Event Notification Report for May 19, 2016
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
05/18/2016 - 05/19/2016
Agreement State
Event Number: 51945
Rep Org: TEXAS DEPT OF STATE HEALTH SERVICES
Licensee: DOW CHEMICAL COMPANY
Region: 4
City: SEADRIFT State: TX
County: CALHOUN
License #: 00051
Agreement: Y
Docket:
NRC Notified By: ARTHUR TUCKER
HQ OPS Officer: KARL DIEDERICH
Licensee: DOW CHEMICAL COMPANY
Region: 4
City: SEADRIFT State: TX
County: CALHOUN
License #: 00051
Agreement: Y
Docket:
NRC Notified By: ARTHUR TUCKER
HQ OPS Officer: KARL DIEDERICH
Notification Date: 05/19/2016
Notification Time: 22:08 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [CDT]
Last Update Date: 05/19/2016
Notification Time: 22:08 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [CDT]
Last Update Date: 05/19/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
GEOFFREY MILLER (R4DO)
NMSS_EVENTS_NOTIFIC (EMAI)
GEOFFREY MILLER (R4DO)
NMSS_EVENTS_NOTIFIC (EMAI)
AGREEMENT STATE REPORT - NUCLEAR GAUGE STUCK SHUTTER
The following information was received via E-mail:
"Event Type: 30.50(b)(2), Events in which equipment is disabled or fails to function as designed.
"Event Narrative: On May 19, 2016 the Agency [Texas Department of State Health Services] was notified by the licensee's radiation safety officer (RSO) that while performing routine shutter checks, the shutter on an Ohmart model SHLM-BR4 could not be closed. The gauge contains a 5.0 curie cesium-137 source. Open is the normal operating position of the gauge. The source does not create any additional risk of exposure to the workers or members of the general public. The RSO stated they will call their service company to repair the gauge. The RSO stated the gauge is scheduled to be replaced during their next outage this fall. Additional information will be provided as it is received in accordance with SA-300."
Texas Incident #: I-9405.
The following information was received via E-mail:
"Event Type: 30.50(b)(2), Events in which equipment is disabled or fails to function as designed.
"Event Narrative: On May 19, 2016 the Agency [Texas Department of State Health Services] was notified by the licensee's radiation safety officer (RSO) that while performing routine shutter checks, the shutter on an Ohmart model SHLM-BR4 could not be closed. The gauge contains a 5.0 curie cesium-137 source. Open is the normal operating position of the gauge. The source does not create any additional risk of exposure to the workers or members of the general public. The RSO stated they will call their service company to repair the gauge. The RSO stated the gauge is scheduled to be replaced during their next outage this fall. Additional information will be provided as it is received in accordance with SA-300."
Texas Incident #: I-9405.
Agreement State
Event Number: 51943
Rep Org: KENTUCKY DEPT OF RADIATION CONTROL
Licensee: TAYLOR REGIONAL HOSPTIAL
Region: 1
City: CAMPBELLSVILLE State: KY
County:
License #: 202-099-27
Agreement: Y
Docket:
NRC Notified By: MARISSA VEGA VELEZ
HQ OPS Officer: RICHARD SMITH
Licensee: TAYLOR REGIONAL HOSPTIAL
Region: 1
City: CAMPBELLSVILLE State: KY
County:
License #: 202-099-27
Agreement: Y
Docket:
NRC Notified By: MARISSA VEGA VELEZ
HQ OPS Officer: RICHARD SMITH
Notification Date: 05/19/2016
Notification Time: 19:10 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [CDT]
Last Update Date: 05/19/2016
Notification Time: 19:10 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [CDT]
Last Update Date: 05/19/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
ANNE DeFRANCISCO (R1DO)
NMSS_EVENTS_NOTIFIC (EMAI)
ANNE DeFRANCISCO (R1DO)
NMSS_EVENTS_NOTIFIC (EMAI)
AGREEMENT STATE REPORT - MEDICAL EVENTS - MISADMINISTRATION
The following was reported to the NRC via phone notification and email:
"As a result of a routine health and safety inspection, Taylor Regional Hospital has reported 13 medical events which occurred [from] 2006 [to] 2011. These medical events are the result of permanent prostate brachytherapy where post implant dosimetry for each of the 13 patients revealed the total dose delivered to the target organ differed from the prescribed dose by 50 REM and 20% or more. The Kentucky Cabinet for Health and Family Services is continuing to communicate with the licensee to ascertain all relevant information related to these events.
