**NRC INSPECTION MANUAL**	NSIR/DSO

INSPECTION PROCEDURE 71130.08

# FITNESS-FOR-DUTY PROGRAM

Effective Date: January 1, 2024

PROGRAM APPLICABILITY:	 IMC 2200 A, IMC 2201 A

Note: For the initial inspection under this attachment, the entire Fitness-for-Duty (FFD) program will be reviewed for adequacy. Subsequent inspections will focus on changes to the licensee’s FFD program and completing a review of a subset of FFD program requirements.

# 71130.08-01 INSPECTION OBJECTIVES

01.01	To verify that the licensee is properly implementing FFD requirements under Title 10 of the *Code of Federal Regulations* (10 CFR) Part 26 (subparts A through H, N, and O), and any other applicable requirement that assures licensee personnel (including contractors and vendors) will perform their tasks in a reliable and trustworthy manner and are not under the influence of any substance or mentally or physically impaired from any cause that may affect their abilities to perform their duties safely and competently.

01.02	To verify that changes to the licensee’s FFD program made since the last inspection: (a) meet commitments to resolve previously identified issues or U.S. Nuclear Regulatory Commission (NRC) requirements under 10 CFR Part 26; and (b) do not adversely affect the performance requirements as prescribed by regulatory requirements and any other applicable requirement.

01.03	To verify that the licensee is properly implementing FFD requirements pertaining to fatigue management under Subpart I of 10 CFR Part 26 and any other applicable NRC requirement to ensure, in part, that nuclear facility security force personnel are not assigned to duty while in a fatigued condition that could reduce their alertness or ability to perform functions necessary to identify and promptly respond to plant security threats.

01.04	To verify that the licensee’s physical protection program associated with this sample is designed and implemented to meet the general performance objective of 10 CFR 73.55(b).

# 71130.08-02	INSPECTION REQUIREMENTS

General Guidance

Through verification of the inspection requirements within this inspection procedure (IP), inspector(s) shall ensure that the licensee’s FFD program associated with this sample is designed and implemented to meet the general performance objectives of 10 CFR 26.23 and 10 CFR 73.55(b).

In preparation to complete this IP, the inspector(s) should become familiar with relevant documentation that may include, but is not limited to, the licensee's site-specific and/or corporate FFD policy statement and FFD procedures, the access authorization provisions that adjudicate FFD authorization under 10 CFR Part 26, Subpart C, and sanctions under 10 CFR 26.75. The inspector(s) should apply additional attention to recent security plan changes that could be relevant to the inspection activity.

The inspector(s) are responsible for ensuring that the minimum range of inspection requirements identified within the sample are completed and evaluated to a level which provides reasonable assurance that licensees are meeting NRC regulatory requirements within the FFD program area being inspected.

The guidance in this IP will assist inspectors by: (1) recommending methods and techniques for determining licensee FFD program compliance and effectiveness related to inspection requirements; and (2) clarifying regulatory requirements associated with inspection requirements.

Where a minimum sample number is indicated (i.e., sample at least (three) preaccess drug testing records, or sample at least 20 percent of the total personnel that had a preaccess drug and alcohol test in the last month), the inspector(s) should adhere as closely as possible to the numbers identified in the guidance. The inspectors may expand the minimum number to aid in determining the extent of the condition, should compliance concerns arise. Completion of other recommended actions contained in this IP should not be viewed as mandatory and is intended to assist inspectors in determining whether an inspection sample has been adequately addressed. Should questions arise regarding IP requirements or guidance, inspector(s) should consult with regional management or the program office in the Office of Nuclear Security and Incident Response (NSIR).

This IP is intended for use in conducting baseline inspections of FFD programs, including fatigue management programs applicable to the security force. In preparation for the inspection, review issues identified during the previous inspection that resulted in significant FFD program, policy, or procedural changes, along with significant FFD policy violations and programmatic failures reported under 10 CFR 26.719(b), drug and alcohol testing errors reported under 10 CFR 26.719(c), and the licensee's FFD program performance data reported under 10 CFR 26.717, where applicable. During the onsite inspection, all major changes, including those related to the resolution of identified issues; the basis for the changes; and the impact of the changes on FFD program effectiveness should be discussed with licensee management.

The inspector(s) should evaluate the site-specific FFD program performance data submitted by the licensee for the period of inspection. All licensees and other entities submit 10 CFR 26.717 data to the NRC using two Portable Document Format (PDF) electronic reporting forms (i.e., NRC Form 891 - Annual Reporting Form for Drug and Alcohol Tests (ARF); and NRC Form 890 -Single Positive Test Form (SPTF)).

The FFD program office in NSIR can provide the inspector(s) with 10 CFR 26.717 annual FFD program performance submission information in a consolidated Excel spreadsheet data format. This spreadsheet format will facilitate the auto-filtering and searching of information to evaluate site-specific performance across years and to assist in identifying records that warrant attention (e.g., subversion attempts; post-event positive results; 24-hour reportable events under 10 CFR 26.719). The Excel format also can reduce inspector time obtaining SPTFs and ARFs from the NRC’s Agencywide Documents Access and Management System (ADAMS) because the Excel spreadsheet data includes all information contained in the forms.

If an inspector would like to obtain the original SPTF and ARF submissions (e-forms), the FFD program office in NSIR can provide the e-forms to the inspector(s). The application the FFD program office uses to process the eforms for data analysis, renames each e-form received to include the year of the report, the eform type (SPTF or ARF), the facility name, the unique identification number provided by the licensee in each SPTF, and the ADAMS Accession Number (ML number). This information can reduce inspector time retrieving files from ADAMS and improve the ability to locate a specific file of interest for review.

Prior to arriving onsite, the inspector(s) should review the FFD program performance summary reports published by the NRC for the period of inspection, if available, to identify any sitespecific information, such as 10 CFR 26.719 reportable events or management actions warranting follow up. Each summary report is available for download at the NRC Website: https://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/performance-reports.html.

Inspection

The appendices to this IP provide materials to assist the inspector(s) in conducting the inspection.

The questionnaires (Urine Collection, Breath Collection, Medical Review Officer, and Substance Abuse Expert) provide a uniform method to collect information from some of the key personnel that support a licensee’s FFD program.

The inspector(s) should use previous inspection findings to assist in determining the FFD program staff to be interviewed. Key personnel who were not a part of the licensee’s FFD program during the previous inspection should be interviewed, as well as the primary FFD program staff who were interviewed during the previous inspection. A cross-section of contractor personnel responsible for assisting with the implementation of the licensee or other entity's FFD program also should be interviewed. The inspector(s) should visit the collection site(s) to interview specimen collectors and to evaluate the facility and collection process.

At a minimum, the inspector(s) should consider reviewing the following FFD program elements:

a. Changes to the licensee’s FFD policy statement and FFD procedures. The onsite inspection should focus on the licensee’s implementation of the FFD policy statement and FFD procedures, and compliance with 10 CFR Part 26.

b. Review a sample of testing records (preaccess; random; for cause; postevent; followup), include tests determined to be subversion attempts.

c. Behavioral observation program. May include any for cause testing documentation produced during the inspection period.

d. Any reports submitted to the NRC under 10 CFR 26.719(c) on significant FFD policy violations, programmatic failures, and drug and alcohol testing errors since the last NRC inspection.

e. Determinations of fitness, specifically how the licensee adjudicated individuals prior to placing them back into a covered work status, including NRC-licensed operators (10 CFR 55.53(j)) and NRC-required security officers (10 CFR Part 73, Appendix B).

f. The results of licensee audits conducted under 10 CFR 26.41(e) since the last NRC inspection.

g. Corrective actions implemented as a result of previous NRC inspection findings.

h. Management of fatigue – security force work hours.

i. Granting and maintaining authorization.

