Event Notification Report for January 15, 2014
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
01/14/2014 - 01/15/2014
EVENT NUMBERS
5078549726497274972849729497304972449734
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Non-Agreement State
Event Number: 50785
Rep Org: IU HEALTH BALL MEMORIAL HOSPITAL
Licensee: IU HEALTH BALL MEMORIAL HOSPITAL
Region: 3
City: MUNCIE State: IN
County: DELAWARE
License #: 13-00951-03
Agreement: N
Docket:
NRC Notified By: ALVIS FOSTER
HQ OPS Officer: DANIEL MILLS
Licensee: IU HEALTH BALL MEMORIAL HOSPITAL
Region: 3
City: MUNCIE State: IN
County: DELAWARE
License #: 13-00951-03
Agreement: N
Docket:
NRC Notified By: ALVIS FOSTER
HQ OPS Officer: DANIEL MILLS
Notification Date: 02/04/2015
Notification Time: 17:23 [ET]
Event Date: 01/15/2014
Event Time: 00:00 [EST]
Last Update Date: 02/26/2015
Notification Time: 17:23 [ET]
Event Date: 01/15/2014
Event Time: 00:00 [EST]
Last Update Date: 02/26/2015
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
LAURA KOZAK (R3DO)
NMSS_EVENTS_NOTIFICA (EMAI)
LAURA KOZAK (R3DO)
NMSS_EVENTS_NOTIFICA (EMAI)
INERT CAPSULE ADMINISTERED TO PATIENT DURING TREATMENT
The following was received from the licensee via email:
"A 40 year old adult male patient was scheduled to receive 150 mCi of radioactive Iodine 131 as a thyroid cancer therapy. The dose, in pill form, was assayed as prescribed on Wednesday 1/15/14 and was believed to have been [administered to the patient].
"On 1/23/14, the patient returned for a whole body scan, [which is] a routine part of the procedure. After scanning the patient, it was noted that there was no activity remaining, which could not be possible under normal circumstances, because Iodine 131 has an 8 day physical half-life. Even with biological excretion occurring, one would expect significant detectable activity 8 days after administration.
"Two technologists were involved, one assayed the dose and put it back in temporary storage, the other subsequently retrieved the capsule and administered it. Upon investigation it was found that an inert capsule was inadvertently retrieved rather than the patient's capsule. The capsule the patient should have received was discovered and assayed, and found to be the actual capsule that should have been delivered.
"The tablet given to the patient had an activity of 30 mCi of Iodine 131 on 8/2/13, this was some 20 half-lives prior to the January 2014 date of this incident and [the capsule] was therefore completely inert, therefore no dose was administered.
"[The licensee] talked with [the licensee's] Nuclear Medicine consultant, to review the regulations. Upon review of USNRC regulations and based upon advice from [the consultant], this was not deemed a medical event but rather a self-identified violation of our procedures.
"Based upon an NRC review during an inspection on 2/3/15 we were advised that this occurrence, in [the NRC inspector's] opinion, constitutes a Medical Event based on Title 10 of the Code of Federal Regulations Part 35.3045.
"We were advised to contact the USNRC offices in Region III by the end of business on 2/4/15 and report the occurrence as a Medical Event.
"With respect to patient impact, papillary/follicular cancers are slowing grow and indolent, and a delay in treatment would not be expected to adversely affect the outcome. The patient was subsequently rescheduled and administered the [prescribed] dose of Iodine 131.
"In order to determine cause and institute corrective measures, a root cause analysis investigation was conducted and as a result, procedure revisions were implemented to prevent the likelihood of additional errors of this type."
* * * RETRACTION FROM ALVIS FOSTER TO CHARLES TEAL AT 1558 EST ON 2/26/15 * * *
Since the patient received no dose as a result of this procedure, it was determined that this event was not a medical event.
Notified R3DO (Stone) and NMSS Events Notification via email.
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.
The following was received from the licensee via email:
"A 40 year old adult male patient was scheduled to receive 150 mCi of radioactive Iodine 131 as a thyroid cancer therapy. The dose, in pill form, was assayed as prescribed on Wednesday 1/15/14 and was believed to have been [administered to the patient].
