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The Oregon Administrative Rules contain OARs filed through March 15, 2014
 
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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 700

LICENSING PROCEDURES AND DEFINITIONS

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 referenced are not included in rule text. Click here for PDF copy of table(s).]
[Publications: 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

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