16 Del. Admin. Code § 3365-2.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3365-2.0 - Licensing Requirements and Procedures

2.1 General Requirements

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

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

2.1.3 A license is not transferable from person to person or from one location to another.

2.1.4 The license shall be posted in a conspicuous place on the licensed premises.

2.1.5 Any facility that undergoes a change of ownership is required to re-apply as a new facility.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the facility and requesting a licensure application from the Department.

2.2.1.1 The issuance 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.

2.2.1.2 Patients shall not be admitted to a facility until a license has been issued.

2.2.1.3 Applicants shall not hold themselves out to the public as being a birthing center until a license has been issued.

2.2.2 Applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of facilities owned or managed by the applicant;

2.2.2.2 Identity of:

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

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

2.2.2.2.3 The governing body;

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

2.2.2.2.5 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest of five percent (5%) or more in a licensee's operation or related businesses.

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

2.2.2.4 Name of the individual (administrator) who is responsible for the management of the birthing center;

2.2.2.5 Policy and procedure manuals as requested;

2.2.2.6 A list of management personnel, including qualifications; and,

2.2.2.7 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Probationary license

2.3.1.1 A probationary license shall be granted for a period of one (1) year to all birthing centers:

2.3.1.1.1 Which have completed the blueprint and construction approval processes; and

2.3.1.1.2 Which have completed the application process and whose policies and procedures have demonstrated willingness to comply with the rules and regulations pertaining to birthing center licensure; or

2.3.1.1.3 Which have experienced a change of ownership (CHOW) and have completed the application process demonstrating a willingness to continue to comply with the rules and regulations pertaining to birthing center licensure.

2.3.1.2 All birthing centers shall have an on-site survey during the first year of operation.

2.3.1.3 A probationary license will permit a facility to hire personnel and establish a patient caseload.

2.3.1.4 A probationary license may not be renewed. A birthing center, at the time of an initial on-site survey, must meet the definition of a birthing center as contained within these regulations and must be in operation and caring for patients.

2.3.1.5 Birthing centers which, at the time of an on-site survey, do not meet the definition of a birthing center or which are not in substantial compliance with these regulations will not be granted a license.

2.3.2 Provisional license

2.3.2.1 A provisional license shall be granted, for a period of less than one year, to all birthing centers

2.3.2.1.1 Which are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Which fail to renew a license within the timeframe prescribed by these regulations.

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

2.3.2.3 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 birthing center.

2.3.2.4 A license will not be granted pursuant to 2.3.3. after the provisional licensure period to any facility that is not in substantial compliance with these rules and regulations.

2.3.3 License

2.3.3.1 A license shall be granted, for a period of one year (12 months), to all birthing centers which are in substantial compliance with these rules and regulations at the time of application.

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

2.3.3.3 Existing birthing centers must apply for renewal of licensure at least thirty (30) calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a birthing center 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.

2.4 Disciplinary proceedings

2.4.1 The Department may impose any of the following sanctions (subsection 2.4.2 of this section) singly or in combination when it finds a licensee or former licensee is guilty of any offense described herein:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of two or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence, or misconduct in operating the birthing center or in providing services to patients;

2.4.1.7 Mistreated or abused patients cared for by the birthing center; or

2.4.1.8 Refused to allow the Department access to the facility or records for the purpose of conducting surveys as deemed necessary by the Department.

2.4.2 Disciplinary sanctions:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status.

2.4.2.4.2 Limit practice to those areas prescribed by the Department.

2.4.2.4.3 Suspend all admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action under this chapter is taken (except as authorized by 2.4.4):

2.4.3.1.1 The Department shall give twenty (20) calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The suspension or revocation shall become final twenty (20) calendar days after the mailing of the notice unless the licensee, within such twenty (20) calendar day period, shall give written notice of the facility's desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the facility shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the facility.

2.4.3.1.6 The decision shall become final twenty (20) calendar days after the mailing of the determination letter unless the licensee, within the twenty (20) calendar day period, appeals the decision to the appropriate court of the State.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by certified mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension shall be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a birthing center occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Facility;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members, or members of a governing body who have a financial interest of five percent (5%) or more in the birthing center; and

2.4.5.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of thirty (30) calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the facility.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights to a new owner;

2.5.3.2 Transfer of the majority interest to a new owner;

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

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

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the facility.

2.6 Fees

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

2.7 Inspection

2.7.1 A representative of the Department shall periodically inspect every birthing center 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.

2.8 Notice to Patients

2.8.1 The birthing center shall notify each patient, the patient's attending physician (as appropriate) and any third-party payers at least thirty (30) calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department.

16 Del. Admin. Code § 3365-2.0

12 DE Reg. 235 (08/01/08)
25 DE Reg. 777( 2/1/2022) (Final)