PNP 2013-063, Unsatisfactory Laboratory Testing Report
| ML13263A111 | |
| Person / Time | |
|---|---|
| Site: | Palisades  |
| Issue date: | 09/18/2013 |
| From: | Gustafson O Entergy Nuclear Operations |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| PNP 2013-063 | |
| Download: ML13263A111 (6) | |
Text
Entergy Nuclear Operations, Inc.
Palisades Nuclear Plant
.iTriterv, 27780 Blue Star Memorial Highway Covert, Ml 49043 Tel 2697642000 Otto W. Gustafson Licensing Manager PNP 2013-063 September 18, 2013 10 CFR 26.719(c)
U. S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001
SUBJECT:
Unsatisfactory Laboratory Testing Report Palisades Nuclear Plant Docket 50-255 License No. DPR-20
Dear Sir or Madam:
In accordance with 10 CFR Part 26.719(c), Entergy Nuclear Operations (ENO) is reporting unsatisfactory blind performance confirmatory testing results from Quest Diagnostics, in Lenexa, Kansas, for the ENO Fitness For Duty Program at the Palisades Nuclear Plant (PNP).
An investigation was conducted pertaining to invalid blind performance testing results.
The cause was determined to be chromatographic interference.
Attachment I contains the investigation report by PNP. Attachment 2 contains the investigation reports from Quest Diagnostics. If you have any questions, please contact Brian Rabideau at (269) 764-2575.
This letter contains no new commitments and no revisions to existing commitments.
Sincerely, OWG/bed
Attachment:
- 1. Blind QA Sample Error Investigation Report
- 2. Quest Diagnostics Investigation Reports cc: Administrator, Region Ill, USNRC Project Manager, Palisades, USNRC Resident Inspectors, Palisades, USNRC
ATTACHMENT I BLIND QA SAMPLE ERROR INVESTIGATION REPORT Identification of Error Blind samples were purchased from ElSohly Laboratories (Lot 0-4442) to meet requirements of sample testing for blind specimens. Blind performance samples were sent to Quest Diagnostics in Lenexa, Kansas in June 2013 for testing.
The laboratory, Quest Diagnostics, reported the results of one blind specimen, with accession number I 44323E, as positive for codeine and morphine, however, 6-acetylmorphine (6-AM) results were reported as invalid rather than positive.
Investigation.
Four samples from Lot 0-4442 were sent to Quest Diagnostics during the month of June. Blinds with accession numbers 144060E, 144187E and 166502E were reported as positive for codeine, morphine and 6-AM. The blind with accession number 144323E was reported as positive for codeine, morphine and invalid for gas chromatography mass spectrometry (GC-MS) interference.
Quest Diagnostics reported that accession number 144323E exhibited chromatographic interference on three CC-MS confirmation loads for 6-AM and were unable to obtain acceptable ion-ratios for the specimen on those loads. The laboratorys acceptable ion-ratio criteria on drug confirmations are a 20% range of the ion-ratio established by the calibrator. The specimen was injected under their regular 6-AM CC-MS method and their alternative 6-AM method. Accession number 144323E failed to meet the laboratorys ion-ratio criteria on any of the confirmation loads.
The Palisades Nuclear Plant (PNP) Medical Review Officer requested that the laboratory, Quest Diagnostics, send the specimen to a Health and Human Services (HHS)-certified laboratory, MedTox laboratories, for re-testing. An aliquot of accession number 144323E was sent to MedTox Laboratories on July 5, 2013. MedTox was able to confirm the presence of codeine and morphine but unable to confirm the presence of 6-AM due to insufficient quantity of the remaining specimen.
Cause Based on documentation from Quest Diagnostics, interference can be caused by a number of different factors such as specimen storage and transport conditions, specimen matrix, specimen container contaminations, preservatives used in the preservation of blind samples, etc., which may occur outside the laboratorys control.
Page 1 of 2
ATTACHMENT I BLIND QA SAMPLE ERROR INVESTIGATION REPORT The laboratory has been unable to identify the cause of the GC-MS interference.
