ML20035E780
| ML20035E780 | |
| Person / Time | |
|---|---|
| Issue date: | 03/29/1993 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| REF-10CFR9.7, RTR-NUREG-0090, RTR-NUREG-90 NUDOCS 9304190239 | |
| Download: ML20035E780 (6) | |
Text
RELEASED TO THE PDR f =%
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NUCLEAR REGULATORY COMMISSION l g
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OFFICE OF THE March 29, 1993 SEC R ET AR Y MEMORANDUM FOR:
James M.
Taylor Executive Director for 0;fe tions FROM:
Samuel J. Chilk, Secretahh 1
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SUBJECT:
SECY-93-057 - SECTION 208
$tEPORT TO THE CONGRESS ON ABNORMAL OCCURRENCES FOR OCTOBER-DECEMBER 1992 l
This is to advise you that the Commission has not objected to the issuance of the proposed Fourth Quarter 1992 Abnormal Occurrence Report to Congress with the changes indicated in the attachment.
In this and future Abnormal Occurrence reports, the descriptions of medical misadministrations should include information concerning required patient notification, and notification of any other exposed individuals.
Attachment:
As stated cc:
The Chairman Commissioner Rogers Commissioner Curtiss i
Commissioner Remick Commissioner de Planque j
OGC OIG Office Directors, Regions, ACRS, ACNW (via E-Mail)
OP, SDBU/CR, ASLBP (via FAX)
SECY UOTE:
THIS SRM AND SECY-93-057 WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS l
SRM i
9304190239 930329 PDR 10CFR PT9.7 h
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t (1)
If power is lost to either one of the two de vital buses, both the safety injection actuation signal and sump recirculation actuation signal would be simultaneously initiated. The recirculation actuation i
signal would result in tripping all low pressure injection pumps. Also, l
the spurious sump recirculation actuation signal would cause one of the j
containment sump outlet valves to open.
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(2)
If power was lost only to the sensor cabinets in one actuation train, both containment sump outlet valves would open.
If this occurred during a loss-of-coolant accident, high pressure in containment could shut both refueling water storage tank check valves, inhibiting flow to all emergency coolant injection pumps.
(3)
The loss of all de power to one actuation train would cause a power 2
operated relief valve in the other train to open.
In addition, when l
1 control power alone is lost to only the sensor cabinets in a single i
actuation train, spurious high pressurizer pressure signals would cause the relief valves in both trains to open.
Both cases would result in a loss of primary coolant.
t The design deficiency in the on-line testing feature could have prevented both emergency diesels from accepting emergency loads under certain single failure conditions. The licensee investigated this event and found several design 4
vulnerabilities related to loss of a vital de bus which may apply to ESFAS at other plants. Although the described event resulted from an ATI modification, the other vulnerabilities are inherent in the ESFAS design and its power supplies.
1 The licensee is planning modifications to correct these problems and is reviewing the design of Unit 2 for other similar problems.
The f1RC will be
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reviewing the licensee's corrective actions prior to plant re-start.
j Cause or Causes - The event was caused by a failure to correctly transfer design package requirements into the plant modification. The implementation plan identified the proper sequence that the inverters would have to be replaced and turned on, but when the work order was prepared the iAw4e_ p aeed l
sequence was not followed.
Some plant design vulnerabilities were known to the licensee prior to this a
event.
In 1990, the licensee discovered a long standing Technical Specifications interpretation that had permitted indefinite operation of an emergency electrical bus on the non-safety related backup supply.
The f4RC reviewed the design change, the outage plan, and the operation implementation procedures.
In addition, the f4RC interviewed the engineer that was responsible for the design change, the personnel that prepared the work order, and the operations personnel that released the work order. The f4RC concluded that there was ample opportunity for the licensee personnel to identify the error in the work order that caused the partial loss of normal power. The staff considers the subsequently discovered design vulnerabilities 5
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l in the ESFAS to be significant because, had the plant been operating at the l
time of the event, the licensee would have been required to take immediate l
remedial action.
j Actions Taken to Prevent Recurrence I
Licensee - Implementation of the pertinent aspects of the Performance i
Enhancement Program will enhance pre-performance review of design change records and help resolve plant requirements to support multiple work activities in outage planning.
An ESFAS analysis has thus far identified three areas in which design changes l
were needed. These include:
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Eliminate the interaction of the Automatic Test Insertion Unit with the Load Shed Actuation Module.
l 2.
