less than 5 feet.

(b) Leveling device. Elevators shall be equipped with a two-way automatic level-maintaining device with an accuracy of ±one-half inch.

(c) Elevator controls:

(A) Elevator call buttons and controls shall not be activated by heat or smoke. Light beams, if used for operating door reopening devices without touch, shall be used in combination with door-edge safety devices and shall be interconnected with a system of smoke detectors so the light control feature will be overridden or disengaged should it encounter smoke at any landing.

(B) Elevator controls, alarm buttons, and telephones shall be accessible to wheelchair occupants and usable by the blind.

(d) Emergency power must comply with NFPA 99 requirements.

(22) Mechanical system design.

(a) In new construction, the mechanical system shall be designed and constructed for overall efficiency in accord with the Oregon Mechanical Specialty Code and the Oregon Energy Efficiency Specialty Code, as enforced by the Oregon Building Codes Division or local jurisdictions having authority.

(b) Efficiency. The mechanical system shall be designed for overall efficiency and appropriate life-cycle cost.

(c) Use of recognized energy-saving mechanisms such as variable-air-volume (VAV) systems, load shedding, programmed controls for unoccupied periods (nights and weekends, etc.), and use of natural ventilation may be considered.

(d) Air-handling systems shall be designed with an economizer cycle where appropriate to use outside air.

(e) VAV systems. The energy-saving potential of VAV systems is recognized, and the standards herein are intended to maximize appropriate use of such systems. Any system used for occupied areas shall include provisions to avoid air stagnation in interior spaces where thermostat demands are met by temperatures of surrounding areas. Reference Table 1 contains minimum ventilation and airflow requirements.

(f) Recirculating rooms units (such as induction unit and unit ventilators) may be used in individual rooms for heating and cooling purposes except as noted in Table 1. Outdoor air requirements shall be met by separate air handling systems with proper filtration. Reference Table 2 contains the filtration requirements.

(g) Vibration isolators. Mechanical equipment, ductwork, and piping shall be mounted on vibration isolators.

(h) System valves. Supply and return mains and risers for cooling, heating, and steam systems shall be equipped with valves to isolate the various sections of each system. Each piece of equipment shall have valves at the supply and return ends.

(i) Testing and documentation.

(A) Prior to licensure of an ASC, all systems shall be tested and operated to demonstrate to the owner or its designated representative that the installation and performance of these systems conform to design intent. Test results shall be documented for maintenance files.

(B) Upon completion of the installation, the owner of an ASC shall ensure that a complete set of manufacturer’s operating, maintenance, and preventive maintenance instructions; a parts list; and complete procurement information, including equipment numbers and descriptions, has been obtained.

(C) An ASC shall ensure that staff who operate the systems shall be provided with instructions for proper operation of systems and equipment. Required information shall include all safety or code ratings as needed.

(23) Ventilation and space-conditioning requirements. All rooms and areas used for patient care shall have ventilation per Table 1. Although natural ventilation shall be permitted, mechanical ventilation shall be provided in all patient care rooms and areas in an ASC.

(24) HVAC Requirements for Specific Locations.

(a) Airborne infection isolation (AII) rooms. These special ventilation areas have an inward air movement relationship to adjacent areas where a patient with airborne infectious diseases may be a risk to the surrounding area. If AII rooms are required per the functional program, the HVAC design must meet the requirements of OAR 333-535-0300.

(b) Protective environment (PE) rooms. These special ventilation areas have an outward air movement relationship to adjacent areas where the patient may be at risk from the surrounding areas. If PE rooms are provided per the functional program, the PE rooms must meet the requirements of OAR 333-535-0300.

(c) Operating rooms.

(A) Air distribution.

(i) Operating room air supply shall be from ceiling outlets near the center of the work area for effective air movement control. Laminar flow design diffusers shall be used in Class B and C operating rooms as required by the functional program.

(ii) Each operating room shall have a minimum of two air inlets located as remotely from each other as possible. The return air inlets shall be located near the floor level in Class B and C operating rooms.

(B) Ventilation rates.

(i) The ventilation systems for Class B and C operating rooms shall operate at all times, except during maintenance and conditions requiring shutdown by the building’s fire alarm system.

(ii) During unoccupied hours, operating room air change rates may be reduced, provided that the positive room pressure is maintained as required and the required air changes are automatically re-established any time the space is being utilized.

(iii) Ventilation systems serving Class A Operating Rooms and Class B Operating Rooms used for Endoscopy may be shut off during unoccupied periods if these areas will not have an inward air pressure relationship to adjacent areas.

(C) Humidity and smoke venting requirements in anesthetizing locations shall be designed per NFPA 99.

(d) Anesthesia storage rooms. The ventilation systems for inhalation anesthesia storage rooms shall conform to the requirements for medical gas storage as described in NFPA 99.

(e) ETO sterilizer space. The space that houses ethylene oxide (ETO) sterilizers shall be designed per OAR 333-535-0300.

(25) Thermal Insulation and Acoustical Provisions. Insulation shall be provided within the building to conserve energy, protect personnel, prevent vapor condensation, and reduce noise.

(a) Renovation.

(A) Existing accessible insulation within areas of ASCs to be modernized shall be inspected, then repaired, or replaced, as determined by inspection.

(B) If existing lined ductwork is reworked in a renovation project, the liner seams and punctures shall be resealed.

(b) Duct linings exposed to air movement shall not be used in ducts serving operating rooms, recovery rooms, central sterile processing, and protective environment rooms. This requirement shall not apply to terminal units and sound attenuators that have coverings over such lining meeting ASTM C1071.

(26) HVAC Air Distribution.

(a) Return air systems. For all areas in Table 1, return air shall be via ducted systems. The bottoms of ventilation openings shall be at least 6 inches above the floor.

(b) Humidifiers, if provided, shall meet the requirements of OAR 333-535-0300.

(c) Construction requirements. Ducts that penetrate construction intended to protect against X-ray, magnetic, RFI, or other radiation shall not impair the effectiveness of the protection.

(d) Exhaust systems.

(A) To enhance the efficiency of recovery devices required for energy conservation, combined exhaust systems shall be permitted unless otherwise noted.

(B) Local exhaust systems shall be used whenever possible in place of dilution ventilation to reduce exposure to hazardous gases, vapors, fumes, or mists.

(C) Fans serving exhaust systems shall be located at the discharge end and shall be readily serviceable.

(D) Airborne infection isolation rooms and other rooms containing contaminated exhaust such as bronchoscopy, decontamination, and sterilizer equipment rooms shall not be served by exhaust systems incorporating air to air heat recovery such as heat wheels. Heat recovery systems are acceptable if there is complete isolation of air streams, such as run-around loops.

(e) Fresh air intakes shall be located at least 25 feet from exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical vacuum systems, plumbing vents, or areas that may collect vehicular exhaust or other noxious fumes. Plumbing vents that terminate above the level of the top of the air intake may be located as close as 10 feet.

(f) New and remodeled ventilation system installations shall be designed and balanced at project completion to provide directional flow as shown in Table 1. A log shall be prepared showing actual ventilation rates at each supply, return and exhaust grill, and be made available to Division on request.

(g) Ventilation Hoods. If lab exhaust hoods, safety cabinets or fume hoods are required per the functional program, these systems shall meet the requirements of OAR 333-535-0300.

(27) HVAC Filters.

(a) Filter requirements. Air handling system filtration shall meet the requirements of Table 2.

(b) Filter frames. Filter frames shall be durable and proportioned to provide an airtight fit with the enclosing ductwork. All joints between filter segments and enclosing ductwork shall have gaskets or seals to provide a positive seal against air leakage.

(28) Plumbing Systems.

(a) Standards. Unless otherwise specified herein, all plumbing systems shall be designed and installed in accordance with the Oregon Plumbing Specialty Code.

(b) Testing and documentation.

(A) All plumbing systems shall be tested to demonstrate that equipment installation and operation is appropriate and functional. Test results shall be documented for maintenance files.

(B) Upon completion of the installation, the owner shall be furnished with a complete set of manufacturer’s operating, maintenance, and preventative maintenance instructions; a parts list; and complete procurement information, including equipment numbers and descriptions.

(C) Operating staff persons shall be provided with instructions for proper operation of systems and equipment. Required information shall include all safety or code ratings as needed.

(29) Plumbing and Other Piping Systems.

(a) General piping and valves.

(A) All piping, except control-line tubing, fire sprinkler, sanitary waste, vent, and condensate drain shall be identified.

(B) All valves shall be tagged, and a valve schedule shall be developed for permanent record and reference.

(b) Potable water supply systems. The following standards shall apply to potable water supply systems:

(A) Valves. Each water service main, branch main, riser, and branch to a group of fixtures shall have valves.

(i) Stop valves shall be provided for each fixture.

(ii) Appropriate panels for access shall be provided at all valves where required.

(B) Dead-end piping (risers with no flow, branches with no fixture) shall not be installed. In renovation projects, dead-end piping shall be removed. Empty risers, mains, and branches installed for future use shall be permitted and shall be valved at the connection to the main.

(c) Hot water systems. The following standards shall apply to hot water systems. These requirements do not apply to ASCs that do not perform invasive operations or procedures.

(A) Hot water distribution systems serving patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet. Non-recirculated fixture branch piping shall not exceed 25 ft in length.

(B) Provisions shall be included in the domestic hot water system to limit Legionella bacteria and opportunistic waterborne pathogens.

(C) Domestic hot water system in an ASC with Class C operating rooms shall provide backup equipment for hot water and sterilizer needs.

(d) Plumbing Fixtures.

(A) Hand-washing stations used by medical and nursing staff, patients, and food handlers shall be trimmed with valves that can be operated without hands. Single-lever or wrist blade devices shall be permitted. Sensor-regulated water fixtures shall meet user need for temperature and length of time the water flows. Electronic faucets shall be capable of functioning during loss of normal power when the ASC is required to have an emergency generator.

(B) Clinical sinks shall have an integral trap wherein the upper portion of the water trap provides a visible seal. Handles on clinical sink faucets shall be at least 6 inches long.

(30) Hemodialysis piping. Where the functional program includes hemodialysis, the requirements of OAR 333-700-0130 shall be met.

(31) Drainage systems.

(a) Piping.

(A) Drain lines from sinks used for acid waste disposal shall be made of acid-resistant material. Drain lines from automatic blood-cell counters using sodium azide shall be made of copper and lead free materials.

(B) Drainage piping shall not be installed within the ceiling or exposed in Class B and C operating rooms. Where exposed overhead drain piping in these areas is unavoidable, special provisions such as FM 1680 fittings or drain pans shall be made to protect the space below from leakage, condensation, or dust particles.

(b) Floor drains.