"On 1/23/14, the patient returned for a whole body scan, [which is] a routine part of the procedure. After scanning the patient, it was noted that there was no activity remaining, which could not be possible under normal circumstances, because Iodine 131 has an 8 day physical half-life. Even with biological excretion occurring, one would expect significant detectable activity 8 days after administration.
"Two technologists were involved, one assayed the dose and put it back in temporary storage, the other subsequently retrieved the capsule and administered it. Upon investigation it was found that an inert capsule was inadvertently retrieved rather than the patient's capsule. The capsule the patient should have received was discovered and assayed, and found to be the actual capsule that should have been delivered.
"The tablet given to the patient had an activity of 30 mCi of Iodine 131 on 8/2/13, this was some 20 half-lives prior to the January 2014 date of this incident and [the capsule] was therefore completely inert, therefore no dose was administered.
"[The licensee] talked with [the licensee's] Nuclear Medicine consultant, to review the regulations. Upon review of USNRC regulations and based upon advice from [the consultant], this was not deemed a medical event but rather a self-identified violation of our procedures.
"Based upon an NRC review during an inspection on 2/3/15 we were advised that this occurrence, in [the NRC inspector's] opinion, constitutes a Medical Event based on Title 10 of the Code of Federal Regulations Part 35.3045.
"We were advised to contact the USNRC offices in Region III by the end of business on 2/4/15 and report the occurrence as a Medical Event.
"With respect to patient impact, papillary/follicular cancers are slowing grow and indolent, and a delay in treatment would not be expected to adversely affect the outcome. The patient was subsequently rescheduled and administered the [prescribed] dose of Iodine 131.
"In order to determine cause and institute corrective measures, a root cause analysis investigation was conducted and as a result, procedure revisions were implemented to prevent the likelihood of additional errors of this type."
* * * RETRACTION FROM ALVIS FOSTER TO CHARLES TEAL AT 1558 EST ON 2/26/15 * * *
Since the patient received no dose as a result of this procedure, it was determined that this event was not a medical event.
Notified R3DO (Stone) and NMSS Events Notification via email.
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.
Power Reactor
Event Number: 49726
Facility: MILLSTONE
Region: 1 State: CT
Unit: [] [2] []
RX Type: [1] GE-3,[2] CE,[3] W-4-LP
NRC Notified By: TIM HALL
HQ OPS Officer: STEVE SANDIN
Region: 1 State: CT
Unit: [] [2] []
RX Type: [1] GE-3,[2] CE,[3] W-4-LP
NRC Notified By: TIM HALL
HQ OPS Officer: STEVE SANDIN
Notification Date: 01/15/2014
Notification Time: 13:29 [ET]
Event Date: 01/15/2014
Event Time: 10:19 [EST]
Last Update Date: 01/15/2014
Notification Time: 13:29 [ET]
Event Date: 01/15/2014
Event Time: 10:19 [EST]
Last Update Date: 01/15/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
JOHN ROGGE (R1DO)
JOHN ROGGE (R1DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 2 | N | Y | 100 | Power Operation | 100 | Power Operation |
HIGH RANGE STACK RADIATION MONITOR REMOVED FROM SERVICE FOR PLANNED MAINTENANCE
"Millstone Unit 2 [removed the] High Range Stack Radiation Monitor, RM 8168, [from service for] pre-planned maintenance. RM 8168 [was] restored to operable at 1157 [EST] on 1/15/2014."
The licensee informed State and local agencies and the NRC Resident Inspector.
"Millstone Unit 2 [removed the] High Range Stack Radiation Monitor, RM 8168, [from service for] pre-planned maintenance. RM 8168 [was] restored to operable at 1157 [EST] on 1/15/2014."
The licensee informed State and local agencies and the NRC Resident Inspector.
