Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Systems Protection (HSP), 4465, pt. K, app A
Current through Register Vol. 28, No. 7, January 1, 2025
Radiation Source Facility
| Severity Level 1 | Severity Level 2 | ||
| 1. | Operating without a permit | 1. | Registration Form |
| 2. | Personnel Overexposure | 2. | Notice to Employees |
| 3. | Radiation Levels Excessive | 3. | Safety Procedures |
| 4. | Personnel Monitoring | 4. | Personnel Monitoring Records |
Medical Uses
| Severity Level 1 | Severity Level 2 | ||
| 1. | Patient exposure (ESE) | 12. | |
| 2. | Tube support | 13. | Maintenance of x-ray system records |
| 3. | Technique indicators | 14. | Speed of film/screen |
| 4. | Multiple tube indication | 15. | Technique chart |
| 5. | Gonadal shielding | 16. | Warning label |
| 6. | Operator apron/barrier | 17. | Patient dose of 1 gray (100 rads) or more not reported to the Agency |
Radiographic
| Severity Level 1 | Severity Level 2 | ||
| 1. | Location of x-ray controls | 1. | Visual/audio signal |
| 2. | Position indicating device | 2. | Adjustment of x-ray field |
| 3. | Beam Collimation | 3. | Indication of field size, upon adjustments |
| 4. | Filtration deficiency of 0.2+ mm | 4. | Means to limit source to skin distance |
| 5. | Variation in timer linearity of 15% or more | 5. | Filtration deficiency of 0.2 mm or less |
| 6. | Variation in exposure reproducibility of 15% or more | 6. | Variation in timer reproducibility linearity more that 10% but less than 15% |
| 7. | Total misalignment of x-ray/light field edges of 5% or more | 7. | Variation in exposure reproducibility more than5% but less than 10% |
| 8. | Total misalignment of x-ray beam/image receptor centers of 5% or more | 8. | Total misalignment of light/x-ray field edges more than 2% but less than 5% |
| 9. | Discorrespondence of indicated x-ray field with beam limited x-ray field of 5% or more | 9. | Total misalignment of x-ray beam/image receptor centers more than 2% but less than 5% |
| 10. | Discorrespondence of indicated x-ray with beam limited x-ray field more than 2% but less than 5% | ||
Fluoroscopic
| Severity Level 1 | Severity Level 2 | ||
| 1. | Activation of x-ray production | 1. | Posting of exposure rate measurements |
| 2. | Annual exposure rate measurement | 2. | Measurement records and posting of same |
| 3. | Exposure rate | 3. | Adjustment of field |
| 4. | Useful beam protective barrier | 4. | Means of field adjustment |
| 5. | Limitation of x-ray field to image receptor | 5. | Indication of kV and mA |
| 6. | Minimum field at maximum SID | 6. | Means to indicate that beam is perpendicular to image receptor |
| 7. | High level control exposure rate limit | 7. | Audible signal to reset |
| 8. | Timing device | 8. | Minimum source to skin distance |
| 9. | Control of scattered radiation | 9. | Exposure rate due to transmission through primary barrier |
| 10. | Failure to report patient dose of 1+ gray to the Agency | ||
Industrial Radiographic
| Severity Level 1 | Severity Level 2 | ||
| 1. > 2 mR/hr. | Failure to maintain radiation level from device < 4" in diameter below maximum allowable limit of 50 mR/hr. at 6" | < 2 mR/hr. | |
| 2. > 2 mR/hr. | Failure to maintain radiation level from device > 4" diameter below maximum allowable limit of 200 mR/hr. at surface | < 2 mR/hr. | |
| 3. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 200 mR/hr. at the surface | < 2 mR/hr. | |
| 4. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 10 mR/hr. at a distance of 1 meter | < 2 mR/hr. | |
| Locking of Source | |||
| 5. | Radiation Source Storage Container was found unlocked and not under the direct surveillance of authorized individual | ||
| 6. | Exposure device and/or storage container was not locked during transit or prior to unit being made secure | ||
| 7. | Device was not physically secured to prevent tampering or removal | ||
Survey Instruments
| Severity Level 1 | Severity Level 2 | ||
| 1. | Failure to adequately maintain survey instruments | 1. | Failure to possess calibrated back up instrument |
| 2. | Survey meter not capable of detecting 2-1000 mR/hr. | 2. | Failure to conduct quarterly calibrations |
| 3. | Failure to calibrate unit after servicing | ||
| 4. | Failure to achieve accuracy of (+ 20%) | ||
