ML20042A138
| ML20042A138 | |
| Person / Time | |
|---|---|
| Issue date: | 03/08/1982 |
| From: | Skov D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20042A133 | List: |
| References | |
| NUDOCS 8203230129 | |
| Download: ML20042A138 (5) | |
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2 Appendix A NOTICE OF VIOLATION Veterans Administration Medical Center License No. 04-01935-03 2615 Clinton Avenus Fresno, California 93703 As a result of the inspection conducted February 11-12, 1932, and in accordance with the Interim Enfcrcement Policy, 45 FR 66754 (October 7,.1980),
the following violations were identified:
A.
License Condition 16.A. states, in part, that each sealed source containing licensed material, other than hydrogen-3, with a half-life.
greater than thirty days, and in any form other than gas, and which-i contains greater than 100 microcuries of beta and/or gama emitting material, shall be tested for leakage and/or contamination at intervals not to exceed six months.
1.
Contrary to the above requirement, a sealed source, containing 251 microcuries of barium-133 (on 1/14/81) was last leak tested on March 18, 1981 and had not been leak tested again as of the date of the inspection, February 11, 1982, a period in excess of nine months.
2.
Contrary to the above requirement, two sealed sources, each 1
containing 14 m!Ilicuries of americium-241, were received on or about March,1980 and had not been leak tested as of the e
date of the inspection February 11, 1982, a period in excess of 23 cmnths.
These items constitute a Severity Level IV Violation (Supplement VII).
O.
License Condition 13 states, in part, that for a period not to exceed sixty days in any calendar year, a visiting physician is authorized to use licensed material for human use, provided the.
visiting physician (a) has the prior written permission of the hospital's Administrator and its Medical Isotopes Comittee, (b) is specifically named as a user on a NRC license authorizing human use, and (c) performs only those procedures 'for which he is speci#i-;
cally authorized by a NRC license.-
1.
Contrary to-the above requirements, at the time of the inspection, x prior written permission of the Medical Isotopes Committee had
,A not been obtained authorizing the use of licensed material by a visiting physician on 18 separate occasions during the A
period from February 6,1981 through February ';,1932.
e 2.
Contrary to the above requirements, at' the time of the. inspection, tne visiting physician was not named as a user on a Nuclear Regulatory Connission license authorizing' human use.'
1 The above items constitute a Severity Level IV Violation (Supplement VII).
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8203230129 820308 NMS LIC30 04-01935-03 PDR
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Appendix A s C.
License Condition 17, in part, states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in application dated January 15, 1981 and letter dated August 18, 1981.
1.
Appendix D. Section 2 of NRC Regulatory Guide 10.8, Guide for the Preparation of Applications for Medical prograns (Revision 1, October 1980), which was submitted as an attachment to the application dated January 15, 1981, states that dose calibrators will be checked for accurate operation by performing the following tests at the indicated frequency:
a.
Instrument constancy (daily) b.
Instrument accuracy (at installation and annually thereafter) c.
Instrument linearity (at installation and quarterly thereafter) d.
Geometrical variation (at installation)
Appendix D, Section 2 alto states that records shall be maintained of results of measurements corresponding to each instrument test.
(1) Contrary to the above requirements, tests to determine instrument-accuracy, linearity, and geometrical variation had not been perforned for two dose calibrators (Serial Numbers 20080 and 3655) during the period of use from April,1981 to the date of the inspection, February 11, 1982.
This is a Severity Level IV Violation (Supplement VII).
(2) Contrary to the above requiremer.ns, records were not maintained of tests to determine instrument constancy for two dose calibrators, one (Serial Number 20080) of which was used during the period of February,1931 through February 11 1982, and the other dose calibrator (Serial Number 3655h which was used from May,1931 to the date of the inspection, February 11, 1982.
This is a Severity Level V Violation (Supplement VII).
2.
Appendix I of NRC Regulatory Guide 10.8, Guide for the Preparation of Apolications for Medical Programs (Revision 1, October 1980),
which was submitted as an attachment to the application dated January 15, 1981, states that all elution, preparation, and injection areas will be surveyed daily with an appropriate low-range survey meter and decontaminated if necessary.
