The licensees and other entities specified in § 26.3(a) through (c) shall establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. The individuals specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and, if necessary, § 26.4(j) shall be subject to these FFD programs. Licensees and other entities may rely on the FFD program or program elements of a C/V, as defined in § 26.5, if the C/V's FFD program or program elements meet the applicable requirements of this part.

Fitness-for-duty programs must—

(a) Provide reasonable assurance that individuals are trustworthy and reliable as demonstrated by the avoidance of substance abuse;

(b) Provide reasonable assurance that individuals are 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 their duties;

(c) Provide reasonable measures for the early detection of individuals who are not fit to perform the duties that require them to be subject to the FFD program;

(d) Provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs and alcohol; and

(e) Provide reasonable assurance that the effects of fatigue and degraded alertness on individuals' abilities to safely and competently perform their duties are managed commensurate with maintaining public health and safety.

(a) General. Each licensee and other entity shall establish, implement, and maintain written policies and procedures to meet the general performance objectives and applicable requirements of this part.

(b) Policy. The FFD policy statement must be clear, concise, and readily available, in its most current form, to all individuals who are subject to the policy. Methods of making the statement readily available include, but are not limited to, posting the policy in multiple work areas, providing individuals with brochures, or allowing individuals to print the policy from a computer. The policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy. At a minimum, the written policy statement must—

(1) Describe the consequences of the following actions:

(i) The use, sale, or possession of illegal drugs on or off site;

(ii) The abuse of legal drugs and alcohol; and

(iii) The misuse of prescription and over-the-counter drugs;

(2) Describe the requirement that individuals who are notified that they have been selected for random testing must report to the collection site within the time period specified by the licensee or other entity;

(3) Describe the actions that constitute a refusal to provide a specimen for testing, the consequences of a refusal to test, as well as the consequences of subverting or attempting to subvert the testing process;

(4) Prohibit the consumption of alcohol, at a minimum—

(i) Within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility, except as permitted in § 26.27(c)(3); and

(ii) During the period of any tour of duty;

(5) Convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty;

(6) Address other factors that could affect FFD, such as mental stress, fatigue, or illness, and the use of prescription and over-the-counter medications that could cause impairment;

(7) Provide a description of any program that is available to individuals who are seeking assistance in dealing with drug, alcohol, fatigue, or other problems that could adversely affect an individual's ability to safely and competently perform the duties that require an individual to be subject to this subpart;

(8) Describe the consequences of violating the policy;

(9) Describe the individual's responsibility to report legal actions, as defined in § 26.5;

(10) Describe the responsibilities of managers, supervisors, and escorts to report FFD concerns; and

(11) Describe the individual's responsibility to report FFD concerns.

(c) Procedures. Each licensee and other entity shall prepare, implement, and maintain written procedures that describe the methods to be used in implementing the FFD policy and the requirements of this part. The procedures must—

(1) Describe the methods and techniques to be used in testing for drugs and alcohol, including procedures for protecting the privacy and other rights (including due process) of an individual who provides a specimen, procedures for protecting the integrity of the specimen, and procedures used to ensure that the test results are valid and attributable to the correct individual;

(2) Describe immediate and followup actions that will be taken, and the procedures to be used, in those cases in which individuals are determined to have—

(i) Been involved in the use, sale, or possession of illegal drugs;

(ii) Consumed alcohol to excess before the mandatory pre-work abstinence period, or consumed any alcohol during the mandatory pre-work abstinence period or while on duty, as determined by a test that measures BAC;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis; or

(v) Had legal action taken relating to drug or alcohol use, as defined in § 26.5;

(3) Describe the process that the licensee or other entity will use to ensure that individuals who are called in to perform an unscheduled working tour are fit for duty. At a minimum—

(i) The procedure must require the individual who is called in to state whether the individual considers himself or herself fit for duty and whether he or she has consumed alcohol within the pre-duty abstinence period stated in the policy;

(ii) If the individual has consumed alcohol within this period and the individual is called in for an unscheduled working tour, including an unscheduled working tour to respond to an emergency, the procedure must—