(A) Floor drains shall not be installed in operating rooms, except as permitted in dedicated cystoscopy rooms.

(B) If a floor drain is installed in a dedicated cystoscopy room, it shall contain a non-splash, horizontal-flow flushing bowl beneath the drain plate.

(c) Plaster traps. Where plaster traps are used, provisions shall be made for appropriate access and cleaning.

(32) Medical Gas and Vacuum Systems. Station outlets shall be provided per Table 3. The use of portable medical gas systems shall be considered for ASCs with Class A operating rooms per the functional program.

(a) Medical gas and vacuum systems. When provided, piped in medical gas and vacuum systems shall be installed, tested, and verified prior to use in accordance with NFPA 99, Gas and Vacuum System Chapter and Other Health Care Facility Chapter. When additions or modifications are made to a system, the new and existing components in the immediate zone or area located upstream (for vacuum systems) and downstream (for medical gas systems) of the altered section shall be tested and verified.

(b) Anesthesia scavenging system. Each space routinely used for administering inhalation anesthesia shall be served by a scavenging system to vent waste gases. Gases from the scavenging system shall be exhausted directly to the outside. If the medical vacuum system is used, the gas collecting system shall be arranged so that it does not interfere with the patient’s respiratory system. The anesthesia evacuation system may be a dedicated air exhaust system, provided the part used for anesthesia gas scavenging exhausts directly to the outside and is not part of the recirculation system.

(33) Communications Systems.

(a) Locations for terminating telecommunications and information system devices shall be provided.

(b) A space shall be provided for central equipment locations. Special air conditioning and voltage regulation shall be provided when recommended by the manufacturer.

(34) Electronic Safety and Security Systems and Fire Alarm System. Any fire alarm system shall be as required by NFPA 101 and installed per NFPA 72.

(35) Electrical Systems.

(a) Applicable standards.

(A) All electrical material, systems, and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of OESC and NFPA 99. In addition, an ASC must meet the specific ambulatory health care requirements found at NFPA 99 (Other Health Care Facilities Chapter).

(B) All electrical material and equipment shall be listed as complying with available standards of listing agencies or other similar established standards where such standards are required.

(b) Testing and documentation.

(A) Electrical installations, including alarm and communication systems, shall be tested to demonstrate that equipment installation and operation is appropriate and functional. Test results shall be documented for maintenance files.

(B) Upon completion of the installation, a complete set of manufacturer’s operating, maintenance, and preventative maintenance instructions; a parts list; and complete procurement information, including equipment numbers and descriptions shall be available on site.

(C) Operating staff persons shall be provided with instructions for proper operation of systems and equipment. Required information shall include all safety or code ratings as needed.

(D) Essential electrical system, grounding system, and receptacles shall be tested per NFPA 99.

(36) Electrical Distribution and Transmission.

(a) Switchboards.

(A) Main switchboards shall be located in an area separate from plumbing and mechanical equipment and shall be accessible to authorized persons only.

(B) Switchboards shall be convenient for use and readily accessible for maintenance.

(C) Switchboards shall be located in dry, ventilated spaces free from corrosive or explosive fumes or gases or any flammable material.

(b) Panelboards.

(A) Panelboards serving normal lighting and appliance circuits shall be located on the same floor as the circuits they serve.

(B) Panelboards serving critical branch emergency circuits shall be located on each floor.

(C) Panelboards serving life safety emergency circuits may also serve one floor above and/or below.

(c) Ground-fault circuit interrupters.

(A) Ground-fault circuit interrupters (GFCIs) shall comply with OESC.

(B) When GFCIs are used in critical care areas, provisions shall be made to ensure that other essential equipment is not affected by activation of one interrupter.

(37) Power Generating and Storing Equipment.

(a) Emergency electrical service. Emergency lighting and power shall be provided in accordance with NFPA 99, NFPA 101, and NFPA 110.

(b) Emergency generator systems are required in an ASC that administers inhalation anesthetics and where a patient requires electrical life support equipment as part of the surgical protocol. An ASC that is required to have an emergency generator system must also meet the specific ambulatory health care requirements found at NFPA 99 (Other Health Care Facilities Chapter).

(38) Lighting.

(a) Lighting shall conform to the recommended lighting standards for public buildings contained in the OSSC (Means of Egress Illumination), Illuminating Engineering Society (IES) RP-29 Hospitals and Health Care Facilities. Approaches to buildings and parking lots, and all occupiable spaces within the building shall have illuminated fixtures as necessary.

(b) Procedure rooms. A portable or fixed examination light shall be provided for procedure rooms.

(c) Operating rooms. Operating rooms shall have general lighting in addition to special lighting units provided at surgical tables. General lighting and special lighting shall be on separate circuits.

(39) Receptacles (Convenience Outlets).

(a) Duplex grounded-type receptacles (convenience outlets) shall be installed in all areas in sufficient quantities for tasks to be performed as needed. Duplex receptacles shall be provided per Table 4.

(b) Emergency system receptacles. Electrical receptacle cover plates or electrical receptacles supplied from the emergency systems shall be distinctively colored or marked for identification. If color is used for identification purposes, the same color shall be used throughout the ASC.

(40) Call Systems.

(a) General. Signaling and nurse call equipment shall be provided in an ASC with Class B and C operating rooms and shall include the following types of call stations: patient stations, staff assist, bath stations, and code call stations.

(A) Call station locations shall be as required in Table 5.

(B) Call stations shall report to an attended location with electronically supervised visual and audible annunciation.

(C) Call system master stations shall be located at the nurse control station and shall provide audible/visual prompting and display all pending calls.

(D) In addition to these rules, call systems shall meet the requirements of Underwriters Laboratory (UL) 1069: Standards for Hospital Signaling and Nurse Call Equipment and state and local requirements.

(E) Alternate technologies including radio frequency systems, shall be permitted for call systems in an ASC with Class A operating rooms.

(b) Patient stations. Patient stations shall be provided to allow each patient to summon assistance from the nursing staff. Use of a dual call station shall be permitted when beds are located adjacent to each other.

(A) The patient station shall be equipped with the following:

(i) A visible signal once it has been activated. An indicator light or call assurance lamp that remains lighted until a call is cancelled shall be provided. In rooms containing two or more patient stations, call assurance lamps shall be provided at each station; and

(ii) A reset switch for canceling a call.

(B) The patient station shall activate a visible signal in the corridor at the patient’s door or at the nurse station within the room with the patients under constant visual surveillance and at the master station.

(c) Bath stations. Bath stations shall be located to the side of toilets within 12 inches of the front of the toilet bowl and 3 to 4 feet above the floor. A bath station with a pull string that can be activated by a patient lying on the floor shall be provided at each room containing a patient water closet, tub, or shower. An alarm in these areas shall be able to be turned off only at the bath station where it is initiated.

(d)(A) Code call stations. Commonly referred to as a “Code Blue,” code call stations are meant for use during a life-threatening situation to summon assistance from others throughout the unit or department.

(B) The code call station shall be equipped with a continuous audible or visual confirmation to the person who initiated the code call.

(e) Staff assist call stations. Staff assist call stations are meant for use during a non-life threatening situation to summon assistance from others throughout the unit or department.

[ED. NOTE: Tables & publications referenced are available from the agency.]

Stat. Auth.: ORS 441.025 & 441.060
Stats. Implemented: ORS 441.025 & 441.060
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(11)(a)-(k); PH 5-2012, f. 3-30-12, cert. ef. 4-1-12


 

Rule Caption: Registry of emergency health care services volunteers to include previously licensed health professionals.

Adm. Order No.: PH 6-2012

Filed with Sec. of State: 3-30-2012

Certified to be Effective: 4-1-12

Notice Publication Date: 2-1-2012

Rules Adopted: 333-003-0117, 333-003-0119

Rules Amended: 333-003-0105, 333-003-0110, 333-003-0115, 333-003-0118, 333-003-0125, 333-003-0140, 333-003-0210

Subject: The Oregon Health Authority, Public Health Division is permanently adopting and amending Oregon Administrative Rules relating to the registration and activation of emergency health care services volunteers in response to the passage of SB 563 during the 2011 legislative session.

 These rules address the registration, training, background check process, activation and extended liability protection and workers’ compensation protection to qualified emergency service volunteers. The rules also help to build more programmatic structure and streamline processes to strengthen the registration process of emergency health care services volunteers to include previously licensed health professionals.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-003-0105

Definitions

For purposes of OAR 333-003-0100 through 333-003-0140, the following definitions apply:

(1) “Cooperative Agreement” means an agreement between the Division and a local public health authority under ORS 401.657.

(2) “Credentialing” means granting privileges or permission, including any limitations or limits on the privileges or permission, authorizing a health care provider to provide health care services at a health care facility.

(3) “Credentialing plan” means the procedures established by an emergency health care center for credentialing registrants and volunteers, including but not limited to a plan for verifying that a health care provider is in good standing.

(4) “Declaration” or “declared emergency” means the Governor has declared a state of emergency to exist under ORS 401.055 or 433.441

(5) “Division” means the Oregon Health Authority, Public Health Division.

(6) “Emergency health care center” means a health care facility, or any portion thereof designated by the Division or by a local public health authority or any other location designated by the Division or by a local public health authority in accordance with OAR 333-003-0130.

(7) “Emergency health care services” means health care services rendered by a registrant or volunteer during a declared emergency.

(8) “Emergency Support Function 8 (ESF-8)” means the Public Health and Medical Services response for the State of Oregon during a declared emergency.

(9) “Health care facility” means a health care facility as defined in ORS 442.015 that has been licensed under ORS chapter 441.

(10) “Health care provider” means:

(a) An individual licensed, certified or otherwise authorized or permitted by the laws of this state or another state to administer health care services in the ordinary course of business or practice of a profession; and

(b) A person entered in the emergency health care provider registry under Oregon Laws 2011, chapter 89 and OAR 333-003-0117.

(11) “Health professional regulatory board” has the meaning given that term in ORS 676.160.

(12) “Incident Command System (ICS)” means a standardized on-scene emergency management system that enables multiple agencies and jurisdictions to respond to single or multiple incidents using an integrated organizational structure.

(13)(a) “In good standing” means that:

(A) A health care provider is currently certified, registered or licensed, does not have any disciplinary restrictions placed on any certificate, registration or license, and who is not suspended or on probation with any certifying, registering or licensing agency that issued a certificate, registration or license for any reason; or

(B) At the time the health care provider was last certified, registered or licensed the health care provider:

(i) Did not have any disciplinary restrictions placed on a certificate, registration or license; and

(ii) Was not on probation or did not have a certificate, registration or license revoked or suspended by the certifying, registering or licensing agency that issued the certificate, registration or license, for any reason.

