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| | number = ML13144A576 | | | number = ML13144A576 |
| | issue date = 05/22/2013 | | | issue date = 05/22/2013 |
| | title = Browns Ferry, Units 1, 2 & 3, Sequoyah, Units 1 & 2 and Watt Bar, Units 1 & 2, Report of Drug Testing Error in Accordance with 10 CFR 26.719(c)(1) | | | title = Watt Bar, Units 1 & 2, Report of Drug Testing Error in Accordance with 10 CFR 26.719(c)(1) |
| | author name = Shea J W | | | author name = Shea J |
| | author affiliation = Tennessee Valley Authority | | | author affiliation = Tennessee Valley Authority |
| | addressee name = | | | addressee name = |
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| =Text= | | =Text= |
| {{#Wiki_filter:Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402 May 22, 2013 10 CFR 26.11 10 CFR 26.719(c)ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Browns Ferry Nuclear Plant, Units 1, 2, and 3 Renewed Facility Operating License Nos. DPR-33, DPR-52, and DPR-68 NRC Docket Nos. 50-259, 50-260, and 50-296 Sequoyah Nuclear Plant, Units 1 and 2 Facility Operating License Nos. DPR-77 and DPR-79 NRC Docket Nos. 50-327 and 50-328 Watts Bar Nuclear Plant, Unit 1 Facility Operating License No. NPF-90 NRC Docket No. 50-390 Watts Bar Nuclear Plant, Unit 2 Construction Permit No. CPPR-92 NRC Docket No. 50-391 | | {{#Wiki_filter:Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402 May 22, 2013 10 CFR 26.11 10 CFR 26.719(c) |
| | ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Browns Ferry Nuclear Plant, Units 1, 2, and 3 Renewed Facility Operating License Nos. DPR-33, DPR-52, and DPR-68 NRC Docket Nos. 50-259, 50-260, and 50-296 Sequoyah Nuclear Plant, Units 1 and 2 Facility Operating License Nos. DPR-77 and DPR-79 NRC Docket Nos. 50-327 and 50-328 Watts Bar Nuclear Plant, Unit 1 Facility Operating License No. NPF-90 NRC Docket No. 50-390 Watts Bar Nuclear Plant, Unit 2 Construction Permit No. CPPR-92 NRC Docket No. 50-391 |
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| ==Subject:== | | ==Subject:== |
| Report of Drug Testing Error In Accordance With 10 CFR 26.719(c)(1) | | Report of Drug Testing Error In Accordance With 10 CFR 26.719(c)(1) |
| In accordance with the requirements of 10 CFR 26.719(c), Tennessee Valley Authority (TVA) is providing the details of testing errors discovered in the performance of testing at a Department of Health and Human Services (HHS) certified laboratory. | | In accordance with the requirements of 10 CFR 26.719(c), Tennessee Valley Authority (TVA) is providing the details of testing errors discovered in the performance of testing at a Department of Health and Human Services (HHS) certified laboratory. TVA completed an investigation of a testing error at the HHS-certified laboratory on April 25, 2013. The Enclosure to this letter provides information concerning the unsatisfactory performance test conducted for TVA by its HHS-certified laboratory. |
| TVA completed an investigation of a testing error at the HHS-certified laboratory on April 25, 2013. The Enclosure to this letter provides information concerning the unsatisfactory performance test conducted for TVA by its HHS-certified laboratory. | | Printedon recycledpaper Ao |
| Ao Printed on recycled paper U.S. Nuclear Regulatory Commission Page 2 May 22, 2013 There are no regulatory commitments contained in this letter. If you have any questions concerning this matter, please contact Dr. Brenda Sowter at 423-751-2599. | | |
| Vice President, Nuclear Licensing | | U.S. Nuclear Regulatory Commission Page 2 May 22, 2013 There are no regulatory commitments contained in this letter. If you have any questions concerning this matter, please contact Dr. Brenda Sowter at 423-751-2599. |
| | Vice President, Nuclear Licensing |
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| ==Enclosure:== | | ==Enclosure:== |
| | 10 CFR 26.719(c) Report Of Testing Errors For Specimen Identification No. 2017260910 cc: Quest Diagnostics Employer Solutions 1777 Montreal Circle Tucker, GA 30084 |
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| | ENCLOSURE TENNESSEE VALLEY AUTHORITY 10 CFR 26.719(c) Report Of Testing Errors For Specimen Identification No. 2017260910 On April 12, 2013, during the investigation of conflicting results between Tennessee Valley Authority's (TVA's) primary contract drug testing laboratory and the split specimen/retest testing laboratory (Quest Diagnostics), TVA determined that a false positive testing error had occurred by TVA's Health and Human Services (HHS)-certified split specimen testing laboratory (Quest Diagnostics) on an actual donor urine specimen obtained during the donor's follow-up drug test. |
| | This report is being made in accordance with 10 CFR 26.719(c), which requires that the licensee submit to the Nuclear Regulatory Commission (NRC) a report of the incident and corrective actions taken or planned within 30 days of completing an investigation of any testing errors. TVA completed the investigation of this testing error on April 25, 2013. |
| | On March 20, 2013, an individual reported to Browns Ferry Nuclear Plant medical to provide a urine specimen for a follow-up drug test. The specimen provided by the individual (Specimen 1; also Specimen No. 2017260910) was out of the acceptable temperature range. In accordance with TVA procedures, medical services performed an observed/witnessed sample collection (Specimen 2). Both specimens were sent to TVA's primary testing laboratory for extended panel testing. Specimen 1 tested analytically negative. Specimen 2 tested analytically positive for amphetamines. Because the donor challenged the results of Specimen 1, TVA had the primary testing laboratory provide bottle B of Specimen 1 to Quest Diagnostics for split specimen testing. On April 7, 2013, Quest Diagnostics provided results stating that Specimen 1 contained amphetamine and methamphetamine metabolites. TVA's Medical Review Officer (MRO)/Substance Abuse Expert (SAE) requested on April 8, 2013, that Quest Diagnostics perform quantitative analyses and that TVA's primary laboratory perform a complete re-analysis to level of detection. Quest Diagnostics provided quantitative test results on April 8, 2013, indicating that Specimen 1 was positive for amphetamine and methamphetamine metabolites. |
| | Because there remained a discrepancy between the two laboratories regarding Specimen 1, TVA's MRO/SAE requested a retest by Quest Diagnostics including a specimen validity test. |