(A) Require a determination of fitness by breath alcohol analysis or other means;

(B) Permit the licensee or other entity to assign the individual to duties that require him or her to be subject to this subpart, if the results of the determination of fitness indicate that the individual is fit to safely and competently perform his or her duties;

(C) Prohibit the licensee or other entity from assigning the individual to duties that require him or her to be subject to this subpart, if the individual is not required to respond to an emergency and the results of the determination of fitness indicate that the individual may be impaired;

(D) State that consumption of alcohol during the 5-hour abstinence period required in paragraph (b)(4)(i) of this section may not by itself preclude a licensee or other entity from using individuals who are needed to respond to an emergency. However, if the determination of fitness indicates that an individual who has been called in for an unscheduled working tour to respond to an emergency may be impaired, the procedure must require the establishment of controls and conditions under which the individual who has been called in can perform work, if necessary; and

(E) State that no sanctions may be imposed on an individual who is called in to perform any unscheduled working tour for having consumed alcohol within the pre-duty abstinence period stated in the policy.

(iii) If the individual reports that he or she considers himself or herself to be unfit for duty for other reasons, including illness, fatigue, or other potentially impairing conditions, and the individual is called in, the procedure must require the establishment of controls and conditions under which the individual can perform work, if necessary;

(4) Describe the process to be followed if an individual's behavior raises a concern regarding the possible use, sale, or possession of illegal drugs on or off site; the possible possession or consumption of alcohol on site; or impairment from any cause which in any way could adversely affect the individual's ability to safely and competently perform his or her duties. The procedure must require that individuals who have an FFD concern about another individual's behavior shall contact the personnel designated in the procedures to report the concern.

(d) Review. The NRC may, at any time, review the written policy and procedures to assure that they meet the performance objectives and requirements of this part.

(a) Training content. Licensees and other entities shall ensure that the individuals who are subject to this subpart have the following KAs:

(1) Knowledge of the policy and procedures that apply to the individual, the methods that will be used to implement them, and the consequences of violating the policy and procedures;

(2) Knowledge of the individual's role and responsibilities under the FFD program;

(3) Knowledge of the roles and responsibilities of others, such as the MRO and the human resources, FFD, and EAP staffs;

(4) Knowledge of the EAP services available to the individual;

(5) Knowledge of the personal and public health and safety hazards associated with abuse of illegal and legal drugs and alcohol;

(6) Knowledge of the potential adverse effects on job performance of prescription and over-the-counter drugs, alcohol, dietary factors, illness, mental stress, and fatigue;

(7) Knowledge of the prescription and over-the-counter drugs and dietary factors that have the potential to affect drug and alcohol test results;

(8) Ability to recognize illegal drugs and indications of the illegal use, sale, or possession of drugs;

(9) Ability to observe and detect performance degradation, indications of impairment, or behavioral changes; and

(10) Knowledge of the individual's responsibility to report an FFD concern and the ability to initiate appropriate actions, including referrals to the EAP and person(s) designated by the licensee or other entity to receive FFD concerns.

(b) Comprehensive examination. Individuals who are subject to this subpart shall demonstrate the successful completion of training by passing a comprehensive examination that addresses the KAs in paragraph (a) of this section. The examination must include a comprehensive random sampling of all KAs with questions that test each KA, including at least one question for each KA. The minimum passing score required must be 80 percent. Remedial training and testing are required for individuals who fail to answer correctly at least 80 percent of the test questions. The examination may be administered using a variety of media, including, but not limited to, hard-copy test booklets with separate answer sheets or computer-based questions.

(c) Training administration. Licensees and other entities shall ensure that individuals who are subject to this subpart are trained, as follows:

(1) Training must be completed before the licensee or other entity grants initial authorization, as defined in § 26.55, and must be current before the licensee or other entity grants an authorization update, as defined in § 26.57, or authorization reinstatement, as defined in § 26.59;

(2) Individuals shall complete refresher training on a nominal 12-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program. Individuals who pass a comprehensive annual examination that meets the requirements in paragraph (b) of this section may forgo the refresher training; and

(3) Initial and refresher training may be delivered using a variety of media (including, but not limited to, classroom lectures, required reading, video, or computer-based training systems). The licensee or other entity shall monitor the completion of training and provide a qualified instructor or designated subject matter expert to answer questions during the course of training.

