DCL-17-059, 10CFR26.719(c) Notification - Testing Error for Two Specimens
| ML17166A534 | |
| Person / Time | |
|---|---|
| Site: | Diablo Canyon  |
| Issue date: | 06/15/2017 |
| From: | Welsch J Pacific Gas & Electric Co |
| To: | Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| DCL-17-059 | |
| Download: ML17166A534 (8) | |
Text
Pacific Gas and Electric Company James M. Welsch Diablo Canyon Power Plant Vice President, Nuclear Generation Mail Code 104/6 P. 0. Box 56 Avila Beach, CA 93424 805.545.3242 Internal: 691.3242 June 15, 2017 Fax: 805.545.4884 PG&E Letter DCL-17-059 U.S. Nuclear Regulatory Commission 10 CFR 26.719(c)
ATTN: Document Control Desk Washington, DC 20555-0001 Docket No. 50-275, OL-DPR-80 Docket No. 50-323, OL-DPR-82 Diablo Canyon Power Plant Units 1 and 2 10 CFR 26.719(c) Notification- Testing Error for Two Specimens
Dear Commissioners and Staff:
In accordance with 10 CFR 26.719(c), "Drug and alcohol testing errors," Pacific Gas
& Electric Company (PG&E) is submitting the enclosed report of an investigation regarding a testing error associated with the Diablo Canyon Power Plant Fitness for Duty (FFD) Program.
On April11, 2017, two specimen test reports were provided by Laboratory Corporation of America (LabCorp) testing facility to the Medical Review Officer Department Staff (MR0-0). LabCorp is a Health and Human Services certified laboratory.
Upon the review of test results by the MR0-0, it was identified that initial specimen validity testing of the two samples (as required by 10 CFR 26.161 (b)) was not completed. LabCorp was notified of this issue. Upon further review of the test results, it was noted the cutoff levels for two of the drugs and drug metabolites (marijuana and opiates) were not at the levels required by 10 CFR 26.163.
The enclosure contains the documented outcome of LabCorp's investigation and corrective action.
If you have any questions regarding the enclosed information or other FFD program activities, please contact Ms. Charlene Miller, Access Authorization/FFD Manager, at 805-545-2672.
A member of the STARS Alliance Callaway
- Diablo Canyon
- Palo Verde
- Wolf Creek
Document Control Desk PG&E Letter DCL-17-059 June 15, 2017 Page2 Sincerely, d:;-;.t=J__
Vice President, Nuclear Generation armb/4743/50915748 Enclosure cc/enc: Kriss M. Kennedy, NRC Region IV Administrator Christopher W.* Newport, NRC Senior Resident Inspector Balwant K. Singal, NRC Project Manager A member of the STARS Alliance Callaway
- Diablo Canyon
- Palo Verde
- Wolf Creek
Enclosure PG&E Letter DCL-17 -059 LabCorp Occupational Testing Services Wrong Profile Used for 0178511705 and 0178456414
LaboratOr)' Corpora tion ol America Holdings PO Bux "12G52 1904 Alexander Drive Research Triangle Park, Norrh Carolina 27709 Telephone: 800-833-3984 May 22, 2017 91 9-572-6900 Ms. Charlene Miller Access/FFD Manager Pacific Gas and Electric Company Diablo Canyon Power Plant P.O. Box 56 Avila Beach, California 93423 RE: Wrong Profile Used for 0178511705 and 0178456414
Dear Ms. Miller:
Specimen ID Numbers 0178511705 and 0178456414 were received by Laboratory Corporation of America Holdings in Research Triangle Park, North Carolina on April 11r 2017. The specimens were tested and reported on April11, 2017. However, on April 12, 2017 and again on April27, 2017, LabCorp was notified by PG&E that specimen validity testing had not been reported on these two samples. A review of data at the laboratory confirmed that the specimen validity testing had not been performed and two of the drugs tested were at the wrong initial test cutoffs.
