View source for ND-14-2009, 4 - 10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample

{{Adams
| number = ML14353A055
| issue date = 12/17/2014
| title = 4 - 10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample
| author name = Gasser J
| author affiliation = Southern Co, Southern Nuclear Operating Co, Inc
| addressee name = 
| addressee affiliation = NRC/Document Control Desk, NRC/NRO
| docket = 05000424, 05000425, 05200025, 05200026
| license number = 
| contact person = 
| case reference number = ND-14-2009
| document type = Letter type:ND, Report, Miscellaneous
| page count = 7
}}

=Text=
{{#Wiki_filter:Jeffrey T. Gasser             Southern Nuclear Executive Vice President      Operating Company, Inc.
Operational Readiness &
Site Integration              7825 River Road Plant Vogtle Units 3&4        Waynesboro, GA 30830 Tel 706.437-6700 SOUTHERN Fax 706-826-5796                                COMPANY jtgasser@southernco.com December 17, 2014 Docket Nos.:           05-424          52-025                                            ND-14-2009 05-425          52-026 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Southern Nuclear Operating Company Vogtle Electric Generating Plant (VEGP) Units 1 - 4 10 CFR 26.719(c) Report:
False Negative Results for a Blind Performance Test Sample Ladies and Gentlemen:
In accordance with the requirements of 10 CFR 26.719(c), Southern Nuclear Operating Company hereby submits the enclosed Report.
This letter contains no regulatory commitments .           If you have any questions, please contact Michael Yox at 706-826-6459.
Respectfully submitted, 1~.LtJ~
Executive Vice President Operational Readiness & Site Integration JTG/MJY/sdc

==Enclosure:==
10 CFR 26.719(c) Report

U.S. Nuclear Regulatory Commission ND-14-2009 Page 2 of 3 cc:
Southern Nuclear Operating Company I Georgia Power Company Mr. S. E. Kuczynski (w/o enclosures)
Mr. J. A Miller Mr. D. G. Bost (w/o enclosures)
Mr. B. K. Taber (w/o enclosures)
Mr. B. L. lvey Mr. M. D. Meier Mr. M. D. Rauckhorst (w/o enclosures)
Mr. J. T. Gasser (w/o enclosures)
Mr. D. H. Jones (w/o enclosures)
Mr. J. R. Johnson (w/o enclosures)
Mr. D. R. Madison Mr. D. M. Lloyd Mr. B. H. Whitley Mr. C. R. Pierce Mr. D. L. Fulton Mr. M. J. Yox Mr. J. C. Harrelson Mr. W. A Sparkman Mr. J.P. Redd Mr. G. W. Gunn Document Services RTYPE: VND.LI.LOO File AR.01.02.06 Nuclear Regulatory Commission Mr. V. M. McCree (w/o enclosures)
Mr. M. Delligatti (w/o enclosures)
Mr. L. Burkhart (w/o enclosures)
Mr. D. H. Jaffe Mr. C. Patel Ms. D. L. McGovern Mr. B. M. Bavol Ms. R. Reyes Ms. M. A Sutton Mr. M. E. Ernstes Mr. G. Khouri Mr. L. M. Cain Mr. J. D. Fuller Mr. C. B. Abbott Mr. C. Huffman Ms. S. Temple Oglethorpe Power Corporation Mr. M. W. Price Ms. K. T. Haynes Ms. A Whaley

