Fitness-for-Duty Drug Testing Program Requirements
Fitness for duty HHS
2019-12-05 2019-12-05 2019-12-05 2019-12-05 2019-11-05 2019-12-05 2019-12-05 2019-12-05 2019-12-05 2019-12-05
NRC-2009-0225-0041 NRC-2009-0225-0042 NRC-2009-0225-0043 NRC-2009-0225-0036 NRC-2009-0225-0028 NRC-2009-0225-0046 NRC-2009-0225-0032 NRC-2009-0225-0034 NRC-2009-0225-0033 NRC-2009-0225-0039
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https://api.regulations.gov/v4/comments/NRC-2009-0225-0041 https://api.regulations.gov/v4/comments/NRC-2009-0225-0042 https://api.regulations.gov/v4/comments/NRC-2009-0225-0043 https://api.regulations.gov/v4/comments/NRC-2009-0225-0036 https://api.regulations.gov/v4/comments/NRC-2009-0225-0028 https://api.regulations.gov/v4/comments/NRC-2009-0225-0046 https://api.regulations.gov/v4/comments/NRC-2009-0225-0032 https://api.regulations.gov/v4/comments/NRC-2009-0225-0034 https://api.regulations.gov/v4/comments/NRC-2009-0225-0033 https://api.regulations.gov/v4/comments/NRC-2009-0225-0039
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26.119 determines the standards for conditions of Shy Bladder.  This section of code has presented with unique challenges for Program Managers and donors alike.  The code stipulates a 5 business day standard for donors to consult with a physician when unable to produce a specimen.  Many of the donor participants are transient workers who do not carry insurance or regularly maintain a personal physician.    Workers who are traveling and away from their residence must now (when unable to produce a specimen)  attempt to travel home and find a physician who will immediately schedule an appointment and see them.  Finding a physician in the immediate area of the plant presents with challenges and appointments are difficult in a short time frame.  In this frequent scenario, the worker is unable to meet the 5 day standard, which invariably results in a permanent denial.  Another issue is that of the alternative process.  It would seem reasonable to immediately proceed to an acceptable alternative testing process such as oral fluid.  Established guidelines recently published should provide MROs and program managers with the needed tools and guidance to address this issue.  Recommendation: Provide for a more reasonable and realistic time frame for review of medical information when an individual cannot provide a specimen under shy bladder conditions.  Ten days seems reasonable since a review under positive conditions may be considered within days (see below).  Providing for a minimum time frame of ten days, and perhaps providing for a extension (not to exceed 30 days) under approved conditions of the MRO or program manager seems reasonable.  Additionally, adopt and clearly outline the conditions for alternative testing.  Oral fluid is less evasive than blood extraction and easily implemented.  Also consider providing program managers with the option to use oral fluid testing in any testing condition at any time.    This provides for flexibility within the program and strengthens the integrity and viability of the program when donors cannot predict the method of testing.    26.119FFD program personnel shall direct the donor to obtain, within 5 business days, an evaluation from a licensed physician who is acceptable to the MRO and has expertise in the medical issues raised by the donors failure to provide a sufficient specimen. If the MRO determines that the medical condition is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, then the MRO shall authorize an alternative evaluation process, tailored to the individual case, for drug testing.Time to complete MRO review. The MRO shall complete his or her review of positive, adulterated, substituted, and invalid test results and, in instances when the MRO determines that there is no legitimate medical explanation for the test result(s), notify the licensees or other entitys designated representative within 10 business days of an initial positive, adulterated, substituted, or invalid test result. The MRO shall notify the licensee or other entity of the results of his or her review in writing and in a manner designed to ensure the confidentiality of the information. 26.187 outlines the credentials of the Substance Abuse Expert.  All industry SAEs are required to hold the credentials noted below.  However, the SAEs providing services to the industry are not practicing field treating addiction personnel, nor do they have the expertise to do so.    Instead, SAEs serving the nuclear industry are assessing, evaluating, and reporting recommendations to FFD program managers for referrals, but are not providing treatment.Conversely, a Masters level addictions professional who has completed a six year addictions program including focused training in assessment, but does not hold a license because they are not providing treatment does not meet the standard as noted below.  Individuals who have completed an addictions program have completed more focused training in substance abuse/addictions than the professionals currently listed.  Recommendation: Consider incorporating language that allows for the completion of an advanced degree in addictions (Masters) as a credential standard for performing as an SAE.  Credentials. An SAE shall have at least one of the following credentials:(1) A licensed physician;(2) A licensed or certified social worker;(3) A licensed or certified psychologist;(4) A licensed or certified employee assistance professional; or Determination of Fitness (DOF) is conducted in the event an individual has violated the FFD program, or is otherwise impaired on a level that compromises their ability to work safely and competently.  Often the DOF is initiated based on observed behavior.  However, code currently does not define what manner of observed behavior constitutes an evaluation.  Logic would dictate that the behavior that requires a DOF would be predicated on a failure of the FFD program or impairment that compromises safe competent operation.  However, utilities are conflicted and are initiating DOFs for any behavior due to an observed report.   