ML24334A032
| ML24334A032 | |
| Person / Time | |
|---|---|
| Issue date: | 12/03/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/AAFPB |
| To: | |
| References | |
| ML24334A027 | |
| Download: ML24334A032 (1) | |
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 December 3, 2024 Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)
Discussion Topics Slide 2 Invalid and Substituted Test Results (new and updated information)
HHS-Certified Laboratory Performance (30-day event reports - 10 CFR 26.719)
Rulemakings:
2022 Part 26 Final Rule (implementation)
Technical Issues Rulemaking Plan (with the NRC Commission)
Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors (proposed rule published October 31, 2024)
Invalid Test Results, 2023 Slide 3
- Operating experience demonstrates 5-8 invalid test results per year with the required directly observed 2nd specimen either drug positive or refused
- Significant increases in 2022 (13 invalids) and 2023 (22 invalids)
Reason for Testing Collection Date Reason for Test Explanation Labor Category Employment Type Outage Worker?
2nd Observed Specimen Result Pre-Access 01/31/23 Maintenance (general facility)
C/V Marijuana 02/07/23 Initial Authorization Facility Support C/V Yes Marijuana 02/09/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Marijuana 02/09/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 02/13/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 03/01/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 04/03/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 04/10/23 Initial Authorization Maintenance (general facility)
Employee No Marijuana 04/12/23 Initial Authorization Maintenance (general facility)
C/V Yes Marijuana 04/20/23 Initial Authorization Maintenance (general facility)
C/V No Testing Refusal 05/01/23 Initial Authorization Maintenance (general facility)
C/V Yes Marijuana 05/04/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Marijuana 05/17/23 Initial Authorization Maintenance (general facility)
Employee No Methamphetamine 08/08/23 Reinstate (31-365 days)
FFD Program Personnel C/V Yes Marijuana 08/09/23 Initial Authorization Maintenance (general facility)
C/V No Testing Refusal 08/30/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Testing Refusal 11/06/23 Initial Authorization Facility Support C/V No Testing Refusal Random 02/15/23 Other (Hanger Tech)
C/V No Testing Refusal 07/31/23 Supervisor C/V No Testing Refusal Followup 03/30/23 Potentially disqualifying FFD information (FFD PDI)
Maintenance (general facility)
C/V Yes Marijuana 04/10/23 Maintenance (general facility)
C/V Yes Marijuana 09/18/23 FFD PDI Maintenance (general facility)
C/V Yes Marijuana
Invalid Results, Examples (2023)
Example 1 (Pre-access test): 1st specimen invalid result (pH 10.18); donor refused 2nd observed collection, admitted to subverting the test, and stated theyd test positive for marijuana if tested.
Example 2 (Pre-access test): 1st specimen invalid result; 2nd non-observed specimen also invalid result; MRO directed 3rd specimen (observed) was positive for marijuana.
Example 3 (Pre-access test): 1st specimen invalid result; 2nd observed specimen tested to LOD was positive for marijuana. Donor was being processed for FFD program personnel role but hadnt completed the screening process (i.e., wasnt in role at time of the subversion determinization).
Example 4 (Random test): 1st specimen invalid result. During 2nd observed specimen collection, a device was discovered (a bag of yellowish fluid with a temperature strip adhered to the bag and wired with 2 batteries which appeared to warm the fluid).
Slide 4
Substituted Test Results, 2023 Slide 5
- Operating experience demonstrates 1-3 substituted urine specimen test results received from an HHS-certified laboratory each year.
- Significant increase in 2023, with at least 13 substituted test results Reason for Testing Collection Date Reason for Test Explanation Labor Category Employment Type Outage Worker?
Pre-Access 03/01/23 Initial Authorization Maintenance (general facility)
C/V Yes 03/22/23 Initial Authorization Maintenance (general facility)
C/V Yes 04/03/23 Maintenance (general facility)
C/V Yes 04/16/23 Reinstate (31-365 days)
Facility Support C/V Yes 05/01/23 Initial Authorization Maintenance (general facility)
C/V Yes 08/28/23 Initial Authorization Maintenance (general facility)
C/V No 10/02/23 Maintenance (general facility)
C/V 10/02/23 Maintenance (general facility)
C/V Yes 10/03/23 Initial Authorization Maintenance (general facility)
C/V 10/10/23 Facility Support C/V Yes Random 04/17/23 Facility Support C/V Yes 07/18/23 Facility Support C/V No Followup 12/11/23 FFD PDI Maintenance (general facility)
C/V No This exhibit originally was presented at the June 4, 2024, DTAB meeting. Providing updated information accounting for three additional substituted results (bolded).
HHS-Certified Laboratory Performance, 2024 10 CFR 26.719, 30-day event reports
- 1) False negative for a blind performance test sample (BPTS) formulated to return an adulterated validity test result (July 2024)
The HHS-certified laboratory investigation:
- Reviewed the initial drug and validity test results and reanalyzed the specimen.
The original testing was performed according to the standard operating procedures and the negative test result did not appear to be a result of specimen or aliquot misidentification based on consistent creatinine results.
