PNO-II-93-073B, provides Update to Info Previously Provided by State of Fl Re Misadministration Using microselectron-HDR Device.State of Fl Has Drawn Listed Conclusions as Result of State Investigation
| ML20059B370 | |
| Person / Time | |
|---|---|
| Issue date: | 12/23/1993 |
| From: | Trojanowski R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| References | |
| PNO-II-93-073B, PNO-II-93-73B, NUDOCS 9401040101 | |
| Download: ML20059B370 (2) | |
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, December 23, 1993 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCZRRENCE PNO-II-93-073B This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by the Region II staff on this date.
Facility Licenseo Emergency Classification Mt. Sinai Medical Center Notifica'J. ion of Unusual Event Greater Miami Alert Miami, Florida Site Area Emergency l
Miami, Florida General Emergency License No:
FL-64-12 X Not Applicable i
i
Subject:
UPDATE, MISADMINISTRATION USING MICROSELECTRON-HDR DEVICE 1
This PN updates the information previously provided in PNO-11-93-073, i
dated December 16, 1993 and PNO-II-93-073A, dated December 21, 1993 with current information provided by the State of Florida through the Office of. State Programs.
As a result of the State's investigation, the State has drawn the following conclusions:
1.
Training of physicians, physicists, dosimetrists and technologists was inadequate with rega;j to the operation of the nucletron microselectron device. Luring the 3 day on-site training conducted by nucletron subsequent to installation of the unit in July / August of 1993, none of the Mt. Sinai staff attended the ei.
re 3 day training class.
2.
The facility relies on an outside contractor to provide radiation oncology services. Some degree of confusion on the part of the licensee was detected by the investigators with regard to who was responsible for the many requirements associated with operating a comprehensive radiation oncology program.
3.
Quality Assurance - the QA program regarding device operation was found to be inadequate and although QA was covered during the initial on-site training by the manufacturer it is not clear who among the current staff attended the QA portion of the training.
4.
State investigators expressed concern that differences in the transfer tube lengths supplied by nucletron were not clearly and easily distinguishable.
The Etate also identified that the nucletron microselectron used by Mt.
Sinai contains two computers. The first one is utilized for dosimetry \\ treatment planning and was not initially capable of operating with different transfer tube lengths. An update of this computer's program was issued by nucletron and was covered during the initial on-site manufacturers training and although the revised program was provide to Mt. Sinai it was never installed. The revised program has since been installed by manufacturer representatives currently conducting on-site training. The second computer is utilized for equipment systems operation.
Ub 9401040101 931223
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0300.47 SAS-1I!53-o73 eda
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.w PNO-II-93-073B Based on information obtained thus far by the State investigators, it appears that only one patient received a clinically significant overexposure.
The State inspector identified a number of documents that they are requiring the licensee to sent the State headquarters office in Tallahassee.
This information is current as of 12:30 p.
m.,
December 23, 1993, and was provided to the Office of State Programs by State inspectors who were on-site at the Mt. Sinai Medical Center in Micmi on December 22, 1993.
The Office of State Programs, and the Region, will continue to evaluate and monitor the corrective actions being developed and implemented to ensure compliance with the Agreement State license.
Contact:
R.
E. Trojanowski (404)331-5597 1
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