j. Conduct interviews. A critical element to the inspection is conducting interviews with key personnel who support the FFD program. This IP provides questionnaires for interviewing the Medical Review Officer (MRO) and the Substance Abuse Expert (SAE). In addition, the inspector(s) should interview the FFD program manager and may need to interview personnel such as those who make determinations of fitness, supervisors, union shop stewards, FFD program personnel who administer the random testing program (e.g., generate random selections, notify individuals about test selection, update the random testing pool), and representatives of the licensee testing facility (if applicable). These questionnaires and interviews are referenced under the applicable inspection requirement or associated guidance.

k. Review records. The drug and alcohol testing records generated under the FFD program provide inspectors with another source of information on the quality of the FFD program. Inspectors should consider contacting the NRC’s FFD program office in NSIR to acquire FFD trend information to inform their review.

l. Evaluate facilities (collection site(s); and licensee testing facility, if applicable). A central element of the FFD program is the facilities used to collect and analyze donor specimens. The inspector(s) should visit the collection site(s) and use the Urine Collection and Breath Collection questionnaires to interview the specimen collector(s). These questionnaires include mock urine and breath specimen collection scenarios, which evaluate the collector’s knowledge of the collection process. Visiting collection sites also provides inspectors information about the collection and testing environment, which may affect the quality of the FFD program (e.g., donor privacy, security, specimen integrity, ability of donors to subvert the testing process). (Note: This IP does not include a visit to the licensee’s U.S. Health and Human Services (HHS)-certified laboratory, but multiple IP requirements do evaluate laboratory performance, as well as the licensee’s auditing of its laboratories.)

Tier I

## 02.01	Policy and Procedures Review

a. Verify that individuals identified in 10 CFR 26.4(a)-(e) and (g) are subject to drug and alcohol testing under the following conditions:

1. Preaccess (10 CFR 26.31(c)(1))

2. For cause (10 CFR 26.31(c)(2))

3. Post-event (10 CFR 26.31(c)(3))

4. Follow-up (10 CFR 26.31(c)(4))

5. Random. (10 CFR 26.31(c)(5))

Specific Guidance

The inspector(s) should interview the FFD program manager to confirm the manager’s understanding of the FFD program, and in particular, the drug and alcohol testing conditions. Further, the inspector(s) should verify that the written FFD procedures state that individuals are subject to drug and alcohol testing under the following conditions:

1. Preaccess

2. For cause

3. Post-event

4. Follow-up

5. Random.

## 02.02	Test Results Review and Medical Review Officer Interview

a. Verify that individuals identified in 10 CFR 26.4(a) that have been subject to the following drug and alcohol testing conditions and have had their test results reviewed by the MRO and interviews conducted, when appropriate.

1. Preaccess (10 CFR 26.31(c)(1))

2. Random (10 CFR 26.31(c)(5))

3. For cause (10 CFR 26.31(c)(2))

4. Post-event (10 CFR 26.31(c)(3))

5. Follow-up. (10 CFR 26.31(c)(4))

Specific Guidance

The inspector(s) should evaluate a sample of negative, positive, substituted, adulterated, invalid, and subverted test result records (e.g., Federal custody and control forms (Federal CCFs), verified test results) to confirm compliance for each test type:

1. Preaccess (10 CFR 26.31(c)(1))

(a) The inspector(s) should obtain a list of all individuals subject to testing under the FFD program for the time period covered by the inspection. The information requested should include: name, dates of verified negative preaccess drug and alcohol test results, and date unescorted access was granted. The inspector(s) should confirm by a sampling of individuals that “covered” activities were not performed without having authorization.

(b) The inspector(s) should verify that the negative test results dates preceded the date unescorted access was granted. For a sample of individuals, the inspector(s) should review the verified negative test results and compare to the information provided by the licensee.

2. Random (10 CFR 26.31(c)(5))

(a) The inspector(s) should request a list of all random tests conducted in the period of the inspection review. The information should include: name, date of test, and results of test.

3. For cause (10 CFR 26.31(c)(2))

(a) The inspector(s) should request a list of all for cause tests conducted in the period of the inspection review. The information should include: name, date of test, and results of test(s).

(b) The inspector(s) should evaluate the positive result rates for the current inspection period of review (by reviewing the FFD performance reports from the licensee submitted under 10 CFR 26.717). Because for cause testing is only to be conducted when an individual demonstrates detectable sign(s) of impairment (visual, odor, etc.), or a credible report is received on substance abuse, the positive result rate is typically much higher than that for any other test type. For example, the rate could be as high as 100 percent if one test was conducted in a year and it was positive.

Note: A low positive rate may indicate that testing may have been conducted in the absence of sign(s) of impairment (evaluate decision-making), or that observable impairment may have been the result of other issues (e.g., use of substance(s) not in the testing panel, illness, fatigue).

(a) The inspector(s) should evaluate for cause testing determinations (i.e., how does the licensee ensure that correct decisions are being made?). A licensee may use a checklist or other method to assist staff in correct decision-making and documentation.

4. Post-event (10 CFR 26.31(c)(3))

(a) The inspector(s) should request a list of all post-event tests conducted in the period of the inspection review. The information provided should include: name, date of test, results of tests.

(b) The licensee must use a method to document that at least one testing threshold specified in 10 CFR 26.31(c)(3)(i) – (iii) was met to support testing.

(c) The inspector(s) should evaluate how the licensee determines who is authorized to make post-event testing decisions (including any required training necessary to make determinations). Two cases exist for post-event testing: Case 1 human error (a subjective determination) and Case 2 human error that results in an illness, injury, or other Occupational Safety and Health Administration (OSHA)condition (10 CFR 26.31(c)(3)(i)). For Case 1 human error, the licensee can elect to conduct either a post-event or for cause test. This determination should be described in the licensee’s procedure. Additionally, the licensee should have guidance on what constitutes a human error so that unnecessary testing is prevented. These instructions will help prevent licensees from leaning forward to test everyone just in case a Case 2 human error may be determined at a later time.

(d) The inspector(s) should consider requesting a list of OSHA-reportable events to evaluate if any may have met the post-event testing criteria in 10 CFR 26.31(c)(3)(i) – “A significant illness or personal injury to the 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.”

(e) The inspector(s) should review decision-making on testing determinations for a sample of tests conducted. For example, does the licensee use a checklist or standard form to complete and document a post-event testing determination?

(f) The inspector(s) should review positive test results (time of test, substance(s) detected, the time from accident/event to testing (important for alcohol testing), and what licensee personnel made the testing determination). The inspector(s) can consult with the FFD program performance reports submitted under 10 CFR 26.717 for the period of inspection to identify information on post-event tests. The ARF, contains information on the number of post-event tests conducted, and the number of positive results. The SPTF submitted for each positive result provides event specific information.

5. Followup (10 CFR 26.31(c)(4))

(a) The inspector(s) should request a list of tests conducted during the period of the inspection review. The information provided should include: name, date of test, results of tests.

(b) The inspector(s) should evaluate the followup testing requirements established by the SAE for a sample of individuals in the followup testing program. For these individuals, review all follow-up tests (Federal CCFs, MROverified drug test results, alcohol test results). The inspector(s) should evaluate if the licensee is complying with the followup testing plan per 10 CFR 26.69(b)(6) (e.g., the number of tests to be conducted, the frequency and timing of tests).

6. Subversion attempts review

(a) Evaluate subversion attempts identified during the period of inspection. NRC staff assessment of FFD program performance data indicates that over 75 percent of subversion attempts occur at preaccess testing, a predictable testing event, with well over 90 percent of all subversion attempts committed by contractors and vendors. If subversion attempts were observed on random, for cause, post-event, or followup tests, focus on reviewing situations where the specimen temperature was out of range on the initial specimen, or subversion paraphernalia was identified (i.e., these observations suggest that the individual obtained cheating paraphernalia prior to arriving for testing). The SPTFs submitted each year under 10 CFR 26.717 include detailed information on each subversion attempt.

## 02.03	Behavioral Observation Program

a. Verify that the licensee has established and implemented a program that ensures that individuals are subject to behavioral observation. (10 CFR 26.33 and 10 CFR 26.31(b)(v))

Specific Guidance

The inspector(s) should verify that the licensee is maintaining a behavior observation program. In particular, the inspector(s) should:

1. Review the licensee procedure to ascertain how individuals may make a behavioral observation that results in a for cause test. Assess how the licensee defined “FFD concern” and whether the process enables a timely for cause test for short-lived substances such as alcohol.

