ML23067A087
| ML23067A087 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/2023 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| Download: ML23067A087 (8) | |
Text
Presentation to the Drug Testing Advisory Board (HHS/SAMHSA)
Program Updates U.S. Nuclear Regulatory Commission Fitness for Duty Programs - 10 CFR Part 26 March 7, 2023
Discussion Topics Rulemaking Update - 10 CFR Part 26 Final Rule FFD Program Performance Trend Update - Subversion Trends HHS-Certified Laboratory Performance Slide 2
Rulemaking Updates -
10 CFR Part 26 Final Rule Slide 3 Final Rule published in the Federal Register on November 22, 2022 (87 FR 71422) o Rule changes effective: December 22, 2022 o Compliance required by: November 22, 2023 Aligns urine drug testing panel and cutoff levels with revisions to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs issued in 2008 and 2017.
Provides option to collect and test an oral fluid specimen for direct observation collections. Must use an HHS-certified laboratory to perform testing per the HHS Mandatory Guidelines for Federal Workplace Drug Testing of Oral Fluid.
Includes lessons learned enhancements to strengthen subversion detection methods by mandating special analyses testing of specimens under certain testing conditions.
A track changes version of Part 26 identifying the final rule changes is available at:
https://www.ecfr.gov/compare/current/to/2022-11-21/title-10/chapter-I/part-26
Rulemaking Updates -
10 CFR Part 26 Final Rule Slide 4 Changes impacting HHS-certified laboratories (appear in 10 CFR 26.163)
Adds initial and confirmatory drug testing for:
hydrocodone, hydromorphone, oxycodone, oxymorphone, MDMA, and MDA Adds initial drug testing for 6-acetylmorphine (6-AM) and updates the confirmatory drug testing method for 6-AM Lowers initial and confirmatory cutoffs for:
amphetamine, cocaine metabolite, and methamphetamine Updates and expands special analyses testing (i.e., using lower drug testing cutoff levels under certain testing conditions).
Required: Dilute specimens AND specimens collected under direct observation When the initial drug test concentration is within 40% of cutoff level Then conduct confirmatory testing to the Limit of Quantitation (LOQ)
HHS distributed a National Laboratory Certification Program (NLCP) Notice on the 10 CFR Part 26 Final Rule on February 9, 2023.
Subversion Attempt Trends (2017-2022)
Subversion attempt: Any willful act or attempted act to cheat on a required test (e.g., refuse to provide a specimen, alter a specimen with an adulterant, provide a specimen that is not from the donors body) 2017 2018 2019 2020 2021 2022*
Number of Subversion Attempts 305 298 307 288 274 264 Percentage of Drug Testing Violations 31.9%
31.0%
34.5%
34.4%
29.2%
29.6%
Identified at Pre-access Testing 67.5%
77.5%
73.3%
74.7%
71.9%
76.2%
Committed by Contractor/Vendors 97.7%
95.6%
97.4%
96.2%
94.5%
93.6%
Percentage of Sites Reporting At Least One Subversion 64%
70%
61%
70%
70%
75%
- Draft data (2022 reporting cycle closed on February 28, 2023)
Subversion attempt sanction:
Permanent denial unescorted access, 10 CFR 26.75(b)
Slide 5
HHS-Certified Laboratory Performance, 2022 10 CFR 26.719 day event reports 1)
Concentration of marijuana metabolite in a blind performance test sample (BPTS) was not within 30% of the target concentration (February 2022).
Deterioration of the calibrator material resulted in a higher drug concentration.
The specimen was reanalyzed with a new calibrator and the result was within the target concentration.
2)
Concentration of marijuana metabolite in a BPTS was not within 30% of the target concentration (July 2022). The discrepant result was isolated random variability in the assay.
3)
Laboratory did not report test results within 5-business days of receipt, as required by 10 CFR 26.169(a) (February 2022). Delays due to quality control and batch failures that resulted in specimen testing on multiple confirmation batches.
4)
False-negative test result for a BPTS formulated to test positive for an expanded panel opioid (April 2022). An incorrect testing code (i.e., for the standard panel) was entered by the laboratory data entry operator.
Slide 6
HHS-Certified Laboratory Performance, 2022 10 CFR 26.719 day event reports 5)
An HHS-certified laboratory incorrectly sent 15 donor specimens to another one of its HHS-certified laboratories for testing (January 2022). Fourteen specimens were forwarded to the correct laboratory for testing. One specimen had already been tested and was discarded. The laboratory provided incorrect express mail shipping labels for the specimens.
6)
An HHS-certified laboratory incorrectly tested two donor specimens at another one of its HHS-certified laboratories (January 2022). Donor retest requests were made for both specimens, neither was shipped to another HHS-certified laboratory within 1-business day as required by 10 CFR 26.165(b)(5).
For one retest request, the specimen also was sent to the wrong HHS-certified laboratory. No information was provided on why the incorrect laboratory performed initial testing. The same laboratory technician processed the retest requests. High work volume and a data entry error resulted in the processing issues.
Slide 7
NRC Fitness for Duty Program Staff Slide 8 U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)
Paul Harris, Senior Program Manager Paul.Harris@nrc.gov (301-287-9294)