ML24185A224
| ML24185A224 | |
| Person / Time | |
|---|---|
| Issue date: | 07/09/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/AAFPB |
| To: | |
| References | |
| ML24185A205 | |
| Download: ML24185A224 (1) | |
Text
Presentation to the Nuclear Energy Institutes Access Authorization and Fitness for Duty Workshop
Discussion Forum for Licensed Professionals
July 9, 2024
Office of Nuclear Security and Incident Response Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287- 0638)
Discussion Topics
MRO Responsibilities MRO Reviews (invalid results, subversion attempts)
Special Analyses Testing Oral Fluid Testing (Optional for Observed Collections)
Employee Assistance Programs Implementation Resources and Guidance Technical Issues Rule Plan - Select Topic Areas
Slide 2 MRO Responsibilities - 10 CFR 26.183(c)
Primary role: review and interpret positive, adulterated, substituted, invalid, and dilute test results AND identify any evidence of subversion of the testing process.
Also identify any issues associated with collecting and testing specimens AND advising and assisting FFD program management in planning/overseeing the overall FFD program.
Shall examine alternate medical explanations for ANY positive, adulterated, substituted, invalid or dilute test result. This action may include, but is not limited to:
o conducting a medical interview with the donor, o reviewing the donor's medical history, or o reviewing any other relevant biomedical factors.
Shall review ALL medical records a donor may make available when a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.
May only consider test results of specimens collected and processed under 10 CFR Part 26.
Slide 3 Invalid Test Results, 2023
- Operating experience demonstrates 5-8 invalid test results per year with the required directly observed 2nd specimen drug positive or refused
- Significant increases in 2022 (13) and in 2023 (22 invalids)
Reason Collection Reason for Test Labor Employment Outage 2nd Observed for Testing Date Explanation Category Type Worker? Specimen Result 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 Pre-Access 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 FFD PDI Maintenance (general facility) C/V YesMarijuana 04/10/23 Maintenance (general facility) C/V Yes Marijuana 09/18/23 FFD PDI Maintenance (general facility) C/V Yes Marijuana
Slide 4 Invalid Result, 10 CFR 26.161(f),
HHS-certified laboratory report
An invalid result is reported for any one or more of the following validity test results (refer to 26.161(f) for specific criteria):
Inconsistent creatinine concentration and specific gravity results pH Nitrite concentration Possible presence of chromium (VI), halogen, glutaraldehyde, oxidizing adulterant, or surfactant Interference on the immunoassay (two separate aliquots)
Interference on drug confirmation assay (two separate aliquots)
Physical appearance of specimen indicates it may damage testing equipment Physical appearance of Bottles A and B (if a split collection) are clearly different, and either test result of Bottle A indicates an invalid specimen or the specimen in Bottle A was screened negative for drugs, or both
Slide 5 Invalid Result, 10 CFR 26.185(f)
MRO Review
MRO consults with certifying scientist to determine if additional testing by a 2nd HHS-certified laboratory may be useful to report a positive or adulterated test result:
- If useful >> forward to a 2nd HHS-certified laboratory for testing
- If NOT useful AND no technical explanation >> MRO contacts donor If a legitimate medical explanation exists:
For a temporary condition >> unobserved urine collection For a condition that would affect another urine test >>
choose an alternative specimen for drug testing If NO legitimate medical explanation exists >>
directly observed urine collection NOTE: if the invalid result is due to pH 9.0 to 9.5, the MRO first must evaluate specimen handling conditions (elapsed time and temperature):
If sufficient evidence exists (see Regulatory Guide 5.89, November 2022) >>
cancel test and order an unobserved urine collection
Slide 6 Invalid Specimen Reviews -
Examples from 2023
Example 1: 1st specimen invalid result (pH 10.18) and 94.5oF temperature; donor refused 2nd observed collection and admitted to the subversion (stated theyd test positive for marijuana).
Example 2: 1st specimen invalid result; 2nd non-observed specimen also invalid result.
MRO directed a 3rd (observed) collection, which was positive for marijuana.