2. Verify that only trained personnel make for cause testing determinations. For a sample of for cause tests, verify that the staff making the determination had received appropriate training prior to making the determination (e.g., evaluate training certificate, evaluate training completion date).

3. Evaluate the training requirements for staff authorized to make for cause testing determinations. Is training and frequency adequate to meet the 10 CFR 26.29 requirement?

(a) How did the licensee determine that the level of training provided was appropriate?

(b) How did the licensee determine that the training materials provided were appropriate?

4. The inspector(s) should review any random, follow-up, and for cause tests where an alcohol positive test result was reported during the period of inspection, especially if the blood alcohol concentration (BAC) of 0.04 percent or greater was reported (i.e., the higher the BAC level, the more likely impairment could be identifiable). Each SPTF submitted under 10 CFR 26.717 for an alcohol positive will capture the BAC level exceeded (i.e., 0.04 or greater; 0.03 and in work status at least 1 hour; 0.02 and in work status at least 2 hours).

b. Verify that the licensee’s FFD policy statement requires individuals to report any FFD concerns about other individuals to the personnel designated in the FFD policy. Assess whether the procedure describes behavioral observations and “FFD concerns” that occur both on and off site. (10 CFR 26.33)

Specific Guidance

The inspector(s) should review the FFD policy statement to ensure that it requires individuals to report any FFD concerns about other individuals to designated personnel.

a. Verify that the licensee’s program to allow off-site employees to maintain unescorted access contains provisions for initial and annual re-qualification of behavior observation training for both the employees and their supervisors. (10 CFR 73.56(f)(2)(i)).

Specific Guidance

No inspection guidance.

## 02.04	Sanctions and Substance Abuse Expert Interview

a. Verify that the licensee has established sanctions in accordance with 10 CFR 26.75 that are imposed when an individual has violated the drug and alcohol provisions in the FFD policy statement.

Specific Guidance

1. The inspector(s) should review the licensee’s FFD policy statement to ensure that it specifies the FFD policy violations.

2. The inspector(s) should examine cases of FFD program violations (e.g., positive drug and/or alcohol test result; testing refusal) and ensure that the correct sanction was assessed to each individual, as specified in the FFD policy statement. 

(a) Ensure for the sample reviewed, that information on the FFD sanction was entered into the industry’s access authorization database). The database is used by licensees and other entities to evaluate if an individual has an FFD policy violation under 10 CFR Part 26.

(b) Ensure for the sample reviewed, that no individual denied access under a 10 CFR 26.75 sanction subsequently has been granted authorization, unless the denial period is no longer applicable and the licensee implemented the requirements under 10 CFR 26.69(b), “Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization.”

b. Verify that the licensee has established management actions that must be taken when an individual shows indication that they may not be fit to perform their duties safely and competently. (10 CFR 26.77, 10 CFR 26.35)

Specific Guidance

1. The inspector(s) should review the licensee’s FFD policy statement or FFD procedures to confirm that it specifies the management actions to be taken when an individual shows indication that they may not be fit for duty (i.e., not able to perform assigned duties safely and competently).

2. The inspector(s) should review the licensee’s FFD procedures or contract with the Employee Assistance Program (EAP) provider to ensure that FFD program management is notified if EAP personnel determine that an individual poses or has posed an immediate hazard to themself or others (e.g., likely to commit self-harm or harm to others; has been impaired using drugs or alcohol while in a work status and has a continuing substance abuse disorder that makes it likely that they will be impaired while in a work status in the future; has engaged in any act that would be reportable to the NRC under 10 CFR 26.719(b)(1) through (b)(3). (10 CFR 26.35)

3. The inspector(s) should examine cases where FFD management took action when an individual was determined not to be fit for duty (e.g., observed behavior, odor of alcohol, slurred speech, credible report of substance abuse) and ensure that the action(s) were consistent with the FFD policy statement and FFD procedures.

c. Verify that the licensee has established and implemented procedures for the review of FFD policy violations. (10 CFR 26.39)

Specific Guidance

1. The inspector(s) should evaluate the licensee’s FFD policy statement and FFD procedure(s) to verify that it includes an objective and impartial review process to assess the facts related to the determination that an individual has violated the FFD policy.

2. The inspector(s) should examine cases of FFD policy violations to verify that a review of the policy violation determination was conducted, if requested by the individual. If an FFD policy violation was overturned, were any corrective actions implemented as a result of this review; and did the licensee make a 30-day report to the NRC under 10 CFR 26.719(c)(1)?

Tier II

## 02.05	FFD Program Policy Statement and FFD Procedures Review

The inspector(s) should evaluate the FFD program policy statement and FFD procedures and discuss the information with the FFD program manager and/or staff directly responsible for the FFD policy, FFD procedures, and the implementation of the FFD program.

a. Verify that all FFD program personnel involved in the day-to-day operations of the program and whose duties require access or the performance of activities specified in 10 CFR 26.4(g)(1) through (5) are subject to the FFD program. (10 CFR 26.4(g))

Specific Guidance

The inspector(s) should interview the FFD program manager and obtain a list of all FFD program personnel involved in the day-to-day operations of the FFD program and whose duties require them to have the types of access or perform the activities described in 10 CFR 26.4(g)(1) through (5), to confirm that each individual is subject to an FFD program.

b. Verify that all contractor and vendor (C/V) personnel performing activities within the scope of 10 CFR Part 26 are subject to either the licensee’s FFD program, or to the C/Vs FFD program that has been formally reviewed and approved by the licensee. (10 CFR 26.21)

Specific Guidance

The inspector(s) should interview the FFD program manager to confirm that all C/V personnel performing activities within the scope of 10 CFR Part 26 have been subject to an FFD program.

c. Verify that the licensee makes its FFD policy statement readily available to all individuals subject to the policy. (10 CFR 26.27(b))

Specific Guidance

The inspector(s) should confirm, through discussion with the FFD program manager and through review of available documentation, that the most up to date FFD policy statement is readily available to all individuals subject to the policy. For example, is the FFD policy statement available for review on a company website or posted on bulletin boards, and are individuals knowledgeable about how to obtain the FFD policy statement? Also, if the FFD policy statement has been updated since the last inspection, confirm that subject individuals have been notified of the policy update.

d. Verify that the licensee’s written FFD policy statement is consistent with rule requirements. (10 CFR 26.27(b) and 10 CFR 26.203(a))

Specific Guidance

The inspector(s) should review the written FFD policy statement to ensure that it addresses the following:

1. Consequences of the use, sale, or possession of illegal drugs on or off-site, the abuse of legal drugs and alcohol, and the misuse of prescription and overthecounter drugs;

2. 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;

3. 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. Prohibits the consumption of alcohol, at a minimum, within an abstinence period of 5 hours preceding the individual’s arrival at the licensee’s facility, and during the period of any tour of duty;

5. Conveys that abstinence from alcohol for 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. Addresses 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. Provides a description of any program available to individuals seeking assistance in dealing with drug, alcohol, fatigue, or other problems that could adversely affect an individual’s ability to perform safely and competently the duties that require an individual to be subject to this subpart;

8. The consequences of violating the policy;

9. The individual’s responsibility to report legal actions, as defined in 10 CFR 26.5;

10. The responsibilities of managers, supervisors, and escorts to report FFD concerns; and

11. The individual’s responsibility to report FFD concerns.

e. Verify that the licensee’s FFD procedures are consistent with rule requirements. (10 CFR 26.27(c) for FFD procedures on drug and alcohol testing, specific guidance items 1 through 4; and 10 CFR 26.203(b) for the fatigue management procedures for the security force, specific guidance items 5 through 8).

Specific Guidance

The inspector(s) should verify that written FFD procedures exist that describe:

1. 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.

