ML18078A544
| ML18078A544 | |
| Person / Time | |
|---|---|
| Issue date: | 03/20/2018 |
| From: | Brian Zaleski NRC/NSIR/DPCP/FCTSB |
| To: | |
| References | |
| HHS/SAMHSA | |
| Download: ML18078A544 (18) | |
Text
Presentation to the Drug Testing Advisory Board (HHS/SAMHSA)
Operating Experience in 2017 Fitness for Duty Programs - 10 CFR Part 26 A Direct Contribution to Safety and Security March 20, 2018
Discussion Topics
- What is Fitness for Duty?
- Program Objective
- Defense-in-Depth Measures
- FFD Performance/Operating Experience
- Laboratory Testing Errors
- FFD Electronic Reporting System DISCLAIMER: Because the annual reporting cycle for 2017 test results closed on February 28, 2018, the NRC has yet to perform the standard quality assurance and quality control process to validate the information received. Therefore, all results for 2017 are DRAFT.
Slide 2
Fitness for Duty A Strategy of Defense in Depth Access Authorization Fit Drug and Reliable Fatigue Alcohol Testing Trustworthy Management Workers Behavioral Observation Slide 3
10 CFR Part 26 FFD Program General 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).
An FFD program developed under Part 26 is intended to create an environment which is free of drugs and alcohol, and the effects of such substances.
Slide 4
FFD Program Defense-in-Depth Elements
- 1. Integrated with access authorization (i.e., employment screening)
- 2. Test categories (pre-access, random, for-cause, post-event, followup)
- 3. Testing
- Permit lower cutoff levels for drugs
- Time-dependent alcohol limits for BACs of 0.02 and 0.03 percent
- 50% annual random testing rate for drugs & alcohol
- Permit drug testing to Limit of Detection for dilute specimens
- Permit testing for additional drugs (local use trends, MRO directed)
- 4. Behavior observation program (both on and offsite)
- 5. Minimum sanctions for violations & industry tracks in a database
- 6. Policy & procedures training (initial & annual refresher)
- 7. 24-hour and 30-day reportable events (10 CFR 26.719)
Slide 5
Overall Industry Performance, 2017 [Draft]
148,357 Individuals drug & alcohol tested (down 3.6% from 2016) 1,143 Individuals tested positive for a drug, alcohol, or refused a test 64.0% identified at pre-access testing (65.1% in 2016) 22.7% identified at random testing (22.3% in 2016) 0.77% Industry overall positive rate (0.76% in 2016) 0.24% LE positive rate (0.22% in 2016) 1.01% C/V positive rate (1.00% in 2016) 0.44% Industry random positive rate (0.42% in 2016) 0.14% LE positive rate (0.16% in 2016) 0.84% C/V positive rate (0.80% in 2016)
- LE = licensee employee; C/V = contractor/vendor
- All results in this presentation are MRO verified Slide 6
Results by Test and Employment Categories, 2017
[DRAFT]
Licensee Employees Contractor/Vendors (CVs) Total Test % of Total Category Percent Percent Percent Positives Tested Positive Tested Positive Tested Positive Positive Positive Positive Pre-Access 8,513 36 0.42% 71,586 695 0.97% 80,099 731 0.91% 64.0%
Random 34,624 48 0.14% 25,100 212 0.84% 59,724 260 0.44% 22.7%
For Cause 111 14 12.61% 757 64 8.45% 868 78 8.99% 6.8%
Post-Event 136 - 0.00% 492 11 2.24% 628 11 1.75% 1.0%
Followup 3,044 13 0.43% 3,994 50 1.25% 7,038 63 0.90% 5.5%
Total 46,428 111 0.24% 101,929 1,032 1.01% 148,357 1,143 0.77% 100.0%
Where were the most tests conducted in 2017 (>90% of tests)?
Licensee Employees Contractor/Vendors Pre-access 18.3% Pre-access 70.2%
Random 74.6% Random 24.6%
Followup 6.6% Followup 3.9%
99.5% 98.8%
Where were most drug and alcohol testing violations identified in 2017 (>90% of positives)?
Licensee Employees Contractor/Vendors Pre Access 32.4% Pre-access 67.3%
Random 43.2% Random 20.5%
For Cause 12.6% For Cause 6.2%
Followup 11.7% 94.1%
100.0%
Slide 7
Detection Trends - NRC Testing Panel Percentage of Total Positives by Substance Tested
[Draft]
60.0%
marijuana 50.0%
Percent of Total Positives 40.0%
30.0%
cocaine alcohol 20.0%
10.0%
amphetamines opiates 0.0% PCP 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 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 8
Results by Employment Category, 2017
[DRAFT]
Licensee Employees Contractors/Vendors (46,428 tested; 111 individuals positive) (101,929 tested; 1,032 individuals positive)
Refusal to Test 2.5%
Cocaine 11.8% Refusal to Cocaine Test 19.2% 12.3%
Amphetamines 13.4% Opiates Opiates Amphetamines 0.8% 10.8% 1.2%
Alcohol 35.3% Other Alcohol 1.7% Other 16.4%
0.2%
PCP 0.1%
Marijuana Marijuana 34.5% 39.9%
n = 119 n = 1,096 Slide 9
Additional Substance Testing
- 10 CFR 26.31(d)(1)(i) permits a licensee or other entity to account for local drug use trends that may affect the workforce in a specific region or locality by expanding the drug testing panel.
- 10 CFR 26.31(d)(1)(ii) permits a licensee or other entity to test for any substance(s) that an individual is suspected of having abused, when performing follow-up, for-cause, and post-event tests.
