NRC-2017-0012, Submitting 10 CFR 26.719(c) Report on Inaccurate Reporting of Laboratory Test Result: Difference between revisions
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{{#Wiki_filter:February 24, 2017 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Point Beach Nuclear Plant, Units 1 and 2 Dockets 50-266 and 50-301 License Nos. DPR-24 and DPR-27 10 CFR 26.719.(c) | {{#Wiki_filter:February 24, 2017 NRC 2017-0012 10 CFR 26.719(c) | ||
Report Inaccurate Reporting of Laboratory Test Result | U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Point Beach Nuclear Plant, Units 1 and 2 Dockets 50-266 and 50-301 License Nos. DPR-24 and DPR-27 10 CFR 26.719.(c) Report Inaccurate Reporting of Laboratory Test Result Pursuant to 10 CFR 26.719(c), drug and alcohol testing errors, NextEra Energy Point Beach, LLC (NextEra), is submitting information for Point Beach Nuclear Plant, Units 1 and 2 (PBNP), | ||
Pursuant to 10 CFR 26.719(c), drug and alcohol testing errors, NextEra Energy Point Beach, LLC (NextEra), is submitting information for Point Beach Nuclear Plant, Units 1 and 2 (PBNP), concerning NextEra DHHS-certified laboratory reporting a false positive test result. 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. The enclosure to this letter provides information and details concerning the reporting of a false positive laboratory test result and the associated corrective actions. This letter contains no new or revised regulatory commitments. | concerning NextEra DHHS-certified laboratory reporting a false positive test result. | ||
Sincerely, NextEra Energy Point Beach, LLC I Robert Coffey Site Vice President Enclosure cc: Regional Administrator, Region Ill, USNRC Project Manager, Point Beach Nuclear Plant, USNRC Resident Inspector, Point Beach Nuclear Plant, USNRC NextEra Energy Point Beach, LLC 6610 Nuclear Road, Two Rivers, WI 54241 ENCLOSURE NEXTERA ENERGY POINT BEACH, LLC POINT BEACH NUCLEAR PLANT, UNIT 1 INACCURATE REPORTING OF LABORATORY TEST RESULT Introduction On January 24, 2017, a pre-access drug test was completed at Point Beach Nuclear Plant (PBNP). The specimen was submitted to NextEra approved DHHS Certified Laboratory, Quest Diagnostic Laboratory in Lenexa Kansas. On January 30, 2017, the NextEra Medical Review Officer (MRO) received the printed laboratory result on the specimen in question. | 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. | ||
The results indicated that the specimen results were positive. | The enclosure to this letter provides information and details concerning the reporting of a false positive laboratory test result and the associated corrective actions. | ||
The MRO had questions pertaining to the information on the laboratory result and contacted the laboratory director for clarification. | This letter contains no new or revised regulatory commitments. | ||
After investigation, the laboratory director contacted the MRO and stated the results were in error, and should have been reported as negative. | Sincerely, NextEra Energy Point Beach, LLC I | ||
An investigation was performed. | Robert Coffey Site Vice President Enclosure cc: Regional Administrator, Region Ill, USNRC Project Manager, Point Beach Nuclear Plant, USNRC Resident Inspector, Point Beach Nuclear Plant, USNRC NextEra Energy Point Beach, LLC 6610 Nuclear Road, Two Rivers, WI 54241 | ||
The details of this investigation are summarized below. Investigation Summary The NextEra DHHS certified laboratory, Quest Diagnostic Laboratory, received specimen 1851640 on January 25, 2017. The testing panel ordered required immunoassay screening for the federal 5-panel of drugs of abuse and, regardless of screening results, quantitative confirmatory testing for cocaine metabolite and marijuana metabolite. | |||
Per the testing panel requirements, quantitative results for these two metabolites are to be reported if the result was equal to or higher than the laboratory's administrative reporting level for the metabolites. | ENCLOSURE NEXTERA ENERGY POINT BEACH, LLC POINT BEACH NUCLEAR PLANT, UNIT 1 INACCURATE REPORTING OF LABORATORY TEST RESULT | ||
If the quantitative results are less than the reporting level (laboratory's lowest administrative quantitative reporting level for benzoylecgonine) the result should be reported as Negative. | |||