As an example, some utilities are launching DOFs for such innocuous behavior as looking at another worker in an odd manner.  A preliminary assessment that collects relevant facts and information can determine if impairment may exist and identify any program violations, so that personnel are not being subjected to unnecessary evaluations.   Recommendation: Consider language that clarifies the role of the FFD program management in conducting relevant information that will contribute to a formal referral for DOF.  A preliminary assessment that clarifies FFD managements responsibility for conducting interviews, ruling out the possibility that drugs may have played a role in the behavior by conducting FFD collection and testing, reviewing past behavior observation reports, reviewing past self reports.  This information is akin to the information gathered by Reviewing Officials.  Conducting relevant information and subsequently providing that information to the SAE, MRO, or Psychologist is absolutely necessary and is in fact occurring at many utilities, while others, out of an abundance of caution, conduct a DOF for any observed behavior.  A determination of fitness must be made in at least the following circumstances:(1) When there is an acceptable medical explanation for a positive, adulterated, substituted, or invalid test result, but there is a basis for believing that the individual could be impaired while on duty;(2) Before making return-to-duty recommendations after an individuals authorization has been terminated unfavorably or denied under a licensees or other entitys FFD policy;(3) Before an individual is granted authorization when potentially disqualifying FFD information is identified that has not previously been evaluated by another licensee or entity who is subject to this subpart; and(4) When potentially disqualifying FFD information is otherwise identified and the licensees or other entitys reviewing official concludes that a determination of fitness is warranted under  26.69.(c) A determination of fitness that is conducted for cause (i.e., because of observed behavior or a physical condition) must be conducted through face-to-face interaction between the subject individual and the professional making the determination. Electronic means of communication may not be used. 26.31 denotes the conditions for collection.  Administration of post event collection specific to the 4 hour reference has cause some confusion in the industry.  Very often a safety event is still under investigation after four hours leaving the OSHA recordable question unanswered.  It may be that the recordable question is not answered for 24 hours or more.  Personnel who are injured and transported for medical treatment may not return to duty days or weeks later without FFD testing.  The rule is clear that medical assistance cannot be delayed for FFD testing consideration.  However, when minor injuries occur, and the subject individual returns to duty the 8-10 hours later, the question of recordability is not yet answered, program personnel are often seeking guidance about whether FFD collections make sense under this standard.   Language that clarifies this frequent scenario would be most beneficial.  Additionally, the term substantial degradation to the level of safety has been frequently debated.  The question is often asked, What constitutes substantial  degradation?  Licensees are generally attempting to define what is meant by substantial.  It seems more prudent to state that degradations of plant safety that generally may compromise general safety and security may be more appropriate.  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(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;(ii) A radiation exposure or release of radioactivity in excess of regulatory limits; or(iii) Actual or potential substantial degradations of the level of safety of the plant; We as a nation need to continue to push the legalization of marijuana and keep it in schedule. Marijuana has been proven to be extremely beneficial to the human body Cannabidiol has the ability to stop cancer by turning off a gene called Id-1. This along with many other amazing things such as preventing Alzheimer are why we need to continue to push these regulations through congress. This needs to be doe for the people. Drug  Alcohol Testing Industry Association (DATIA) Comments 26.33 denotes the standard for the behavior observation program as noted below.  Behavior Observation is the cornerstone of the FFD program and has contributed to crucial observations that have protected the safety and security of licensee personnel.  Behavior observation has been extremely effective when implemented properly, but disastrous when not executed in the manner prescribed by code.  Over the years there have been note worthy examples of personnel who had expressed knowledge of FFD issues, but chose to ignore or down play observations for fear of becoming involved or implicated in actions that could impact an individuals  that could employment.   Additionally, the current language stipulates, detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty.  This language specifically addresses use, sale or possession of illegal drugs or alcohol, but does not address the abuse of legal drugs or other substances that have the propensity of impair and endanger safety.   Recommendation: Consider additional language that emphasizes the vital importance of the FFD Behavior Observation program and the potential consequences of purposely ignoring the mandate to report behavior observation concerns.  In two recent cases I was involved with, two supervisors observed serious behavior observation issues that were attributed to severe mental illness in each case.   In these cases, the observations were overt and abundantly apparent but were ignored.  Language should address willful noncompliance.  Additionally, recommend language that addresses detecting behaviors that may indicate possible sale or possession of abused legal or illegal drugs, alcohol, or any substance used for the expressed purpose of impairing an individuals ability to work safely and competently.  