For special analyses testing performed under 10 CFR 26.163(a)(2) on specimens with dilute validity test results and specimens collected under the direct observation conditions specified in 10 CFR 26.115(a)(1) through (3) and (5), confirm that the testing process is documented in the FFD policy statement and FFD procedures.

2. Immediate and follow-up actions that will be taken, and the procedures to be used, in cases in which an individual is determined to have:

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

(b) 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;

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

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

(e) Had legal action taken relating to drug or alcohol use.

3. The process that the licensee will use to ensure that individuals who are called in to perform unscheduled work are fit for duty;

4. 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 perform their duties safely and competently. The procedure must require that individuals who have a FFD concern about another individual’s behavior shall contact the personnel designated in the FFD policy statement or FFD procedures to report the concern;

5. The process to be followed when a security officer makes a self-declaration that they are not fit to perform their duties safely and competently for any part of a working tour as a result of fatigue;

6. The process for implementing the work hour controls for security officers;

7. The process to be followed when conducting a fatigue assessment of a security officer; and

8. The disciplinary actions that the licensee may impose on a security officer following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.

f. Verify that the licensee has implemented an auditing program that:

1. Assures continuing effectiveness of the FFD program, including an audit of the FFD program elements provided by C/V programs accepted by the licensee, the FFD programs of C/Vs accepted by the licensee, and the management of security officer fatigue. (10 CFR 26.41(a) and 10 CFR 26.203(f))

2. Audits the entire FFD program on at least a 24-month frequency and ensures that corrective actions are implemented to resolve problems identified in accordance with the licensee's corrective action program. (10 CFR 26.41(b), 10 CFR 26.41(f), and 10 CFR 73.55(b)(10))

3. Audits program services provided to a licensee or other entity by C/V personnel that are off-site or are not under the direct daily supervision or observation of the licensee or other entity on a nominal 12-month frequency. (10 CFR 26.41(c))

Specific Guidance

The inspector(s) should verify that the licensee’s audit program is implemented according to the following criteria:

1. The inspector(s) should verify that the licensee is performing audits to assure the effectiveness of the FFD program, including FFD elements that are provided by C/V programs as well as the FFD programs of C/Vs that are accepted by the licensee. In particular, the inspector(s) should review:

(a) The audit methodology;

(b) The audit reports completed; and

(c) The oversight exercised over C/V programs.

2. The inspector(s) should verify that the licensee is conducting FFD program audits at least once every 24 months, and that corrective actions are taken to address identified deficiencies. In particular, the inspector(s) should:

(a) Evaluate corrective actions implemented by the licensee as a result of audit findings.

(b) Assess identified FFD program deficiencies identified in the NRC inspection to determine if the license’s audit program needs improvement and or revised auditing approaches/strategies.

3. The inspector(s) should verify that the licensee is conducting audits on a 12month frequency of the FFD services provided to the licensee by C/V personnel who are off-site or are not under the direct daily supervision or observation of the licensee and HHScertified laboratories providing service to the licensee. The inspector(s) should verify that corrective actions are taken to address identified deficiencies. In particular, the inspector(s) should:

(a) Evaluate corrective actions implemented by the licensee, C/V, and/or HHScertified laboratory as a result of audit findings.

(b) Assess identified FFD program deficiencies identified in the current NRC inspection to determine if the licensee’s audit program needs improvement and/or revised auditing approaches/strategies.

g. Verify that initial and refresher training has been provided and taken as required. (10 CFR 26.29(c))

Specific Guidance

The inspector(s) should review the FFD training records and personnel records to ensure that individuals have been trained as follows:

1. Individuals have completed training before granting initial authorization, or training is current before granting an authorization update or authorization reinstatement.

2. Individuals have completed refresher training on a nominal 12-month frequency, or more frequently if a need is indicated.

h. Verify that the training content and comprehensive examination incorporated the required knowledge and abilities (KAs). (10 CFR 26.29(a) and 10 CFR 26.203(c))

Specific Guidance

The inspector(s) should review the training materials to ensure that they address the following KAs:

1. Knowledge of the FFD policy and FFD procedures that apply to the individual, the methods that will be used to implement them, and the consequences of violating any FFD policy or FFD procedure;

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 Employee Assistance Program (EAP) staff;

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 by prescription and overthecounter 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;

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 to receive FFD concerns;

11. Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and

12. Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

Note: Many licensees and other entities utilize a standard web-based training created by the National Academy for Nuclear Training e-Learning (NANTeL) for generic FFD program and behavioral observation training. If a deficiency in the training materials is identified, the impact may be larger than for just the current site under inspection.

i. Verify, by reviewing procedures and records, that the licensee has implemented a method to ensure that all individuals who maintain unescorted access to the protected area (PA), including supervisors and escorts, are subject to a behavioral observation program and receive behavioral observation training. (10 CFR 26.33, and 10 CFR 73.56(f)(1))

Specific Guidance

When inspecting this requirement, the inspector(s) should review the licensee’s implementing procedures, training records, access authorization records, etc., to determine that the licensee maintains a behavioral observation program, and that all personnel with unescorted access to the PA are included in the program and receive the appropriate initial and requalification behavioral observation training in accordance with 10 CFR 73.56(f).

j. Verify that the licensee’s procedures provide details on behavioral observation training. (10 CFR 73.56(f)(2)(ii).

Specific Guidance

1. When inspecting this requirement, the inspector(s) should review the licensee’s implementing procedures and/or behavioral observation training material to ensure that the training addresses the detection of behaviors and activities that constitute an unreasonable risk to the health and safety of the public and common defense and security, including the potential threat to commit radiological sabotage. The training should also address the individual’s responsibilities for reporting behavioral observation concerns in accordance with 10 CFR 73.56(f)(3).

2. The inspector(s) should verify that the licensee has established a method that demonstrates that individuals have completed this training in accordance with 10 CFR 73.56(f)(iii) and (iv). For example, comprehensive examination for initial training and either refresher training or comprehensive examination for nominal annual requalification.

k. Verify, through a review of records, that the licensee effectively implements a preaccess drug and alcohol testing program for persons requesting unescorted access and a random drug and alcohol testing program for persons maintaining unescorted access. (10 CFR 26.65, and 10 CFR 26.67)

Specific Guidance

No inspection guidance.

l. Verify that the licensee documents behavioral observation program training and refresher training. (10 CFR 26.713(b)(1), 10 CFR 73.56(o)(3)(i))

Specific Guidance

No inspection guidance.

## 02.06	Test Results Review and Medical Review Officer Interview

a. Verify that each MRO used by the FFD program meets the requirements in 10 CFR 26.183.

Specific Guidance

1. The inspector(s) should refer to the MRO Questionnaire (Attachment 3) of this IP.

2. For utilities with multiple operating power reactor facility locations in the same NRC Region and that use the same MRO, the inspector(s) should consider if completing the Medical Review Officer Questionnaire is necessary when performing each sitespecific inspection during the same inspection cycle (i.e., 1year time period). A more targeted interview with the MRO may still be needed based on site-specific records review conducted by the inspector(s), as well as if follow-up actions were identified during a prior inspection conducted in the same year.

b. Verify that an MRO review is performed on all positive, adulterated, substituted, dilute, and invalid specimen test results received from the HHScertified laboratory. (10 CFR 26.185(a), (c), and (f) – (n))

Note: The MRO may permit MRO staff to review negative drug test results. (10 CFR 26.183(d)(2))

Specific Guidance.

The inspector(s) should refer to the MRO Questionnaire (Attachment 3) of this IP.

c. Verify the method(s) that the HHScertified laboratory used to transmit drug test results to the MRO maintain(s) the confidentiality and security of the information. (10 CFR 26.169(e) and (f)).

