ML22301A137
| ML22301A137 | |
| Person / Time | |
|---|---|
| Issue date: | 10/28/2022 |
| From: | Cherie Crisden, Anne Defrancisco, Kenneth Kolaczyk, Tindle-Engelmann E NRC Region 1, NRC/RGN-III, NRC/NRR/DRO/IRAB |
| To: | |
| References | |
| Download: ML22301A137 (27) | |
Text
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Cross Regional KT:
Cabell Huntington Hospital Cherie Crisden, Enforcement Specialist RI Anne DeFrancisco, Branch Chief RI Elizabeth Tindle-Engelmann, Health Physicist RIII
Outline
- Background
- Routine Inspection
- NRC Findings
- Enforcement
- Stakeholders
- Lessons Learned
=
Background===
10 CFR 20.1502 requires that each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits in 10 CFR Part 20.
- Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed sources under the control of the licensee and shall supply and require the use of individual monitoring devices by (1)
Adults likely to receive in 1 year from sources external to the body, a dose
> 10 % of the limits; Inaccurate dosimeter readings arise from:
- Not wearing dosimeters
- Wearing dosimeters incorrectly or inconsistently
- Improper storage of dosimeters
- Failure to return dosimeters
=
Background===
- Physicians use radioactive material for diagnostic and therapeutic uses such as Yttrium-90 (Y-90) microspheres for radioembolization.
- In Y-90 procedures, interventional radiologists (IR) use fluoroscopy to place a microcatheter.
=
Background===
- Occupational dose to IR from the Y-90 handling is small but greater than zero.
- Many licensee fail to evaluate abnormal results.
- IN-21-02, Recent Issues Associated With Monitoring Occupational Exposure To Radiation From Licensed And Unlicensed Radiation Sources, issued to communicate the issues to the industry
Who is Cabell Huntington Hospital?
Routine Inspection Table 1. CHH Dosimetry Results for AUs 1-5 AU 2021 QTD Facility 1
(mrem) 2021 Facility 2
(mrem) 2020 Facility 1
(mrem) 2020 Facility 2
(mrem) 2019 Facility 1
(mrem) 2019 Facility 2
(mrem)
AU1 Minimal Unused Minimal 67 Minimal Unused AU2 Minimal Unused Minimal Minimal Minimal Minimal AU3 Minimal Unused Minimal Minimal Minimal Minimal AU4 Minimal Unused Minimal Unused Minimal Unused AU5 Minimal 382 Minimal 334 Minimal Minimal
Overexposure Report
- YTD TEDE: 2632 mrem
- YTD Extremity: 121538 rem
- Actions
- Education
- Administrative controls
- Engineering controls
Overexposure Report Table 2. Vendor Dosimetry Results for AU 1 for Jan-Aug 2021 Facility Wear period TEDE (mrem)
Extremity (mrem) 1 January-April M
M 1
May 93 3236 1
June 210 37029 1
July 235
?
1 August 194
?
2 January - April M
M 2
May 73 1853 2
June 225 2287 2
July 50 690 2
August
?
11524 E
Dose Reconstruction Extremity TEDE Lens of the Eye 2021 2020 2019 2021 2020 2019 2021 2020 2019 AU1 475.526 560.880 571.294 10.202 12.051 11.670 17.003 20.085 19.449 AU2 24.815 26.873 28.301 7.445 8.062 8.490 12.408 13.436 14.150 AU3 13.774 14.270 18.321 4.132 4.281 5.496 6.887 7.135 9.161 AU4 25.748 23.325 30.151 3.984 3.614 4.675 6.640 6.023 7.792 AU5 10.552 9.739 14.926 3.165 2.922 4.478 5.276 4.869 7.463 Table 3. Dose per Calendar Year (rem)
Reactive Inspection Service provider Service provider RSO and CHH RSO Source Vendor State of Louisiana RIV SAO RI SAO RI MLAB
Reactive Inspection Vendor FedEx Hospital Vendor FedEx Food bank box truck Hospital
NRC Findings
- Failure to control occupational exposures to the limits
- Possession of RAM at an unauthorized location Safety consequences
- Failure to develop ALARA program.
- Failure to monitor occupational exposure to radiation from licensed and unlicensed radiation.
- Failure to provide adequate instruction.
Causal Factors Causal Factors
- Lack of management oversight.
- Lack of adequate resources.
Most likely root cause Most likely root cause
NRC Findings 14 violations and 1 willful determination from OI case
- License condition 14
- The Enforcement Policy does not distinguish between dose from licensed versus unlicensed sources of radiation
- When very little dose is from licensed sources of radiation, should that be considered?
- Was there impact to public health and safety?
- Did the circumstances warrant consideration?
Possession of RAM at an unauthorized location Possession of RAM at an unauthorized location
- SLI, SLII, and SLIII policy examples for the various overexposures
- SLIII policy example for the failure to control the Ir-192
- SLIII precedent for program issues
- Willful determination Significance Significance
Enforcement Tool Kit
- A confirmatory action letter was issued in November to reaffirm the corrective actions communicated in the first overexposure report.
- The licensee received a choice letter offering a PEC or ADR.
- ADR was conducted in August an order is forthcoming!
Enforcement Tool Kit
- The individual involved in deliberate misconduct received a choice letter offering a PEC or written response.
- A written response was received final action is forthcoming!
Internal Stakeholders R1 OE NMSS OGC OI OEDO NSIR R3 R4 OPA
- MD 8.3 guidance relative to the overexposures:
- 1. An IIT should be considered for a significant event with one or more of the following characteristics:
- Led to a significant occupational exposure
- 2. For an event of lesser health and safety or safeguards significance an AIT should be formed:
- Led to a radiological release of byproduct, source, or special nuclear material to unrestricted areas that resulted in occupational exposure or exposure to a member of the public in excess of the Involved the deliberate misuse of byproduct, source, or special nuclear material from applicable regulatory limit
- It was determined that an AIT and IIT were not needed. However, the inspection charter committed to determining if the inspection should be elevated to an augmented inspection team based on Management Directive 8.3, NRC Incident Investigation Program and Management Directive 8.10, NRC Assessment Program for a Medical Event of an Incident Occurring at a Medical Facility.
External Stakeholders NRC WV DHHR OSHA
Lessons Learned Exhibit flexibility in Processes!
- Inspection approach
- Team characterization
- ADR conduct Communications!
- Key messaging to the licensee regarding 14 violations
- Stakeholder updates Knowledge base!
- Mixed doses scenarios may be a basis for further review and may push staff to learn about different technologies.
- Inter-agency and intra-agency coordination is critical, you can inform your decision with input from others.
QUESTIONS?
INSPECTION PROCEDURES - HOW SHOULD THEY BE APPLIED FOLLOWING FEEDBACK FROM THE OIG?
Next Week - Operating Reactor Refresher Training: