ML19158A403
| ML19158A403 | |
| Person / Time | |
|---|---|
| Issue date: | 06/11/2019 |
| From: | Harris P NRC/NSIR/DPCP/FCTSB |
| To: | US Dept of Health & Human Services, Substance Abuse and Mental Health Services Admin |
| Harris P | |
| References | |
| Download: ML19158A403 (27) | |
Text
Presentation to the Drug Testing Advisory Board (HHS/SAMHSA)
Operating Experience in 2018 and Policy Considerations 10 CFR Part 26, Fitness-for-Duty Programs A Direct Contribution to Safety and Security June 11, 2019
Disclaimer The information in this presentation is provided as a public service and solely for informational purposes and is not, nor should be deemed as, an official NRC position, opinion or guidance, or "a written interpretation by the General Counsel" under 10 CFR 26.7, on any matter to which the information may relate. The opinions, representations, positions, interpretations, guidance or recommendations which may be expressed by the NRC technical staff during this presentation or responding to an inquiry are solely the NRC technical staff's and do not necessarily represent the same for the NRC. Accordingly, the fact that the information was obtained through the NRC technical staff will not have a precedential effect in any legal or regulatory proceeding.
Slide 2
Discussion Topics Slide 3 Fitness-for-Duty (FFD) Program Objective Individuals covered by the FFD Program Assuring Safety and Security through a Defense-in-Depth Strategy Industry Activities/Initiatives FFD Performance Data and Insights
FFD Program Objective Provide reasonable assurance that nuclear power plant personnel are trustworthy, reliable, and not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform assigned duties or be afforded unescorted access to the protected areas of nuclear power plants, sensitive information, or strategic special nuclear material (SSNM).
Slide 4 An FFD program developed under 10 CFR Part 26 is intended to create an environment which is free of drugs and alcohol, and the effects of such substances.
Individuals Covered by the FFD Program Slide 5 Security Officers Control Room Operators Maintenance & Surveillance (craft & supervisors)
Health Physics, Chemistry, & Emergency Response Construct or Direct the Construction of Reactor Plants All other persons who have unescorted access FFD Program Personnel*
Slide 5
- FFD Program Personnel include the managers, technicians, collectors, Medical Review Officers, and Substance Abuse Experts who implement the program Fit for Duty Reliable Trustworthy
Assuring Safety and Security through a Defense-in-Depth Strategy Slide 6 People Education, experience, training, qualification, etc.
Drug and Alcohol Testing (pre-access, random, for cause, follow-up, and post-event)
Behavioral Observation Fatigue Management Access Requirements (e.g., background checks, fingerprinting, psychological testing)
Physical Protection (e.g., vehicle barriers, blast walls, blast resistant enclosures, etc.)
Detection (e.g., cameras, infra-red, motion, explosive vapors, x-ray, etc.)
Programs for Insider Mitigation, Cyber Protection, and Information Controls
Items of Interest Slide 7 Oral fluid testing Expanded panel testing Marijuana Rescheduling Auditing of HHS-certified laboratories Blind performance testing 10 CFR Part 26, Fitness for Duty Programs, staff-proposed rulemaking Slide 7
Slide 8 Operating Experience in 2018
Overall Industry Performance, 2018 [Draft]
145,798 Individuals drug & alcohol tested (down ~2% from 2017) 1,185 Individuals positive for drug(s), alcohol, or refused a test 69.8% identified at pre-access testing (64.3% in 2017) 17.7% identified at random testing (22.5% in 2017) 0.81%
Industry overall positive rate (0.78% in 2017) 0.28% LE positive rate (0.24% in 2017) 1.06% C/V positive rate (1.04% in 2017) 0.37%
Industry random positive rate (0.44% in 2017) 0.17% LE positive rate (0.14% in 2017) 0.68% C/V positive rate (0.89% in 2017)
LE = licensee employee; C/V = contractor/vendor All results in this presentation are MRO verified Slide 9
Results by Test and Employment Categories, 2018
[DRAFT]
Slide 10 Tested Positive Percent Positive Tested Positive Percent Positive Tested Positive Percent Positive Pre-Access 8,291 36 0.43%
72,934 791 1.08%
81,225 827 1.02%
69.8%
Random 34,676 59 0.17%
22,221 151 0.68%
56,897 210 0.37%
17.7%
For Cause 132 11 8.33%
302 65 21.52%
434 76 17.51%
6.4%
Post-Event 148 0.00%
348 2
0.57%
496 2
0.40%
0.2%
Follow-up 2,859 21 0.73%
3,887 49 1.26%
6,746 70 1.04%
5.9%
Total 46,106 127 0.28%
99,692 1,058 1.06%
145,798 1,185 0.81%
100.0%
Test Category Licensee Employees Contractor/Vendors (C/Vs)
Total
% of Total Positives Where were the most tests conducted in 2018 (>90% of tests)?
Licensee Employees Contractor/Vendors Pre-access 18.0%
Pre-access 73.2%
Random 75.2%
Random 22.3%
Follow-up 6.2%
Follow-up 3.9%
99.4%
99.3%
Where were most drug and alcohol testing violations identified in 2018 (>90% of positives)?
Licensee Employees Contractor/Vendors Pre Access 28.3%
Pre-access 74.8%
Random 46.5%
Random 14.3%
For Cause 8.7%
For Cause 6.1%
Follow-up 16.5%
95.2%
100.0%
Detection Trends 1990-2018, NRC Testing Panel Percentage of Total Positives by Substance Tested
[Draft]
Since at least 2014, this chart under reports the substances used by individuals with a drug testing violation. This is because of the high number of subversion attempts each year, and because in at least 60% of these subversion attempts, no specimens were tested.
Slide 11
Results by Employment Category, 2018
[DRAFT]
Licensee Employees (46,106 tested; 127 individuals positive)
Contractors/Vendors (99,692 tested; 1,058 individuals positive)
Alcohol 42.1%
Amphetamines 6.0%
Cocaine 9.8%
Marijuana 30.8%
Opiates 1.5%
Other 1.5%
Refusal to Test 8.3%
n = 133 Alcohol 15.3%
Amphetamines 11.1%
Cocaine 10.4%
Marijuana 42.1%
Opiates 1.6%
PCP 0.1%
Refusal to Test 19.4%
n = 1,125 Slide 12
Substances Detected by Labor Category, 2018
[DRAFT]
Slide 13
Measuring Effectiveness of Lower Cutoff Levels for Alcohol, 2018 [DRAFT]
Slide 14 42% of alcohol positives (BAC < 0.04) are the result of time dependent cutoff levels, which have been required since 2008 32-60% of positive alcohol results per test category were BAC < 0.04
Testing for Additional Substances A licensee or other entity can:
Expand the drug testing panel to account for local drug use trends that may affect the workforce --10 CFR 26.31(d)(1)(i)
Test for any substance(s) that an individual is suspected of having abused, when performing follow-up, for cause, and post-event tests
A forensic toxicologist must first review and validate the testing assays and cutoff levels used by the HHS-certified laboratory, unless already in use in the current HHS Guidelines -- 10 CFR 26.31(d)(1)(i)(D)
Slide 15
Testing for Additional Substances In 2018, eight facilities conducted expanded panel testing in two ways:
Tested all specimens collected for barbiturates, benzodiazepines, methadone, and propoxyphene (four facilities, one FFD program)
Tested follow-up, for-cause, and post-event testing specimens for benzodiazepines (i.e., alprazolam, clonazepam, and lorazepam), and hydromorphone, hydrocodone, and oxycodone (four facilities, one FFD program)
Typically, a few facilities each year conduct testing for one or more additional substances when ordered by the MRO (e.g., for-cause or follow-up test).
Slide 16
Additional Substance Test Results, 2011-2018
[Draft]
The 33 test results in this table reflect positive results for 25 individuals (see next slide). That is, some individuals test positive for more one of substance in the same testing event Substance 2011 2012 2013 2014 2015 2016 2017 2018 Total Benzodiazepines 1
2 1
1 1
1 7
Buprenorphine 1
1 1
3 Fentanyl 1
1 Hydrocodone 1
1 1
3 Hydromorphone 1
1 2
Methadone 1
1 1
1 4
Norbuprenorphine 1
1 Oxycodone 1
1 1
1 1
5 Oxymorphone 1
1 1
1 1
5 Propoxyphene 1
1 Tramadol 1
1 Total 2
6 4
7 7
1 4
2 33 Slide 17
Additional Substance Results by Test Category (2011-2018) [Draft]
68% of individuals (17 of 25) tested positive on for cause testing 36% of individuals (9 of 25) also tested positive for a substance in the NRC-required testing panel Substances Pre-Access Random For Cause Follow-up Total Benzodiazepines 1
1 2
4 Benzodiazepines; Amphetamine; Methamphetamine 2
2 Benzodiazepines; Amphetamine; Methamphetamine; Marijuana 1
1 Benzodiazepines; Cocaine 1
1 Benzodiazepines; Marijuana; 1
1 Benzodiazepines; Methadone; Marijuana 1
1 Buprenorphine 1
1 Buprenorphine; Norbuprenorphine 1
1 Hydrocodone 1
1 Hydrocodone; Hydromorphone; Amphetamine; Marijuana 1
1 Hydrocodone; Hydromorphone; Amphetamine; Methamphetamine 1
1 Hydrocodone; Oxycodone; Oxymorphone 1
1 Methadone 1
1 2
Oxycodone; Oxymorphone 3
3 Oxycodone; Oxymorphone; Fentanyl 1
1 Propoxyphene; Marijuana 1
1 Tramadol 2
2 Total 4
2 17 2
25 Slide 18
Subversion Attempt Trends [Draft]
Subversion attempt is 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)
Sanction for a subversion attempt is a permanent denial of unescorted access (10 CFR 26.75)
Slide 19 Subversion Attempt Trends (last 5 years) 2014 - 187 subversions (21.2% of drug testing violations) 2015 - 232 subversions (21.2% of drug testing violations) 2016 - 305 subversions (32.4% of drug testing violations) 2017 - 301 subversions (33.5% of drug testing violations) 2018 - 298 subversions (31.0% of drug testing violations)
Subversion Attempts in 2018:
70.0% facilities with at least 1 subversion attempt (50 of 71) 77.5% identified at Pre-Access testing (231 of 298) 95.6% by contractor/vendors (285 of 298)