In order to test for any additional substance, a forensic toxicologist first must review and validate the testing assays and cutoff levels the HHS-certified laboratory will use to perform the tests.
Slide 10
Additional Substance Testing
- In 2017, 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)
(four facilities, one FFD program).
- Typically, a few facilities each year will conduct testing for one or more additional substances when ordered by the MRO (e.g., for-cause or follow-up test).
Slide 11
Additional Substance Test Results, 2011-2017
[Draft]
2011 2012 2013 2014 2015 2016 2017 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 4 Oxymorphone 1 1 1 1 4 Propoxyphene 1 1 Tramadol 1 1 Total 2 6 4 7 7 1 4 31 The 31 test results in this table reflect positive results for 24 individuals.
That is, some individuals tested positive for more than one of the substances in the same testing event Slide 12
Additional Substance Results by Test Category (2011-2017) [Draft]
Substances Pre-Access Random For Cause Followup Total Amphetamine; Marijuana; Hydrocodone; Hydromorphone 1 1 Amphetamine; Methamphetamine; Marijuana; Benzodiazepines 1 1 Amphetamine; Methamphetamine; Benzodiazepines 2 2 Amphetamine; Methamphetamine; Hydrocodone; Hydromorphone 1 1 Benzodiazepines 1 1 2 4 Buprenorphine 1 1 Buprenorphine; Norbuprenorphine 1 1 Cocaine; Benzodiazepines 1 1 Fentanyl; Oxycodone; Oxymorphone 1 1 Hydrocodone 1 1 Hydrocodone; Oxycodone; Oxymorphone 1 1 Marijuana; Benzodiazepines 1 1 Marijuana; Benzodiazepines; Methadone 1 1 Marijuana; Propoxyphene 1 1 Methadone 1 1 2 Oxycodone; Oxymorphone 2 2 Tramadol 2 2 Total 4 2 16 2 24
- 66% of individuals (16 of 24) tested positive on forcause testing
- 25% of individuals (6 of 24) tested positive for one or more of the semisynthetic opiates in the updated HHS Guidelines (i.e., hydrocodone, hydromorphone, oxycodone, oxymorphone)
- 57% of individuals that tested positive for an additional substance, also tested positive for a substance in the NRCrequired testing panel (i.e., amphetamine, methamphetamine, cocaine, marijuana)
Slide 13
Subversion Attempt Trends [Draft]
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)
Sanction for a subversion attempt: Permanent denial of unescorted access (10 CFR 26.75)
Subversion Attempt Trends 2012 - 177 of 1,114 violations (15.8% subversions) 2013 - 148 of 1,007 violations (14.7% subversions) 2014 - 187 of 1,133 violations (16.5% subversions) 2015 - 232 of 1,200 violations (19.3% subversions) 2016 - 304 of 1,164 violations (26.1% subversions) 2017 - 298 of 1,143 violations (26.1% subversions)
Subversion Attempts in 2017:
- 45 facilities with at least 1 subversion attempt
- 67% identified at Pre-Access testing (200 of 298)
- 98% by contractor/vendors Slide 14
HHS-Certified Laboratory Testing Errors (2017) 10 CFR 26.719 (30-day event reports)
- Specimen validity tests not performed on two donor specimens. The laboratory determined the data entry operator entered the incorrect testing profile, which resulted in the inconsistencies in the tests performed. The laboratory also reported that incorrect initial testing cutoff levels for marijuana and opiates were used in the tests performed.
- Two BPTS formulated to return substituted validity test results, were reported as negative. The laboratory reported that while specimen aliquotting is normally performed via an automated process, manual aliquotting was performed for these specimens. The event was determined to be human error in the manual aliquotting step.
- A BPTS formulated to test positive for marijuana was reported as negative.
The laboratory determined that the THC screening reagent for one of the initial testing instruments was improperly prepared. The testing supervisor had directed the staff to discard the reagent, but staff inadvertently missed the supervisors direction.
Slide 15
HHS-Certified Laboratory Testing Errors (2017) 10 CFR 26.719 (30-day event reports)
- A BPTS formulated to test positive for marijuana was reported as negative.
The laboratory determined that when the specimen was injected on the mass spectrometer, a series of strong peaks to the far right of the chromatogram interfered with the visual display of the peaks. This unusual presentation was misinterpreted as a negative result. The confirmation assay was not interpreted accurately by the Certifying Scientist and should have been set up for re-extraction.
- A BPTS formulated to test positive for amphetamine and methamphetamine was reported as positive only for amphetamine. The laboratory determined that the specimen had also tested positive for methamphetamines, but that an administrative error had occurred in the recording of the results in the report sent to the MRO. The scientist conducting the testing had failed to enter the data into the necessary computer reporting field for methamphetamine, which prevented the result from being recorded as positive.
Slide 16
Electronic Reporting FFD Program Performance Information
- Meets annual reporting requirements in 10 CFR 26.417(b)(2) and 26.717
- Available since 2009 (100% ereporting since 2014)
- Provides uniform, robust, and event specific information permitting additional trending and analyses (NRC Summary Reports on industry performance available at:
https://www.nrc.gov/reactors/operating/opsexperience/fitnessforduty programs/performancereports.html)
- Reporting forms (PDF forms) available at:
www.nrc.gov/reactors/operating/opsexperience/fitnessfordutyprograms/submitffdreports.html Annual Reporting Form Single Positive Test Form Slide 17
NRC Fitness for Duty Program Staff 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)
Slide 18