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 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 §12.3.3(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 §§12.3.3(E) and
(F) of this Part, or for expedited reviews
conducted pursuant to §12.3.3(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 processed 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.
12.3.5
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.