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Power Reactor
Event Number: 49727
Facility: QUAD CITIES
Region: 3 State: IL
Unit: [] [2] []
RX Type: [1] GE-3,[2] GE-3
NRC Notified By: JAMES BURKE
HQ OPS Officer: STEVE SANDIN
Region: 3 State: IL
Unit: [] [2] []
RX Type: [1] GE-3,[2] GE-3
NRC Notified By: JAMES BURKE
HQ OPS Officer: STEVE SANDIN
Notification Date: 01/15/2014
Notification Time: 15:47 [ET]
Event Date: 01/15/2014
Event Time: 07:23 [CST]
Last Update Date: 02/07/2014
Notification Time: 15:47 [ET]
Event Date: 01/15/2014
Event Time: 07:23 [CST]
Last Update Date: 02/07/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(C) - POT UNCNTRL RAD REL
10 CFR Section:
50.72(b)(3)(v)(C) - POT UNCNTRL RAD REL
Person (Organization):
RICHARD SKOKOWSKI (R3DO)
RICHARD SKOKOWSKI (R3DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 2 | N | Y | 100 | Power Operation | 100 | Power Operation |
DRYWELL RADIATION MONITOR INOPERABLE
"At 0723 [CST] hours on January 15, 2014, the 2A Drywell Radiation Monitor was declared inoperable after exhibiting erratic performance. This monitor provides the input into one division of the primary containment isolation logic for a Group II isolation. As a result, the channel was placed in a tripped condition in accordance with Technical Specification 3.3.6.1, Condition B.
"Given both divisions are required to complete the Group II isolation logic, this condition is reportable in accordance with 10 CFR 50.72(b)(3)(v)(C) as an event or condition that could have prevented the fulfillment of a safety function.
"The 2A Drywell Radiation Monitor has been repaired and restored to an operable condition.
"The NRC Resident Inspector has been notified."
* * * RETRACTION FROM JAMES BURKE TO JOHN SHOEMAKER AT 1447 EST ON 2/7/14 * * *
"The purpose of this notification is to retract the ENS notification made on January 15, 2014 (ENS 49727). Upon further investigation it was verified that the Drywell Radiation Monitors do not mitigate the consequences of an accident as discussed in Chapters 6 and 15 of the Updated Final Safety Analysis Report and the Technical Specifications Bases for 3.3.6.1. Therefore, the threshold for reporting the issue as an event or condition that could have prevented the fulfillment of a safety function was not met (NUREG 1022 Revision 3 - Event Report Guidelines Section 3.2.7).
"The NRC Resident Inspector has been notified."
Notified the R3DO (Orlikowski).
"At 0723 [CST] hours on January 15, 2014, the 2A Drywell Radiation Monitor was declared inoperable after exhibiting erratic performance. This monitor provides the input into one division of the primary containment isolation logic for a Group II isolation. As a result, the channel was placed in a tripped condition in accordance with Technical Specification 3.3.6.1, Condition B.
"Given both divisions are required to complete the Group II isolation logic, this condition is reportable in accordance with 10 CFR 50.72(b)(3)(v)(C) as an event or condition that could have prevented the fulfillment of a safety function.
"The 2A Drywell Radiation Monitor has been repaired and restored to an operable condition.
"The NRC Resident Inspector has been notified."
* * * RETRACTION FROM JAMES BURKE TO JOHN SHOEMAKER AT 1447 EST ON 2/7/14 * * *
"The purpose of this notification is to retract the ENS notification made on January 15, 2014 (ENS 49727). Upon further investigation it was verified that the Drywell Radiation Monitors do not mitigate the consequences of an accident as discussed in Chapters 6 and 15 of the Updated Final Safety Analysis Report and the Technical Specifications Bases for 3.3.6.1. Therefore, the threshold for reporting the issue as an event or condition that could have prevented the fulfillment of a safety function was not met (NUREG 1022 Revision 3 - Event Report Guidelines Section 3.2.7).
"The NRC Resident Inspector has been notified."
Notified the R3DO (Orlikowski).
Power Reactor
Event Number: 49728
Facility: ZION
Region: 3 State: IL
Unit: [1] [2] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: RANDALL THORNTON
HQ OPS Officer: STEVE SANDIN
Region: 3 State: IL
Unit: [1] [2] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: RANDALL THORNTON
HQ OPS Officer: STEVE SANDIN
Notification Date: 01/15/2014
Notification Time: 16:25 [ET]
Event Date: 01/15/2014
Event Time: 09:15 [CST]
Last Update Date: 01/15/2014
Notification Time: 16:25 [ET]
Event Date: 01/15/2014
Event Time: 09:15 [CST]
Last Update Date: 01/15/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
26.719 - FITNESS FOR DUTY
10 CFR Section:
26.719 - FITNESS FOR DUTY
Person (Organization):
RICHARD SKOKOWSKI (R3DO)
RICHARD SKOKOWSKI (R3DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | N | 0 | Decommissioned | 0 | Decommissioned |
| 2 | N | N | 0 | Decommissioned | 0 | Decommissioned |
FITNESS-FOR-DUTY REPORT INVOLVING A LICENSED SUPERVISOR
A licensed supervisor had a confirmed positive for alcohol during a for-cause fitness-for-duty test. The employee's access to the plant has been terminated.
