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Event Notification Report for August 08, 2018

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
8/7/2018 - 8/8/2018

** EVENT NUMBERS **


53430 53506 53527 53530 53531 53538

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Agreement State Event Number: 53430
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: UNIVERSITY OF PENNSYLVANIA
Region: 1
City: PHILADELPHIA   State: PA
County:
License #: PA-0131
Agreement: Y
Docket:
NRC Notified By: JOHN CHIPPO
HQ OPS Officer: STEVEN VITTO
Notification Date: 05/29/2018
Notification Time: 14:48 [ET]
Event Date: 05/25/2018
Event Time: 00:00 [EDT]
Last Update Date: 08/07/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
GLENN DENTEL (R1DO)
GRETCHEN RIVERA-CAPELLA (NMSS DAY)
NMSS_EVENTS_NOTIFICATION (EMAIL)
PATRICIA MILLIGAN (INES)

Event Text

AGREEMENT STATE REPORT - PATIENT SKIN CONTAMINATION

The following was received from the Commonwealth of Pennsylvania via email:

"On May 29, 2018, the Department's [Bureau of Radiation Protection] staff in Central Office became aware of a medical event (ME) at U PENN hospital in Philadelphia. The ME is reportable as per 10 CFR 35.3045(a)(1)(i) and also meets criteria for an Abnormal Occurrence.

"On May 25, 2018, a 17 year old pediatric patient underwent an 834 millicurie metaiodobenzylguanidine (MIBG) lodine-131 (I-131) treatment for brain cancer. The dose was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medical technician present during the infusion reported seeing a small amount of blood, but other than that, nothing unusual was noted. However, upon completion of the infusion, meter readings noted high activities on the patient's clothing and bed linen. The possible reason given being a faulty connection line on the automatic pump. The contamination is believed to have also been present on the skin all weekend. Due to the large dose of I-131 infused, the licensee's staff were not able to see the contamination on the patient's skin until he developed erythema. The licensee is in the process of doing a dose reconstruction for the skin contamination. Based on the reading from the patient and estimated activity in the various contaminated items, the licensee currently estimates that approximately 50% of the intended dosage was successfully infused. The authorized user has been informed and is currently notifying the patient's parents and the referring physician.

"A reactive inspection is planned by the Department. More information will be provided upon receipt."

PA Event Report ID No: PA 180012

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.


* * * UPDATE FROM JOHN CHIPPO TO DONALD NORWOOD AT 1451 EDT ON 7/12/2018 * * *

"The University of Pennsylvania (U Penn) reported that a patient's skin became contaminated during medical treatment on 5/25/2018. The 17-year-old pediatric patient was scheduled to receive 30.86 GBq (834 mCi) of I-131 metaiodobenzylguanidine (MIBG) for treatment of brain cancer. The dosage was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medicine technician present during the infusion saw a small amount of blood, but nothing unusual other than that was noted. However, upon completion of the infusion, radiation surveys revealed high activities of I-131 on the patient's clothing and bed linen.

"U Penn stated that the patient's upper right thigh was cleaned. On 5/27/2018, the patient reported discomfort and reddening (i.e. erythema) on the skin of his upper right thigh, which developed into a lesion and further into desquamation (grade 3) the next day. Radioactive contamination is believed to have been present on the patient's skin for 24 to 48 hours.

"Based on U Penn measurements, nuclear medicine imaging, and the patient's clinical symptoms, the dose to the skin was estimated to be between 50,000 and 120,000 cGy (rad) to a 15 cm2 area. Radiation safety staff consulted with U.S. DOE's REAC/TS in Oak Ridge TN, to verify dose calculations. Calculations of the activity in the waste and the exposure rate from the patient in previous treatments estimated the activity delivered at 15.54 GBq (420 mCi). It was calculated that approximately 7.77 GBq (210 mCi) went to the waste.

"The cause of the incident is believed to be a faulty connection line on the automatic pump. The patient was also disconnected from the infusion pump at the 'Spiros tube' to use the lavatory part way through the procedure. Due to the large dosage of I-131 infused, U Penn staff were unable to detect the contamination on the patient's skin until he developed erythema.

"The authorized user was informed and notified the patient's parents and referring physician. Pennsylvania DEP, Bureau of Radiation Protection, performed a reactive inspection on 6/7 and 6/13/2018. U Penn is conducting a full root cause analysis to develop and implement corrective actions. Procedures that have already been implemented for I-131 MIBG patients included placing absorbent chucks between all parts of the infusion line and the patient's body and requiring an authorized user to be contacted for approval if it is necessary to disconnect a patient during the infusion.