Example 3: 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: 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 7 Special Analyses Testing, 26.163(a)(2)
Required for:
Dilute specimens AND Directly observed specimens collected under four conditions:
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 90-100 oF 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)
Verif y testing conducted correctly by reviewing the HHS-cer tified laborator y test result repor t
Slide 8 Subversion Attempt Reviews Subversion and subvert the testing process mean a willful act to avoid being tested or to bring about an inaccurate drug or alcohol test result for oneself or others at any stage of the testing process (including selection and notification of individuals for testing, specimen collection, specimen analysis, and test result reporting), and adulterating, substituting, or otherwise causing a specimen to provide an inaccurate test result. (10 CFR 26.5 definition)
Case 1: 1st specimen is out of temperature range (negative results) and the 2nd specimen collected under direct observation is drug positive
Case 2: Testing refusals (e.g., 1st specimen out of temperature range and donor refuses directly observed 2nd specimen)
Case 3: 1st specimen is reported by the HHS-certified laboratory as invalid, and after the MRO interview with the donor a 2nd specimen is collected under direct observation and is drug positive
Case 4: 1st specimen out of temperature range (negative results), 2nd specimen collected under direct observation (negative results), subversion determination based on other information (e.g., differences in pH, creatinine)
Slide 9 Subversion Determination - Case 1 1st specimen is out of temperature range (negative results),
and the directly observed 2nd specimen is drug positive
Slide 10 Subversion Determination - Case 2 Testing Refusals
- 1st specimen is out of temperature range, donor refuses directly observed 2nd specimen
- Collector discovered subversion paraphernalia and collection process stopped
- Inability to provide a specimen (shy-bladder with no medical condition)
Slide 11 Subversion Determination - Case 3 1st specimen is reported by the HHS-certified laboratory as invalid, and the directly observed 2 nd specimen is drug positive
Slide 12 Subversion Determination - Case 4 1st specimen out of range temperature, 2nd directly observed (both negative results)
Slide 13 Substituted Specimen Test Results, 2023
- 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 Collection Reason for Test Outage for Testing Date Explanation Labor Categor y Employment Ty p eWorker?
03/01/23 Initial Authorization Maintenance (general facility) C/V Ye s 03/22/23 Initial Authorization Maintenance (general facility) C/V Ye s 04/03/23 Maintenance (general facility) C/V Ye s 04/16/23 Reinstate (31-365 days) Facility Suppor t C/V Ye s Pre-Access 05/01/23 Initial Authorization Maintenance (general facility) C/V Ye s 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 Ye s 10/03/23 Initial Authorization Maintenance (general facility) C/V -
10/10/23 Facility Suppor t C/V Ye s
Random 04/17/23 Facility Suppor t C/V Ye s07/18/23 Facility Suppor t C/V No
Followup 12/11/23 FFD PDI Maintenance (general facility) C/V No
Slide 14 Employee Assistance Programs, 26.35
- Strengthen the FFD program by offering confidential assessment, short-term counseling, referral services, and treatment monitoring to individuals who have problems that could adversely affect the safe and competent performance of duties
- Must be designed to achieve early intervention and provide confidential assistance
- EAP staff shall protect the identity and privacy of any individual (including those who have self-referred ), except:
- if the individual waives the right to privacy in writing, OR
- the condition or actions of an individual pose or have posed an immediate hazard to themself or others (EAP shall inform the FFD program):
likely to commit harm to self or others impaired from using drugs or alcohol while in a work status, or has a continuing substance abuse disorder that makes it likely they would be impaired in a work status in the future has ever engaged in any action that would be reportable under 26.719(b)(1) through (b)(3)
Slide 15 Oral Fluid Testing (Optional)
The 2022 Part 26 final rule enabled the option to collect and drug test oral fluid specimens under four observed specimen collection conditions (i.e., 26.115(a)(1) through (a)(3) and (a)(5)).