(b) An individual is not in good standing if he or she voluntarily surrendered a certificate, registration or license while under investigation by a certifying, registering, or licensing board or surrendered a certificate, registration or license in lieu of discipline.

(14) “Local public health authority” has the meaning provided in ORS 431.260.

(15) “Registrant” means a health care provider listed on the Registry.

(16) “Registry” means the Health Care Provider Registry established by the Division.

(17) “Volunteer” means a health care provider who is not a registrant or is a registrant but is not deployed by the Registry, who provides emergency health care services at an emergency health care center.

Stat. Auth.: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Hist.: PH 26-2004, f. & cert. ef. 7-30-04; PH 8-2008, f. & cert. ef. 5-5-08; PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0110

The Health Care Provider Registry

(1) Under ORS 431.654 the Division is authorized to maintain a registry of health care providers who may, during a declared emergency, be deployed by the Division to provide emergency health care services. The Division shall include the following minimum information in the Registry concerning each registrant:

(a) Name;

(b) Contact information;

(c) Current license, registration or other certification, or previous license, registration or certification; and

(d) Information about the registrant’s usual or former practice or specialty, if that information is available and the Division determines it is necessary to include in the Registry.

(2) Health care providers that may be registered include but are not limited to individuals currently or previously within the last 10 years licensed, registered or certified by the:

(a) State Board of Examiners for Speech-Language Pathology and Audiology;

(b) State Board of Chiropractic Examiners;

(c) State Board of Licensed Social Workers;

(d) Oregon Board of Licensed Professional Counselors and Therapists;

(e) Oregon Board of Dentistry;

(f) Board of Examiners of Licensed Dietitians;

(g) State Board of Massage Therapists;

(h) Oregon Board of Naturopathic Medicine;

(i) Oregon State Board of Nursing;

(j) Oregon Board of Optometry;

(k) State Board of Pharmacy;

(l) Oregon Medical Board;

(m) Occupational Therapy Licensing Board;

(n) Physical Therapist Licensing Board;

(o) State Board of Psychologist Examiners;

(p) Board of Medical Imaging;

(q) State Board of Direct Entry Midwifery;

(r) State Board of Denture Technology;

(s) Respiratory Therapist Licensing Board; or

(t) Oregon Health Authority, to the extent that the Authority certifies emergency medical technicians.

(3) The Division may share information about registrants with state and local emergency management departments, local public health authorities, and other state or federal agencies and health care facilities as necessary, for emergency response purposes. Nothing in this section prohibits the Division from sharing registry information for any lawful purpose.

Stat. Auth.: ORS 401.651 - 401.670
Stats. Implemented: ORS 401.651 - 401.670
Hist.: PH 26-2004, f. & cert. ef. 7-30-04; PH 8-2008, f. & cert. ef. 5-5-08; PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0115

Registration of Currently Licensed Health Care Providers; Renewal

(1) A health care provider who is currently licensed, registered or certified may apply to the Division to be registered as a health care provider to provide emergency health care services during an emergency.

(2) A health care provider shall apply by completing a form prescribed by the Division and submitting the form in the manner prescribed by the Division.

(3) The Division shall verify that an applicant is in good standing.

(4) The Division may request additional information from an applicant if the application is incomplete or questions arise about the applicant during the Division’s verification process.

(5) The Division may require that an applicant undergo a criminal background check if during the application process the Division learns of issues related to the applicant’s history that reasonably raises questions about the ability of the applicant to safely provide emergency health care services. If the Division does require a criminal background check an applicant must sign any necessary authorizations for the criminal background check, provide fingerprints if requested and pay any necessary fees to cover the costs for the background check.

(6) The Division shall notify an applicant, in writing, if he or she has been accepted as a registrant and if not, why not.

(7) If an applicant has been accepted, the Division shall also provide the registrant information described in OAR 333-003-0118.

(8) The Division shall issue a registrant a registry identification card once the registrant has completed the orientation and training required in OAR 333-018-0118. The identification card shall:

(a) Identify the registrant;

(b) Indicate that the registrant is registered as an emergency health care provider;

(c) Identify the license or certification held by the registrant; and

(d) Identify the registrant’s usual area of practice if that information is available and the authority determines that it is appropriate to provide that information.

(9) The Division shall require each registrant to update his or her registration information every two years, or when changes occur, and a registrant shall be required to sign a form, prescribed by the Division, that indicates the registrant is willing and able to remain on the Registry.

(10) A registrant identification card shall be renewed and provided to a registrant who fulfills the requirements in section (9) of this rule.

(11) The Division may remove a registrant from the Registry if the Division:

(a) Is notified or learns that a registrant is not in good standing with his or her licensing board or certifying agency;

(b) Determines that a registrant is not capable of providing emergency health care services;

(c) Determines that a registrant has a personal or criminal history that calls into question the ability of the registrant to safely provide emergency health care services; or

(d) Determines that a registrant is not complying with these rules.

(12) A registrant removed from the Registry may reapply at any time but must include with his or her application an explanation that describes how the issue that led to removal has been addressed.

(13) The Division may require a registrant to undergo a criminal background check if at any time the Division learns of issues related to the registrant’s history that reasonably raises questions about the ability of the applicant to safely provide emergency health care services. If the Division does require a criminal background check a registrant must sign any necessary authorizations for the criminal background check, provide fingerprints if requested and pay any necessary fees to cover the costs for the background check.

Stat. Auth.: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Hist.: PH 26-2004, f. & cert. ef. 7-30-04; PH 8-2008, f. & cert. ef. 5-5-08; PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0117

Registration of Formerly Licensed Health Care Providers; Renewal

(1) A person who was licensed, certified or otherwise authorized to provide health care services not more than 10 years prior to the date of application, may apply to the Division to be registered as a health care provider to provide emergency health care services during an emergency.

(2) A person described in section (1) of this rule shall apply by completing a form prescribed by the Division and submitting the form in the manner prescribed by the Division.

(3) An applicant shall provide evidence from the entity that licensed, certified, or otherwise authorized the applicant to previously provide health care services that verifies that the applicant was in good standing at the time the applicant surrendered his or her license, certification or authorization to provide health care services.

(4) The Division may request additional information from an applicant if the application is incomplete or questions arise about the applicant during the Division’s verification process.

(5) An applicant shall undergo a criminal background check and shall sign any necessary authorizations and pay any necessary fees for the criminal background check.

(6) The Division shall notify an applicant, in writing, if he or she has been accepted as a registrant and if not, why not.

(7) If an applicant has been accepted, the Division shall also provide the registrant information described in OAR 333-003-0118.

(8) The Division shall issue a registrant a registry identification card once the registrant has completed the orientation and training required in OAR 333-018-0118. The identification card shall:

(a) Identify the registrant;

(b) Indicate that the registrant is registered as an emergency health care provider;

(c) Identify the license or certification previously held by the registrant; and

(d) Identify the registrant’s former area of practice if that information is available and the Division determines that it is appropriate to provide that information.

(9) The Division shall require each registrant to update his or her registration information every two years, or when changes occur, and a registrant shall be required to sign a form, prescribed by the Division, that indicates the registrant is willing and able to remain on the Registry. A registrant shall provide documentation of completed continuing education credits with the renewal form.

(10) The Division shall conduct a criminal background check on registrants registered under this rule every five years. A registrant is responsible for signing any necessary authorizations and paying any necessary fees.

(11) A registrant identification card shall be renewed and provided to a registrant who fulfills the requirements in section (9) and (10) of this rule.

(12) The Division may remove a registrant from the Registry if the Division:

(a) Is notified or learns that a registrant is not in good standing with his or her licensing board or certifying agency;

(b) Determines that a registrant is not capable of providing emergency health care services;

(c) Determines that a registrant has a personal or criminal history that calls into question the ability of the registrant to safely provide emergency health care services; or

(d) Determines that a registrant is not complying with these rules.

(13) A registrant removed from the Registry may reapply at any time if the registrant meets the criteria in section (1) of this rule but must include with his or her application an explanation that describes how the issue that led to removal has been addressed.

Stat. Auth.: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Hist.: PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0118

Duties of Registrants

(1) A registrant is required to complete an orientation session offered or approved by the Division and complete mandatory training offered or approved by the Division including but not limited to ICS training, prior to receiving an identification card.

(2) A registrant has one year from the date the registrant is notified of acceptance into the Registry to complete the orientation and required training or the Division shall remove the registrant’s name from the Registry.

(3) If the Division notifies a registrant of an activation, the registrant shall respond to the Division within 24 hours whether or not the registrant is willing to be activated and deployed in accordance with OAR 333-003-0125.

(4) A registrant is required to notify the Division, as soon as practicable, but within 30 days, of the following:

(a) A change in mailing address, phone number, or electronic mail address;

(b) A change in licensure status, certification or registration status; and

(c) A change in mental or physical health that renders a registrant unable to perform emergency health care services.

(5) A registrant shall immediately notify the Division if a registrant’s identification card is lost or stolen. The Division shall replace a lost or stolen identification card and may charge a fee for the replacement card.

(6) A registrant may request removal from the Registry at any time by notifying the Division, in writing, of the request, and by returning the identification card described in OAR 333-003-0115. Upon receipt of such request and verification that it came from the registrant, the Division shall remove the registrant from the Registry.

(7) If at any time a registrant is notified by the Division that the registrant has been removed from the Registry, the registrant shall return the identification card described in OAR 333-003-0115 to the Division within 10 days of the date the notification was mailed or electronically mailed. Removed registrants may re-apply at a later date subject to Division approval.

(8) A registrant may only provide health care services during an emergency that the registrant is competent to perform.

Stat. Auth.: ORS 401.670
Stats. Implemented: ORS 401.654
Hist.: PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0119

Criminal Background Checks

The Division shall perform criminal background checks in accordance with OAR chapter 943, division 7, or through the Oregon State Police.

Stat. Auth.: ORS 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.654 & 2011 OL Ch. 89
Hist.: PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0125

Activation of Registrants

(1) The Division may activate the Registry in the event of a declaration and direct registrants willing to provide emergency health care services to proceed to any place in Oregon where emergency health care services are required by reason of the emergency or crisis.

(2) The Division may also activate the Registry pursuant to the Emergency Management Assistance Compact and the Pacific Northwest Emergency Management Arrangement and direct registrants willing to provide emergency health care services to proceed to another state where emergency health care services are required by reason of the emergency or crisis in that state.

(3) The activation of the Registry may be used to support the state Emergency Coordination Center, the State Emergency Management Plan and to implement ESF 8 plans, protocols, and procedures to integrate registrants into the state and local emergency response.

(4) The Division shall notify registrants of activation by phone, electronic mail, or any other means of communications.

(5) The Division shall provide, at a minimum, the following to a registrant willing to be deployed:

(a) A mission order;

(b) A description of items needed during the deployment; and

(c) If applicable, items that will be provided to a registrant.