Subversion Attempts, 2018 (draft)
Positive Results for Specimens Collected under Direct Observation 298 individuals identified as subverting a test in 2018 68 provided specimens under direct observation (68/298 = 22.8%)
Test Result Pre-Access Random For Cause Follow-up Total Marijuana 39 5
2 1
47 Cocaine 3
1 2
6 Amphetamine; Methamphetamine 3
3 Cocaine; Marijuana 3
3 Amphetamine; Marijuana 1
1 2
Amphetamine; Methamphetamine; Marijuana 2
2 Amphetamine 1
1 Amphetamine; Methamphetamine; Cocaine 1
1 Cocaine; 6-AM; Codeine; Morphine; PCP 1
1 Methamphetamine 1
1 Morphine 1
1 Total 54 7
4 3
68 Slide 20
Limit of Detection (LOD) Testing of Dilute Specimens 10 CFR 26.163(a)(2) permits a licensee to require the HHS-certified laboratory to conduct confirmatory drug testing to LOD for a substance if:
- 1. Validity test result = Dilute, and
- 2. Immunoassay response is equal to or greater than 50% of cutoff 66 of 71 sites maintained the optional LOD testing policy in 2018 422 dilute specimens were tested to LOD in 2018, with 17 individuals testing positive 35% sites (23 of 66) conducted at least one 26.163(a)(2) test in 2018 Slide 21
LOD Testing of Dilute Specimens (2010-2018) - 10 CFR 26.163(a)(2)
Slide 22
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
A blind performance test sample (BPTS) formulated to return an adulterated validity test result (due to low pH) was reported with negative drug test results. The forensic processing technician did not properly aliquot all of the original specimen to the correct sample cup, which caused the incorrect result.
A donor specimen was reported as negative dilute. Two days later, the laboratory updated the result to negative. It was determined that the Screening Technician did not load the specimen on the refractometer consistent with the Standard Operating Procedure, which resulted in an incorrect specific gravity value. A second aliquot of the sample consistent with the applicable procedure determined the specimen was not dilute.
Slide 23
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
A BPTS formulated to return an adulterated validity test result was submitted for testing. Initial validity testing indicated general oxidants were above normal and required confirmation. However, the laboratorys confirmatory oxidant testing equipment (ion chromatograph instrument) was out of service. The laboratory sent the specimen to a second HHS-certified laboratory for additional adulterant testing, but that laboratory was not the licensees authorized backup laboratory. That specimen was then sent to the licensees authorized backup laboratory, but the specimen was empty upon receipt and was reported as invalid.
A BPTS formulated to test positive for marijuana was reported by the HHS-certified laboratory as negative. The BPTS was a false negative challenge sample formulated at between 130 and 155 percent of the initial testing cutoff concentration for marijuana). The licensee determined the unexpected results were related to the BPTS supplier's preparation and/or preservation of the samples.
Slide 24
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
A licensee sent two donor specimens for testing to the HHS-certified laboratory, and both specimens were reported as "rejected for testing" due to the Bottle B specimens being switched. The licensee and the laboratory conducted investigations, with conflicting conclusions reached.
o The laboratory reported the accessioner identified a switch in the bottle B specimens for the two donors and the accessioner's supervisor verified the bottle switch.
o The licensee concluded that it was likely that the Bottle B specimens were switched at the laboratory because the licensee only allows for one collection to be performed at a time and that the donor certifies the Bottle A and B specimens and observes the sealing of the specimens in the tamper-evident bag. In addition, in one of the two cases, the specimen was monitored by another member of management that observed the process from beginning to end, including sealing of the tamper evident bag.
Slide 25
Electronic Reporting FFD Program Performance Information Meets annual reporting requirements in 10 CFR 26.417(b)(2) and 26.717 Available since 2009 (100% e-reporting since 2014)
Provides uniform, robust, and event specific information permitting additional trending and analyses (NRC Summary Reports on industry performance available at:
Reporting forms (PDF forms) available at:
www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/submit-ffd-reports.html Annual Reporting Form Single Positive Test Form Slide 26
NRC Fitness for Duty Program Staff Slide 27 U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Paul Harris, Senior Program Manager Paul.Harris@nrc.gov (301-287-9294)
Brian Zaleski, Fitness-for-Duty Program Specialist Brian.Zaleski@nrc.gov (301-287-0638)