DCL-09-063, Submittal of Report of an Investigation Into Unsatisfactory Performance Test Results Associated with Diablo Canyon Fitness for Duty Program
| ML092530258 | |
| Person / Time | |
|---|---|
| Site: | Diablo Canyon  |
| Issue date: | 09/02/2009 |
| From: | Becker J Pacific Gas & Electric Co |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| DCL-09-063 | |
| Download: ML092530258 (9) | |
Text
PacificGas and Electric Company James R.Becker Diablo Canyon Power Plant Site Vice President Mail Code 104/5/601 P.0. Box 56 Avila Beach, CA 93424 September 2, 2009 805.545.3462 Internal: 691.3462 Fax: 805.545.6445 PG&E Letter DCL-09-063 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555-0001 Docket No. 50-275, OL-DPR-80 Docket No. 50-323, OL-DPR-82 Diablo Canyon Units 1 and 2 10 CFR 26.719(c) Notification
Dear Commissioners and Staff:
Pursuant to 10 CFR 26.719, "Reporting requirements," part (c), "Drug and alcohol testing errors," Pacific Gas and Electric Company (PG&E) is submitting the following report of an investigation into unsatisfactory performance test results associated with the Diablo Canyon Power Plant (DCPP) Fitness For Duty (FFD) Program.
On July 28, 2009, an unsatisfactory performance discovered in testing of a blind performance sample processed at Health and Human Services (HHS) certified, laboratory, Quest Diagnostics (QD) testing facility, was reported to the DCPP FFD Program Supervisor. A dilute urine specimen spiked with THC prepared by a contracted blind performance provider was reported by QD as "negative dilute," and the specimen should have been reported as "positive dilute for THC." QD was advised of the performance specimen results and the potential performance error.
The laboratory has reviewed its records, and Enclosure 1, dated August 6, 2009, documents the outcome of QD's investigation.
On July 28, 2009, an unsatisfactory performance discovered in testing of a blind performance sample processed at HHS certified laboratory, Laboratory Corporation of America (LabCorp) testing facility, was reported to the DCPP FFD Program Supervisor. A dilute urine specimen spiked with THC prepared by a contracted blind performance provider was reported by LabCorp as "negative dilute," and the specimen should have been reported as "positive dilute for THC." LabCorp was advised of the performance specimen results and the potential performance error. The laboratory has reviewed its records, and Enclosure 2, dated August 25, 2009, documents the outcome of LabCorp's investigation. The Medical Review Officer (MRO) service provider, Concentra Medical Centers, also investigated the potential performance error. The MRO service provider has completed its review and Enclosure 3, dated August 14, 2009, documents the outcome of the Concentra Medical Centers investigation.
A member of the STARS (Strategic Teaming and Resource Sharing) Alliance Callaway
- Comanche Peak
- Diablo Canyon ° Palo Verde
- San Onofre ° South Texas Project
- Wolf Creek
Document Control Desk PG&E Letter DCL-09-063 September 2, 2009 Page 2 PG&E makes no regulatory commitments under this submittal.
If you have any questions regarding the information enclosed or other FFD Program activities, please contact William F. Ryan, Access/FFD Supervisor, at (805) 545-3329.
Sincer ly, James R. Becker Site Vice President swh2/50259703/50259704 Enclosures cc/enc: Elmo E. Collins, NRC Region IV Michael S. Peck, NRC Senior Resident Inspector Alan B. Wang, NRC Project Manager A member of the STARS (Strategic Teaming and Resource Sharing) Alliance Callaway . Comanche Peak ° Diabto Canyon
- Palo Verde
- San Onofre
- South Texas Project
- Wolf Creek
Enclosure 1 PG&E Letter DCL-09-063 Quest Diagnostics Report Dated August 6, 2009
Quest Dagnosffcs Aigiut,6, 2009 William F. Ryan.
Pacific Gas and Electric Company Diablo Canyon Powrer Plant Avila Beach, CA ý93424
Dear MrRyan.:
This -letter is in regard to QuestDiagnpostics' investigation of dilute specimen 9189884, which was not r'eflexed to LOD testing as called forby .Contract3500758742, Change Orer#5, section 1:4. This minvesýtigation was conducted'du tooriqiyo July30 2009. In response to your questiofis,we have determined hfollowing:
1, Are there otherspecimens that were reported as dilute and di not haV'e LOD testing since March j1,6049 There was one saple: 985 107F 9183 877 LSAC 5/30/2009.ILaborator Operati6ns Director Brian: Bruneliireviewed the,data for tat sampe and e has, h indicated that-it would not have gone on to LOD testing, since the'i* *unoassy*
results showed no activity for the presence of*ugat 50/% ofthe cutoff.
.2. hy w.as PG&E's acciount.not updated to-matc h the revised contrc~taInguage?
This was unfortunately due to.human error.- did not ideti the change-top flagit, nor did thedatabase.group when te contract Ihange orqer was submittedthe. ThePG&E account needed to be updated -specificaýllyso'thadt-t~hi~stesting woud take placewhen' requiredn adttwAsot done&.
3.6Can the dilutetLOD testing be addcd tiithePG&EaMcount?
This oas 08/0/200 dne andso w lleffective ,for all, sam#ples tete from 068/05/20.09 ýforwards.
- 4. Can someone at the lab review the .contratt Iaigagel to assure all lements are.
being compliedwith.
this hasubeen don.e War nowi nompliane. with all. aspects0o the contract-th.. Was the only. issue.thaitwas out of compliance.
