ML19346A029
| ML19346A029 | |
| Person / Time | |
|---|---|
| Issue date: | 05/13/1981 |
| From: | Joyner J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML19346A027 | List: |
| References | |
| 30-09870-81-01, 30-9870-81-1, NUDOCS 8106040399 | |
| Download: ML19346A029 (2) | |
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ARENDIXA NOTICE OF v10LATION Thomas J. Lapine, M.D.
Docket No. 30-9870 Peabody, Massachusetts 01960 License No. 20-15335-01 As a result of the inspection conducted on March 11, 1981, and in accordance with the Interim Enforcement Policy, A5 FR 66754 (October 7, 1980), the following violations were identified:
A.
Condition 15 of your license requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in your application dated January 1,1979.
1.
Items 10.2 and 10.3 of this application require that you perform daily constancy checks on your dose calibrator with cobalt-57 and cesium-107 check sources.
Contrary to this requirement, as of the day of the inspection, Maren 11, 1981, you failed to perform constancy checks on your dose calibrator on a daily basis.
This is a Severity Level IV Violation (Supplement VII).
2.
Item 10.4 of this application requires that activity linearity test results performed on your dose calibrator be within + 5% of the predicted values.
Errors greater than + 5% indicate a need for repair and/or adjustment to the instrument.
Contrary to this requirement, as of the day of the inspection, March 11, 1981, linearity tests performed on your dose calibrator in February 1980 and August 1980 showed up to a 14% difference from the predicted values and no repairs on adjustments were made on the dose calibratnr.
This it
- Severity Level IV Violation (Supplement VII).
3.
Item 15.4 ot *.his application requires that you use syringe shields for preparation of patient doses and administration of radiopharma-ceuticals to patients.
Contrary to this requirement, as of the day of the inspection, March 11, 1981, you failed to use syringe shields during kit and dose preparation.
This is a Severity Level IV Violation (Supplement VII).
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Appendix A 2
4.
Item 17.0 of this application requires that you perform a series of wipe tests in ill areas where radioactive materials are used and that this test be sufficiently sensitive to detect 100 disintegrations per minute of removable contamination.
Contrary to this requirement, as of the day of the inspection, March 11, 1981, you counted your wipe tests in your dose calibrator, a method which is not sensitive enough to detect 100 disintegrations per minute of removable contamination.
I This is a Severity Level V Violation (Supplement VII).
8.
10 CFR 20.201(b) requires that you made such surveys as may be necessary for you to comply wIth all sections of Part 20. As defined in 10 CFR 20.201(a), " survey" means an evaluation of the radiation hazards incident i
to the production, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions.
Contrary to this requirement, you failed to make such surveys as ware necessary to assure compliance with 10 CFR 20.301, a regulation that describes authorized means of d;sposing of licensed material contained in waste.
Specifically, as of March 11, 1981, you failed to make such surveys of all waste material prior to discharge to the normal trash as were necessary to assure that waste material containing licensed materfal j
was not disposed of in a manner that was not authorized by 10 CFR 20.301.
l This is a Severity Level IV Violatica (Supplement IV).
i pursuant to the provisions of 10 CFR 2.201, Thomas J. Lapine, M.D. Is hereby required to submit to this office within twenty-five days of the date of this Notice,:t written statement or explanation in reply, includi'ng:
(1) the j
corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid further violations; and (3) the data when i
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 cath or affirmation.
13 MAY 1981 Mg Dated i
mes H. Joyn p f, Chfef echnical In5pYttion Branch i
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