| 5. | Failure to calibrate each scale using 2 points other than zero | ||
| 6. | Failure to maintain calibration records for two years | ||
Leak Testing/Repair
| Severity Level 1 | Severity Level 2 | ||
| 1. | Service to sealed source not conducted by authorized individual | 1. | Failure to conduct leak test within 6 month interval |
| 2. | Failure to immediately withdraw contaminated unit from service to effect decontamination/repair | 2. | Leak test procedure not capable of detecting unit 0.005 uCi of removable contamination |
| 3. | Failure to properly label unsecured source | 3. | Failure to record test results in microcuries |
| 4. | Failure to notify agency within 5 days of receiving test results | ||
Inventory/Inspection
| Severity Level 1 | Severity Level 2 | ||
| 1. | Failure to perform quarterly operational safety maintenance and inspection | 1. | Failure to conduct quarterly inventory |
| 2. | Failure to withdraw defective unit from service | 2. | Failure to maintain utilization log |
| 3. | Failure to conduct and record alarm tests at the beginning of each period of use | 3. | Failure to log required information |
| 4. | Failure to properly document quarterly inspection and maintenance of radiation devices | ||
| 5. | Failure to record and maintain test results | ||
Limitations/Procedures/Controls
| Severity Level 1 | Severity Level 2 | ||
| 1. | Individual is not qualified Industrial Radiographer | 1. | Failure to maintain training and test records |
| 2. | Individual is not a qualified radiographer's assistant trainee | 2. | Failure to record dosimetry data |
| 3. | Qualified operator(s) not wearing personal monitoring devices | ||
| 4. | Operating and Emergency procedures do not meet the requirements | ||
Precautionary Procedures
| Severity Level 1 | Severity Level 2 | ||
| 1. | Failure of qualified operators to maintain direct surveillance | 1. | Failure to post required information |
| 2. | Failure to have calibrated and operable survey instrument available | 2. | Failure to maintain survey records for 2 years |
| 3. | Failure to conduct physical radiation survey | ||
| 4. | Failure to maintain records at temporary job site | ||
Special Requirements
| Severity Level 1 | Severity Level 2 | ||
| 1. | Failure to meet requirements for enclosed radiography | 1. | Failure to maintain evaluation records for 2 years |
| 2. | Failure to meet exemption requirements and maintain unit | ||
Analytical
| Severity Level 1 | Severity Level 2 | ||
| 1. | Failure to provide safety device | 1. | Failure to label equipment |
| 2. | Failure to provide warning devices | 2. | Failure to have appropriate warning lights |
| 3. | Failure to install shutter | 3. | Failure to provide protective cabinet to prevent leakage |
| 4. | Failure to construct tube housing in manner which ensures compliance | 4. | Failure to conduct Radiation Surveys |
| 5. | Failure to obtain Radiation Safety Officer's approval for by-passing safety device | 5. | Failure to document survey record |
| 6. | Failure to provide and/or ensure the use of extremity dosimeters | 6. | Failure to post area |
| 7. | Failure to instruct and/or ensure operator competence | 7. | Failure to secure unused ports |
Particle Accelerators Limitations
| Severity Level 1 | Severity Level 2 | ||
| 1. | Operator did not receive radiation safety instruction or could not demonstrate understanding of radiation safety | 1. | Operator had not received copies |
| 2. | Operator unable to demonstrate competency in the use of the accelerator | 2. | Radiation Safety Committee/Radiation Safety Officer is not authorized to terminate operations |
Controls/Interlocks
| Severity Level 1 | Severity Level 2 | ||
| 1. | HRA not provided with Interlock | 1. | Instrumentation and controls are not clearly identified |
| 2. | Interlock does not require manual reset | 2. | Scram buttons do not require manual reset |
| 3. | Safety interlocks not independently wired | 3. | Not all HRA entrances are equipped with warning lights |
| 4. | All safety interlocks are not fail safe | 4. | Not all HRA are equipped with audible warning devices which activate for 15 seconds |
| 5. | Scram buttons not located in HRA | 5. | HRA barriers/pathways are not identified |
Operating Procedures
| Severity Level 1 | Severity Level 2 | ||