| | The primary testing laboratory's test results were provided on April 11, 2013, confirming a negative test result. This laboratory specifically analyzed for amphetamines and methamphetamines and noted that neither of these were detected. On April 11, 2013, TVA's MRO/SAE, after having received similar specimen validity results from both laboratories, contacted both laboratories to request that the specimen be sent for analysis by a third independent laboratory. Quest Diagnostics provided the requested re-test results on April 12, 2013, indicating a failure to reconfirm amphetamines and methamphetamines on Specimen 1 (i.e, they reported a negative result). Based on these results, Quest Diagnostics had provided incorrect results indicating a false positive on April 7, 2013. Furthermore, since Quest Diagnostics had now confirmed the results were negative for amphetamines, the specimen was not sent to a third independent laboratory. |
| | As an interim corrective action, on April 12, 2013, TVA ceased requesting that the primary contract laboratory forward split specimens to Quest Diagnostics. TVA currently has alternative pathways developed for split specimen testing. |
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| 10 CFR 26.719(c)
| | On April 25, 2013, Quest Diagnostics provided TVA the results of their internal investigation into the cause of the discrepant test results. The laboratory identified the source of the discrepant result to be related to a sample handling error during the original confirmation procedure, resulting in two consecutive samples with the same confirmatory test results. As part of the investigation, the laboratory reviewed the job performance of the individual responsible for removal of the test aliquot from the original specimen container and the job performance of the individual responsible for preparation of the test aliquot for confirmation analysis. Both individuals appeared to follow procedures as written during the evaluation period and no aberrations were identified. In order to prevent a recurrence of this issue, the laboratory has updated the standard operating procedure to require repeat analysis of any sample containing discrepant results from the primary laboratory. Based on the new standard operating procedure requirement, if any specimen is tested and has discrepant results from the original laboratory, the test will be repeated to verify the result prior to reporting. The laboratory will document re-training of each individual to ensure consistent performance. |
| Report Of Testing Errors For Specimen Identification No. 2017260910 cc: Quest Diagnostics Employer Solutions 1777 Montreal Circle Tucker, GA 30084 ENCLOSURE TENNESSEE VALLEY AUTHORITY 10 CFR 26.719(c)
| |
| Report Of Testing Errors For Specimen Identification No. 2017260910 On April 12, 2013, during the investigation of conflicting results between Tennessee Valley Authority's (TVA's) primary contract drug testing laboratory and the split specimen/retest testing laboratory (Quest Diagnostics), TVA determined that a false positive testing error had occurred by TVA's Health and Human Services (HHS)-certified split specimen testing laboratory (Quest Diagnostics) on an actual donor urine specimen obtained during the donor's follow-up drug test.This report is being made in accordance with 10 CFR 26.719(c), which requires that the licensee submit to the Nuclear Regulatory Commission (NRC) a report of the incident and corrective actions taken or planned within 30 days of completing an investigation of any testing errors. TVA completed the investigation of this testing error on April 25, 2013.On March 20, 2013, an individual reported to Browns Ferry Nuclear Plant medical to provide a urine specimen for a follow-up drug test. The specimen provided by the individual (Specimen 1;also Specimen No. 2017260910) was out of the acceptable temperature range. In accordance with TVA procedures, medical services performed an observed/witnessed sample collection (Specimen 2). Both specimens were sent to TVA's primary testing laboratory for extended panel testing. Specimen 1 tested analytically negative.
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| Specimen 2 tested analytically positive for amphetamines.
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| Because the donor challenged the results of Specimen 1, TVA had the primary testing laboratory provide bottle B of Specimen 1 to Quest Diagnostics for split specimen testing. On April 7, 2013, Quest Diagnostics provided results stating that Specimen 1 contained amphetamine and methamphetamine metabolites.
| |
| TVA's Medical Review Officer (MRO)/Substance Abuse Expert (SAE) requested on April 8, 2013, that Quest Diagnostics perform quantitative analyses and that TVA's primary laboratory perform a complete re-analysis to level of detection.
| |
| Quest Diagnostics provided quantitative test results on April 8, 2013, indicating that Specimen 1 was positive for amphetamine and methamphetamine metabolites.
| |
| Because there remained a discrepancy between the two laboratories regarding Specimen 1, TVA's MRO/SAE requested a retest by Quest Diagnostics including a specimen validity test.The primary testing laboratory's test results were provided on April 11, 2013, confirming a negative test result. This laboratory specifically analyzed for amphetamines and methamphetamines and noted that neither of these were detected.
| |
| On April 11, 2013, TVA's MRO/SAE, after having received similar specimen validity results from both laboratories, contacted both laboratories to request that the specimen be sent for analysis by a third independent laboratory.
| |
| Quest Diagnostics provided the requested re-test results on April 12, 2013, indicating a failure to reconfirm amphetamines and methamphetamines on Specimen 1 (i.e, they reported a negative result). Based on these results, Quest Diagnostics had provided incorrect results indicating a false positive on April 7, 2013. Furthermore, since Quest Diagnostics had now confirmed the results were negative for amphetamines, the specimen was not sent to a third independent laboratory.
| |
| As an interim corrective action, on April 12, 2013, TVA ceased requesting that the primary contract laboratory forward split specimens to Quest Diagnostics.
| |
| TVA currently has alternative pathways developed for split specimen testing.1 On April 25, 2013, Quest Diagnostics provided TVA the results of their internal investigation into the cause of the discrepant test results. The laboratory identified the source of the discrepant result to be related to a sample handling error during the original confirmation procedure, resulting in two consecutive samples with the same confirmatory test results. As part of the investigation, the laboratory reviewed the job performance of the individual responsible for removal of the test aliquot from the original specimen container and the job performance of the individual responsible for preparation of the test aliquot for confirmation analysis.
