IR 015000202/2030001
| ML24311A006 | |
| Person / Time | |
|---|---|
| Site: | 03012150, 015000202 |
| Issue date: | 11/07/2024 |
| From: | Rhex Edwards NRC/RGN-III/DRSS/MIB |
| To: | Hunter S Northwest Health - Porter |
| Piskura D | |
| References | |
| IR 2023001 | |
| Download: ML24311A006 (11) | |
Text
November 7, 2024
SUBJECT:
NRC ROUTINE INSPECTION REPORT NO. 030-12150/2023001(DRSS) AND NOTICE OF VIOLATION - NORTHWEST HEALTH - PORTER
Dear Sarah Hunter:
This letter refers to the routine inspection conducted on November 16, 2023, by an inspector from the U.S. Nuclear Regulatory Commission (NRC) at your medical center in Valparaiso, Indiana, with continued in-office review through October 25, 2024. The purpose of the inspection was to review activities performed under your NRC license to ensure that these activities were being performed in accordance with NRC requirements. The purpose of the in-office review was to evaluate additional information not available during the on-site inspection. You provided information on your dosimetry data and analysis in a letter dated April 29, 2024 (NRCs Agencywide Documents Access and Management System (ADAMS)
Accession ML24152A235). Deborah Piskura of my staff conducted a final exit meeting by videoconference with members of your staff on October 25, 2024, to discuss the inspection findings. This letter presents the results of the inspection.
This inspection examined activities conducted under your license as they relate to public health and safety, and to confirm compliance with the NRCs rules and regulations, and with the conditions of your license. Within these areas, the inspection consisted of selected examination of procedures and representative records, observations of activities, and interviews with personnel.
Based on the results of this inspection, the NRC has determined that one Severity Level IV violation of NRC requirements occurred. The violation concerned the failure to monitor individuals extremity exposure from licensed and unlicensed radiation sources as required by Title 10 of the Code of Federal Regulations (10 CFR) 20.1502(a)(1). The violation was evaluated in accordance with the NRC Enforcement Policy, available on the NRCs website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation is cited in the enclosed Notice of Violation (Notice) (Enclosure 1). The NRC is citing the violation in the enclosed Notice because the inspector identified it.
The root cause of the violation was determined to be a misunderstanding of regulatory requirements. As corrective action, you retrained involved staff on the requirement and revised procedures to clarify expectations for compliance with that requirement. The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved is already adequately addressed on the docket in this letter and in additional correspondence. Therefore, you are not required to respond to this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter, its enclosures, and any response you provide, will be made available electronically for public inspection in the NRCs Public Document Room or from the NRCs Agencywide Documents Access and Management System (ADAMS), accessible from the NRCs website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, any response should not include any personal privacy, proprietary, or security-related information so that it can be made publicly available without redaction.
Please feel free to contact Deborah Piskura of my staff if you have any questions regarding this inspection. Deborah Piskura can be reached at 630-829-9867 or Deborah.piskura@nrc.gov.
Sincerely, Rhex A. Edwards, Chief Materials Inspection Branch Division of Radiological Safety and Security Docket No. 030-12150 License No. 13-17073-01 Enclosures:
1. Notice of Violation 2. Inspection Report No. 030-12150/2023001(DRSS)
cc w/encl: State of Indiana Signed by Edwards, Rhex on 11/07/24 Letter to from R. Edwards, dated November 7, 2024.
SUBJECT:
NRC ROUTINE INSPECTION REPORT NO. 030-12150/2023001(DRSS) AND NOTICE OF VIOLATION - NORTHWEST HEALTH - PORTER DISTRIBUTION w/encl:
Jack Giessner Mohammed Shuaibi David Curtis Jonathan Feibus Diana Betancourt-Roldan Kenneth Lambert Geoffrey Edwards Jason Draper MIB Inspectors ADAMS Accession Number: ML24311A006 OFFICE RIII-DRSS RIII-DRSS
NAME DPiskura:brt REdwards
DATE 11/6/24 11/7/24 OFFICIAL RECORD COPY
Enclosure 1 NOTICE OF VIOLATION Northwest Health - Porter License No.13-17073-01 Valparaiso, IN Docket No. 030-12150 During a U.S. Nuclear Regulatory Commission (NRC) inspection conducted on November 16, 2023, with continued in-office review through October 25, 2024, one violation of NRC requirements was identified. In accordance with the NRC Enforcement Policy, the violation is listed below:
Title 10 of the Code of Federal Regulations (10 CFR) 20.1502(a)(1) requires, in part, that each licensee monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in 10 CFR 20.1201(a).
