ML20010E519

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Notice of Violation from Insp on 810805-07.Noncompliance Noted:Bioassays & Leak Tests of Sealed Sources Not Being Performed at Required Intervals
ML20010E519
Person / Time
Issue date: 08/28/1981
From: Sreniawski D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20010E518 List:
References
NUDOCS 8109040217
Download: ML20010E519 (4)


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Appendix A NOTICE OF VIOLATION Ohio State University Licence No. 34-00293-02 Lies se No. 34-00292-08 License No. 34-00293-12 i

As a result of the inspection conducted on August 5-7, 1981, and in accordance with the Interim Enforcevent Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:

The following items were identified for License No. 34-00293-02:

1.

License Condition 27 states that tne licensee shall possess and use licensed material in accordance with statements, representations and procedures listed in the application dated December 4, 1979.

Item 23 of this application states that (a) individuals involved in operations which utilize, at any one time, more than 1 mci of I-131 or I-125 in an i

iodination procedure, shall have bioassays performed within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> following a singular operation and at weekly intervals for continuing operations, and (b) individuals involved in the direct handling of I-125 and/or I-131 in a noncontained manner, other than iodinations proce-dures described above, in quentities in excess of.1 mci per quarter 4

j will be monitored on a quarterly basis.

i Contrary to the above, bioassays were not being performed at the re-quired frequency. For example, (1) an individual utilizing millicurie quantities of I-125 per month in iodination procedures has had only two bioassays (January and May, 1981) and (2) an individual involved in the direct handling of approximat :ly 70 millicuries of I-131 per week i

has had only four bioassays over the last ten quarters.

This is a Severity Level V violation (Supplement VII).

4 2.

License Condition 27 states that the licensee shall possess and use licensed material in accordance with statements, representations and procedures listed in the application dated December 4, 1979.

Item 17 of that application specifies daily area surveys of all elution, pre-paration and injection area as well as weekly surveys of laboratories using quantities in excess of 100 microcuries and monthly surveys of laboratories nsing less than 100 microcuries of material. Records of results of these surveys, including negative results, are to be main-l tained.

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OOf7810833 34-00293-02 PDR

Appendix A Contrary to the above, r-daily GM area surveys were performed in the patient dosing area bei sen October 30 and Noveeber 17, 1980, November 17 and December 1, 1980; Lccember 17 and 29, 1980; and ne records were avail-able for surveys purportedif performed between December 30, 1980 and February 9, 1981.

In addition, approximately 90% of the research labs inapected were na 2ng surveyed at the required frequencies.

For example:

Wiseman Hall Room 2020 and 2024 - no surveys between March 24 and June 18, 1981.

Room 2036 - no weekly surveys between July 22, 1981 and inspection date.

Gross Laboratory Room 219 - no surveys prior to April 14, 1981 or after May 27, 1981.

Room 326 - surveyed June 10, 1980 and April 2R, 1981 only.

Room 214 - no surveys over last 9 months use.

Parks Hall Room 240 - surveyed April and July 1980 only.

This is a repeat item of noncompliance.

This is a Severity Level V violation (Supplement VII).

3.

License Condition 27 states that the licensee shall possess and use licensed material in accordance with statements, representations and procedures listed in the application dated December 4, 1979.

Item 15 of that application prohibits eating, drinking, smoking and the application of cosmetics in any area within three feet of where radio-active material is used.

Contrary to the above, evidence of eating and drinking was found adjacent to areas of use of radioactive material including:

Gross Laboratory Room 232B - used coffee cups.

Room 214 - open bag of potato chips next to BPM fume hood Parks Hall Room 517 - large coffee maker on work bench.

Appendix A This is a repeat item of noncompliance.

Th:.s is a Severity Level V violation (Supplement VII).

4.

License Condition 15 requires that sealed sources containing greater than 100 microcuries of byproduct material in any form other than gas be tested for leakage and/or contamination at intervals not to exceed six months.

a Contrary to the above, leak tents of sealed sources had not been performed at the required inte : val. For example, a 1.6 mci Sr-90 source, a 250 Ci Cs-137 soucce and a 1.65 mci Co-60 source had not j

been leak tested between May 30, 1980 and July 31, 1981.

This is a Severity Level V violation (Supplement VII).

5.

License Condition 27 states that the licensee shall possess and use licensed material in accordance with statements, representations and procedures listed in application dated December 4, 1979.

Item 9 of that application specifies an annual calibration frequency for survey instruments.

Contrary to the above, this atnual calibration frequency is not being met.

For example, a Victoreen Model 410 (Serial No. 728) had not been calibrated between November 1979 and the date o'

?.his inspection as well as two Eberline E-120 instruments (Serial Nos. 7337 and 1831) between June 1979 and the date of the inspection and September 1979 and the date of this inspection, respectively.

This is a Severity Level V violation (Supplement VII).

The following item applies to Licenses No. 34-00293-08 and 34-00293-12.

6.

License Condition 20 requires that each teletherapy machine be full r inspected and serviced during source replacement or at intervals ne to exceed five (5) years, whichever comes first, to assur prop,-

functioning of the source exposure mechanism. The inspect on servicing must be performed by persons specifically authorized

  • s do so by the NRC, and a report of the inspection and servici,ausc be kept on file.

Contrary to the above, neither of your Cs-137 teletherapy units have had their source exposure mechanisms serviced and inspected within the past five years.

This is a Severity Level V violation (Supplement VII).

The following item applies to License No. 34-00293-12.

3 Appendix A 7.

10 CFR 20.203(c) requires each high radiation area be conspicuously posted with a sign or signs bearing the radiation caution symbol and r.he words:

" Caution High Radiation Area."

Contrary to the above, on the day of this inspection the required posting was not present at the entrance to the University Hospital teletherapy treatment room.

This is a Severity Level V 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 statement or explanation in reply, including for each item of noncompliance:

(1) cor-rective 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 chown.

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Dated I

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D. J.

reniawski, Chief Materia s Radiation Protection Sectio 2 4

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