Specific Guidance

The inspector(s) should verify the security of the communication method(s) used by the HHScertified laboratory to transmit test results to the MRO and/or the MRO staff and are in accordance with site FFD policy and FFD procedures.

d. Verify that the MRO is receiving drug test results from the HHScertified laboratory within 5 business days after the laboratory receives each specimen for testing. (10 CFR 26.169(a))

Specific Guidance

The inspector(s) should verify that the MRO is receiving drug test results from the HHScertified laboratory within 5 business days after the laboratory receives each specimen for testing by evaluating a sample of test results reviewed under this IP. Laboratories typically report negative results to the MRO within 24 hours of receipt of a specimen for testing and may take several days to report a positive result (which is dependent on the drug or drug metabolite identified in the donor’s specimen).

e. Verify that the MRO completes their review and notifies the licensee’s designated representative within 10 business days of receiving: (1) any positive, adulterated, substituted, or invalid test result from the HHScertified laboratory; and (2) in instances where no legitimate medical explanation for the test result(s) exist(s). (10 CFR 26.185(p))

Specific Guidance.

1. The inspector(s) should verify that the MRO(s) supporting the FFD program complies with the FFD policies and 10 CFR Part 26 requirements by completing the following activities:

(a) Validate through reviews of the Federal CCF, the laboratory test result, and the MRO-verified result for a sample of tests (i.e., drug positive; adulterated; substituted; invalid) that the MRO is conducting the required reviews and that each review is completed, and the licensee is notified within 10 days of the MRO receiving the result from the laboratory. The inspector(s) may need to request from the MRO the laboratory test result as the licensee may not be in possession of this document.

f. Verify that the licensee is conducting confirmatory alcohol testing for any individual with an initial alcohol test result of 0.02 percent BAC or greater. (10 CFR 26.99)

Specific Guidance

The inspector(s) should review a sample of positive alcohol test results to ensure that:

1. Confirmatory alcohol testing was conducted in instances where an initial alcohol test result was 0.02 percent BAC or greater.

2. The positive alcohol test determinations for confirmatory test results less than 0.04 percent BAC include documentation/evidence such that the inspector can confirm the amount of time each individual was in work status and verify the licensee’s positive test decision.

g. Verify the licensee’s determination process for positive alcohol test results associated with work hour status (i.e., confirmatory results of 0.03 percent BAC and the individual was in work status at least 1 hour, or 0.02 percent BAC and the individual was in work status for at least 2 hours). (10 CFR 26.103(a)(2))

Specific Guidance

Ensure the FFD procedure that the licensee uses to determine the time the individual was in work status to make the determination on the positive alcohol test result.

## 02.07	Collection Site Inspection and Urine and Breath Collection Interviews

Administer the Urine Collection Questionnaire (Attachment 1) and Breath Collection Questionnaire (Attachment 2) to evaluate the compliance of the licensee’s collection site, alcohol testing equipment, and specimen collection procedures with requirements in Subpart E of 10 CFR Part 26. If the licensee uses more than one dedicated collection site, the inspectors(s) should determine which collection site(s) to evaluate (e.g., large number of collections, if errors in collections or cancelled tests identified in records reviews).

Specific guidance for the collection of other specimens for drug and alcohol testing.

Note: Under 10 CFR 26.83, “Specimens to be collected,” the NRC permits the collection of breath or oral fluid for initial tests for alcohol, and the collection of urine specimens for drug testing unless the licensee adopts through policy and procedure to collect and drug test oral fluid specimens for any of the direct observation collection conditions specified in 10 CFR 26.115(a)(1) through (3) and (5).

This inspection procedure only includes standardized questionnaires for the collection and testing of a breath specimen for alcohol (Attachment 2) and the collection of a urine specimen for drug testing (Attachment 1). If a licensee uses an alcohol screening device (ASD) to test oral fluid or collects oral fluid specimens for drug testing, in addition to delivering the Urine and Breath Collection questionnaires, the inspector(s) also should evaluate the specimen collection process for oral fluid specimens.

To verify collector compliance, obtain the instructions provided by the test device manufacturer and evaluate through a mock collection that the collector correctly completes the specimen collection.

a. Verify that the licensee uses a designated collection site meeting the requirements in 10 CFR 26.87(a), (b), (d) and (e).

b. Verify that the licensee only uses devices that meet the requirements in 10 CFR 26.91(a) to conduct initial alcohol testing and that the collection site maintains the devices according to the quality assurance and quality controls requirements in 10 CFR 26.91(d).

c. Verify that the oral fluid specimen collection and testing process for alcohol is conducted in accordance with the applicable requirements in Subpart E of 10 CFR Part 26. (10 CFR 26.89, 10 CFR 26.93, 10 CFR 26.97, 10 CFR 26.99, 10 CFR 26.101, and 10 CFR 26.103)

d. Verify that the oral fluid specimen collection process for drug testing is conducted in accordance with the applicable requirements in Subpart E of 10 CFR Part 26. (10 CFR 26.89, 10 CFR 26.97, 10 CFR 26.105, and 10 CFR 26.117)

e. Verify that the specimen collectors used by the licensee meet the collector qualification requirements in 10 CFR 26.85(a) and (d).

## 02.08	Sanctions and Substance Abuse Expert Interview

Administer the Substance Abuse Expert Questionnaire (Attachment 4) to evaluate the training and credentials of the SAE, the SAE’s knowledge of the treatment and follow-up testing requirements associated with FFD program policy violations, and the SAE’s knowledge of the determination of fitness process.

Specific guidance for all samples contained in this section.

a. Verify that the licensee only uses SAEs that meet the requirements in 10 CFR 26.187.

b. Verify that the SAE is knowledgeable of the responsibilities related to evaluating individuals who have violated the substance abuse provision(s) of the FFD policy (10 CFR 26.187(g)) and performs each determination of fitness in accordance with 10 CFR 26.189.

c. For utilities with multiple operating power reactor facility locations in the same NRC Region and that use the same SAE, the inspector(s) should consider if completing the Substance Abuse Expert Questionnaire is necessary when performing each site-specific inspection during the same inspection cycle (i.e., 1-year time period). A more targeted interview with the SAE may still be needed based on site-specific records review conducted by the inspector(s), as well as if follow-up actions were identified during a prior inspection conducted in the same year.

## 02.09	Licensee Testing Facility and/or Health and Human Services-Certified Laboratory

a. Verify that the licensee is testing each urine specimen, at a minimum, for the substances specified in 10 CFR 26.31(d)(1) and at the cutoff levels specified in 10 CFR 26.133 (Licensee Testing Facilities) and/or 10 CFR 26.163 (HHScertified laboratories).

1. If the licensee is using more stringent cutoff levels than specified in 10 CFR 26.163, verify that the cutoff levels have been evaluated and certified, in writing, by a forensic toxicologist meeting the requirements in 10 CFR 26.31(d)(1)(i)(D) (or NRC-approved the lower cutoff levels before April 30, 2008).

2. If the licensee is testing for drug(s) in addition to those specified in 10 CFR 26.31(d)(1), verify that:

(a) Each drug is listed in Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812]. (10 CFR 26.31(d)(1)(i)(A))

(b) The assay and cutoff levels used for each drug have been certified in writing by a forensic toxicologist as scientifically sound and legally defensible. Certification of the assay and cutoff levels by a forensic toxicologist is not required if the HHS Guidelines are revised to authorize use of the testing assay and cutoff levels. (10 CFR 26.31(d)(1)(i)(D))

3. For special analyses testing of specimens with a dilute validity test result and specimens collected under the direct observation conditions specified in 10 CFR 26.115(a)(1) through (3) and (5), verify that the process is implemented as described in 10 CFR 26.163(a)(2). This only pertains to testing performed at an HHScertified laboratory.

Specific Guidance

The inspector(s) should review drug and validity testing results provided by the licensee’s testing facility (as applicable) and the HHScertified laboratory to the MRO. The MRO may provide these results as part of the verified results sent to the FFD program. If so, inspector(s) should evaluate the test results during the records reviews conducted under this inspection. If not, request that the MRO provide, for a sample of selected testing events, the laboratory test results to verify drug and validity testing requirements (substances tested, cutoff levels used, etc.).

1. If the licensee tests for drugs in addition to those specified in 10 CFR 26.31(d)(1), ensure that each drug is listed in Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812].