(6) A registrant willing to be deployed shall bring his or her registry identification card and driver’s license to the deployment site.

(7) A registrant may decline to be deployed at the time the registrant is notified of the activation. A registrant shall remain on the Registry whether or not the registrant agrees to be deployed unless the registrant notifies the Division in accordance with OAR 333-003-0118 that he or she wants to be removed from the Registry.

(8) If a registrant deployed under these rules provides emergency health care services at a designated emergency health care center the registrant must provide those services in accordance with the emergency operations plan and credentialing plan adopted by the designated emergency health care center.

(9) In anticipation of a declaration of emergency or during a declared emergency the Division may register health care providers without complying with OAR 333-003-0115 and provide just-in-time orientation and training. Under this section the Division shall verify licensure status as quickly as possible and shall issue the health care provider a temporary identification card.

Stat. Auth.: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Hist.: PH 26-2004, f. & cert. ef. 7-30-04; PH 8-2008, f. & cert. ef. 5-5-08; PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0140

Training

(1) The Division may require or otherwise make available to registrants training that the Division determines necessary or beneficial to the provision of emergency health care services that may be rendered by registrants pursuant to ORS 401.651 through 401.670 and these rules, including but not limited to training in the emergency response system structure, operations, emergency preparedness and table top or other emergency response exercises. The Division shall not require training that is related to a registrant’s professional license.

(2) A person who is registered in accordance with OAR 333-003-0117 shall:

(a) Prior to being eligible for activation, and thereafter every three years, complete the following training and provide documentation of completion to the Division.

(A) First Aid that includes CPR and AED use;

(B) Basic Disaster Life Support;

(C) Triage; and

(D) Psychological First Aid.

(b) Complete at least a total of six hours of continuing education credits every two years on the following subjects or substantially similar subjects:

(A) Disaster medicine;

(B) Psychological first aid;

(C) Disaster life support; and

(D) Wilderness first aid or medicine.

Stat. Auth.: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Stats. Implemented: ORS 401.651 - 401.670 & 2011 OL Ch. 89
Hist.: PH 26-2004, f. & cert. ef. 7-30-04; PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12

333-003-0210

Liability Protection; Workers’ Compensation

(1) Registrants and volunteers who perform emergency health care services in accordance with ORS 401.651 through 401.670 and these rules are agents of the state under 30.260 through 30.300 for the purposes of any claims arising out of services that are provided under 401.651 through 401.670 and these rules pursuant to directions from a public body and that are within the course and scope of the registrant’s or volunteer’s duties, without regard to whether the registrant or volunteer is compensated for the services.

(2) If the Governor declares an emergency a designated emergency health care center and persons operating a designated emergency health care center are agents of the state under ORS 30.260 through 30.300 for the purposes of any claims arising out of services that are provided through the designated emergency health care center pursuant to directions from a public body and that are within the course and scope of the duties of the health care facility or other person, without regard to whether the health care facility or other person is compensated for the services.

(3) A registrant participating in training authorized by the Oregon Health Authority under ORS 401.651 through 401.670 and OAR 333-003-0140 is an agent of the state under ORS 30.260 through 30.300 for the purposes of any claims arising out of that training.

(4) The provisions of section (2) of this rule apply only to a designated emergency health care center that has adopted an emergency operations plan and credentialing plan that governs the use of registrants and volunteers. An emergency operations plan and a credentialing plan must comply with these rules.

(5) A registrant shall also be considered a qualified emergency services volunteer under ORS 401.358 through 401.368 for the purpose of receiving workers’ compensation coverage if injured in the course and scope of providing emergency health care services.

(6) A volunteer must meet the definition of a qualified emergency services volunteer under ORS 401.358 in order to receive workers’ compensation coverage under 401.358 through 401.368.

Stat. Auth.: ORS 401.670
Stats. Implemented: ORS 401.667
Hist.: PH 17-2010, f. & cert. ef. 8-12-10; PH 6-2012, f. 3-30-12, cert. ef. 4-1-12


 

Rule Caption: Changes to Home Health Agency licensing rules in response to 2009 and 2011 legislation.

Adm. Order No.: PH 7-2012

Filed with Sec. of State: 3-30-2012

Certified to be Effective: 4-1-12

Notice Publication Date: 1-1-2012

Rules Adopted: 333-027-0017, 333-027-0018, 333-027-0029, 333-027-0033, 333-027-0036, 333-027-0037, 333-027-0038, 333-027-0064, 333-027-0175, 333-027-0180, 333-027-0185, 333-027-0190

Rules Amended: 333-027-0000, 333-027-0005, 333-027-0010, 333-027-0015, 333-027-0020, 333-027-0025, 333-027-0040, 333-027-0050, 333-027-0060, 333-027-0080, 333-027-0090, 333-027-0100, 333-027-0110, 333-027-0120, 333-027-0130, 333-027-0140, 333-027-0150, 333-027-0170

Rules Repealed: 333-027-0030, 333-027-0035

Subject: The Oregon Health Authority, Public Health Division is permanently adopting, amending and repealing Oregon Administrative Rules relating to home health agencies in response to legislation passed in 2009 (SB 158) and 2011 (HB 2650). These rules update and clarify the process for licensure, OHA oversight and enforcement, establish requirements for criminal background checks, and make the rules consistent with certain federal requirements. SB 158 attempts to correct inadequate oversight due to gaps in law, inadequate resources, and clarifies statutes governing the roles and responsibilities of many facilities and agencies providing care to patients or clients. SB 158 also requires on-site surveys of all licensed health care facilities and agencies at a minimum of every three years. HB 2650 repeals provisions passed in 2009 requiring the Department of Human Services to conduct criminal background checks for home health and in-home care agencies. Home health and in-home care agencies may use private vendors to conduct criminal background checks but must comply with the provisions of ORS 443.004(3). The Public Health Division is required to prescribe the process for home health and in-home care agencies conducting background checks.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-027-0000

Purpose

The purpose of these rules is to establish the standards for licensure of home health agencies.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.005 - 443.090
Hist.: HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 22-1988, f. & cert. ef. 9-16-88; OHD 13-1998, f. & cert. ef. 11-6-98; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0005

Definitions

The following definitions shall apply in OAR 333-027-0000 through 333-027-0190:

(1) “Admission” means acceptance of a patient for the provision of services by an agency.

(2) “Authority” means the Oregon Health Authority.

(3) “Agency” means Home Health Agency.

(4) “Branch Office” means a location or site from which a home health agency provides services to patients within a portion of the total geographic area served by the parent agency and does not exceed 60 miles from the parent agency.

(5) “Clinical Note” means a dated, written, and signed notation by a member of the home health agency team of a contact with the patient that describes care rendered, signs and symptoms, treatment and/or drugs given, patient’s reaction, and any changes in patient’s physical or mental condition.

(6) “Clinical Record” means all information and documentation pertaining to the care of a patient.

(7) “Division” means the Public Health Division of the Oregon Health Authority.

(8) “Governing Body” means the designated person(s) having ultimate responsibility for the home health agency.

(9) “Home Health Agency” means a public or private entity providing coordinated home health services on a home visiting basis.

(10) “Home Health Aide” means a person who is certified as a nursing assistant by the Oregon State Board of Nursing in accordance with OAR chapter 851, division 062 and who assists licensed nursing personnel in providing home health services.

(11) “Home Health Service” means items and services furnished to an individual by a home health agency, or by others under arrangement with such agency, on a visiting basis in a place of temporary or permanent residence used as the individual’s home for the purpose of maintaining that individual at home.

(12) “Licensed Practical Nurse” means a person licensed as such by the Oregon State Board of Nursing in accordance with ORS chapter 678.

(13) “Nurse Practitioner” has the meaning given that term in ORS 678.010.

(14) “Occupational Therapist” has the meaning given that term in ORS 675.210.

(15) “Occupational Therapy Assistant” has the meaning given that term in ORS 675.210.

(16) “Parent Home Health Agency” (“Parent Agency”) means an agency that has branches or subunits.

(17) “Physical Therapist Assistant” has the meaning given that term in ORS 688.010 and is licensed in accordance with 688.020

(18) “Physical Therapist” has the meaning given that term in ORS 688.010.

(19) “Physician” means a person who is licensed by the Oregon Medical Board and that meets the definition in ORS 677.010(13) and (14).

(20) “Plan of treatment” means a document developed by the treating physician or nurse practitioner in consultation with agency staff after a patient assessment that identifies the patient’s medical status and needs, and outlines the services that will be provided to the patient to meet identified needs. The plan of treatment may also be referred to as the plan of care.

(21) “Primary Agency” means the agency that admits the patient for the provision of curative, rehabilitative, and/or preventive services in the patient’s home by home health professionals.

(22) “Professional Policy-Making Committee” (Committee) means a group of individuals who are appointed by the governing body of an agency, and who has authority and responsibility for the development and monitoring of all professional policies pertaining to the home health agency.

(23) “Progress Note” means a documented summary of a patient’s response to care provided during a specific period of time.

(24) “Registered Nurse” means a person licensed as such by the Oregon State Board of Nursing in accordance with ORS chapter 678.

(25) “Skilled Nursing” means the patient care services pertaining to the curative, rehabilitative, or preventive aspects of nursing performed by, or under the supervision of, a registered nurse pursuant to the plan of treatment.

(26) “Social Worker” means a person who has a master’s degree from a school of social work accredited by the Council on Social Work Education and has one year of social work experience in a health care setting.

(27) “Social Work Assistant” means a person who has a baccalaureate degree in social work, psychology, or another field related to social work and has at least one year of social work experience in a health care setting.

(28) “Speech Pathologist” means a person who is licensed in accordance with ORS 681.250 and has a Certificate of Clinical Competence in speech pathology or audiology from the American-Speech-Language-Hearing Association.

(29) “Stable and predictable condition” means a situation where the patient’s clinical or behavioral state is known, not characterized by rapid changes, and does not require continuous reassessment and evaluation.

(30) “Subunit” means an agency that provides services for a parent agency in a geographic area different from that of the parent agency and at a distance that exceeds 60 miles from the parent agency.

(31) “Survey” means an inspection of an applicant for a home health agency license or licensed home health agency to determine the extent to which the applicant or agency is in compliance with ORS chapter 443 and these rules.

(32) “Therapeutic services” means services provided for curative, rehabilitative, or preventive purposes.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.005 & 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 1-1982, f. & ef. 2-4-82; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 22-1988, f. & cert. ef. 9-16-88; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 11-2011, f. & cert. ef. 10-27-11; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0010

Application for Licensure

(1) An agency that establishes, purports to manage or operate as a home health agency must be licensed by the Division and comply with ORS 443.005–443.095 and OAR chapter 333, division 027.

