216-RICR-40-10-12
216-RICR-40-10-12. Rules and Regulations for the Licensing of Kidney Disease Treatment Centers (version Technical Revision, 12/10/2012 to 01/04/2022)
12.1 Authority
These amended Rules and Regulations for Licensing of Kidney Disease
Treatment Centers are promulgated under the authority conferred under
R.I. Gen. Laws § 23-17-10, and are established for the purpose of
adopting minimum standards for licensed kidney disease treatment
centers in this state.
12.2 Definitions
A. Whenever used in these rules and regulations, the following terms
shall be construed as follows:
1. "Acute dialysis" means short term intensive dialysis
requiring hospitalization.
2. "Change in
operator" means
a transfer
by the
governing body
or operator
of a
kidney disease
treatment center to any other person (excluding delegations of
authority to the medical or administrative staff of the facility) of
the governing body's authority
to:
a. Hire or fire the chief executive officer of the kidney disease
treatment center;
b. Maintain and control the books and records of the kidney disease
treatment center;
c. Dispose of
assets and
incur liabilities
on behalf
of the
kidney disease
treatment center;
or
d. Adopt and enforce policies regarding operation of the kidney
disease treatment center.
e. This definition is not applicable to circumstances wherein the
governing body of a kidney disease treatment center retains the
immediate authority and jurisdiction over the activities enumerated
in §§ 12.2(A)(2)(a) through (d) of this Part herein.
3. "Change in owner"
means:
a. In the case of a kidney disease treatment center which is a
partnership, the removal, addition or substitution of a partner which
results in a new partner acquiring a controlling interest in such
partnership;
b. In the case of a kidney disease treatment center which is an
unincorporated sole proprietorship, the transfer of the title and
property to another person;
c. In the case of a kidney disease treatment center which is a
corporation;
(1) A sale, lease, exchange or other
disposition of all, or substantially all of the property and assets
of the corporation; or
(2) A merger of the corporation into
another corporation; or
(3) The
consolidation of
two or
more corporations,
resulting in
the creation
of a
new corporation;
or
(4) In
the case
of a
kidney disease
treatment center
which is
a business
corporation, any transfer of corporate stock which results in
a new person acquiring a controlling interest in such corporation; or
(5) In the case of a kidney disease
treatment center which is a non-business corporation,
any change
in membership
which results
in a
new person
acquiring controlling vote in such corporation.
4. "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 semipermeable membrane either by the
use of hemodialysis or peritoneal
dialysis.
5. "Director" means the Director of the Rhode Island
Department of Health.
6. “Equity” means non-debt funds contributed towards the capital
costs related to an initial licensure
or change
in owner
or change
in operator
of a
kidney disease
treatment center
which funds are free and clear of any repayment or liens
against the assets of the proposed owner and/or licensee and that
result in a like reduction in the portion of the capital cost that is
required to be financed or
mortgaged.
7. "Health Services Council" means the advisory body to the
Rhode Island Department of Health
established in
accordance with
R.I. Gen Laws Chapter
23-17 ,
appointed and
empowered in
accordance with
R.I. Gen. Laws Chapter
23-15 ,
as amended, to serve as the advisory body to the state agency in its
review functions.
8. "Home dialysis" means carrying out the therapeutic
process of dialysis in the patient's place of residence by a properly
trained patient or `helper'.
9. "Hospital affiliation" means a contractual arrangement
with a licensed hospital for the provision
of services
for patients
with medical
problems in
need of
hospital services,
equipment and personnel for in-patient care.
10. "Kidney disease
treatment center"
means a
"free-standing
(non-hospital) dialysis
facility for renal
disease" which
may be
a public
or private
organization or
sub-unit of
such an
agency or organization
providing chronic
maintenance dialysis
to ambulatory
patients on
the premises of
the facility or in the patient's place of
residence.
11. "Licensing agency" or "state agency" means
the Rhode Island Department of
Health.
12. "The licensed capacity" of a kidney disease treatment
center refers to the number of
dialysis stations that the center is licensed to
operate.
13. "Person" means any individual, trust or estate,
partnership, corporation (including associations,
joint stock
companies) state,
or political
subdivision or
instrumentality of
a state.
14. "Self-care dialysis"
means dialysis
performed with
nominal professional
supervision by
a patient who has completed an appropriate course of
training.
15. "Sub-unit" means a satellite of a licensed kidney
disease treatment center which serves patients in a geographic area
different from its parent agency and which can share administration,
supervision and services on a daily basis with its parent
agency.
16. "Technical advisory committee" means a
multidisciplinary body of persons with professional training in renal
disease and other related professional fields, acceptable to the
affiliated hospital, to serve as an advisory body on matters
pertaining to standards, policies, staffing, program and services of
the free-standing facility.
12.3 Licensing Procedures
12.3.1 General Requirements for
Licensure
No person acting severally or jointly
with any other person, shall establish, conduct or maintain a kidney
disease treatment center in this state without a license in
accordance with the requirements of R.I. Gen. Laws § 23-17-4 .
12.3.2 Application for License or for
Changes in the Owner, Operator, or Lessee
A. Application
for a
license to
conduct, maintain
or operate
a kidney
disease treatment
center shall be
made to the licensing agency upon forms provided by it one month
prior to the expiration date of the license and shall contain such
information as the licensing agency reasonably requires which may
include affirmative evidence of ability to comply with the provisions
of R.I. Gen. Laws § 23-17-4
and the rules and regulations herein.
