ML23047A447

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Submittal of 30 Day Report Per 10 CFR 26.719(c) Blind Performance Testing
ML23047A447
Person / Time
Site: Grand Gulf Entergy icon.png
Issue date: 02/16/2023
From: Hardy J
Entergy Operations
To:
Office of Nuclear Security and Incident Response, Document Control Desk
References
GNRO2023-00004
Download: ML23047A447 (1)


Text

entergy Entergy Operations, Inc.

P.O. Box 756 Port Gibson, Mississippi 39150 Jeffery A. Hardy Manager Regulatory Assurance Grand Gulf Nuclear Station Tel: 802-380-5124 10 CFR 26.719(c)

GNRO2023-00004 February 16, 2023 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001

SUBJECT:

Unsatisfactory Laboratory Testing Report Grand Gulf Nuclear Station, Unit 1 Docket No. 50-416 Renewed License No. NPF-29 In accordance with 10 CFR 26.719(c), Grand Gulf Nuclear Station, Unit 1 (Grand Gulf) is reporting unsatisfactory blind performance testing results from Quest Diagnostics, for the Grand Gulf Fitness for Duty Program (FFD).

An investigation was conducted pertaining to invalid blind performance testing results. The cause was determined to be chromatographic interference. contains the investigation report by Grand Gulf. Attachments 2 & 3 contain the investigation report and follow-up investigation report from Quest Diagnostics. Attachment 4 contains correspondence from EISohly Laboratories indicating the action taken to resolve the interference.

This letter contains no new Regulatory Commitments. Should you have any questions concerning the content of this letter, please contact me at 802-380-5124.

SincerOL ~ -

JAH/trj

Attachment:

1. Blind Sample Investigation Report
2. Quest Diagnostics Investigation Report
3. Quest Diagnostics Investigation Follow-up Report
4. Email from EISohly Laboratories, Incorporated (ELI)

G N RO2023-00004 Page 2 of 2 cc: NRC Senior Resident Inspector Grand Gulf Nuclear Station Port Gibson, MS 39150 U.S Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001

G NRO2023-00004 Page 1 of 2 Attachment 1 Blind Sample Error Investigation Report Identification of Error Blind Specimen Identification Number (ID) 3590783 was purchased from EISohly Laboratories to meet requirements of sample testing for blind specimens. Blind performance samples were sent to Quest Diagnostics in Lenexa, Kansas in October 2021 for testing.

The laboratory, Quest Diagnostics, reported the results of one blind specimen, with accession number 815859D, as positive for codeine, morphine and invalid: Gas Chromatography-Mass Spectrometry (GC/MS) interference.

Investigation Specimen 3590783 was submitted to Quest Diagnostics on 10/14/2021 with predetermined value and positive for Opiates. Results were returned from Quest Diagnostics on 10/19/2021.

Investigation report was received from Quest Diagnostics on January 30, 2021.

The specimen reported as positive for Opiates as expected, but the 6-Acetylmorphine returned as Invalid results: GC/MS Interference.

Quest Diagnostics reported the specimen exhibited chromatographic interference on two different GC/MS confirmation procedures for 6-acetylmorphine (6-AM). The laboratory was unable to obtain acceptable ion-ratios for the specimen in both confirmation batches.

The specimen was analyzed using both their routine and alternative methods for 6-AM. The specimen was analyzed on both methods twice and failed to meet the ion-ratio criteria within plus or minus 20%.

The specimen was purchased from EISohly laborites. The specimen was received and immediately placed in refrigeration upon receipt. Preparation and shipment for this specimen was consistent with conventional preparation and shipment practices.

Follow-up report from Quest Diagnostics dated January 3, 2023, states that from November 2021 to November 2022 there was a total of 6 specimens that were reported as invalid, but none of them were invalid for 6-AM.

Email from EISohly Laboratories dated February 2, 2023, states that the issue was resolved by using a different blank urine matrix.

Cause Quest Diagnostics has been unable to identify the cause of the GC/MS interference. The interference exhibited by this blind is a known issue. The laboratory has been working with EISohly Laboratories to rectify the problem. Email from EISohly Laboratories dated February 2, 2023, states that the issue was resolved by using a different blank urine matrix.

GN RO2023-00004 Page 2 of 2 GGNS Actions

1. Notified Entergy Fleet Plants of the discrepancy
2. Notified the Manager, AA/FFD and the Medical Review Officer
3. Notified EISohly Laboratories and Quest Diagnostics - Lenexa of the discrepancy and requested an investigation/inquiry
4. No additional actions are required at this time.