(d) Acceptance of training. Licensees and other entities may accept training of individuals who have been subject to another training program that meets the requirements of this section and who have, within the past 12 months, either had initial or refresher training, or have successfully passed a comprehensive examination that meets the requirements in paragraph (b) of this section.

(a) General. To provide a means to deter and detect substance abuse, licensees and other entities who are subject to this part shall implement drug and alcohol testing programs for individuals who are subject to this subpart.

(b) Assuring the honesty and integrity of FFD program personnel. (1) Licensees and other entities who are subject to this subpart shall carefully select and monitor FFD program personnel, as defined in § 26.4(g), based on the highest standards of honesty and integrity, and shall implement measures to ensure that these standards are maintained. The measures must ensure that the honesty and integrity of these individuals are not compromised and that FFD program personnel are not subject to influence attempts attributable to personal relationships with any individuals who are subject to testing, an undetected or untreated substance abuse problem, or other factors. At a minimum, these measures must include the following considerations:

(i) Licensees and other entities shall complete appropriate background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel before assignment to tasks directly associated with administration of the FFD program. The background investigations, credit and criminal history checks, and psychological assessments that are conducted to grant unescorted access authorization to individuals under a nuclear power plant licensee's access authorization program are acceptable to meet the requirements of this paragraph. The credit and criminal history checks and psychological assessments must be updated nominally every 5 years;

(ii) Individuals who have personal relationships with a donor may not perform any assessment or evaluation procedures, including, but not limited to, determinations of fitness. These personal relationships may include, but are not limited to, supervisors, coworkers within the same work group, and relatives of the donor;

(iii) Except if a directly observed collection is required, a collector who has a personal relationship with the donor may collect specimens from the donor only if the integrity of specimen collections in these instances is assured through the following means:

(A) The collection must be monitored by an individual who does not have a personal relationship with the donor and who is designated by the licensee or other entity for this purpose, including, but not limited to, security force or quality assurance personnel; and

(B) Individuals who are designated to monitor collections in these instances shall be trained to monitor specimen collections and the preparation of specimens for transfer or shipping under the requirements of this part;

(iv) If a specimen must be collected under direct observation, the collector or an individual who serves as the observer, as permitted under § 26.115(e), may not have a personal relationship with the donor; and

(v) FFD program personnel shall be subject to a behavioral observation program designed to assure that they continue to meet the highest standards of honesty and integrity. When an MRO and MRO staff are on site at a licensee's or other entity's facility, the MRO and MRO staff shall be subject to behavioral observation.

(2) Licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs” to collect specimens for drug and alcohol testing from the FFD program personnel listed in § 26.4(g).

(c) Conditions for testing. Licensees and other entities shall administer drug and alcohol tests to the individuals who are subject to this subpart under the following conditions:

(1) Pre-access. In order to grant initial, updated, or reinstated authorization to an individual, as specified in subpart C of this part;

(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;

(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—

(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;

(4) Follow-up. As part of a follow-up plan to verify an individual's continued abstinence from substance abuse; and

(5) Random. On a statistically random and unannounced basis, so that all individuals in the population subject to testing have an equal probability of being selected and tested.

(d) General requirements for drug and alcohol testing—(1) Substances tested. At a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol.

(i) In addition, licensees and other entities may consult with local law enforcement authorities, hospitals, and drug counseling services to determine whether other drugs with abuse potential are being used in the geographical locale of the facility and by the local workforce that may not be detected in the panel of drugs and drug metabolites specified in paragraph (d)(1) of this section.

(A) When appropriate, the licensee or other entity may add other drugs identified under paragraph (d)(1)(i) of this section to the panel of substances for testing, but only if the additional drugs are listed in Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812].

