216-40-10 R.I. Code R. § 8.4

Current through June 12, 2024

Section 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.

216 R.I. Code R. § 216-RICR-40-10-8.4

Amended effective 11/25/2018