ML20031G699
| ML20031G699 | |
| Person / Time | |
|---|---|
| Issue date: | 10/15/1981 |
| From: | Book H, Spencer G, Thomas R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20031G696 | List: |
| References | |
| NUDOCS 8110230481 | |
| Download: ML20031G699 (6) | |
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U.S. iiUCLEAR REGULATORY COMMISSI0tl 7FICE OF IMSPECTION AND E!!FORCEMENT REGION V Report Mo.8J-0_2 License no.53-00458-04 Priority 4
Category G1 Licensee: Department of the Army Tripler Army Medical Center Oahu. Hawaii 96819 Facility Name:!Luclear Med.icine Service Inspection at:Tripler Hospital Inspection Concucted:
September 24, 1981
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Inspectors:
ms G. S.
pender, Director Date Signed
/0/6/$l H. E. Book, CfiieT, R Hiological Safety Branch Da'te Signed Approved by:
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R. D. Thomas, Chief Date S4gned Materials Radiation Protection Section Approved by:
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t H. E. Book, Chief, Radiological Safety Branch [ Tate '51gned Sumary:
An Enforcement Conference was held on September 24, 1981.
The following matters were discussed:
1.
Noncompliance observed during the last inspection of License 53-00458-04 at Tripler Army Medical Center.
2.
Enforcement history at Tripler Medical Center related to License 53-00458-04 3.
NRC Enforcement Policies and Procedures.
4 NRC actions to be taken in present situation.
5.
Possible future ac': ions by NRC.
6.
Other matters of concern to NRC.
The Enforcement Conference involved a total of two hours on site by two NRC representatives.
RV From 219 (1) 8110230481 811016 NMS LIC30 53-00458-04 PDR
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DETAILS 1.
Enforcement Conference Participants Maj. Gen. E. Huycke, Comanding Officer Col. D. Devaris, Acting Deputy Comander Col. B. Kennedy, Mcdical Physicist Maj. W. Wright, Radiation Protection-Officer Mcj. M. Hill, Acting Chief of Radiology Maj. A. Chaco, Nuclear Medicine Service Capt. R. Embry, Staff Radiologist G. Spencer, Director, Div. of Technical Inspection, NRC H. Book, Chief, Radiological Safety Branch, NRC 2.
Enforcement Conference On September 24, 1981 an enforcenent conference was held at the Tripler Army Medical Center, with the individuals listed above participating.
The enforcement conference was related to a routine safety inspection of activities authorized by NRC license number 53-00458-04, for the nuclear medicine service. That inspection was conducted on July 24 and 27, 1981. The enforcement conference was announced in a letter to the licensee dated September 9, 1981. A copy of that letter is attached. A similar conference was held for the teletherapy program at the same facility. That conference is covered in a separate report.
The Notice of Violation dated August 28, 1981 had already been received by the licensee.
A copy of Appendix A of that Notice of Violation is attached. Mr. H. E. Book, Chief, Radiological Safety Branch discussed the violations listed in that letter. Concerning Item A on the Notice of Violation, the licensee was informed that the Order issued by the NRC had the same effect as a license condition and was a requirement.
It was noted that molybdenum-99 contamination in the technetium-99m increased the radiation dose to the patient with no benefit, and increased the possibility of side effects. The licensee pointed out that corrective action had been prompt, and had included retraining of technicians, discharge of one technician and the posting of additional information and notices in the lab.
The licensee stated that this item had not been included in the exit interview by the inspector. Mr. Book explained that there was some confusion at the time of the inspection, but the matter must have been discussed with someone on the staff, since the inspector had all details on the matter, including corrective action.
It was also noted that it had been included in the Notice of Violation, and also was being discussed with licensee menagement as part of the enforcement conference.
a 2
With regard to item B on the Notice of Violation, it was pointed out that the licensee had made certain comitments to the NRC in the license application. The comitmeats became a part of the license, and a requirement, by reference of the application in one license condition.
In this case, the application stated that xenon-133 gas would be administered to patients utilizing a lung function unit. However, the inspection revealed that xenon-133 gas was being administered without the use of a lung fts tion unit. The licensee stated that the lung function unit described in the application had been installed subsequent to the inspection and tas now in use.
Mr. Book explained that any escalated NRC enforcement action took into account the enforcement history at the facility. A review of NRC files for license number 53-00458-04 revealed that the last inspection was in April, 1979. Two violations were observed, one involving lack of annual -eviews of Radioisotope Authorizations, and one involving lack of a warning label on a fluorescence thyroid scanner containing a sealed source of Am-241. The inspection previous to that was in November, 1975 and the one violation observed involved use of radioactive material at Schofield Barracks, an unauthorized place of use.