U.S. Nuclear Regulatory Commission ND-14-2009 Page 3 of 3 Municipal Electric Authority of Georgia Mr. J. E. Fuller Mr. S. M. Jackson Dalton Utilities Mr. D. Cope CB&I Mr. J. Simmons (w/o enclosures)
Ms. K. Stoner (w/o enclosures)
Mr. C. A. Castell Westinghouse Electric Company, LLC Mr. T. C. Geer (w/o enclosures)
Mr. S. W. Gray (w/o enclosures)
Mr. L. Woodcock Mr. P. A. Russ Mr. G. F. Couture Mr. M. Y. Shaqqo Mr. B. J. Bedford Mr. M. P. Rubin Ms. S. DiTommaso Other Mr. R. W. Prunty, Bechtel Power Corporation Ms. K. K. Patterson, Tetra Tech NUS, Inc.
Dr. W. R. Jacobs, Jr., Ph.D., GDS Associates, Inc.
Mr. S. Roetger, Georgia Public Service Commission Ms. S. W. Kernizan, Georgia Public Service Commission Mr. K. C. Greene, Troutman Sanders Mr. S. Blanton, Balch Bingham Mr. R. Grumbir, APOG

Southern Nuclear Operating Company ND-14-2009 Enclosure Vogtle Electric Generating Plant (VEGP) Units 1 - 4 10 CFR 26.719(c) Report:
False Negative Results for a Blind Performance Test Sample

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure Vogtle Electric Generating Plant HHS Laboratory Blind Performance Error

==
Introduction:==

10 CFR 26.719(c)(1), "Drug and alcohol testing errors", describes the requirements for reporting Fitness for Duty (FFD) drug testing errors or unsatisfactory performance discovered at any Health and Human Services (HHS) certified laboratory or licensee testing facility. Any identified errors involving false negative test results must be reported to the NRC within 30 days of completing an investigation in accordance with 10 CFR 26.719(c). Southern Nuclear Operating Company (SNC) performs on-site analysis of urine specimens at each of its nuclear plant sites.
Laboratory Corporation of America (LabCorp) is utilized for analysis of urine specimens collected at SNC Corporate headquarters and to perform confirmation testing for initial positive drug tests when analyzed on-site by SNC FFD personnel.
On September 28, 2014, the Medical Services Supervisor at Plant Vogtle performed on-site analysis of a blind performance specimen and verified the initial positive results for phencyclidine (PCP). The specimen was prepared for shipment and was received for testing at LabCorp on September 30, 2014. Specimen ID 011150869 was assigned by LabCorp and testing was completed on October 2, 2014. LabCorp released the specimen to SNC with a negative result. SNC's Medical Services Supervisor contacted the laboratory on October 2, 2014 to inform the laboratory that the specimen was a blind performance specimen for PCP with a target concentration of 37.5 ng/mL and the expected result was not reported. The Laboratory initiated an investigation into the incident.
Investigation Summary:
On September 28, 2014, the Medical Services Supervisor selected a blind specimen to analyze in accordance with SNC procedures. The specimen was analyzed and confirmed as an initial positive for phencyclidine. This specimen was prepared for shipment to the HHS certified laboratory, LabCorp, for further confirmation. The specimen was received at LabCorp on September 30, 2014 and assigned Specimen ID 0111550869. The initial test of the specimen was positive at LabCorp for phencyclidine and negative for all other drugs on immunoassay.
The specimen was scheduled for GC/MS (Gas Chromatography-Mass Spectrometry) confirmation testing on September 30, 2014. The specimen was aliquoted, extracted and analyzed on October 1, 2014. The specimen was tested in PCP batch 199636 and received a confirmation result of 14 ng/mL which is below the cutoff of 25 ng/mL and was reported as negative on October 2, 2014.
The Vogtle Medical Services Supervisor contacted the laboratory on October 2, 2014 and notified the laboratory responsible person that the specimen was a blind performance specimen and the expected results were not obtained. Use of LabCorp was immediately suspended pending the outcome of the investigation. The laboratory initiated an investigation into the incident on October 2, 2014. The laboratory had not discarded the original specimens. As part of the investigation, the samples from this PCP batch were re-injected on two different GC/MS instruments. The data from the two additional GC/MS runs was analyzed and all parameters were found acceptable, including calibration, and quality control specimens. The batch contained four (4) specimens, three of which contained no drug and matched the data from the original GC/MS run. However, Specimen ID 0111550869 was quantitated at 36 ng/mL and