The investigation confirmed that the certifying scientist did not apply the administrative reporting level to the result and inadvertently reported the quantitative benzolyecgonine result as positive both electronically and on the custody and control form on January 28, 2017. Based upon the reporting criteria of this panel for benzolyecgonine, the certifying scientist should have reported the results of the laboratory quantitative testing for cocaine metabolite as negative. | Introduction On January 24, 2017, a pre-access drug test was completed at Point Beach Nuclear Plant (PBNP). The specimen was submitted to NextEra approved DHHS Certified Laboratory, Quest Diagnostic Laboratory in Lenexa Kansas. On January 30, 2017, the NextEra Medical Review Officer (MRO) received the printed laboratory result on the specimen in question. The results indicated that the specimen results were positive. The MRO had questions pertaining to the information on the laboratory result and contacted the laboratory director for clarification. After investigation, the laboratory director contacted the MRO and stated the results were in error, and should have been reported as negative. An investigation was performed. The details of this investigation are summarized below. | ||
A corrected report was issued for the specimen on January 30, 2017. The laboratory's investigation confirmed that the confirmatory test data reviewer and certifying scientist failed to verify the administrative reporting level prior to releasing the report. In this panel, the interpretation and reporting of the quantitative results for the two metabolites, for which "level of detection" testing is performed, is a manual process. Both the reviewer and certifying scientist are therefore required to verify the laboratory's administrative reporting level prior to releasing the laboratory test report. Corrective Actions The laboratory has addressed the issue with both the individual reviewer and certifying scientist and appropriate corrective actions have been completed, which included re-training (with all of the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.). | Investigation Summary The NextEra DHHS certified laboratory, Quest Diagnostic Laboratory, received specimen 1851640 on January 25, 2017. The testing panel ordered required immunoassay screening for the federal 5-panel of drugs of abuse and, regardless of screening results, quantitative confirmatory testing for cocaine metabolite and marijuana metabolite. Per the testing panel requirements, quantitative results for these two metabolites are to be reported if the result was equal to or higher than the laboratory's administrative reporting level for the metabolites. If the quantitative results are less than the reporting level (laboratory's lowest administrative quantitative reporting level for benzoylecgonine) the result should be reported as Negative. | ||
In addition, the laboratory has conducted an in-service training with all the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.}} | The investigation confirmed that the certifying scientist did not apply the administrative reporting level to the result and inadvertently reported the quantitative benzolyecgonine result as positive both electronically and on the custody and control form on January 28, 2017. Based upon the reporting criteria of this panel for benzolyecgonine, the certifying scientist should have reported the results of the laboratory quantitative testing for cocaine metabolite as negative. A corrected report was issued for the specimen on January 30, 2017. | ||
The laboratory's investigation confirmed that the confirmatory test data reviewer and certifying scientist failed to verify the administrative reporting level prior to releasing the report. In this panel, the interpretation and reporting of the quantitative results for the two metabolites, for which "level of detection" testing is performed, is a manual process. Both the reviewer and certifying scientist are therefore required to verify the laboratory's administrative reporting level prior to releasing the laboratory test report. | |||
Corrective Actions The laboratory has addressed the issue with both the individual reviewer and certifying scientist and appropriate corrective actions have been completed, which included re-training (with all of the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.). In addition, the laboratory has conducted an in-service training with all the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.}} | |||
Latest revision as of 07:39, 30 October 2019
| ML17058A038 | |
| Person / Time | |
|---|---|
| Site: | Point Beach  |
| Issue date: | 02/24/2017 |
| From: | Coffey R Point Beach |
| To: | Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| NRC-2017-0012 | |
| Download: ML17058A038 (3) | |
Text
February 24, 2017 NRC 2017-0012 10 CFR 26.719(c)
U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Point Beach Nuclear Plant, Units 1 and 2 Dockets 50-266 and 50-301 License Nos. DPR-24 and DPR-27 10 CFR 26.719.(c) Report Inaccurate Reporting of Laboratory Test Result Pursuant to 10 CFR 26.719(c), drug and alcohol testing errors, NextEra Energy Point Beach, LLC (NextEra), is submitting information for Point Beach Nuclear Plant, Units 1 and 2 (PBNP),
concerning NextEra DHHS-certified laboratory reporting a false positive test result.
