ML20040F457
| ML20040F457 | |
| Person / Time | |
|---|---|
| Issue date: | 02/02/1982 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20040F454 | List: |
| References | |
| NUDOCS 8202090219 | |
| Download: ML20040F457 (3) | |
Text
t Appendix-NOTICE OF VIOLATION Port Huron Hospital License No. 21-20137-01 dm a result of the inspection conducted on January 12, 1982,; 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 requires that sealed calibration or reference sources possessed pursuant to 10 CFR 35.14(d) be tested for leakage and/or contamination at intervals not to exceed six' months. Records of leak test results shall be kept in units of microcuries and main-tained for inspection by the Commission.
Contrary to this requirement, you failed _to leak test your sealed cesium-137 and barium-133 calibration sources from the date of license issuance.
'This is a Severity Level V violation (Supplement VII).
2.
License Condition No. 16 requires that licensed material be possessed and used in accordance.with statements, representations, and procedures
~
contained in application dated March 27, 1981.
'The above referenced application states, the procedures described in Appendix I of the draft " Guide for Preparation of Applications for Medical Programs" will be followed. Appendix I requires specific laboratory areas be surveyed on a daily, weekly, and monthly basis.
Item No. 9 of the application states that an EON G-M low range. survey meter is available for use.in the radiation safety program.'
Contrary to the above, surveys were not performed nor was an EON G-M or comparable low range survey instrument available from the date of license issuance.
This is a Severity Level V violation (Supplement VII).
3.
10 CFR 35.14(b)(6) requires that-for Groups.I, II and III any licensee using byproduct material'for clinical procedures other'than those specified in the product labeling (package insert) shall comply with the labeling regarding:
8202090219 B20203 NMS LIC30-21-20137-01 PDR
4 Appendix (i)
Chemical and physical form; (ii)
Route of administration; and, (iii)
Dosage range.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspector's review of records that this condition is not being met.
Specifically, during the last three months, an intra-urethra catheterization of the urinary bladder (Cystogram) was performed. This procedure is not described in the manufacturer's package insert as an authorized route of administration.
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 statementa, representation, and procedures contained in application dated March 27, 1981.
The above referenced application states that procedures in Appendix D, Section 2 of the draft " Guide for the Preparation of Applications for Medical Programs" will be followed. This appendix requires a daily constancy test on your dose calibrator.
In addition, Item No. 10 of the application requires monthly accuracy tests on the dose calibrator, using Appendix D procedures.
Contrary to the above, it was determined through observations of the inspector and statements by licensee representatives that these re-quirements are not being met.
Specifically, constancy tests were performed weekly, instead of daily, and the last accuracy test was' performed in October 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 March 27, 1981.
Item No. 7 of the above referenced application states that meetings of the Medical Isotopes Committee shall be held not less than once in each calendar quarter.
Contrary to the above, it was determined through review of records that this requirement is not being met.
Specifically, your Medical Isotopes Committee has not met since the date of license issuance.
This is a Severity Level V violation (Supplement VII).
Appendix 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 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 compliatice 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.
Con-sideration may be given to extending your response time for good cause shown.
Dh/Ba b
1 Dated / [
D. J.
f,eniawski, Chief Mater'a s Radiation Protection Secti n 2
,