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure 30ng/ml on the additional GC/MS instruments. The specimen was not re-injected on the original GC/MS instrument as it was out of service for maintenance.
The laboratory used a separate aliquot and repeated the extraction and analysis of PCP for Specimen ID 0111550869 (Batch 27501) on all three GC/MS instruments, including the original instrument post maintenance. The confirmation results were all consistent between the three instruments and ranged from 34-37 ng/ml. All calibration, quality control, recovery, and documentation were found acceptable. The instrument log for the original GC/MS instrument showed that the instrument was taken out of service shortly after PCP batch 199636 was completed and prior to analysis of any other batch. The GC/MS technologist was unable to achieve the daily auto-tune of the instrument and upon further investigation revealed a crack in the GC/MS column which caused leaking at the interface between the Gas Chromatograph and the Mass Spectrometer. As part of the corrective action, the GC/MS source was cleaned and a new column was installed on the instrument.
Based on the laboratory investigation which was released on October 14, 2014, the corrective actions initiated were the replacement of the GC/MS column and the implementation of a quality control specimen injection at the end of each batch to ensure acceptable instrument performance throughout the analysis of each batch.
SNC contracted with an independent Forensic Toxicologist, to oversee the investigation and to review the investigation results released by LabCorp. The results of the initial investigation were rejected by the independent reviewer and SNC due to the lack of depth and broadness review. This decision was based on the fact that the laboratory had an earlier PCP blind performance issue at Plant Hatch on July 4, 2014 in which an extraction technician inadvertently failed to utilize the correct amount during the extraction of the specimen. This in turn led to the incorrect result being reported to SNC. SNC requested LabCorp conduct a more thorough investigation to include a broadness review of the PCP analysis at the laboratory. This was communicated to the laboratory on October 31, 2014.
LabCorp immediately initiated a new investigation into the PCP issues at its facility. The second investigation report was released to SNC on November 20, 2014. This investigation report was reviewed by the independent Forensic Toxicologist and SNC and was found to be acceptable on December 1, 2014.
Corrective Actions:
: 1. Addition of a quality control specimen injected as the last sample of each confirmation batch.
: 2. Extractors will be required to complete a Visual Verification of Volumes sheet for each batch.
: 3. NRC sample numbers will be manually identified either when the batch is created or prior to certification and reporting.
: 4. Internal Standard Abundance criteria will be applied to NRC samples, i.e. any NRC sample with internal standard that is not within 50-200% of the calibrator and quality controls will be repeated in accordance with HHS/DOT guidelines.
: 5. An up-front dilution of 1:5 has been added to the SOP for PCP when the initial test result is equal to or greater than 100. This was instituted because samples with high

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure concentrations of PCP must be re-extracted due to column overloading. This dilution based on initial results is currently in place for THC and Cocaine confirmation assays.
: 6. NRC samples initially testing positive for THC, Cocaine, and PCP that confirm negative will be repeated and the entire batch held until the repeat is complete and still negative.
If the repeat does not correlate with the extraction, the whole batch will be repeated. In accordance with HHS/DOT guidelines, this is currently done for THC and Cocaine.
: 7. Vogtle FFD will increase the number of blind performance specimens submitted to the HHS lab from one percent (1 %) of all specimens sent to the HHS lab, to two percent (2%) for 30 days and review the results to verify that the laboratory corrective actions were effective.

==
Conclusions:==

Recently, SNC has identified blind performance testing errors with PCP at LabCorp. SNC Letter NL-14-1245 was previously submitted documenting a July 2014 lab error on a Hatch blind specimen. The second error, as outlined in this 30-day report, involved a failure of an instrument at the HHS laboratory. An independent investigation documented that LabCorp has instituted policies and procedures to address Corrective Actions 1-6 above. SNC has initiated actions (Corrective Action 7) increasing the number of blind samples sent to the HHS lab to verify that the laboratory corrective actions were effective. The investigation and corrective actions adequately address the false negative result and have strengthened the testing process.
These measures are deemed adequate to prevent recurrence of this type of problem.

