ML040150618
| ML040150618 | |
| Person / Time | |
|---|---|
| Site: | Harris, Brunswick, Crystal River, Robinson  |
| Issue date: | 01/08/2004 |
| From: | Holt J Progress Energy Carolinas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| PE&RAS-04-001 | |
| Download: ML040150618 (5) | |
Text
to1 Prores Energy10 CFR 26, Appendix A, Subpart B, 2.8(e)(4)
"I Progress Energy PO Box 1551 411 Fayetteville Street Mall Ralegh NC 27602 Serial: PE&RAS-04-001 January 8, 2004 United States Nuclear Regulatory Commission ATTENTION: Document Control Desk Washington, DC 20555 BRUNSWICK STEAM ELECTRIC PLANT, UNIT NOS. 1 AND 2 DOCKET NOS. 50-325 AND 50-324 / LICENSE NOS. DPR-71 AND DPR-62 SHEARON HARRIS NUCLEAR POWER PLANT, UNIT NO. 1 DOCKET NO. 50400 / LICENSE NO. NPF-63 H. B. ROBINSON STEAM ELECTRIC PLANT, UNIT NO. 2 DOCKET NO. 50-261 / LICENSE NO. DPR-23 CRYSTAL RIVER UNIT 3 NUCLEAR GENERATING PLANT DOCKET NO. 50-302 / LICENSE NO. DPR-72 10 CFR 26 UNSATISFACTORY FITNESS-FOR-DUTY BLIND PERFORMANCE TESTING INCIDENT Ladies and Gentlemen:
Pursuant to 10 CFR 26, Appendix A, Subpart B, Section 2.8 (e)(4), Progress Energy Carolinas, Inc.
(PEC) and Progress Energy Florida, Inc. (PEF) submit the attached investigation report on an unsatisfactory blind performance testing incident. This incident involved a failure to reconfirm by the secondary laboratory. The PEC and PEF investigation of the incident was concluded on December 9, 2003. As documented in the attached signed letter dated December 16, 2003, the investigation report, including investigative findings and corrective actions, has been reviewed by the Director, Forensic Toxicology, who is the person responsible for the day-to-day management and operation of the Department of Health and Human Service (HHS) certified laboratory.
This document contains no new regulatory commitment.
Please contact me at (919) 546-6901 if you need additional information.
Sincerely, 0.
James W. Holt Manager - Performance Evaluation & Regulatory Affairs HAS A/OS Attachments
United States Nuclear Regulatory Commission PE&RAS-03-065 Page 2 C:
L. A. Reyes, USNRC Regional Administrator - Region II USNRC Resident Inspector - BSEP, Unit Nos. I and 2 USNRC Resident Inspector - CR3 USNRC Resident Inspector - SHNPP, Unit No. 1 USNRC Resident Inspector - HBRSEP, Unit No. 2 B. L. Mozafari, NRR Project Manager - BSEP, Unit Nos. I and 2; CR3 C. P. Patel, NRR Project Manager - SHNPP, Unit No. 1; HBRSEP, Unit No. 2 J. A. Sanford - North Carolina Utilities Commission
United States Nuclear Regulatory Commission
-pE&RAS-04-001 Page 3 ATTACHMENT 1 Investigation Report Action Request Number:
00108995
- 1. Event Description The secondary laboratory reported results for one blind specimen inconsistent with the primary lab. Quest Diagnostics, the secondary lab failed to confirm a positive quality control sample.
Progress Energy's Medical Review Officer was contacted and requested both the primary and secondary laboratories to reanalyze the specimen.
- 2. Problem Description / Investigation Summary Code of Regulations 10 Part 26, Appendix A, 2.8(e) requires licensee blind performance test procedures to be conducted at a quarterly rate of 10% of all samples submitted to the lab with an 80:20 negative/positive ratio as a quality assurance control. Progress Energy purchases control specimens from an HHS certified laboratory (El Sohly) and submits them to Laboratory Corporation of America (LabCorp). LabCorp's specimen results are compared with the known blind sample. A minimum of 10% of the blind samples submitted to the primary laboratory are forwarded to Progress Energy's secondary laboratory, Quest Diagnostics, for split sample testing.
Quest Diagnostics reported one blind specimen with results inconsistent with the blind supplier and primary lab.
Specimen Number El Sohlv Lab Corp Report Quest Diagnostics Report 0157362278 THC 97.2 ng/ml THC 89 ng/ml Failed to Reconfirm Progress Energy's Medical Review Officer was notified immediately and requested both the primary and secondary lab to reanalyze the sample. Upon notification of the discrepancy, Dr. Edward A'Zary, Quest Diagnostics' Director of Forensic Toxicology determined an error had occurred on the part of Quest Diagnostics and initiated an investigation to determine the cause.
