ML23181A096
| ML23181A096 | |
| Person / Time | |
|---|---|
| Issue date: | 07/11/2023 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| ML23181A091 | |
| Download: ML23181A096 (1) | |
Text
Presentation to the Nuclear Energy Institutes Access Authorization and Fitness for Duty Workshop
FFD Program Manager and Auditor Trainings 10 CFR Part 26 Final Rule (November 2022)
July 10- 11, 2023
Office of Nuclear Security and Incident Response Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287- 0638)
Part 26 Final Rule (November 2022 )
FFD Program Manager/Auditor Training Topics
Drug testing panel changes (cutoffs, substances)
MRO invalid specimen review (pH 9.0 - 9.5)
Special analyses testing, 26.163(a)(2)
Definition changes (overview)
MRO documenting donor retest requests Collector documenting observations on the Federal CCF Collector actions when a refusal to test is determined Direct observation of urine - use of mirrors Observing a hydrating donor (use of hydration monitors/other collectors)
Oral fluid - observed collection conditions (optional use)
Blind performance test samples Regulatory guidance and implementation resources
Slide 2 Par t 26 Final Rule (November 2022)
Aligns Par t 26 drug testing requirements more closely with the U.S. Depar tment of Health and Human Ser vices 2008 and 2017 Mandator y Guidelines for Federal Workplace Drug Testing of urine specimens. Also incorporates lessons learned from implementing Par t 26.
- Published: November 22, 2022 (87 FR 71422)
- Effective: December 22, 2022
- Compliance Required by: November 22, 2023 Substantive changes:
Adds testing for MDMA, MDA, hydrocodone, hydromorphone, oxycodone, oxymorphone Lowers drug testing cutoff levels for amphetamine, methamphetamine, cocaine Improves testing method to identif y heroin metabolite, 6-acetylmorphine (6-AM)
Improves methods to detect donor subversion attempts (special analyses testing)
Includes option to collect and drug test oral fluid for most obser ved urine collection conditions
Slide 3 Part 26 Final Rule (November 2022)
Drug Testing Panel Changes - Urine, 26.163
Drugs or drug metabolites Testing Cutoff Levels (ng/mL)Initial Confirmatory Cocaine metabolites 300150 150100 Opioids Opiate metabolites:
6-acetylmorphine (6-AM) 10101 Hydrocodone 300 100 Hydromorphone 100 Oxycodone 100 100 Oxymorphone 100 Amphetamines Amphetamine 1000500 500250 Methamphetamine 5002502 Methylenedioxymethamphetamine (MDMA) 500 250 Methylenedioxyamphetamine (MDA) 250
1 Confirmator y testing for 6-AM per formed only when morphine concentration exceeds 2,000 ng/mL
2 To be repor ted positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 200100 ng/mL Only substances with changes displayed
Slide 4 Part 26 Final Rule (November 2022)
Invalid Specimen Review (pH 9.0- 9.5) - 26.185(f)(3)
[New]
- If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value.
- If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.
See also new Regulator y Guide 5.89, November 2022, for guidance
Slide 5 Part 26 Final Rule (November 2022)
Special Analyses Testing, 26.163(a)(2)
Required for:
Dilute specimens (before was 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 specimen outside the required temperature range of 90 to 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 (before was 50% of the initial test cutoff or greater)
Then: Conduct confirmatory drug testing to the Limit of Quantitation (LOQ)
(before was to the Limit of Detection (LOD))
Slide 6 Part 26 Final Rule (November 2022) 26.5 Definition Updates
Added Definitions Revised Definitions cancelled test calibrator carr yover control Cer tif ying Scientist dilute specimen Federal custody and control form cer tified laborator y (Federal CCF) HHS-lot invalid result rejected for testing limit of quantitation Responsible Person substituted specimen
Not discussing in this presentation - for awareness
Slide 7 Part 26 Final Rule (November 2022)
Donor Retest Requests, 26.165(b)(2) and (b)(3)
- 26.165(b)(2) [New] documentation requirement when a donor makes a written or oral request to the MRO to initiate the retesting of a single specimen or the testing of Bottle B of a split specimen for a confirmed positive, adulterated or substitute test result:
The MRO shall document in his or her records when (i.e., date and time ) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.