1. Each application shall be accompanied by an application fee as set
forth in the Rules and Regulations Pertaining to the Fee Structure
for Licensing, Laboratory and Administrative Services Provided by the
Department of Health.
B. A notarized listing of names and
addresses of direct and indirect owners whether individual,
partnership or
corporation with
percentages of
ownership designated
shall be
provided with
the application for licensure and shall be updated annually.
The list shall include each owner (in whole
or in
part) of
any mortgage,
deed or
trust note
or other
obligation secured
(in whole
or in part)
by the
facility or
any of
the property
or assets
of the
facility. The
list shall
also include
all officers, directors
and other
persons or
any subsidiary
corporation owning
stock, if
the facility
is organized as a corporation, and all partners if the
facility is organized as a
partnership.
C. Application
for initial
licensure or
changes in
the owner,
operator, or
lessee of
a kidney
disease treatment center
shall be
made on
forms provided
by the
licensing agency
and shall
contain but not
be limited
to information
pertinent to
the statutory
purpose expressed
in R.I. Gen. Laws §
23-17-3
or to the considerations enumerated in § 12.4.3(E) of this
Part. Twenty-five (25) copies of such applications are required to be
provided.
1. Each application
filed pursuant
the provisions
of this
section shall
be accompanied
by a non-refundable, non-returnable application fee, as set
forth in the Rules and Regulations Pertaining to the Fee Structure
for Licensing, Laboratory and Administrative Services Provided by the
Department of Health.
12.3.3 Issuance and Renewal of
License
A. Upon
receipt of
an application
for a
license, the
licensing agency
shall issue
a license
or renewal thereof
for a period of one (1) year if the applicant meets the requirements
of R.I. Gen. Laws Chapter 23-17
and the
rules and
regulations herein.
Said license,
unless sooner
suspended or
revoked, shall
expire by limitation
on the
31st day
of December
following its
issuance and
may be
renewed from
year to year after inspection and approval by the licensing
agency.
1. All renewal applications shall be accompanied by a license renewal
fee as set forth in the Rules and Regulations Pertaining to the Fee
Structure for Licensing, Laboratory and Administrative Services
Provided by the Department of
Health.
B. A license shall be issued to a
specific licensee for a specific location and shall not be
transferable. The license shall be issued only for the premises and
the individual owner, operator or lessee, or to the corporate entity
responsible for its governance.
1. Any initial
licensure or
change in
owner, operator,
or lessee
of a
licensed kidney
disease treatment center
shall require
prior review
by the
Health Services
Council and
approval of the licensing agency as provided in §§ 12.4.3(E)
and (F) of this Part, or for expedited reviews conducted pursuant to
§ 12.4.3(H) of this Part, as
a condition
precedent to the
transfer, assignment or issuance of a new
license.
C. A
license issued
hereunder shall
be the
property of
the state
and loaned
to such
licensee and
it shall be kept posted in a conspicuous place on the licensed
premises.
D. Except for expedited reviews
conducted pursuant to § 12.4.3(H) of this Part, reviews of
applications for initial licensure or for changes in the owner,
operator or lessee of licensed kidney disease treatment center shall
be conducted according to the following
procedures:
1. Within ten
(10) working
days of
receipt, in
acceptable form,
of an
application for
initial licensure or
a license
in connection
with a
change in
the owner,
operator or
lessee of
an existing kidney
disease treatment
center, the
licensing agency
will notify
and afford
the public thirty (30) days to comment on such
application.
2. The decision of the licensing agency will be rendered within
ninety (90) days from acceptance of the
application.
3. The decision of the licensing agency shall be based upon the
findings and recommendations of the Health Services Council unless
the licensing agency shall afford written justification for variance
therefrom.
4. All applications
reviewed by
the licensing
agency and
all written
materials pertinent
to licensing agency review, including minutes of all Health
Services Council meetings, shall be accessible to the public upon
request.
E. Except as otherwise provided in R.I.
Gen. Laws Chapter 23-17 ,
a review
by the
Health Services
Council of
an application
for initial
licensure or
for a license in
the case of a proposed change in owner, operator, or lessee of a
licensed kidney disease
treatment center,
may not
be made
subject to
any criterion
unless the
criterion directly
relates to the statutory purpose expressed in R.I. Gen. Laws §
23-17-3 .
In conducting reviews of such applications the Health Services
Council shall specifically consider, and it shall be the applicant’s
burden of proof to demonstrate:
1. The character,
commitment, competence,
and standing
in the
community
of the
proposed owners,
operators, or
directors of
the kidney
disease treatment
center as
evidenced by:
a. In cases where the proposed owners, operators, or directors of the
health care facility currently
own, operate,
or direct
a health
care facility,
or in
the past
five years owned, operated or directed a health care facility,
whether within or outside Rhode
Island, the
demonstrated commitment
and record
of that
(those) person(s):
(1) In
providing safe
and adequate
treatment to
the individuals
receiving the
health care facility's
services;
(2) In encouraging, promoting and
effecting quality improvement in all aspects of health care facility
services; and
(3) In providing appropriate access to
health care facility services;
b. A complete disclosure of all individuals and entities comprising
the applicant; and
c. The applicant’s
proposed and
demonstrated financial
commitment to
the health care
facility.
