ML18284A028
| ML18284A028 | |
| Person / Time | |
|---|---|
| Site: | 03001303 |
| Issue date: | 10/10/2018 |
| From: | Trapp J M Division of Nuclear Materials Safety I |
| To: | Anzilotti K F Christiana Care Health Services |
| References | |
| EA-18-112, NMED 180259 IR 2018001 | |
| Download: ML18284A028 (12) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BLVD. KING OF PRUSSIA, PA 19406-2713 October 10, 2018 EA-18-112 NMED NO. 180259
Kert F. Anzilotti, MD, MBA Chief Medical Officer Acute Care
Christiana Care Health Services CH Management Suite 1218
4755 Ogletown-Stanton Road Newark, DE 19718
SUBJECT:
CHRISTIANA CARE HEALTH SERVICES, INC. - NRC INSPECTION REPORT NO. 03001303/2018001 AND EXERCISE OF ENFORCEMENT DISCRETION
Dear Dr. Anzilotti:
This letter refers to a reactive and routine, unannounced inspection conducted on June 5 and July 9-12, 2018, at the Christiana Care Health Services, Inc. (CCHS) facilities in Newark, Bear, Smyrna, Middletown, and Wilmington, Delaware. The reactive inspection was conducted to review the circumstances surrounding the loss of 50 Iodine-125 (I-125) seeds as reported to the NRC on June 1, 2018.
The routine inspection examined activities conducted under your license as they relate to safety and compliance with the Commission's rules and regulations and with the conditions in your license. Within these areas, the inspection consisted of an examination of selected procedures and representative records, observations of activities, and interviews with personnel. The inspector discussed the preliminary inspection findings with you, Carol Wen, and other members of your staff at the conclusion of the on-site portion of the inspection. A final exit briefing was conducted (telephonically) with you and other members of your staff on September 12, 2018. The enclosed report documents the results of this inspection.
Based on the results of this inspection one apparent violation was identified and is being considered for escalated enforcement action in accordance with the NRC Enforcement Policy.
The current Enforcement Policy is included on th e NRC's Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The apparent violation involved the failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and was not in storage, as required by 10 CFR 20.1802. The circumstances surrounding the apparent violation, the significance of the issue, and the need for lasting and effective corrective action were discussed with you and members of your staff at the inspection
exit meeting on September 12, 2018. As a result, it may not be necessary to conduct a pre-decisional enforcement conference (PEC) in order to enable the NRC to make an enforcement decision.
Since the apparent violation involves the loss of approximately 14.8 millicuries of I-125
brachytherapy seeds, the NRC is considering proposing imposition of a civil monetary penalty. Section 2.3.4, Civil Penalty, of the NRC Enforcem ent Policy states that for violations where a K. Anzilotti 2 licensee has lost control of its regulated licensed material for any period of time, the NRC normally will impose at least a base civ il penalty. The base civil penalty amount is approximately three times the expected average cost of authorized disposal. In this case, in accordance with Tables A and B in Section 8 of the Enforcement Policy, for material of the type and amount of material involved, the NRC would propose a civil penalty of $3500. However, the NRC may exercise discretion to mitigate or escalate a civil penalty amount based on the merits of a specific case. Therefore, you may provide information regarding the actual expected cost of authorized disposal that you believe the NRC should consider in making a final enforcement decision.
Before the NRC makes its enforcement decision, we are providing you an opportunity to either (1) respond to the apparent violation addressed in this inspection report within 30 days of the date of this letter, (2) request a PEC to meet with the NRC and present your views in person, or (3) request Alternative Dispute Resolution (ADR). Alternately, you may choose to accept the apparent violation as characterized in this letter and its enclosure, in which case the NRC will proceed with an enforcement decision.
If you choose to provide a written response, it should be clearly marked as a "Response to Apparent Violation" in NRC Inspection Report 03001303/2018001; EA-18-112 and should include for the apparent violation: (1) the reason for the apparent violation or, if contested, the basis for disputing the apparent violation; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved. Additionally, your response should be sent to the NRC's Document Control Center, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 with a copy mailed to James Trapp, Director, DNMS, Region I, 2100 Renaissance Boulevard, Suite 100, King of Prussia, PA 19406-2713, within 30 days of the date of this letter. If an adequate response is not received within the time specified or an extension of time has not been granted by the NRC, the NRC will proceed with its enforcement decision or schedule a PEC.
