16 Del. Admin. Code § 3335-4.0

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

Section 3335-4.0 - General Requirements

4.1 All records maintained by the facility shall be open to inspection by the authorized representatives of the Department.

4.2 The facility must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations or accepted standards of practice. The Department shall keep patient information confidential in accordance with state and federal laws.

4.3 Report of adverse events:

4.3.1 The facility must report all adverse events to the Department within forty-eight (48) business hours of the occurrence.

4.3.2 The facility must conduct an investigation of all adverse events.

4.3.3 The facility must forward a complete investigative report to the Department within 30 calendar days of the event.

4.4 The facility must keep reports of adverse events, accidents and medical emergencies on file at the facility for a minimum of five years.

4.5 Facility procedures shall not:

4.5.1 Generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; or

4.5.2 Be generally emergent or life-threatening in nature.

4.6 All personnel who provide clinical care in a facility must be qualified to perform services commensurate with appropriate levels of education, training and experience and in keeping with practice standards. Nothing in these regulations shall prohibit a licensed individual from performing procedures within his/her scope of practice.

4.7 All services shall be provided in a safe and effective manner in accordance with accepted standards of practice.

4.7.1 The facility shall maintain policies and procedures based upon accepted standards of practice.

4.8 Back-up power sufficient to ensure patient protection in the event of an emergency shall be immediately available.

4.9 There must be sufficient space in the room in which the procedure is being performed.

4.9.1 The room shall accommodate all necessary equipment and personnel allowing for expeditious access to the patient and all resuscitation and monitoring equipment.

4.10 All equipment shall be maintained and functional to ensure patient safety.

4.11 A facility that chooses to stop performing office-based surgery and voluntarily surrenders accreditation must notify the Department in writing, 30 days prior to the voluntary surrender of accreditation or cessation of office-based surgery.

16 Del. Admin. Code § 3335-4.0

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