ML20052C721
| ML20052C721 | |
| Person / Time | |
|---|---|
| Issue date: | 04/13/1982 |
| From: | Deyoung R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Hebner M PHARMATOPES, INC. |
| References | |
| EA-82-016, EA-82-16, NUDOCS 8205050429 | |
| Download: ML20052C721 (3) | |
Text
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/ E /2 A APR 1319P 4 altFna eser License No 34-16654-01MD
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EA 82-16 f
Pharmatopes, Incorporated Y
ATTN: Mr. Mark Hebner pj President
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Ferndale, Michigan 48220 ft
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pn This refers to the inspection conducted by Mr. S. R. Lasuk of our Region-P (Chicago) office on November 3 and 4,1981, of activities at your facility in Toledo, Ohio, authorized by NRC Byproduct Material License No. 34-16654-01MD.
The results of the inspection involving an extremity exposure were discussed during an enforcement conference on November 18, 1981, in the Region III office between Messrs. Monty M. C. Fu and Robert F. Irwin of Pharmatopes, and Mr. A. B. Davis and others of the Region III staff.
As you are aware, three civil penalties have been imposed on Pharmatopes, Incorporated since December 1980.
Two of these penalties also involved extremity overexposures. One of them, an extremity overexposure during the fourth quarter of 1980, occurred at your Washington, D.C. facility under the same management and Radiation Safety Officer who is now at the Toledo, Ohio facil i ty.
We are concerned about the recurrence of these extremity exposure violations and believe they indicate a breakdown in your health physics controls in an area that should be of particular concern to a nuclear pharmacy.
On March 17, 1982 an enforcement conference was held with Mr. Hebner and other members of Pharmatopes, Incorporated at the Inspection and Enforcement Office in Bethesda, Maryland.
The purpose of this conference was to emphasize NRC's concern over the recurrence of extremity radiation doses to individuals and to discuss what actions you have taken or plan to take to improve your health physics program at all of your NRC licensed facilities.
At the enforcement conference Pharmatopes nanagement submitted to the NRC a detailed report outlining the corrective actions taken or planned by Pharmatopes, Incorporated to reduce the probability of extremity exposures and to enhance its radiation protection program.
After careful review of the report, NRC has convluded that if the corrective actions are implemented as outlined in the report, Pharmatopes, Incorporated will have taken satisfactory corrective action.
CERTIFIED MAIL RETURN RECEIPT REQUESTED 8205050429 820413 NMS LIC30 34-16654-01MD PDR
Pharmatopes, Incorporated In view of your compliance history and in order to emphasize the responsibility of Pharmatopes, Incorporated to properly control its licensed programs, we believe a civil penalty is appropriate.
The violations described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties have been categorized at the severity levels described in accordance with the NRC Enforcement Policy published in the Federal Register, 47 FR 9987 (March 9, 1982).
Matters of partic-ular concern were your failure to adequately evaluate the significance of a 13.99 rem extremity radiation dose received by an individual in a one-month period during the third calendar quarter of 1981, and your permitting this individual to continue working at activities where he was subject to additional radiation exposure.
As a result, the individual received a quarterly extremity radiation dose in excess of regulatory limits.
Accordingly, we propose to impose civil penalties in the cumulative amount of Four Thousand Dollars for the violations set forth in the Appendix to this letter.
During the November 1981 inspection at your Toledo facility we learned that a diagnostic misadministration occurred on October 9, 1981, when a Pharmatopes, Incorporated employee placed a radiopharmaceutical in a vial and did not verify that it was properly labeled.
This was similar to another occurrence that the licensee reported in a letter dated April 8, 1981 to the Region III Office.
In your response please specify corrective measures and procedures you will take to preclude similar occurrences in the future.
It also appears that you failed to adequately evaluate a reported 20.73 rem extremity dose to an individual during the second quarter of 1979.
In your letters dated December 1 and 22, 1981 to the Region III Office you submitted calculations that led you to conclude that the 20.73-rem extremity dose was not a valid exposure.
However, the Region III review of your letters does not support this conclusion.
In your response clarify why you consider the exposure to be invalid.
You are required to respond to the Notice of Violation and Proposed Imposition j
of Civil Penalties and, in preparing your response, you should follow the instruc-l tions specified in the Appendix.
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In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, l
Title 10, Code of Federal Regulations, a copy of this letter and the enclosure will be placed in the NRC Public Document Room.
l The responses directed by this letter and the enclosed Appendix are not subject to the clearance procedures of the Office of Management and Budget as required l
by the Paperwork Reduction Act of 1980, PL 96-511.
Sincerely, i
i Richard C. DeYoung, Director l
Office of Inspection and Enforcement l
Enclosure:
Appendix - Notice of Violation and l
Proposed Impositio gof Civil Penalties s
_flE ELDpv Q Region III 0:E E
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EFlack/bts JMurray RWarnick J 'e rman niezek RD'e rig 4/I /82 4 )) 2 4Af/82 4/]/82 w.w%(
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Pharmatopes, Incorporated 3~-
Distribution POR-NSIC TIC.
SECY-4 CA RCDeYoung, IE JHSniezek, IE JLieberman, IE VStello, DED/ROGR LCobb, IE FIngram, PA JMurray, ELD (3)
VMiller, NMSS JCrooks, AE00 JCummings, DIA DNussbaumer, OSP TWBrockett, IE i
EFlack, IE APuglise, CON Director, El Staff, RI, RII, RIII, RIV, RV Central Files ES Files E00 Reading Fil?
EA Book 4
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