16 Del. Admin. Code § 3355-3.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3355-3.0 - Licensure Requirements and Procedures

3.1 General requirements

3.1.1 No person shall establish, conduct or maintain in this State any FSSC without first obtaining a license from the Department.

3.1.2 A license issued hereunder shall be subject, at any time, to revision or revocation by the State.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Each license shall be issued for a specific number and class of operating rooms along with the specific number of pre-operative and post-anesthesia recovery beds to support them. The number of admitted patients shall not exceed the total number of licensed beds.

3.1.6 Separate licenses are required for FSSCs maintained in separate locations, even though operated under the same management.

3.1.7 Any FSSC that undergoes a modification of ownership and control is required to re-apply as a new FSSC and must meet the current design and construction standards recognized by the Department.

3.1.8 Licenses will be issued for specific hours of operation and FSSCs may not operate beyond those hours for which it is licensed.

3.1.9 The submission of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.10 Patients shall not be admitted to a FSSC until a license has been issued.

3.2 Application process

3.2.1 All persons or entities wanting to apply to open a FSSC shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered by the FSSC;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee's operation or related businesses.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or independent contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals;

3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction certifying that the proposed use will not conflict with any zoning restrictions, deed restrictions and local noise ordinances prior to applying for licensure to the Department; and

3.2.1.12 Any other information required by the Department.

3.2.2 A currently licensed FSSC wishing to change its hours of operation to accommodate patient stays of 23 hours and 59 minutes must request approval in writing from the local government having jurisdiction. Once written approval is received from the local government having jurisdiction, the FSSC may then apply to the Department for approval of the extended hours.

3.3 Issuance of licenses

3.3.1 Initial license:

3.3.1.1 An initial license shall be granted for a period of nine (9) calendar months to every FSSC that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to FSSC licensure.

3.3.1.2 An initial license will permit a FSSC to hire or contract with personnel and begin to offer services.

3.3.1.3 All FSSCs shall have an on-site survey, conducted by the Department, during the first nine (9) calendar months of operation.

3.3.1.4 A FSSC, at the time of an initial on-site survey, must meet the definition of a FSSC as contained within these regulations and must be in operation and caring for patients. Facilities that, at the time of an on-site survey, do not meet the definition of a FSSC or that are not in substantial compliance with these regulations will not be granted a license.

3.3.1.5 An initial license may not be renewed.

3.3.2 Provisional license:

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all FSSCs that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.3.2.3 A provisional license may not be renewed unless a Plan of Correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the FSSC.

3.3.2.4 A license will not be granted after the provisional licensure period to any FSSC that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License:

3.3.3.1 An annual license shall be granted, for a period of one year (12 months) to all FSSCs which are, and remain, in substantial compliance with these rules and regulations.

3.3.3.2 An annual license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is modified to a provisional, suspended, revoked or surrendered prior to the expiration date.

3.3.3.3 FSSCs must reapply for licensure at least 30 days prior to the expiration date of the license.

3.3.3.4 FSSCs which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.5 An annual license may not be issued to a FSSC which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 Modification of ownership and control (MOC)

3.4.1 Any proposed MOC must be reported to the Department a minimum of 30 calendar days prior to the change.

3.4.2 An MOC occurs whenever the ultimate legal authority for the responsibility of the FSSC's operation is transferred.

3.4.3 An MOC voids the current license in possession of the FSSC.

3.4.4 An MOC will be treated as an initial license and the FSSC must meet the current design and construction standards recognized by the Department.

3.4.5 An MOC may include but is not limited to:

3.4.5.1 Transfer of the FSSC's legal title;

3.4.5.2 Transfer of full ownership rights;

3.4.5.3 Transfer of the majority interest;

3.4.5.4 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

3.4.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.4.5.6 Transfer resulting in a measurable impact upon the operational control of the FSSC;

3.4.5.7 Dissolution of any partnership that owns, or owns a controlling interest in the FSSC;

3.4.5.8 Merger of a FSSC owner (a corporation) into another corporation where, after the merger, the owner's shares of capital stock are canceled; or

3.4.5.9 The consolidation of a corporate FSSC owner with one or more corporations.

3.4.5.10 Any other transfer or action under 8 Del.C. is considered an MOC under these regulations.

3.4.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.4.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.4.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.4.6.3 Changes in the membership of a non-profit corporation; or

3.4.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.4.7 Applications for licensure, as a result of an MOC must include a description of:

3.4.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.4.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.4.7.3 Any actual or anticipated change in policies and procedures; and

3.4.7.4 Any change in the manner of delivery of health care services.

3.5 Fees. Fees shall be in accordance with 16 Del.C. § 122 (3) p.

3.6 Inspection. A representative of the Department shall periodically inspect every FSSC for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

3.7 Notice to patients. The FSSC shall notify each patient (or the patient's authorized representative) scheduled for an upcoming surgical procedure of the voluntary surrender of its license, or as directed under an order of denial, revocation or suspension of license issued by the Department.

3.8 Exclusions from licensure. The following persons, associations or organizations are not required to obtain a FSSC license:

3.8.1 A FSSC that is directly adjacent to and licensed as part of a hospital; or

3.8.2 A FSSC which is used as an office for the private practice of a physician, podiatrist or dentist.

16 Del. Admin. Code § 3355-3.0

25 DE Reg. 627( 12/1/2021) (final)