ML20235G425
| ML20235G425 | |
| Person / Time | |
|---|---|
| Issue date: | 09/29/1986 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Heltemes C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| Shared Package | |
| ML20235G382 | List: |
| References | |
| FOIA-87-377 NUDOCS 8707140252 | |
| Download: ML20235G425 (8) | |
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'p., r, SEP 2 9 1986 MEMORANDUM FOR: C. J. Heltemes, Jr., DirectorOffice for Analysis ard of Operational Data FROM: Richard E. Cunningham, DirectorDivision of Fue
SUBJECT:
ABNORMAL OCCURRENCE REPORT TO CON .
SECOND QUARTER CY 1986 ds has reviewed the The Office of Nuclear Material Safety and Safeguar memorandum of d on the draft Abnormal Occurrence Report forwarded September 18, 1986.
enclosed pages. Origin'al Signed by Richard E. Cunningham Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS As stated
Enclosure:
wo/ enc 1.
NMSS # 860905 DISTRIBUTION: DBMausshardt ;
FC Central File RECunningham FCUF r/f WTCrow FCTA r/f w/ enc 1. GATerry NMSS r/f BClausser !
! RLO'Connell /
CJenkins 9/23 . SG No .comments No coments . S. Jones- R. Gramann 9/24 . WM j
- SEE PREVIOUS CONCURRENCE :FC SHEET g...
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- GATerry :WTCrow.............................
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.... :9/29/86 DATE:9/29/86
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Comments / Corrections / Updates i
Pages 16,17, 22, corrections as marked.
Page 40 " Breakdown of Management Controls at an Irradiator Facility" .
- a. The update should discuss NRC's second suspension of RTI's license this year.
- b. The IE Information Notice does not pertain to the RTI case, but to Pittsburg Testing Laboratories (PTL). It is probably appropriate to " reopen" the PTL case, update it ($58,000 civil penalty proposed in second quarter) and explain that issuance of the IE Information Notice was prompted by the PTL case. Page 3 of the, Commission. paper should also be corrected to reflect this item.
Page 40 - top of page.
It might be of interest to add that the licensee paid the
$68,000 civil penalty.
Pages 38, 39 - Rupture of UF6 cyclinder Correction and update as noted on attached pages.
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. Nature 2nd Probable Consequences - A physician asked the Nuclear Medic ne i
Department to order a dose of phosphorus-32 as colloidal chromic phosphate on April 7,1986, for administration to a kidney carcimoma patient for abdominal ascites reduction on April 9, 1986. This verbal order was relayed to Nuclear Medicine through a third party, and the chemical form of phosphorus-32 was not made clear. Nuclear Medicine proceeded to order 15 millicuries of phosphorus-32 as rodium phosphate because this chemi. cal form was used more frequently than the colleidal form. The order was processed and received in the hospital in the normal manner.
On April 9,1986, the physicist drew up the dose in a syringe, assayed it in the dose calibrator, and then put it aside. Shortly thereafter, a physician (other than the physician who ordered the dose) administered the dose intra-peritoneally to the patient. Later the same day, the Chief Nuclear Medicine i
Technologist, while discussing this particular patient with a nurse, discovered that the dose was administered intraperitoneally rather than intravenously, This information was relayed as to .
intended by the physician who ordered the dose.
several physicians and was also reported later that day to the NRC.
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On April 10, 1986, the patient was Blood administered stable phosphor /us to accelerate +
counts for leucocytes, red blood cells, 't-excretionofthephosphory'us-32.
hematocrits and platelets showed no significant depression as of April 21, 1986.
The consequences of the misadministration was a significant unintended dose to The licensee estimated the dose to be at least the patient's 150 rads.
bone marrow.However, the NRC's medical consultant believes the dose could have rads to the patient's bone marrow with an increased been as much as 700-800 chance of the patient contrg.cting leukemia.
The misadministration constituted a significant f ailure to comply with NRC regulatory requirements. The patient was subjected to a procedure unrelated to the authorized uses of phosphorus-32 as sodium phosphate.
Cause or Causes - The root cause was the lack of written prescriptions for ordering therapeutic doses.
Actions Taken to Prevent Recurrence Licensee - The li,censee established written procedures and forms The to licensee's provide for written prescriptions and therapeutic radionuclides procedures.
agreement to establish procedures for ordering and administering therapy doses had been previously documented in an NRC Confirmation of Action Letter, dated April 10, 1986.
HRC - In addition to engaging a medical consultant and issuing the Confirmation of Action Letter, the NRC Region 11 conducted a special inspection at the hos-pital on April 11, 1986. An Enforcement Conferer.ce with the licensee wasAtheld on May 2,1986, to discuss NRC concerns regarding the inspection findings.
the conference, the licensee presented the previously mentioned written proce- .
dures and forms.
