Event Notification Report for May 25, 2018
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
05/24/2018 - 05/25/2018
EVENT NUMBERS
53430
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
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
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
10 CFR Section:
AGREEMENT STATE
Person (Organization):
GLENN DENTEL (R1DO)
GRETCHEN RIVERA-CAPELLA (NMSS DAY)
NMSS_EVENTS_NOTIFICATION (EMAIL)
PATRICIA MILLIGAN (INES)
GLENN DENTEL (R1DO)
GRETCHEN RIVERA-CAPELLA (NMSS DAY)
NMSS_EVENTS_NOTIFICATION (EMAIL)
PATRICIA MILLIGAN (INES)
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.
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.