16 Del. Admin. Code § 4465-K-5.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-K-5.0 - Inspections

5.1 Inspection Frequency.

5.1.1 An inspection of a registered facility shall be performed at least every two (2) years for medical facilities utilizing angiography, radiography, fluoroscopy, computed tomography (CT), mammography, stereotactic breast biopsy systems and radiation therapy modalities, and at least every four (4) years for other registered facilities, including dental, bone densitometry, podiatry, veterinary, academic and industrial.

5.1.2 Additional inspections of registered facilities as described in the regulations shall be performed as often as necessary to ensure and verify compliance with the regulations.

5.2 Access

5.2.1 The Authority or its duly authorized representatives shall have the power to enter at all reasonable times upon any private or public property for the purpose of determining whether or not there is compliance with or violations of16Del.C., Ch.74 and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly authorized designated representative.

5.2.2 The Agency may suspend for a period not to exceed (30) days, the certificate, license or registration to operate/use a source of radiation for refusing access to the representative(s) of the Agency if the Agency can show good cause that there is a risk of imminent harm to the public from ionizing radiation at the facility to which the Agency is attempting access.

5.3 Inspection Report Form

5.3.1 Facility Inspection Form ORC-R11 shall be used to record the results of inspections at registered radiation source facilities as specified in (Part K), Compliance Procedures.

5.3.1.1 The co-signed original of the completed inspection report form shall be furnished to the person named on the license or registration or the Radiation Safety Officer (RSO) at the conclusion of the inspection.

5.3.1.2 The completed inspection form shall list the violation(s) (if any), give the time period for correcting the violation(s) and state the corrections to be made. The inspection report form shall summarize the requirement(s) of the regulations.

5.3.1.3 The form shall also state that "Failure to comply with time limits for correction of any violations cited in this notice shall result in automatic license or registration suspension and immediate cessation of use of a source radiation or radiation area in accordance with Compliance Procedures of the regulations of the Authority on Radiation Protection."

5.3.2 The completed inspection report form is a public document that shall be made available for public disclosure to any person who requests it in accordance with the "Freedom of Information Act 29Del.C., Ch. 100."

5.3.3 A Notice of Violation (Form ORC-R10) must be posted in a conspicuous location until the violation has been corrected.

5.4 Types of Inspections. Inspections are performed to verify compliance with all applicable laws and regulations.

5.4.1 Regular Inspections

5.4.1.1 Regular inspections are performed on a routine basis in permanent, operating, registered facilities. These inspections shall address all items on the inspection report form. Items in violation shall be recorded by item number.

5.4.2 Follow-up Inspections

5.4.2.1 Follow-up inspections shall be performed when a regular inspection finds one (1) or more Severity Level 1 violation(s) or three (3) or more Severity Level 2 violations.

5.4.2.2 Follow-up inspections may also be performed to verify proper posting of certificates, licenses or registrations, after complaint and investigation inspections, or after administrative hearings.

5.4.3 Complaint Inspections

5.4.3.1 Complaint inspections are performed in response to formal or informal complaints against registered facilities.

5.4.3.2 A complete inspection may be performed by the Agency in the interest of protecting the public.

5.4.4 Investigation Inspections

5.4.4.1 Investigation inspections are performed on non-registered radiation facilities for determining whether compliance with the regulations is required.

5.4.5 Other Inspections

5.4.5.1 Other inspections include construction/modification, pre-operational and other inspections not included above.

16 Del. Admin. Code § 4465-K-5.0

16 DE Reg. 1274 (6/1/2013) (Final)