Contrary to the above, during calendar year 2022 through November 16, 2023, the licensee failed to monitor an individuals occupational exposure to radiation from licensed and unlicensed radiation sources under the licensees control and failed to require the use of individual monitoring devices by interventional radiologists who were likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in 10 CFR 20.1201(a). Specifically, three interventional radiologists failed to consistently wear their assigned extremity dosimetry between 2022 and 2023 while working with licensed and unlicensed sources.
This is a Severity Level IV violation (Section 6.7).
The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in this letter and in additional correspondence. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation, IR 03012150/2023001(DRSS)" and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555-0001 with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice.
Any response you provide will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible at http://www.nrc.gov/reading-rm/adams.html. Therefore, to the extent possible, your response should not include any personal privacy, proprietary, or security-related information so that it can be made available to the Public without redaction.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days of receipt.
Dated this 7th day of November 2024.
Enclosure 2 U.S. Nuclear Regulatory Commission Region III Docket No.
030-12150 License No.
13-17073-01 Report No.
030-12150/2023001(DRSS)
Licensee:
Northwest Health - Porter Address:
85 E. U.S. Hwy 6 Valparaiso, Indiana Locations Inspected:
85 E. U.S. Hwy 6.
Valparaiso, Indiana Inspection Dates:
November 16, 2023, with continued in-office review through October 25, 2024 Exit Meeting Date:
October 25, 2024 Inspector:
Deborah A. Piskura, Senior Health Physicist Approved By:
Rhex A. Edwards, Chief Materials Inspection Branch Division of Radiological Safety and Security
EXECUTIVE SUMMARY Northwest Health - Porter NRC Inspection Report 030-12150/2023001 (DRSS)
The U.S. Nuclear Regulatory Commission (NRC) conducted a routine, unannounced inspection on November 16, 2023. The inspection was conducted to assess the adequacy of the medical institutions operations authorized under its NRC license. The inspection included an in-office review through October 25, 2024, to evaluate the licensees dose reconstruction data for three interventional radiologists who failed to consistently wear their assigned extremity dosimetry due to a misunderstanding of the monitoring requirements.
The inspector identified that three interventional radiology physicians, authorized as users for yttrium-90 administrations, had not consistently worn their assigned personnel extremity dosimeters for a period of several years, which were intended to be used to monitor radiation dose to these individual. At the NRCs request, the licensee performed a retrospective evaluation of the radiation dose received by the interventional radiology physicians during calendar years 2022 to 2023. One violation of NRC requirements was identified during this inspection involving the licensees failure to monitor individuals extremity exposure from licensed and unlicensed radiation sources as required by 10 CFR 20.1502(a)(1).
Following the onsite inspection, the licensee implemented several corrective actions to address the personnel dosimetry issue. This included revising the licensees policies that monitor the use of dosimetry and providing individuals with instruction regarding the use of personnel extremity monitoring devices.
REPORT DETAILS
Program Overview and Inspection History Northwest Health - Porter (the licensee) was authorized under NRC Materials License No. 13-17073-01 for materials permitted in Title 10 of the Code of Federal Regulations (CFR) Sections 35.100, 35.200, 35.300, 35.400 (limited to manual brachytherapy), and 35.1000, including yttrium-90 microspheres. This licensee was a large medical institution and conducted licensed activities at two locations; the licensee ceased operations at its office clinic in November 2023 requesting the removal of this facility form its NRC license. The licensee retained the services of a consulting physicist who audited the radiation safety program on a quarterly basis.
The licensees main hospital in Hobart, Indiana, administered on average five yttruim-90 microsphere treatments annually using the Sirtex SIR-Spheres brachytherapy system.
Three interventional radiologists (IRs) were specifically named on the NRC License as authorized users for yttrium-90 microspheres. These IRs also served as authorized users of radiation-producing devices, such as fluoroscopes and other x-ray generating devices, that are not licensed or regulated by the NRC. The licensee instituted a multi-departmental approach for the use of yttrium-90 microspheres. The team consisted of an IR/authorized user, a nurse, and a nuclear medicine technologist. The team administered all microspheres treatments in the interventional radiology suite.
The NRC conducted routine inspections on August 18, 2021, and November 20, 2018; no violations of NRC requirements were identified during these previous inspections.
Management Oversight and the Radiation Safety Committee 2.1 Inspection Scope The inspector reviewed the licensees organization and management controls for the radiation protection program, including the organizational structure, management, and Radiation Safety Committee (RSC) involvement and oversight, radiation safety office staffing, and the effectiveness of procedures and management practices in implementing the program. The inspector reviewed audit reports and RSC meeting minutes for the calendar years 2022 through 2023.