| |
| Both individuals appeared to follow procedures as written during the evaluation period and no aberrations were identified. | |
| In order to prevent a recurrence of this issue, the laboratory has updated the standard operating procedure to require repeat analysis of any sample containing discrepant results from the primary laboratory. | |
| Based on the new standard operating procedure requirement, if any specimen is tested and has discrepant results from the original laboratory, the test will be repeated to verify the result prior to reporting. | |
| The laboratory will document re-training of each individual to ensure consistent performance. | |
| No other samples in the batch were adversely affected by the incident and no other correction reports were required for other specimens. | | No other samples in the batch were adversely affected by the incident and no other correction reports were required for other specimens. |
| This issue is being tracked in TVA's Corrective Action Program as PER 715507. As identified above in the description of the Quest Diagnostics internal investigation, the laboratory has updated their standard operating procedure and performed training of the staff on the updated procedure, and will take actions to re-train all individuals. | | This issue is being tracked in TVA's Corrective Action Program as PER 715507. As identified above in the description of the Quest Diagnostics internal investigation, the laboratory has updated their standard operating procedure and performed training of the staff on the updated procedure, and will take actions to re-train all individuals. TVA has submitted this information to the Operating Experience group for consideration in sharing this information, and has provided the information to the Quality Assurance group for consideration during future audits. |
| TVA has submitted this information to the Operating Experience group for consideration in sharing this information, and has provided the information to the Quality Assurance group for consideration during future audits.2}} | | 2}} |
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Category:Letter
MONTHYEARML24032A4762024-02-0101 February 2024 Final Report of a Part 21 Evaluation Associated with Starter Contactors for the BFN Unit 1 High Pressure Coolant Injection Suppression Pool Inboard Suction Valve ML24032A0202024-01-31031 January 2024 NPDES Biocide/Corrosion Treatment Plan Annual Report, Cy 2023 ML23319A2452024-01-29029 January 2024 Issuance of Amendment Nos. 366 and 360; 164 and 71 Regarding the Adoption of TSTF-567, Revision 1, Add Containment Sump TS to Address GSI-191 Issues ML24023A2802024-01-23023 January 2024 Final Report of a Deviation or Failure to Comply Associated with a Relay in the Reactor Core Isolation Cooling Condensate Pump ML24008A2462024-01-18018 January 2024 Revision to the Reactor Vessel Material Surveillance Capsule Withdrawal Schedule CNL-24-017, Tennessee Valley Authority - Central Emergency Control Center Emergency Plan Implementing Procedure and Emergency Preparedness Department Procedure Revisions2024-01-17017 January 2024 Tennessee Valley Authority - Central Emergency Control Center Emergency Plan Implementing Procedure and Emergency Preparedness Department Procedure Revisions ML24018A0142024-01-17017 January 2024 Engine Systems, Inc., Report No. 10CFR21-0137, Rev. 1, 56913-EN 56913 ML24016A3042024-01-16016 January 2024 Final Report of a Part 21 Evaluation Associated with Check Valve 0-CKV-023-0565 for D1 Residual Heat Removal Service Water Pump CNL-23-071, Response to Request for Additional Information Regarding Browns Ferry Nuclear Plant, Units 1, 2, and 3, Inservice Inspection and Augmented Program Interval Revised Request for Alternative 0-ISI-472024-01-11011 January 2024 Response to Request for Additional Information Regarding Browns Ferry Nuclear Plant, Units 1, 2, and 3, Inservice Inspection and Augmented Program Interval Revised Request for Alternative 0-ISI-47 IR 05000327/20234422024-01-11011 January 2024 95001 Supplemental Inspection Report 05000327/2023442 and 05000328/2023442 and Follow-Up Assessment Letter ML24011A3162024-01-11011 January 2024 Submittal of Discharge Monitoring Report (Dmr), August 2023 ML24011A3172024-01-11011 January 2024 Submittal of Discharge Monitoring Report (Dmr), September 2023 ML24011A3182024-01-11011 January 2024 Submittal of Discharge Monitoring Report (Dmr), October 2023 ML24011A3192024-01-11011 January 2024 Submittal of Discharge Monitoring Report (Dmr), November 2023 ML24011A3202024-01-11011 January 2024 Submittal of Discharge Monitoring Report (Dmr), December 2023 ML24010A2132024-01-10010 January 2024 CFR 21.21 Final Report Regarding Siemens Medium Voltage Circuit Breakers CNL-24-016, Supplement to Application to Modify the Technical Specification Surveillance Requirement 3.9.5.1 (WBN-TS-21-14)2024-01-10010 January 2024 Supplement to Application to Modify the Technical Specification Surveillance Requirement 3.9.5.1 (WBN-TS-21-14) CNL-23-052, Application to Adopt TSTF-427-A, Revision 2, Allowance for Non-Technical Specification Barrier Degradation on Supported System Operability2024-01-0909 January 2024 Application to Adopt TSTF-427-A, Revision 2, Allowance for Non-Technical Specification Barrier Degradation on Supported System Operability CNL-23-062, Application to Revise the Technical Specifications Section 3.8.2, AC Sources-Shutdown, to Remove Reference to the C-S Diesel Generator (WBN-TS-23-018)2024-01-0808 January 2024 Application to Revise the Technical Specifications Section 3.8.2, AC Sources-Shutdown, to Remove Reference to the C-S Diesel Generator (WBN-TS-23-018) ML24018A0952024-01-0404 January 2024 Engine Systems, Inc., 10CFR21 Reporting of Defects and Non-Compliance Report No. 10CFR21-0137, Rev. 0 ML24004A0332024-01-0303 January 2024 Interim Report of a Deviation or Failure to Comply Crompton Instruments Type 077 Ammeter ML24004A0402024-01-0303 January 2024 Response to NRCs November 8, 2023, Request for Additional Information - Related to Independent Spent Fuel Storage Installation ML23346A1382024-01-0303 January 2024 Regulatory Audit Summary Related to Request to Increase the Number of Tritium Producing Burnable Absorber Rods ML24022A1732024-01-0303 January 2024 Receipt and Availability of the Subsequent License Renewal Application ML23319A1992024-01-0303 January 2024 Issuance of Amendment Nos. 333, 356, and 316 Regarding the Technical