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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
This rule lists the codes and standards
referenced in OAR 333-700-0000 through 333-700-0130. If conflicts exist among the
provisions of the codes and standards listed in this rule, the most restrictive
provisions shall apply. The following codes and standards are hereby adopted by
reference:
(1) American Society of Heating,
Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 170-2008 "Ventilation
of Health Care Facilities";
(2) Association for the Advancement
of Medical Instrumentation (AAMI) publication, "Dialysate for Hemodialysis," approved
by the American National Standards Institute (ANSI), ANSI/AAMI RD 52:2004;
(3) Association for the Advancement
of Medical Instrumentation (AAMI) publication, "Reuse of Hemodialyzers," Third Edition
ANSI/AAMI RD 47:2002/A1:2003;
(4) National Fire Protection
Association, NFPA 90A Standard for Installation of Air-Conditioning and Ventilating
Systems, 2012 Edition;
(5) National Fire Protection
Association, NFPA 99 Standard for Healthcare Facilities, 1999 Edition or 2012 Edition.
Note: If the 2012 Edition of NFPA 99 is used, the 2012 Edition of NFPA 101 must
also be used;
(6) National Fire Protection
Association, NFPA 101 Life Safety Code, 2000 Edition or 2012 Edition.
NOTE: If the 2012 Edition of NFPA 101
is used, the 2012 Edition of NFPA 99 must also be used;
(7) National Fire Protection Association,
NFPA 110 Standard for Emergency and Standby Power Systems, 2013 Edition;
(8) Oregon Electrical Specialty
Code, 2014 Edition;
(9) Oregon Energy Efficiency
Specialty Code, 2014 Edition;
(10) Oregon Mechanical Specialty
Code, 2014 Edition;
(11) Oregon Plumbing Specialty
Code, 2014 Edition;
(12) Oregon Structural Specialty
Code, 2014 Edition; and
(13) Oregon Fire Code, 2014
Edition.
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; PH 3-2015, f. 1-16-15, cert. ef. 2-1-15
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; and
(c) Conduct an on-site certification
survey and verify compliance with the Conditions for Coverage if the applicant has
requested Medicare and Medicaid certification.
(2) In determining whether
to license an outpatient renal dialysis facility, the Division shall only 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.
The Division shall 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; PH 3-2015, f. 1-16-15, cert. ef. 2-1-15
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 Outpatient 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. At minimum, the facility
shall satisfy the following requirements:
(a) Hot water used for hand
washing shall have a water temperature between 105 and 120 degrees Fahrenheit;
(b) All facilities shall
have a smoke detection system;
(c) At least one type 2A:10B:C
fire extinguisher shall be installed for every eight patient stations in locations
that are readily accessible to staff;
(d) All interior and exterior
materials and surfaces and all equipment necessary for the health, safety and comfort
of patients shall be kept clean and in good repair. Examples include, but are not
limited to: floors, walls, roofs, ceiling, windows, furnishings and equipment;
(e) Floor surfaces shall
be relatively level and free of tripping hazards;
(f) All buildings shall be
maintained in good condition with sound structural integrity;
(g) The facility shall be
in compliance with local codes, laws and ordinances; and
(h) Minimum egress requirements
shall include:
(A) Door latching that is
classified as simple hardware;
(B) Exit signs from all common
locations of the facility;
(C) Exit illumination with
alternate power source; and
(D) The means of egress shall
be free of obstructions.
(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."
(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 necessary 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
station or staff 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) Minimum emergency preparedness
requirements are as follows:
(a) Each facility shall develop,
maintain, update, train, and exercise an emergency preparedness plan that protects
all individuals in the event of an emergency, in accordance with the Oregon Fire
Code, as defined by the Department of State Police, Office of State Fire Marshal
in Oregon Administrative Rules chapter 837, division 40.
(b) Each facility shall conduct
at least two emergency preparedness 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 preparedness
plan shall include the contact information for the local emergency management office.
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 preparedness
plan shall address all local hazards that have been identified by the local emergency
management office. Potential hazards include, but are not limited to:
(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; and
(N) Tsunamis (for coastal
areas only).
