Event Notification Report for March 18, 2015
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
03/17/2015 - 03/18/2015
Agreement State
Event Number: 50908
Rep Org: WISCONSIN RADIATION PROTECTION
Licensee: WHEATON FRANCISCAN HEALTHCARE - FRANKLIN, INC.
Region: 3
City: FRANKLIN State: WI
County:
License #: 079-1375-01
Agreement: Y
Docket:
NRC Notified By: KYLE WALTON
HQ OPS Officer: JEFF HERRERA
Licensee: WHEATON FRANCISCAN HEALTHCARE - FRANKLIN, INC.
Region: 3
City: FRANKLIN State: WI
County:
License #: 079-1375-01
Agreement: Y
Docket:
NRC Notified By: KYLE WALTON
HQ OPS Officer: JEFF HERRERA
Notification Date: 03/19/2015
Notification Time: 17:18 [ET]
Event Date: 03/18/2015
Event Time: 00:00 [CDT]
Last Update Date: 03/19/2015
Notification Time: 17:18 [ET]
Event Date: 03/18/2015
Event Time: 00:00 [CDT]
Last Update Date: 03/19/2015
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
GREGORY ROACH (R3DO)
NMSS_EVENTS_NOTIFIC (EMAI)
GREGORY ROACH (R3DO)
NMSS_EVENTS_NOTIFIC (EMAI)
AGREEMENT STATE REPORT - UNDER DOSAGE OF PATIENT UNDERGOING TREATMENT
The following report was received from the State of Wisconsin Department of Health Services via email:
"On March 18, 2015, the Wisconsin Radiation Protection Section received a notice from the Radiation Safety Officer (RSO) at Wheaton Franciscan Healthcare-Franklin of a medical event that occurred from a halted administration of Yttrium 90 SIR-Spheres. During the administration, air bubbles were noticed to be collecting in the tubing delivering the dose. The procedure was stopped in order to avoid injecting air bubbles into the patient. The prescribed dose was 33.26 mCi. 26.35 mCi had been delivered to the patient, based on pre-and post-procedure assays of the material. This is 79.2% of the prescribed dose. The licensee believes placement of the needles drawing the solution was to blame for the collection of air bubbles. The Radiation Protection Section will perform an investigation and update through NMED."
Wisconsin Event Report ID No.: WI150005
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 report was received from the State of Wisconsin Department of Health Services via email:
"On March 18, 2015, the Wisconsin Radiation Protection Section received a notice from the Radiation Safety Officer (RSO) at Wheaton Franciscan Healthcare-Franklin of a medical event that occurred from a halted administration of Yttrium 90 SIR-Spheres. During the administration, air bubbles were noticed to be collecting in the tubing delivering the dose. The procedure was stopped in order to avoid injecting air bubbles into the patient. The prescribed dose was 33.26 mCi. 26.35 mCi had been delivered to the patient, based on pre-and post-procedure assays of the material. This is 79.2% of the prescribed dose. The licensee believes placement of the needles drawing the solution was to blame for the collection of air bubbles. The Radiation Protection Section will perform an investigation and update through NMED."
Wisconsin Event Report ID No.: WI150005
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.
Part 21
Event Number: 51075
Rep Org: CHICAGO BRIDGE AND IRON
Licensee: CHICAGO BRIDGE AND IRON
Region: 4
City: THE WOODLANDS State: TX
County:
License #:
Agreement: Y
Docket:
NRC Notified By: ADAM MOHR
HQ OPS Officer: VINCE KLCO
Licensee: CHICAGO BRIDGE AND IRON
Region: 4
City: THE WOODLANDS State: TX
County:
License #:
Agreement: Y
Docket:
NRC Notified By: ADAM MOHR
HQ OPS Officer: VINCE KLCO
Notification Date: 05/17/2015
Notification Time: 11:28 [ET]
Event Date: 03/18/2015
Event Time: 00:00 [CDT]
Last Update Date: 05/17/2015
Notification Time: 11:28 [ET]
Event Date: 03/18/2015
Event Time: 00:00 [CDT]
Last Update Date: 05/17/2015
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(a)(2) - INTERIM EVAL OF DEVIATION
10 CFR Section:
21.21(a)(2) - INTERIM EVAL OF DEVIATION
Person (Organization):
BRIAN BONSER (R2DO)
JACK WHITTEN (R4DO)
PART 21/50.55 REACT (EMAI)
BRIAN BONSER (R2DO)
JACK WHITTEN (R4DO)
PART 21/50.55 REACT (EMAI)
MEASURING AND TEST EQUIPMENT DEFICIENCIES
The following information was received by facsimile:
"This report is being provided as an interim report in accordance with 10CFR 21.21.
