ULNRC-06371, Blind Test Specimens
| ML17131A165 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 05/11/2017 |
| From: | Mclachlan M Ameren Missouri |
| To: | Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| ULNRC-06371 | |
| Download: ML17131A165 (5) | |
Text
ULNRC-06371 May 11, 2017 Page 2 cc: Mr. Kriss M. Kennedy Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. L. John Klos Project Manager, Callaway Plant Office of Nuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop O8H4 Washington, DC 20555-0001 ULNRC-06371 May 11, 2017 Page 3 Index and send hardcopy to QA File A160.0761 Hardcopy: Certrec Corporation 6100 Western Place, Suite 1050 Fort Worth, TX 76107 (Certrec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed.) Electronic distribution for the following can be made via Other Situations ULNRC Distribution: F. M. Diya T. E. Herrmann B. L. Cox M. A. McLachlan B. Brown R. C. Wink T. B. Elwood A. E. Enloe M. W. Haglund Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. Jay Silberg (Pillsbury Winthrop Shaw Pittman LLP) Missouri Public Service Commission Enclosure to ULNRC-06371 May 11, 2017 Page 1 of 2 Blind Test Specimen Issue In June 2016, the Nuclear Oversight department at Callaway conducted an audit Fitness for Duty (FFD) program. It was identified from the audit that, over a period of time, Callaway had not been submitting quarterly blind specimens for all of the drug metabolites required to be tested under to the contracted HHS laboratories. This is contrary to the requirements of 10 CFR 26.168(b), Blind performance testing. Specifically, no blind performance specimens containing 6- Acetylmorphine (6-AM) or Codeine had been submitted since the 3rd quarter of 2014. A corrective action document was generated to document and evaluate the deficiency. ing blind specimens by the drug class vice each individual drug. This interpretation carried through to procedures and forms used in the FFD program. It appears the blind sampling program, as described in its administrative procedure, was never directly compared to the regulation wording. Corrective Actions: The blind specimen provider, at that time, was contacted to discuss the availability of all opiate types required. That provider was unable to supply specimens for all of the required drug metabolites. A new blind specimen provider (Elsohly laboratories) was acquired who was able to meet the regulatory requirements. The plant procedure for blind performance testing/sampling and associated forms were revised to ensure all drug metabolites included under the opiate and amphetamine classes are sent to the HHS laboratories as required. The revised procedure changes, applicable forms changes, and blind submittal process changes were reviewed with all FFD coordinators, medical staff, and FFD management. Reportability: At the time the issue was documented in a corrective action document, it was evaluated for reportability per 10 CFR 26.719(b), (c), and (d). It was concluded that the issue did not meet the reportability requirements under (b) significant FFD policy violations or programmatic failures or (c) drug and alcohol testing errors. It was considered a program weakness under (d) for which the licensee is required to document, trend, and correct the weakness in its corrective action program. During a recent NRC inspection of the Fitness for Duty program, the inspector identified that the situation described above, with respect to not submitting blind test specimens for each of the drugs that are required to be tested, should have been reported to the NRC per 10 CFR 26.719(c)(1).
Enclosure to ULNRC-06371 May 11, 2017 Page 2 of 2 10 CFR 26.719 states in part "(c) Drug and alcohol testing errors. (1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing ... as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. ... The inspector determined that the situation could adversely reflect on the integrity of the random selection or testing process. Consequently, a report required per 10 CFR 26.719(c) should have been However, in light of the NRC port is being submitted now. .