GNRO2023-00004 Page 1 of 1 Attachment 2 Quest Diagnostics Investigation Report St@ven P. Cllamblfss, Supel"Yisor M/FFD/Medical Grand Gulf Nudear Statton RE: Spedi'Oi!!!n ID: 3590783 Aceiession No. 815859D

Dear Mr. Chamblfss:

Thhi letter Is In response to a communication rec~wd from your offrce on October 28, 2021, re,ardlrc the reporting of the abo\lll! rofetll!Oced specimen.

Peryoor request, we haw completed th@ tnveStigation fnto the analysis of the above rofll!'r<<ia!!cl specimen rdentified by you as a blind specfmen. The specimen w.is received at the laboratory October l, 2021, and reported as positive for codeiM, morphine and Invalid: GCMS lnterferenc@ on October 14, 2021.

The specimen exhibited chrom3'tographlc lnt<<ference on two different 11:S chromatogniiphy-mass spectrometry (GC-MS} confirmation procedurEis for 6-acetylmorphine (6-AM}. The laboratory was unable to obtafn ac:ceptable ion-ratios for the Sf:)eclmert In both ci:mfirmation batches.

The specimen w.u analyzed US!Tl@ both our routine and altttrnatlve methods for 6-acetylmorplllne. An alternative methQ<f is utiUzed In Instances wile<<! a sample exhibits chromatographic ioterference on the prim.;iry, routme method. Th,ls specfmen was analvzed on both m~(lds twice and failed to meet the laboratory's ideritification aiter"8 flon*ratlo within +/-20%} on both methods. On the first analysfs usr111 the rm.1tine and altemat:Tve methods1 the specimen guantmed at 18 nlfm L and 19 ng/ml., respectf\lely, with unacceptable ion-ratios. In an attempt to n!!solve the issue, the speeimen was n!ip@ated on diJYtlon on both methods. The quantitrnw rMults for thil!! diluted specimen using thie routine and il'ltem1tiw methods were 23 ng/ml and 24 ng{m l, Nspectively, with un,a,cceptaible ion ratios on both analyses. Since all quantitative testfoS of this spedm@n failed to ml!et identific:atkm crit@ria the sample was reported ai Indicated above Th4'? tnterfenmc:e ediibited by thb blrnd Is a known issue. The laborDtonJ Is working with EISohly Laboratories to r@ctffy the problem and h,ope to have It rMolwd In the near future, Ple3:Se a.II me at 91:3-577*1512 if you need any other Information or have questions, Shane Responsible Person / Lab Marnager

GNRO2023-00004 Page 1 of 1 Attachment 3 Quest Diagnostics Investigation Follow-up Report Quest Diagnostics"'

January 3, 2023 Steven P. Chambliss, Supervisor AA/FFD/Medical Grand Gutt Nuclear Station RE: Follow-up to Specimen ID: 3590783 Accession No: 815859D

Dear Mr. Chambliss:

This letter is a follow-up to a communication we sent to your office on December 9, 2021, regarding the reporting of the above referenced specimen and our corrective action.

In the original communication, the laboratory stated that the interference on the 6-acetylmorphine (6-AM) blind was a known issue and that the laboratory was working with EISohly Laboratories, manufacturer of the blind, to rectify the problem. The laboratory is not able to provide any details into what EISohly Laboratories did to resolve the issue. However, we did review your account to look for specimens that reported as Invalid from November 2021 through the end of November 2022. There was a total of 6 specimens that reported as Invalid, but none of them were Invalid for 6-AM. This leads the laboratory to believe that EISohly Laboratories has rectified the problem as seen with specimen ID 3590783.

Please call me at 913-577-1632 if you need any other information or have questions.

Sincerely, n~~

Dawn Hahn Laboratory Operation Director/Responsible Person

G N RO2023-00004 Page 1 of 1 Attachment 4 Email from EISohly laboratories, Incorporated (EU)

From: Denise Forsyth <dforsyth@elsohly.com>

Sent: Thursday, February 2, 2023 4:49 PM To: Ezell, Dennis <DEZELL@entergy.com>

Cc: Chambliss, Steven P <schamb4@entergy.com>

Subject:

RE: BLIND REPORT Hi Dennis, I did speak with our lab manager, Tim Murphy. He said the issue was resolved by using a different blank urine matrix.

Denise Forsyth Office Manager EISohly laboratories, Incorporated (Ell) 5 Industrial Park Drive Oxford, MS 38655 Phone: (662) 236-2609 Fax: (662) 234-0253 www.elsohly.com