"(i) Name and address of the individual or individuals informing the Commission.
Adam Mohr; President, Fabrication and Manufacturing; CB&I; One CB&I Plaza; 2103 Research Forest Drive; The Woodlands, TX; 77380.
"(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.
This is an interim report. The deviations being evaluated pertain to deficiencies identified within the Measuring and Test Equipment program at Chicago Bridge and Iron (CB&I) Laurens, 366 Old Airport Road, Laurens, SC.
"(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
This is an interim report. The construction activities for the V.C. Summer [Units 2 and 3] and Vogtle AP1000r [Units 3 and 4] nuclear projects, which include procurement of the piping assemblies, are being performed by CB&I Power, 128 S. Tryon St., Charlotte, NC 28202.
"(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
This is an interim report. The evaluations of vendors and previously performed calibrations is under evaluation and equipment in question is being re-calibrated by an approved lab and evaluated for extent of condition. Additionally, causal analysis is being performed that is expected to provide relevant information pertaining to the cause of the deviations and if any quality assurance breakdowns may have occurred that could have produced a defect. Evaluation of the condition is expected to be completed by June 26, 2015.
"(v) The date on which the information of such defect or failure to comply was obtained.
The discovery date of the deviations that require evaluation is March 18, 2015, based on the nonconformance reports and C/PAR that identify the deviations. Evaluation of reportability in accordance with 10 CFR Part 21 was not able to be completed within the 60 day evaluation period. Additional time is needed to collect additional data pertaining to the identified nonconformances, perform causal analysis, and complete the evaluation.
"(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of these components in use at, supplied for, being supplied for, or may be supplied for, manufactured. or being manufactured for one or more facilities or activities subject to the regulations in this part.
No basic components have been determined to fail to comply or contain a defect. This is an interim report.
"(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
No basic components have been determined to fail to comply or contain a defect. This is an interim report.
"(viii) Any advice related to the defect or failure to comply about the facility, activity. Or basic component that has been, is being, or will be given to purchasers or licensees.
None at this time.
"(ix) In the case of an early site permit, the entities to whom an early site permit was transferred.
Not applicable."
The following information was received by facsimile:
"This report is being provided as an interim report in accordance with 10CFR 21.21.
"(i) Name and address of the individual or individuals informing the Commission.
Adam Mohr; President, Fabrication and Manufacturing; CB&I; One CB&I Plaza; 2103 Research Forest Drive; The Woodlands, TX; 77380.
"(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.
This is an interim report. The deviations being evaluated pertain to deficiencies identified within the Measuring and Test Equipment program at Chicago Bridge and Iron (CB&I) Laurens, 366 Old Airport Road, Laurens, SC.
"(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
This is an interim report. The construction activities for the V.C. Summer [Units 2 and 3] and Vogtle AP1000r [Units 3 and 4] nuclear projects, which include procurement of the piping assemblies, are being performed by CB&I Power, 128 S. Tryon St., Charlotte, NC 28202.
"(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
This is an interim report. The evaluations of vendors and previously performed calibrations is under evaluation and equipment in question is being re-calibrated by an approved lab and evaluated for extent of condition. Additionally, causal analysis is being performed that is expected to provide relevant information pertaining to the cause of the deviations and if any quality assurance breakdowns may have occurred that could have produced a defect. Evaluation of the condition is expected to be completed by June 26, 2015.
"(v) The date on which the information of such defect or failure to comply was obtained.
The discovery date of the deviations that require evaluation is March 18, 2015, based on the nonconformance reports and C/PAR that identify the deviations. Evaluation of reportability in accordance with 10 CFR Part 21 was not able to be completed within the 60 day evaluation period. Additional time is needed to collect additional data pertaining to the identified nonconformances, perform causal analysis, and complete the evaluation.
"(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of these components in use at, supplied for, being supplied for, or may be supplied for, manufactured. or being manufactured for one or more facilities or activities subject to the regulations in this part.
No basic components have been determined to fail to comply or contain a defect. This is an interim report.
"(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
No basic components have been determined to fail to comply or contain a defect. This is an interim report.
"(viii) Any advice related to the defect or failure to comply about the facility, activity. Or basic component that has been, is being, or will be given to purchasers or licensees.
None at this time.
"(ix) In the case of an early site permit, the entities to whom an early site permit was transferred.
Not applicable."