2. The extent
to which
the facility
will provide
or will
continue, without
material effect
on its viability at the time of change of owner, operator or
lessee, to provide safe and adequate treatment for individuals
receiving the facility's services as evidenced
by:
a. The immediate
and long
term financial
feasibility of
the proposed
financing plan;
(1) The proposed amount and sources of
owner's equity to be provided by the applicant;
(2) The proposed financial plan for
operating and capital expenses and
income for
the period
immediately prior
to, during
and after the
implementation of
the change
in owner,
operator or
lessee of the
health care facility;
(3) The relative availability of funds
for capital and operating needs;
(4) The applicant's demonstrated
financial capability;
(5) Such
other financial
indicators as
may be
requested by
the state
agency;
3. The extent to which the facility will provide or will continue to
provide safe and adequate treatment for individuals receiving the
facility's services and the extent to which
the facility
will encourage
quality improvement
in all
aspects of
the operation
of the health care facility as evidenced
by:
a. the credibility and demonstrated or potential effectiveness of the
applicant's proposed quality assurance
programs;
4. The extent to which the facility will provide or will continue to
provide appropriate access with respect to traditionally underserved
populations as evidenced by:
a. In cases where the proposed owners, operators, or directors of the
health care facility currently own, operate, or direct a health care
facility, or in the past five years owned, operated or directed a
health care facility, both within and outside of Rhode Island, the
demonstrated record of that person(s) with respect to access of
traditionally underserved populations to its health care facilities;
and
b. The proposed immediate and long term plans of the applicant to
ensure adequate and appropriate access to the programs and health
care services to be provided by the health care
facility.
5. In consideration
of the
proposed continuation
or termination
of emergency,
primary
care and/or other core health care services by the
facility.
a. The effect(s) of such continuation or termination on the provision
of access to safe and adequate treatment of individuals, including
but not limited to traditionally underserved populations.
6. And in
cases where
the application
involves a
merger, consolidation
or otherwise
legal affiliation of
two or
more health
care facilities,
the proposed
immediate and
long term plans
of such
health care
facilities with
respect to
the health
care programs
to be
offered and health care services to be provided by such health
care facilities as a result of the merger, consolidation or otherwise
legal affiliation.
F. Subsequent to reviews conducted under
§§ 12.4.3(D), (E), (G) and (H) of this Part, the issuance of a
license by the licensing agency may be made subject to any condition,
provided that no condition may be made unless it directly relates to
the statutory purpose expressed in R.I. Gen. Laws §
23-17-3 ,
or to
the review
criteria set forth
in § 12.4.3(E) of this Part. This shall not limit the
authority of the licensing agency to require correction of conditions
or defects which existed prior to the proposed change of owner,
operator or lessee and of which notice had been given to the facility
by the licensing agency.
G. Applicants
for initial
licensure may,
at the
sole discretion
of the
licensing agency,
be reviewed under
expedited review
procedures established
in § 12.4.3(H) of this Part if
the licensing
agency determines
1. that the legal entity seeking licensure is the licensee for one or
more health care facilities licensed in Rhode Island pursuant to the
provisions of R.I. Gen. Laws Chapter 23-17
whose records of compliance with licensure standards and requirements
are deemed by the licensing agency to demonstrate
the legal
entity’s ability
and commitment
to provide
quality health
services;
and
2. that the licensure application demonstrates complete and
satisfactory compliance with the review criteria set forth in set
forth in § 12.4.3(E) of this Part.
H. Expedited
reviews of
applications for
initial licensure
of kidney
disease treatment
centers shall be
conducted according to the following
procedures:
1. Within ten
(10) working
days of
receipt, in
acceptable form,
of an
application for
initial licensure the licensing agency will determine if such
application will be granted expedited review and the licensing agency
will notify the public of the licensing agency’s initial assessment
of the application materials with respect to the review criteria in §
12.4.3(E) of this Part as well as the licensing agency’s intent to
afford the application expedited
review. At
the same
time the
licensing agency
will afford
the public
a twenty (20) day
period during which the public may review and comment on the
application and the licensing agency’s initial assessment of the
application materials and the proposal to afford the application
expedited review.
2. Written objections
from affected
parties directed
to the
processing under
the expedited
procedures and/or the satisfaction of the review criteria shall be
accepted during the twenty (20) day comment period. Objections must
provide clear, substantial and unequivocal rationale as to why the
application does not satisfy the review criteria and/or why the
application ought not to be processed under the expedited review
mechanism. The
licensing agency
may propose
a preliminary
report on
such
application provided
such proposed report incorporates findings relative to the review
criteria set forth in § 12.4.3(E) of this Part. The Health Services
Council may consider such proposed report and may provide its
advisory to the Director of Health by adopting such report in amended
or unamended form. The Health Services Council, however, is not bound
to recommend to the Director that the application be process under
the provisions for expedited review as delineated in §§ 12.4.3(G)
and (H) of this Part. The Health Services Council shall
take under
advisement all
objections both
to the
merits of
the application
and to
the proposed expedited processing of the proposed application
and shall make a recommendation
to the
Director regarding
each. Should
the Health
Services Council
not recommend to
the Director that the application be processed under expedited review
procedures as initially proposed, such application may continue to be
processed consistent with the time frames and procedures for
applications not recommended for expedited
review. If
expedited review
is not
granted, then
the comment
period may
be forthwith extended consistent with the time frames in §
12.4.3(D) of this Part for applications not proposed for expedited
review. The Director, with the advice of the Health Services Council,
shall make the final decision either to grant or to deny expedited
review and shall make
the final
decision to
grant or
to deny
the application
on the
merits within
the expedited review mechanism and time
frames.