Jeffrey T. Gasser             Southern Nuclear Executive Vice President      Operating Company, Inc.
Operational Readiness &
Site Integration              7825 River Road Plant Vogtle Units 3&4        Waynesboro, GA 30830 Tel 706.437-6700 SOUTHERN Fax 706-826-5796                                COMPANY jtgasser@southernco.com December 17, 2014 Docket Nos.:           05-424          52-025                                            ND-14-2009 05-425          52-026 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Southern Nuclear Operating Company Vogtle Electric Generating Plant (VEGP) Units 1 - 4 10 CFR 26.719(c) Report:
False Negative Results for a Blind Performance Test Sample Ladies and Gentlemen:
In accordance with the requirements of 10 CFR 26.719(c), Southern Nuclear Operating Company hereby submits the enclosed Report.
This letter contains no regulatory commitments .           If you have any questions, please contact Michael Yox at 706-826-6459.
Respectfully submitted, 1~.LtJ~
Executive Vice President Operational Readiness & Site Integration JTG/MJY/sdc

==Enclosure:==
10 CFR 26.719(c) Report

U.S. Nuclear Regulatory Commission ND-14-2009 Page 2 of 3 cc:
Southern Nuclear Operating Company I Georgia Power Company Mr. S. E. Kuczynski (w/o enclosures)
Mr. J. A Miller Mr. D. G. Bost (w/o enclosures)
Mr. B. K. Taber (w/o enclosures)
Mr. B. L. lvey Mr. M. D. Meier Mr. M. D. Rauckhorst (w/o enclosures)
Mr. J. T. Gasser (w/o enclosures)
Mr. D. H. Jones (w/o enclosures)
Mr. J. R. Johnson (w/o enclosures)
Mr. D. R. Madison Mr. D. M. Lloyd Mr. B. H. Whitley Mr. C. R. Pierce Mr. D. L. Fulton Mr. M. J. Yox Mr. J. C. Harrelson Mr. W. A Sparkman Mr. J.P. Redd Mr. G. W. Gunn Document Services RTYPE: VND.LI.LOO File AR.01.02.06 Nuclear Regulatory Commission Mr. V. M. McCree (w/o enclosures)
Mr. M. Delligatti (w/o enclosures)
Mr. L. Burkhart (w/o enclosures)
Mr. D. H. Jaffe Mr. C. Patel Ms. D. L. McGovern Mr. B. M. Bavol Ms. R. Reyes Ms. M. A Sutton Mr. M. E. Ernstes Mr. G. Khouri Mr. L. M. Cain Mr. J. D. Fuller Mr. C. B. Abbott Mr. C. Huffman Ms. S. Temple Oglethorpe Power Corporation Mr. M. W. Price Ms. K. T. Haynes Ms. A Whaley

U.S. Nuclear Regulatory Commission ND-14-2009 Page 3 of 3 Municipal Electric Authority of Georgia Mr. J. E. Fuller Mr. S. M. Jackson Dalton Utilities Mr. D. Cope CB&I Mr. J. Simmons (w/o enclosures)
Ms. K. Stoner (w/o enclosures)
Mr. C. A. Castell Westinghouse Electric Company, LLC Mr. T. C. Geer (w/o enclosures)
Mr. S. W. Gray (w/o enclosures)
Mr. L. Woodcock Mr. P. A. Russ Mr. G. F. Couture Mr. M. Y. Shaqqo Mr. B. J. Bedford Mr. M. P. Rubin Ms. S. DiTommaso Other Mr. R. W. Prunty, Bechtel Power Corporation Ms. K. K. Patterson, Tetra Tech NUS, Inc.
Dr. W. R. Jacobs, Jr., Ph.D., GDS Associates, Inc.
Mr. S. Roetger, Georgia Public Service Commission Ms. S. W. Kernizan, Georgia Public Service Commission Mr. K. C. Greene, Troutman Sanders Mr. S. Blanton, Balch Bingham Mr. R. Grumbir, APOG