2. Review the forensic toxicologist certification for any additional drugs and/or more stringent cutoff levels used by the licensee. Ensure that the documentation is consistent with the requirements in 10 CFR 26.31(d)(1)(D).

3. The inspectors may also review the contract with the HHScertified laboratory to confirm the drug testing program used by the licensee (substances tested, cutoff levels used, validity tests performed, etc.).

4. If special analyses testing has been performed on specimens with dilute validity test results and specimens collected under direct observation conditions, ensure that the HHS-certified laboratory test results and MRO reviews are consistent with the requirements in 10 CFR 26.163(a)(2) and 10 CFR 26.185. Request from the licensee the Federal CCF, MRO-verified result, and HHS-certified laboratory test results for each specimen subject to special analyses testing.

b. Verify that the licensee is conducting validity testing at an HHScertified laboratory for all urine specimens as described in 10 CFR 26.31(d)(3)(i) and 10 CFR 26.161. Validity screening and/or initial validity testing also may be performed at a licensee testing facility (LTF) as described in 10 CFR 26.131.

Specific Guidance

The inspector(s) should review the licensee’s FFD policy statement to ensure that it specifies that validity testing is to be performed on all urine specimens. Review the HHScertified laboratory contract to ensure that validity testing is being performed in accordance with 10 CFR 26.31(d)(3)(i) and 10 CFR 26.161 and review a sample of urine specimen test results to confirm that validity testing has been performed. The inspector(s) should examine any FFD program violations for adulterated and substituted validity test results.

c. If the licensee uses an LTF, verify the following:

1. LTF personnel meet the training and credential requirements in 10 CFR 26.125.

2. The LTF is submitting a minimum of 5 percent (or at least one) of donor specimens screened as negative from each analytical run to the HHScertified laboratory for testing. (10 CFR 26.137(e)(5))

3. The licensee is receiving testing information from the LTF to assess LTF performance (10 CFR 26.75(i) and 26.719(c)), and to inform the annual FFD performance report to the NRC. (10 CFR 26.139(d) and (e))

4. The LTF is reporting testing program errors. (10 CFR 26.137(f))

Specific Guidance

The inspector(s) should verify the following elements of the LTF’s testing program (only applicable if the licensee uses an LTF).

1. Request and review the training and credential requirements for LTF staff to confirm compliance with 10 CFR 26.125.

2. Speak with staff at the LTF to verify the procedure used to ensure that a minimum of 5 percent (or at least one) of donor specimens screened as negative from each analytical run are sent to the HHScertified laboratory for quality control testing. Request a list of the specimens sent for testing and review a sample of the test results received from the LTF.

3. Review the annual statistical summary report provided to the licensee that details tests conducted at the LTF. The FFD performance report submitted by the licensee will consist of data supplied by the LTF and the HHScertified laboratory.

4. Evaluate any reports submitted to the licensee related to testing errors required to be reported under 10 CFR 26.137(f). Ensure that corrective actions have been implemented.

b. For each HHScertified laboratory used by the licensee to conduct drug testing of specimens, ensure that:

1. The laboratory is an HHScertified laboratory (10 CFR 26.31(d)(3) and 10 CFR 26.153(a))

2. The licensee is receiving the annual statistical summary of testing as specified in 10 CFR 26.169(h).

Specific Guidance

Inspector(s) should verify the following regarding the HHScertified laboratory(s) used by the licensee to conduct testing on urine specimens:

1. That each laboratory used is listed on the current list of HHScertified laboratories available at: https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list.

2. Request that the licensee provide a copy of the latest annual statistical summary of testing provided by the HHScertified laboratory and evaluate the document for compliance with 10 CFR 26.169(h).

b. Verify the following about the blind performance test samples (BPTSs) that the licensee’s FFD program is submitting to the HHScertified laboratory:

1. The licensee is submitting the minimum number of BPTSs each quarter, as specified in 10 CFR 26.168(a).

2. The licensee is submitting each BPTS type (i.e., negative, drug positive, false negative challenge, adulterated, substituted, dilute) and in the correct percentages of samples submitted for testing. (10 CFR 26.168(b) – (f))

3. All BPTSs used by the licensee are certified by the supplier and formulated as specified in 10 CFR 26.168(g) and (h).

4. The licensee is submitting all BPTSs in a manner such that each sample is indistinguishable to laboratory personnel from a donor’s specimen. (10 CFR 26.168 (i))

Specific Guidance.

Inspector(s) should evaluate the following about the BPTSs submitted to the HHScertified laboratory by the licensee:

1. Discuss with the licensee the method used to track the number and type (e.g., adulterated, negative, etc.) of BPTSs submitted each quarter and evaluate how the licensee ensures that it meets the minimum number of BPTSs and in the correct percentage by type for testing each quarter.

2. Request for each quarter of testing covered by the period of the inspection:

(a) the total number of donor specimens tested at the HHScertified laboratory;

(b) a list of the BPTSs submitted for testing to include the date each sample was submitted and the type of each sample (e.g., positive for marijuana, substituted, etc.). See Attachment 5, Blind Performance Test Sample Submissions, for information to assist the inspector(s) in evaluating the number and types of BPTSs submitted each quarter.

3. Does the licensee send BPTSs to each HHScertified laboratory that the licensee is under contract with to perform drug and validity testing of specimens?

4. Ask the licensee to explain who reviews the BPTS test results from the HHScertified laboratory (i.e., the MRO or MRO staff), and what is the review procedure used to ensure that any unsatisfactory performance from the laboratory is identified in a timely manner?

5. Ask the licensee’s staff to explain when BPTSs are submitted in each quarter. Is the frequency consistent with normal specimens submitted throughout the quarter, or are all BPTSs submitted at one time towards the end of the quarter? The later approach would alert the laboratory to the likelihood that the specimens were not donor specimens, because of the high number of positive results.

6. Ask the licensee’s staff to explain how it completes the Federal CCF for a BPTS. Review the CCFs for a sample of BPTSs submitted for testing. Verify that each Federal CCF was completed as though it were a donor sample.

7. Request that the licensee provide documentation from the BPTS supplier that confirms that the BPTSs meet the requirements in 10 CFR 26.168(g) and (h).

8. Evaluate the process the licensee uses to ensure that no BPTS is submitted for testing that has exceeded the product expiration date. (10 CFR 26.168(h))

Tier III

## 02.10	FFD Events and Log Review

Review and evaluate licensee event reports under 10 CFR 26.719, and safeguards log entries for the previous 12 months or since the last NRC inspection that are associated with the FFD program and follow up if appropriate.

Security Program Review. Verify that the licensee is conducting security program reviews in accordance with 10 CFR 26.41 and that the licensee's FFD program was included in the security program reviews, as required by the regulation. (10 CFR 73.55(b)(1), (b)(9)(ii), and (m); 10 CFR 26.41(b); and Security Plans)

Identification and Resolution of Problems. Verify that the licensee is identifying issues related to its FFD program at an appropriate threshold and entering them into the corrective action program. Verify that the licensee has appropriately resolved the issues regarding regulatory requirements for a selected sample of problems associated with its protective strategy. (10 CFR 73.55(b)(10), 10 CFR 26.41(f), and 10 CFR 26.719(d))

Specific Guidance

The inspector(s) should review the documented results of the security program reviews or audits performed by the licensee to ensure the continued effectiveness of its FFD program. The inspector(s) should ensure that the reviews have been conducted in accordance with the requirements of 10 CFR 73.55(m). The inspector(s) should also request a copy of the report that was developed and provided to licensee management for review. The inspector(s) should review the report to identify any findings of the review or audit and ensure that the findings were entered in the licensee's corrective action program.

## 02.11	FFD Program Policy and FFD Procedures Review

a. Verify that time limit(s) have been established in the FFD policy statement that is reasonable and practicable for individuals to report to the collection site for random testing once notified. (10 CFR 26.27(b)(2) and 10 CFR 26.31(d)(2)(iii))

Specific Guidance

The inspector(s) should verify that the FFD policy statement and FFD procedures state that individuals must report to the collection site in the time frame specified by the licensee.