Specification Surveillance Requirements 3.4.3.2 and 3.5.1.11 Regarding Safety Relief Valves ML23355A2062023-12-21021 December 2023 Request for Exemption from Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Implementation CNL-23-068, Request for Exemption from Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Implementation2023-12-21021 December 2023 Request for Exemption from Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Implementation CNL-23-069, Request for Exemption from Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Implementation2023-12-21021 December 2023 Request for Exemption from Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Implementation IR 05000390/20234412023-12-21021 December 2023 Plantfinal Significance Determination for a Security-Related Greater than Green Finding, Nov, and Assessment Follow-up, 05000390-2023441 and 05000391-2023441-Public CNL-23-036, Application to Revise Function 5 of Technical Specification Table 3.3.2-1, Engineered Safety Feature Actuation System Instrumentation, for the Sequoyah Nuclear Plant and Watts Bar Nuclear Plant (SQN-TS-23-02 and WBN-TS-23-08)2023-12-18018 December 2023 Application to Revise Function 5 of Technical Specification Table 3.3.2-1, Engineered Safety Feature Actuation System Instrumentation, for the Sequoyah Nuclear Plant and Watts Bar Nuclear Plant (SQN-TS-23-02 and WBN-TS-23-08) IR 05000390/20234042023-12-14014 December 2023 Security Baseline Inspection Report 05000390/2023404 and 05000391/2023404 ML23348A3942023-12-14014 December 2023 Interim Part 21 Report of a Potential Deviation or Failure to Comply Associated with Starter Contactors for the High Pressure Coolant Injection Suppression Pool Inboard Suction Valve CNL-23-001, Rebaseline of Sections 3.1 and 3.2 of the Technical Specifications (WBN-TS-23-01)2023-12-13013 December 2023 Rebaseline of Sections 3.1 and 3.2 of the Technical Specifications (WBN-TS-23-01) ML23346A1222023-12-12012 December 2023 Annual Non-Radiological Environmental Operating Report - 2023 IR 05000259/20230102023-12-11011 December 2023 Commercial Grade Dedication Inspection Report 05000259/2023010 and 05000260/2023010 and 05000296/2023010 ML23293A0572023-12-0606 December 2023 Issuance of Amendment Nos. 163 and 70 Regarding Adoption of TSTF-501-A, Revision 1, Relocate Stored Fuel Oil and Lube Oil Volume Values to Licensee Control ML23335A0722023-12-0101 December 2023 Interim Report of a Deviation or Failure to Comply Associated with a Relay in the Unit 2 Reactor Core Isolation Cooling Condensate Pump ML23334A2492023-11-30030 November 2023 Site Emergency Plan Implementing Procedure Revision IR 05000390/20230102023-11-30030 November 2023 RE-Issue Watts Bar Nuclear Plant - Biennial Problem Identification and Resolution Inspection Report 050000390/2023010 and 05000391/2023010 and Apparent Violation CNL-23-070, Submittal of Fifth 10-Year Interval Inservice Testing Program Plan2023-11-29029 November 2023 Submittal of Fifth 10-Year Interval Inservice Testing Program Plan IR 05000327/20234202023-11-28028 November 2023 Security Baseline Inspection Report 05000327/2023420 and 05000328/2023420 CNL-23-067, Central Emergency Control Center Emergency Plan Implementing Procedure Revisions2023-11-27027 November 2023 Central Emergency Control Center Emergency Plan Implementing Procedure Revisions ML23331A2532023-11-27027 November 2023 Summary Report for 10 CFR 50.9 Evaluations, Technical Specifications Bases Changes, Technical Requirement Manual Changes, and NRC Commitment Revisions ML23325A1102023-11-21021 November 2023 Anchor Darling Double Disc Gate Valve Commitment Revision ML23320A2542023-11-16016 November 2023 Interim Part 21 Report of a Deviation or Failure to Comply Associated with Check Valve 0-CKV-023-0565 for D1 Residual Heat Removal Service Water Pump IR 05000259/20230032023-11-13013 November 2023 Integrated Inspection Report 05000259/2023003, 05000260/2023003 and 05000296/2023003 IR 05000390/20230032023-11-13013 November 2023 Integrated Inspection Report 05000390/2023003 and 05000391/2023003 and Apparent Violation 2024-02-01
[Table view] Category:Report
MONTHYEARCNL-24-016, Supplement to Application to Modify the Technical Specification Surveillance Requirement 3.9.5.1 (WBN-TS-21-14)2024-01-10010 January 2024 Supplement to Application to Modify the Technical Specification Surveillance Requirement 3.9.5.1 (WBN-TS-21-14) ML23346A1382024-01-0303 January 2024 Regulatory Audit Summary Related to Request to Increase the Number of Tritium Producing Burnable Absorber Rods ML23284A4252023-10-11011 October 2023 10 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report; Commitment Summary Report; and Update to the Fire Protection Report ML23192A4472023-07-31031 July 2023 Staff Assessment of Updated Seismic Hazards at TVA Sites Following the NRC Process for the Ongoing Assessment of Natural Hazards Information WBL-23-018, Revised Pressure and Temperature Limits Report (PTLR)2023-04-10010 April 2023 Revised Pressure and Temperature Limits Report (PTLR) CNL-23-002, Application to Revise Watts Bar Nuclear Plant Units 1 and 2 Technical Specifications to Change the Number of Tritium Producing Burnable Absorber Rods (WBN-TS-21-02) and Proposed Revision to Reactor Vessel Surveillance Capsule Removal Sche2023-03-20020 March 2023 Application to Revise Watts Bar Nuclear Plant Units 1 and 2 Technical Specifications to Change the Number of Tritium Producing Burnable Absorber Rods (WBN-TS-21-02) and Proposed Revision to Reactor Vessel Surveillance Capsule Removal Schedu ML23025A0752023-01-25025 January 2023 American Society of Mechanical Engineers, Section XI, Third 10 Year Inspection Interval, Inservice Inspection, System Pressure Test, Containment Inspection, and Repair and Replacement Programs, Owners Activity Report Cycle . ML22363A3922022-12-28028 December 2022 Cycle 14 Mellla+ Eigenvalue Tracking Data CNL-22-090, Request to Use a Later Edition of the American Society of Mechanical Engineers Operation and Maintenance Code and Alternative Requests for the Fifth Inservice Testing Interval2022-12-12012 December 2022 Request to Use a Later Edition of the American Society of Mechanical Engineers Operation and Maintenance Code and Alternative Requests for the Fifth Inservice Testing Interval CNL-22-100, to Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 for Browns Ferry Nuclear Plant Units 1, 2, and 3,in Support of Atrium 11 Fuel Use at Browns Ferry (TS-535)2022-12-0909 December 2022 to Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 for Browns Ferry Nuclear Plant Units 1, 2, and 3,in Support of Atrium 11 Fuel Use at Browns Ferry (TS-535) WBL-22-034, Update to Fire Protection Report Figures Redacted2022-08-0101 August 2022 Update to Fire Protection Report Figures Redacted CNL-22-066, Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 for in Support of Atrium 11 Fuel Use Supplement 3, Response to Request for Additional Information2022-07-18018 July 2022 Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 for in Support of Atrium 11 Fuel Use Supplement 3, Response to Request for Additional Information ML22154A4042022-06-0303 June 2022 Unit 3 Cycle 20 Mellla+ Eigenvalue Tracking Data CNL-22-057, to Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 in Support of Atrium 11 Fuel Use2022-05-27027 May 2022 to Request for License Amendment Regarding Application of Advanced Framatome Methodologies, and Adoption of TSTF-564 Revision 2 in Support of Atrium 11 Fuel Use WBL-21-057, Cycle 4 Mid-Cycle Outage Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report2021-12-16016 December 2021 Cycle 4 Mid-Cycle Outage Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report WBL-21-056, Revised Pressure and Temperature Limits Report (PTLR)2021-12-0909 December 2021 Revised Pressure and Temperature Limits Report (PTLR) CNL-21-018, Application to Adopt TSTF-205-A, Revision of Channel Calibration, Channel Functional Test, and Related Definitions, and TSTF-563-A, Revise Instrument Testing Definitions to Incorporate the Surveillance .2021-12-0909 December 2021 Application to Adopt TSTF-205-A, Revision of Channel Calibration, Channel Functional Test, and Related Definitions, and TSTF-563-A, Revise Instrument Testing Definitions to Incorporate the Surveillance . ML21277A1232021-10-0404 October 2021 Submittal of Browns Ferry Unit 2 Reactor Pressure Vessel Vertical Weld Flaw Evaluation ML21246A2802021-09-29029 September 2021 Final Ea/Fonsi for Tva'S Initial and Updated Triennial Decommissioning Funding Plans for Sequoyah Nuclear Plant ISFSIs ML21246A2952021-09-29029 September 2021 Memo to File ML21246A2942021-09-29029 September 2021 Enclosufinal Ea/Fonsi for Tva'S Initial and Updated Triennial Decommissioning Funding Plans for Browns Ferry Nuclear Plant ISFSIs ML21244A3452021-09-20020 September 2021 Proposed Alternative IST RR 9 to the Requirements of the ASME OM Code for Test Plan Group 6 Relief Valves IR 05000327/20210052021-08-18018 August 2021 Updated Inspection Plan for Sequoyah Nuclear Plant, Units 1 and 2 Report 05000327/2021005 and 05000328/2021005 CNL-21-072, TVA Nuclear Calculation Coversheet/ Ecm Metadata Update2021-08-13013 August 2021 TVA Nuclear Calculation Coversheet/ Ecm Metadata Update CNL-21-055, Revision to Refueling Outage 3 Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report2021-07-20020 July 2021 Revision to Refueling Outage 3 Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report ML21140A0282021-05-14014 May 2021 Gravel Lot Restoration Project, Construction General Permit, Notice of Intent CNL-21-040, Supplement to Expedited Application for Approval to Use a Growth Rate Temperature Adjustment When Implementing the Generic Letter 95-05 Analysis for the (WBN TS-391-21-002)2021-03-23023 March 2021 Supplement to Expedited Application for Approval to Use a Growth Rate Temperature Adjustment When Implementing the Generic Letter 95-05 Analysis for the (WBN TS-391-21-002) ML21060A9132021-03-17017 March 2021 Final Environmental Assessment and Finding of No Significant Impact for Initial and Updated Decommissioning Funding Plans for Watts Bar ISFSI CNL-21-011, Expedited Application for Approval to Use a Growth Rate Temperature Adjustment When Implementing the Generic Letter 95-05 Analysis for the (WBN TS-391-21-002)2021-02-25025 February 2021 Expedited Application for Approval to Use a Growth Rate Temperature Adjustment When Implementing the Generic Letter 95-05 Analysis for the (WBN TS-391-21-002) WBL-21-006, Refueling Outage 3 Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report2021-02-11011 February 2021 Refueling Outage 3 Generic Letter 95-05 Voltage-Based Alternate Repair Criteria Final Report CNL-20-102, 10 CFR 71.95 Report for 3-60B Casks User2020-12-16016 December 2020 10 CFR 71.95 Report for 3-60B Casks User WBL-20-066, Revised Pressure and Temperature Limits Report (PTLR)2020-12-16016 December 2020 Revised Pressure and Temperature Limits Report (PTLR) ML20350B7202020-12-15015 December 2020 Discharge Monitoring Report Quality Assurance Study 40 Final Report 2020 ML20308A4762020-11-0202 November 2020 10 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report and Commitment Summary Report ML20304A4032020-10-28028 October 2020 Revisions to the Sequoyah Nuclear Plant Units 1 and 2 Technical Requirements Manual ML20255A0002020-09-24024 September 2020 Staff Review of Seismic Probabilistic Risk Assessment Associated with Reevaluated Seismic Hazard Implementation of the Near Term Task Force Recommendation 2.1: Seismic CNL-20-074, Submittal of Additional Supplement to License Amendment Request for Measurement Uncertainty Recapture Power Uprate (WBN-TS-19-06)2020-08-28028 August 2020 Submittal of Additional Supplement to License Amendment Request for Measurement Uncertainty Recapture Power Uprate (WBN-TS-19-06) ML20112F4852020-05-0606 May 2020 Staff Assessment of Flooding Focused Evaluation WBL-20-004, Analysis of Capsule U from Watts Bar Unit 2 Reactor Vessel Radiation Surveillance Program2020-04-16016 April 2020 Analysis of Capsule U from Watts Bar Unit 2 Reactor Vessel Radiation Surveillance Program CNL-19-082, License Amendment Request for Measurement Uncertainty Recapture Power Uprate (WBN-TS-19-06)2019-10-10010 October 2019 License Amendment Request for Measurement Uncertainty Recapture Power Uprate (WBN-TS-19-06) CNL-19-074, Extended Power Uprate - Flow Induced Vibration Summary Report2019-09-0404 September 2019 Extended Power Uprate - Flow Induced Vibration Summary Report L-19-034, Wafts Bar Nuclear Plant, Unit 1 - Technical Specification (TS) 5.9.8 - Post Accident Monitoring System (Pams) Report2019-06-18018 June 2019 Wafts Bar Nuclear Plant, Unit 1 - Technical Specification (TS) 5.9.8 - Post Accident Monitoring System (Pams) Report CNL-19-004, Tennessee Valley Authority, Browns Ferry Nuclear Plant, Unit 2, Completion of Required Action for NRC Order