- Reported that retesting of the specimen suggested that an unknown adulterant or other component from the preparation of the BPTS was not evenly mixed on the day it was received and that handling of the specimen at the laboratory during the investigation redistributed the adulterant (this statement was based on declining pH values for each successive screening test performed).
A second adulterated specimen from the same BPTS batch was sent to the laboratory in August 2024 and the correct adulterated test result was reported.
Slide 6
HHS-Certified Laboratory Performance, 2024 10 CFR 26.719, 30-day event reports
- 2) False negative BPTS formulated to test positive for hydrocodone and hydromorphone (August 2024)
- The HHS-certified laboratory determined that the false-negative result was due to a failure to maintain proper specimen identification during the confirmation process. The specimen was retested, and correct results were reported.
- The laboratory reported that it would:
retrain all staff in related departments on maintaining specimen identification (i.e., handle one sample at a time and verify the entire specimen identification number during each transfer step).
instruct certifying scientists to investigate hydrocodone/hydromorphone results that screen positive but confirm negative.
change its below threshold control (BTC) for opioid assays to contain only the opioids of interest for each assay. The BTC used by the laboratory for all opioid assays contained six opioids, which did not allow the laboratory to detect errors if batches were switched.
Slide 7
HHS-Certified Laboratory Performance, 2024 10 CFR 26.719, 30-day event reports
- 3) Special analyses testing was not performed on a donors urine specimen that was collected under direct observation (August 2024)
- A negative test result was reported for the donors observed urine specimen.
- The MRO determined that a subversion attempt had occurred because of differences in specimen temperature and creatinine concentration between the initial (unobserved) specimen and the donors observed 2nd specimen.
- MRO staff review of the laboratory test result for the observed specimen discovered that the result did not specify that special analyses testing was conducted. The laboratory provided an updated report, with a positive cocaine test result on confirmatory testing to the limit of quantitation.
Slide 8 Special analyses testing is performed under 10 CFR 26.163(a)(2) and applies lower testing cutoff levels for dilute specimens, and most directly observed specimens. This testing is unique to the NRCs 10 CFR Part 26 regulations. Additional detail on special analyses testing is provided on slide 11.
Part 26 Rulemaking Updates Slide 9
2022 Part 26 Final Rule (RIN 3150-AI67; Docket NRC-2009-0225)
Slide 10 Aligned Part 26 drug testing requirements more closely with the U.S. Department of Health and Human Services 2008 and 2017 Mandatory Guidelines for Federal Workplace Drug Testing of urine specimens. Also incorporated lessons learned from implementing Part 26.
Published: November 22, 2022 (87 FR 71422)
Compliance required by: November 22, 2023 Most licensees came into compliance in October or early November 2023 Licensee activities to address Final Rule changes:
o Updated policies and procedures o
Revised contract with HHS-certified laboratory(ies) o Updated quarterly blind performance test samples (cutoff changes for existing drugs, added drugs) o Trained staff on rule changes Implementation questions on special analyses testing (dilutes, observed specimens)
2022 Part 26 Final Rule Special Analyses Testing, 26.163(a)(2)
Required for:
Dilute specimens (previously optional) AND Directly observed specimens collected under four conditions (new):
26.115(a)(1): Donor provided a urine specimen with a substituted, adulterated, or invalid result with no adequate medical explanation 26.115(a)(2): Donor presents at this collection a urine specimen outside the required temperature range of 90-100oF 26.115(a)(3): Donor conduct indicates an attempt to subvert the testing process 26.115(a)(5): Donor requests a retest and either Bottle B or the single specimen is not available for testing When: The initial drug test concentration is 40% of the cutoff level or greater Then: Conduct confirmatory drug testing to the Limit of Quantitation (LOQ)
Slide 11
Tech Issues Rulemaking Plan Development Drugs and Alcohol: Technical Issues and Editorial Changes (RIN 3150-AJ15, Docket: NRC-2012-0079)
Slide 12 Effectiveness and efficiency improvements in three topic areas:
1)
Incorporating 15+ years of lessons learned from implementing Part 26 2)
Aligning with updates to HHS and DOT testing program requirements 3)
Resolving three petitions for rulemaking accepted by the NRC Why now? A key driver for rulemaking is the continuing prevalence of subversion attempts of the urine drug testing process (~30 percent of drug testing violations annually).
Public meeting to discuss plan held on February 7, 2024 (NRC slides: ML24036A330; Meeting transcript: ML24116A143)
Rulemaking Plan delivered to the NRC Commission on July 9, 2024 (ML24060A008)
Rulemaking Plan Regulatory Basis Proposed Rule Final Rule (were here)
Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors (RIN 3150-AK31, Docket: NRC-2019-0062)
- The NRC published a proposed rule in the Federal Register on October 31, 2024 (89 FR 86918).
- The NRC is proposing to create a risk-informed, performance-based, and technology-inclusive regulatory framework for the licensing and regulating of commercial nuclear plants under a new 10 CFR Part 53.
- The proposed rule includes a new Subpart M to 10 CFR Part 26, which provides a risk-informed graded approach to FFD programs that enables the use of innovative technologies for drug testing, which may be needed to accommodate for variations in the workforce size, as well as geographic siting of reactors.
- Comment period closes on February 28, 2025.
Slide 13
Questions Slide 14