Southern Nuclear Operating Company ND-14-2009 Enclosure Vogtle Electric Generating Plant (VEGP) Units 1 - 4 10 CFR 26.719(c) Report:
False Negative Results for a Blind Performance Test Sample

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure Vogtle Electric Generating Plant HHS Laboratory Blind Performance Error

==
Introduction:==

10 CFR 26.719(c)(1), "Drug and alcohol testing errors", describes the requirements for reporting Fitness for Duty (FFD) drug testing errors or unsatisfactory performance discovered at any Health and Human Services (HHS) certified laboratory or licensee testing facility. Any identified errors involving false negative test results must be reported to the NRC within 30 days of completing an investigation in accordance with 10 CFR 26.719(c). Southern Nuclear Operating Company (SNC) performs on-site analysis of urine specimens at each of its nuclear plant sites.
Laboratory Corporation of America (LabCorp) is utilized for analysis of urine specimens collected at SNC Corporate headquarters and to perform confirmation testing for initial positive drug tests when analyzed on-site by SNC FFD personnel.
On September 28, 2014, the Medical Services Supervisor at Plant Vogtle performed on-site analysis of a blind performance specimen and verified the initial positive results for phencyclidine (PCP). The specimen was prepared for shipment and was received for testing at LabCorp on September 30, 2014. Specimen ID 011150869 was assigned by LabCorp and testing was completed on October 2, 2014. LabCorp released the specimen to SNC with a negative result. SNC's Medical Services Supervisor contacted the laboratory on October 2, 2014 to inform the laboratory that the specimen was a blind performance specimen for PCP with a target concentration of 37.5 ng/mL and the expected result was not reported. The Laboratory initiated an investigation into the incident.
Investigation Summary:
On September 28, 2014, the Medical Services Supervisor selected a blind specimen to analyze in accordance with SNC procedures. The specimen was analyzed and confirmed as an initial positive for phencyclidine. This specimen was prepared for shipment to the HHS certified laboratory, LabCorp, for further confirmation. The specimen was received at LabCorp on September 30, 2014 and assigned Specimen ID 0111550869. The initial test of the specimen was positive at LabCorp for phencyclidine and negative for all other drugs on immunoassay.
The specimen was scheduled for GC/MS (Gas Chromatography-Mass Spectrometry) confirmation testing on September 30, 2014. The specimen was aliquoted, extracted and analyzed on October 1, 2014. The specimen was tested in PCP batch 199636 and received a confirmation result of 14 ng/mL which is below the cutoff of 25 ng/mL and was reported as negative on October 2, 2014.
The Vogtle Medical Services Supervisor contacted the laboratory on October 2, 2014 and notified the laboratory responsible person that the specimen was a blind performance specimen and the expected results were not obtained. Use of LabCorp was immediately suspended pending the outcome of the investigation. The laboratory initiated an investigation into the incident on October 2, 2014. The laboratory had not discarded the original specimens. As part of the investigation, the samples from this PCP batch were re-injected on two different GC/MS instruments. The data from the two additional GC/MS runs was analyzed and all parameters were found acceptable, including calibration, and quality control specimens. The batch contained four (4) specimens, three of which contained no drug and matched the data from the original GC/MS run. However, Specimen ID 0111550869 was quantitated at 36 ng/mL and