EA-13-109, Reliable Hardened Containment Vents Capable of Operation Under Severe Accident Conditions2019-06-0707 June 2019 Tennessee Valley Authority, Browns Ferry Nuclear Plant, Unit 2, Completion of Required Action for NRC Order EA-13-109, Reliable Hardened Containment Vents Capable of Operation Under Severe Accident Conditions ML19156A2612019-06-0505 June 2019 10 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report and Commitment Summary Report CNL-19-041, Extended Power Uprate - Unit 1 Flow Induced Vibration Summary Report2019-04-16016 April 2019 Extended Power Uprate - Unit 1 Flow Induced Vibration Summary Report L-19-026, Revised Pressure and Temperature Limits Report (PTLR)2019-04-0404 April 2019 Revised Pressure and Temperature Limits Report (PTLR) CNL-19-032, Proposed Technical Specifications (TS) Change TS-510 - Request for License Amendments - Maximum Extended Load Line Limit Analysis Plus - Supplement 8, Additional Operator Training Information2019-03-13013 March 2019 Proposed Technical Specifications (TS) Change TS-510 - Request for License Amendments - Maximum Extended Load Line Limit Analysis Plus - Supplement 8, Additional Operator Training Information ML19039A0492019-02-0808 February 2019 Amd 1 to USAR Chapter 9 Auxiliary System NRC Additional Redactions ML19003A5692019-01-16016 January 2019 Review of the Fall 2017 Steam Generator Tube Inspection Report ML18352A2292018-12-17017 December 2018 Pressure Temperature Limits Report, Revision 7 2024-01-03
[Table view] Category:Miscellaneous
MONTHYEARML23346A1382024-01-0303 January 2024 Regulatory Audit Summary Related to Request to Increase the Number of Tritium Producing Burnable Absorber Rods ML23284A4252023-10-11011 October 2023 10 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report; Commitment Summary Report; and Update to the Fire Protection Report ML23025A0752023-01-25025 January 2023 American Society of Mechanical Engineers, Section XI, Third 10 Year Inspection Interval, Inservice Inspection, System Pressure Test, Containment Inspection, and Repair and Replacement Programs, Owners Activity Report Cycle . CNL-22-090, Request to Use a Later Edition of the American Society of Mechanical Engineers Operation and Maintenance Code and Alternative Requests for the Fifth Inservice Testing Interval2022-12-12012 December 2022 Request to Use a Later Edition of the American Society of Mechanical Engineers Operation and Maintenance Code and Alternative Requests for the Fifth Inservice Testing Interval WBL-22-034, Update to Fire Protection Report Figures Redacted2022-08-0101 August 2022 Update to Fire Protection Report Figures Redacted ML21244A3452021-09-20020 September 2021 Proposed Alternative IST RR 9 to the Requirements of the ASME OM Code for Test Plan Group 6 Relief Valves IR 05000327/20210052021-08-18018 August 2021 Updated Inspection Plan for Sequoyah Nuclear Plant, Units 1 and 2 Report 05000327/2021005 and 05000328/2021005 ML19156A2612019-06-0505 June 2019 10 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report and Commitment Summary Report ML19003A5692019-01-16016 January 2019 Review of the Fall 2017 Steam Generator Tube Inspection Report ML18242A0382018-08-30030 August 2018 Technical Specification (TS) 5.9.8 - Post Accident Monitoring System (Pams) Report CNL-18-092, Application to Revise the Technical Specifications to Adopt TSTF-266-A, Revision 3, Eliminate the Remote Shutdown System Table of Instrumentation and Controls (WBN-TS-18-02)2018-08-0101 August 2018 Application to Revise the Technical Specifications to Adopt TSTF-266-A, Revision 3, Eliminate the Remote Shutdown System Table of Instrumentation and Controls (WBN-TS-18-02) CNL-18-060, Completion of Required Action for NRC Order EA-13-109, Reliable Hardened Containment Vents Capable of Operation Under Severe Accident Conditions2018-05-31031 May 2018 Completion of Required Action for NRC Order EA-13-109, Reliable Hardened Containment Vents Capable of Operation Under Severe Accident Conditions CNL-18-007, Seismic Probabilistic Risk Assessment Supplemental Information2018-04-10010 April 2018 Seismic Probabilistic Risk Assessment Supplemental Information ML17313A1282017-11-0909 November 2017 Revised Pressure and Temperature Limits Report (PTLR) ML17278A7592017-10-0505 October 2017 Soarca Sequoyah Updated Draft Executive Summary ML17272A0192017-09-29029 September 2017 Technical Specification (TS) 5.9.8 - Post Accident Monitoring System (Pams) Report ML17263A1162017-09-20020 September 2017 Technical Specification (TS) 5.9.8 - Post Accident Monitoring System (Pams) Report ML17209A5542017-07-28028 July 2017 Cycle 14 Steam Generator Tube Inspection Report ML17170A0732017-06-15015 June 2017 Report Pursuant to 10 CFR 71.95 (a)(3) and (B) - Failure to Follow Conditions of TN-RAM Packaging Certificate of Compliance No. 9233 ML17033B1642017-02-0202 February 2017 American Society of Mechanical Engineers Section XI, Inservice Inspection, System Pressure Test, Containment Inservice Inspection, and Repair and Replacement - Cycle 11 Operation Programs ML17024A0362016-12-31031 December 2016 Operating Data Report for 2016 ML16215A1042016-08-0202 August 2016 Technical Specification (TS) 5.9.8 - Post Accident Monitoring System Report ML16146A0182016-05-25025 May 2016 Special Report 296/2016-001 for Inoperable Post Accident Monitoring (PAM) Instrumentation ML16113A0202016-04-22022 April 2016 Submittal of Title 10, Code of Federal Regulations 50.59 Summary Report CNL-16-038, Application to Revise Technical Specification 4.2.1, Fuel Assemblies and Radioactive Waste System Design Basis Source Term Supplement to Response to NRC Request for Additional Information2016-03-31031 March 2016 Application to Revise Technical Specification 4.2.1, Fuel Assemblies and Radioactive Waste System Design Basis Source Term Supplement to Response to NRC Request for Additional Information CNL-16-034, TMI Task Action I.D.1 Commitment Closure Regarding Control Room Design Review Special Program2016-02-19019 February 2016 TMI Task Action I.D.1 Commitment Closure Regarding Control Room Design Review Special Program ML16028A2952016-01-29029 January 2016 10 CFR 71.95 Notification Associated with the Failure to Observe Certificate of Compliance Condition of the 8-120B Secondary Lid Test Port Configuration CNL-15-263, Application to Revise Technical Specification 4.2.1, Fuel Assemblies (WBN-TS-15-03) - Supplemental Information Related to the Onsite Regulatory