If you choose to request a PEC, the meeting should be held in our office in King of Prussia, PA within 30 days of the date of this letter. The conference will afford you the opportunity to provide
your perspective on these matters and any other information that you believe the NRC should take into consideration before making an enforcement decision. The topics discussed during the conference may include information to determine whether a violation occurred, information to determine the significance of a violation, information related to the identification of a violation, and information related to any corrective actions taken or planned. The PEC would be open for public observation, and the NRC would issue a press release to announce the conference time and date, in accordance with Section 2.4, "Participation in the Enforcement Process," of the NRC enforcement policy.
In lieu of a PEC, you may also request ADR with the NRC in an attempt to resolve this issue. ADR is a general term encompassing various techniques for resolving conflicts using a neutral third party. The technique that the NRC has decided to employ is mediation. Mediation is a voluntary, informal process in which a trained neutral (the "mediator") works with parties to help them reach resolution. If the parties agree to use ADR, they select a mutually agreeable neutral mediator who has no stake in the outcome and no power to make decisions. Mediation gives parties an opportunity to discuss issues, clear up misunderstandings, be creative, find areas of agreement, and reach a final resolution of the issues. Additional information concerning the NRC's program can be obtained at http://www.nrc.gov/about nrc/regulatory/enforcement/adr.html. The Institute on Conflict Resolution (ICR) at Cornell K. Anzilotti 3 University has agreed to facilitate the NRC's program as a neutral third party. Please contact ICR at 877-733-9415 within 10 days of the date of this letter if you are interested in pursuing resolution of this issue through ADR.
Please contact Donna Janda at 610-337-5371 within 10 days of the date of this letter to notify which of the above options you choose. If you do not contact the NRC within the time specified, and an extension of time has not been granted by the NRC, the NRC will proceed with its enforcement decision.
Additionally, the NRC determined that two violations of NRC requirements occurred. The first violation involved the failure to calibrate the Rubidium-82 (Rb-82) generator unit used to measure activity of the dosage before administration to each patient or human research subject, as required by 10 CFR 35.60. This calibration may either be performed in accordance with nationally recognized standards or calibration instructions provided by the manufacturer. Until such standards or procedures are developed, compliance with 10 CFR 35.60 is not possible. The second violation involved the failure to determine the activity of each dosage administered before medical use, as required by 10 CFR 35.63. Due to the 76 second half-life of Rb-82 and the direct infusion of the Rb-82 into the patient, users of this generator system are unable to measure patient dosage of Rb-82 prior to administration.
Although violations of 10 CFR 35.60 and 35.63 were identified and, in accordance with the NRC Enforcement Policy, would normally be categorized at Severity Level IV, CCHS met all of the criteria listed in NRC Enforcement Guidance Memorandum (EGM) 13-003, "Interim Guidance for Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of
Instrumentation to Measure the Activity of Rubidium-82 and the Determination of Rubidium-82 Patient Doses," dated April 18, 2013. Therefore, the NRC is exercising enforcement discretion and not pursuing any enforcement action for these violations. The NRC initially exercised enforcement discretion for these violations in Inspection Reports 03001303/2015001 (EA 129) and 03001303/2016001 (EA-16-142). No further action or response is required on your part with regards to these issues.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to provide one, 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 from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.
K. Anzilotti 4 If you have any questions concerning this matter, please contact Farrah Gaskins of my staff at 610-337-5143.
Sincerely,
/RA/ James M. Trapp, Director Division of Nuclear Materials Safety
Docket No. 03001303 License No. 07-12153-02
Enclosure:
Inspection Report No. 03001303/2018001
cc w/Encl: C. Wen, RSO State of Delaware
ML18288A207 After declaring this document "An Official Agency Record" it will be released to the Public. To receive a copy of this document, indicate in the box:
"C" = Copy w/o attach/encl "
E" = Copy w/ attach/encl "
N" = No copy OFFICE RI:DNMS RI:DNMS RI:OE OE NAME Gaskins/fcg*
Janda/tlw f/*
Crisden/cc SWoods/via email
DATE 09/24/18 09/24/18 09/25/18 10/09/18 OFFICE NMSS RI:DNMS NAME LBaer/via email Trapp/jt DATE 10/09/18 10/10/18 *see previous concurrence Enclosure Inspection Report No. 03001303/2018001 U.S. NUCLEAR REGULATORY COMMISSION REGION I INSPECTION REPORT
Inspection No. 03001303/2018001
Docket No. 03001303 EA No. EA-18-112
NMED Item No. 180259
License No. 07-12153-02
Licensee: Christiana Care Health Services, Inc.