(2) An applicant wishing to apply for a license to operate a home health agency shall submit an application on a form prescribed by the Division and pay the applicable fee as specified in OAR 333-027-0025.

(3) If an owner or administrator will have direct contact with a patient, the owner or administrator must submit background information to the Division, in accordance with OAR 333-027-0064 for the purposes of conducting a criminal records check.

(4) If any of the information delineated in the agency’s most recent application changes at a time other than the annual renewal date, the agency shall notify the Division in writing within 30 days.

(5) A subunit must independently comply with all licensure requirements.

(6) A branch office is part of the parent agency and therefore need not independently comply with these licensure requirements. The Division shall determine on a case-by-case basis exceptions to the 60 mile travel distance from the parent agency requirement for a branch office and subunits as defined in OAR 333-027-0005.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.015 & 443.065
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1987, f. 11-10-87, ef. 12-1-87; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0015

Review of License Application

(1) In reviewing an application for a home health agency license, the Division shall verify that the agency:

(a) Is primarily engaged in providing skilled nursing and at least one of the following other services: physical therapy, occupational therapy, speech therapy, medical social services, home health aide, or other therapeutic services;

(b) Has a governing body established pursuant to ORS 443.055 and OAR 333-027-0060;

(c) Has policies established by professional personnel associated with the entity, including one or more physicians and one or more registered nurses, at least two of whom are neither owners or employees of the agency, and two consumers, to govern the services that it provides;

(d) Has a physician, a nurse practitioner or registered nurse supervise all services provided by the agency as described under subsection (1)(a) of this rule;

(e) Maintains clinical and financial records on all patients; and

(f) Has an overall plan and budget in effect.

(2) The Division shall conduct a survey in accordance with OAR 333-027-0035 of the agency, and may include subunits or branch locations, to determine if the agency is in compliance with ORS chapter 443 and OAR chapter 333, division 027 and has the intent to provide home health services. If an agency is in compliance and has the intent to provide home health services to patients, a license may be issued for the operation of the agency.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.015
Hist.: HD 151, f. & ef. 12-30-77; HD 1-1982, f. & ef. 2-4-82; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 3-1989, f. & cert. ef. 5-24-89; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0017

Approval of License Application

(1) The Division 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 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.

Stat. Auth.: ORS 443.085

Stat. Implemented: ORS 443.015, 443.085 & 443.090
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0018

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.

Stat. Auth: ORS 443.085

Stat. Implemented: ORS 443.045
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0020

Expiration and Renewal of License

(1) Each license shall expire on the 31st day of December of each calendar year.

(2) An agency shall submit a completed application for renewal on a form prescribed by the Division, accompanied by the required fee, to the Division not less than 30 days prior to the license expiration date.

(3) The Division may issue a renewal license contingent upon evidence of the agency’s compliance with ORS chapter 443 and OAR chapter 333, division 027; 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 Division.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.015
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98, Renumbered from 333-027-0095; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0025

Fees

(1) The fee for an initial agency license shall be $1,600 plus an additional $1,600 for each subunit of a parent agency.

(2) If the ownership of an agency changes, other than at the time of the annual renewal, the agency’s licensure fee shall be $500, plus an additional $500 for each subunit. If the change of ownership of the agency does not involve the majority owner or partner, or the administrator operating the agency, the license fee shall be $100.

(3) The annual license renewal fee for an agency shall be $850 plus an additional $850 for each subunit.

(4) A hospital exempted under ORS 443.025 may provide home health services without maintaining a separate governing body and administrative services so long as the services provided meet the requirements of 443.005 through 443.095 and the hospital pays the home health licensing fee under 443.035.

(5) License fees will not be prorated and are non-refundable.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.015 & 443.035
Hist.: HD 151, f. & ef. 12-30-77; HD 20-1981, f. & ef. 10-9-81; HD 21-1986(Temp), f. & ef. 12-24-86; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98, Renumbered from 333-027-0075; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0029

Denial, Suspension, or Revocation of License

(1) The Division may deny an agency’s initial or renewal application, and may suspend or revoke an agency’s license for failure to comply with ORS 443.004, 443.005 through 443.105 or OAR chapter 333, division 027.

(2) If the Division intends to suspend or revoke an agency license, it shall do so in accordance with ORS Chapter 183.411 through 183.470.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.045
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0033

Return of Agency 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, or if operation is discontinued by the voluntary action of the licensee.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0036

Surveys

(1) The Division shall, in addition to any investigations conducted pursuant to OAR 333-027-0038, conduct at least one on-site inspection of each agency prior to licensure and once every three years thereafter as requirement of licensing and at such other times as the Division deems necessary.

(2) In lieu of the on-site inspection required by section (1) of this rule, the Division may accept a certification or accreditation from a federal agency or an accrediting body approved by the Division that the state licensing standards have been met if the agency:

(a) Notifies the Division to participate in any exit interview conducted by the federal agency or accrediting body; and

(b) Provides copies of all documentation concerning the certification or accreditation requested by the Division.

(3) An agency shall permit Division staff access to any location from which it is operating its agency or providing services during a survey.

(4) A survey may include but is not limited to:

(a) Interviews of patients, patient family members, agency management and staff;

(b) On-site observations of patients and staff performance;

(c) Review of documents and records;

(d) Patient audits.

(5) An agency 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 the agency owner or his or her designee. During the exit conference, Division staff shall:

(a) Inform the agency representative of the preliminary findings of the inspection; and

(b) Give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings.

(7) Following the survey, Division staff shall prepare and provide the agency owner or his or her designee specific and timely written notice of the findings.

(8) If the findings result in a referral to another regulator agency, Division staff shall submit the applicable information to that referral agency for its review and determination of appropriate action.

(9) If no deficiencies are found during a survey, the Division shall issue written findings to the agency owner indicating that fact.

(10) If deficiencies are found, the Division shall take informal or formal enforcement action in compliance with OAR 333-027-0180 or 333-027-0185.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.019 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0037

Complaints

(1) Any person may make a complaint verbally or in writing to the Division 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 will be kept confidential.

(3) Information obtained by the Division during an investigation of a complaint or reported violation under this section is confidential and not subject to public disclosure under ORS 192.410 through 192.505.

(4) Upon the conclusion of the investigation, the Division may publicly release a report of its findings but may not include information in the report that could be used to identify the complainant or any patient of a home health agency. The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of a home health agency.

(5) An employee or contract provider with knowledge of a violation of ORS Chapter 443 or OAR chapter 333, division 027, shall use the reporting procedures established by the home health agency before notifying the Division 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.

(6) 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 Division will refer the matter to that agency.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.355
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0038

Investigations

(1) An unannounced complaint investigation will be carried out within 45 calendar days 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.

(2) Should the complaint allegation represent an immediate threat to the health or safety of a patient, the Division will notify appropriate authorities to ensure a patient’s safety, and an investigation will be commenced within two working days.

(3) An agency shall permit Division staff access to the agency during an investigation.

(4) The agency shall cooperate with investigations of allegations of client abuse and neglect conducted by the Department of Human Services, Oregon Health Authority, Adult Protective Services, and other agencies such as law enforcement.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.355
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0040

Services and Supplies

If services or supplies are required by law to be prescribed by a physician or a nurse practitioner, the agency shall offer or provide such services and supplies only under an order for treatment and plan of treatment. Services and supplies offered or provided by an agency shall include only the following:

(1) Nursing care provided by or under the supervision of a registered nurse;

(2) Physical, occupational, or speech therapy, or medical social services;

(3) Other therapeutic services conforming to generally accepted and established standards;

(4) Home health aide services; and

(5) Medical supplies, other than drugs and biologicals, and medical appliances. When patient care supplies are stored in the agency, the agency shall store such supplies in a manner that prevents their contamination and ensures that the supplies do not exceed the manufacturer’s expiration date.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.075
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1986, f. & ef. 12-9-86; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 20-1993, f. & cert. ef. 10-23-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0050

Changes in Services Provided

(1) An agency must obtain written approval from the Division 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) The agency’s professional policy-making committee development and approval of all policies and procedures pertaining to the new services; and

(c) Adherence to agency personnel policies and ORS Chapter 443 and OAR chapter 333, division 027 by all individuals providing services through the agency. If a new service is provided under the designation of “other therapeutic services” and is not in a category of licensure/certification covered by Oregon law, the governing body must designate and approve standards of educational or technical qualifications of personnel providing the services.

(2) An agency must notify the Division if it no longer provides a service listed on its current license.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 1-1982, f. & ef. 2-4-82; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0060

Administration of Home Health Agency

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.

(1) The primary agency shall monitor and control all services provided through contractual agreements between the primary agency and any patient service provider.

(2) An agency shall maintain appropriate administrative records for each of its offices. If an agency has any branch offices, it shall ensure that each branch office is part of the agency and shares administration, supervision, and services on a daily basis.

(3) If an agency chooses to provide professional students with a practicum in home health, the governing body must ensure that:

(a) A contract between the agency and the accredited educational institution is in effect and it includes at a minimum, a description of:

(A) Program objectives;

(B) Program coordination;

(C) Student supervision;

(D) Adherence to agency policy; and

(E) Conformance with applicable professional practice laws, rules, and regulations.

(b) The agency maintains documentation of each practicum and the student’s activities, supervision and the evaluation of these activities.

(c) The agency maintains documentation of patient care services provided by the student.

(4) An agency’s governing body, or its designee, shall assume full legal and fiscal responsibility for the agency’s operation. The agency’s governing body shall provide for effective communication with administration of the agency and the owner of the agency.

(5) An agency’s governing body shall:

(a) Employ a qualified administrator, unless exempted under ORS 443.025, who may also serve as Director of Professional Services;

(b) Regularly monitor the performance of the administrator;

(c) Appoint a professional policy-making committee;

(d) Adopt and annually review its written by-laws or acceptable equivalent; and

(e) Document all decisions affecting home health services.

(6) The Administrator shall have the following qualifications:

(a) A physician or registered nurse, currently licensed in Oregon, who has education, experience, and knowledge in community health service systems appropriate to the fulfillment of his/her responsibilities; or

(b) An individual who has education, experience, and knowledge in a related community health service systems and at least one year overall administrative experience in home health care or related community health program appropriate to the fulfillment of his/her responsibilities.

(7) The Administrator shall:

(a) Have authority and responsibility for the agency’s overall management and operation;

(b) Organize and direct the agency’s ongoing functions;

(c) Maintain ongoing communication between agency’s governing body, professional policy-making committee, and staff;

(d) Employ qualified personnel and ensure the provision of adequate staff education and the completion of performance evaluations;

(e) Involve the Director of Professional Services in health care decisions;

(f) Ensure the accuracy of information provided to the public regarding the agency and its services;

(g) Implement an effective budgeting and accounting system;

(h) Designate, in writing, an individual qualified to serve as acting administrator in the administrator’s absence; and

(i) Ensure that adequate and appropriate staff resources are available and used to meet the care needs of the agency’s patients as identified in the plans of treatment.

