ML053250333
| ML053250333 | |
| Person / Time | |
|---|---|
| Site: | Arkansas Nuclear  |
| Issue date: | 11/07/2005 |
| From: | James D Entergy Operations |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| OCAN110501 | |
| Download: ML053250333 (5) | |
Text
Entergy Operations, Inc.
Ln7Z C T 1448ES.R. 333 l )
Russellville, AR 72802 Tel 501 858 5000 OCAN110501 November 7! 2005 t.S. Nu:1earRegulatory'Commission.,,
Attn: 'Docurnent C6ntrol Desk.
Washington, DC 20555-0601
Subject:
Drug Testing Laborato.ry Performnance' Report Arkanisas.uiar Onre - Units' 'and 2
'~~D "'Dcket;N~o-s.50-313,-and.50-3~68; License Nos. DPR-51 and NPF-6
Dear Sir or Madam:
As part of the routine blind performance drug testing program, Arkansas Nuclear One (ANO) sent two blind samples with an HHS certified concentration of PCP to Northwest Toxicology/Lab One along with other certified samples on August 30, 2005. On August 31, 2005, Northwest Toxicology/Lab One reported to ANO that all samples of the subject lot tested negative. Upon receipt of this information, ANO began an investigation of the incident.
On September 6, 2005, Northwest/Toxicolog'y.Lab One was notified of the discrepancy and was requested to'conduct an'investigation into the cause of the error. The laboratory reported that the sampled were retested and were 'found to contain 23 ng/ml of PCP, below the 6utoff level of 25 ng/l. Theirefore, these specimens were not reported as positive.
During the investigation of the incident, the supplier of the certified samples reported that another of their clients had experienced similar problems with samples from the same lot number as ANO's problemsamples. 'Subsequently, the supplier had samples from the suspect lot retested by an independent lab with satisfactory results.
The supplier noted that at the time the subject samples were shipped to ANO and the other client that experienced problems, extremely hot temperatures existed in the mid-west. The supplier concluded that these high temperatures were the likely cause of the sample degradation.
OCAN1 10501 Page 2 of 2 In accordance with paragraph 2.8(e)(4) of Appendix 'A' to 10CFR26, enclosed is the investigation report provided to ANO by Northwest Toxicology/Lab One concerning the unsatisfactory performance test result.
There are no commitments contained in this submittal.
SPY.
nale E. Ja es
/Manager, icensing DEJ/rhs cc:
Dr. Bruce S. Mallett
-'Regional Administrator U. S. Nuclear Regulatory Commission Region IV 611 Ryan Plaza Drive, Suite 400 Arlington, TX 76011-8064 NRC Senior Resident Inspector Arkansas Nuclear One P.O. Box 310 London, AR 72847 U. S. Nuclear Regulatory Commission Attn: Mr. Drew Holland Mail Stop 0-7 D1 Washington, DC 20555-0001
Attachment to OCAN 10501 Vendor Quality Assurance Report
Z,
I'--
This is a confidential report for improvement of laboratory procedures. il it'not part of the record of testingfor any specimen and not to he used in litigation QUALITY ASSURANCE REPORT Client:
Entergy/ENTOIOOC ANO
Subject:
Blind QC Failure Specimen ID #s:
Lab Accession#s:
E104145251E10414531 4255027/4255061 BACKGROUND:
Northwest Toxicology/labOne was notified by Steve Kaufmann of Entergy on 9/06/05 that the specimens identified above were submitted as a blind quality control samples and the reported negative results wvcre not consistent with the expected results. These specimens were knnown to contain PCP at a target concentration of 39 ng/ml,.
The details of the issue were forwarded to Laurie Tobler, Director of Quality Improvement for investigation and follow-up documentation.
INVESTIGATION:
Determining cause of the error:
- 1. Specimens E10414525(LAN4255027) and E10414531(LAN4255061) were received at the laboratory on 8/31/05. These specimens were analyzed by immunoassay (KIMS) and found to be negative. These results werc certified and reported on 9/01/05.
- 2. On 9/13/05, the Laboratory was requested to perform an LOD PCP confirmation by GCMS on these specimens in order to determine the concentration of PCP in them. On 9/20/05, both specimens were found to contain 23 ng/ml, of PCP by GC/MS.
DISCUSSION/
SUMMARY
OF FINDINGS:
We have concluded that the discrepancy between the reported and expected results were due to an insufficient concentration of PCP submitted in the blind quality control specimens identified above. The initial test cutoff for PCP is 25 nglmL; therefore, specimens that contain 23 ng/ml, would not be identified/reported as positive.
Prepared bv:
lr ic Tobl Erector of Quality Improvement Date:
q-Stb 27, 20 September 2 7, 2005 I
ihist s a conjidential rep)rtfor improvement of laboratory procedures.
Is noi lxr: of Ste record of testing for any specimen and not to be use in Ir4zattio.
ENTERGY/ANO Page2of2 Blind QC Failure Reviewed' by:
David J. Kunt 4
Laboratory Director Date:
October/25, 2065 cc:
Raffie S. Bczdjian, Director of Operations David J. Kuntz, Ph.D., Laboratory Director Todd Bjorklund, Client Service Manager