Must be tested at an HHS-certified laboratory - 26.153(a), 26.31(d)(3)(i)
(No laboratory has yet to apply for certification)
Tables added for initial and confirmatory test cutoff levels for drugs and drug metabolites - 26.163 Specimen collector must meet same training requirements as for alcohol and urine specimen collectors - 26.85(a)
Visual privacy must be provided during the collection - 26.87 Store specimens under conditions specified by the device manufacturer - 26.117(j)
NOTE: No changes in the 2022 final rule on when alternative specimens may be collected:
- Medical condition prevents providing urine (shy-bladder) - 26.119(g)(3)
- Acceptable medical explanation for an invalid result that would affect the testing of another urine specimen - 26.185(f)(2)
- Medical condition makes collecting a urine specimen difficult/hazardous - 26.31(d)(5)(i)
Slide 16 2022 Part 26 Final Rule -
Implementation Resources
- Part 26 Final Rule, November 22, 2022 (87 FR 71422)
(https://www.federalregister.gov/documents/2022/11/22/2022 -24903/fitness -for -
duty-drug-testing -requirements )
- eCFR track changes version of Part 26 (identifies all final rule changes)
(https://www.ecfr.gov/compare/current/to/2022-11-21/title -10/chapter-I/part -26)
- Regulatory Guide 5.89, Fitness -for-Duty Programs for Commercial Power Reactor and Category I Special Nuclear Material Licensees (Nov. 2022)
(https://www.nrc.gov/docs/ML2014/ML20143A034.pdf).
Covers 3 topics:
Donor hydration during shy -bladder events Observed collections using mirrors MRO review of invalid specimens, pH 9.0 to 9.5
Slide 17 Additional MRO Guidance
HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs (revised February 1, 2024).
(https://www.samhsa.gov/sites/default/files/mro-guidance -manual-2024.pdf )
- Specifically, Chapter 5, Interpretation of Results and Drug Information), which provides information on the routes of administration, metabolism and excretion, and pharmaceuticals and use.
- Remember though, this manual is for Federal agency drug testing programs that implement the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs and not 10 CFR Part 26.
National Laboratory Certification Program (NLCP), Drug Testing Matters. A continuing education newsletter on topics of interest to laboratories, laboratory staff, and NLCP inspectors. For a free email subscription, send an email with your name and the phrase Subscribe-DTM in the email subject line to NLCP@rti.org.
Slide 18 Tech Issues Rulemaking Plan Development Drugs and Alcohol: Technical Issues and Editorial Changes (RIN 3150-A J15, Docket: NRC-2012-0079)
Effectiveness and efficiency improvements in three topic a reas:
- 1) Incorporating 15 years of lessons learned from implementing Par t 26
- 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 Februar y 7, 2024 (NRC slides: ML24036A330; Meeting transcript: ML24116A143 )
Rulemaking Plan Regulatory Basis Proposed Rule Final Rule (were here)
Slide 19 Technical Issues Rule Plan -
Medical Review Officers
Considerations:
- Legitimate medical explanation for a positive drug test result (Part 26 does not define)
- 26.5 defines illegal drug as any drug that is included in Schedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812], but not when used pursuant to a valid prescription or when used as otherwise authorized by law.
(Part 26 does not define valid prescription)
- Test results review (subversion attempts)
- Test results review (misuse) - 26.185(j)(2)
- Time to complete test result review and notify FFD program (10 business days from receipt of positive, adulterated, substituted, or invalid test result) - 26.185(p)
- Retraining? An MRO is only required to receive initial training - 26.183(a)
(i.e., pass an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of Federally mandated drug tests)
Slide 20 Technical Issues Rule Plan -
Substance Abuse Experts
Considerations:
- FFD program personnel involved in the day -to-day operations of the FFD program 26.4(g) and frequency of job activity performance
- Behavioral observation program applicability when an SAE is remote (i.e., does not have unescorted access to a site)
- Initial evaluation performed after an FFD policy violation (e.g., positive result)
- Face-to-face determination of fitness conducted for cause (i.e., because of observed behavior or a physical condition), 26.189(c)
Slide 21 Technical Issues Rule Plan - Subversions
Considerations
- Prohibit possession of subversion paraphrenia (e.g., product in backpack, product in locker - events not tied to the collection process)
- Products illegal in some states
- No legitimate reason for possession
- Include 26.75 permanent denial for possession of subversion paraphernalia
- Evaluate if more restrictive urine specimen temperature range would be beneficial in identifying additional subversion attempts (current range = 90-100 oF)
- Improve information on MRO test result reviews, for example:
- 1st specimen out of temperature (negative); 2nd observed specimen (positive)
- 1st specimen (invalid result); 2nd observed specimen (positive)
- Clarify that the MRO is to consider all information in making subversion determinations, such as comparison of specimen characteristics when multiple specimens are collected (temperature, creatinine, pH, specific gravity)
Slide 22 Questions
Slide 23