ML24152A151
| ML24152A151 | |
| Person / Time | |
|---|---|
| Issue date: | 06/04/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| ML24152A147 | |
| Download: ML24152A151 (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 June 4, 2024 Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)
Discussion Topics FFD Program Performance Trends and Operating Experience HHS-Certified Laboratory Performance Rulemaking Updates Slide 2
FFD Performance and Trends - Background This presentation reflects the drug and alcohol test results for individuals subject to 10 CFR Part 26, Fitness For Duty Programs.
These individuals work at:
- Commercial nuclear power reactors (operating and under construction)
- Formerly operating power reactors
- Category I special nuclear material facilities
- Corporate FFD program offices (e.g., a utility with multiple operating power reactor sites may administer the fleet FFD program at a central location)
Test result information is reported to the NRC on an annual basis under 10 CFR 26.717 and 26.417(b)(2).
All drug test results are medical review officer (MRO)-verified.
All results for 2023 are draft, as the NRC continues to perform data quality reviews on the information.
Slide 3
FFD Program Performance Results, 2019-2023
- Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test Slide 4 2019 2020 2021 2022 2023 Number of Facilities Reporting 70 70 69 65 63 Individuals Tested 131,417 124,678 114,150 112,611 106,985 Individuals Testing Positive*
1,085 1,048 1,112 1,083 1,080 Identified at Pre-access Testing 67.3%
67.4%
66.5%
70.5%
72.5%
Identified at Random Testing 21.8%
22.7%
24.8%
20.3%
18.3%
Pre-Access Testing Positive Rates 1.03%
1.01%
1.17%
1.20%
1.33%
Licensee Employee 0.44%
0.38%
0.64%
0.84%
0.97%
Contractors/Vendors 1.10%
1.08%
1.17%
1.27%
1.40%
Random Testing Positive Rates 0.45%
0.49%
0.61%
0.51%
0.47%
Licensee Employees 0.19%
0.23%
0.28%
0.30%
0.31%
Contractors/Vendors 0.86%
0.92%
1.15%
0.87%
0.81%
Average Worker Population 91,954 89,205 82,512 78,472 75,782 Licensee Employees 56,152 54,190 50,094 48,103 49,434 Contractors/Vendors 35,802 35,015 31,608 30,349 26,348
Results by Employment Category, 2023 Slide 5 Licensee Employees (40,726 tested, 207 individuals positive)
Contractor/Vendors (66,259 tested, 873 individuals positive)
Marijuana 53.0%
Alcohol 11.3%
Cocaine 7.0%
Refusal to Test 20.3%
Amphetamines 6.2%
Opioids 2.2%
n = 924 Marijuana 43.0%
Alcohol 25.2%
Cocaine 9.3%
Refusal to Test 9.8%
Amphetamines 11.7%
Opioids 0.9%
n = 214
Pre-Access and Random Positive Rates - Marijuana Slide 6 Pre-Access Random 0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
0.9%
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Positive Rate Year Marijuana Positive Rates - Contractor/Vendors Pre-Access Random 0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
0.9%
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Positive Rate Year Marijuana Positive Rates - Licensee Employees
Subversion Attempt Trends (2018-2023)
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) 2018 2019 2020 2021 2022 2023 Number of Subversion Attempts 298 307 288 272 268 289 Percentage of Drug Testing Violations 31.0%
34.5%
34.3%
29.3%
29.7%
30.9%
Identified at Pre-access Testing 77.5%
73.3%
74.7%
72.4%
79.1%
80.3%
Committed by Contractor/Vendors 95.6%
97.4%
96.2%
94.5%
93.3%
90.7%
Percentage of Sites Reporting At Least One Subversion 70%
61%
70%
70%
74%
78%
- Draft data (2023 reporting cycle closed on February 29, 2024)
Subversion attempt sanction:
Permanent denial unescorted access, 10 CFR 26.75(b)
Slide 7
Subversion Attempt Trends by Labor Category (2018-2023)
Slide 8 Labor Category 2018 2019 2020 2021 2022 2023 Maintenance (general facility) 226 255 245 217 211 205 Facility Support 25 18 17 26 30 41 Maintenance (safety-significant) 14 10 10 2
5 12 Security 4
6 4
9 5
8 Supervisor 7
4 1
3 3
4 FFD Program Personnel 1
Engineering 2
3 4
3 5
HP/RP 2
2 1
6 6
2 Non-Licensed Operator 2
3 Other 16 7
6 6
5 11 QA/QC 2
Total 298 307 288 272 268 289
Substituted Specimen Test Results, 2023 Slide 9 Operating experience demonstrates that 1-2 urine specimens per year are reported by an HHS-certified laboratory as substituted.
In 2023, at least 10 substituted urine specimen test results were received.
Collection Date Employment Type Outage Worker?
Reason for Test Reason for Test Explanation Labor Category Validity Testing Result 03/01/23 C/V Yes Pre-Access Initial Authorization Maintenance (general facility)
Substituted 03/22/23 C/V Yes Pre-Access Initial Authorization Maintenance (general facility)
Substituted 04/03/23 C/V Yes Pre-Access Maintenance (general facility)
Substituted 05/01/23 C/V Yes Pre-Access Initial Authorization Maintenance (general facility)
Substituted 07/18/23 C/V No Random Facility Support Substituted 10/02/23 C/V Pre-Access Maintenance (general facility)
Substituted 10/02/23 C/V Yes Pre-Access Maintenance (general facility)
Substituted 10/03/23 C/V Pre-Access Initial Authorization Maintenance (general facility)
Substituted 10/10/23 C/V Yes Pre-Access Facility Support Substituted 12/11/23 C/V No Followup Potentially disqualifying FFD information Maintenance (general facility)
Substituted
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 1) False negative for a blind performance test sample (BPTS) formulated to test positive for marijuana (January 2023). When notified of the test result inconsistency, the HHS-certified laboratory:
Reviewed the initial testing data and identified that the THC screening absorbance was abnormally depressed.
Determined that a potential sampling issue occurred on the chemistry analyzer for the initial test.
Reviewed all other specimens and analytes on the load (no other abnormally depressed results were identified).
Updated its standard operating procedure to require all certifying scientists to look for abnormally depressed results. Any specimen exhibiting depressed results for any assay ( -1000) would be aliquoted for another initial test.
Slide 10
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 2) Test results for a donors specimen were not received within 5-business days after the laboratory received the specimen for testing, as required by 10 CFR 26.169(a) (March 2023)
- The specimen was received for testing on March 22 and confirmatory positive test results were not returned until March 29.
- The laboratory determined that the delay was due to unacceptable quality controls resulting in batch failures.
- The specimen was tested on multiple confirmation batches before final results were obtained. Multiple batch failures do not occur routinely.
- An increase in the failure rate for the assay during that last two weeks in March was observed by the laboratory.
- A fresh bottle of reagent was placed in service on March 29 and no additional failures were observed for the assay.
Slide 11
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 3) A BPTS formulated to return a substituted validity test result was reported as negative, dilute (June 2023)
- The BPTS was prepared to measure 1.0000 for specific gravity and the absence of creatinine. The laboratory reported a specific gravity of 1.0023 and a creatinine concentration of 7.9 mg/dL.
- The laboratory re-tested the specimen, and a substituted test result was reported (creatinine concentration <1.0 mg/dL, specific gravity of 1.0000).
- The laboratory investigation concluded that human error during specimen aliquoting was the most likely cause of the original test result error. Specifically, that the sample immediately preceding the sample in question may have splashed into the BPTS sample.
- The laboratory retested all other samples in the original batch using the original screening batch location. All results confirmed the accuracy of the original tests performed.
- Retraining was performed with all laboratory personnel involved in specimen aliquoting for screening batch preparation.
Slide 12
Part 26 Final Rule (November 2022)
(RIN 3150-AI67; Docket NRC-2009-0225)
Slide 13 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 Substantive changes:
Added testing for MDMA, MDA, hydrocodone, hydromorphone, oxycodone, oxymorphone
Lowered drug testing cutoff levels for amphetamine, methamphetamine, cocaine
Improved testing method to identify heroin metabolite (6-acetylmorphine)
Strengthened methods to detect donor subversion attempts (special analyses testing)
Included option to collect and drug test oral fluid for most observed collection conditions
2022 Part 26 Final Rule - Is it working?
Expanded Opioid Panel Results Slide 14 Reason for Test Collection Date Employment Type Outage Worker?
Reason for Test Explanation Labor Category Substance(s)
Reason for the Action 1
Pre-Access 08/21/23 C/V Yes Reinstatement (31 to 365 days)
Maintenance (general facility)
Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 2
09/26/23 C/V Yes Reinstatement (31 to 365 days)
Maintenance (general facility)
Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 3
10/02/23 C/V Yes Reinstatement (31 to 365 days)
Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 4
10/17/23 C/V Yes Reinstatement (31 to 365 days)
Maintenance (general facility)
Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 5
10/18/23 C/V Yes Reinstatement (31 to 365 days)
Facility Support Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 6
10/23/23 C/V No Initial Authorization Maintenance (general facility)
Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 7
11/27/23 C/V No Update Authorization Engineering Opioid: Oxymorphone 1st Positive 8
Random 08/17/23 C/V No Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 9
10/16/23 C/V No Facility Support Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 10 11/28/23 C/V No Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 11 12/18/23 C/V Facility Support Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive
Slide 15 Questions?