12.3.4 Capacity and Classification
Each license shall be issued for the
licensed dialysis station capacity of the kidney disease treatment
center. No
kidney disease
treatment center
shall have
more stations
or operate
more shifts than authorized by the licensing
agency.
12.3.5 Change of Ownership, Operation
and/or Location
A. When a change of ownership or
operation or location of a kidney disease treatment center or when
discontinuation of a service is contemplated, the owner and/or
operator shall notify the licensing agency in writing no later than
six (6) weeks prior to the proposed
action.
B. A license shall immediately become
void and shall be returned to the licensing agency when operation of
a kidney disease treatment center is discontinued or when any changes
in ownership occur in accordance with the rules and regulations
herein and R.I. Gen. Laws § 23-17-6 .
1. When there
is change
in ownership
or in
the operation
or control
of an
existing kidney
disease treatment
center the
licensing agency
reserves the
right to
extend the
expiration date of
such license,
allowing the
kidney disease
treatment center
to operate
under the same
conditions which
applied to
the prior
licensee for
such time
as shall
be required
for the processing of a new application or for transfer of
patients, not to exceed six (6) weeks.
12.3.6 Inspections
A. The licensing agency shall make or
cause to be made such inspections and investigations as deemed
necessary in accordance with R.I. Gen. Laws § 23-17-10
or Chapter 23-17 and the rules and regulations herein.
B. Every kidney disease treatment center
shall be given prompt notice by the licensing agency of all
deficiencies reported as a result of an inspection or investigation.
C. Written reports and recommendations
of inspections shall be maintained on file in each kidney disease
treatment center for a period of no less than three (3)
years.
12.3.7 Denial, Suspension, Revocation
of License or Curtailment of Activities
A. The
licensing agency
is authorized
to deny,
suspend or
revoke the
license or
curtail activities
of any kidney disease treatment center which: has failed to
comply with the rules and regulations pertaining to licensing of
kidney disease treatment centers; and has failed to comply with the
provisions of R.I. Gen. Laws Chapter 23-17.
1. Lists of deficiencies noted in inspections conducted in accordance
with § 12.4.6 of this Part
shall be
maintained on
file in
the licensing
agency, and
shall be
considered by
the licensing agency
in rendering
determinations to
deny, suspend
or revoke
the license
or curtail activities of a kidney disease treatment
center.
B. Where
the licensing
agency deems
that operation
of a
kidney disease
treatment center
results in undue
hardship to
patients as
a result
of deficiencies,
the licensing
agency is
authorized to
deny licensing to facilities not previously licensed, or to
suspend for a stipulated period of time or revoke
the license
of a
kidney disease
treatment center
already licensed
or curtail
activities of the
kidney disease treatment center.
C. Whenever an action shall be proposed
to deny, suspend or revoke a kidney disease treatment center license,
or curtail its activities, the licensing agency shall notify the
kidney disease treatment center by certified mail, setting forth
reasons for the proposed action, and the applicant
or licensee
shall be
given an
opportunity for
a prompt
and fair
hearing in
accordance with R.I. Gen. Laws §§ 23-17-8
and 42-35-9.
1. However, if
the licensing
agency finds
that public
health, safety,
or welfare
imperatively requires
emergency action and incorporates a finding to that effect in its
order, the licensing agency
may order
summary suspension
of license
or curtailment
of activities
pending proceedings
for revocation
or other
action in
accordance with
R.I. Gen Laws §§
23-1-21
and 42-35-14(c) .
D. The appropriate state and federal
placement and reimbursement agencies shall be notified of any
action taken
by the
licensing agency
pertaining to
either denial,
suspension, or
revocation of
license or curtailment of
activities.
12.4 Organization and
management
12.4.1 Governing Body and Management
A. Each
facility shall
have an
organized governing
body or
other legal
authority, responsible
for:
1. the management and control of the
operation;
2. the assurance of quality of care and services;
3. the conformity
of the
facility with
all federal,
state and
local laws
and regulations
relating to fire, safety, sanitation, infection control; and
4. other relevant health and safety requirements and with all the
rules and regulations herein.
B. The governing body or other legal
authority shall provide appropriate physical resources and equipment
and personnel required to meet the special needs of patients on
chronic dialysis maintenance.
C. The governing body or other legal
authority shall designate an administrator who will be responsible
for the management and operation of the facility and a medical
director to ensure achievement and maintenance of quality standards
of professional practice.
D. The
governing body
shall adopt
and maintain
by-laws defining
responsibilities and
identifying purposes and means of fulfilling such, in addition
to:
1. A statement relating to development and implementation of long
range plans;
2. A statement of qualifications and responsibilities of the medical
director and administrator;
3. A statement
of the
governing body's
responsibilities for
the quality
of care
and services;
4. A statement relating to conflict of interest on the part of the
governing body, medical staff and
employees;
5. A policy statement concerning publication of an annual report
including a certified financial statement;
and
6. Such other matters as may be relevant to the organization of the
facility.