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure 30ng/ml on the additional GC/MS instruments. The specimen was not re-injected on the original GC/MS instrument as it was out of service for maintenance.
The laboratory used a separate aliquot and repeated the extraction and analysis of PCP for Specimen ID 0111550869 (Batch 27501) on all three GC/MS instruments, including the original instrument post maintenance. The confirmation results were all consistent between the three instruments and ranged from 34-37 ng/ml. All calibration, quality control, recovery, and documentation were found acceptable. The instrument log for the original GC/MS instrument showed that the instrument was taken out of service shortly after PCP batch 199636 was completed and prior to analysis of any other batch. The GC/MS technologist was unable to achieve the daily auto-tune of the instrument and upon further investigation revealed a crack in the GC/MS column which caused leaking at the interface between the Gas Chromatograph and the Mass Spectrometer. As part of the corrective action, the GC/MS source was cleaned and a new column was installed on the instrument.
Based on the laboratory investigation which was released on October 14, 2014, the corrective actions initiated were the replacement of the GC/MS column and the implementation of a quality control specimen injection at the end of each batch to ensure acceptable instrument performance throughout the analysis of each batch.
SNC contracted with an independent Forensic Toxicologist, to oversee the investigation and to review the investigation results released by LabCorp. The results of the initial investigation were rejected by the independent reviewer and SNC due to the lack of depth and broadness review. This decision was based on the fact that the laboratory had an earlier PCP blind performance issue at Plant Hatch on July 4, 2014 in which an extraction technician inadvertently failed to utilize the correct amount during the extraction of the specimen. This in turn led to the incorrect result being reported to SNC. SNC requested LabCorp conduct a more thorough investigation to include a broadness review of the PCP analysis at the laboratory. This was communicated to the laboratory on October 31, 2014.
LabCorp immediately initiated a new investigation into the PCP issues at its facility. The second investigation report was released to SNC on November 20, 2014. This investigation report was reviewed by the independent Forensic Toxicologist and SNC and was found to be acceptable on December 1, 2014.
Corrective Actions:
: 1. Addition of a quality control specimen injected as the last sample of each confirmation batch.
: 2. Extractors will be required to complete a Visual Verification of Volumes sheet for each batch.
: 3. NRC sample numbers will be manually identified either when the batch is created or prior to certification and reporting.
: 4. Internal Standard Abundance criteria will be applied to NRC samples, i.e. any NRC sample with internal standard that is not within 50-200% of the calibrator and quality controls will be repeated in accordance with HHS/DOT guidelines.
: 5. An up-front dilution of 1:5 has been added to the SOP for PCP when the initial test result is equal to or greater than 100. This was instituted because samples with high

U.S. Nuclear Regulatory Commission ND-14-2009 Enclosure concentrations of PCP must be re-extracted due to column overloading. This dilution based on initial results is currently in place for THC and Cocaine confirmation assays.
: 6. NRC samples initially testing positive for THC, Cocaine, and PCP that confirm negative will be repeated and the entire batch held until the repeat is complete and still negative.
If the repeat does not correlate with the extraction, the whole batch will be repeated. In accordance with HHS/DOT guidelines, this is currently done for THC and Cocaine.
: 7. Vogtle FFD will increase the number of blind performance specimens submitted to the HHS lab from one percent (1 %) of all specimens sent to the HHS lab, to two percent (2%) for 30 days and review the results to verify that the laboratory corrective actions were effective.

==
Conclusions:==

Recently, SNC has identified blind performance testing errors with PCP at LabCorp. SNC Letter NL-14-1245 was previously submitted documenting a July 2014 lab error on a Hatch blind specimen. The second error, as outlined in this 30-day report, involved a failure of an instrument at the HHS laboratory. An independent investigation documented that LabCorp has instituted policies and procedures to address Corrective Actions 1-6 above. SNC has initiated actions (Corrective Action 7) increasing the number of blind samples sent to the HHS lab to verify that the laboratory corrective actions were effective. The investigation and corrective actions adequately address the false negative result and have strengthened the testing process.
These measures are deemed adequate to prevent recurrence of this type of problem.}}