16 Del. Admin. Code § 3335-9.0

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

Section 3335-9.0 - Accreditation Requirements and Procedures

9.1 General requirements

9.1.1 All facilities must register with the Department at least 15 days prior to the first day of operation using a form created by the Department. It will include:

9.1.1.1 The facility name;

9.1.1.2 Facility address;

9.1.1.3 Facility phone number;

9.1.1.4 A contact person; and

9.1.1.5 Acknowledgment that office-based surgery is performed in the facility.

9.1.2 No person shall establish, conduct or maintain in this State any facility without obtaining accreditation from an accrediting organization that is approved by the Department.

9.1.2.1 The Department shall maintain a list of approved accrediting organizations.

9.1.3 All facilities must provide proof of accreditation to the Department within 12 months of the first day of operation of such facility.

9.1.4 The accreditation certificate shall be posted in a conspicuous place on the facility premises, at or near the entrance, in a manner which is plainly visible and easily read by the public.

9.1.5 The facility must submit an accreditation certificate to the Department within 30 days of each accrediting organization survey.

9.1.5.1 The Department may request and the facility must submit a copy of the entire accreditation report.

9.1.5.2 Facilities required to submit a plan of correction to an accrediting organization will also be required to submit a copy of the plan of correction to the Department.

9.1.6 The accreditation organization shall report to the Department, at a minimum, all of the following regarding facilities the organization has accredited:

9.1.6.1 The findings of surveys;

9.1.6.2 The findings of complaint and incident investigations; and

9.1.6.3 Data for all facilities that perform office-based surgery.

9.2 Accreditation termination

9.2.1 Termination of accreditation may occur secondary to:

9.2.1.1 Voluntary surrender of accreditation by the facility.

9.2.1.2 Revocation of accreditation by the accrediting organization.

9.2.2 Any facility that fails to maintain accreditation shall immediately cease to operate.

9.2.2.1 The facility may be required to remain open for administrative purposes for a period of time to be determined by the Department.

9.3 Inspection

9.3.1 Unannounced inspections of any facility by authorized representatives of the Department may occur:

9.3.1.1 Anytime upon receipt of a complaint by a current facility employee or patient or upon the occurrence of any adverse event.

9.3.1.2 Anytime upon receipt of a referral from the Division of Professional Regulation.

9.3.2 Facilities certified by the Centers for Medicare and Medicaid Services (CMS) will be inspected pursuant to the process required by CMS rather than otherwise stated in these regulations.

9.4 Notice to patients

9.4.1 The facility shall notify each patient (or the patient's authorized representative) scheduled for an upcoming office-based surgery of an accreditation termination, or as directed under an order issued by the Department.

9.4.2 The facility shall include in the notification information regarding alternative healthcare providers.

9.5 Exclusions from accreditation

9.5.1 The following persons, associations or organizations are not required to obtain accreditation as facilities:

9.5.1.1 Those facilities required to be licensed under Title16 of the Delaware Code.

16 Del. Admin. Code § 3335-9.0

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