(8) The agency shall employ a Director of Professional Services who must be a physician or registered nurse. The agency shall ensure that the Director of Professional Services or a similarly qualified alternate, designated in writing, is available for consultation at all times during operating hours of the agency. The Director of Professional Services or designee shall have written authority, responsibility, and accountability for:

(a) Functions, activities, and evaluations of all health care personnel;

(b) The quality of home health services;

(c) Orientation and in-service education for all agency health care personnel;

(d) Coordination of home health services;

(e) Development and documentation of all written material related to agency services, including policies, procedures, and standards;

(f) Participation and involvement in employment decisions affecting home health care personnel;

(g) Assignment of adequate and appropriate staff resources to meet the home health care needs of the agency’s patients; and

(h) Designating, in writing, a person qualified to serve as acting Director of Professional Services in the Director’s absence.

(9)(a) The agency shall develop personnel policies which must be appropriate to the agency, be documented, and include:

(A) Hours of work;

(B) Orientation that is appropriate to the classification of the employee. The following portions of the orientation shall be completed within two weeks of employment; and shall include at a minimum: policies and procedures of the agency; job description and responsibility; role as team member providing services in the home setting; and information regarding other community agencies, infection control, ethics and confidentiality.

(C) An inservice program that provides ongoing education to ensure that staff skills are maintained for the responsibilities assigned and ensures that staff are educated in their responsibility in infection control;

(D) Work performance evaluations;

(E) Employee health program;

(F) Provisions for tuberculosis screening in accordance with OAR 333-019-0041; and

(G) Provisions for the completion of criminal records checks in accordance with ORS 443.004 and OAR 333-027-0064.

(b) Personnel records shall include job descriptions, personnel qualifications, evidence of any required licensure or certification, evidence of orientation and performance evaluations, evidence of a completed criminal records check and fitness determination.

(c) An agency may provide services by agency personnel working out of their individual homes within a portion of the geographic area served by an agency. The individual homes are not construed to be a branch. These services must be controlled, supervised, and evaluated by the agency, in accordance with all written agency policies. Such policies shall, at a minimum require documentation of:

(A) A meeting at least every two weeks of the supervisor and the individual to review the plan(s) of treatment;

(B) A telephone conference on at least a weekly basis between meetings;

(C) Supervisor participation in the development of each plan of treatment; and

(D) Procedures for submitting clinical and progress notes, summary reports, schedule of visits and periodic evaluations.

(10) An agency contracting with individual personnel or public or private entities for home health care services shall maintain written contracts and shall clearly designate:

(a) That patients are accepted for care only by the primary agency;

(b) The services to be provided;

(c) The rights and responsibilities of the contracting individual or entity in the coordination, supervision, and evaluation of the care or service provided;

(d) The obligation to comply with all applicable agency policies;

(e) The party with responsibility for development and revisions of the plan of treatment, patient assessment, progress reports, and patient care conferences, scheduling of visits or hours, and discharge planning;

(f) Appropriate documentation of services provided on record forms provided by the agency; and

(g) The terms of the agreement and basis for renewal or termination.

(11) An agency, under the direction of the governing body, shall prepare and document an overall program plan and annual operating budget. The agency’s operating budget shall include all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. The agency’s overall program plan and budget shall be reviewed and updated at least annually by a committee consisting of representatives of the governing body, the administrative staff, and the professional staff of the agency.

(12) An agency’s governing body shall appoint a professional policy-making committee composed of professional personnel associated with the agency.

(a) The committee shall include one or more physicians and one or more registered nurses, at least two of whom are neither owners nor employees of the agency, and two consumers.

(b) The committee shall establish in writing and review annually, the agency’s policies governing scope of services, admission and discharge policies, medical supervision, plans of treatment, emergency care, clinical records, personnel qualifications, and program evaluation.

(c) The committee shall meet as needed to advise the agency on other professional issues.

(d) The committee members shall participate with the agency staff in the annual evaluation of the agency’s program.

(e) The agency shall document the committee’s systematic involvement and effective communication with the governing body and the management of the agency.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.004, 443.055, 443.065 & 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 22-1988, f. & cert. ef. 9-16-88; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0064

Criminal Records Check

(1) For the purposes of this rule, the following definitions apply:

(a) “Direct contact with” means to provide home health services and includes meeting in person with a potential or current patient to discuss services offered by an agency or other matters relating to the business relationship between an agency and client;

(b) “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;

(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 has direct contact with an agency client or potential client; and

(C) A prospective contractor, temporary worker, or volunteer or owner who may have direct contact with an agency client.

(d) “Vendor” means a researcher or company hired to provide a criminal records check on a subject individual.

(2) An agency shall conduct a criminal records check before hiring or contracting with an SI and before allowing an SI to volunteer to provide services on behalf of the agency, if the SI will have direct contact with a patient of the agency.

(3) An SI who has or will have direct contact with a recipient of home health services may not be employed, contract with, or volunteer with an agency in any capacity if the criminal records check conducted reveals the SI has been convicted of a crime as described in ORS 443.004(3).

(4) An agency shall have a policy on criminal records check requirements which shall include weighing test actions should the background check screening indicate that an SI has been convicted for crimes against an individual or property other than those identified in ORS 443.004(3). The policy must include the following provisions for performing a weighing test:

(a) The agency shall consider circumstances regarding the nature of potentially disqualifying convictions and conditions including but not limited to:

(A) The details of incidents leading to the charges of potentially disqualifying convictions or resulting in potentially disqualifying conditions;

(B) Age of the SI at time of the potentially disqualifying convictions or conditions;

(C) Facts that support the convictions or potentially disqualifying conditions; and

(D) Passage of time since commission of the potentially disqualifying convictions or conditions.

(b) Other factors which should be considered when available include but are not limited to:

(A) Other information related to criminal activity including charges, arrests, pending indictments and convictions. Other behavior involving contact with law enforcement may also be reviewed if information is relevant to other criminal records or shows a pattern relevant to criminal history;

(B) Periods of incarceration;

(C) Status of and compliance with parole, post-prison supervision or probation;

(D) Evidence of alcohol or drug issues directly related to criminal activity or potentially disqualifying conditions;

(E) Evidence of other treatment or rehabilitation related to criminal activity or potentially disqualifying conditions;

(F) Likelihood of repetition of criminal behavior or behaviors leading to potentially disqualifying conditions, including but not limited to patterns of criminal activity or behavior;

(G) Changes in circumstances subsequent to the criminal activity or disqualifying conditions including but not limited to:

(i) History of high school, college or other education related accomplishments;

(ii) Work history (employee or volunteer);

(iii) History regarding licensure, certification or training for licensure or certification; or

(iv) Written recommendations from current or past employers;

(H) Indication of the SI’s cooperation, honesty or the making of a false statement during the criminal records check process, including acknowledgment and acceptance of responsibility of criminal activity and potentially disqualifying conditions.

(c) An agency shall consider the relevancy of the SI’s criminal activity or potentially disqualifying conditions to the paid or volunteer position, or to the environment in which the SI will work, especially, but not exclusively:

(A) Access to medication;

(B) Access to clients’ personal information;

(C) Access to vulnerable populations.

(5) An agency shall document the weighing test and place in the employee’s file.

(6) A background check shall be performed by:

(a) The Department of Human Services Background Check Unit; or

(b) A vendor that:

(A) Is accredited by the National Association of Professional Background Screeners (NAPBS); or

(B) Meets the following criteria:

(i) Has been in business for at least two years;

(ii) Has a current business license and private investigator license, if required in the company’s home state; and

(iii) Maintains an errors and omissions insurance policy in an amount not less than $1 million.

(7) An agency may use the Oregon State Police, Open Records Unit in order to fulfill the state records requirement for a criminal records check, however, an agency would still need to complete a nationwide check through a qualified vendor.

(8) The criminal records check must include the following:

(a) Name and address history trace;

(b) Verification that the SI’s records have been correctly identified, via date of birth check and Social Security number trace;

(c) A local criminal records check, including city and county records for SI’s places of residence for the last seven years;

(d) A nationwide multijurisdictional criminal database search, including state and federal records;

(e) A nationwide sex offender registry search;

(f) The name and contact information of the vendor who completed the background check;

(g) Arrest, warrant and conviction data, including but not limited to:

(A) Charge(s);

(B) Jurisdiction; and

(C) Date.

(h) Source(s) for data included in the report.

(9) An agency shall perform and document a query of an SI with the National Practitioner Data Bank (NPDB) and the List of Excluded Individuals and Entities (LEIE).

(10) All criminal records checks conducted under this rule shall be documented in writing and made part of the agency’s personnel files.

(11) An agency that has a contract with the Department of Human Services (Department) or Oregon Health Authority for the provision of home health services on or after April 1, 2012 and who is subject to the Department’s criminal records check rules does not have to comply with subsection (12) of this rule.

(12) For an SI working or volunteering for an agency on or after July 6, 2011, an agency shall have until July 1, 2012 to ensure that the agency is in compliance with section (3) of this rule.

(13) On or after April 1, 2012 an agency shall ensure that a criminal records check is performed on an SI every three years from the date of the SIs last criminal records check in accordance with these rules.

(14) Notwithstanding subsections (12) and (13) of this rule, the Division and not the agency shall conduct a criminal records check on an owner of any agency who is subject to a criminal records check under subsection (1)(c) of this rule. The Division shall conduct a criminal records check:

(a) At the time of application for a person who applies for a license on or after April 1, 2012 and every three years thereafter.

(b) By April 1, 2013 for an agency that is licensed on or before April 1, 2012, and every three years thereafter.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.004 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0080

Patients’ Rights

(1) Bill of Rights: An agency must provide each patient with a written notice of the patient’s rights prior to furnishing care to the patient or during the initial evaluation visit prior to the initiation of treatment. This notice shall state that a patient of the agency has the following rights:

(a) The right to have personal property treated with respect;

(b) The right to voice grievances regarding treatment or care, a lack of respect for property by anyone furnishing services on behalf of the agency, or any other issue, without discrimination or reprisal for exercising such rights. The agency must investigate all complaints made by the patient or the patient’s family or guardian regarding the above and must document the investigation and the resolution of the complaint;

(c) The right to be informed, in advance, about the care to be furnished, any changes in the care to be furnished, the disciplines that will furnish care, and the frequency of visits proposed to be furnished;

(d) The right to participate in the planning of care;

(e) The right to have clinical records confidentially maintained by the agency;

(f) The right to be advised, before care is initiated, of the extent that payment for the agency services may be expected from Medicare or other sources, and the extent that payment may be required from the patient. The agency must provide this information orally and in writing before care is initiated; and

(g) The right to be advised orally and in writing of any changes in the information provided in accordance with subsection (1)(f) as soon as possible, but no later than 30 working days from the date that the agency becomes aware of a change.

