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 12/10/2012)
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)(0)
through (0) 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 § 0) 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 §§ 0) and 0)
of this Part, or for expedited reviews
conducted pursuant
to §
0 ) 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 § 0) 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 § §
0), 0), 0) and 0) 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 §
0 ) 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 §
0 ) 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 § 0)
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 § 0) 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 § 0) 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 §§ 0) and 0) 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 § 0)
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 § 0
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 §§
0 ) and 0 ) 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 § 0 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 § 0 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 § 0 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 §
0 ) 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 § 0) 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
§ 0 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.