ML20030D967
| ML20030D967 | |
| Person / Time | |
|---|---|
| Issue date: | 09/02/1981 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20030D965 | List: |
| References | |
| NUDOCS 8109170219 | |
| Download: ML20030D967 (3) | |
Text
---~
o Appendix A NOTICE OF VIOLATION St. Francis Hospital License No. 22-15538-01 As a result of the inspection conducted on August 20, 1981, and in accord-ance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
1.
10 CFR 35.14(e)(1)(i) requires each licensee who possesses sealed sources as calibration or reference sources shall perform tests for leakage and/or contamination at intervals not to exceed six months.
Contrary to this requirement, as of the day of the inspection, you had not tested your sealed source containing cesium-137 for contamination or leakage since June 1978.
This is a Severity Level V violation (Supplement VII).
2.
10 CFR 20.207(a) requires that licensed materials stored in an unre-stricted area be secured against unauthorized removal from the place of storage.
10 CFR 20.207(b) requires that materials not in storage be under constant surveillance and immediate control of the licensee.
As defined in 10 CFR 20.3(17), an unrestricted area is any area access to which is not controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive materials.
Contrary to this requirement, as of the day of the inspection, your Nuclear Medicine Laboratory, which contained millicurie quantities of licensed material, was occasionally unlocked when it was not under your constant surveillance and immediate control.
The laboratory, during these periods, was accessible to visitors, employees, and ambulatory patients and the licensed material was not under constant surveillance or your immediate control.
This is a Severity Level V violation (Supplement IV).
3.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated May 8, 1978.
The above referenced application states that Appendix I of the NRC Medical Licensing Guide will be followed. Appendix I requires daily surveys w.ith a G-M survey meter of all preparation and injection areas.
8109170219 810902 NMS LIC30 22-15538-01 PDR
h Appendix A e o
Contrary to the above, it was learned through statements of licunsee representatives and t he absence of records, that the requirement for daily surveys with a G-M survey meter has not been met.
Specifically, daily G-M surveys are not performed in the hot lab and injection areas.
This is a repeat item of noncompliance.
This is a Severity Level V violation (Supplement VII).
4.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated May 8, 1978.
Item 10 of the above referenced application states that Appendix D, Section 2 of the NRC Medical Licensing Guide will be followed. Appendix D of the Licensing Guide requires specific tests and calibrations of the dose calibrator.
Contrary to the above, it was learned through statements of licensee representatives and review of records that daily constancy, quarterly linearity and annual accuracy tests of the dose calibrator were not performed during 1980 and 1981.
This is a Severity Level V violation (Supplement VII).
5.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated May 8, 1978.
Item 10 of the above referenced application states that Appendix D, of the NRC Medical Licensing Guide will be followed. Appendix D requires survey instruments to be calibrated at least annually.
Contrary to the above requirement, it was determined through state-ments by licensee representatives that this condition is not being met.
Specifically, your Picker G-M Survey Meter (Serial No. 618) was last calibrated in April 1980.
This is a Severity Level V violation (Supplement VII).
6.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated May 8, 1978.
Item 7 of the above referenced application states that Appendix B, of the NRC Medical Licensing Guide will be followed. Appendix B requires quarterly meetings of the Medical Isotopes Committee.
t a
~
Appendix A Contrary to the above, meetings of your Medical Isotopes.ommittee have not been held since February 1981.
This is a Severity Level V violation (Supplement VII).
7.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated May 8, 1978.
Item 14 of the above referenced application states that Appendix F, of the NRC Medical Licensing Guide will be followed. Appendix F requires surveys and wipe tests of all incoming packages for the detection of possible radioactive contamination.
Contrary to we above requirement, it was determined through state-ments by liteusee representatives that this condition is not being met.
Specifically, incoming packages have not been surveyed or wipe tested during 1980 and 1981.
This is a Severity Level V violation (Supplement VII).
8.
10 CFR 20.401(b) requires that you maintain records showing the results of surveys required by 10 CFR 20.201(b), " Surveys."
Contrary to this requirement, as of the day of the inspection, you failed to maintain records of surveys that you performed to assure compliance with 20.301, " Waste Disposal, General Requirement."
-This is a Severity Level VI violation (Supplement IV).
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 state-ment or explanation 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 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.
6W 9+W
~
Dated D. C. Wiedeman, Acting Chief
-Materials Radiation Protection Section 1
_ _ _. _ _ _ _ - - _ _ _ _ _ _. _ _ _ _ _ _ _ _ _ -.