'5. Can you provide a summary.report identifyisg the cause for the incorrect account information andiwhat measures the lab will take r hae taken topfrevent such occurrences in :the future?
ourplan of i*acdn is to have aniy c6ntrhat c. n submitted to the Laboratoir Operations Director (Brian Brunelli) for compliance review, as well as to the normal channelS (myself and the databaise girop).
We regret this error and-believe that the steps' we have kn wilprevent thýs or simlar err fro" happen g in the future.
Please let me know if you have any questions.
Sincerely, Natiptdfk Set'ciail'is Quest Diagnostic, 6ntroated
- i801-208-9357 ... ..
.toddlx~ibjorklund~questdiagnostics~com.
Enclosure 2 PG&E Letter DCL-09-063 Laboratory Corporation of America Report Dated August 25, 2009
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Laboratory Corporation of America Holdings P0 Box 12652 i 1904 Alexander Drive Research Triangle Park, North Carolina 27709 Telephone: 800-833-3984 919-572-6900 William Ryan August 25, 2009 Pacific Gas and Electric Company Diablo Canyon Power Plant PO Box 56 Avila Beach, California 93424
Dear Mr. Ryan,
Specimen ID Number 153263009 was reported to PG&E as a negative-dilute sample with LCD testing to follow for THC. Bottle A had leaked in transit and Bottle B had been used for the initial testing. During the initial testing, this specimen was found to be dilute with borderline activity for THC, indicating the need to perform LCD testing for THC.
This specimen was scheduled for additional testing for THC metabolite under Laboratory Accession number 294979005 and placed in the lab's inhouse account. Bottle A was pulled for the confirmation testing and was found to contain insufficient quantity of urine. Bottle B should have been pulled at the same time and used for the confirmation testing. The internal paperwork did not indicate that there was a Bottle B and it did not get pulled with the Bottle A. Consequently, Bottle B was inadvertently discarded. LaD testing was cancelled under laboratory accession number 294979005.
The certifying scientists have been instructed to report out the negative-dilute on the COF with a comment attached indicating that LOD testing either is in progress or is not necessary. Results for the LCD testing are communicated to the MRO on a typed report in order to comply with 26.163(a)(2)(iii) and to "report the numerical values obtained from this special analysis to the MRO".
The laboratory identified areas for improvement during this investigation. The internal paperwork that directs additional testing has been modified to indicate whether or not a split collection was performed. This will ensure that both bottles are retained when additional testing is required. The laboratory will also add a notification process that will allow the lab to track them more closely.
The laboratory did review fourteen more negative-dilute samples received after March 31, 2009.
One additional sample (0153264809) was identified that required LOD testing but was inadvertently discarded prior-to the LOD testing being done. This sample was properly reported out with the "LOD testing to follow" comment but the manual notification process for adding the additional LCD testing did not occur. The automatic notification process to be implemented August 30, 2009 will prevent future errors of this kind.
If we can be of further assistance to you, please do not hesitate to call Phyllis Chandler at 1-800-341-1150 X3254 or Dr. Randy Lynn at X3690.
Sincerely, Palllis K. Chandler Wil R. Lynn, Ph.D.
Responsible Person La irecto
Enclosure 3 PG&E Letter DCL-09-063 Concentra Medical Centers Report dated August 14, 2009
p 01 09 07:28a PG&E Utility User 805-545-3864 p,1 AUG-31-2009 11:22 EUSINESS HEALTH MGT 603 929 0?32 P.02 August 14, 2009 .,;
William Ryan Pacific Gas & Electric/Diablo Canyon PO Box 56, Trailer 163 Avila Beach, CA 93424
Dear Mr. Ryan:
RE: BLIND SAMPLE- ID#0153263009-DATED 711512009 Why Error Occurred:
There were two blind samples collected on 7(15109. One of the samples was sent to Quest the other to LabCorp On the sample that was sent to LabCorp, sample ID# 0153263009, the MRO Assistant received a hard copy fax result on 7116)09 with the following comment; (LOD testing in progressresults to follow - dilute). She did not process this result at this time where the faxed report included the comment -testing in progress results to follow. She waited until a final result and the certified scientific copy came across the system. This test result was downloaded by LabCorp as a Negative Dilute sample. It also matched the certified scientific copy sent by the Laboratory. Her understanding is that once the certified scientific copy is sent and the result downloaded it represents a final result. She did not receive any further communication from the Laboratory stating that the further testing did not take place because of leakage in transit and not enough sample to test, until notified by DCPP.
Corrective Action:
To amend Report For Blind Sample Test-On August 11. Teresia Ebron from LabCorp sent an e-mail requesting advise on whether the negative-dilute report should be amended to "Cancelled" from the MRO to correct this sample, the MRO Assistant will notify the Laboratory to send an amended hard copy with 'Cancelled" result, a download for this result, and a certirfied scientific copy.
Correctfve Action for MRO Assistant-The MRO Assistant, in the future will check all comments on the taxed hard copy of the Laboratory result. She will check to see if the Laboratory transmits a preliminary result. If this copy states the testing is incomplete or testing in progress, she will check with the Laboratory to ensure that no preliminary result will be reported out before receiving the final result. This will not be reported out unless hard copy results say final result. The dates of the downloaded results as well as the certifying scientist copy all must match the final copy result.
t'a n6IsBut~au Concentra Medical Compliance Administration Medical Review Office (603) 929-1648 (603) 9294398 T .02 TOTPL. P. 02