E. Financial Interest Disclosure
1. Any health
care facility
licensed pursuant
to R.I. Gen. Laws Chapter
23-17 ,
which refers
clients to
another such
licensed health
care facility
or to
a residential
care/assisted living facility licensed pursuant to R.I. Gen. Laws
Chapter 23-17.4 ,
or to a certified adult day care program in which the referring
entity has a financial
interest shall, at the time a referral is made, disclose in writing
the following information to the client:
a. that the referring entity has a financial interest in the facility
or provider to which the referral is being made;
b. that the client has the option of seeking care from a different
facility or provider which is also licensed and/or certified by the
state to provide similar services to the
client.
2. The referring entity shall also offer the client a written list
prepared by the Department of Health of all such alternative licensed
and/or certified facilities or providers. Said written list may be
obtained by contacting:
Rhode Island Department of Health,
Division of Facilities Regulation
3 Capitol Hill, Room 306
Providence, RI
02908
401.222.2566
F. Non-compliance
with §§ 12.5.1(E)(1) and (2) of this Part shall constitute
grounds to
revoke, suspend or
otherwise discipline the licensee or to deny an application for
licensure by the Director, or may
result in
imposition of
an administrative
penalty in
accordance with
R.I. Gen. Laws Chapter
23-17.10 .
G. Pending and Actual Labor
Disputes/Actions
1. Health care facilities shall provide the licensing agency with
prompt notice of pending and actual
labor disputes/actions
which would
impact delivery
of patient
care services
including, but
not limited
to, strikes,
walk-outs, and
strike notices.
Health care
facilities shall
provide a
plan, acceptable to
the Director,
for continued
operation of
the facility,
suspension of
operations, or
closure in the event of such actual or potential labor
dispute/action.
12.4.2 Administrator
A. The governing body shall appoint a
qualified administrator who may be the medical director, who shall be
responsible for:
1. the management and operation of the facility;
2. the enforcement of
policies, rules
and regulations
and statutory
provisions pertaining
to the
health and safety
of patients;
3. serving
as liaison
between the
governing body
and the
staff; and
4. the planning, organizing and directing of such other activities as
may be delegated by the governing body.
12.4.3 Medical Director
A. The
clinical services
of the
facility shall
be under
the direction
of a
physician licensed
in Rhode Island
who shall
be trained
in dialysis
techniques, has
an appointment
in that
specialty service
at the affiliated hospital and who shall be responsible for no
less than the following:
1. The coordination and supervision of all
services;
2. The selection
of patients
for dialysis
(either for
chronic maintenance,
self-care, or
home dialysis) in
accordance with
criteria established
with the
technical advisory
committee (see §
12.5.4 of this Part);
3. The achievement and maintenance of quality assurance of
professional practice;
4. The training
of physicians,
nurses and
paramedical personnel
in dialysis
techniques; and
5. The establishment of provisions for infection control.
12.4.4 Technical Advisory Committee
A. Each facility shall establish a
Technical Advisory Committee with representatives from the affiliated
hospital as defined in § 12.1 of this Part to serve as an advisory
body to:
1. Determine the
appropriateness of
renal dialysis
care, treatment
procedures and
policies and services delivered to
patients;
2. Review adequacy of patient selection for
care;
3. Review appropriateness of medical services provided including
ancillary services; and
4. Make necessary recommendations to maintain quality care and
services.
12.4.5 Personnel
A. Each facility shall maintain a
sufficient number of qualified personnel to provide effective patient
care and other related services.
B. There
shall be
written personnel
policies and
procedures which
shall be
available to
personnel.
C. A health care facility shall require
all persons, including students, who examine, observe, or treat
a patient
or resident
of such
facility to
wear a
photo identification
badge which
states, in
a reasonably legible
manner, the
first name,
licensure/registration
status, if
any, and
staff position of
such person.
D. Health Screening
1. Upon hire
and prior
to delivering
services, a
pre-employment health
screening shall
be required for
each individual who has or may have direct contact with a patient in
the kidney disease treatment center. Such health screening shall be
conducted in accordance with the rules and regulations pertaining to
“Immunization, Testing, and Health Screening for Health Care
Workers” promulgated by the Department of
Health.
12.4.6 Affiliation and Transfer
Agreement
A. There shall be evidence of a current
contractual arrangement with a licensed hospital for the provision of
services as defined in § 12.1 of this Part. Said contract shall
clearly define the mutual responsibilities and relationships of
parties involved and shall include reasonable assurance of:
1. Transfer or referral of patients as medically determined with
timely acceptance and admission;
and
2. Transfer of patient care plans and other necessary medical
information.
B. Arrangement with any other agency or
facility for the provision of such services, such as laboratory,
radiology or
other, shall
be with
a facility
which maintains
quality standards
and is certified
or licensed as may be required by
statute.
12.4.7 Rights of Patients
Each facility shall observe the
standards with respect to each patient admitted to its facility as
enumerated in R.I. Gen. Laws § 23-17-19.1 .
12.4.8 Disaster Preparedness
A. Each facility shall develop and
maintain a written disaster preparedness plan which shall include
specific provisions and procedures for the emergency care of patients
in the event of fire, natural disaster or functional failures of
internal systems and/or
equipment.
1. Such a plan shall be developed and coordinated with appropriate
state and local agencies and representatives concerned with emergency
safety and rescue and with representatives of the affiliate
hospital.
2. A copy of such plan shall be submitted to the licensing
agency.