Location: Newark, Delaware Inspection Dates: June 5, July 9-12, 2018 and continued through September 12, 2018
Date Followup Information Received: July 26, 2018
/RA FGaskins/ 9/24/18 Inspectors: ______________________________ _______________
Farrah C. Gaskins date Health Physicist Medical and Licensing Assistance Branch Division of Nuclear Materials Safety
/RA JNick/ 9/24/18 Approved By: ______________________________ _______________
Donna M. Janda, Chief date Medical and Licensing Assistance Branch Division of Nuclear Materials Safety
ii Inspection Report No. 03001303/2018001 EXECUTIVE
SUMMARY
Christiana Care Health Services, Inc.
NRC Inspection Report No. 03001303/2018001
A reactive inspection was initiated on June 5, 2018, followed up by an unannounced routine inspection on July 9-12, 2018 at Christiana Care Health Services, Inc. (CCHS) in Newark, Delaware and continued in office through September 12, 2018. The inspection examined activities conducted under License No. 07-12153-02 as they relate to safety and compliance with the Commission's rules and regulations and with the conditions of the license. In addition, the inspection included a review of circumstances surrounding the loss of 14.8 millicuries of Iodine-125 (I-125) permanent prostate implant seeds. The inspection was performed in accordance with NRC Inspection Procedures 87132, "Brachytherapy Programs," and 87103, "Inspections of Materials Licensee Involved In an Incident or Bankruptcy Filing."
CCHS reported the missing seeds to the NRC on June 1, 2018, (NRC Event 53437) and a site visit was conducted on June 5, 2018 to gather details about the event. In-office evaluation of the licensee's required 30 day event report, which included corrective actions, was reviewed prior to the July 9-12, 2018 routine inspection. The report, submitted by CCHS on June 15, 2018, outlined the circumstances surrounding the lost seeds, which had not been located as of the date of the routine inspection. Additional information submitted on July 26, 2018 was also reviewed.
CCHS is a medical institution authorized for materials under 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600 and 35.1000. Five of the licensee's seven locations of use in Delaware were inspected; two in Newark and one each in Smyrna, Bear, and Wilmington. The inspection included a review of licensee's facilities, direct observations, interviews with radiation workers, and review of required records. The licensee is also authorized to use a Rubidium 82 (Rb-82) generator. CCHS is unable to comply with the requirements of 10 CFR 35.60 and 10 CFR 35.63 because of the short half-life of Rb-82 and the direct infusion required for administration. These items of non-compliance would generally result in a SL IV violation but enforcement discretion is used because the licensee meets the criteria in Enforcement Guidance Memorandum (EGM) 13-003.
Based on the results of this inspection, one apparent violation was identified and is being considered for escalated enforcement for failure to control and maintain constant surveillance for licensed material that is in a controlled area. Two additional violations were identified for the
use of the Rb-86 generator.
1 Inspection Report No. 03001303/2018001 REPORT DETAILS I. Program Description and Event Details
- a. Inspection Scope An inspection of the licensee's radioactive materials programs was conducted on June 5, 2018, July 9-12, 2018, and continued through September 12, 2018. CCHS is a large hospital network which is authorized to use and possess byproduct materials in accordance with 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000. The inspection examined the full scope of the licensee's radioactive materials program. The inspection was conducted in accordance with Inspection Procedures 87103, 87130, 87131, and 87132. The licensee is authorized for seven locations of use, however, five were locations were inspected. The locations inspected included the Main Hospital and the Helen F. Graham Center in Newark, Delaware, Smyrna Health and Wellness Center in Smyrna, Delaware, and the Cardiac Diagnostic Centers in Wilmington and Bear, Delaware.
The inspection also included a review of the circumstances surrounding the loss of 14.8 millicuries of I-125 seeds reported missing to the NRC on June 1, 2018. A site visit was conducted on June 5, 2018 which included interviews with staff, direct observations, and a review of required records. The 30 day report was received and reviewed prior to the July 9-12, 2018 site visit.
- b. Observations and Findings
Radioactive Materials Program.
CCHS is a large hospital network authorized for a variety of modalities. License No.
07-12153-02 authorizes CCHS for use of materials in accordance with 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000. The licensee has 14 Authorized Users (AU) and five Authorized Medical Physicists (AMP). The licensee's Radiation Safety Committee (RSC) meets on a quarterly basis to discuss radiation safety issues. CCHS has a very active program with seven locations of use. The main hospital, in Newark, performs all authorized functions. Nuclear Medicine is performed on a daily basis at the main hospital. The Nuclear Medicine department also houses a Rubidium-82 (Rb-82) generator. In 2017, there were 281 therapy treatments, 31 permanent prostate implants, and 726 fractions of High Dose Rate Remote After Loader (HDR) therapy. There are two HDR units, one in the main hospital and one in the Helen F. Graham Cancer Center, which is located on the same campus as the main hospital. The Helen F. Graham Cancer Center also provides PET services. Cardiac studies only are performed at the Wilmington Hospital, Smyrna Health and Wellness Center, and the Cardiac Diagnostic Centers on Limestone Road, and Silverside Road in Wilmington, Smyrna, Bear, and Middletown. The Wilmington Hospital's nuclear medicine department operates on a daily basis, but the other sites vary dependent on patient load.