(B) The licensee or other entity shall establish appropriate cutoff limits for these substances.

(C) The licensee or other entity shall establish rigorous testing procedures for these substances that are consistent with the intent of this part, so that the MRO can evaluate the use of these substances.

(D) The licensee or other entity may not conduct an analysis for any drug or drug metabolites except those identified in paragraph (d)(1) of this section unless the assay and cutoff levels to be used are certified in writing as scientifically sound and legally defensible by an independent, qualified forensic toxicologist who has no relationships with manufacturers of the assays or instruments to be used or the HHS-certified laboratory that will conduct the testing for the licensee or other entity, which could be construed as a potential conflict of interest. The forensic toxicologist may not be an employee of the licensee or entity, and shall either be a Diplomate of the American Board of Forensic Toxicology or currently holds, has held, or is eligible to hold, the position of Responsible Person at an HHS-certified laboratory. All new assays and cutoff levels must be properly validated consistent with established forensic toxicological standards before implementation. Certification of the assay and cutoff levels is not required if the HHS Guidelines are revised to authorize use of the assay in testing for the additional drug or drug metabolites and the licensee or other entity uses the cutoff levels established in the HHS Guidelines for the drug or drug metabolites, or if the licensee or other entity received written approval of the NRC to test for the additional drug or drug metabolites before April 30, 2008.

(ii) When conducting post-event, followup, and for-cause testing, as defined in § 26.31(c), licensees and other entities may test for any drugs listed on Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812] that an individual is suspected of having abused, and may consider any drugs or metabolites so detected when determining appropriate action under subpart D of this part. If the drug or metabolites for which testing will be performed under this paragraph are not included in the FFD program's drug panel, the assay and cutoff levels to be used in testing for the additional drugs must be certified by a forensic toxicologist under paragraph (d)(1)(i)(D) of this section. Test results that fall below the established cutoff levels may not be considered when determining appropriate action under subpart D of this part, except if special analyses of the specimen is performed under § 26.163(a)(2) by the HHS-certified laboratory.

(iii) The licensee or other entity shall document the additional drug(s) for which testing will be performed in written policies and procedures in which the substances for which testing will be performed are described.

(2) Random testing. Random testing must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected. At a minimum, the FFD program shall—

(A) Take reasonable steps to either conceal from the workforce that collections will be performed during a scheduled collection period or create the appearance that specimens are being collected during a portion of each day on at least 4 days in each calendar week at each site. In the latter instance, the portions of each day and the days of the week must vary in a manner that cannot be predicted by donors; and

(B) Collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays, and at various times during a shift;

(ii) At a minimum, be administered by the FFD program on a nominal weekly frequency;

(iii) Require individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program policy;

(iv) Ensure that all individuals in the population subject to testing have an equal probability of being selected and tested;

(v) Require that individuals who are off site when selected for testing, or who are on site and are not reasonably available for testing when selected, 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;

(vi) Provide that an individual completing a test is immediately eligible for another unannounced test; and

(vii) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program.

(3) Drug testing. (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 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. Specimens that yield positive initial drug test results or are determined by initial validity testing to be of questionable validity must be subject to confirmatory testing by the laboratory, except for invalid specimens that cannot be tested. Licensees and other entities shall ensure that laboratories report results for all specimens sent for testing, including blind performance test samples.

(ii) Licensees and other entities may conduct validity screening, initial validity, and initial drug tests of urine aliquots to determine which specimens are valid and negative and need no further testing, provided that the licensee's or other entity's staff possesses the necessary training and skills for the tasks assigned, the staff's qualifications are documented, and adequate quality controls for the testing are implemented.

(iii) At a minimum, licensees and other entities shall apply the cutoff levels specified in § 26.163(a)(1) for initial drug testing at either the licensee testing facility or HHS-certified laboratory, and in § 26.163(b)(1) for confirmatory drug testing at the HHS-certified laboratory. At their discretion, licensees and other entities may implement programs with lower cutoff levels in testing for drugs and drug metabolites.