This would include inhalants or other household substances that have been used to alter or impair consciousness.  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. The conditions detailing remote collections (collections remote from the licensee) are not clearly denoted in the present code verbiage.  26.4 h,2, featured below seems to suggest that licensees may conduct remote collections via personnel who are asked to provide collections for the licensees.  There are sections of the code that allow for remote collections at hospitals for example, as a contingency when emergency conditions dictate.  Some licensees have established remote collection sites to manage personnel who are remote from the licensees collection facilities.  Examples include Information Technology, Engineering and other personnel who may reside in other states hundreds of miles from the licensee and provide services to the licensee remotely.  This section of code (26.4 h, 2) is confusing and does not clearly provide sufficient guidance on managing the issue of remote collections.  IF remote collections are permissible; under what conditions may they be managed?  Concerns have been raised regarding how such collection facilities should or should not be audited if they are providing infrequent services to the licensee, and are not involved the daily operations of the FFD program.  Should licensees depend on other licensee collection facilities to manage this unique population of workers?  If so, what guidance dictate the methods for managing the process?  What should occur if the donor tests positive at licensee who is collecting a specimen for another licensee? Clearly, licensees collecting specimens for each other is a far better option than relying on unvetted remote collection facilities.  However, there are scenarios that create the possibly that remote collections could not be completed by another licensee due to distance.  Recommend guidance that provides for clear direction concerning this unique issue.  Licensee companys increasingly are placing demands on FFD program personnel to accommodate remote collection conditions that would allow the licensee to meet the definition of critical group, thereby requiring placement in the FFD program.   Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to  26.31(c)(1), 26.35(b), 26.37, 26.39, and the applicable requirements of subparts C, and E through H of this part.(i) The following individuals are not subject to an FFD program under this part:(1) Individuals who are not employed by a licensee or other entity in this part, who do not routinely provide FFD program services to a licensee or other entity in this part, and whose normal workplace is not at the licensees or other entitys facility, but who may be called on to provide an FFD program service, including, but not limited to, collecting specimens for drug and alcohol testing, performing behavioral observation, or providing input to a determination of fitness. Such individuals may include, but are not limited to, hospital, employee assistance program (EAP) or substance abuse treatment facility personnel, or other medical professionals; The current rule stipulates personnel who are considered a part of the FFD program.  26.4 g, featured below states that personnel who are involved in the day to day operations of the program are considered FFD personnel, yet there are licensee employees who are called upon to perform infrequent duties, (For Cause, Post Event, back shift random testing) who are not involved in day to day operations.  A typical example would include Security personnel.  Security personnel, if not given access to random lists, are certainly notifying personnel and conducting collections.  This wording has caused confusion among licensees.  Recommend this section be clarified to clearly denote personnel who are considered FFD program personnel.    All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in  26.3(a) through (c), and, as applicable, (d), and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part, and, at the licensees or other entitys discretion, subpart C of this part:(1) All persons who can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to the MRO;(2) All persons who make determinations of fitness;(3) All persons who make authorization decisions;(4) All persons involved in selecting or notifying individuals for testing; and(5) All persons involved in the collection or onsite testing of specimens. 10 CFR 26.75 provides for sanctions on any individual who violates the FFD program.  As noted below, the sanction for possession of illegal drugs, consumption of alcohol within a protected area, or while performing duties shall result in a minimum 5 year denial. This section does not address use of other intoxicating agents such as solvents, computer cleaners, glue, etc that have a equal to or greater impairing effect.  Additionally, the abuse of prescription drugs with the sole intent of impairing  or producing a high is also not discussed in this section.  Clearly the focus of this section is to address any individual who would willfully abuse substances with the sole intent of producing a high to alter consciousness, thus jeopardizing safety and security.    There have been cases noted with licensees involving the use of inhalants and/or prescription drug abuse where other entities have argued that the language of the code did not support sanctions in these specific cases.  Recommendation: Consider language that addresses substance abuse in all forms within the protected area or during performance of any tour of duty.    Any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, within a transporters facility or vehicle, or while performing the duties that require the individual to be subject to this subpart shall immediately have his or her authorization unfavorably terminated and denied for a minimum of 5 years from the date of the unfavorable termination of authorization.