(2) Health Care Directives: 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, that provide for:

(a) Delivery to the patient or the patient’s legal representative of 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;

(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 127.531 along with a disclaimer attached to each form in at least 16-point bold type stating “You do not have to fill out and sign this form”; and

(D) The name of a resource that can provide additional information concerning the forms for advance directives.

(b) Documentation placed prominently in the patient’s record and reflecting whether the patient has executed an advance directive.

(c) Compliance by the agency with Oregon law relating to advance directives; and

(d) Education of agency personnel and the community on issues relating to advance directives.

(3) An agency shall provide the written information described in section (2) to the patient not later than 15 days after the initial provision of care by the agency, but in any event before discharge of the patient;

(4) An agency need not furnish a copy of an advance directive to a patient or the patient’s legal representative if it has reason to believe that the patient has received a copy of an advance directive in the form set forth in ORS 127.531 within the preceding 12-month period or has previously executed an advance directive.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1987, f. 11-10-87. ef. 12-1-87; OHD 13-1998, f. & cert. ef. 11-6-98; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0090

Plan of Treatment

The primary agency is responsible for the patient’s plan of treatment signed by the physician or nurse practitioner, including home health services provided to the patient through contractual arrangements with other organizations or individuals. A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient. When rehabilitation therapy service (speech therapy, physical therapy or occupational therapy) is the only service ordered by the physician, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional.

(1) The agency shall ensure that the plan of treatment is developed in consultation with the agency personnel and established at the time of, or prior to, acceptance of the patient.

(2) The agency shall ensure that the plan of treatment is transmitted to the patient’s physician or nurse practitioner for signature within 10 calendar days of admission to service.

(3) The plan of treatment shall cover the following:

(a) All pertinent diagnoses, mental status, types of services and equipment required;

(b) Frequency of visits;

(c) Prognosis;

(d) Rehabilitation potential;

(e) Functional limitations;

(f) Activities permitted;

(g) Nutritional requirements;

(h) Medications and treatments;

(i) Safety measures to protect against injury;

(j) Instructions for timely discharge or referral; and

(k) Any other appropriate items.

(4) If a patient is accepted under a plan of treatment that cannot be completed until after an evaluation visit, the physician or nurse practitioner shall be consulted to approve revisions to the original plan.

(5) Orders for therapy services shall include the specific procedures and modalities to be used and, as appropriate, the amount, frequency, and duration.

(6) The therapist and other agency personnel shall participate in developing the plan of treatment.

(7) The plan of treatment shall be signed by the physician or nurse practitioner and included in the patient’s clinical record within the time period specified in the agency’s policy but no longer than 30 calendar days after admission.

(8) The agency shall submit all plans of treatment to the primary physician or nurse practitioner and shall send copies to other physicians or nurse practitioners involved in the patient’s care.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.075 & 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0100

Periodic Review of Plan of Treatment

An agency shall ensure that:

(1) The plan of treatment shall be reviewed by the attending physician or nurse practitioner and agency personnel as often as the patient’s condition requires, but at least once every two months;

(2) Agency professional personnel promptly alert the physician or nurse practitioner to any changes that suggest a need to alter the plan of treatment;

(3) Information provided to the physician or nurse practitioner is documented in the clinical record; and

(4) The updated plan of treatment is included in the patient’s clinical record within 30 calendar days of the revision.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.075 & 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 20-1993, f. & cert. ef. 10-28-93; OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0110

Conformance with Physician’s or Nurse Practitioner’s Orders

(1) Agency personnel shall administer drugs and treatments only as ordered by the patient’s physician in accordance with 42 CFR 484.18 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 nurse practitioner within 72 hours.

(3) The physician’s or nurse 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 nurse 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 nurse practitioner.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.075 & 443.085
Hist.: OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0120

Coordination of Patient Services

(1) All personnel furnishing services shall ensure that their efforts are coordinated effectively and support the objectives outlined in the patient’s plan of care.

(2) The clinical record or minutes of case conferences shall reflect that effective communication and coordination of patient care occurs.

(3) A written summary report for each patient shall be sent to the attending physician or nurse practitioner at least every 62 days.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.085
Hist.: OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0130

Nursing Services

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 treatment. Such services shall comply with applicable laws. For the purposes of this rule, “critical and fluctuating” means a situation where the patient’s clinical or behavioral state is of a serious nature, expected to rapidly change, and in need of continuous reassessment and evaluation.

(1) Registered Nurse’s Duties: The registered nurse shall make the initial visit, regularly reevaluate the patient’s nursing needs, initiate appropriate preventive and rehabilitative nursing procedures, provide those services requiring substantial specialized nursing skills, prepare clinical and progress notes, coordinate services, inform the physician or nurse practitioner and other personnel (including paid caregivers) of changes in the patient’s condition and needs, counsel the patient, family or other caregivers (as applicable) in meeting nursing and related needs, participate in inservice programs, and supervise, teach, and assign care tasks to other nursing personnel. The registered nurse may delegate aspects of patient care to unlicensed individuals in accordance with OAR chapter 851, division 047.

(a) Supervision of the licensed practical nurse shall include:

(A) Initial evaluation of the patient to identify appropriate tasks to be performed by the licensed practical nurse. These tasks shall be documented in the patient’s clinical record; and

(B) A supervisory visit every 60 days when the patient’s condition is stable and predictable, and at least every two weeks when the patient’s condition is critical and fluctuating. This visit shall be made either when the licensed practical nurse is present to observe and assist or when the licensed practical nurse is absent, to assess relationships and determine that goals are being met. Documentation of these activities shall be maintained in the patient’s clinical record.

(b) Home Health Aide Supervision: 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. Supervisory visits by the registered nurse or therapist shall be documented in the patient’s clinical record.

(A) When skilled nursing services and home health aide services are being furnished to the patient, the registered nurse shall make a supervisory visit to the patient’s residence at least every two weeks, either when the home health aide is present to observe and assist, or when the home health aide is absent to assess relationships and determine if goals are being met.

(B) If a patient is receiving only skilled therapy services and home health aide services, a skilled therapist may make the supervisory visits at least every two weeks, in lieu of a registered nurse. The therapist must convey information about the performance of the home health aide to the aide’s registered nurse supervisor.

(C) When only home health aide services are being furnished to a patient, a registered nurse must make a supervisory visit to the patient’s residence at least once every 60 days. Each supervisory visit must occur when the aide is furnishing patient care.

(2) Licensed Practical Nurse:

(a) Duties: The licensed practical nurse shall provide services in accordance with agency policies, prepare clinical and progress notes, assist the physician or nurse practitioner or registered nurse in performing specialized procedures, prepare equipment and materials for treatments, observe aseptic techniques as required, and assist the patient in learning designated self-care techniques.

(b) Supervision of Licensed Practical Nurse: A licensed practical nurse shall provide services only under the supervision of a registered nurse.

(3) Home Health Aide: When an agency provides or arranges for home health aide service, an aide shall be assigned if the plan of treatment, as described in OAR 333-027-0090, specifies that the patient needs personal care. Home health aide services shall be provided under the supervision of the registered nurse and in accordance with the registered nurse’s assignment and agency policies.

(a) The duties of a home health aide shall include:

(A) Performance of simple procedures as assigned by the registered nurse;

(B) Personal care;

(C) Ambulation and exercise;

(D) Household services essential to health care at home;

(E) Assistance with medications that are ordinarily self-administered;

(F) Reporting changes in the patient’s condition and needs; and

(G) Completing appropriate records.

(b) A home health aide must have the following qualifications:

(A) Oregon Certified Nursing Assistant (CNA) certification and inclusion on the Oregon State Board of Nursing Nurse Aide Registry.

(B) Prior to providing care to a patient, the home health aide must be evaluated by a registered nurse for competency in each of the following areas:

(i) Communication skills;

(ii) Observation of, reporting of, and documentation about the patient and care provided;

(iii) Maintenance of a clean, safe and healthy environment;

(iv) Basic infection control procedures;

(v) Basic nutrition and fluid intake, including food preparation techniques as appropriate;

(vi) Reading and recording temperature, pulse, and respiration;

(vii) Basic elements of body functioning and changes in body function that must be reported to an aide’s supervisor;

(viii) Recognizing emergencies and knowledge of emergency procedures;

(ix) The physical, emotional, and developmental needs of, and ways to work with, the populations served by the agency, including the need for respect for the patient, the patient’s privacy, and the patient’s property;

(x) Appropriate and safe techniques in personal hygiene and grooming that include:

(I) Bed bath;

(II) Sponge, tub, or shower bath;

(III) Shampoo: sink, tub, or bed;

(IV) Nail and skin care;

(V) Oral hygiene; and

(VI) Toileting and elimination.

(xi) Safe transfer techniques and ambulation;

(xii) Normal range of motion and positioning; and

(xiii) Any other task the agency may choose to have the home health aide perform.

(c) Home health aide competency evaluation:

(A) An individual may furnish home health aide services on behalf of an agency only after that individual has successfully completed a competency evaluation program that meets the following requirements:

(i) The competency evaluation program must address each of the subjects listed in subparagraphs (3)(b)(B)(i) through (xiii) of this rule;

(ii) The subject areas listed at subparagraphs (3)(b)(B)(vi), (x), (xi), and (xii) of this rule must be evaluated through observation of the aide’s performance of the tasks with a patient; and

(iii) All other subject areas listed in paragraph (3)(b)(B) of this rule may be evaluated through written examination, oral examination, or observation of the aide with a patient.

(B) A home health aide is not considered competent in any task for which the aide’s performance is evaluated as unsatisfactory. The aide must not perform that task without direct supervision by a licensed nurse until the aide receives training in the tasks for which the aide’s performance was evaluated as unsatisfactory and passes a subsequent evaluation with a satisfactory rating.

(C) A home health aide has not successfully passed a competency evaluation if the aide’s performance is unsatisfactory in more than one of the areas delineated in paragraph (3)(b)(B) of this rule.

(D) The agency must maintain documentation that demonstrates that the home health aide has met competency evaluation requirements.

(d) Home Health Aide Orientation: The agency shall complete orientation of the home health aide to the agency’s program and document the completion within two weeks of employment. This orientation must include information about:

(A) Policies and objectives of the agency;

(B) The duties of a home health aide;

(C) The functions of other agency personnel and how they relate to each other in caring for the patient;

(D) Other community agencies; and

(E) Ethics and confidentiality.