(e) The emergency preparedness
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 all of the following
conditions:
(A) Extended power outage;
(B) Running water is unavailable;
(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 preparedness
plan shall address evacuation, including:
(A) Each individual staff
member's 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 to people unknown to
them;
(E) Method for tracking and
reporting the physical location of specific patients until a different entity assumes
responsibility for the patient; and
(F) Notification to the Division
about the status of the evacuation.
(g) The emergency preparedness
plan shall address the clinical and medical needs of the patients, including:
(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, including 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 are 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 preparedness
plan shall be made available to the Division upon request and during licensing and
certification surveys. Each plan shall be re-evaluated and revised if there is a
significant change in the facility's physical environment, its staffing levels or
the number of patients it serves and when otherwise necessary.
(i) The facility shall post
a plan for evacuation of patients, staff and visitors in case of fire or other emergencies.
(j) Fire drills shall be
completed at least once every six months. The facility shall document the participation
of staff and patients in fire drills and vary the timing of fire drills during each
calendar year to include all shifts. If a fire drill indicates procedural problems,
records shall show what corrective action has been implemented.
(k) Employees shall receive
initial and ongoing training in the use of fire extinguishers. The facility shall
document this training. Documentation shall include verification that fire extinguishers
are checked at least once every month to ensure 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) Each patient shall be
informed of his or her respective role during a medical and non-medical emergency,
including 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; PH 3-2015, f. 1-16-15, cert. ef. 2-1-15

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
Construction Requirements
(1) Applicability. This rule shall apply
to:
(a) All outpatient renal
dialysis facilities that apply for an initial license from the Division on or after
February 1, 2015; and
(b) All outpatient renal
dialysis facilities that propose a major alteration and submit plans to the Division
on or after February 1, 2015. In the event of a major alteration, this rule shall
apply only to the areas to be altered and not to other areas of the facility.
(2) All facilities subject
to this rule must comply with all applicable Oregon state building codes, occupancy
Business Group B, Ambulatory Care Facility.
(3) Minimum facility requirements
are as follows:
(a) Facility Location &
Accessibility.
(A) The facility shall be
located to allow for prompt access by ambulances and buses, including wheelchair-lift
equipped vehicles, without the need for patients to traverse across vehicular pathways
or parking areas. If this requirement cannot be satisfied, the project sponsor shall
propose 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 the facility that is free of traffic
by non-related persons;
(C) Accessible parking shall
be provided for patients and visitors that complies with the Oregon Structural Specialty
Code;
(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; and
(E) Corridors, doorways,
and stairways serving the unit shall be sized to allow at least one exit route for
emergency medical personnel to transport a patient by stretcher to an ambulance.
(b) Treatment Areas.
(A) Dialysis stations must
meet the following minimum criteria:
(i) Individual patient treatment
areas shall be at least 80 square feet in size with a minimum of 4 feet 0 inches
of open space available at the foot of the recliner or hospital bed;
(ii) Hand washing stations
that are readily available for staff use shall be provided within the treatment
area. At a minimum, one hand washing station shall be provided for every four patients
and appropriately located to facilitate hand washing between each patient contact;
(B) Patient care staff station(s)
shall be located within the dialysis treatment area. Each station shall be no higher
than 3 feet 8 inches and allow visual observation of all patients; and
(C) To prevent contact transmission
of infectious materials, the treatment area must include an Isolation Room that
meets the following minimum requirements:
(i) Provides a door and walls
that go to the floor, but not necessarily the ceiling, and allows for visual monitoring
of the patient;
(ii) Accommodates only one
patient; and
(iii) Contains a hand washing
station located in each patient room.
(4) To ensure adequate patient
support, the facility shall provide the following:
(a) Adequate waiting space
with a minimum seating capacity of one seat or wheelchair space for every two patient
stations;
(b) An accessible toilet
for patients that is convenient to the waiting room and includes an emergency nurse
call annunciated to the patient care staff station;
(c) Dedicated space for a
patient scale; and
(d) Dedicated space for wheelchair
storage.