3. Each facility shall
develop a plan, approved and adopted by the governing board and
consistent with
the requirements
of this
section, to
address the
year 2000
computer/chip problem
(“Y2K”) by
September 30,
1999 and
must test
such plan
by October
30, 1999.
a. The plan shall include, at a minimum, facility identification of
potential problem areas, remediation of identified problems, and
testing for functionality, and shall also include consideration of
vendor and supplier compliance.
B. Simulated
drills testing
the effectiveness
of the
plan shall
be conducted
at least
semi-annually. Written reports and evaluation of all drills
shall be maintained by the
facility.
C. Fully
equipped emergency
trays including
emergency drugs,
and medical
supplies sufficient
to meet the emergency needs of the facility shall be available
at all times on the premises.
D. Emergency steps of action shall be
clearly outlined and posted in conspicuous locations throughout the
facility.
12.4.9 Uniform Reporting System
A. Each
facility shall
establish and
maintain records
and data
in such
a manner
as to
make uniform the
system of
periodic reporting.
The manner
in which
the requirements
of this
regulation may be
met shall
be prescribed
from time
to time
in directives
promulgated by
the Director
with the advice of
the Health Services Council.
B. Each
facility shall
report to
the licensing
agency detailed
financial and
statistical data
pertaining to its
operation, services,
and facility.
Such reports
shall be
made at
such intervals
and by
such dates as determined by the Director and shall include but
not be limited to the following:
1. Utilization of services;
2. Unit of cost of services;
3. Charges for services;
4. Financial condition of the kidney disease treatment center;
and
5. Quality of care.
C. The licensing agency is authorized to
make the reported data available to any state agency concerned with
or exercising jurisdiction over the reimbursement of the
facility.
D. The
directives promulgated
by the
Director pursuant
to these
regulations shall
be sent
to each facility
to which
they apply.
Such directives
shall prescribe
the form
and manner
in which
the financial and statistical data required shall be furnished
to the licensing agency.
12.5 Patient care
services
12.5.1 Patient Care Management
A. Each patient shall be under the
continuing supervision of a physician and provisions shall be made
by the
facility to
assure the
availability of
medical care
at all
times to
patients whether
on chronic maintenance dialysis, self-care or home dialysis
programs.
B. A mechanism shall be established for
the development and periodic review and revision of patient
care policies
and procedures
by a
professional group
including no
less than
the medical
director of the facility, the nursing director and representatives of
the Technical Advisory Group.
C. Patient care policies and procedures
shall be established for each specific program carried by the
facility, (chronic
maintenance dialysis,
self-care dialysis
or home
dialysis) and
shall pertain to
no less than the following:
1. Scope of services provided either directly or per contractual
arrangement;
2. Criteria for
admission, transfer
or discharge
from or
to chronic
maintenance, self-care
or home dialysis, or to acute
dialysis;
3. Availability and accessibility of services in medical or other
emergency;
4. Medical supervision and physician
services;
5. Patient care plans and methods of
implementation;
6. Pharmaceutical, dietary and social
services;
7. Availability of services for working
patients;
8. Evaluation of patient care services by the technical advisory
committee;
9. Transfer of patient to affiliate hospital;
and
10. The self-care and home dialysis
programs.
D. There
shall be
posted at
each nursing
station a
roster with
the names
and telephone
number(s) of
physicians to be called in an
emergency.
12.5.2 Patient Care Plans
A. There
shall be
a patient
care plan
for each
patient, developed
by the
professional team
to ensure
appropriate modality of care.
1. Such a
plan shall
be based
on the
nature of
the patient's
illness, treatment
prescribed and
assessment of patient's needs based on prior medical work
up.
2. The patient
care plan
shall furthermore
reflect medical,
psychological and
social needs of
patients.
3. The plan shall be reviewed at least monthly until the patient is
stable and thereafter every six (6) months and revised as necessary
to meet ongoing needs of the
patient.
4. The patient, parent, or legal guardian shall be involved in the
development of the care
plan with the professional team and due consideration shall be given
to the patient's preferences when not medically
contraindicated.
12.5.3 Nursing Services
A. The
nursing service
shall be
under the
supervision of
a full
time licensed
registered nurse
who has clinical nursing experience and training in dialysis
techniques.
B. There shall be a sufficient number of
registered nurses to plan, assign supervise and evaluate nursing
care as
well as
a sufficient
number of
ancillary nursing
personnel to
meet patient
care needs based on the types of programs (e.g., chronic
maintenance, self-care or home dialysis) and staff
capabilities.
C. A registered nurse with the
experience in dialysis techniques shall be on the premises of the
dialysis facility at all times whenever a patient is undergoing renal
dialysis treatment.
12.5.4 Medical Records
A. A
member of
the professional
staff shall
be designated
to supervise
the medical
records and
to ensure proper documentation, completion, indexing, filing,
retrieval and safe storage.
B. A
medical record
shall be
established and
maintained for
every patient
treated on
the premises or at
his place of residence.
C. Each
medical record
shall contain
sufficient information
and data
to support
the diagnosis,
plan of treatment to define treatment modalities, responses to
treatment and on-going progress reports of patient care.
D. Each medical record shall contain no
less than the following:
1. documented evidence of assessment
of the
needs of
the patient
an of
establishment of
an appropriate
plan of
treatment;
2. identification and social data;
3. referral information with authentication of diagnosis;
4. medical and
nursing history
of patient;
5. report(s)
of physician
examination(s);
6. observation and
progress notes;
7. reports
of treatments
and clinical
findings;
8. laboratory
reports; and
9. other related reports.