"Event report ID No: KY160004"
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 reported to the NRC via phone notification and email:
"As a result of a routine health and safety inspection, Taylor Regional Hospital has reported 13 medical events which occurred [from] 2006 [to] 2011. These medical events are the result of permanent prostate brachytherapy where post implant dosimetry for each of the 13 patients revealed the total dose delivered to the target organ differed from the prescribed dose by 50 REM and 20% or more. The Kentucky Cabinet for Health and Family Services is continuing to communicate with the licensee to ascertain all relevant information related to these events.
"Event report ID No: KY160004"
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.
Non-Agreement State
Event Number: 52063
Rep Org: GEORGETOWN HOSPITAL
Licensee: GEORGETOWN HOSPITAL
Region: 1
City: WASHINGTON State: DC
County:
License #: 08-30577-01
Agreement: N
Docket: 03035409
NRC Notified By: DR. DAVID SMITH
HQ OPS Officer: BETHANY CECERE
Licensee: GEORGETOWN HOSPITAL
Region: 1
City: WASHINGTON State: DC
County:
License #: 08-30577-01
Agreement: N
Docket: 03035409
NRC Notified By: DR. DAVID SMITH
HQ OPS Officer: BETHANY CECERE
Notification Date: 07/05/2016
Notification Time: 16:03 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [EDT]
Last Update Date: 07/05/2016
Notification Time: 16:03 [ET]
Event Date: 05/19/2016
Event Time: 00:00 [EDT]
Last Update Date: 07/05/2016
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):
NMSS_EVENTS_NOTIFIC (EMAI)
FRED BOWER (R1DO)
NMSS_EVENTS_NOTIFIC (EMAI)
FRED BOWER (R1DO)
MEDICAL EVENT - WRITTEN DIRECTIVE NOT FOLLOWED
The following is excerpted from the report sent via email:
"On June 16, 2016 [the licensee's Director of Radiation Safety] was notified by the Authorized User (AU) of an issue regarding the May 19, 2016 radioembolization of a patient. During the subsequent review of the patient's treatment plan in preparation for an additional radioembolization of the Right Hepatic Lobe (scheduled for June 16, 2016) the AU observed the May 19, 2016 Written Directive/treatment plan was completed for the Right Hepatic Lobe, but treatment had been delivered to the Left Hepatic Lobe.
"Review of the physician notes for the caseú reveal the intended primary treatment site, as noted by the Interventional Radiologist (IR) was the Left Hepatic Lobe, however, communication between the IR and AU requested a treatment plan for the Right Hepatic Lobe. On 16 June 2016 the AU confirmed with the IR that the Left Hepatic Lobe was indeed the intended treatment site for the 19 May 2016 procedure. Of note, the 19 May 2016 delivery was not completed as stasis was achieved.
"The AU and Medical Physicist (MP) recalculated the 19 May 2016 treatment plan based on the administered activity and the treatment volume for the Left Hepatic Lobe. The resultant delivered dose was 119.4% of the prescribed dose. The AU determined there was no harm to the patient.
"After review of the circumstances relative to the requirements stipulated in 10 CFR 35.3045 Report and Notification of a Medical Event, it does not appear this is a Medical Event and therefore, does not meet the reporting requirements of 10 CFR 35.3045. The dose was delivered to the Left Hepatic Lobe prior to the planned delivery to the Right Hepatic Lobe, i.e. both lobes were intended for treatment at different times; the original Written Directive was reviewed and corrected to account for the delivery to the Left Hepatic Lobe and the resultant dose did not exceed any thresholds specified in 10 CFR 35.3045.
"Although not believed to be reportable as a Medical Event, this incident may be a violation of 10 CFR 35.40, Written Directives, paragraph (c) and/or 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, paragraphs (a)(2) and (b)(2). Therefore, I am submitting this report for your review.
"Actions taken to preclude a recurrence:
1. A Time Out will occur wherein the AU, Medical Physicist and Interventional Radiologist (IR) communicate the specifics of the treatment plan by asking open-ended questions requiring more than a 'yes/no' answer. The Time Out will be documented via signatures from each of the aforementioned team members.
2. After the mapping study, the IR will clearly indicate the preferred treatment site(s) in his notes so the AU is clear as to the development of the treatment plan.