On Augus't 7,1986, the 'NRC issued to the licensee (1) a Confirmatory Order Modifying License, and, (2) a Notice of Violation and Proposed Imposition of _
Civil Penalty in the amount of $2,500 (Ref.15). 1he Order, effective
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immediately, was issued to confirm implementation of corrective procedures and to ensure their continued implementation.
NRC Region II will review the ef festiveness of the procedures during subsequent inspections.
Unless new, significant information becomes available, this item is closed for the purposes of this report.
AAAAAAAAAA 86-14 Willful Failure to Report Diagnostic Medical Misadministration The following information pertaining to this event is also being reported con-currently in the Federal Register, Appendix A (see the general criterion) of this report notes that an cvent involving a moderate or more severe impact on In addition, public health or safety can be considered an abnormal occurrence.
in management or procedural controls in major areas can be considered an abnor-mal occurrence.
Date and Place - On April 22, 1986, the NRC Office of Inspection and Enforcement issued an Order, effective immediately, removing a physician from the position of Radiation Safety Officer (R50) and Authorized User at Bloomington Hospital, Bloomington, Indiana (Ref.16). s 19W '
12,1986, NRC Region III received Nature and Probable Consequences - On October an allegation that five diagnostic misadministration had occurred at Bloomington (A diag-Hospital and that they had not been reported to the NRC as r During a subsequent inspec-pharmaceutical used for a diagno'stic medical test.)
tion, the physician serving as R50 informed the NRC that only one m tration had occurred.
information gathered by the inspectors, the physician admitted that the other four diagnostic pisadministrations did occur.
During the inspection, however, the physician obstructed the inspection and mis-led the inspectors by instructing hospital employees to inform the inspectors that the misadministration had not occurred and by withholding or concealing nuclear medicine films from the inspectors.
Because of the low levels of radiation exposures to the patients in diagnostic tests, no detrimental medical effects are anticipated as a result of these misadministration.
Cause or Causes - The NRC determined that the failure to report the misadminis-trations was willful. ..
Actions Taken to Prevent Recurrence 22, 1986 (Ref. 16), the Licensee - As required by the NRC Order dated April licensee removed the physician from the position Another of R50 individual andhospital on the as an Authorized staff ~-
User designated in the NRC license.
was placed in the position of R50 with the approval of NRC Region III.
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j Af ter determining that the scanning equipment was not at fault, the licensee 1 suspected molybdenum-99 breakthrough.
A physician at the San Diego Veterans He estimated l Administration Hospital confirmed the presence of the contaminant.
liver doses to the patients ranging from 130 rads to 260 rads. As discussed fur-i l
ther below, it is believed that DTPA was inadvertently used, ratherTherefore, than the '
saline solution, for removing technetium-99m from the generator.
due to possible rapid clearance of the DTPA from the body, the actual doses may have been less than those estimated.
Blood test results of the patients were reported to be normal, perhaps The wholebecause body the material may not have deposited in the vascular compartment.The nuclear medicine dose for each patient was estimated to be a few mrad.
physician at the hospital reported in January 1986 that "no adverse ef fects have been identified in any of the four patients."
Cause or Causes - After many milkings of the generator with normal eluants;. it appears that DTPA, a chelating agent, was inadvertently used Thisin place DTPA of the a removed usual saline solution (the vials were almost identical).
substantial amount of the molybdenum-99 f rom the column. After the fact tests Secondly, estimate that as much as 1.0 mei/cc may have ended up in the doses.
although molybdenum-99 breakthrough testing was routinely performed, it appears that the nuclear medicine technologist observing the dose calibrator readings had come to ignore which indicator light was lit, i.e. , millicurie or microcurie There is and to simply record the digital readout assuming it was microcurie.
a practical certainty that the calibrator was indicating millicuries which should have been noticed by the technologist.
Actions Taken to Prevent Recurrence L.icensee - Upon suggestion of,Mo99 breakthrough, the generator was taken out of service and af fected patients were identified. The dose calibrator which had been independently checked and calibrated only one month earlier was reapproved All succeeding molybdenum-99 and aluminum break-by the licensee's consultant.through safety checks were confirmed by either cian or nuclear medicine physician.
Later, the hospital discontinued the use of generators and began using bulk technetium-99m.. But tests for molybdenum-99 breakthrough were continued as a precautionary measure.
State Agency - The event was investigated during an onsite visit by the Agency.
The licensee was cited under one of its license conditions for failure to per- -
form adequate molybdenum-99 breakthrough tests on the generator cluaat.elv0 R <f--
This report by the Agency was considerably delayed because the Agency's medical consultant, who was asked to evaluate the patients' doses, provided vastly dif-ferent (and lower) estimates than the hospital physician but did not provide further information to explain the discrepancies. Having received no response from .the consultant to its inquiries, the Agency has accepted the hospital physician's dose estimates. __
This item is considered closed for the purposes of this report.
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Order requiring dua.1, verification of certain actiyities associated with distri-bution of radiopharmaceuticals, and violations which occurred at several other Nuclea'r Pharmacy, Inc. , facilities.