(5) To ensure adequate general
support areas, the facility shall provide the following:
(a) Clean supply room with
space for bulk storage of necessary medical supplies. If the room is used to prepare
patient care supplies, it must contain a hand washing station and work counter;
(b) Soiled holding room or
area for medical waste storage that includes a mechanism to sanitize hands;
(c) Secure medications storage
that includes a dedicated refrigerator and hand washing station;
(d) Emergency cart and equipment
storage located close to the patient treatment area, readily accessible by staff,
and not located in an exit path;
(e) Access to a janitor closet
with a floor sink or service sink and adequate space for cleaning supplies within
or close to the unit;
(f) Adequate equipment storage
and service room or area. Space allocated for bio-medical interventions shall not
be in proximity to patients while they are undergoing dialysis;
(g) 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;
(h) Solution mixing and preparation
area for central concentrate delivery system or individual preparation, sized to
meet the facility's needs;
(i) Dedicated space for central
or individual water treatment equipment with waste drain sized to meet equipment
requirements;
(j) Dedicated staff toilet
that includes a hand washing station within or near the treatment area;
(k) If a home training program
is offered, the facility shall provide separate, 120 square foot training room(s)
each with a hand washing station, counter space and separate drain for fluid disposal
that is constructed to prevent cross-contamination of the hand washing station.
In addition, at least one convenient program office and general support space shall
be provided to meet program needs, and an emergency nurse call, annunciated at the
patient care staff station, or the home training office, shall be provided in each
home training room;
(l) Staff office; and
(m) Consultation space available
for private conferences with patients and their families.
(6) Minimum facility finish
requirements are as follows:
(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 conditions; and
(c) All soiled holding room,
medical waste storage area, and janitor closet flooring shall be seamless with an
integral coved wall base.
(7) Minimum maintenance and
housekeeping requirements are as follows:
(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 the manufacturer's recommendations, and each
dialysis machine shall be cleaned after each use in accordance with the facility’s
written policies and procedures.
(8) Minimum mechanical and
plumbing requirements are as follows:
(a) All heating, ventilation
and cooling systems shall comply with the Oregon Mechanical Specialty Code and shall
be maintained in full compliance;
(b) Hot water used for hand
washing shall have a water temperature between 105 and 120 degrees Fahrenheit; and
(c) All water treatment and
dialysate concentrate equipment and distribution systems shall be in compliance
with Association for the Advancement of Medical Instrumentation standards at all
times. Floor drain(s) shall also 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 accordance with chapter
4 of the National Fire Protection Association, NFPA 99 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 patient discomfort,
heating, cooling and ventilation systems shall be designed to minimize drafts and
temperature changes at treatment stations; and
(g) Hand washing stations
shall be trimmed with fittings that are operable without use of the hands. Note:
wrist blade controls are not considered to be operable without the use of hands.
(9) Minimum electrical requirements
are as follows:
(a) All electrical installations
shall comply with the Oregon Electrical Specialty Code 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 at patient stations, staff support stations and
paths of egress shall be five-foot candles minimum for a minimum of 90 minutes;
(c) 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 the lighting required in subsection (9)(b) of this rule and continued
provision of dialysis services;
(d) An independent ground
fault interrupter shall be provided for each dialysis machine; and
(e) Hospital-grade electrical
outlets shall be provided for all dialysis equipment connections.
(10) Minimum structural,
Fire & Life Safety Code and maintenance requirements are as follows:
(a) The facility shall be
constructed to comply with the Oregon Structural Specialty Code and shall be maintained
in full compliance;
(b) All dialysis treatment
spaces shall be located on the ground floor unless the space to be licensed qualifies
as a "Business Group B, Ambulatory Care Facility" occupancy class under the Oregon
Structural Specialty Code and, if certified by the Centers for Medicare and Medicaid,
is certified as an "Ambulatory Health Care Occupancy" under the National Fire Protection
Association, NFPA 101 Life Safety Code;
(c) The facility shall not
be located adjacent to a "hazardous occupancy" as defined under the Oregon Structural
Specialty Code unless the space to be licensed qualifies as a "Business Group B,
Ambulatory Care Facility" occupancy class under the Oregon Structural Specialty
Code and, if certified by the Centers for Medicare and Medicaid, is certified as
an "Ambulatory Health Care Occupancy" under the National Fire Protection Association,
NFPA 101 Life Safety Code; and
(d) All interior and exterior
materials and surfaces and all equipment necessary for the health, safety and comfort
of patients shall be kept clean and in good repair. Examples include, but are not
limited to: floors, walls, roofs, ceiling, windows, furnishings and equipment.
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; PH 3-2015, f. 1-16-15, cert. ef. 2-1-15

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