- 26.165(b)(3) [Revised] Addresses an inconsistency where some licensees interpreted 26.165(b)(3) to require the MRO to receive a donor s written permission prior to initiating retesting, even though 26.165(b)(2) permits the donor to make an oral request to test:
The donor shall provide his or her permission for retesting an aliquot of the single specimen or the testing of Bottle B. Neither the licensee, MRO, NRC nor any other No entity, other than the MRO as permitted in§26.185(l), may order the retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen in Bottle B without the donor s written permission, except as permitted in§26.185(l).
Slide 8 Part 26 Final Rule (November 2022)
Documenting Observations on the Federal CCF, 26.107(b)(1) and (d)(3), 26.111(b)
Part 26 requires a specimen collector to document observations on the Federal CCF in several instances. However, the Federal CCF only contains a single blank line to write text (i.e., on the Remarks line of the form).
[New flexibility in three circumstances] If sufficient space does not exist on the Federal CCF, the collector may document information another documentation method consistent with the collection procedures of the licensee or other entity:
Conduct indicating an attempt to subvert the testing process - 26.107(b)(1)
Refusal to test description - 26.107(d)(3)
Unusual findings about specimen color, clarity, and any signs of contaminants or adulteration - 26.111(b)
Slide 9 Part 26 Final Rule (November 2022)
Collector actions - refusal to test, 26.107(d)
26.107(d) [New ] instructions included for the collector to follow if a refusal to test is determined at any point during the specimen collection process.
The collector must do the following:
Inform the donor that a refusal to test has been determined Terminate the collection process Document a description of the refusal to test (on the Federal CCF or through another documentation method consistent with collection procedures)
Discard any urine specimen(s) provided by the donor, unless the specimen was collected for a post-event test under§26.31(c)(3)
Immediately inform the FFD program manager
Slide 10 Part 26 Final Rule (November 2022)
Direct Observation of Urine, Use of Mirrors - 26.115(f)(2)
[New flexibility] Provides option to use a reflective mirror to assist in directly observing the provision of a urine specimen under a limited circumstance:
26.115 Collecting a urine specimen under direct observation (f)(2) The observer shall watch the donor urinate into the collection container. Specifically, the observer shall watch the urine go from the donor's body into the collection container. A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area used for urination is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted.
See also new Regulator y Guide 5.89, November 2022, for guidance
Slide 11 Part 26 Final Rule (November 2022)
Observing a Hydrating Donor, 26.109(b)(1)
When a donor is unable to provide a urine specimen of at least 30 mL on the initial attempt, the donor is provided with up to 40 ounces of fluid over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> to provide a specimen.
[New flexibility ] Under 10 CFR 26.109(b)(1), the collector that initiated the collection process with a donor may assign responsibility for monitoring a donor during the hydration process to:
Another trained collector that meets the 10 CFR 26.85(a) requirements, OR A hydration monitor
- The original collector MUST record the name of the other collector or hydration monitor on the Federal CCF
- If a hydration monitor is used, the initial collector MUST explain the hydration process and acceptable donor behavior to the hydration monitor
- The original collector may perform other collections while the donor is in the hydration process
See also new Regulator y Guide 5.89, November 2022, for guidance
Slide 12 Part 26 Final Rule (November 2022)
Observed Collections - Option Use of Oral Fluid
- Enabled the option to collect and drug test oral fluid specimens under four observed specimen collection conditions [new]:
26.83 Specimens to be collected.
(b) Collect only urine specimens for both initial and confirmatory tests for drugs, unless the licensee or other entity establishes through its policy and procedures that an oral fluid specimen can be collected and tested for any of the observed specimen collection conditions under§26.115(a)(1) through (3) and (a)(5). For each observed collection condition under§26.115(a)(1) through (3) and (a)(5), the licensee or other entity shall always collect and test the same specimen type.
- Must be established through the FFD policy and procedures.
- Must use the same specimen for a directly obser ved collection condition (e.g., collect urine for 26.115(a)(2) and (a)(3);
and collect oral fluid for 26.115(a)(1) and (a)(5)).