1. The inspector(s) should verify that a time limit is specified in the FFD policy statement for an individual to report to the collection site. This time period should accommodate for travel time to the collection from the location of notification. An individual should not be notified to appear for testing prior to their availability to report for the test (i.e., notifying an individual at the start of shift to report to testing at the end of shift).

2. The inspector(s) should review the FFD policy statement and procedures to verify that the licensee uses a method to document the time of notification and the time of arrival at the collection site to ensure that individuals report within the required amount of time.

## 02.12	Random Testing Program, Test Results Review, and Medical Review Officer Interview

a. Verify the following about the licensee’s random testing program:

1. Each individual in the population subject to testing has an equal probability of being selected and tested, and each individual tested is immediately eligible to be selected for another test each time a random selection list is generated. Ascertain how FFD program personnel are randomly tested (i.e., are FFD personnel in another entity’s random testing pool?). (10 CFR 26.31(d)(2)(iv) and (vi))

2. Individuals selected for random testing, but not available to appear for testing (either off-site or not reasonably available for testing when selected), are tested at the earliest reasonable and practical opportunity and without prior notice of the test. (10 CFR 26.31(d)(2)(v))

3. Testing is conducted at a minimum on a nominal weekly frequency, including conducting testing on weekends and holidays. (10 CFR 26.31(d)(2)(i)(B) and (d)(2))

4. Testing is conducted in a manner that provides reasonable assurance that individuals cannot predict the days and time periods when specimens will be collected, such as taking 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 the 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. (10 CFR 26.31(d)(2)(i))

5. Each individual notified to appear for a test reports to the collection site as soon as reasonably practicable after notification and within the time period specified in the FFD policy statement. (10 CFR 26.31(d)(2)(iii))

6. The number of random tests conducted each calendar year is equal to at least 50 percent of the population subject to testing. (10 CFR 26.31(d)(2)(vii))

Specific Guidance

Inspector(s) should evaluate the following elements of the licensee’s random testing program:

1. The inspector(s) should verify that all individuals in the population subject to testing have an equal probability of being selected and tested.

(a) Testing pool maintenance. The inspector(s) should verify that all individuals subject to testing are included in the random testing pool. If the list of covered personnel is not up to date when a random selection list is created, each person does not have an equal probability of selection and testing. The inspector(s) should:

(1) Request all random selection lists generated during the period of review. Request a list of all random tests conducted for the period of review (date of test, individual name, results).

(2) Request a list of all staff start dates and termination dates during the period of the inspection review. The inspector(s) should evaluate if the random testing pool is updated effectively (examples could include, are individuals that have been granted authorization not included in the random selection pool? Does the selection pool include individuals who no longer have authorization?)

(3) The inspector(s) should speak to the individual(s) who maintain(s) the random testing pool and discuss: (1) how updates are made (is the pool updated before each selection list is generated – very important to ensure new hires are included in the pool and subject to testing); and (2) how frequently random lists are generated (if the employee’s population changes frequently the random testing pool must be updated frequently and the period that a random selection list is valid would be limited). The inspectors may wish to assess how the FFD program personnel are randomly tested.

(4) The inspector(s) should verify that each individual completing a test is immediately eligible for another random test. The inspector(s) should evaluate the random selection method used (how is the random selection list created; does an opportunity exist for any tested individual to be removed from the testing pool?).

(5) The inspector(s) should evaluate the security of the random selection lists to ensure limited access. How does the licensee communicate the selection of an individual for random testing to ensure that the individual receives no prior notice of the selection for a test?

2. The inspector(s) should evaluate the instances where individuals selected for random testing were not initially tested (i.e., verify why the person was not tested the day originally intended for the testing event). This is a key component of the random testing program, ensuring that the licensee is not exercising discretion when to excuse or test a selected individual. If an individual is not tested on the day of selection for testing, what method does the licensee use to ensure that testing is completed at the earliest reasonable and practical opportunity when both the donor and collector are available to collect specimens for testing and without prior notice of the test?

3. Ensure that testing is conducted at least on a nominal weekly frequency. The inspector(s) should request a list of all random tests (e.g., date of each test) to verify compliance during the period of review. The inspector(s) should consider using a spreadsheet analysis method for this step. For example, one method to determine testing frequency is to sort the list of test dates in chronological order and then evaluate the number of days between tests. Another possible method is to use the “weeknum” formula in Microsoft Excel which will assign a week number (i.e., 1 to 52) based on the date of the test entered into the formula.

4. The inspector(s) should verify that random testing is conducted in a manner that provides assurance that individuals cannot predict the days and time periods when specimens will be collected.

a. The inspector(s) should evaluate if the subject population is likely to detect any patterns regarding when random testing is to be conducted. Examples of predictable patterns include only testing one day in each 7day calendar week (e.g., test on Monday this week, no tests until at least the following Sunday which is the start of the next week), testing on the same day of each week; only testing during limited time periods each day when testing is performed (e.g., 8:00 a.m. to 10:00 a.m.; 3:00 p.m. to 5:00 p.m.), not conducting testing on weekends or holidays.

1. To evaluate if predictability exists in the random testing program, request a list of a random tests conducted during the period of inspection review. The information should include: name, testing date, and test times.

2. Consider using graphical analyses of random testing information to evaluate predictability over a relatively long period of time (e.g., 12 months).

b. Evaluate if it is possible for individuals to determine that random testing will be conducted prior to notification for testing. For example:

1. Does the arrival of the mobile collector onsite to conduct testing notify staff that testing will be conducted during the day?

2. Is the location where testing is conducted only occupied on days when testing is performed (e.g., office is closed, and no staff are present when no testing is performed)?

3. Is backshift testing only conducted by a certain security supervisor?

c. The inspector(s) should evaluate the method(s) used by the licensee to determine the frequency and timing of testing:

1. Number of days per week (testing is required at least on a nominal weekly basis).

2. Number of days per month.

3. Coverage across days of the week (is testing conducted on each day of the week, including weekends and holidays?). For example, if weekend testing is only conducted during outages, that would be predictable.

4. Time of the day of testing events (including backshifts).

d. The inspector(s) should obtain information on how the collection site(s) operate (hours of service, how is off peak testing conducted?).

e. Does the licensee test a large number of staff each time testing is conducted (i.e., a limited number of testing days and a lot of tests conducted on each testing day)?

5. The inspector(s) should verify time limit(s) established by the FFD policy statement for individuals to report to the collection site for random testing once notified.

(a) The inspector(s) should ensure that upon notification, individuals appear for testing at the earliest reasonable and practicable opportunity, as described in licensee procedures. If no legitimate work, travel, or other demands would prevent an individual from immediately reporting for testing, the individual is to report as soon as they are notified.

(b) The licensee may not notify an individual for testing until they can proceed for testing (e.g., notifying an individual at the start of a shift to appear for testing at the end of the shift is not appropriate; notifying an individual to appear for testing the next day is not appropriate).

(c) The inspector(s) should evaluate if the established time period to report for random testing is reasonable. For example, if it takes a person 25 minutes to get to the collection site from inside the PA, an individual should not be reporting 45 minutes later.

(d) The inspector(s) should ascertain how the licensee ensures that persons reporting for random drug testing meet the “earliest reasonable and practicable opportunity” requirement. For example, does the licensee document the time of notification and time of arrival at the collection site? The inspector(s) should review the documentation on notification and arrival times and follow-up actions to see if individuals who report late for testing are held responsible and ascertain whether corrective actions were taken. Are reviews conducted?

6. Verify that the licensee is meeting the minimum annual random testing rate of 50 percent of the population subject to testing.

(a) The annual random testing rate is reported for each calendar year in the FFD performance report (i.e., the ARF) submitted to NRC. Evaluate the method that the licensee uses to ensure that the annual testing rate is accurate (i.e., verify the calculation of the value).

