16 Del. Admin. Code § 3335-8.0

Current through Register Vol. 28, No. 3, September 1, 2024
Section 3335-8.0 - Disciplinary Actions
8.1 The Department may impose sanctions singly or in combination when it finds a facility has:
8.1.1 Violated any of these regulations;
8.1.2 Violated standards for safe and sanitary care in a facility;
8.1.3 Failed to correct deficiencies in accordance with a timetable submitted by the facility and agreed upon by the Department;
8.1.4 Engaged in any conduct or practices detrimental to the welfare of the patients; or
8.1.5 Refused to allow the Department access to the facility or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department based on the receipt of a complaint or report of an adverse event.
8.2 Disciplinary sanctions:
8.2.1 The Department may make and enforce such emergency orders as it deems necessary to protect the health and safety of the public.
8.2.1.1 If the Department determines during the course of any investigation or inspection that any facility poses an immediate and substantial risk to the health or safety of any person, the Department may order that such facility be closed until such time as it no longer poses a substantial risk.
8.2.1.1.1 An order of closure under this section shall remain in effect for a period not longer than 90 calendar days from the date of the issuance of said order, unless the facility requests a continuance of the date for the final hearing before the Department.
8.2.1.2 If the Department determines during the course of any investigation or inspection that any facility poses a possible risk to the health or safety of any person, the Department may:
8.2.1.2.1 Issue of a letter of reprimand; and/or
8.2.1.2.2 Require the facility to complete a plan of correction.
8.3 Imposition of Disciplinary Action
8.3.1 The Department may issue an order to close the facility immediately.
8.3.1.1 An order to close may apply to the performance of office-based surgery.
8.3.1.2 An order to close may apply to the facility as a whole.
8.3.2 The facility shall be notified forthwith in writing. The order to close shall be personally served upon the facility or sent by mail, return receipt requested, to the facility's last address of record.
8.3.2.1 A statement of deficiencies (identified during the investigation/inspection) will be forwarded to the facility within 48 hours of completion of the investigation/inspection.
8.3.3 In response to the order to close, the facility may:
8.3.3.1 Take no action, in which case the order to close shall remain in effect.
8.3.3.2 Take action to correct the unsafe and unsanitary practices identified during the survey.
8.3.3.2.1 The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.
8.3.3.2.1.1 A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.
8.3.3.2.2 The Department shall determine if the plan of correction is acceptable.
8.3.3.2.3 Once accepted, the Department shall schedule a revisit as soon as possible.
8.3.3.3 Request, in writing, an administrative hearing with the Secretary of the Department to contest the order to close.
8.3.3.3.1 Such request must be received within 20 calendar days from the date on which the order to close was issued.
8.3.3.3.1.1 As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.
8.3.3.3.1.2 The Department shall make a determination based upon the evidence presented.
8.3.3.3.1.3 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
8.3.3.3.2 A facility may request an expedited hearing.
8.3.3.3.2.1 The Department shall schedule the hearing on an expedited basis provided that the Department receives the facility's written request for an expedited hearing within five (5) calendar days from the date on which the facility received notification of the Department's decision to close the facility.
8.3.3.3.2.2 The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.
8.3.3.3.2.3 The Department shall make a determination based upon the evidence presented.
8.3.3.3.2.4 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
8.3.4 During an administrative hearing:
8.3.4.1 The facility has the right to be represented by counsel.
8.3.4.2 All statements made shall be under oath.
8.3.4.3 The facility has the right to examine and cross-examine witnesses.
8.3.4.4 A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.
8.3.4.5 The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.
8.3.5 Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with § 10128 of Title 29.
8.3.6 All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§ 10142 - 10145 of Title 29.

16 Del. Admin. Code § 3335-8.0

23 DE Reg. 125( 8/1/2019) (final)