In. July 1985 Nuclear Pharmacy, Inc. , merged with Syncor. Since the merger, the principal individuals involved in Nuclear Pharmacy's May 1984 incident have resigned, been terminated, or are no longer involved in NRC-licensed activities.
A new management structure is in place for the merged concern.
This item is considered closed for the purposes of this report.
R A A * **A R A A 86-6 Breakdown of Management Controls at an Irradiator Facility This abnormal occurrence, which involved Radiation Technology, Incorporated (RTI), Rockaway, New Jersey, was originally reported in NUREG-0090, Vol. 9, ~-
No.1, " Report to Congress on Abnormal Occurrences: January-March 1986." It is updated as follows. ,
On June 27, 1986, the NRC issued Inspection and Enforcement Information Notice No. 86-54 (" Criminal Prosecution of a Former Radiation Safety Officer Who Will-fully Directed an Unqualified Individual to Perform Radiography") to all holders of an NRC license authorizing the possession of byproduct, source, or special nuclear material (Ref. B-14).
The Notice described the event at RTI and was provided to alert recipients and their employees of criminal prosecution that can result for directing unqualified personnel to perform licensed activi ies and making material false statements to the NRC. It is expected that reci ients will review this notice and dis-seminate it to all of their employees.., The NRC further suggests that recipients remind their employees that not only are licensees subject to civil enforcement action for violations of NRC requiremen,ts, but individuals who intentionally violate these requirements may also.be subject to criminal prosecution. '
Future reports will be made as appropria\ te.
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I On June 12, 1986, Sacramento Municipal Utility District (the licensee) met with I the NRC Staff to discuss the scope and content of the preliminary action plan ;
for performance improvement. The intent was to obtain NRC comments so that As a result of the meeting, they could be incorporated into the final report.
- an NRC team visited the Rancho Seco site on June 17-18, 1986, to review in detail the method being utilized by the licensee to define its system review and test program. The team found that the licensee had a structured program underway to l find and correct problems with hardware, procedures, maintenance, etc. However, i work on defining the system review and test program had just started and little information was available on program scope or content.
The licensee submitted its action plan for performance improvement on July 3, 1986, and the Staf f has initiated its review. The Staff plans to The have a working critical meeting with the licensee to discuss the action plan in August.
path to restart decision is the Staff's review of the action plan and issuance ~-
of the Staff's safety evaluation report.
Future reports will be made as appropriate.
- A A A A A A FUEL CYCLE FACILITIES 86-3 Rupture of Uranium Hexafluoride Cylinder and Release of Gases This abnormal occurrence, involving Sequoyah fuels Corporation, Gore, Oklahoma, was originally reported in NUREG-0090, Vol. 9, No.1, " Report to Congress on Abnormal Occurrences: January-March 1986." It is updated as follows.
By letter dated May 8, 1986, Sequoyah Fuels Corporation requested authorization to restart production of UFe. However, triis request was not accompanied by com-mitments that could be incorporated into the license. Accordingly, by letter dated May 23, 1986, the NRC Staff requested that additional information be pro-vided. A response to this request was received by letter dated June 25, 1986, Q and the review of the information is -ir. pqrne NRC has also held two public meetings in Gore, Oklahoma, to solicit the concerns of local individuals so that these concerns can be taken into consideration during the restart review.
The NRC Staff estimates that action will be taken on the restart request during the latter part of the third calendar quarter of 1986.
As discussed in NUREG-0090, Vol. 9, No.1, a Lessons-Learned Group was reviewing the event as well as regulatory practices in general regarding such fuel facili-ties. This Group was formed on February 20, 1986, by the NRC Acting Executive Director for Operations to prepare a report based on experience gained from this event. The goal of the Group was to identify actions NRC might reasonably take from a licensing and inspection standpoint to prevent similar incidents, as well as to clarify NRC's regulatory role regarding facilities of this type.
A further goal was to assess the adequacy of the NRC response to the incident, as well as the follow-on activities. .
The The Group's report was issued during June 1986 as NUREG-1198 (Ref. B-10).
report presents discussions and recommendations on the process, operation and'
. design 'of the facility, as well as on the responses of the licensee, NRC, and 38
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It also provides re-other local, state and federil agencies to the incident.
commendations in the areas of NRC licensing and inspertion of fuel facility and certain other non power reactor licensees. The implementation of some recom-mendations will depend on decisions to be made regarding the scope of NRC responsibilities with respect to those aspects of the design and operation of
[ such facilities that are not directly related to radiological safety.
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Future reports will be made as appropriate.
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- RC staff responses to those recommendations were published in August,19d6, as NUREG-1193 Supplement 1 (Ref. ). On July 28, 1986, the NRC staff performed I the final facility inspectinn needed for restart authorization, to verify that all license required changes / improvements had been made. Determination of specific enforcement actions has yet to be completed.
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