LabCorp's reanalysis confirmed their initial results.
Time Line of Events:
10/15/03 Blind specimen 0157362278 submitted to LabCorp.
10/16/03 Specimen 0157362278 received by LabCorp.
10/17/03 LabCorp reported positive THC results for specimen 0157362278.
10/17/03 Level Of Detection (LOD) request submitted to LabCorp for specimen 0157362278.
10119103 LabCorp reported LOD for specimen 0157362278 positive for THC.
10/23/03 Progress Energy's Medical Review Officer requested LabCorp to send Bottle B of specimen 0157362278 to Quest Diagnostics for split sample testing.
,0/24103 Quest Diagnostics received specimen number 0157362278.
10/28/03 Quest Diagnostics reported results for specimen number 0157362278 as "Failed to Reconfirm".
Progress Energy's Medical Review Officer requested both the primary and secondary lab to reanalyze the specimen.
Dr. Edward A'Zary notified Progress Energy that they should disregard the results reported for the specimen due to a processing error at Quest Diagnostics and a statement describing events would be forthcoming.
10/29/03 NRC notified via telephone courtesy call of the event.
United States Nuclear Regulatory Commission PE&RAS-04-001 Page 4 ATTACHMENT Investigation Report 10/30/03 Quest Diagnostics reported results for specimen number 0157362278 positive forTHC at 98 ng/ml.
10/31/03 LabCorp reported results of reanalyzed sample positive forTHC at a level of 80 ng/ml.
11/25/03 Quest Diagnostics' complete investigative response submitted to Progress Energy.
Quest Diagnostics' internal investigation found processing errors involving two split samples.
However, only one of these results was released so this condition report focuses on the sample which reported incorrectly. On October 24, 2003. Quest Diagnostics received two specimens from LabCorp for split sample testing. During the accessioning process these two bottles were switched and therefore were not analyzed for the requested drug. In addition, after completion of the drug analysis, the certifying scientist failed to comply wth Quest Diagnostics' Standard Operating Procedure (SOP) instructing the certifying scientist to notify the Responsible Person for each "Failed to Reconfirm".
- 3. Inappropriate Acts / Equipment Failures Quest Diagnostics, the secondary laboratory switched specimen bottles which had been submitted for split sample testing. As a result, a positive specimen was reported as Fail to Reconfirm".
Quest Diagnostics' certifying scientist failed to follow the laboratory's procedure for specimens which failed to reconfirm.
- 4. Apparent Causal Factor associated with each Inappropriate Act / Equipment Failure Q2 External Entities, Vendor/Supplier
- 5. Corrective Action Plan Apparent Causal Factor #
Planned I Completed Action (Annotate committed Assignments as Committed)
Assignment Type Assignee /
Concurred By Initial Due Date 1
Reanalysis of specimen by LabCorp CORR LabCorp Complete 2
Reanalysis of specimen by Quest Diagnostics CORR Quest Diagnostics Complete 3
Intemal investigation by Quest Diagnostics CORR Quest Diagnostics Complete 4
Retraining of processor who switched the CORR Quest Diagnostics Complete specimen bottles and Chain Of Custody (COC) forms 5
Change Quest Diagnostics' procedure to CORR Quest Diagnostics Complete require the certifying scientist to compare and verify the bottle's specimen number with the COC number prior to reporting any retest results.
6 Retrain certifying scientist to ensure CORR Quest Diagnostics Complete compliance with SOP.
7 Capture event in the next NRC Six Month GNRL Cindy 02/27/04 Summary Report Cunningham 8
I OCFR26 required notification to the NRC.
GNRL Harold Stiles 01/07/04
United States Nuclear Regulatory Commission PE&RAS-04-001 Page 5 ATTACHMENT 2 Director, Forensic Toxicology, Letter QST DAN TLAt4NA 770SS6S012 12/16/03
£1S46m P.
2 Aill Quet Diagostia Xacerpetmtd 3517 PrcadesitiA Drive Atanu. GA 0340 December 16,2003 Rhonda McKiton Progress Energy 412 South Wilmington Street Raleigh, NC 27601
Dear Ms. McKinnon:
This letter is in response to your request for Quest Diagnostics Incorporated to review Progress Energy's completed investigation pertaining to AR# 108995.
I have reviewed the investigation and corrective actions documentation. The portion of the documentation referring to Quest Diagnostics Atlanta laboratory is accurate.
If you have any questions pertaining to the information provided, please contact me directly at 770-936-5007.
Respect.ihly, Edward A'Zary, Ph.D.
Director, Forensic Toxicology