(A) If a licensee or other entity implements lower cutoff levels, and the MRO determines that an individual has violated the FFD policy using the licensee's or other entity's more stringent cutoff levels, the individual shall be subject to all management actions and sanctions required by the licensee's or other entity's FFD policy and this part, as if the individual had a confirmed positive drug test result using the cutoff levels specified in this subpart. The licensee or other entity shall document the more stringent cutoff levels in any written policies and procedures in which cutoff levels for drug testing are described.

(B) The licensee or other entity shall uniformly apply the cutoff levels listed in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing, or any more stringent cutoff levels implemented by the FFD program, to all tests performed under this part and equally to all individuals who are tested under this part, except as permitted in §§ 26.31(d)(1)(ii), 26.163(a)(2), and 26.165(c)(2).

(C) In addition, the scientific and technical suitability of any more stringent cutoff levels must be evaluated and certified, in writing, by a forensic toxicologist who meets the requirements set forth in § 26.31(d)(1)(i)(D). Certification of the more stringent cutoff levels is not required if the HHS Guidelines are revised to lower the cutoff levels for the drug or drug metabolites in Federal workplace drug testing programs and the licensee or other entity implements the cutoff levels published in the HHS Guidelines, or if the licensee or other entity received written approval of the NRC to test for lower cutoff levels before April 30, 2008.

(4) Alcohol testing. Initial tests for alcohol must be administered by breath or oral fluids analysis using alcohol analysis devices that meet the requirements of § 26.91(a). If the initial test shows a BAC of 0.02 percent or greater, a confirmatory test for alcohol must be performed. The confirmatory test must be performed with an EBT that meets the requirements of § 26.91(b).

(5) Medical conditions. (i) If an individual has a medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous, the MRO may authorize an alternative evaluation process, tailored to the individual case, to meet the requirements of this part for drug and alcohol testing. The alternative process must include measures to prevent subversion and achieve results that are comparable to those produced by urinalysis for drugs and breath analysis for alcohol.

(ii) If an individual requires medical attention, including, but not limited to, an injured worker in an emergency medical facility who is required to have a post-event test, treatment may not be delayed to conduct drug and alcohol testing.

(6) Limitations of testing. Specimens collected under NRC regulations may only be designated or approved for testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes.

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.

(a) Each licensee and other entity who is subject to this part shall maintain an EAP to 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 individuals' abilities to safely and competently perform their duties. Employee assistance programs must be designed to achieve early intervention and provide for confidential assistance.

(b) Licensees and other entities need not provide EAP services to a C/V's employees, including those whose work location is a licensee's or other entity's facility, or to individuals who have applied for, but have not yet been granted, authorization under subpart C of this part.

(c) The EAP staff shall protect the identity and privacy of any individual (including those who have self-referred) seeking assistance from the EAP, except if the individual waives the right to privacy in writing or a determination is made that the individual's condition or actions pose or have posed an immediate hazard to himself or herself or others.

(1) Licensees and other entities may not require the EAP to routinely report the names of individuals who self-refer to the EAP or the nature of the assistance the individuals sought.

(2) If EAP personnel determine that an individual poses or has posed an immediate hazard to himself or herself or others, EAP personnel shall so inform FFD program management, and need not obtain a written waiver of the right to privacy from the individual. The individual conditions or actions that EAP personnel shall report to FFD program management include, but are not limited to, substantive reasons to believe that the individual—

(i) Is likely to commit self-harm or harm to others;

(ii) Has been impaired from using drugs or alcohol while in a work status and has a continuing substance abuse disorder that makes it likely he or she will be impaired while in a work status in the future; or

(iii) Has ever engaged in any acts that would be reportable under § 26.719(b)(1) through (b)(3).

(3) If a licensee or other entity receives a report from EAP personnel under paragraph (c)(2) of this section, the licensee or other entity shall ensure that the requirements of §§ 26.69(d) and 26.77(b) are implemented, as applicable.