Slide 13 Part 26 Final Rule (November 2022)
Observed Collections - Option Use of Oral Fluid
- Must be tested at an HHS-certified laboratory 26.153(a) Licensees and other entities who are subject to this part shall use only HHS-certified laboratories as defined in 26.5.
26.31(d)(3)(i) Testing of urine specimens for drugs and validity, except validity screening and initial drug and validity tests performed by licensee testing facilities under paragraph (d)(3)(ii) of this section, must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Urine S specimens sent to HHS-certified laboratories must be subject to initial validity and initial drug testing by the laboratory. Oral fluid specimens sent to HHS-certified laboratories must be subject to initial drug testing by the laboratory....
- Updated numerous Part 26 requirements to remove/clarify references to specimens. For example,
- 26.117 Preparing drug testing urine specimens for storage and shipping
Slide 14 Part 26 Final Rule (November 2022)
Observed Collections - Option Use of Oral Fluid
- Specimen collector qualifications:
26.85(a) Urine c Collector qualifications. Each Urine collectors shall be knowledgeable of the requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed, and shall keep current on any changes to urine the collection procedures for each specimen the individual is qualified to collect under this part. Each Ccollectors shall receive qualification training that meets the requirements of this paragraph and demonstrate proficiency in applying the requirements of this paragraph before serving as a collector
- Collection condition (visual privacy):
26.87 Collection Sites (b)The collection site must provide for the donors v Visual privacy must be provided to while the donor and collector when are viewing alcohol test the results of an alcohol test, and during the collection of an oral fluid specimen for drug testing. The donor must be provided with and for individual privacy while the donor is submitting a urine specimen, except if a directly observed urine specimen collection is required.
Slide 15 Part 26 Final Rule (November 2022)
Observed Collections - Option Use of Oral Fluid
- Specimen storage condition (as specified by the device manufacturer):
26.117(j) Collection site personnel shall arrange to transfer the collected specimens to the HHS-certified laboratory. Oral fluid specimens shall be stored under the conditions specified by the oral fluid specimen collection device manufacturer.
NOTE: No changes in the final rule on when alternate 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 Part 26 Final Rule (November 2022)
Blind Performance Test Samples (BPTS), 26.168
BPTS Lot In-Service Requirement - 10 CFR 26.168(h)(1) [revised]
- Eliminated requirement that BPTS suppliers place a sample lot in service for no more than 6 months.
- The BPTS supplier is already required to provide the expiration date for each BPTS provided - 10 CFR 26.168(h)(2).
BPTS Formulation Requirements - 10 CFR 26.168(g)
- The final rule did not change the BPTS formulation requirements, BUT the final rule DID:
lower the testing cutoff levels for some substances, and add new substances to the testing panel.
As a result, a licensee/other entity needs to purchase new BPTSs for the substances with lower cutoff levels, and new BPTSs for substances added to the testing panel.
Slide 17 Part 26 Final Rule (November 2022)
BPTS Quarterly Submission Example, 26.168
Red font identifies the 3 new BPTS submissions per quarter covering the substances added to the panel for an existing HHS-certified laboratory (1 containing MDMA/MDA; 1 containing HYC/HYM; and 1 containing OXYC/OXYM)
Slide 18 Part 26 Final Rule (November 2022)
Regulatory Guidance
Regulatory Guide 5.89, Fitness -for-Duty Programs for Commercial Power Reactor and Category I Special Nuclear Material Licensees [new]
- Provides guidance on three topic areas:
Monitoring a donor during the 3 -hydration period (shy-bladder)
Use of mirrors to assist in observed urine collections MRO review of invalid specimens, pH 9.0 to 9.5
- Available for download at:
https://www.nrc.gov/docs/ML2014/ML20143A034.pdf
Slide 19 Part 26 Final Rule (November 2022)
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)
- Part 26 Final Rule Q&A Session - Public Meeting held on April 26, 2023 Discussed 8 questions received on the final rule. Responses captured in the following two documents:
- NRC slide presentation (ML23122A176)
- Meeting summary (ML23146A126)
Slide 20