The inspection consisted of a tour of the facilities visited, a representative review of records, and interviews with AU's, AMP's, and other licensee staff. Observations of staff performing daily spot checks and administration of HDR treatment, routine nuclear medicine administrations, required surveys, instrumentation QC, and a LutaThera (Lu-177) therapy were also observed as part of the inspection. Written directives were 2 Inspection Report No. 03001303/2018001 reviewed of patient procedures which required them and were found to be in accordance with regulations and licensee procedures. A secured waste storage area in the basement of the main hospital was toured. The area houses waste from nuclear medicine. Before disposal, all waste is properly surveyed and results are recorded.
Event Chronology, Reporting, On-Site Inspection, and Corrective/Preventative Actions The inspection reviewed the circumstances surrounding the loss of approximately
14.8 millicuries of I-125 permanent prostate implant seeds. Specifically, CCHS reported to the NRC on June 1, 2018 (NRC Event 53437) the discovery of 50 I-125 seeds that were missing from the radiation oncology hot lab.
The following is a timeline of the events:
February 6, 2018 - The licensee performed tw o I-125 permanent brachytherapy seed implants in the CCHS SurgiCenter located in the main hospital in Newark, Delaware.
Following the implants, 25 seeds, from each procedure, were left over and taken to the radiation oncology hot lab. The licensee's normal practice was to place empty cartridges in front of the L-block to be recycled and to place trays containing seeds behind the L-block to be decayed and returned to the manufacturer. Physicist B, who supported the procedures and usually supports another area of CCHS, was not aware of the distinction and placed the trays containing the seeds in front of an L-block shield. On this date, the combined activity of the seeds was approximately 23.1 millicuries.
March 16, 2018 - The licensee determined through camera footage that the Occupational Safety (OS) Department picked up the seeds that were stored in front of the L-block for recycling. The OS staff was not aware that the trays contained seeds. On the day of the pickup, the Occupation Safety Specialist (OSS), who does not have access to the hot lab, was given access by another Physicist, who was unaware that unused trays of seeds were stored in front of the L-block. When the OSS arrived to retrieve the trays for recycling, the physicist performed a survey of the trays before they were removed from the hot lab. The activity of the seeds on March 16, 2018, was calculated to be 14.8 millicuries.
May 30, 2018 - While planning to return the unused seeds back to the manufacturer, Physicist A discovered that a combined total of 50 I-125 seeds from the February 6, 2018, patient procedures were missing from the hot lab. Physicist A contacted Physicist B about the location of the unused seeds. Physicist B, informed Physicist A that the two trays containing the unused seeds from the procedure were placed on top of a pile of trays stored in front of the L-block in the hot lab. During the conversation with Physicist B, Physicist A realized that Physicist B had placed the unused seeds in the wrong storage location and recalled that he requested a waste pickup to dispose of the empty stainless steel trays stored in the hot lab. Physicist A then contacted the OSS, the individual who picked up the trays, to confirm that the scheduled pick-up had taken place. Physicist A noted that there was no disposal information for the two procedures
performed on February 6, 2018. Physicist A then confirmed with the vendor that CCHS' inventory and disposal information was consistent the vendor's records. The vendor also confirmed that it had not received the unused seeds from the February 6, 2018, implants. CCHS maintains an inventory for all of the seeds ordered. The inventory documents the: (1) number of seeds received for each patient, (2) number of seeds that were implanted, (3) number of seeds returned to the hot lab, and (4) final disposal of the 3 Inspection Report No. 03001303/2018001 seeds. CCHS made several attempts to lo cate the seeds. T he physicists and the Radiation Safety Officer (RSO) searched the room where the procedures took place.
The licensee contacted the company that hauled the materials to be recycled and confirmed that the hauler did not find or identify the seeds. The licensee reviewed badge access to the hot lab and did not find anything out of the ordinary. Additionally, they reviewed the camera footage inside the hot lab, but could not confirm any specific details about the trays that were stored. The camera footage of the truck that hauled the recyclables was also reviewed, but CCHS was not able to determine if the seeds were present because of the angle of the camera. On the day the seeds were discovered missing, the combined activity of the seeds would have been 6.2 millicuries.