The Enforcement Policies and Procedures of the NRC, as published in 45 FR 66754, were explained by G. S. Spencer, Director, Division of Technical Inspection.
Particular emphasis was placed on escalated enforcement actions such as civil penalties, orders to modify, suspend or revoke licenses, and orders to cease and desist. The explanation included a discussion of when escalated enforcement was utilized and how it was applied. The relative significance of the different severity levels was 1xplained, and it was pointed out that any violations at this licensse would fall into Supplements IV and VII of the Federal Register Notice. A copy of the Federal Register Notice (45 FP 66754) was given to the licensee. The licensee was told that the en.
cement action to be taken at this time consisted of the Notice of Vio ' ion in conjunction with the Enforcement Conference which was being t ld.
The licensee was told that the NRC still expected a written response to the Notice of Violation.
The licensee was told that the violation involving administration of contaminated technetium-99m was categorized as a Severity IV, and that Severity IV violations were safety related and considered significant by the NRC.
It was explained that if the violation was not corrected satisfactorily, if it was repeated, or if a similar violation occurred, escalated enforcement action would probably be taken by the NRC.
It was explained that this provision would remain in effect for two years or until the next inspection, whichever was longer. The licensee was also informed that an early reinspection would be conducted by the NRC.
At this point, the discussion turned to item 6. on the agenda, "Other matters of concern to the NRC." Mr. Book explained that while no
. violations were involved, some other matters were of concern to the NRC. The inspector noted that one misadministration occurred with accelerator produced material not under NRC jurisdiction.
In addition, poor resolution had been experienced on some scans, because of Xe-133 background increase when air conditioning failed. These items along with the mo-99 breakthru problem all indicate lost information and increased patient dose, and are of concern. 'It was also pointed out that the NRC inspections involved spot checks and a sampling process, and there were several questionable areas where additional emphasis would be placed during future inspections. These included timeliness of entries on personnel dosimetry records (DD 1141), waste disposal, and use at locations other than Tripler Hospital, such as Schofield Barracks.
It was suggested to the licensee that more attention should be placed on detailed knowledge of requirements of the license and the NRC regulations, and on the comitments made in the various documents which make up the license application.
This meeting began at about 2:00 P.M. and the NRC representatives
, left the facility at about 4:30 P.M.
This included time spent related to both licenses at this facility and additional discussions following the formal portion of the meeting.
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APPENDIX A DESICHATD 01TGnig fl0TICE OF VIOLATION 9
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Department of the Amy License No. 53-00458-04 u m U. S. Army Tripler Army Medical Center Oahu, Hawaii 96819 As a result of the inspection conducted on July 23, 24 and 27,1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
A.
An Order modifying all medical licenses on March 12, 1979 states that by March 22, 1979, technetium-99m containing more than one microcurie of molybdenum-99 per millicurie of technetium-99m or more than five microcuries of molybdenum-99 per dose of technetium-99m shall not be administered to patients.
Contrary to this requirement, on August 6,1979, four patients were administered doses of technetium-99m which contained more than five microcuries of molybdenum-99 per dose. One patient's dose contained 19.85 microcuries of molybdenum-99.
Three patients' doses contained 11.85 microcuries of molybdenum-99.
This is a Severity Level IV Violation (Supplement VII).
B.
License Condition 20. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contairied in application dated October 11, 1978; letter dated October 9,1979; and letter dated January 3,1979 (received January 18,1980).
Item 21, " Procedures and Precautions for Use of Radioactive Gases (e.g., Xenon-133)," of the application dated October 1,1978, states that xenon-133 gas is administered to the patient using a xenon lung function unit and that the system exhaust is expelled through a "NONEX" xenon gas trap.
Contrary to these requirements, at the time of the inspection, no lung function unit was being used when xenon-133 gas was administered to patients. A NONEX gas trap was in use.
Licensee personnel stated that a lung function unit had been ordered but had not been received.
This is a Severity Level V Violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, Tripler Army Medical Center, is hereby required to submit to this office within thirty days of the date of this Notice, a written statement or explanation in reply, including:
(1) the corrective steps which have been taken and the results achieved; 310ci1%O @
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w August 28, 1981 DESIGrc ED OIIIGINAL C M itied By Y'
hlfik (2) corrective steps which will be taken to avoid furlI6F Ttemshomplia'nce; and (3) the date when full compliance will be achieved.
Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation.
Consideration may be given to extending your response time for good cause shown.
The responses directed by thi: flotice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
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dated August 28, 1981 B. A. Riedlinger,fRadiation Specialist t
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