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Event Notification Report for June 07, 2018

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
6/6/2018 - 6/7/2018

** EVENT NUMBERS **


53430 53431 53432 53445

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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: 10/12/2018
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).

* * * UPDATE FROM JOHN CHIPPO TO OSSY FONT AT 0833 EDT ON 10/12/2018 * * *

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

"UPDATE 3, clarifications:

"The written directive prescribed 30.23 GBq (817 mCi) of I-131. The dosage administered measured 30.86 GBq (834 mCi) and was delivered over the course of 90 minutes.

"The estimated activity delivered to the correct treatment site was determined to be 22.68 GBq (613 mCi), not 15.54 GBq (420 mCi) as previously reported.

"No decontamination of the patient (right upper thigh) was performed at the time the contamination of bed linens and pants was discovered. This wasn't completed until signs of erythema were present."

PA Event Report ID No: PA 180012

NRC Item# 180252

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

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Agreement State Event Number: 53431
Rep Org: NE DIV OF RADIOACTIVE MATERIALS
Licensee: MARY OUR QUEEN KENNY CENTER
Region: 4
City: OMAHA   State: NE
County:
License #: GL0604
Agreement: Y
Docket:
NRC Notified By: MALISA MCCOWN
HQ OPS Officer: STEVEN VITTO
Notification Date: 05/29/2018
Notification Time: 17:42 [ET]
Event Date: 05/10/2018
Event Time: 00:00 [CDT]
Last Update Date: 05/29/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
THOMAS FARNHOLTZ (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 TRITIUM EXIT SIGN

The following was received from the state of Nebraska via email:

"DHHS [Nebraska Department of Health and Human Services] - Office of Radiological Health received written notification on 5/29/18 from GL0604 - Mary Our Queen Kenny Center indicating a lost/not found tritium exit sign during their Annual Renewal. Licensee initially telephoned DHHS on 5/10/18 to indicate they could not locate the device at the listed location and would be checking additional buildings. Licensee checked several additional buildings on their campus and contacted the electrician used during recent (2016) renovation in an effort to locate the device. Licensee believes the device was removed either during a prior renovation or due to regular maintenance and repair but cannot verify due to staffing changes.

"Source/radioactive material: Sealed Source Luminous
Manufacturer: Safety Light Corp.
Model number: 880-12-6-10
Serial number: A21170
Radionuclide: H-3
Activity: 7.5 Ci (277.5 GBq)"

Nebraska Item Number: NE180005

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: 53432
Rep Org: TEXAS DEPT OF STATE HEALTH SERVICES
Licensee: TERRACON CONSULTANTS INC
Region: 4
City: HOUSTON   State: TX
County:
License #: 05268
Agreement: Y
Docket:
NRC Notified By: ART TUCKER
HQ OPS Officer: KENNETH MOTT
Notification Date: 05/30/2018
Notification Time: 11:14 [ET]
Event Date: 05/29/2018
Event Time: 00:00 [CDT]
Last Update Date: 05/30/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
THOMAS FARNHOLTZ (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
This material event contains a "Less than Cat 3" level of radioactive material.

Event Text

AGREEMENT STATE REPORT - DAMAGED TROXLER GAUGE

The following was received from the state of Texas via email:

"On May 30, 2018, the Agency [Texas Department of State Health Services] was notified by the licensee's radiation safety officer (RSO) that on May 29, 2018, a Troxler model 3440 moisture/density gauge was damaged at a field site. The gauge contains an 8 millicurie cesium-137 source and a 40 millicurie americium-241 source. While the gauge was in taking a measurement and the technician and the job site foreman were talking, a bobcat operator working in the area failed to see the gauge and ran over it. The RSO stated the foreman and technician attempted to stop the operator of the bobcat, but were unable to get his attention. The RSO stated the operating rod for the cesium source was slightly bent, but the technician was able to return the source to the shielded position. The RSO stated the gauge was surveyed and radiation levels were normal. The gauge was returned to the licensee's location in San Antonio, Texas, for storage. The manufacturer has been contacted for guidance on what to do with the gauge. Additional information will be provided as it is received in accordance with SA-300."

Texas Incident # - 9577


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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!!!!! THIS EVENT HAS BEEN RETRACTED.THIS EVENT HAS BEEN RETRACTED !!!!!
Fuel Cycle Facility Event Number: 53445
Facility: LOUISIANA ENERGY SERVICES
RX Type:
Comments: URANIUM ENRICHMENT FACILITY
GAS CENTRIFUGE FACILITY
Region: 2
City: EUNICE   State: NM
County: LEA
License #: SNM-2010
Docket: 70-3103
NRC Notified By: BLAKE BIXENMAN
HQ OPS Officer: DONG HWA PARK
Notification Date: 06/06/2018
Notification Time: 15:48 [ET]
Event Date: 06/05/2018
Event Time: 15:14 [MDT]
Last Update Date: 07/11/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
PART 70 APP A (b)(1) - UNANALYZED CONDITION
Person (Organization):
MIKE ERNSTES (R2DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
FUELS GROUP (EMAIL)