Our investigation determined that specimen ID Numbers 017851170? and 0178456414 should have been tested using Profile 16 under Order Number 15 for PG&E account 3001. Instead, the data entry operator entered Profile 6 which did not include the specimen validity testing and did not have the correct initial test cutoffs for THC and Opiates. PG&E did notify the key account specialist assigned to your account on April 12r 2017 that the reports for these two specimens were missing some of the required results. Miscommunication between the key account specialist and the customer care editors caused the specimens not to be set up for the additional testing. By the time laboratoty management was notified on
- April 27r 2017, the laboratory was unable to perform the correct testing on these two specimens because they had been discarded in accordance with the Standard Operating Procedure.
Retraining has been conducted with the 9ata entry operator who ordered the wrong profile on these specimens.
In addition, Profile 6 has been made inactive and Profile 16 is currently the only active profile for PG&E Account 3001. Client Profile Maintenance screens are attached that confirm that profile 16 is active ("A") and contains the required assays at the require cutoffs; screens attached also confirm that Profile 6 is inactive ("I") and did not contain the required assays at the required cutoffs.
Retraining is also being conducted with the key account specialist and customer care editor to perform all requested edits in a timely manner to ensure testing can be completed.
We apologize for any inconvenience this incident may cause you . : If we can be of further assistance to you, please do not hesitate to call Phyllis Chandler at 919-572-7512 or Michael Bachmann at 919-224-5293.
- S2Jrely, Y'f/ f<: (}~---U---
Phyllis K. Chandler Responsible Person t1Miitl Michael Bachmann i Responsible Person
PreHs F2 to view drugs .
Client Profile Maintenance for Drug Analysis MAPS TO TEST# 789609 Action R (Add, Retrieve, Change)
Account 3001.- *k Contract Books **
Ot~der 16 Cont f.\CCt Pro*fne (16'*~\
oocc oocc Contr'aot 702 PACIFIC GAS & ELECTRIC P.O. 350 '1097098 Account Class DI Oelivet'ables C~~-..q 00 Y 5 (Status A._\
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Press F~ t o display another Profile; F5 and 'F6 to scroll; FB t o exit .
Client Pr ofile for Drug Analysis t\ocount 00300*1 PACtFIC GAS & ELECTlUC Test Number 789609 Order OOOOi5 Profile @16) Turnaround ? 3 CR BUNDLED Contr*aot Books: Cont oocc 7\CC~ oocc
- -Screen-- --Confirm-~ --Confirm-*
Ot*der DI,Ug Cutoff Cutof-F Test Nbr 8 s Amphetamines 1000 . 00 600,00 :
8 s Gocalne 300.00 150 . 00 ,
s s Harij uana Hotab . 50.00 . 15.00 8 s Opiates 2000.00 2000, 00 I s s PCP 25.00 25.00 0 0 Gr*eatJnine Isomer 6 -Acetyl Mol'phine 0 0 pH ss Nitr:J.te 200.00 2.00.00
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Pn:s~l F2 to v:Lev*I clruus .
Cli.ent PI'o'fHf.l Maintenance for Drug Analysis MAPS TO TESTlj 011615 Action R (Add, RetPieve, Change)
Account 3001 ** Contract Books **
Oi~det' 15 Cont Acot Pr*o'file (:~), oocc oocc Contt~aot 702 PAGIFIC GAS & ELECTRIC P.O. 3500487'1 05 Account Class . DI Deliverables Code A oo 00 Y Status 6I )-
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PiGSS F*l to displD.y 3tlotll<H' Pro*fDe; F5 and F6 to so r-oll; FB l:o 8><it, Client Pr*o"l'ilH *r'ol" Drug Ana1ys:Ls Account 003001 PACIFIC GAS & ELECTRIC Test Number 011615 Order 0 ooo15 PI~ of ile (6-006""') Tu t'nat'OLinCI 2 3 CFl BUNDLED Contract Bool<s: Cont oocc AcCt oocc
--screen-- -*Confirm-- --Confirm--*
Ot,der DI'UG cutoff cutoff Test Nbr s 8 Amplletam.i.nes 1000.00 500.00 8 s Cocaine 300.00 i50.00 s s 11ar'ij u ana Mst ab. 100.00 ; 5' 00 s s Op.i.ates 300.00 300.00 ss PCP 25.00 25.00 Isolllet' 6-Acetyl Morphina
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