ENS 49857

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v t e ENS Event
13:30 Feb 26, 2014
Title	24 Hour Fitness-For-Duty Report Involving False Negative Errors During Quality Assurance Testing
Event Description	Contrary to the requirements in 10 CFR 26.137(b), a DHHS [Department of Health and Human Services] certified laboratory returned results for a blind specimen that were inconsistent with what was expected. On 02/25/2014, dilute blind specimens from the same lot # were sent to the three contracted DHHS laboratories. Upon review by the Callaway MRO [Medical Review Officer] at approximately 07:30 [CST] on 2/26/2014, it was discovered that one of the laboratories (Toxicology) reported results of negative. That result was inconsistent with the certification received from the blind provider (ProTox) certifying the specimen as negative and dilute. Later in the day on 2/26/14, the remaining two labs (Quest and CRL) also returned results of negative instead of negative and dilute. 10 CFR 26.719(c)(3), reporting requirements requires that 'If a false negative error occurs on a quality assurance check of validity screening tests, as required in � 26.137(b), the licensee or other entity shall notify the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of the error.' While it initially appears that the blind specimen certification provided by ProTox may be in error, since all three DHHS labs obtained the same testing result, additional investigation is necessary. This report is being made conservatively until the cause can be determined. The licensee informed the NRC Resident Inspector.

ENS 49857 +/-
Where
Callaway Missouri (NRC Region 4)
Reporting

10 CFR 26.719, FFD Reporting requirements
Time - Person (Reporting Time:+4.8 h0.2 days <br />0.0286 weeks <br />0.00658 months <br />)
Opened:	David Hurt 18:18 Feb 26, 2014
NRC Officer:	Steve Sandin
Last Updated:	Feb 26, 2014
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v • d • e

v t e Emergency Notification System
Callaway with 10 CFR 26.719, FFD Reporting requirements
WEEKMONTHYEAR2023-09-06T13:30:00 [Table view]
[ENS list for Callaway]

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