Modify the action of the simultaneous Safety Injection Actuation i
Signal and the Sump Recirculation Actuation Signal to eliminate
_ the_LPSI pump trip and to prevent premature pump suction shift to l
6m og /
the' containment sump.
3.
Modify the PORV control relay logic to prevent inadvertent opening l
on loss of control power.
These changes are complete. Satisfactory operation of the ESFAS was demonstrated during recent testing performed as a part of startup preparations i
following the steam generator replacement project.
An Independent Review Committee was formed to investigate this event. The recommendations from this Committee have been evaluated and, where appropriate, implemented.
NRC - The NRC conducted an inspection to investigate the circumstances of the July 6, 1992 event (Ref. 2). On February 4, 1993, the NRC issued Information Notice No. 93-11, " Single failure Vulnerability of Engineered Safety Features Actuation Systems," that described the Millstone 2 event (Ref. 3).
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This item is considered closed for the purposes of this. report.
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FUEL CYCLE FACILITIES (Other Than Nuclear Power Plants)
The NRC is reviewing events reported by these licensees.
For this report, the NRC has determined that no events were abnormal occurrences.
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r 2duced dose. b k inc3et ocaan n
I chart. Due to excessive drainage of bile at the implant site during the evening and early morning hours, the patient's dressings were changed several times and then reinforced with additional absorbent. At 4: 15 a.m. on the morning of October 2,1992, the nurse on duty noted that the dressing was completely displaced and acted to replace the dressing. The nurse noticed that the two ribbons were displaced but, not knowing what they were, coiled i
the ribbons in her hand and taped the ribbons to the patient's abdomen.
A routine x-ray identified that the seeds were no longer implanted, and the coiled ribbons were removed from the surface of the patient's abdomen by a physician at approximately 12:00 p.m. on October 2, 1992.
The licensee estimated that the patient received 1,145 rads to the targeted tumor site, between 172 and 1,032 rads to the skin of the abdomen, 19.9 rads to the liver and small bowel,12.7 rads to the kidneys, 50.9 rads to the colon, and 6.7 rads to the testes.
The licensee estimated that the nurse who I coiled the ribbons and taped them to the patient's abdomen received clWeat approximatelv 7.6 rads to her hands. The licensee expects no adverse 3 effects m asaresultofth4misadministraticnesincethisbrachytherapytreatmentwasa booster to the external beam dose that was yet to be administered.
Cause or Causes - The misadministration was caused by: 1) lack of oversight of the procedure by the licensee's Radiation Safety Officer (RS0); and
- 2) inadequate training of the nursing staff in that they were unable to identify the brachytherapy source ribbon.
Actions Taken to Prevent Recurrence Licensee - The licensee initiated an expanded training program that includes familiarization of personnel with the size and appearance of the radioactive sources used in brachytherapy treatments at the licensee's facility.
The licensee stated that a manager will be responsible for ensuring that personnel on all shifts involved in the care and treatment of radiation therapy patients receive this training. The licensee decided to name a new RSO because the current RSO was unable to devote sufficient time to the radiation safety program due to his other responsibilities. The licensee's actions also i
included: 1) committing that a new RSO would be in place before another brachytherapy procedure is performed; 2) developing a nurses' procedure manual; 3) conducting formal inservice training in radiation safety with all nursing unit workers; and 4) requiring a written directive be initiated before ordering radioactive material.
NRC - NRC Region I conducted an inspection on October 5, 5, 7, and 9, 1992, and held an Enforcement Conference on November 5,1992, to discuss the inspection findings. The licensee's corrective and preventive actions will be reviewed during the next inspection of the licensed program.
Several violations of NRC requirements were identified including: 1) failure to adequately train nursing personnel to recognize brachytherapy procedures;
- 2) failure to train personnel on potential radiological emergencies for brachytherapy procedures; and 3) failure to implement radiation safety and quality management programs to ensure adequate safety.
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i A civil penalty of $10,000 was proposed in a letter dated January 11, 1993 (Ref. 5). The licensee paid the civil penalty on February 5,1593.
This item is considered closed for the purposes of this report.