A licensed supervisor had a confirmed positive for alcohol during a for-cause fitness-for-duty test. The employee's access to the plant has been terminated.
Power Reactor
Event Number: 49729
Facility: COLUMBIA GENERATING STATION
Region: 4 State: WA
Unit: [2] [] []
RX Type: [2] GE-5
NRC Notified By: MATT HUMMER
HQ OPS Officer: JOHN SHOEMAKER
Region: 4 State: WA
Unit: [2] [] []
RX Type: [2] GE-5
NRC Notified By: MATT HUMMER
HQ OPS Officer: JOHN SHOEMAKER
Notification Date: 01/15/2014
Notification Time: 16:37 [ET]
Event Date: 01/15/2014
Event Time: 09:07 [PST]
Last Update Date: 01/15/2014
Notification Time: 16:37 [ET]
Event Date: 01/15/2014
Event Time: 09:07 [PST]
Last Update Date: 01/15/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(C) - POT UNCNTRL RAD REL 50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
10 CFR Section:
50.72(b)(3)(v)(C) - POT UNCNTRL RAD REL 50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
Person (Organization):
RAY KELLAR (R4DO)
RAY KELLAR (R4DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 2 | N | Y | 100 | Power Operation | 100 | Power Operation |
LOSS OF SECONDARY CONTAINMENT DIFFERENTIAL PRESSURE
"Reactor Building (Secondary Containment) pressure increased to above the Technical Specification Surveillance requirement of 0.25 inches vacuum water gauge briefly (5 minutes or less). This is reportable as an event that could have prevented fulfillment of a safety function needed to control the release of radiation and mitigate the consequences of an accident. Reactor Building pressure has been restored to normal (greater than 0.25 inches vacuum water gauge), returning Secondary Containment to operable status. Highest actual value was 0.21 inches vacuum water gauge.
"There were no radiological releases associated with the event."
The differential pressure change is believed to have been caused by a momentary shift in Heating and Ventilation Systems dampers.
The licensee has notified the NRC Resident Inspector.
"Reactor Building (Secondary Containment) pressure increased to above the Technical Specification Surveillance requirement of 0.25 inches vacuum water gauge briefly (5 minutes or less). This is reportable as an event that could have prevented fulfillment of a safety function needed to control the release of radiation and mitigate the consequences of an accident. Reactor Building pressure has been restored to normal (greater than 0.25 inches vacuum water gauge), returning Secondary Containment to operable status. Highest actual value was 0.21 inches vacuum water gauge.
"There were no radiological releases associated with the event."
The differential pressure change is believed to have been caused by a momentary shift in Heating and Ventilation Systems dampers.
The licensee has notified the NRC Resident Inspector.
Power Reactor
Event Number: 49730
Facility: WATTS BAR
Region: 2 State: TN
Unit: [1] [] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: DAMON FEGLEY
HQ OPS Officer: JOHN SHOEMAKER
Region: 2 State: TN
Unit: [1] [] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: DAMON FEGLEY
HQ OPS Officer: JOHN SHOEMAKER
Notification Date: 01/15/2014
Notification Time: 17:18 [ET]
Event Date: 01/15/2014
Event Time: 07:32 [EST]
Last Update Date: 01/15/2014
Notification Time: 17:18 [ET]
Event Date: 01/15/2014
Event Time: 07:32 [EST]
Last Update Date: 01/15/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
26.719 - FITNESS FOR DUTY
10 CFR Section:
26.719 - FITNESS FOR DUTY
Person (Organization):
MICHAEL F. KING (R2DO)
MICHAEL F. KING (R2DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | Y | 100 | Power Operation | 100 | Power Operation |
FITNESS-FOR-DUTY INVOLVING A CONTRACT SUPERVISOR
A contract supervisor had a confirmed positive for alcohol during a random fitness-for-duty test. The employee's access to the plant has been suspended.
