ML111590887

Submittal of 10 CFR 26.719(c) Report, Unsatisfactory Laboratory Performance Tests

ML111590887
Person / Time
Site:	Peach Bottom
Issue date:	06/08/2011
From:	Jesse M D Exelon Generation Co, Exelon Nuclear
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
Download: ML111590887 (4)

Text

10 CFR 26.719(c)June 8,2011 U.S.Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Peach Bottom Atomic Power Station, Units 2 and 3 Renewed Facility Operating License Nos.DPR-44 and DPR-56 NRC Docket Nos.50-277 and 50-278

SUBJECT:

10 CFR 26.719(c)Report Unsatisfactory Laboratory Performance Tests Pursuant to 10 CFR 26.719(c),"Drug and alcohol testing errors," Exelon Generation Company, LLC (Exelon), is submitting information for Peach Bottom Atomic Power Station, Units 2 and 3 (PBAPS), concerning unsatisfactory performance in quality control testing during an analytical run.After calibrating two reagents (amphetamine and THC), a laboratory technician ran only the 25 percent below control test and failed to run the 25 percent above control test as required by 10 CFR 26.137(e)(6)(ii).

10 CFR 26.719(c)stipulates in part that licensees shall notify the NRC within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at either a licensee testing facility or an HHS-certified laboratory in the testing of quality control or actual specimens that could adversely reflect on the integrity of the random selection or testing process.Attachment 1 to this letter provides information and details concerning unsatisfactory performance discovered in quality control of testing and the associated corrective actions.There are no regulatory commitments contained within this letter.If you have any questions or require additional information, please contact Frank Mascitelli at 610-765-5512.

Respectfully, Michael D.Jess Director, Licensi egulatory Affairs Exelon Generation Company, LLC Attachment 1: 10 CFR 26.719(c)Report-Summary of Unsatisfactory Laboratory Quality Control Test cc: USNRC Region I, Regional Administrator, w/attachments USNRC Senior Resident Inspector, PBAPS, w/attachments ATTACHMENT 1 10 CFR 26.719(c)Report Summary of Unsatisfactory Laboratory Quality Control Test Peach Bottom Atomic Power Station, Units 2 and 3 Docket Nos.50-277 and 50-278 Attachment 1 10 CFR 26.719(c)Report Summary of Unsatisfactory Laboratory Quality Control Test Page 1 of 2 Introduction 10 CFR 26.137,"Quality assurance and quality control" and Exelon Nuclear procedure SY-AA-102-244,"On-Site Collection Facility Quality Control Program," describe the procedure for the Quality Control Program for on-site urine specimen testing.On April 26, 2011, the Professional On-Site Testing (POST)Supervising Technician was on-site at Peach Bottom performing a scheduled pre-access testing shift.When entering the calibration reports into the binder for the analytical run, it appeared that there was an error in testing from the previous day's analytical run that did not meet the specific requirements of 10 CFR 26.137(e)(6).

An investigation was performed.

The details of this investigation are summarized below.Summary On Tuesday, April 26, 2011, the POST Supervising Technician was onsite at Peach Bottom performing a scheduled pre-access testing shift.When entering the reports into the binder for the analytical run, it appeared there was an error in testing from the previous day's analytical run.Upon researching the issue, it was discovered that the POST Technician (Technician) on-site on April 25, 2011, made errors in testing during the analytical run.The Technician had problems on the morning of April 25, 2011, with the 25 percent below control for amphetamines (Lot#C3, Expiring 4/30/2011) and THC 50 (Lot#C3, Expiring 10/31/2011).

The Technician tried re-running the 25 percent below control several times, without success.The Technician then proceeded to change out both reagents for new lot numbers.The amphetamine (Lot#C7, Expiring 9/30/2011) and THC 50 (Lot#01, Expiring 7/31/2011) were both calibrated.

After calibrating these two reagents, the Technician only ran the 25 percent below control and failed to run the 25 percent above control.Per 10 CFR 26.137(e)(6)(i) and (ii)and Exelon Nuclear procedure SY-AA-1 02-244, the quality control samples for each analytical run must include at least one positive control targeted at 25 percent above the cutoff and at least one positive control targeted at 25 percent below the cutoff.Immediately after finding and verifying the issue, the Exelon Corporate Fitness-for-Duty (FFD)Analyst for the Exelon east sites was contacted.

The POST Supervising Technician also contacted the onsite Technician (on April 25, 2011)to question how and why the issue could have occurred.The Technician stated that they understood that they should have run the control and that they did not really have a response.The Technician understood that they had made a mistake.The Technician stated that they must not have been thinking about it at the time since prior to having to re-calibrate the two drug reagents, they were not having problems with the 25 percent above controls.

Attachment 1 10 CFR 26.719(c)Report Summary of Unsatisfactory Laboratory Quality Control Test Page 2 of 2 As part of the investigation, a second issue was discovered on Wednesday, April 27, 2011.It was discovered that the two reagents, amphetamine and THC 50, that were placed in service by the same Technician on Monday, April 25, 2011, were not labeled per SY-AA-1 02-244.When opening and using a new reagent, the reagent bottles must be labeled with the received date, opened date, expiration date, the lot number, and the initials of the Technician.

The Technician failed to do this with both reagents that were placed into service.Corrective Actions Exelon has entered this identified discrepancy into the Corrective Action Program (CAP)under Issue Report (I R)1208533.Immediate actions taken included: notifying the Technician's immediate supervisor; notifying the on-site Technician on April 25,2011;notifying POST management of the issue;and immediately suspending the Technician's qualifications until further training was completed.

Follow-up actions included: re-collecting samples from the seven individuals who were in-processed on April 25, 2011;requiring the Technicians to forward all calibration paperwork to the POST Supervising Technician for review until decided otherwise in the future.The POST Supervising Technician had been previously performing a quarterly review of all the day-to-day operations of the other Technicians for the Exelon east sites (Limerick, Oyster Creek, Peach Bottom, and Three Mile Island)and the information is documented in an IR each quarter.It is routine for the POST Supervising Technician to review the Technicians' work.No adverse trends in regards to unsatisfactory performance for laboratory quality control tests had been previously identified.