E. All
medical records
either original
or accurate
reproductions shall
be retained
for a
minimum of five
(5) years following discharge of the patient. Records of minors shall
be kept for at least five (5) years after such minor shall have
reached the age of 18 years.
12.5.5 Laboratory Services
Each facility shall make provisions for
laboratory services.
12.5.6 Related Services
A. Social services and dietetic services
shall be provided either directly or per contractual arrangements
with qualified professional personnel, on either a full or part time
basis, depending on the scope of the program and patient care
needs.
B. The
social worker
and dietitian
shall have
clearly delineated
responsibilities which
shall include
their participation with the professional team to plan and
evaluate the psychosocial and nutritional needs of patients.
C. Accurate notations shall be made in
the patient’s medical record of all services
rendered.
12.5.7 Infection Control
A. A mechanism shall be established with
appropriate professional staff to establish infection control
policies and
procedures for
the mutual
protection of
patients, personnel
and the
public. Such policies and procedures shall pertain to:
1. Infection surveillance
activities including
a plan
for systematic
monitoring of
hepatitis in patients and
personnel.
2. Sanitation and asepsis;
3. Isolation of patients with known or suspected infectious
disease;
4. Handling and disposal of waste and
contaminants;
5. Sterilization, disinfection and
laundry;
6. Reporting, recording and evaluation of occurrences of infections;
and
7. Documentation of infection
rate.
B. The facility shall report promptly to
the licensing agency infectious diseases which may represent a
potential hazard to patients, personnel and the public. Included are
the reportable diseases and the occurrence of other diseases in
outbreak form.
12.5.8 Home Dialysis
A. The therapeutic regimen for any
patient to be cared for at home shall be arranged after a sufficient
period of
initial study,
dialysis, planning
and self-care
dialysis on
the premises
of the facility
and with the responsible person(s) who will assist the
patient.
B. Facilities providing home dialysis
shall make available either directly or per contractual arrangements
with a community agency(ies) the following
services:
1. Home visits for supervision of
care;
2. Consultation with qualified social worker and
dietitian;
3. Installation and maintenance of
equipment;
4. Testing appropriateness of
water;
5. A record-keeping system to assure continuity of
care;
6. Assurance of emergency coverage on a 24 hours basis with affiliate
hospital;
7. Arrangements for emergency transportation to affiliate hospital in
the event of emergency; and
8. Ordering of supplies.
C. Patients on a home dialysis program
shall be visited no less than every three (3) months by professional
staff of
the facility
to assess
and review
patient care
plan and
to observe
patient and
‘helper’ carry out dialysis treatment.
12.5.9 Continuity of Care for
Traveling Patients
A. Facilities
shall be
responsible to
make temporary
arrangements with
dialysis facilities
or centers
throughout the
country or
outside the
United States
for patients
who will
be traveling
and may be
confronted with medical problems requiring acute
care.
1. Patients shall
be given
the name
and address
of facilities
in those
states or
countries in which
the patient
will be
traveling. In
addition instructions
will be
given to
the patient in
emergency measures to be taken in the event medical problems should
arise.
12.6 Environmental
Maintenance
12.6.1 Environment
A. The facility shall be maintained and
equipped to provide a functional sanitary, safe and comfortable
environment with an adequate amount of well lighted space for the
services provided.
B. The areas used by patients shall be
maintained in good repair and kept free of
hazards.
C. Equipment
and supplies
shall be
provided for
cleaning of
all surfaces.
Such equipment
shall be
maintained in a safe, sanitary
condition.
D. Hazardous cleaning solutions,
compounds, and substances shall be labeled, stored in a safe place
and kept in an enclosed section separate from other cleaning
materials.
E. Cleaning shall be performed in a
manner which will minimize the spread of pathogenic organisms in the
atmosphere.
12.7 Physical Plant and
Equipment
12.7.1 General Maintenance Provisions
A. A
qualified technically
trained and
competent person
shall be
designated to
oversee the
general maintenance and functional operation of all the
mechanical equipment relative to dialysis treatment in a safe and
properly functioning order.
B. Each facility utilizing a
central-batch delivery system shall provide either on the premises or
through contractual
arrangement with
a supplier,
sufficient individual
delivery systems
for the treatment
of any patient requiring special dialysis
solutions.
C. Records
of calibration
and testing
of equipment
shall be
maintained for
at least
three (3)
years.
12.7.2 Physical Facility
A. The
dialysis unit(s)
shall be
separate from
other activities
and shall
be located
in an
area free
of traffic by non-unit staff or patients.
B. The
nursing station
shall be
located in
an area
which provides
adequate surveillance
of patients on
dialysis machines.
C. Treatment
areas shall
be designed
and equipped
to provide
adequate and
safe treatment,
as well as privacy
and comfort for patients. Sufficient space shall be provided to
accommodate emergency equipment and staff to move freely to reach
patients in emergencies.
D. Heating and ventilation systems shall
be capable of maintaining adequate and comfortable temperatures.
E. Each
facility shall
met the
fire and
safety provisions
of R.I. Gen. Laws
Chapter 23-28.1 ,
and shall
conform with
all state and local building codes.
12.7.3 Emergency Power
A. The facility shall be equipped with
an emergency power source.