(a) Each licensee or other entity who is subject to this subpart who collects personal information about an individual for the purpose of complying with this part, shall establish, use, and maintain a system of files and procedures that protects the individual's privacy.

(b) Licensees and other entities shall obtain a signed consent that authorizes the disclosure of the personal information collected and maintained under this part before disclosing the personal information, except for disclosures to the following individuals:

(1) The subject individual or his or her representative, when the individual has designated the representative in writing for specified FFD matters;

(2) Assigned MROs and MRO staff;

(3) NRC representatives;

(4) Appropriate law enforcement officials under court order;

(5) A licensee's or other entity's representatives who have a need to have access to the information to perform their assigned duties under the FFD program, including determinations of fitness, FFD program audits, or some human resources functions;

(6) The presiding officer in a judicial or administrative proceeding that is initiated by the subject individual;

(7) Persons deciding matters under review in § 26.39; and

(8) Other persons pursuant to court order.

(c) Personal information that is collected under this subpart must be disclosed to other licensees and entities, including C/Vs, or their authorized representatives, who are legitimately seeking the information for authorization decisions as required by this part and who have obtained a signed release from the subject individual.

(d) Upon receipt of a written request by the subject individual or his or her designated representative, the FFD program, including but not limited to, the collection site, HHS-certified laboratory, substance abuse expert (SAE), or MRO, possessing such records shall promptly provide copies of all FFD records pertaining to the individual, including, but not limited to, records pertaining to a determination that the individual has violated the FFD policy, drug and alcohol test results, MRO reviews, determinations of fitness, and management actions pertaining to the subject individual. The licensee or other entity shall obtain records related to the results of any relevant laboratory certification, review, or revocation-of-certification proceedings from the HHS-certified laboratory and provide them to the subject individual on request.

(e) A licensee's or other entity's contracts with HHS-certified laboratories and C/Vs providing specimen collection services, and licensee testing facility procedures, must require test records to be maintained in confidence, except as provided in paragraphs (b), (c), and (d) of this section.

(f) This section does not authorize the licensee or other entity to withhold evidence of criminal conduct from law enforcement officials.

(a) Each licensee and other entity who is subject to this subpart shall establish procedures for the review of a determination that an individual who they employ or who has applied for authorization has violated the FFD policy. The review procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.

(b) The review procedure must provide notice to the individual of the grounds for the determination that the individual has violated the FFD policy, and must provide an opportunity for the individual to respond and submit additional relevant information.

(c) The review procedure must ensure that the individual who conducts the review is not associated with the administration of the FFD program [see the description of FFD program personnel in § 26.4(g)]. Individuals who conduct the review may be management personnel.

(d) If the review finds in favor of the individual, the licensee or other entity shall update the relevant records to reflect the outcome of the review and delete or correct all information the review found to be inaccurate.

(e) When a C/V is administering an FFD program on which licensees and other entities rely, and the C/V determines that its employee, subcontractor, or applicant has violated its FFD policy, the C/V shall ensure that the review procedure required in this section is provided to the individual. Licensees and other entities who rely on a C/V's FFD program need not provide the review procedure required in this section to a C/V's employee, subcontractor, or applicant when the C/V is administering its own FFD program and the FFD policy violation was determined under the C/V's program.

(a) General. Each licensee and other entity who is subject to this subpart is responsible for the continuing effectiveness of the FFD program, including FFD program elements that are provided by C/Vs, the FFD programs of any C/Vs that are accepted by the licensee or other entity, any FFD program services that are provided to the C/V by a subcontractor, and the programs of the HHS-certified laboratories on whom the licensee or other entity and its C/Vs rely. Each licensee and other entity shall ensure that these programs are audited and that corrective actions are taken to resolve any problems identified.

(b) FFD program. Each licensee and other entity who is subject to this subpart shall ensure that the entire FFD program is audited as needed, but no less frequently than nominally every 24 months. Licensees and other entities are responsible for determining the appropriate frequency, scope, and depth of additional auditing activities within the nominal 24-month period based on the review of FFD program performance, including, but not limited to, the frequency, nature, and severity of discovered problems, testing errors, personnel or procedural changes, and previous audit findings.

