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.