"Root Cause(s): possible equipment failure, training, and/or human error in connecting the line to the infusion pump.

"Actions: A reactive inspection has been completed by the Department. More information will be provided upon receipt from U Penn."

Notified R1DO (Bower), NMSS Events Notification E-mail Group, and INES Coordinator (Milligan).

* * * UPDATE FROM JOHN CHIPPO TO HOWIE CROUCH AT 1102 EDT ON 8/7/18 * * *

The following update was received from the Commonwealth via fax:

"Licensee has provided additional information; Corrective Actions include:

"A complete evaluation is being performed of the infusion system used for this treatment to identify any deficiencies, including comparison of CT imaging of the Spiros connection used in this treatment and an unused one.

"A multidisciplinary I-131 MIBG team with representatives from Nuclear Medicine, Radiation Safety, Nursing and Oncology has been established. The team will meet regularly to review and update policies and procedures for I-131 MIBG therapies. Some immediate steps have included:
(1) use of absorbent material under the administration line over the patient's body,
(2) a change to the administration procedure to require that the infusion not be stopped unless medically necessary and determined by the Authorized User,
(3) planned implementation of continuous patient observation during administration including evaluation of the use of portable video monitoring,
(4) a new procedure has been implemented to address patient fluid management prior to and during infusion,
(5) a review of the infusion system has commenced with focus on the Spiros connector, including additional training on their use.

"Patient specific decontamination procedures have been developed for each treatment treated since the incident. Since decontamination procedures must take into account the patient's age and medical condition, it has been necessary that the medical staff have major input into the procedures for these patients. The knowledge gained from the patient-specific decontamination procedures will be used to refine the decontamination SOP.

"For therapeutic doses in which an activity on the skin that would result in desquamation can be two thousandths of a percent of the dose. It is important to be able to make measurements in these difficult environments. Testing has begun to determine the capabilities of systems that might be used to measure betas in environments in which gammas are several orders of magnitude more abundant than betas.

"Radiation Safety incident response procedures have been revised to include a time out and immediate involvement of additional Health Physics staff during incidents, including during possible Medical Events. The procedure is aimed at refocusing the attention of Health Physicists on all aspects of the incident response, and to prevent the Medical Event reporting requirements from distracting attention from other aspects of the response.

"CAUSE OF THE EVENT:
a) A leak in the system caused by a failure of the Spiros connection in the infusion line.
b) Policies and procedures relating to I-131 MIBG dose administration lacked coordination and oversight. SOPs have been managed separately by each Department (Nursing, Nuclear Medicine, Oncology, and EHRS).
c) Policies and procedures relating to patient contamination and decontamination during dose administration were incomplete.

"ACTIONS: A reactive inspection has been completed by the Department."

Notified R1DO (Cahill), NMSS Events Notification (email), and INES Coordinator (Milligan).

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!!!!! THIS EVENT HAS BEEN RETRACTED. THIS EVENT HAS BEEN RETRACTED !!!!!
Non-Agreement State Event Number: 53506
Rep Org: VARIAN MEDICAL SYSTEMS
Licensee: SE GEORGIA HEALTH SYSTEMS
Region: 1
City: BRUNSWICK   State: GA
County:
License #: 45-309857-01
Agreement: Y
Docket:
NRC Notified By: KATHARINE ARZATE
HQ OPS Officer: THOMAS KENDZIA
Notification Date: 07/13/2018
Notification Time: 16:21 [ET]
Event Date: 07/13/2018
Event Time: 00:00 [EDT]
Last Update Date: 08/07/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
30.50(b)(2) - SAFETY EQUIPMENT FAILURE
30.50(b)(3) - MED TREAT INVOLVING CONTAM
Person (Organization):
STEVE ROSE (R2DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
GREG PICK (R4DO)
FRED BOWER (R1DO)

Event Text

MEDICAL EVENT

The following information is a synopsis of information received via E-mail:

A HDR [high dose rate] brachytherapy incident occurred in Brunswick Georgia, on July 13, 2018. No one, including the patient, was exposed to excessive radiation. SE Georgia Health Systems treated a Gyn [gynecology] patient using the GammaMed Plus HDR unit and a Tandem and Ring applicator set, both supplied by Varian. Upon completion of the treatment, the source wire retracts back into the shielded HDR unit for safe storage. At that time the room was checked with a survey meter and no exposure readings above background were measured. The HDR unit was surveyed to ensure that the source wire had retracted. The exposure reading on the surface demonstrated that the wire had retracted, and the room was safe. Upon scanning the patient's surface, however, a reading of approximately 2.5mR/hr was measured, which was higher than the expected background reading. The applicator was removed from the patient and scanned, the increased exposure reading was in the applicator. The applicator was placed into a large shielded container provided by Varian and immediately placed in safe storage. The patient, the bedding, and all other materials associated with the implant were re-scanned with no readings above background. The patient was removed from the room, deemed safe and released. The time was recorded to be approximately 5 to 6 minutes and will be used for dose estimates.