92-16 Medical Therapy Misadministration at the Lahey Clinic Medical Center in Burlinoton Massachusetts The following information pertaining to this event is also being reported concurrently in the Federal Reaister. Appendix A (see Event Type 3 in Table A-1) of this report notes that a therapeutic exposure to a part of the body not scheduled to receive radiation can be considered an abnormal occurrence.
Date and Place - October 14, 1992; Lahey Clinic Medical Center; Burlington, i
l Nature and Probable Consecuences - On October 19, 1992, the licensee notified the NRC Operations Center of a therapeutic misadministration involving a high dose rate remote afterloader (HDR) that occurred at the facility on October i
14, 1992. A patient was scheduled to receive brachytherapy treatment to the l
right main stem bronchus in three fractions using a Gamma Med HDR.
Each fraction was to deliver 700 rads to the targeted tumor site. On October 7, 1992, the patient was administered the first treatment as prescribed. On October 14, 1992, the therapist made an error during input of the offset I
distance into the treatment computer, entering an offset distance of 7 millimeters rather than 7 centimeters as required.
This error resulted in the second fraction delivering 90 percent of the prescribed fractionated radiation dose to unintended tissues away from the tumor site and under-dosing the tumor site. The under-dose was made up during the administration of the third fraction on October 22, 1992. The physician stated that he expected no adverse clinical effect on the patient due to 4hc -indWBtrcticrfas the
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dose was made up in the third and final fraction.
unau dodng ne_
% m c c M e-Cause or Causes - The licensee followed established procedures; however, the procedure did not include a mechanism to verify data entries on the HDR console at the time of treatment.
Actions Taken to Prevent Occurrence Licensee - The licensee instituted a new procedure that requires that a second individual verify the data input on the HDR console prior to administration of the therapy.
NRC - NRC Region I conducted a routine inspection at the facility on December 3, 1992. The inspection resulted in the identification of six apparent violations: (1) failure to have a quality management program to meet the regulatory requirements; (2) failure to make timely notification to the NRC; (3) failure to provide radiation safety training to workers; (4) failure to 10
i After being notified by BFI, the nursing home called the IRCC on December 1, 1992. The cancer center had not used the HDR afterloader after the single treatment on November 16, 1992.
Upon being informed of the source discovery, the medical physicist determined that no source was present in the HDR afterloader and informed the NRC Region I office of this fact. The physician and the medical physicist drove to Carnegie and retrieved the source.
A second Omnitron 2000 source wire broke at the Greater Pittsburgh Cancer Center (GPCC) of OSC on December 7, 1992. This wire broke in the same approximate location as the first wire. The GPCC medical physicist who was conducting the treatment was aware of the first incident and immediately reccgnized the problem and promptly and appropriately intervened, thereby preventing significant dose consequences to the patient or the cancer center staff.
j An NRC medical consultant concluded that an analysis of the medical records and physical dosimetry would indicate that the massive radiation dose was a I
probable contributing cause of death in this patient.
The licensee reported 1
the prescribed dose at one centimeter was 1,800 rads to be delivered in three treatments and that the delivered dose was 1,600,000 rads to the same point, an overdose of about three orders of magnitude. The licensee stated the effect on the patient would be significant local tissue damage and possible significant tissue damage to organs outside the treatment area, depending upon i
i the progression of radiation damage with time before the patient expired. The l
l licensee stated the dose was of sufficient magnitude that it believed it was l
highly probable that the radiation exposure was at least a contributing factor to the patient's subsequent death.
In a press release dated January 26, 1993, the Indiana County Coroner stated that the cause of death listed in the official autopsy report was " Acute Radiation Exposure and Consequences Thereof."
In addition to the patient, the team evaluated the radiation doses to 94 persons associated with the IRCC event.
Radiation doses received by these i
individuals ranged between 40 mrem and 22 rem.
1 Cytogenetic studies were also performed on a number of these exposed individuals and the results were consistent with calculated doses within the limits of accuracy of both techniques. The highest extremity dose was calculated to be between 73 to 160 rem to the hands of one of the Certified l
Nursing Assistants.
No personnel or property contamination occurred and no occupational worker received a whole body radiation dose above the NRC occupational limit of i
1.25 rem. While members of the public received radiation doses above applicable limits, no one received a dose at which acute radiation injury or clinical signs are expected to occur.
The. IIT nwted er Cause or Causes -Jhe event was caused by the following:
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OSC had weaknesses in their radiation safety program that were a major contributing cause of the seriousness of the event and radiation 14 l
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