ML20040D472
| ML20040D472 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/1982 |
| From: | Greger L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20040D468 | List: |
| References | |
| NUDOCS 8202010327 | |
| Download: ML20040D472 (5) | |
Text
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Appendix A NOTICE OF VIOLATION Leila Y. Post Montgomery Hospital License No. 21-01354-03 License No. 21-01354-04 As a result of the inspection conducted on December 4, 1981, and in accord-ance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
License No. 21-01354-04 1.
License. Condition No. 17 states that Group VI. sources for. treatment of patients shall be used in accordance with procedures contained in Appendix L, NUREG-0338, Revision 1, Navember 1, 1977. Appendix L states in Item 6 that. nurses caring for brachytherapy patients will be assigned film badges.
Contrary to the above, nurses who attended patients being treated with Group VI sealed sources on April 5, May 9, June 26, and July 28, 1981, were not assigned film badges.
This is a Severity Level V violation (Supplement VII).
2.
License Condition No. 18 requires that licensed material be possessed and used in accordance with the statements,. representations, and pro-cedures contained in certain referenced applications and letters.
The referenced letter dated November 29, 1979, states in Item 9.E. that survey meters will be calibrated at least annually. -
Contrary to the above, a Picker Model 655-186 G-M meter and a Victorten Model 740-F, both used for routine surveyin;, have not been calibrated since April 20, 1980.
This is a Severity Level V violation (Supplement VII).
3.
License Condition No. 18 requires that licensed material be possessed and used in accordance with the statements, representations, and pro-cedures contained in certain referenced applications and letters.
The referenced letter dated October 5,1978, on page 12, Item XIII
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states that technologists will wear finger film badges while preparing or manipulating radiopharmaceuticals.
Contrary to the above, the inspector observed an individual inject a-radiopharmaceutical and the individual was not wearing nor had been assigned a finger badge.
This is a Severity Level V violation (Supplement VII).
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Appendix A 4.
License Condition No. 18 requires that licensed material be possessed and used in accordance with the statements, representations, and pro-cedures contained in certain referenced applications and letters.
The referenced letter dated October 5,1978, states on page 12, Item A.I.
that the " hot lab" will be surveyed at the end of each working day and the rest of the department will be surveyed each week. These surveys will be in accordance with those described in Appendix I of the Medical Licensing Guide. Appendix I states the weekly survey will consist of a G-M survey and a series of wipe tests.
Contrary to the above, the " hot lab" has not been surveyed daily since the requirement began in March 1979, and the other areas of the department have not been surveyed as required since October 8, 1980.
This is a Severity Level V violation (Supplement VII).
5.
License Condition No. 18 requires that licensed material be possessed and used in accordance with the statements, representations, and pro-cedures contained in certain referenced applications and letters.
The referenced letter dated October 5,1978, states in Item 8, page 2, that the Isotope Committee will meet at least quarterly.
Contrary to the above, the Isotope Committee has not met from May 13, 1981, to the day of this inspection.
This is a Severity Level V violation (Supplement (II).
6.
10 CFR 35.14 requires that sealed calibration or reference sources possessed pursuant to 10 CFR 35.14(e) be tested for leakage and/or contamination at intervals not to exceed six racoths.
Contrary to the above, a 197 microcurie cesium-137 sealed source received February 1977, has not been tested for leakage since September 8, 1980.
In addition, a 100 millicurie cesium-137 sealed source was not leak tested from March 3, 1980, to the date it was put into storage on September 8, 1981.
This is a Severity Level V violation (Suppleecnt VII).
7.
License Condition No. 18 requires that licensed material be possessed and used in accordance with the statements, representations, and pro-cedures contained in certain referenced applications and letters.
The referenced letter dated October 5, 1978, states on page 4 that the dose calibrator will be checked on a monthly basis using cesium-137 to obtain readings over a range of settings (30 to 500) and for linearity annually.
Appendix A Contrary to the above, the dose calibrator has not been tested over a range of settings since July 6, 1981, and has not been tested for linearity since April 9, 1980.
This is a Severity Level.V violation (Supplement VI1).
License No. 21-01354-03 8.
10 CFR 35.24 states the licensee shall determine if a person is an expert qualified by training and experience to calibrate a teletherapy unit and establish procedures for (and review the results of) spot-check measure-ments. The licensee shall determine that the qualified expert meets the requirements of 10 CFR 35.24.
Contrary to the above, the licensee failed to determine that the person performing calibrations was qualified in accordance with 10 CFR 35.24.
Specifically, an individual who performed annual full calibration measurements on November 3, 1981, does not meet the minimum training and experience of 10 CFR 35.24 and has not been excepted from these require-ments by license amendment.
This is a Severity Level V violation (Supplement VII).
9.
License Condition No. 14.A. states that teletherapy. sources shall be tested for leakage at intervals not to exceed six months.
Contrary to the above, the teletherapy source has not b: en leak tested from March 11, 1981, to the date of the inspection.
This is a Severity Level V violation (Supplement VII).
10.
10 CFR 35.21(b) states in part that full calibration measurements of your teletherapy unit shall include determination of the uniformity of the radiation field and its dependence upon the orientation of the useful beam.
Contrary to the above requiremcuts, full calibration measurements performed on November 3,1981, did not include determination of the unifonnity of the radiation field and its dependence upon the orientation of the useful beam.
This is a Severity Level V violation (Supplement VII).
11.
10 CFR 35.22 states the licensee shall cause spot-check measurements to be performed on each teletherapy unit at intervals not exceeding one month.
Appendix A Contrary.to the above, spot-check measurements were not performed on the teletherapy unit at the-required intervals.
Specifically, the checks were performed on ~ July 6, September 18, 'and November 3,1981, these two intervals exceed one month.
This is a Severity Level V violation (Supplement VII).
Fursuant 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 state-ment or explann Lion in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action-to be taken to avoid further noncompliance; and (3) the date when full com-pliance 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.
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L. R. Sfegel, Acting Chief Technical Inspection Branch 1
' Appendix B MANAGEMENT CONTROL
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In order to provide you with some guidance in assessing the adequacy of your management _ control program, the NRC Region III office provides the following as the acceptance criteria for adequate management control for materials licensees. " Management Control" is a system instituted by man-agement to assure that' licensed activities are performed safely and in accordance with regulatory requirements (license conditions and-applicable regulations).
This will include:
a.
Delineation of duties and responsibilities of all persons involved in licensed activities, b.
Providing for indcctrination and traicing of all personnel performing licensed activities, specifically in those areas directly affecting-compliance with NRC regulations and license conditicns.
c.
Verification, as by checking, auditing and inspecting, that activities affecting safety related functions have been correctly performed. The verifying process should be performed by individusls or groups other than those performing the safety related procedures.
d.
-Insuring' continued compliance of licensed activities throughout periods
.during which routine activities may be interrupted, such as changes in equipment, personnel or facilities.
Because'of the many_ variables involved, such as the number of personnel, type of activity being performed and the location or locations where activities are performed, the organizational structure for executing the management control program may take various forms; however, irrespective of the organizational structure, the individual or. group responsible for this control sbould have the flexibility and authority to institute changes or corrections as required to maintain compliance'with NRC regulations and.
. license conditions.