Frequently Asked Questions About Program Administration
This section provides the NRC staff's answers to the following questions related to Program Administration, as it relates to fitness-for-duty:
Index to All Frequently Asked Questions Pages
When an employee is requested to perform a random drug and alcohol (D&A) test, does the rule require the formal communication to be made verbally? Does the rule require the communication to be made in person? Should a non-supervisor co-employee contact a fellow employee to report to a random test after a supervisor directs the co-employee to make this notification to the selected employee for a random test?
The 2008 rule does not specify the method(s) a licensee or other entity should or shall use to notify an individual to report to the collection site for random drug and alcohol testing. However, § 26.27(c) does require each licensee and other entity to maintain and implement written procedures that describe the methods to be used in implementing the FFD policy. These procedures should describe the process to be followed to ensure that individuals who are called upon for random testing are tested as soon as reasonably practicable after notification (see § 26.31(d)(iii)). These procedures should also specify the individuals who are authorized to inform a donor that he or she has been selected for random testing and how the individual is to be informed, such as acceptable communication/notification methods.
Furthermore, notifying an employee who is off site to report for random testing is inconsistent with § 26.31(d)(2)(v) which requires "that individuals who are off site when selected for testing… shall be tested at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing and without prior notification to the individual that he or she has been selected for testing" (emphasis added). Notifying an employee that he or she has been selected for random testing when the employee is off site provides a potential opportunity for the individual to subvert the testing process.
Although the question does not specify that the employee's supervisor was the individual authorized by the FFD program to notify the selected employee, if that were the case, then relying on a peer of the selected individual to notify the employee would be a violation of the licensee's notification procedure. In the "Section-by-Section Analysis of Substantive Changes" accompanying the Part 26 final rule, on page 17168 of the March 31, 2008, Federal Register Notice, the NRC provides some context to this issue as it relates to a new reporting requirement in § 26.719(b)(3). Section 26.719(b)(3) requires the reporting of intentional acts that cast doubt on the integrity of the FFD program. While it is not clear that the example described in the question was an intentional act to subvert the testing process, the Section-by-Section discussion describes the underlying concerns: "Because of the wide array of possible acts that could fit this definition and be of concern to the NRC, the final rule does not specify the acts that licensees and other entities must report. However, such intentional acts may include, but are not limited to: (1) Notifying individuals, outside of the FFD program's normal notification procedures, that they will be selected for random or followup testing on a particular date or at a specific time so that the individuals have sufficient time available to attempt to mask drug use by, for example, obtaining a substitute urine specimen or an adulterant, drinking large amounts of liquid in order to provide a dilute urine specimen, or leaving the site to avoid testing…"
If the HHS lab detects the presence of drug metabolites below the cutoff and the sample is not dilute, can and should it be reported to the MRO to determine if an observed recollect is warranted. OR can it automatically be taken to limits of detection? As another alternative, can all specimens be tested to limits of detection?
Section 26.115 specifies the exclusive grounds for collecting a urine specimen under direct observation. A specimen with drug metabolites detected by the HHS-certified laboratory, but at a concentration below the initial cutoff level for the drug is not a condition where a second specimen collection under direct observation is permitted. However, § 26.163(a) and (b) do permit licensees and other entities to establish more stringent cutoff levels for initial and confirmatory testing respectively, if the cutoff levels have been certified in writing to be scientifically sound and legally defensible by an independent, qualified forensic toxicologist as described in § 26.31(d)(i)(D).
Section 26.163(a)(2) applies to dilute samples and does not provide the option to conduct limit of detection testing on any specimen that does not meet the dilute criteria.
What is the difference between the scheduled drug list in Section 812 and Section 1308.13? It seems the regs refer to Section 812 for the identification of schedule 1-V drugs but the footnotes in Section 812 indicate that 1308.13 is the most up to date. Does the NRC utilize the most up to date list of Scheduled substances and if so why doesn't the regulatory language refer to section 1308.13?
The fitness-for-duty rule refers to the schedules of controlled substances listed in 21 U.S.C. Section 812. Footnote 1 to Section 812 states that amendments to the schedule of drugs will be published in 21 CFR Part 1308. Therefore, please refer to 21 CFR Part 1308 for the current schedule of controlled substances. NRC applies the current schedule of controlled substances as listed in 21 CFR Part 1308 to the fitness-for-duty rule. Note, that Section 1308.13 only contains a list of substances classified in Schedule III. References to the schedules of controlled substances in the fitness-for-duty rule include all applicable sections of Part 1308 (i.e., Sections 1308.11 through 1308.15).
