ML20041F282
| ML20041F282 | |
| Person / Time | |
|---|---|
| Issue date: | 03/08/1982 |
| From: | Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20041F278 | List: |
| References | |
| 30-02024-82-01, 30-2024-82-1, NUDOCS 8203160358 | |
| Download: ML20041F282 (3) | |
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Appendix NOTICE OF VIOLATION Hutzel Hospital License No. 21-03001-01 As a result of the inspection conducted on December 15 and 17,1981 and January 12-14, 1982, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
1.
10 CFR 20.201(b) requires each licensee to make or cause to be made such surveys (evaluations) as may be necessary for him to comply with the regulations in Part 20.
Contrary to this requirement, the licensee failed to make an evaluation of several individuals' whole body exposure to radiation to determine compliance with 10 CFR 20.101(a). Specifically, the licensee failed to provide any personnel monitoring devices for an individual for three months during which she cared for patients containing cesium-137 implants. Also, the film badges for an individual involved in nuclear medicine activities could not be evaluated, due to various reasons, for eight months in the first three quarters of 1981.
In addition, film badges were not submitted for processing on a timely basis and, in several cases, were too old to be evaluated.
In each case, no attempt was made to evaluate and assign an occupational dose for these individuals for the periods during which the film badges were worn and for the periods during which no personnel monitoring devices were provided.
Also, contrary to this requirement, the licensee failed to adequately survey the radiation levels in unrestricted areas to determine compliance with 10 CFR 20.105(b). Specifically, radiation levels in an area adjacent te an implant patient room on December 15, 1981 was such that, if an individual were continuously present in this area, could result in his receiving a dose in excess of two millirems in any one hour.
This is a Severity Level IV violation (Supplement IV).
2.
License Condition 16 requires patients containing cesium-137 implants, or other implants, to remain hospitalized until surveys made with a radiation detection instrument indicate that all implants have been removed. The results of these surveys shall be recorded and main-tained for inspection by the Commission.
8203160358 820308 NpM3 LIC30 21-03001-01 PDR
Appendix 2
4 Contrary to this requirement, no radiation survey was made to indicate j,
all' cesium-137 implants were removed from patients on January 22, 1981, February 9, 1981, April 16,-1981, and May 22, 1981.
i This is a Severity Level V violation (Supplement VII).
This is a repeat item of noncompliance.
3.
10 CFR 35.14(b)(5)(v) requires a quarterly physical inventory to account for all sealed sources and devices received and possessed.
Contrary to this requirement, the licensee failed to conduct a physical inventory to account for all of their cesium-137 brachy-therapy sources from October 21, 1980 to November 24, 1981, a period in excess of a calendar quarter.
This is a Severity Level V violation (Supplement VII).
This is' a repeat item of noncompliance.
4.
10 CFR 20.105(b) requires that no licensee shall use licensed material in such a manner as to create in any unrestricted area radiation levels which, if an individual were continuously present in the area, could result in his receiving a dose in excess of two millirems in any one hour.
Contrary to this requirement, radiation level measurements in unre-stricted areas adjacent to rooms containing patients with cesium-137 implants on December 15, 1981 showed levels in excess of two millirems per hour.
This is a Severity Level V violation (Supplement IV).
5.
10 CFR 19.11(a) & (b) requires that copies of specified documents be posted or a notice that describes the documents and states where they may be examined; 10 CFR 19.11(c) requires the posting of Form NRC-3, " Notice to Employees."
Contrary to the above requirements, neither the documents nor the l
notices were posted in the area where cesium-137 brachytherapy sources are handled and stored.
This is a Severity Level VI violation (Supplement VII).
This item was corrected prior to the conclusion of this inspection.
Appendix 3
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement or explanation in reply, including for each item of noncompli-ance:
(1) corrective action taken and the results achieved; (2) correc-tive action to be taken to avoid further noncompliance; 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 ex-tending your response time for good cause shown.
MAR 8 1982 i,ggng sigmi by C.E. More11us" C. E. Norelius, Director Division of Engineering and Technical Programs