216 R.I. Code R. § 216-RICR-40-10-8.4 - Licensing Procedures
8.4.1 General
Requirements for Licensure
A. No person or
governmental unit acting severally or jointly with any other person or
governmental unit shall establish, conduct, maintain or operate or hold itself
out as a Birth Center in Rhode Island without a license in accordance with the
requirements of R.I. Gen. Laws §
23-17-4 and this Part.
B. Each license
shall specify the licensed capacity of the Center.
C. The number of women in active labor,
admitted to birth rooms at any given point in time shall be no greater than the
number of birth rooms in the Center.
D. Centers shall be limited to those
practices normally accomplished in uncomplicated childbirth, including simple
episiotomies and repairs. Any other surgical procedures such as tubal ligation,
termination of pregnancy or such other would require the Center to be
specifically licensed as a Freestanding Ambulatory Surgical Center in
accordance with the rules and regulations for Licensing of Freestanding
Ambulatory Surgical Centers (Part 5 of this Subchapter).
E. Proposed changes in birth room capacity
shall be submitted in writing to the Department and shall be subject to the
approval of the Department.
F. Any
Birth Center that utilizes latex gloves shall do so in accordance with the
provisions of Use of Latex Gloves by Health Care Workers, in Licensed Health
Care Facilities, and by Other Persons, Firms, or Corporations Licensed or
Registered by the Department (Part
20-15-3
of this Title).
G. Each Birth
Center shall establish and maintain a health care facility specific electronic
mail address (i.e., e-mail address) to be provided to the Department for the
purposes of contacting the Birth Center with both routine communications and
emergency notices. The Birth Center shall be responsible for providing notice
to the Department at any time that the Birth Center's specific electronic mail
address is changed or updated.
8.4.2 Application for License, Initial
License or Changes in Owner, Operator, or Lessee
A. Application for a license to conduct,
maintain or operate a Birth Center shall be made to the Department upon forms
provided by it, and shall contain such information as the Department reasonably
requires, including but not limited to evidence of ability to comply with the
provisions of R.I. Gen. Laws §
23-17-4 and this Part.
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 Center of any of the property or assets of the Center. The list shall
also include all officers, directors and other persons or any subsidiary
corporation owning stock, if the Center is organized as a corporation, and all
partners if the Center is organized as a partnership.
C. Application for initial licensure or
changes in the owner, operator, or lessee of a Center shall be made on forms
provided by the Department 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 §8.4.3(D) of this Part. Three (3)
paper copies and an electronic copy of such applications are required to be
provided.
1. Each application filed pursuant
the provisions of this section shall be accompanied by a non-returnable,
non-refundable 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 (Part 10-05-2 of this
Title).
8.4.3
Issuance and Renewal of License
A. Upon
receipt of an application for license, the Department shall issue a license or
renewal thereof for a period of no more than one (1) year if the applicant
meets the requirements of R.I. Gen. Laws §
23-17-4 and this Part. 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
Department.
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 license or
any change in owner, operator, or lessee of a licensed Center shall require
prior review by the Health Services Council and approval of the Department as
provided in §§8.4.3(D) and (E) of this Part or for expedited review
conducted pursuant to §8.4.3(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 of Rhode Island loaned to such licensee and it shall be
kept posted in a conspicuous place on the licensed premises.
D. Except for expedited review conducted
pursuant to §8.4.3(H) of this Part, reviews of applications for initial
licensure or for changes in owner, operator, or lessee of licensed Center shall
be conducted according to the procedures stated in R.I. Gen. Laws §
23-17-14.4.
The Department will notify and afford the public thirty (30) days to comment on
such application.
E. The limits on
licensing criteria are stated in R.I. Gen. Laws §
23-17-14.3. 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 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 (5) 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;
b. The proposed amount and sources of owner's
equity to be provided by the applicant;
c. 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;
d. The
relative availability of funds for capital and operating needs;
e. The applicant's demonstrated financial
capability;
f. 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 service 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 §§8.4.3(D), (E), (G) and (H) of this Part, the issuance of a
license by the Department 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 §8.4.3(E) of this Part. This shall not
limit the authority of the Department 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
Department.
G. Applicants for
initial licensure may, at the sole discretion of the Department, be reviewed
under expedited review procedures established in §8.4.3(H) of this Part if
the Department 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 Department 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 §8.4.3(E) of this Part.
H. Expedited reviews of applications for
initial licensure of Birth 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 Department will determine if such application will be granted
expedited review and the Department will notify the public of the Department's
initial assessment of the application materials with respect to the review
criteria in §8.4.3(E) as well as the Department's intent to afford the
application expedited review. At the same time the Department will afford the
public a twenty (20) day period during which the public may review and comment
on the application and the Department'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.
3. The
Department may propose a preliminary report on such application provided such
proposed report incorporates findings relative to the review criteria set forth
in §8.4.3(E) of this Part.
4.
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.
a. 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 §§8.4.3(G) and (H) of this Part.
5. 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.
6. 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.
7. If expedited review is not granted, then
the comment period may be forthwith extended consistent with the time frames in
§8.4.3(D) for applications not proposed for expedited review.
8. 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.
8.4.4
Inspections
A. The Department shall make or
cause to be made such inspections and investigations, as it deems necessary, in
accordance with R.I. Gen. Laws §
23-17-10 and this Part.
B. Every Center
shall be given notice within fifteen (15) business days by the Department of
any deficiencies reported as a result of an inspection or
investigation.
C. A duly authorized
representative of the Department shall have the right to enter at any time
without prior notice to inspect the entire premises and services, including all
records of any Center for which an application has been received or for which a
license has been issued. Any application shall constitute permission for and
willingness to comply with such inspections.
D. Refusal to permit inspections shall
constitute a valid ground for license revocation.
8.4.5 Denial, Suspension, Revocation of
License or Curtailment of Activities
A. The
Department is authorized to deny, suspend or revoke the license of or to
curtail the activities of any Center which:
1.
Has failed to comply with the rules and regulations pertaining to the licensing
of Birth Centers; and
2. Has failed
to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3. Reports of deficiencies noted in
inspections conducted in accordance with §8.4.4 of this Part shall be
maintained on file in the Department, and shall be considered by the Department
in rendering determinations to deny, suspend or revoke the license or to
curtail activities of a Center.
B. Whenever an action shall be proposed to
deny, suspend or revoke the license of or to curtail the activities of a
Center, the Department shall notify the 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 and in accordance with the provisions of §8.9.2 of this Part.
1. However, if the Department finds that
public health, safety, or welfare imperatively requires emergency action and
incorporates a finding to that effect in its order, the Department 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).
C. The appropriate state and
federal agencies shall be notified of any action taken by the Department
pertaining to denial, suspension, revocation of license, or curtailment of
activities.
Notes
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