Appendix I also states that the waste storage area and all
l Appendix A.
other laboratories using amounts larger than 200 microcuries of licensed material, will be surveyed weekly using a survey meter and a series of wipe tests to measure contamination levels. Also, Appendix I requires that a permanent record' will be maintained of all survey results and that the record will include measured exposure rates in units of mr/hr and datected contamination levels in units of dpm.
(1) Contrary to the above requirements, monthly rather than the required daily surveys had been performed of the Radiopharmacy Room during the period of April 9,1981 thrcugh February 11, 1982. Monthly instead of the required weekly surveys were made in the second and third floor Nuclear Medicine Laboratories during the period from May 12, 1981 through February 11, 1982. Monthly rather than weekly surveys were also performed in the Waste Storage Room during the period from Novenber 6,1981 to the date of the inspection, February 11, 1982.
This is a Severity Level IV Violation (Supplement IV).
(2) Contrary to the above requirements, a record cf the results of surveys which were made to determine radiation levels and the activity of wipes, were not adequate because they did not include appropriate units (mr/hr and dpm) for weekly surveys in the Radiopharmacy and Nuclear Medicine and Radioinnunoassay Laboratories during the period from January 15, 1979 to April 9, 1981.
The results of room area and :urface contamination surveys.
were recorded as a numerical value without an indication of the units of radiation or activity levels obtained from the measurements.
This is a Severity Level V Violation (Supplement IV).
3.
Item 2, page 2 of the attachment, Criteria and Procedures for Bioassay of Personnel (December 1980), which was subnitted with the application dated January 15, 1981, states that technologists and physicians who are involved in the admini-stration of a small iodine-131 therapeutic dose (less than 30 millicuries) to a patient, will have a measurement of iodine-131 in the thyroid gland 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the procedure.
Item 1 of the attachment also states that Huclear Medicine technologists and physicians will have a measurement of iodine-131 in the thyroid gland once every' three months.
Contrary to the above requirements, at the time of the ins'pection, no measurements had been made to detennine the presence of iodine-131 in the thyroid gland of certain nuclear medicine
4-Appendix A personnel following the administration of a 30 millicurie dose of iodir.e-131 to a patient on February 10, 1981.
This is a Severity Level IV Violation (Supplement IV).
A CFR 35.14(f)(2) states that a quarterly pl$ysical inventory shall D.
be conducted to account for all sources received and possessed pursuantto10CFR35.14(d)(4). Records of the inventories shall be maintained for inspection by the Commission and shall include the quantities and kinds of byproduct material, location of sources, and the date of the inventory.
Contrary to the above requirements, records had not been maintained for quarterly inventories that were performed during the 48 month period between llovember 20, 1978 and December 22, 1981.
An inven-tory was performed on December 22, 1981 but did ncc indicate the location of sealed sources.
This,isaSeverityLevelVViolation(SupplementVII).
E.
10 CFR 19.11(a) states that each licensee shall post current copies of the follow'ng documents: -(1) 10 CFR 19 and 10 CFR 20;-(2) the license, license conditions, or documents incorporated into a license by reference, and amendments thereto; and (3) the operating 10 CFR 19.11(b) also procedures applicable to licensed activities.
states that if posting of a document specified in paragraph (a)(1),
(2) or (3) of this section is not practicable, the licensee may post a notice which describes the-document and states where it may be examined.
Contrary to the above requirements, at the time of the inspection,.
a URC license dated December 3,1974 was posted in the iluclear t
fledicine Laboratory which is not current. The most recent license issued to the licensee is dated March 13, 1981 and amendment dated February 18, 1982 but were not posted. Also, the above remaining documents were neither posted nor was there a notice which describes the documents and states where they may be examined.
This is a Severity Level VI Violation (Supplement VII).
pursuant to the provisions of 10CFR2.201, Veterans Administration 11edical Center, Fresno is hereby required to submit to this ' office within thirty days of the date of this flotice, a written statement or (1) the corrective _ steps which have explanation in reply, including:
been taken' and the results achieved; (2) corrective steps which will be taken to avoid further items of noncompliance; and-(3) the date when full compliance will be achieved.
Consideration may be given to ex-tending your response time for good cause shown. Under the authority of
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' Appendix A,.
Section 182 of the Atomic Energy Act of 1954, as amended, this reponse shall be submitted under oath or affirmation.
Original signed by D. D. Skov dated March 8, 1982 David D. Skov, Radiation Specialist Radiological Safety Branch
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