The licensee has notified the NRC Resident Inspectors.
A contract supervisor had a confirmed positive for alcohol during a random fitness-for-duty test. The employee's access to the plant has been suspended.
The licensee has notified the NRC Resident Inspectors.
Power Reactor
Event Number: 49724
Facility: MILLSTONE
Region: 1 State: CT
Unit: [] [] [3]
RX Type: [1] GE-3,[2] CE,[3] W-4-LP
NRC Notified By: TODD FISHER
HQ OPS Officer: STEVE SANDIN
Region: 1 State: CT
Unit: [] [] [3]
RX Type: [1] GE-3,[2] CE,[3] W-4-LP
NRC Notified By: TODD FISHER
HQ OPS Officer: STEVE SANDIN
Notification Date: 01/15/2014
Notification Time: 12:29 [ET]
Event Date: 01/15/2014
Event Time: 09:48 [EST]
Last Update Date: 01/15/2014
Notification Time: 12:29 [ET]
Event Date: 01/15/2014
Event Time: 09:48 [EST]
Last Update Date: 01/15/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
JOHN ROGGE (R1DO)
JOHN ROGGE (R1DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 3 | N | Y | 100 | Power Operation | 100 | Power Operation |
NORMAL VENTILATION RADIATION MONITOR REMOVED FROM SERVICE FOR PLANNED MAINTENANCE
"[The] Normal Ventilation Normal Range Process Radiation Monitor 3HVR*RE10B [was] removed from service for planned maintenance. [The affected Radiation Monitor] will be returned to service following maintenance."
The licensee informed State and local agencies and the NRC Resident Inspector.
"[The] Normal Ventilation Normal Range Process Radiation Monitor 3HVR*RE10B [was] removed from service for planned maintenance. [The affected Radiation Monitor] will be returned to service following maintenance."
The licensee informed State and local agencies and the NRC Resident Inspector.
Agreement State
Event Number: 49734
Rep Org: ARKANSAS DEPARTMENT OF HEALTH
Licensee: CENTRAL ARKANSAS RADIATION THERAPY INSTITUTE INC
Region: 4
City: CONWAY State: AR
County:
License #: ARK-0654-0220
Agreement: Y
Docket:
NRC Notified By: STEVE MACK
HQ OPS Officer: CHARLES TEAL
Licensee: CENTRAL ARKANSAS RADIATION THERAPY INSTITUTE INC
Region: 4
City: CONWAY State: AR
County:
License #: ARK-0654-0220
Agreement: Y
Docket:
NRC Notified By: STEVE MACK
HQ OPS Officer: CHARLES TEAL
Notification Date: 01/17/2014
Notification Time: 11:41 [ET]
Event Date: 01/15/2014
Event Time: 18:00 [CST]
Last Update Date: 06/23/2014
Notification Time: 11:41 [ET]
Event Date: 01/15/2014
Event Time: 18:00 [CST]
Last Update Date: 06/23/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
RAY KELLAR (R4DO)
FSME EVENT RESOURCE (EMAI)
RAY KELLAR (R4DO)
FSME EVENT RESOURCE (EMAI)
AGREEMENT STATE REPORT - PROSTATE SEED IMPLANT MISADMINISTRATION
The following was received from the State of Arkansas via email:
"Central Arkansas Radiation Therapy Institute, Inc. (CARTI), ARK-0654-02200, reported a medical event involving a patient treated for prostate cancer. The treatment plan included implanting 128 I-125 brachytherapy seeds (6 seeds were not implanted), containing a total activity of 1.592 GBq (43.036 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 14,400 cGy. It appears that approximately 40 of the total number of seeds were implanted into the prostate gland. The seeds were implanted on December 31, 2013. On January 15, 2014, the patient returned to the facility for a post implant CT scan. The scan showed that the implanted seeds, although in an appropriate pattern, were placed outside the intended target.
"The State performed an on-site review on January 16, 2014, of the event and discussed the initial details of the event.
"The licensee is continuing to investigate the cause and is preparing a written report.
"The State is continuing to investigate and will update this report when the report is received from the licensee.
"This event is reportable under 10 CFR 35.3045 of the NRC Regulations and RH-8800 of the Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing Radiation."