(c) C/Vs and HHS-certified laboratories. (1) FFD services that are provided to a licensee or other entity by C/V personnel who are off site or are not under the direct daily supervision or observation of the licensee's or other entity's personnel and HHS-certified laboratories must be audited on a nominal 12-month frequency.

(2) Audits of HHS-certified laboratories that are conducted for licensees and other entities who are subject to this subpart need not duplicate areas inspected in the most recent HHS certification inspection. However, the licensee and other entity shall review the HHS certification inspection records and reports to identify any areas in which the licensee or other entity uses services that the HHS certification inspection did not address. The licensee or other entity shall ensure that any such areas are audited on a nominal 12-month frequency. Licensees and other entities need not audit organizations and professionals who may provide an FFD program service to the licensee or other entity, but who are not routinely involved in providing services to a licensee's or other entity's FFD program, as specified in § 26.4(i)(1).

(d) Contracts. (1) The contracts of licensees and other entities with C/Vs and HHS-certified laboratories must reserve the right to audit the C/V, the C/V's subcontractors providing FFD program services, and the HHS-certified laboratories at any time, including at unannounced times, as well as to review all information and documentation that is reasonably relevant to the audits.

(2) Licensees' and other entities' contracts with C/Vs and HHS-certified laboratories must also permit the licensee or other entity to obtain copies of and take away any documents, including reviews and inspections pertaining to a laboratory's certification by HHS, and any other data that may be needed to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements. In a contract with a licensee or other entity who is subject to this subpart, an HHS-certified laboratory may reasonably limit the use and dissemination of any documents copied or taken away by the licensee's or other entity's auditors in order to ensure the protection of proprietary information and donors' privacy.

(3) In addition, before awarding a contract, the licensee or other entity shall ensure completion of pre-award inspections and/or audits of the procedural aspects of the HHS-certified laboratory's drug-testing operations, except as provided in paragraph (g)(5) of this section.

(e) Conduct of audits. Audits must focus on the effectiveness of the FFD program or program element(s), as appropriate, and must be conducted by individuals who are qualified in the subject(s) being audited. The individuals performing the audit of the FFD program or program element(s) shall be independent from both the subject FFD program's management and from personnel who are directly responsible for implementing the FFD program.

(f) Audit results. The result of the audits, along with any recommendations, must be documented and reported to senior corporate and site management. Each audit report must identify conditions that are adverse to the proper performance of the FFD program, the cause of the condition(s), and recommended corrective actions. The licensee or other entity shall review the audit findings and take corrective actions, including re-auditing of the deficient areas where indicated, to preclude, within reason, repetition of the condition. The resolution of the audit findings and corrective actions must be documented.

(g) Sharing of audits. Licensees and other entities may jointly conduct audits, or may accept audits of C/Vs and HHS-certified laboratories that were conducted by other licensees and entities who are subject to this subpart, if the audit addresses the services obtained from the C/V or HHS-certified laboratory by each of the sharing licensees and other entities.

(1) Licensees and other entities shall review audit records and reports to identify any areas that were not covered by the shared or accepted audit.

(2) Licensees and other entities shall ensure that FFD program elements and services on which the licensee or entity relies are audited, if the program elements and services were not addressed in the shared audit.

(3) Sharing licensees and other entities need not re-audit the same C/V or HHS-certified laboratory for the same period of time.

(4) Each sharing licensee and other entity shall maintain a copy of the shared audit and HHS certification inspection records and reports, including findings, recommendations, and corrective actions.

(5) If an HHS-certified laboratory loses its certification, in whole or in part, a licensee or other entity is permitted to immediately use another HHS-certified laboratory that has been audited within the previous 12 months by another NRC licensee or entity who is subject to this subpart. Within 3 months after the change, the licensee or other entity shall ensure that an audit is completed of any areas that have not been audited by another licensee or entity who is subject to this subpart within the past 12 months.