However, as the laboratory correctly identified the 6-AM in the other two specimens, the interference appears to be isolated to the one specific blind specimen and it does not appear that there are systematic problems with the laboratorys confirmation procedures for 6-AM. Therefore, it is not feasible for Quest Diagnostics to implement corrective actions to prevent the interference from recurring.
PNP Actions
- 1. Notified Entergy fleet, plants of the discrepancy.
- 2. Notified the Manager, AA/FFD and the Medical RviCw Officer.
- 3. Notified ElSohly Laboratories and Quest Diagnostics Lenexa of the discrepancy and requested an investigation/inquiry.
- 4. No additional actions are anticipated at this time.
Page 2 of 2
ATTACHMENT 2 QUEST DIAGNOSTICS INVESTIGATION REPORTS 2 Pages Follow
Quest Diagnostic July 31, 2013 Dale Plpp, M.D.
728 E 8 Street Suite 2 Holland, Mi 49423 RE: Specimen ID 6468098, 6468101, 6468095, 6468107 Accession No: 144323E, 144060E, 144187E, 166502E
Dear Dr. Plapp,
Per your request, we have completed the investigation into the anaylsis of the above referenced specimens identified by you as blinds. The specimens were received into the laboratory during the month of June, 2013. Specimens with accession numbers I 44060E, 1441 87E and 1 66502E were reported as positive for codeine, morphine and 6-acetylmorphine. The specimen with accession number 1 443 23E was reported as positive for codeine, morphine and Invalid for GCMS Interference.
Accession number 1443 23)3 exhibited chromatographic interference on three GCMS confirmation loads for 6-acetylmorphine. The laboratory was unable to obtain acceptable ion-ratios for the specimen on those loads. The laboratorys acceptable ion-ratio criteria on drug confirmations is a 20% range ofthe ion-ratio established by the calibrator. The specimen was injected under our regular 6-acetylmorphine GCMS method and our alternative 6-acetylmorphine method. Specimen ID 6468098 failed to meet the laboratorys ion-ratio criteria on any of the confirmation loads.
An aliquot of accession number 144323)3 was sent to Medtox for testing on July 5, 2013 at your request.
Please let me know if you need any other information or have questions.
Sincerely, Anne Roberts Lab Manager
Quest Diagnostic August22, 2013 Dale Plr M.D.
728 13 8 Street Suite 2 Holland, MI 49423 RE: Specimen ID 6468098, 6468101, 6468095, 6468107 Accession No: 144323E, 144060E, 144187E, 166502E
Dear Dr. Plapp,
Specimens with accession numbers 14406013, 14418713 and 16650213 were reported as positive for codeine, morphine and 6-acetylmorphine (6-AM). The specimen with accession number 14432313 was reported as positive for codeine, morphine and Invalid for CC/MS Interference.
As mentioned in ourprevious correspondence, accession number 144323E exhibited chromatographic interference on three different CC/MS confirmation batches for 6-AM.
The laboratory has two different (IC/MS confirmation methods for 6-AM a primary method and an alternative method, which is used when a chromatographic interference is exhibited. The specimen (14432313) was injected on both of these (IC/MS testing methods and exhibited the chromatographic interference using both methods..
Interference can be caused by a number of different factors such as specimen storage and transport conditions, specimen matrix, specimen container contaminations, preservatives used in the preservation of blind samples, etc., which may occur outside the laboratorys control.
The laboratory has been unable to identiI the cause of the GC/MS interference.
However, as the laboratory correctly identified the 6-AM in the other two specimens, the interference appears to be isolated to the one specific blind specimen and it does not appear that there is systematic problem with the laboratorys confirmation procedures for 6-AM. Consequently, it is not feasible to implement corrective actions to prevent the interference from recurring with blind specimens submitted by your office.
Sincerely, Anne Roberts Lab Manager Employer Solutions Quest Diagnostics