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.
The enclosure to this letter provides information and details concerning the reporting of a false positive laboratory test result and the associated corrective actions.
This letter contains no new or revised regulatory commitments.
Sincerely, NextEra Energy Point Beach, LLC I
Robert Coffey Site Vice President Enclosure cc: Regional Administrator, Region Ill, USNRC Project Manager, Point Beach Nuclear Plant, USNRC Resident Inspector, Point Beach Nuclear Plant, USNRC NextEra Energy Point Beach, LLC 6610 Nuclear Road, Two Rivers, WI 54241
ENCLOSURE NEXTERA ENERGY POINT BEACH, LLC POINT BEACH NUCLEAR PLANT, UNIT 1 INACCURATE REPORTING OF LABORATORY TEST RESULT
Introduction On January 24, 2017, a pre-access drug test was completed at Point Beach Nuclear Plant (PBNP). The specimen was submitted to NextEra approved DHHS Certified Laboratory, Quest Diagnostic Laboratory in Lenexa Kansas. On January 30, 2017, the NextEra Medical Review Officer (MRO) received the printed laboratory result on the specimen in question. The results indicated that the specimen results were positive. The MRO had questions pertaining to the information on the laboratory result and contacted the laboratory director for clarification. After investigation, the laboratory director contacted the MRO and stated the results were in error, and should have been reported as negative. An investigation was performed. The details of this investigation are summarized below.
Investigation Summary The NextEra DHHS certified laboratory, Quest Diagnostic Laboratory, received specimen 1851640 on January 25, 2017. The testing panel ordered required immunoassay screening for the federal 5-panel of drugs of abuse and, regardless of screening results, quantitative confirmatory testing for cocaine metabolite and marijuana metabolite. Per the testing panel requirements, quantitative results for these two metabolites are to be reported if the result was equal to or higher than the laboratory's administrative reporting level for the metabolites. If the quantitative results are less than the reporting level (laboratory's lowest administrative quantitative reporting level for benzoylecgonine) the result should be reported as Negative.
The investigation confirmed that the certifying scientist did not apply the administrative reporting level to the result and inadvertently reported the quantitative benzolyecgonine result as positive both electronically and on the custody and control form on January 28, 2017. Based upon the reporting criteria of this panel for benzolyecgonine, the certifying scientist should have reported the results of the laboratory quantitative testing for cocaine metabolite as negative. A corrected report was issued for the specimen on January 30, 2017.
The laboratory's investigation confirmed that the confirmatory test data reviewer and certifying scientist failed to verify the administrative reporting level prior to releasing the report. In this panel, the interpretation and reporting of the quantitative results for the two metabolites, for which "level of detection" testing is performed, is a manual process. Both the reviewer and certifying scientist are therefore required to verify the laboratory's administrative reporting level prior to releasing the laboratory test report.
Corrective Actions The laboratory has addressed the issue with both the individual reviewer and certifying scientist and appropriate corrective actions have been completed, which included re-training (with all of the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.). In addition, the laboratory has conducted an in-service training with all the confirmatory and certification staffs reviewing this issue to ensure results are properly reported in the future.