B. The emergency electrical power system
shall be adequate to supply power to maintain the operation
of the
dialysis machines
and other
life-support systems,
and lighting
for egress,
fire detection equipment, alarm and extinguishing
systems.
12.7.4 Lighting and Electrical
Services
All
electrical and
other equipment
used in
the facility
shall be
maintained free
of defects
which could be a potential hazard to patients or personnel. A
planned program of preventive maintenance of equipment used in
dialysis and related procedures in the facility shall be established.
12.7.5 New Construction
A. All new construction shall be subject
to the provisions of R.I. Gen. Laws Chapters 23-28.1 ,
23-27.3 ,
and 23-1 .
B. All new construction shall also be
subject to the provisions of “Specifications for Making Buildings
and Facilities Accessible to and Usable by the Physically
Handicapped”, American National Standards Institute (1980), not
including any further editions or amendments thereof and only to the
extent that the provisions therein are not inconsistent with these
Regulations.
C. In addition, any other applicable
state and local laws, codes and rules and regulations shall apply.
Where there is a difference between codes, the code having the higher
standard shall apply.
12.7.6 Plumbing
A. All
plumbing material
and plumbing
systems or
parts thereof
installed shall
meet the
minimum requirements of R.I. Gen. Laws Chapter 23-27.3 .
B. All plumbing shall be installed in
such a manner as to prevent back siphonage or cross-connections
between potable and non-potable water
supplies.
12.7.7 Water Supply
A. Water shall be obtained from a
community water system and shall be distributed to conveniently
located taps
and fixtures
throughout the
facility and
shall be
adequate in
volume and pressure for all purposes including fire f ighting.
B. Water used for dialysis purposes
shall be analyzed periodically and treated as necessary to maintain a
continuous water supply that is biologically and chemically
compatible with acceptable dialysis
techniques.
12.7.8 Waste Disposal
A. Medical
Waste:
1. Medical waste as defined in the Rules and Regulations Governing
the Generation, Transportation, Storage,
Treatment, Management
and Disposal
of Regulated
Medical Waste
of the Rhode Island Department of Environmental Management,
shall be managed in accordance with the provisions of the
aforementioned regulations.
B. Other
Waste:
1. Wastes which are not classified as infectious waste, hazardous
wastes or which are not otherwise regulated by law or rule may be
disposed in dumpsters or load packers provided the following
precautions are maintained:
a. Dumpsters shall
be tightly
covered, leak
proof, inaccessible
to rodents
and animals,
and placed on
concrete slabs preferably graded to a drain. Water supply shall be
available within easy accessibility for washing down of the area. In
addition, the pick-up schedule shall be maintained with more frequent
pick-ups when required. The dumping site of waste materials must be
in sanitary landfills approved by the Department of Environmental
Management.
b. Load packers must conform to the same restrictions required for
dumpsters and, in addition, load packers shall be:
(1) high enough off the ground to
facilitate the cleaning of the underneath areas of the stationary
equipment; and
(2) the loading section should be
constructed and maintained to prevent rubbish from blowing from said
area site.
12.7.9 Waste Water Disposal
If
a municipal
sanitary sewer
system is
available, the
facility shall
be connected
to the
system if
feasible. If a municipal sanitary sewer system is not available, the
facility shall meet the standards set forth by the Department of
Environmental Management.
12.7.10 Deficiencies and Plans of Correction
A. The licensing agency shall notify the
governing body or other legal authority of a facility of violations
of individual
standards through
a notice
of deficiencies
which shall
be forwarded
to the facility
within fifteen
(15) days
of inspection
of the
facility unless
the Director
determines that immediate
action is
necessary to
protect the
health, welfare,
or safety
of the
public or
any member thereof through the issuance of an immediate
compliance order in accordance with R.I. Gen. Laws § 23-1-21 .
B. A facility which received a notice of
deficiencies must submit a plan of correction to the licensing agency
within fifteen (15) days of the date of the notice of deficiencies.
The plan of correction
shall detail any requests for variances as well as document the
reasons therefore.
C. The
licensing agency
will be
required to
approve or
reject the
plan of
correction submitted
by a facility in accordance with § 12.8.10(B) of this Part within
fifteen (15)
days of
receipt of
the plan
of correction.
D. If the licensing agency rejects the
plan of correction, or if the facility does not provide a plan of
correction within the fifteen (15) day period stipulated in §
12.8.10(B) of this Part, or if a facility whose plan of correction
has been approved by the licensing agency fails to execute its plan
within a reasonable time, the licensing agency may invoke the
sanctions enumerated in § 12.4.7 of this Part. If the facility is
aggrieved by the sanctions of the licensing agency, the facility may
appeal the decision and request a hearing in accordance with R.I.
Gen. Laws Chapter 42-35 .
E. The notice of the hearing to be given
by the Department of Health shall comply in all respects with the
provisions of R.I. Gen. Laws Chapter 42-35 .
The hearing shall in all respects comply with all provisions therein.
12.8 Exception and
Severability
12.8.1 Exception
Modification of any individual
standards herein, for experimental or demonstration
purposes, or any other purpose, shall require advance written
approval from the licensing agency.
12.8.2 Severability
If any provision of these regulations
or the application thereof to any facility or circumstances shall be
held invalid, such invalidity shall not affect the provisions or
application of the regulations which can be given effect, and to this
end the provisions of the regulations are declared to be severable.