The HDR unit was re-scanned along with the Linac vault. All were deemed clear and safe. The HDR unit was locked and secured. Patient treatments in the Linac continued.

The applicator device was then scanned one piece at a time and it was determined that the Ring portion of the Tandem and Ring set was contaminated. It was assumed that the contamination was secure inside the ring which is a rounded hollow metal tube. Exposure readings at the surface of the ring were 96 mR/hr at the surface and approximately 30 mR/hr at 6 inches.

SE Georgia Health Systems notified the Georgia Radiation Protection Programs, and Varian Medical Systems of this incident.

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

* * * RETRACTION FROM KATHY ARZATE TO HOWIE CROUCH AT 1050 EDT ON 8/7/18 * * *

"After investigation and arrival on site to determine the cause of the contamination, it was found there was no contamination on the patient's body. It was not a failure of the device. We [Varian] inspected the device. We attempted to remove the contamination from the applicator, but were unable to. Therefore, the manufacturer of the source took the applicator back to their facility and were able to remove the contamination there. Ultimately, there was no equipment failure per 10 CFR 30.50(b)(2) or (b)(3)."

Notified R1DO (Cahill), R2DO (Sykes), R4DO (Vasquez), and NMSS Events (by email).

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!!!!! THIS EVENT HAS BEEN RETRACTED.THIS EVENT HAS BEEN RETRACTED !!!!!
Fuel Cycle Facility Event Number: 53527
Facility: GENERAL ELECTRIC CO.
RX Type: ADVANCED FUEL R&D AND PILOT PLANTS
Comments: HOT CELL R&D
Region: 4
City: PLEASANTON   State: CA
County: ALAMEDA
License #: SNM-960
Docket: 07000754
NRC Notified By: SCOTT MURRAY
HQ OPS Officer: ANDREW WAUGH
Notification Date: 07/27/2018
Notification Time: 13:00 [ET]
Event Date: 07/26/2018
Event Time: 13:55 [PDT]
Last Update Date: 08/07/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
PART 70 APP A (b)(2) - LOSS OR DEGRADED SAFETY ITEMS
Person (Organization):
HEATHER GEPFORD (R4DO)

Event Text

DISABLED VENTILATION SYSTEM

"On 7/26/18 at approximately 1355 PDT, the Building 103 laboratory facility ventilation exhaust system was disabled during a scheduled evacuation drill at the Vallecitos Nuclear Center (VNC).

"The system was restored on 7/26/18 at approximately 1407 PDT. There were no active fissile material operations in Building 103, thus no unsafe condition existed, and no release of material occurred.

"This event is being reported pursuant to the requirements of 10 CFR 70.50 (b)(2)."

The licensee will notify the NRC Region 4 office.

* * * RETRACTION FROM SCOTT MURRAY TO HOWIE CROUCH AT 1031 EDT ON 8/7/2018 * * *

"EN53527, made July 27, 2018, reported an event in accordance with 10CFR70.50(b)(2) in which the Vallecitos Nuclear Center Building 103 facility ventilation exhaust system was disabled for approximately 12 minutes.

"At the time of the report, information regarding the special nuclear material (SNM) in the affected Building 103 areas was not available and a conservative decision was made that the ventilation system was required to prevent releases or exposures to radioactive materials exceeding regulatory limits or to mitigate the consequences of an accident.

"Based on a subsequent review of SNM inventory records and additional survey measurements, it has been determined the event report should be retracted due to the minimal amount of SNM that could have been affected.

"Notified R4 Fuel Cycle Decommissioning Branch and NMSS Enrichment and Conversion Branch."

Notified R4DO (Vasquez) and NMSS Events Notification (email).

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Agreement State Event Number: 53530
Rep Org: COLORADO DEPT OF HEALTH
Licensee: CARDINAL HEALTH 414, LLC
Region: 4
City: GLENWOOD SPRINGS   State: CO
County:
License #: CO 1219-01
Agreement: Y
Docket:
NRC Notified By: PHILLIP PETERSON
HQ OPS Officer: ANDREW WAUGH
Notification Date: 07/30/2018
Notification Time: 15:42 [ET]
Event Date: 07/24/2018
Event Time: 00:00 [MDT]
Last Update Date: 07/30/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
VINCENT GADDY (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB (EMAIL)
This material event contains a "Less than Cat 3" level of radioactive material.