10 CFR 26.4 states that Fitness for Duty program personnel includes: "All persons involved in the selecting or notifying individuals of testing," which according to § 26.31 requires these individuals to have an updated FFD background check every five years. Are supervisors or other plant management who coordinate the reporting of the subject to the Fitness for Duty collection station included in the category of Fitness for Duty program personnel? Does this also include persons who schedule and notify these supervisors and who monitor to ensure that the subject reports as scheduled for random collections?
Fitness for Duty program personnel who select and notify individuals of testing are those personnel involved in selecting individuals for testing and providing the initial notification that an individual has been selected for testing. This definition is not intended to broaden the scope of FFD program personnel to individual other personnel (e.g., secretaries or laborers) or supervisors (e.g., team/shift leads) who may receive and pass on the notification from the FFD program group that an individual needs to report for random testing.
If an individual who would fall under the 10 CFR 26.719(b)(2) requirement for licensees to report significant violations within 24 hours to the NRC Operations Center, requests a re-test as allowed in accordance with 26.165(b)(2), when would the licensee be required to report and make the 24 hour call? After the initial MRO-confirmed positive or after the re-test results, if reconfirmed?
While licensees shall administratively withdraw an individual's authorization based on an MRO-confirmed positive, adulterated, or substituted test result(s) from the first HHS-certified laboratory under 10 CFR 26.165(f), the determination of violation would not be made until the retest confirms the positive test result, in accordance with 10 CFR 26.185(n).
As the 10 CFR 26.719 requirement is for notification to the NRC ". . . within 24 hours after the licensee or other entity discovers the violation," the notification would be required within 24 hours after the positive test result is reconfirmed and the individual is determined to have violated the licensee's FFD policy as determined and reported by the MRO.
Why is there a 4 hour time limit for significant illness or personal injury?
Regulations:
§§ 26.31(c)(3) and 26.31(c)(3)(i)state the following:
"(3) Post-event. As soon as practical after an event involving a human error that was committed by an individual who is subject to this subpart, where the human error may have caused or contributed to the event. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in—
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(i) A significant illness or personal injury to the individual to be tested or another individual, which within 4 hours after the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, "General Recording Criteria," and subsequent amendments thereto, and results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness;"
Staff response:
The staff acknowledges that it can be difficult to detect illnesses and injuries that meet the threshold for post-event testing at the time they occur. It may take more than four hours or even days before an injury or illness rises to the level of the OSHA recording criteria. That being the case, it would be too late for post-event testing to be of any value in determining whether the individual used drugs or alcohol, and whether the use could have contributed to the event.
The rule limits post event testing to situations in which the licensee or other entity can determine, within four hours after the event has occurred, that an injury or illness meets the OSHA recordable threshold, and can conduct the testing within a time frame that will provide useful information about the individual's condition at the time of the event. However, this section of the rule should not be misinterpreted as requiring post-event testing be conducted within four hours of the event. Section 26.31(c)(3) defines the time period after the event within which testing must be completed as "as soon as practical."
Does that make the sites vulnerable to regulatory violation if in these instances the individual is not for cause or fatigue assessed?
Regulations:
§ 26.31(c)(2) For cause.
In response to an individual's observed behavior or physical condition indicating possible substance abuse or after receiving credible information that an individual is engaging in substance abuse, as defined in § 26.5;
§ 26.33 Behavioral observation.
Licensees and other entities shall ensure that the individuals who are subject to this subpart are subject to behavioral observation. Behavioral observation must be performed by individuals who are trained under § 26.29 to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security. Individuals who are subject to this subpart shall report any FFD concerns about other individuals to the personnel designated in the FFD policy.
§ 26.211 Fatigue assessments.
(a) Licensees shall ensure that fatigue assessments are conducted under the following conditions:
(1) For cause. In addition to any other test or determination of fitness that may be required under §§ 26.31(c) and 26.77, a fatigue assessment must be conducted in response to an observed condition of impaired individual alertness creating a reasonable suspicion that an individual is not fit to safely and competently perform his or her duties, except if the condition is observed during an individual's break period. If the observed condition is impaired alertness with no other behaviors or physical conditions creating a reasonable suspicion of possible substance abuse, then the licensee need only conduct a fatigue assessment. If the licensee has reason to believe that the observed condition is not due to fatigue, the licensee need not conduct a fatigue assessment;
Staff response:
The licensee does not violate 10 CFR 26.31 if it does not conduct a for-cause test or fatigue assessment within 4 hours of the event when more than 4 hours are needed for the illness or injury to meet the OSHA recording criteria. Moreover, the licensee does not need to conduct a for-cause test or fatigue assessment unless the individual meets the criteria of § 26.31(c)(2) or § 26.211(a)(1) respectively. All site personnel are trained in behavioral observation to detect behaviors that may indicate the use of drugs and alcohol, or impairment from fatigue. In other words, it doesn't have to be a post event determination to conduct for-cause testing or a fatigue assessment.