ML20034C173
| ML20034C173 | |
| Person / Time | |
|---|---|
| Issue date: | 04/23/1990 |
| From: | Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Mcgrevin G SYNCOR INTERNATIONAL CORP. |
| References | |
| EA-90-053, EA-90-53, NUDOCS 9005020135 | |
| Download: ML20034C173 (3) | |
Text
.. _.
i APR 2 31990 Syncor Internationat License No.:
34-18903-01MD ATTN: Mr. Gene McGrevin EA 90-053 President
)]O Og
'l 20001 Prairie Street Post Office Box 2185 Chatsworth, CA 91313-2185 Gentlemen l
This refers to the enforcement conference to be held at the Region III office on April 27, 1990, between members of our respective organizations.
We sent you a March 23, 1990 meeting notice which outlined, in general terms, the items we plan to discuss.
The aurpose of this letter is to provide you with a more concise listing of the cey issues which we plan to discuss.
I is a summary of the violations and concerns that we will present for discussion.
You should be prepared to discuss their acceracy and provide us information on what you believe to be the cause, your corrective actions and any mitigating circumstances. We have information on the corrective actions you took at the time as a result of the meeting we held with you on j
January 19, 1989. We would be interested in information on any actions you l
have taken subsequent to that meeting.
We ask that you also be prepared to discuss the four issues listed _in, which arose from our Office of Investigation >' investication as referenced in our March 23, 1990 letter to you.
If you have any questions, please contact Dr. Bruce Na11ett of.my staff at (708) 790-5645..
Sincerely, Charles E. Norelius, Director Division of Radiation Safety and Safeguards
Enclosures:
1.
Sumary List of Apparent 1
Violations and Concerns
[di0 2.
0! Issues to Address sg (10 CFR PART 2.790 INFORMATION)
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E. Pawlik, RIII l
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Summary List of Apparent Violations and Concerns Apparant Viniatinna 1.
Radiopharmaceuticals were dispensed on October 8, 1987, April 28, 1988, and June 9, 1988, with the incorrect pharmaceutical form listed on the dose container.
2.
The Prepared Radiopharmaceutical Data Sheet for radiopharmaceuticals prepared in-house on April 28, 1988, did not include the correct chemical form of the radionuclide.
3.
Alumina breakthrough tests were not performed on each eluate of the Ho-99/Tc-90m generators.
4.
Falsification of records of alumina breakthrough checks and of a daily survey record (10 CFR 30.9(a)).
5.
Dose calibrator accuracy teste performed on March 17 and May-21, 1988, did not include the use of a barium-133 reference standard.
6.
Semiannual testing for proper operation of the fune hood used for storage or radioactive materials was not performed since October 21, 1987.
7.
Semiannual sealed source leak testing of the nominal 148 microcurie barium-133 sealed source was not performed since March 1986.
Cnnnavnm 1.
Inadequate followup on audits to ensure identified problems are corrected.
For example, failure to timely correct documentation deficiencies.
2.
Inadequate and untimely followup to search for root cause in response to reports of incidents involving distributed, radiopharmaceuticals that were not as prescribed.
3.
Failure to perform or complete quality control testa prior to distribution of radiopharmaceuticals.
4.
Failure to perform adequate quality. control tests on all radiopharmaceutical preparations.
S.
Lack of standardized procedures for radiopharmaceutical preparations and quality control.
B.
Not using calibration correction factors on instruments used to perform package surveys of prepared radiopharmaceuticals.
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