June 1, 2018 - CCHS notified the NRC Operations Center of 50 missing I-125 seeds (event number 53437). The seeds were discovered missing on May 30, 2018. CCHS made several attempts to locate the missing seeds before reporting the event to the NRC. June 5, 2018 - An inspector conducted an onsite visit to gather additional information about the circumstances surrounding the lost seeds. In addition, a full inspection of the CCHS' program was conducted on July 9-12, 2018. At the time of the inspection, the seeds had not been located.
- c. Conclusions Based on the inspector's observations, one apparent violation being considered for escalated enforcement was identified. The apparent violation being considered for escalated enforcement was for the failure to maintain constant surveillance of licensed material in a controlled or unrestricted area as required by 10 CFR 20.1802.
Specifically, on May 30, 2018, CCHS discovered that 50 I-125 seeds that were left over from a procedure completed on February 6, 2018, were missing from its hot lab. CCHS concluded that the seeds, with an activity of approximately 14.8 mCi, were either dropped in the universal waste trailer and either lost during transportation or disposed with the metal trays as scrap metal.
CCHS reported the event as required by 10 CFR 20.2201 and put into place appropriate corrective and preventative actions which include:
Revision of the Departmental Policy to state that all empty seed packages are required to be returned back to the seed manufacturer by a qualified medical physicist (QMP).
Immediately instituting a bi-monthly shipment of leftover seeds to prevent the overflow of seed packages behind the L-block.
Storage space behind the L-block will be inspected monthly. If needed, a return shipment of the leftover seeds will be performed by the QMP who conducted the monthly inspection.
Empty trays will no longer be stored in front of the L-block. Empty trays will first be disassembled by a QMP to verify that no seed cartridges remain in them and will then be surveyed while disassembled. They will be placed in a clearly 4 Inspection Report No. 03001303/2018001 marked box sitting in a designated space in the hot lab for future shipment back to the manufacturer. A final survey prior to shipping will be performed and
documented by the QMP.
All return shipments of the leftover seeds will be verified in a timely manner by the physics group. A column was added to the Excel Spreadsheet that is used to track the inventory of implant seeds to provide the date that the return shipment verification is received by the Department of Radiation Oncology from the
manufacturer.
Two violations, which are not being considered for escalated enforcement, were also identified and are related to the use of the Rb-82 generator for: (a) failure to calibrate the instrument used to measure activity of the dosage before administration and (b) failure to determine the activity of each dosage before each medical use. Regulations in 10 CFR 35.60 requires, in part, that licensees calibrate the instrument used to measure the activity of the dosage before it is administered to each patient or human research subject. This calibration may either be performed in accordance with nationally recognized standards or calibration instructions provided by the manufacturer. Contrary to the above, CCHS was unable to calibrate a Rb-82 generator in accordance with the regulations because there are currently neither nationally recognized standards nor specific calibration procedures for calibrating detectors in a dynamic mode (i.e. while liquids are flowing past the detector). Until such standards or procedures are developed, compliance with 10 CFR 35.60 is not possible. Regulations set forth in 10 CFR 35.63 requires, in part, that a licensee determine the activity of each dosage administered before each medical use. Due to the short half-life of Rb-82 and direct infusion of the Rb-82 into the patient, users of this generator system are unable to measure patient dosages of Rb-82 prior to administration. These items of non-compliance would generally result in a Severity Level IV violation, but enforcement discretion is being used because the licensee meets the criteria in Enforcement Guidance Memorandum (EGM)13-003.
II. Exit Meeting A preliminary exit meeting was conducted on July 12, 2018, to discuss the scope of the inspection and the inspector's initial observations. On September 12, 2018, an exit meeting was held by telephone with Kert Anzilotti, M.D., Chief Medical Officer Acute
Care; Carol Wen, Radiation Safety Officer; and other members of CCHS staff, to discuss the results of this inspection.
5 Inspection Report No. 03001303/2018001 PARTIAL LIST OF PERSONS CONTACTED Licensee
+* Xioqin (Carol) Wen, Radiation Safety Officer
+*Kert Anzilotti, Chief Medical Officer Acut e Care (Licensee's Management Representative) +*Hung Dam, MD, Chair of RSC
+William Holden, Vice President of Cancer Program
+Firas Mourtada, PhD, Chief Medical Physicist +Donna Bogari, Corporate Director Patient Safety & Accreditation +*Lana de Souza Lawrence, MD, Radiation Oncologist
- Present at preliminary exit meeting July 12, 2018 + Participated in telephonic exit meeting conducted on September 12, 2018