Audit at Pacific Northwest National Laboratory2015-12-29029 December 2015 Application to Revise Technical Specification 4.2.1, Fuel Assemblies (WBN-TS-15-03) - Supplemental Information Related to the Onsite Regulatory Audit at Pacific Northwest National Laboratory ML15356A6542015-12-22022 December 2015 Submittal of 10 CFR 50.46 30-Day Report ML15336A9402015-11-26026 November 2015 Submittal of 10 CFR 50.46 Combined Annual and 30-Day Report ML15321A4542015-11-13013 November 2015 Submittal of 10 CFR 71.95 Report on the 8-120B Cask ML15254A5432015-09-11011 September 2015 Submittal of 10 CFR 72.48 Changes, Tests, and Experiments, Biennial Summary Report Associated with the Independent Spent Fuel Storage Installation CNL-15-165, Submittal of Electromagnetic Interference (EMI) Survey Results2015-08-20020 August 2015 Submittal of Electromagnetic Interference (EMI) Survey Results CNL-15-131, Individual Plant Examination of External Events (IPEEE) Report, Revision 32015-07-15015 July 2015 Individual Plant Examination of External Events (IPEEE) Report, Revision 3 CNL-15-106, 3, Sequoyah and Watts Bar, Units 1 & 2 - Provides Service List Update for Routine Information2015-07-0808 July 2015 3, Sequoyah and Watts Bar, Units 1 & 2 - Provides Service List Update for Routine Information ML15121A6562015-05-0101 May 2015 NRC Region II - CIB1 Watts Bar 2 Ip&S 194 Additional Questions Request List ML15156A3892015-04-28028 April 2015 LTR-SGMP-15-25 Np, Response to NRC Request for Additional Information on the Design Features of the Sequoyah, Unit 2, Replacement Steam Generators. CNL-15-043, Flood Hazard Reevaluation Report for Watts Bar, Response to NRC Request for Information Per Title 10 of CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3 of the Near-Term Task Force Review of Insights from the Fukushima Dai-ichi Acc2015-03-25025 March 2015 Flood Hazard Reevaluation Report for Watts Bar, Response to NRC Request for Information Per Title 10 of CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3 of the Near-Term Task Force Review of Insights from the Fukushima Dai-ichi Accid ML14356A3622015-02-11011 February 2015 Interim Staff Evaluation Relating to Overall Integrated Plan in Response to Order EA-13-109 (Severe Accident Capable Hardened Vents) CNL-14-212, Expedited Seismic Evaluation Process Report (CEUS Sites) Response to NRC Request for Information Pursuant to 10 CFR 50.54(f) Re Recommendation 2.1 of the Near-Term Task Force Review of Insights from Fukushima Dai-ichi Accident2014-12-30030 December 2014 Expedited Seismic Evaluation Process Report (CEUS Sites) Response to NRC Request for Information Pursuant to 10 CFR 50.54(f) Re Recommendation 2.1 of the Near-Term Task Force Review of Insights from Fukushima Dai-ichi Accident CNL-14-210, Expedited Seismic Evaluation Process Report (CEUS Sites) Response to NRC Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendation 2.1 of the Near-Term Task Force Review of Insights from the Fukushima.2014-12-22022 December 2014 Expedited Seismic Evaluation Process Report (CEUS Sites) Response to NRC Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendation 2.1 of the Near-Term Task Force Review of Insights from the Fukushima. ML14325A0692014-11-17017 November 2014 CFR 50.59 and 10 CFR 72.48 Changes, Tests, and Experiments Summary Report ML14163A6582014-09-18018 September 2014 Closeout of Generic Letter, 2004-02, Potential Impact of Debris Blockage on Emergency Recirculation During Design Basis Accidents at Pressurized-Water Reactors ML14259A3382014-09-12012 September 2014 Plant(Sqn) - NPDES Permit No. TN0026450 - Discharge Monitoring Report(Dmr) for August 2014 CNL-14-129, Third Six-Month Status Report in Response to the March 12, 2012, Commission Order Modifying Licenses with Regard to Reliable Spent Fuel Pool Instrumentation (Order Number EA-12-051) for Browns Ferry Nuclear Plant2014-08-28028 August 2014 Third Six-Month Status Report in Response to the March 12, 2012, Commission Order Modifying Licenses with Regard to Reliable Spent Fuel Pool Instrumentation (Order Number EA-12-051) for Browns Ferry Nuclear Plant CNL-14-130, Third Six-Month Status Report in Response to the March 12, 2012, Commission Order Modifying Licenses with Regard to Reliable Spent Fuel Pool Instrumentation (Order Number EA-12-051) for Sequoyah Nuclear Plant2014-08-28028 August 2014 Third Six-Month Status Report in Response to the March 12, 2012, Commission Order Modifying Licenses with Regard to Reliable Spent Fuel Pool Instrumentation (Order Number EA-12-051) for Sequoyah Nuclear Plant ML14212A6032014-07-31031 July 2014 WBRD-50-391/86-60 - Final Report and Revised Completion Schedule IR 05000391/19860602014-07-31031 July 2014 WBRD-50-391/86-60 - Final Report and Revised Completion Schedule ML14149A1502014-06-16016 June 2014 Staff Assessment of the Flooding Walkdown Report Supporting Implementation of Near-Term Task Force Recommendation 2.3 Related to the Fukushima Dai-Ichi Nuclear Power Plant Accident ML14133A5422014-05-23023 May 2014 Staff Assessment of the Seismic Walkdown Report Supporting Implementation of Near-Term Task Force Recommendation 2.3 Related to the Fukushima Dai-Ichi Nuclear Power Plant Accident 2024-01-03
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Text
Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402 May 22, 2013 10 CFR 26.11 10 CFR 26.719(c)
ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Browns Ferry Nuclear Plant, Units 1, 2, and 3 Renewed Facility Operating License Nos. DPR-33, DPR-52, and DPR-68 NRC Docket Nos. 50-259, 50-260, and 50-296 Sequoyah Nuclear Plant, Units 1 and 2 Facility Operating License Nos. DPR-77 and DPR-79 NRC Docket Nos. 50-327 and 50-328 Watts Bar Nuclear Plant, Unit 1 Facility Operating License No. NPF-90 NRC Docket No. 50-390 Watts Bar Nuclear Plant, Unit 2 Construction Permit No. CPPR-92 NRC Docket No. 50-391
Subject:
Report of Drug Testing Error In Accordance With 10 CFR 26.719(c)(1)
In accordance with the requirements of 10 CFR 26.719(c), Tennessee Valley Authority (TVA) is providing the details of testing errors discovered in the performance of testing at a Department of Health and Human Services (HHS) certified laboratory. TVA completed an investigation of a testing error at the HHS-certified laboratory on April 25, 2013. The Enclosure to this letter provides information concerning the unsatisfactory performance test conducted for TVA by its HHS-certified laboratory.