State Event Report Number: AR-2014-001
* * * UPDATE PROVIDED VIA EMAIL BY STEVE MACK TO JEFF ROTTON AT 1557 EDT ON 06/23/2014 * * *
"Doses: The D90 for the prostate pre-plan was 167.86 Gy and the D90 for the prostate post-plan is 25.31 Gy.
"Estimated mean doses to other organs and tissues were, Seminal Vesicles 13.99 Gy, Rectum 45.80 Gy, Bladder 3.89 Gy, and the Penile Bulb 185.24 Gy.
"Root cause of the event: The licensee stated: 'the facts of the case lead us to believe that the complexity of the patient anatomy contributed to anatomical misidentification by the attending urologist, i.e. mistaking the penile bulb with the prostate gland.'
"Corrective Actions
"Multiple corrective actions were implemented including: (1) Centralizing prostate seed implant programs to fewer facilities under the Radioactive Material License, (2) At those facilities continuing to perform prostate seed implants, ensure consistent adherence to the seed implant procedural and policies at each facility, (3) Re-evaluation of the prostate seed implant procedures by the radiation oncologists, (4) Require quality assurance documents on the ultrasound equipment utilized for prostate seed implants, and (5) Require training and proficiency records for operating room staff assisting with prostate seed implants.
"Manufacturer and model number of the seeds: The seeds used during this misadministration were Oncura, OncoSeed, Model 6711, containing 0.336 mCi of I-125. Thirty-four (34) seeds of 128 were implanted into the prostate.
"The Department [Arkansas Department of Health] considers this event to be closed."
Notified R4DO (Allen) and FSME Resources via email.
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.
The following was received from the State of Arkansas via email:
"Central Arkansas Radiation Therapy Institute, Inc. (CARTI), ARK-0654-02200, reported a medical event involving a patient treated for prostate cancer. The treatment plan included implanting 128 I-125 brachytherapy seeds (6 seeds were not implanted), containing a total activity of 1.592 GBq (43.036 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 14,400 cGy. It appears that approximately 40 of the total number of seeds were implanted into the prostate gland. The seeds were implanted on December 31, 2013. On January 15, 2014, the patient returned to the facility for a post implant CT scan. The scan showed that the implanted seeds, although in an appropriate pattern, were placed outside the intended target.
"The State performed an on-site review on January 16, 2014, of the event and discussed the initial details of the event.
"The licensee is continuing to investigate the cause and is preparing a written report.
"The State is continuing to investigate and will update this report when the report is received from the licensee.
"This event is reportable under 10 CFR 35.3045 of the NRC Regulations and RH-8800 of the Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing Radiation."
State Event Report Number: AR-2014-001
* * * UPDATE PROVIDED VIA EMAIL BY STEVE MACK TO JEFF ROTTON AT 1557 EDT ON 06/23/2014 * * *
"Doses: The D90 for the prostate pre-plan was 167.86 Gy and the D90 for the prostate post-plan is 25.31 Gy.
"Estimated mean doses to other organs and tissues were, Seminal Vesicles 13.99 Gy, Rectum 45.80 Gy, Bladder 3.89 Gy, and the Penile Bulb 185.24 Gy.
"Root cause of the event: The licensee stated: 'the facts of the case lead us to believe that the complexity of the patient anatomy contributed to anatomical misidentification by the attending urologist, i.e. mistaking the penile bulb with the prostate gland.'
"Corrective Actions
"Multiple corrective actions were implemented including: (1) Centralizing prostate seed implant programs to fewer facilities under the Radioactive Material License, (2) At those facilities continuing to perform prostate seed implants, ensure consistent adherence to the seed implant procedural and policies at each facility, (3) Re-evaluation of the prostate seed implant procedures by the radiation oncologists, (4) Require quality assurance documents on the ultrasound equipment utilized for prostate seed implants, and (5) Require training and proficiency records for operating room staff assisting with prostate seed implants.
"Manufacturer and model number of the seeds: The seeds used during this misadministration were Oncura, OncoSeed, Model 6711, containing 0.336 mCi of I-125. Thirty-four (34) seeds of 128 were implanted into the prostate.
"The Department [Arkansas Department of Health] considers this event to be closed."
Notified R4DO (Allen) and FSME Resources via email.
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.