ML20034B001
| ML20034B001 | |
| Person / Time | |
|---|---|
| Issue date: | 03/23/1990 |
| From: | Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Mcgrevin G SYNCOR INTERNATIONAL CORP. |
| Shared Package | |
| ML20034B002 | List: |
| References | |
| EA-90-053, EA-90-53, NUDOCS 9004250202 | |
| Download: ML20034B001 (3) | |
Text
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t g 2 3 1993 Syncor International License No. 34-18903-01MD ATTN: Mr. Gene McGrevin EA 90-053 President 20001 Prairie Street Post Office Box 2185 Chatsworth, CA 91313-2185 Gentlemen This refers to the telephone conversation between Mr. Richard Keesee of your staff and Mr. Roy J. Caniano of my staff on March 16, 1990, regarding the arrangements for an enforcement conference between members of our respective organizations. This meeting is scheduled for 9:00 a.m. (CDT). April 27,.1990, at the Region III office at 799 Roosevelt Road, Building 4, Glen Ellyn, Illinois.
The purpose of the meeting is to discuss the apparent violations previously identified in our inspection report ipsued to Syncor, Blue Ash, Ohio on October 25, 1988, and to discuss the findings of the investigation performed by the NRC Office of Investigations (01). A copy of the 01 synopsis is enclosed with this letter for your infortr,ation. We will also discuss your corrective actions with regard to these matters and the enforcement options available to the NRC.
t If you have any questions related to this meeting, please contact Mr. Roy J. Caniano of my staff at (708) 790-5721.
Sincerely, wWiritd. SKht0 BT C. L lehh r
Charles E. Norelius, Director Division of Radiation Safety and Safeguards
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SYNOPSIS On August 9, 1988, the NRC Office of Investigations (01:R!ll) received a Request for Investigation from the NRC Region 111 (NRC:RllI) Regional Administrator. The request evolved from information obtained during the course of an inspection into multiple diagnostic misadministrations of technetium-99m.
Information developed during the inspection indicated that the senior lab technician (Sr. Tech.) at Syncor International Corporation control (QC)y in Blue Ash, Ohio (SEA), may have failed to perform qualitytests on radiopharmac falsified the radiopharmacy record to indicate that the tests had been performed. The matter was referred to 01: Rill to determine if the Sr. Tech, willfully failed to perform the QC tests and subseouently falsified the record to inoicate that the tests were done. 01: Rill was also asked to determine if the Sr. Tech.'s actions were directed by or known to any supervisors or managers.
As a result of the NRC: Rill inspection ano preliminary interviews conductrd by 01:RIII, NRC: Rill staff determired that the apparent violations set forth in the originc1 Request of Investigation were not valid, and the Request for Investigation was amended. As a result of information obtained during the inspection and investigation, the amended Request for Investigation requested OI: Rill to:
(1) determine the cause and extent of the failure to foilow the manufacturer's procedures for compounding bone imaging doses; (2) determine if an SBA employee, who admitted falsifying records of required alumina break-(
through checks, was acting alone or was directed to falsify those records; and (3) determine the scope of the record falsification problem at SBA. The 01: Rill investigation substantiated that some pharmacists at SBA admitted that they willfully failed to compound medronate diphosphonate (MDP) in accord 6nce with the manufacturer's instructions, as recuired by SDA's NRC License Condition 19.
It was established that several SBA employees, including the radiopharmacy manager, were aware that the manufacturer's package inserts were not being folicwed as recuired. The Syncor corporate manual does not suggest or advocate the practices of the pharmacists at SBA with regard to the failure i
to follow the manufacturer's package insert. However, the SBA manager stbted that it was an accepted procedure to exceed the specifications described in the manufacturer's package insert.
p 01: Rill also substantiateo the second allegation that pharnachts at SBA willfully failed to perform required alumina breakthrough checks on each l
generator elution and falsified records incicating that they had been i.
performed. The pharmacists indicated that they had been trained to perform l
them on each elution and knew that they were required to be performed according to SBA's NRC License Condition 23. Two pharmacists admitted that they had failed to perform the requireo checks and falsified records I
indicating thht they had been performed. Another employee also acknowledged that she had been told by a third pharmacist that the checks were not performed on each elution.
bidence also substantiated that on at least two occasions in 1988, the SBA manager asked an employee to backfit requireo daily area survey record:,, The caployee admitted that on one occasien she falsified the record at thc Case No. 3-68-009 1
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direction of the SBA manager. On a second occasion, the SBA manager again
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directed the employee to backfit the record, but the employee refused.
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3 The investigation also substantiated that there was other record falsification by SBA employees; however, these records are not required to be maintained by SBA's NRC license and there is no relevant regulatory violation.
This investigation revealed that three allegations have been substantiated:
(1) SBA pharmacists willfully failed to compound MDP in accordance with the manufacturer's instructions and NRC License Condition 19; (2)'SBA pharmacists willfully failed to perform required alumina breakthrough checks on each generator eluticn and then falsified records to indicate that the checks had been performed, in violation of NRC License Condition 23; and (3) an SBA employee falsified a required daily area survey record, in violation of HRC License Condition 23.
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Case No. 3-88-009 2