2.2 Observations and Findings The radiation protection program was overseen by one of the authorized physician users who was specifically named on the NRC license as the radiation safety officer. The licensee retained the services of a consultant physicist who audited the radiation protection program on a quarterly basis. The consultant presented their audit findings during the licensees quarterly radiation safety committee meetings. The inspector reviewed a sampling of audit reports which included areas of radiation safety, surveys, personnel monitoring, operations, transportation, training, sealed source leak tests and inventory, equipment calibrations and quality assurance checks, and radioactive waste management.
The licensee established a RSC which met on a quarterly basis. The inspector reviewed selected radiation safety committee meeting minutes. The radiation safety committee established a quorum for its meetings to review the radiation safety program, program audit results, and corrective actions for self-identified violations.
The licensees consultant conducted quarterly reviews of the radiation safety program.
The results of the annual review were provided to the RSC in a written report. The report served as an overall status report to senior management on the state of the radiation safety program.
2.3 Conclusions The inspector concluded that the licensees audits of the radiation safety program were comprehensive. No violations of NRC requirements were identified in this program area.
Personnel Monitoring Program for Interventional Radiologists 3.1 Inspection Scope This inspection included a review of the licensees personnel monitoring program with focus on the IRs. The inspector reviewed records, procedures, and documents maintained by the licensee, observed licensed activities, and interviewed selected licensee personnel. The inspector reviewed personnel monitoring reports including the IRs for the calendar years 2022 to 2023.
3.2 Observations and Findings The inspector reviewed a select sampling of personnel dosimetry records for the IR staff.
This licensee utilized a double dosimeter approach as its method for monitoring the whole-body radiation exposures of its IRs occupational exposures received during IR fluoroscopy procedures (unlicensed sources) and yttrium-90 (licensed sources)
administrations. The licensee furnished a digital monitoring collar dosimeter to be worn outside the lead apron and one digital monitoring dosimeter to be worn at the waist under the lead apron. The licensee also provided ring badges to monitor the physicians extremity dose; the ring badges were exchanged on a monthly basis.
The inspector initially identified three IRs who failed to consistently wear their assigned personnel extremity monitoring for several years while working with licensed and unlicensed sources of radiation. Based on the inspector's review of dosimetry reports between 2022 and 2023, the IRs had no extremity dose history, with some months showing no recorded extremity dose and some months where no extremity badge was apparently returned to the dosimetry provider for processing. The inspector reviewed the whole body and collar badge recorded exposures in comparison with the exposure data to each physicians workload. Discussions with the consultant and the licensee staff revealed that the hospitals practice required the IRs to wear these extremity badges while working with yttrium-90. It was their understanding that the use of extremity badges was required only when working with licensed sources (yttrium-90) of radiation.
The inspector explained that extremity monitoring was expected to be worn by individuals at all times while working with licensed and unlicensed sources of radiation in order to provide an accurate exposure history for each individual that was required to be monitored.
The inspector requested the licensee perform a dose reconstruction for the IRs estimated extremity exposure from all sources of radiation (licensed and unlicensed)
used by these physicians, including fluoroscopy and all locations, if applicable. The licensee provided its extremity dose reconstruction estimate in its letter dated April 29, 2024. The licensees estimated exposures for each IR for the years 2022 through 2023 were below the regulatory limits [ML24152A235 (redacted) and ML24124A154 (original with PII) and are summarized in the table below.
Northwest Health - Porter Summary of IR Dose and Dose Reconstruction Data IR 1 2022 2023 Recorded extremity (mrem)
0 Extremity dose (SDE)
reconstruction (mrem)
10,144 11,630 No. of IR cases 351 409 No. of Y-90 cases
0 IR 2 2022 2023 Recorded extremity (mrem)
0 Extremity dose (SDE)
reconstruction (mrem)
5,391 3,027 No. of IR cases 250 231 No. of Y-90 cases
0 IR 3 2022 2023 Recorded extremity (mrem)
0 Extremity dose (SDE)
reconstruction (mrem)
14,864 14,894 No. of IR cases 388 369 No. of Y-90 cases
3 Title 10 CFR 20.1502(a) requires, in part, that each licensee shall monitor exposure to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of 10 CFR Part 20. At a minimum, each licensee shall monitor exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in 10 CFR 20.1201(a).