These have been incorporated into the Radiation Medicine Sirsphere Policy and each member of the team has been instructed regarding the changes. Additionally, this incident is being tracked through our internal Risk Management system for further review and potential improvements to the program. These actions/reviews have been conducted and implemented prior to the next case, which is scheduled for 30 June 2016.
"Details of Incident
1. Original Written Directive for Right Hepatic Lobe (19 May 2016)
a. Activity prescribed: 25.49 mCi
b. Dose to Lobe prescribed: 32.13 Gy
c. Activity delivered: 23 .48 mCi
d. Dose to Lobe delivered: 29.59 Gy
2. Revised Written Directive for Left Hepatic Lobe (16 June 2016)
a. Activity prescribed: 19.67 mCi
b. Dose to Lobe prescribed: 43.37 Gy
c. Activity delivered: 23.48 mCi
d. Dose to Lobe delivered: 51. 77 Gy
e. Percent variation of administered activity to that prescribed = 19 .4%"
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 is excerpted from the report sent via email:
"On June 16, 2016 [the licensee's Director of Radiation Safety] was notified by the Authorized User (AU) of an issue regarding the May 19, 2016 radioembolization of a patient. During the subsequent review of the patient's treatment plan in preparation for an additional radioembolization of the Right Hepatic Lobe (scheduled for June 16, 2016) the AU observed the May 19, 2016 Written Directive/treatment plan was completed for the Right Hepatic Lobe, but treatment had been delivered to the Left Hepatic Lobe.
"Review of the physician notes for the caseú reveal the intended primary treatment site, as noted by the Interventional Radiologist (IR) was the Left Hepatic Lobe, however, communication between the IR and AU requested a treatment plan for the Right Hepatic Lobe. On 16 June 2016 the AU confirmed with the IR that the Left Hepatic Lobe was indeed the intended treatment site for the 19 May 2016 procedure. Of note, the 19 May 2016 delivery was not completed as stasis was achieved.
"The AU and Medical Physicist (MP) recalculated the 19 May 2016 treatment plan based on the administered activity and the treatment volume for the Left Hepatic Lobe. The resultant delivered dose was 119.4% of the prescribed dose. The AU determined there was no harm to the patient.
"After review of the circumstances relative to the requirements stipulated in 10 CFR 35.3045 Report and Notification of a Medical Event, it does not appear this is a Medical Event and therefore, does not meet the reporting requirements of 10 CFR 35.3045. The dose was delivered to the Left Hepatic Lobe prior to the planned delivery to the Right Hepatic Lobe, i.e. both lobes were intended for treatment at different times; the original Written Directive was reviewed and corrected to account for the delivery to the Left Hepatic Lobe and the resultant dose did not exceed any thresholds specified in 10 CFR 35.3045.
"Although not believed to be reportable as a Medical Event, this incident may be a violation of 10 CFR 35.40, Written Directives, paragraph (c) and/or 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, paragraphs (a)(2) and (b)(2). Therefore, I am submitting this report for your review.
"Actions taken to preclude a recurrence:
1. A Time Out will occur wherein the AU, Medical Physicist and Interventional Radiologist (IR) communicate the specifics of the treatment plan by asking open-ended questions requiring more than a 'yes/no' answer. The Time Out will be documented via signatures from each of the aforementioned team members.
2. After the mapping study, the IR will clearly indicate the preferred treatment site(s) in his notes so the AU is clear as to the development of the treatment plan.
These have been incorporated into the Radiation Medicine Sirsphere Policy and each member of the team has been instructed regarding the changes. Additionally, this incident is being tracked through our internal Risk Management system for further review and potential improvements to the program. These actions/reviews have been conducted and implemented prior to the next case, which is scheduled for 30 June 2016.
"Details of Incident
1. Original Written Directive for Right Hepatic Lobe (19 May 2016)
a. Activity prescribed: 25.49 mCi
b. Dose to Lobe prescribed: 32.13 Gy
c. Activity delivered: 23 .48 mCi
d. Dose to Lobe delivered: 29.59 Gy
2. Revised Written Directive for Left Hepatic Lobe (16 June 2016)
a. Activity prescribed: 19.67 mCi
b. Dose to Lobe prescribed: 43.37 Gy
c. Activity delivered: 23.48 mCi
d. Dose to Lobe delivered: 51. 77 Gy
e. Percent variation of administered activity to that prescribed = 19 .4%"
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.