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U.S. Nuclear Regulatory Commission Page 2 May 22, 2013 There are no regulatory commitments contained in this letter. If you have any questions concerning this matter, please contact Dr. Brenda Sowter at 423-751-2599.
Vice President, Nuclear Licensing
Enclosure:
10 CFR 26.719(c) Report Of Testing Errors For Specimen Identification No. 2017260910 cc: Quest Diagnostics Employer Solutions 1777 Montreal Circle Tucker, GA 30084
ENCLOSURE TENNESSEE VALLEY AUTHORITY 10 CFR 26.719(c) Report Of Testing Errors For Specimen Identification No. 2017260910 On April 12, 2013, during the investigation of conflicting results between Tennessee Valley Authority's (TVA's) primary contract drug testing laboratory and the split specimen/retest testing laboratory (Quest Diagnostics), TVA determined that a false positive testing error had occurred by TVA's Health and Human Services (HHS)-certified split specimen testing laboratory (Quest Diagnostics) on an actual donor urine specimen obtained during the donor's follow-up drug test.
This report is being made in accordance with 10 CFR 26.719(c), which requires that the licensee submit to the Nuclear Regulatory Commission (NRC) a report of the incident and corrective actions taken or planned within 30 days of completing an investigation of any testing errors. TVA completed the investigation of this testing error on April 25, 2013.
On March 20, 2013, an individual reported to Browns Ferry Nuclear Plant medical to provide a urine specimen for a follow-up drug test. The specimen provided by the individual (Specimen 1; also Specimen No. 2017260910) was out of the acceptable temperature range. In accordance with TVA procedures, medical services performed an observed/witnessed sample collection (Specimen 2). Both specimens were sent to TVA's primary testing laboratory for extended panel testing. Specimen 1 tested analytically negative. Specimen 2 tested analytically positive for amphetamines. Because the donor challenged the results of Specimen 1, TVA had the primary testing laboratory provide bottle B of Specimen 1 to Quest Diagnostics for split specimen testing. On April 7, 2013, Quest Diagnostics provided results stating that Specimen 1 contained amphetamine and methamphetamine metabolites. TVA's Medical Review Officer (MRO)/Substance Abuse Expert (SAE) requested on April 8, 2013, that Quest Diagnostics perform quantitative analyses and that TVA's primary laboratory perform a complete re-analysis to level of detection. Quest Diagnostics provided quantitative test results on April 8, 2013, indicating that Specimen 1 was positive for amphetamine and methamphetamine metabolites.
Because there remained a discrepancy between the two laboratories regarding Specimen 1, TVA's MRO/SAE requested a retest by Quest Diagnostics including a specimen validity test.
The primary testing laboratory's test results were provided on April 11, 2013, confirming a negative test result. This laboratory specifically analyzed for amphetamines and methamphetamines and noted that neither of these were detected. On April 11, 2013, TVA's MRO/SAE, after having received similar specimen validity results from both laboratories, contacted both laboratories to request that the specimen be sent for analysis by a third independent laboratory. Quest Diagnostics provided the requested re-test results on April 12, 2013, indicating a failure to reconfirm amphetamines and methamphetamines on Specimen 1 (i.e, they reported a negative result). Based on these results, Quest Diagnostics had provided incorrect results indicating a false positive on April 7, 2013. Furthermore, since Quest Diagnostics had now confirmed the results were negative for amphetamines, the specimen was not sent to a third independent laboratory.
As an interim corrective action, on April 12, 2013, TVA ceased requesting that the primary contract laboratory forward split specimens to Quest Diagnostics. TVA currently has alternative pathways developed for split specimen testing.
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On April 25, 2013, Quest Diagnostics provided TVA the results of their internal investigation into the cause of the discrepant test results. The laboratory identified the source of the discrepant result to be related to a sample handling error during the original confirmation procedure, resulting in two consecutive samples with the same confirmatory test results. As part of the investigation, the laboratory reviewed the job performance of the individual responsible for removal of the test aliquot from the original specimen container and the job performance of the individual responsible for preparation of the test aliquot for confirmation analysis. Both individuals appeared to follow procedures as written during the evaluation period and no aberrations were identified. In order to prevent a recurrence of this issue, the laboratory has updated the standard operating procedure to require repeat analysis of any sample containing discrepant results from the primary laboratory. Based on the new standard operating procedure requirement, if any specimen is tested and has discrepant results from the original laboratory, the test will be repeated to verify the result prior to reporting. The laboratory will document re-training of each individual to ensure consistent performance.
No other samples in the batch were adversely affected by the incident and no other correction reports were required for other specimens.
This issue is being tracked in TVA's Corrective Action Program as PER 715507. As identified above in the description of the Quest Diagnostics internal investigation, the laboratory has updated their standard operating procedure and performed training of the staff on the updated procedure, and will take actions to re-train all individuals. TVA has submitted this information to the Operating Experience group for consideration in sharing this information, and has provided the information to the Quality Assurance group for consideration during future audits.
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