Statutes, codes, and regulations
Delaware Administrative Code
Title 16 - Health and SafetyDepartment of Health and Social ServicesDivision of Public HealthHealth Systems Protection (HSP)Delaware Radiation Control Regulations
Part K - COMPLIANCE PROCEDURES
Section 4465-K-6.0 - Correction of Violations

16 Del. Admin. Code § 4465-K-6.0

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Current through Register Vol. 28, No. 7, January 1, 2025
Section 4465-K-6.0 - Correction of Violations
6.1 Violations of the regulations have been classified as Severity Level 1 and Severity Level 2 depending upon the impact of the violation.
6.1.1 Severity Level 1 violations generally could result in overexposure to the patient or operator or violate individual's rights as outlined in the regulations.
6.1.2 Severity Level 2 violations generally will not result in overexposure but may indicate a lack of administrative controls over the use of the radiation source. Reference Appendix A for violation classifications.
6.2 Severity Level 1 Items
6.2.1 When one (1) or two (2) Severity Level 1 items of violation are found by any inspection, the related source(s) of radiation shall be tagged "out-of-use." All violations shall be corrected prior to returning the unit in service.
6.2.2 When three (3) or more Severity Level 1 items of violation are found by any inspection, the certificate, license or registration shall be suspended in accordance with Compliance Procedures. All violations shall be corrected prior to resuming registered activities.
6.2.3 The licensee or registrant shall inform the Agency in writing within 10 days of issuance of the inspection report of the proposed method or means of correcting the Severity Level 1 violation(s) and of the date when the correction will be made.
6.2.4 Follow-up inspections shall be conducted within 30 days to assure correction.
6.3 Severity Level 2 Items
6.3.1 All Severity Level 2 items shall be corrected as soon as possible, but in any event, within 60 days.
6.3.2 Follow-up inspections shall be conducted within 60 days to assure corrections have been completed.
6.4 If a follow-up inspection of a registered facility indicates non-compliance of a previously cited violation of the last inspection, a hearing before the Authority on Radiation Protection shall be scheduled. Additionally, the Agency may file a complaint to the Authority.

16 Del. Admin. Code § 4465-K-6.0

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