| 1. | Particle accelerator not unsecured from unauthorized use | ||
| 2. | Bypass of safety interlock not authorized by Radiation Safety Officer and/or Radiation Safety Committee or not recorded and posted | 2. | Safety interlocks are used as routine "off" switch |
| 3. | Electrical circuit diagram not maintained and available | ||
| 4. | Current operating and emergency procedures are not kept at control panel | ||
| 5. | Record of quarterly safety device operability check are not available | ||
Radiation Monitoring
| Severity Level 1 | Severity Level 2 | ||
| 1. | Radiation protection survey not performed and/or documented by an approved person following operation or facility changes | 1. | Portable monitoring equipment not available, operable and calibrated) |
| 2. | Radiation levels not continuously monitored in all HRAs | 2. | All area monitors are not calibrated annually |
| 3. | Periodic surveys of airborne particulates are not performed | ||
| 4. | Periodic Smear Surveys are not conducted for contamination | ||
| 5. | All area surveys are not performed according to proper written procedures | ||
| 6. | Current records of all surveys and tests were not available at facility | ||
Ventilation Systems
| Severity Level 1 | |||
| 1. | Means are not provided to ensure compliance with Part D airborne concentrations | ||
| 2. | Airborne concentrations in excess of Part D limits were discharged to an uncontrolled area | ||
Notice and Reports to Workers
Posting of Notices
| Severity Level 1 | Severity Level 2 | ||
| 1. | |||
| 2. | Facility radiation permit/document not posted | ||
| 3. | Radiation operating procedures not posted | ||
| 4. | Notice of violation for radiological working conditions not posted | ||
| 5. | Notice to employees, Agency Form X not posted | ||
| 6. | Violations not posted within five (5) days nor remain posted for at least (5) days | ||
| 7. | Documents do not appear in sufficient number of conspicuous places | ||
Instructions to Workers
| Severity Level 1 | Severity Level 2 | ||
| 1. | Workers were not instructed to report any conditions that could cause unnecessary exposure to radiation | 1. | Workers were not kept informed of radiation sources |
| 2. | Workers were not instructed about warnings for unusual occurrence or malfunction that may involve exposure to radiation | 2. | Workers were not instructed of health protection problems associated with radiation exposure |
| 3. | Workers were not advised of radiation exposure reports | 3. | Workers were not instructed to observe applicable parts of DRCR |
Notifications
| Severity Level 1 | Severity Level 2 | ||
| 1. | Written report of specified Radiation exposure data are not given to the worker | 1. | Workers are not advised annually of their radiation exposure |
| 2. | Workers are not furnished a radiation exposure report within 30 days after the licensee becomes informed of exposure or termination of employment | 2. | As required pursuant to Part D, Sections 46.0, 47.0 and 48.0 exposed individuals are not provided a report of their radiation exposure |
Representatives of Registrant/Workers
| Severity Level 1 | |||
| 1. | Agency not afforded opportunity to inspect equipment and activities | ||
| 2. | Agency not permitted to consult with workers privately | ||
| 3. | Worker authorized representative not given opportunity to accompany agency during inspection of physical working conditions | ||
| 4. | Worker representative does not meet qualifications set forth in routine radiation | ||
| 5. | Different facility/worker representatives not permitted to accompany agency on inspection | ||
| 6. | Mutually agreed upon "outside" individual(s) was not permitted to accompany agency inspectors | ||
| 7. | Worker(s) was not allowed to privately consult with the Agency inspector about perceived radiological condition | ||
| 8. | A worker has been discharged or discriminated against for filing a radiological complaint on behalf of himself or others | ||
Therapeutic Radiation Machines
| Severity Level 1 | Severity Level 2 | ||
| 1. | All non-compliance with the requirements of Part X are Severity Level 1 violations. | ||
Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Systems Protection (HSP), 4465, pt. K, app A
22 DE Reg. 401( 11/1/2018) (Final)