(e) Training on the Job: In addition to orientation, an agency shall provide the home health aide patient-specific, on-the-job instruction for carrying out procedures that are not transferable to another patient. Such training shall be in accordance with OAR chapter 851, division 061, and shall be documented in the patient’s clinical record.

(f) Inservice Training: The agency shall arrange for and document at least 12 hours of inservice training annually. These training sessions shall pertain to the role and responsibilities of the home health aide.

(g) Home Health Aide Assignment: The agency shall provide teaching and supervision of the home health aide in accordance with OAR chapter 851, division 061. All assignments for patient care shall be written, prepared by a registered nurse, and updated on a monthly basis, or more often if the patient’s condition requires. Special tasks of nursing care may be delegated by a registered nurse to a home health aide according to the provisions of OAR chapter 851, division 047.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.065 & 443.085
Hist.: OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0140

Therapy Services

(1) Physical Therapy Services: If an agency provides physical therapy services, either directly or under contract, these services shall be provided only by a physical therapist or by a physical therapist assistant. The physical therapist and the physical therapist assistant shall provide physical therapy services in accordance with applicable laws, rules, agency policies and the patient’s plan of treatment. Services provided by a physical therapist assistant shall be supervised by a physical therapist.

(a) Duties of a physical therapist include: assisting a physician in evaluating levels of function, helping to develop and revise the plan of treatment, preparing clinical and progress notes, advising and consulting with the family and other agency personnel, participating in inservice programs, and providing services.

(b) Duties of the physical therapist assistant include: performing services that are planned, assigned, delegated, and supervised by the physical therapist; assisting in preparation of clinical notes and progress reports; participating in the education of the patient and family; and participating in inservice programs.

(c) Supervision of the physical therapist assistant shall include at a minimum:

(A) Initial evaluation of the patient by the physical therapist to identify appropriate tasks to be performed by the physical therapist assistant. These tasks shall be documented in each patient’s clinical records; and

(B) A visit to the patient’s residence by the physical therapist at least once a month when the patient’s condition is no longer stable and predictable, or at 60-day intervals when the patient’s condition is stable, either when the assistant is present to observe and assist or when the assistant is absent, to assess relationships and determine that goals are being met. Documentation of these visits by the physical therapist shall be maintained in the patient’s clinical record.

(2) Occupational Therapy Services: If an agency provides occupational therapy services, either directly or under contract these services shall be provided only by an occupational therapist or by an occupational therapy assistant under the supervision of an occupational therapist. The occupational therapist and occupational therapy assistant shall provide occupational therapy services in accordance with applicable statutes, rules, agency policies and the patient’s plan of treatment. The agency shall assure that services provided by an occupational therapy assistant shall be supervised by an occupational therapist.

(a) Duties of the occupational therapist include: assisting the physician in evaluating levels of function, helping to develop and revise the plan of treatment, preparing clinical and progress notes, advising and consulting with the family and other agency personnel, participating in inservice programs, and providing services.

(b) Duties of the occupational therapy assistant include: performing services planned, assigned, delegated, and supervised by the occupational therapist; assisting in the preparation of clinical notes and progress reports; participating in the education of the patient and family; and participating in inservice programs.

(c) Supervision of the occupational therapy assistant shall include at a minimum:

(A) Initial evaluation of the patient by the occupational therapist to identify appropriate tasks to be performed by the occupational therapy assistant. These tasks shall be documented in each patient’s clinical record; and

(B) A visit to the patient’s residence by the occupational therapist at least once a month when the patient’s condition is no longer stable and predictable, or at 60-day intervals when the patient’s condition is stable, either when the assistant is present to observe and assist or when the assistant is absent, to assess relationships and determine that goals are being met. The occupational therapist shall document these visits in each patient’s clinical record.

(3)(a) Speech Therapy Services: If an agency provides speech therapy services, either directly or under contract, these services shall be provided only by a speech pathologist. The speech pathologist shall provide speech therapy services in accordance with applicable statutes, rules, agency policies and the patient’s plan of treatment.

(b) Duties of the speech pathologist include: assisting the physician in evaluating the patient’s level of function; helping to develop and revise the plan of treatment; preparing clinical and progress notes; advising and consulting with the family and other agency personnel; participating in inservice programs; and providing services.

(4) Medical Social Services: If an agency provides medical social services, either directly or under contract these services shall be provided only by a social worker, or by a social work assistant. The social worker or the social work assistant shall provide social work services in accordance with applicable statutes, rules, agency policies and the patient’s plan of treatment.

(a) Duties of the social worker include: assisting the physician, other team members, and the family in understanding the significant social and emotional factors related to health problems of the patient; participating in the development of the plan of treatment; preparing clinical and progress notes; working with the family; utilizing appropriate community resources; participating in discharge planning and inservice programs; and acting as a consultant to other agency personnel.

(b) Duties of the social work assistant include: performing services planned, assigned, delegated, and supervised by the qualified social worker, preparing clinical notes and progress reports; and participating in inservice programs.

(c) Supervision of the social work assistant shall include at a minimum:

(A) Initial evaluation of the patient by the social worker to identify appropriate tasks to be performed by the social work assistant. These tasks shall be documented in the individual patient’s clinical records; and

(B) After the initial evaluation by the social worker and development of the plan of treatment, documented supervisory conferences with the social work assistant shall be held at least two times monthly to assess adherence to the goals and quality of relationships. In the event the patient’s situation changes and requires a change in the treatment plan and goals, the social worker will make a joint visit with the social work assistant to revise the plan of treatment.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.065 & 443.085
Hist.: HD 151, f. & ef. 12-30-77; HD 19-1987, f. 11-10-87, ef. 12-1-87; HD 20-1993, f. & cert. ef. 10-28-93; Renumbered from 333-027-0055, OHD 13-1998, f. & cert. ef. 11-6-98; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0150

Clinical Records

General Requirements for 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. All entries in the patient’s clinical record must be dated and authenticated. Authentication of an entry requires the use of a unique identifier such as a signature, code thumbprint, voice print, or other means, that provides identification and the title of the individual responsible for the entry. Clinical notes shall be written the day services are rendered and shall be incorporated into the clinical record at least weekly. The agency shall maintain an approved list of standard abbreviations, signs and symbols for use in the clinical record.

(a) The record of each patient receiving home health services shall contain pertinent past and current findings. The findings shall include, but not be limited to, history and physical examination, and hospital discharge summary. The record shall contain other appropriate information such as: patient identifying information; name of physician; signed and dated clinical and progress notes; copies of summary reports that have been sent to the physician; and a discharge summary.

(b) The record shall contain the patient’s plan of treatment.

(c) Clinical records shall contain all original or facsimile physician orders and agency caregiver documentation.

(2) Retention and Protection of Records:

(a) The administrator of the agency shall be responsible for proper preparation, adequate content, and preservation of the clinical records. The agency shall permit authorized personnel of the Division to review clinical records as necessary to determine compliance with these rules.

(b) An agency shall have written policies governing access to, and maintenance, retention, utilization, storage, and disposition of all clinical records.

(c) An agency shall complete all clinical records of discharged patients within 30 calendar days of the patient’s discharge.

(d) Clinical records are the property of the agency.

(e) Upon a patient’s request, the agency shall provide information from the patient’s clinical record related to the patient’s condition and the care provided.

(f) An agency shall ensure that original clinical records are readily retrievable. Clinical records may be retained on paper, microfilm, electronic, or other media.

(g) An agency shall keep all clinical records for a period of 10 years after the date of the patient’s last discharge from the agency.

(h) An agency shall keep clinical records in a safe and secure environment that will protect them from damage and harm.

(i) If an agency changes ownership, the agency shall retain all clinical records in original or microfilmed form and it shall be the responsibility of the successor agency to protect and maintain these records.

(j) In the event of dissolution of an agency, the agency administrator shall notify the Division where the clinical records will be stored.

(k) The agency shall retain non-medical records according to the policy of the individual agency.

(l) An agency shall comply with ORS 192.518 through 192.529, which governs the use and disclosure of patient’s protected health information.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.065 & 443.085
Hist.: OHD 13-1998, f. & cert. ef. 11-6-98; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0170

Waivers

(1) Each agency must comply with ORS chapter 443 and OAR chapter 333, division 027. However, an agency may request that the Division grant an exception to these rules for the use of alternative concepts, methods, procedures, techniques, equipment, facilities, personnel qualifications or the conducting of pilot projects or research. If an agency seeks an exception to the Division’s rules, it must:

(a) Submit the request in writing to the Division;

(b) Identify the specific rule for which an exception is requested;

(c) Explain the special circumstances relied upon to justify the exception;

(d) List any alternatives that were considered and the reasons those alternatives were not selected;

(e) Demonstrate that the proposed exception is desirable to maintain or improve the health and safety of the patients and will not jeopardize patient health and safety; and

(f) State the proposed duration of the exception.

(2) After reviewing the written request, the Division may grant the exception. If the Division grants an exception, it shall issue its decision in writing.

(3) An agency may not implement any exception until it has received the Division’s written approval of the exception.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.085
Hist.: HD 20-1993, f. & cert. ef. 10-28-93; Renumbered from 333-027-0067, OHD 13-1998, f. & cert. ef. 11-6-98; OHD 9-2002, f. & cert. ef. 7-2-02; PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

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 Division 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 Division;

(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.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.045 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0180

Informal Enforcement

(1) If during an investigation or survey Division staff document violations of home health licensing rules or laws, the Division 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 Division 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 Division 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 Division. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(4) The Division shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Division, the Division shall notify the agency owner in writing or by telephone:

(a) Identifying which provisions in the plan the Division finds unacceptable;

(b) Citing the reasons the Division 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.

(5) If the agency 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 Division may propose to deny, suspend, or revoke the agency license, or impose civil penalties.

Stat Auth.: ORS 443.085
Stats. Implemented: ORS 443.045 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

333-027-0185

Formal Enforcement

(1) If during an investigation or survey Division 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, the Division may issue a Notice of Proposed Suspension or Notice of Proposed Revocation in accordance with 183.411 through 183.470.

(2) The Division may issue a Notice of Imposition of Civil Penalty for violations of home health licensing laws.

(3) At any time the Division may issue a Notice of Emergency License Suspension under ORS 183.430(2).

(4) If the Division revokes an agency license, the order shall specify when, if ever, the agency may reapply for a license.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.045 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

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 the amount of a civil penalty, the Division shall consider whether:

(a) The Division 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.

(3) The Division 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 183.746.

Stat. Auth.: ORS 443.085
Stats. Implemented: ORS 443.045 & 443.085
Hist.: PH 7-2012, f. 3-30-12, cert. ef. 4-1-12

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2011.

2.) Copyright 2012 Oregon Secretary of State: Terms and Conditions of Use

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