Event Text

UNANALYZED CONDITION RESULTING FROM INCORRECT IMPLEMENTATION OF ITEMS RELIED ON FOR SAFETY (IROFS)

"Appendix A to 10 CFR 70 (b)(1)

"An incorrect implementation of IROFS36c (Limit Cylinder Mover to Electric or Diesel with less than 280L [74 gallons] Fuel Load) has been identified as having occurred for feed deliveries into the Cylinder Receipt and Dispatch Building (CRDB). IROFS36c requires that UF6 transporters/movers inside CRDB truck bays utilize a tractor which has a limited fuel capacity of less than 74 gallons. This requires the Over the Road (OTR) tractor truck to disconnect the trailer in a designated staging area and a local tractor with a fuel tank capacity less than 74 gallons be utilized with the OTR trailers. Methods were used allowing an OTR truck trailer to access the CRDB with the OTR tractor and fuel tanks of the vehicle remaining outside. Activities involving OTR tractor trailers entering the CRDB truck bay in this manner have not been evaluated in the ISA.

"10 CFR 70.50 (c)(iii)

"(A) There was not a material release, no radiological or chemical hazards were present.
"(B) No exposure occurred
"(C) A condition exists which resulted in the facility being in a state that was different from that analyzed in the Integrated Safety Analysis. The method for cylinder transport into the CRDB truck bay by an OTR tractor, in proximity to cylinders inside the CRDB, has not been specifically evaluated as the evaluated condition prohibited the use of vehicles with fuel capacities in excess of 74 gallons within the CRDB truck bay. The only piece of equipment which entered the CRDB was the OTR trailer; the tractor remained connected and outside the CRDB.
"(D) IROFS36c remains available and reliable to perform its safety function. The identified deficiency only affects OTR tractors that could potentially expose UF6 cylinders in the CRDB to fuel sources greater than 74 gallons. UUSA [Urenco USA] has issued a stop work to prevent the introduction of excessive fuel capable of causing a release of UF6 inventory in the area of concern should a fire occur. The capabilities of existing IROFS are sufficient to meet the performance requirements of 10 CFR 70.61.
"(iv) No external conditions affect this event.
"(v) A stop work was issued to prevent the access of OTR tractor trucks to the CRDB where proximity to UF6 cylinders could occur.
"(vi) An event did not occur at UUSA. UUSA remains in a safe and stable condition.
"(vii) Current and planned site status is normal. No emergencies have been or will be declared.
"(viii) No local, state, or federal agencies will be notified.
"(ix) No press releases will occur.

"Condition has been entered into the UUSA Corrective Action Program. Event Record 125051."

The licensee will notify R2 (Lopez).


* * * RETRACTION ON 07/11/2018 AT 1534 EST FROM BLAKE BIXENMAN TO STEVEN VITTO * * *

"EN53445, made June 5th, 2018, reported a condition in accordance with Appendix A to 10 CFR 70 (b)(1) in which the facility was in a state different from that analyzed in the Integrated Safety Analysis, and which resulted in failure to meet the performance requirements of 10 CFR 70.61.

"This report was prompted by an incorrect implementation of IROFS36c (Limit Cylinder Mover to Electric or Diesel with <280L Fuel Load) during feed deliveries into the Cylinder Receipt and Dispatch Building (CRDB). An Over the Road (OTR) tractor containing greater than the maximum allowable fuel load was permitted access the CRDB Truck Bay with the OTR truck trailer.

"At the time of the report, this method for cylinder transport into the CRDB Truck Bay by an Over the Road (OTR) tractor in proximity to cylinders inside the CRDB had not been evaluated. URENCO USA conservatively assumed a failure in the performance requirements of 10 CFR 70.61 at the time of the 24 hour report. Since the time of the initial report, URENCO USA has completed an assessment of safety significance for the events reported in EN53445.

"With detailed results documented in the UUSA corrective action program, Event Record EV125051, the following conclusion has been made:

"The fuel delivery events using the OTR truck into the CRDB can be categorized as events with low safety significance since they would not result in breached/ruptures of UF6 cylinders and no uranic material would be released in the event of a fire involving UF6 cylinders in the CRDB Truck Bay. This correlates with a low consequence event.

"Based on calculations shown in the 'Assessment of Safety Significance for Events Documented in EV125051', the conditions reported in EN53445 did not result in failure to meet the performance requirements of 10 CFR 70.61. Therefore, the condition reported in EN53445 did not exceed the criteria which would necessitate an event be reported to the NRC. URENCO USA hereby retracts Event Notification 53445."

Notified R2DO(Rose), Fuels Group, and NMSS Events Notification email.


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