0CAN091305, Units 1 and 2: Unsatisfactory Blind Quality Assurance Drug Testing Samples
| ML13269A097 | |
| Person / Time | |
|---|---|
| Site: | Arkansas Nuclear  |
| Issue date: | 09/25/2013 |
| From: | Pyle S Entergy Operations |
| To: | Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| 0CAN091305 | |
| Download: ML13269A097 (6) | |
Text
0CAN091305 September 25, 2013 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001
SUBJECT:
Unsatisfactory Blind Quality Assurance Drug Testing Samples Arkansas Nuclear One - Units 1 and 2 Docket Numbers 50-313 and 50-368 License Numbers DPR-51 and NPF-6
Dear Sir or Madam:
On July 30, 2013, Arkansas Nuclear One (ANO) Fitness for Duty (FFD) Staff confirmed inaccurate test results from four blind Quality Assurance drug testing samples that were purchased from Professional Toxicology and sent to the Quest Diagnostics Laboratory in Lenexa, Kansas for analysis.
The ANO FFD Staff completed an investigation pertaining to the blind sample errors on September 05, 2013, and pursuant to the reporting requirements of 10 CFR 26.719(c)(1), the investigation results and corrective actions are documented in the attachment to this letter.
There are no commitments contained in this submittal. Should you have any questions concerning this issue, please contact Robert Jackson, Supervisor, ANO FFD, at 479-858-6875.
Sincerely, Original signed by Stephenie L. Pyle SLP/slc
Attachment:
Arkansas Nuclear One - Blind QA Sample Error Investigation Report Entergy Operations, Inc.
1448 S.R. 333 Russellville, AR 72802 Tel 479-858-4704 Stephenie L. Pyle Manager, Licensing Arkansas Nuclear One 10 CFR 26.719(c)(1)
0CAN091305 Page 2 of 2 cc:
Mr. Steven A. Reynolds Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 NRC Senior Resident Inspector Arkansas Nuclear One P.O. Box 310 London, AR 72847
Attachment to 0CAN091305 Arkansas Nuclear One - Blind QA Sample Error Investigation Report
Attachment to 0CAN091305 Page 1 of 3
Blind QA Sample Error Investigation Report ANO Condition Report CR-ANO-C-2013-02015 Identification of Error:
Thirty Fitness for Duty (FFD) blind Quality Assurance (QA) samples were purchased from Professional Toxicology (Pro Tox) on 7/22/2013. Within this group were samples from Lots 1307THC and 1305DIL. These lots had been certified at Substance Abuse and Mental Health Services Administration (SAMSHA) / Health and Human Services (HHS) certified labs with the following predetermined values:
Lot #1305DIL Samples 2847118 2847127 Creatinine target level of >5, <20; Specific gravity 1.0015. These criteria meet the blind QA sample criteria for a dilute specimen.
Lot #1307THC Samples 2847115 2847117 Marijuana metabolite target 90 ng/ml. All other values in this lot were certified to be within acceptable parameters including creatinine.
These criteria meet the blind QA sample criteria for a positive THC specimen.
All of the above samples were maintained under strict refrigeration and/or were kept frozen until prepared for shipment to the Quest Diagnostics Laboratory in Lenexa, Kansas. When prepared, all samples were warmed to room temperature in manners traditionally used to prepare blind QA samples. Sample numbers 2847115, 2847117, and 2847118 were shipped on 7/24/2013; specimen number 2847127 was shipped on 7/25/2013. Results were received as follows:
Sample #2847115 Results received on 7/26/2013 Positive for marijuana with a quantified value of 66 ng/ml, creatinine value of 16.6 mg/dl Sample #2847117 Results received on 7/26/2013 Positive for marijuana with a quantified value of 66 ng/ml, creatinine value of 16.0 mg/dl Sample #2847118 Results received on 7/25/2013 Normal creatinine value (46.8 mg.dl)
Sample #2847127 Results received on 7/26/2013 Normal creatinine value (42.8 mg/dl)
These results are not consistent with expected results. Samples 2847115 and 2847117 should have reported positive for THC with normal creatinine values. Instead, the creatinine values were low. Samples 2847118 and 28447127 should have reported creatinine and specific gravity results consistent with dilute samples. Instead, they both reported with normal creatinine values. It should be noted that when creatinine values are normal, specific gravity is not checked by the laboratory.
Attachment to 0CAN091305 Page 2 of 3 Investigation:
Upon receipt of these results, the following actions were initiated:
- 1. Professional Toxicology was notified and asked to initiate an investigation into the cause of the incorrect results. When notified, the Pro Tox scientist, Dr. Stanley Kammerer, indicated that he had made a mathematical error when adjusting the creatinine level on Lot #1305DIL by misplacing the decimal, and consequently added 10X the anticipated quantity of creatinine. This error caused specimens from this lot to have normal creatinine levels instead of low creatinine levels consistent with dilute samples. When asked specifically about the abnormally low creatinine levels associate with Lot #1307DIL, he offered no plausible explanation. He indicated that all remaining volumes from the two lots had been discarded immediately upon notification of the erroneous results. In addition, Pro Tox was asked to provide replacement specimens from newly prepared lots for dilute and positive THC samples.
- 2. Quest Diagnostics was contacted and asked to retests all specimens in an effort to validate the results. Upon retest, all retest results were significantly similar to the original tests with one exception; creatinine levels from samples 2847115 and 2847117, both from Lot #1307THC, decreased from 16.6 -> 11.5, and 16.0 -> 10.9 respectively.
- 3. Entergy fleet plants were notified of the Lot numbers of the specimens in question.
While other fleet plants had obtained samples from these lots, only Waterford had processed these samples. Two samples from Lot #1305DIL had been processed at the Quest Diagnostics laboratory in Lenexa, Kansas, and both produced results consistent with the pre-determined, certified values. Waterford 3 sample numbers 8235756 and 8235758 were both reported with creatinine values of 12.3 mg/dl and 12.2 mg/dl respectively, and both with a specific gravity value of 1.0016.
- 4. The Medical Review Officer was informed of the error.
Samples provided by Pro Tox to replace the four in question were also submitted to the Quest Diagnostics laboratory in Lenexa, Kansas. The two samples processed as dilute were reported correctly. Two of four additional samples processed as positive THC return positive for THC but with low creatinine results. Dr. Kammerer was advised of this finding.
No explanation was provided.
==
Conclusion:==
Lot #1305DIL - Dilute Samples Based on the above findings, the error involving Lot #1305DIL occurred when a mathematical miscalculation caused 10X the requisite amount of creatinine to be added to batch of urine. This resulted in a normal creatinine level instead of a low creatinine level.
Attachment to 0CAN091305 Page 3 of 3 Lot #1307THC - Positive THC, Normal Creatinine The error involving samples from Lot #1307THC is unexplained at this time. The results were verified by Quest Diagnostics. No explanation was provided by Pro Tox for the sample results from this lot, or from the 2 samples from newly prepared Lot #1308THC which also provided low creatinine levels.
Corrective Actions:
Entergy Fleet plants were notified of the discrepancy.
The condition was entered into the Entergy Corrective Action Process.
An investigation for the cause of the sample errors was conducted.
ANO FFD requested and received a formal written response from the Professional Toxicology staff regarding the sample errors, as documented in this attachment.
Report Prepared by Jerry D. Woods, ANO FFD, Phone 479-858-7846.