Contrary to the above, the licensee failed to monitor exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual extremity monitoring devices by adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in 10 CFR 20.1201(a). The licensees failure to monitor three individuals occupational extremity exposure to radiation and radioactive material was a violation of 10 CFR 20.1502(a).
The inspector evaluated the licensees radiation dose estimates. The licensees methodology described in its dose reconstruction efforts did not appear to underestimate the radiation dose and resulted in conservative, but reasonable radiation extremity dose estimates for the three IR physicians. Based on the licensees dose reconstruction, no IR exceeded the NRCs allowable dose limit for that respective monitoring year. The inspectors determined this was a Severity Level IV violation in accordance with NRC Enforcement Policy Section 6.7 because the licensees dose estimate was conservative, and there was not a substantial potential for exposures in excess of applicable 10 CFR Part 20 limits.
The licensee implemented the following measures to restore compliance: (1) training to the IR physicians regarding the licensees policies and NRC regulations for personnel monitoring, specifically the use of the extremity badges; (2) ensuring that the IR physicians consistently wear their assigned dosimetry during a time-out; and updating each IR physicians NRC Form-5 to include the extremity dose reconstruction data.
3.3 Conclusions The inspector identified one violation involving the licensees failure to monitor three individuals extremity occupational exposure to radiation and radioactive material. The licensee implemented actions to restore compliance for the violation.
Other Areas Inspected 4.1 Inspection Scope The inspector observed licensed activities, interviewed licensee personnel, and reviewed selected records concerning the use and security of licensed materials, and other aspects of the radiation safety program. The inspector observed the use of byproduct material, including the administration of several dosages for various nuclear medicine studies. The inspector performed confirmatory surveys in areas of radioactive materials use and in public areas using a Thermo Scientific Model RadEye G survey instrument (Serial No. 30649), calibration date May 9, 2023.
4.2 Observations and Findings The inspector observed that the licensee personnel maintained constant surveillance of its licensed material. In addition, the nuclear medicine hot lab remained secured. The inspector determined that the licensees radiation safety officer provided annual training to all staff working with or in the vicinity of licensed material. Through interviews, the inspector determined that the licensee staff understood security requirements for licensed material.
The licensee monitored radiation exposure to nuclear medicine technologists using whole body and extremity personnel dosimeters provided by an accredited laboratory.
The inspector reviewed a sampling of dosimetry reports and determined that all monitoring results for the monitoring of nuclear medicine personnel were below Part 20 occupational exposure limits.
The inspector reviewed written directives and treatment plans (when applicable) for several iodine-131 and yttrium-90 patient treatments. The licensee documented the written directive, the confirmation of the patient identity, and prescribed dose/dosage verification. No medical events were identified.
The inspector examined selected sealed sources in the licensees possession. Each source container was noted to bear a clearly visible label identifying the radionuclides and source activities. The licensees consultant performed inventories and leak tests of the sealed sources and documented the results in their reports.
The licensee posted caution signs, NRC-3 forms, and license documents in accordance with 10 CFR Parts 19 and 20. The nuclear medicine hot labs were also posted with emergency/decontamination procedures and an approved dosage chart. During facility tours the inspector noted no evidence of eating, drinking, smoking, or cosmetic application in restricted areas.
The licensee possessed several calibrated survey instruments used by the nuclear medicine staff. The inspector observed licensee staff perform package surveys, area surveys and dose calibrator constancy checks. Confirmatory surveys indicated radiation levels consistent with licensee survey records and postings.
4.3 Conclusions Based on record reviews, interviews with personnel, and the observations described above, the inspector determined that no violations of NRC requirements were identified.
Exit Meeting Summary The NRC inspector presented the preliminary inspection findings following the onsite inspection on November 17, 2023. The licensee did not identify any documents or processes reviewed by the inspector as proprietary. The licensee acknowledged the findings presented. The final exit meeting was conducted via videoconference on October 25, 2024.
LIST OF PERSONNEL CONTACTED
- Angela Hamilton, RT(R), Manager, Radiology Sarah Hunter, Chief Operating Officer
- Sharon Long, Consultant, Medical Physics Consultants, Inc.
James M. Forde, M.D., Radiation Safety Officer Vivek Mishra, M.D., Interventional Radiologist/Authorized User
- Lori Plankey, CNMT
- Melissa Rainwater, CNMT
- Darnella Young, BS, RHIT, Director of Quality Several nuclear medicine professionals were also contacted as part of this inspection.
- Attended the on-site exit meeting on November 16, 2023
- Attended exit videoconference on October 25, 2024 INSPECTION PROCEDURES USED IP 87130, Nuclear Medicine Programs IP 87132, Brachytherapy Programs