Event Text

AGREEMENT STATE REPORT - LOST PACKAGE OF RADIOACTIVE MATERIAL

The following information was received from the State of Colorado via email:

"Cardinal Health 414, LLC reported a lost package of Ra-223 in transit via [a common carrier]. The amount shipped was 11.4075 MBq (0.3083 mCi). The intended destination was Valley View Hospital in Glenwood Springs, Colorado. [The common carrier] is currently investigating the location of the package."

Colorado Event Report ID No.: CO180014

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

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Agreement State Event Number: 53531
Rep Org: ILLINOIS EMERGENCY MGMT. AGENCY
Licensee: ALEXIAN BROTHERS MEDICAL CENTER
Region: 3
City: ELK GROVE VILLAGE   State: IL
County:
License #: IL-01418-01
Agreement: Y
Docket:
NRC Notified By: GARY FORSEE
HQ OPS Officer: BETHANY CECERE
Notification Date: 07/30/2018
Notification Time: 17:10 [ET]
Event Date: 05/14/2015
Event Time: 00:00 [CDT]
Last Update Date: 07/30/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
STEVE ORTH (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - BRACHYTHERAPY SOURCE DID NOT FULLY RETRACT

The following report was received by e-mail from the state of Illinois:

"During a routine inspection [Illinois Emergency Management] Agency inspectors discovered an unreported event that occurred on May 14, 2015. On that date an intravascular brachytherapy procedure was attempted using two BRX-0346 extra-long delivery catheters with a Novoste transfer device and a 40mm Best Vascular, Inc. Sr-90 source train. On the initial treatment attempt, the source would not extend to the treatment location and was promptly returned to the transfer device. A kinked catheter was suspected and a second BRX-0346 XL catheter was put in place. The same train was sent into the second catheter and the same inability to reach the treatment location encountered. At this point, the hydraulic return mechanism failed to return the source train to the transfer device. The licensee's emergency procedure was employed and the entire system was manually removed from the patient. The transfer device, delivery catheter and source train were placed in a temporary storage container and locked in the hot lab. The patient was surveyed and no radioactivity was found to be above background. The treatment was aborted.

"The licensee was able to determine that a deformation in the delivery catheter impeded movement of the source train to the treatment location. The source was found to be lodged in the catheter, approximately 11.3 cm from the attachment point to the transfer device. As a result, exposure occurred in the aortic root. Estimates on the exposure to the surrounding tissue is pending from the licensee. Best Vascular representatives were reportedly notified and arrived at the licensee's site the following day for evaluation and return shipping to the manufacturer.

"A deformation in the catheter was confirmed as the root cause. The event was not reported to the State. Supporting documentation was reviewed on 7/30/18 and determined to be, at a minimum an equipment-related event. Pending exposure estimates, this is also being entered as a possible medical event and will remain open while the investigation continues.

"Radionuclide: Sr-90
Activity: 58.65 mCi (2.17005 GBq)
Dose: 18.4 rad (184 mGy)"

Illinois Item Number: IL180031

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

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Power Reactor Event Number: 53538
Facility: VOGTLE
Region: 2     State: GA
Unit: [3] [4] []
RX Type: [3] W-AP1000,[4] W-AP1000
NRC Notified By: DANIEL MICKINAC
HQ OPS Officer: RODNEY CLAGG
Notification Date: 08/07/2018
Notification Time: 14:45 [ET]
Event Date: 08/07/2018
Event Time: 09:09 [EDT]
Last Update Date: 08/07/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
26.719 - FITNESS FOR DUTY
Person (Organization):
MARVIN SYKES (R2DO)
FFD GROUP (EMAIL)
Unit SCRAM Code RX Crit Initial PWR Initial RX Mode Current PWR Current RX Mode
3 N N 0 Under Construction 0 Under Construction
4 N N 0 Under Construction 0 Under Construction

Event Text

CONTRACTOR SUPERVISOR TESTS POSITIVE FOR ALCOHOL

"At 0909 [EDT] on August 7, 2018, Southern Nuclear Operating Company (SNC) determined a contractor supervisor confirmed positive for alcohol during a random Fitness-for-Duty (FFD) test. The employee's unescorted access to the plant has been suspended. The NRC Resident Inspector has been notified."


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