(b) Evaluate how the licensee tracks in the current year of testing progress in meeting the 50 percent testing rate. What method(s) does the licensee use to ensure that the annual random testing rate is met?

## 02.13	Recordkeeping and Reporting

a. Verify that the licensee retains records and for the time periods specified in Subpart N of 10 CFR Part 26. (10 CFR 26.711(a) and 10 CFR 26.713)

Specific Guidance

The inspector(s) should ensure that the FFD procedures require records to be retained as follows:

1. For at least 5 years after the licensee terminates or denies an individual’s authorization or until the completion of all related legal proceedings, whichever is later:

(a) Records of self-disclosures, employment histories, and suitable inquiries that result in the granting of an authorization;

(b) Records pertaining to the determination of a violation of the FFD policy and related management actions;

(c) Documentation of the granting and termination of an authorization;

(d) Records of any determinations of fitness, including any recommendations for treatment and follow-up testing plans; and

(e) Superseded versions of the FFD policy statement and FFD procedures.

2. For at least 3 years or until the completion of all related legal proceedings, whichever is later:

(a) Records of FFD training and examinations;

(b) Records of audits, audit findings, and corrective actions taken; and

(c) Fatigue-related records for security officers.

3. For at least 40 years or until, on application, the NRC determines that the records are no longer needed:

Records pertaining to any 5-year denial of authorization and any permanent denial of authorization.

4. For the life of the agreement or until completion of all legal proceedings, whichever is later:

Written agreements for the provision of services under 10 CFR Part 26.

5. For the length of the individual’s employment by or contractual relationship with the licensee, or until the completion of all related legal proceedings, whichever is later:

Records of the background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel.

6. For the time the FFD program follows these practices or until the completion of all related legal proceedings, whichever is later:

If the licensee tests for drugs in addition to the ones required by 10 CFR Part 26 or uses more stringent cutoff levels, documentation certifying the scientific and technical suitability of the assays and cutoff levels used.

b. If a licensee maintains records electronically, ensure that the electronic records:

1. Provide an accurate representation of the original record;

2. Prevent alteration of any archived information and/or data once it has been committed to storage; and

3. Permit easy retrieval and recreation of the original record. (10 CFR 26.711(b)).

Specific Guidance

The inspector(s) should review a sample of employee records that are maintained electronically. The inspector(s) should assess the accuracy, permanence, and ease of access associated with the records.

c. Verify that the licensee is submitting the following reports to the NRC:

1. Annual FFD program performance report that includes information on the licensee’s drug and alcohol testing program for the full site, and the fatigue program for security officers. (10 CFR 26.717(b)(1)-(8) and 10 CFR 26.203(e))

2. Twenty-four hour event reports on significant FFD policy violations and programmatic failures. (10 CFR 26.719(b)(1)-(4))

3. Thirtyday event reports on drug and alcohol testing errors. (10 CFR 26.719(c))

Specific Guidance

The inspector(s) should request to see all documentation associated with licensee reports to the NRC relating to:

1. Meeting the annual FFD performance report requirement that includes information on the drug and alcohol testing program and fatigue program for security officers. Confirmation can be made through contacting NRC staff who maintain the FFD performance reporting data collection system and/or through review of licensee’s files completed during the inspection. Evaluate issues included in the annual FFD performance reports related to:

Drug and alcohol testing program. Review positive test rates, testing refusals, and adulterated and substituted specimens. A comparison to previous reports will permit an evaluation of trends. Adulterated and substituted specimens indicate that individuals have subverted the collection process and their action was detected during the testing process. A spike in positive rates for a specific employee category or for a particular substance may indicate a program deficiency or new trend. Discuss with FFD management apparent changes in trends.

(a) Drug and alcohol testing program. Programmatic issues with the testing laboratories, implementation of program policies and procedures, and program and system management.

(b) Performance reporting categories describe deviations from established procedures and protocols. Ensure that the licensee is adequately addressing all deficiencies reported.

(c) Fatigue reporting program for site security force. Evaluate the waivers issued and ensure that the licensee is adequately addressing staffing issues, when necessary. Were a large number of waivers issued to site security? Were specific individuals issued a large number of waivers?

2. Reporting cases of significant FFD policy violations and programmatic failures including the discovery of any intentional act or acts that cast doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse. The inspector(s) should verify through the licensee’s internal documentation and through discussions with relevant staff that each report was made to NRC within 24 hours of discovery. Inspector(s) should ensure that the licensee is adequately addressing all deficiencies and follow up on corrective actions implemented as appropriate.

3. Drug and alcohol testing errors. Review the reports provided on any errors related to the unsatisfactory performance of the licensee’s testing facility (as applicable), the HHScertified laboratory, and any other errors that could adversely affect the integrity of the testing program. The inspector(s) should verify through the licensee’s internal documentation and through discussions with relevant staff that each report was made to NRC within 30 days of completing the investigation of any testing error or program performance issue. Inspector(s) should ensure that the licensee is adequately addressing all deficiencies and follow up on corrective actions implemented as appropriate.

4. If available, consult the annual summary report published by the NRC on FFD program performance, which includes information on all 24-hour and 30-day event reports received by the NRC under 10 CFR 26.719, including a summary of each event and associated NRC Event Notice number (for 24-hour event reports) and ADAMS Accession Number (for 30-day event reports).

d. Verify that the licensee is retaining fatigue-related records for security officers for at least 3 years or until the completion of all related legal proceedings, whichever is later. (10 CFR 26.203(d))

Specific Guidance.

No inspection guidance.

e. Verify that the licensee establishes, uses, and maintains a system of files and procedures that protects the individual’s privacy. (10 CFR 26.37)

Specific Guidance

The inspector(s) should review the licensee’s written procedure to verify that provisions exist to protect personal information. The inspector(s) should evaluate the adequacy and implementation of the provisions by visually observing the file and recordkeeping system(s).

1. Verify who is permitted to access FFD program records and personnel files.

2. Request to see where FFD administration records and personal files (e.g., test results, Federal custody and control forms (Federal CCFs), consent forms, appeal records) are maintained and stored. The inspector(s) should verify that the system(s) restricts access to individuals authorized to access the information.

3. Request a sample of records to review while at the facility and observe the retrieval of the information from the storage location to verify that the personnel information is stored in accordance with the licensee’s or other entity’s procedures to protect personal information.

## 02.14	Managing Fatigue – Security Force Work Hours

a. Verify that security officers do not exceed work hour limits. (10 CFR 26.205)

Specific Guidance

The inspector(s) should examine the work hour records for a sample of security officers. These work hour records should not be work schedules; rather, the records should represent actual hours worked by security officers during the period of inspection. The inspector(s) should ensure that the work hours do not exceed the work hour requirements in 10 CFR 26.205.

b. Verify that the waivers issued from work hour limits were authorized and documented in accordance the rule requirements. (10 CFR 26.207)

Specific Guidance

1. The inspector(s) should examine a sample of waivers from the work hour limits that were issued to security officers during the period of inspection. The inspector(s) should ensure that the waivers were authorized and documented in accordance with 10 CFR 26.207.

2. The inspector(s) can evaluate if a licensee has issued any waivers to work hour limits for the security force by reviewing the Annual Fatigue Reporting Form (NRC Form 892) submitted to the NRC under 10 CFR 26.203(e).

c. Verify that the licensee developed or augmented procedures to describe the process to be followed if a security officer:

1. Declares that, due to fatigue, they are unable to perform their duties safely and competently.

2. Requires a fatigue assessment. (10 CFR 26.209 and 10 CFR 26.211)

Specific Guidance.

The inspector(s) should review written procedures to ensure that they describe the process to be followed if a security officer:

1. Declares that, due to fatigue, they are unable to perform their duties safely and competently. Requires a fatigue assessment.

# 71130.08-03	PROCEDURE COMPLETION

The minimum number of inspection requirements that constitute the completion of this IP are as follows: completion of Tier I inspection requirements (8) and completion of Tier II inspection requirements (15).

The inspection requirement range for completion of this IP is as follows: minimum range of 23 inspection requirements, and nominal range of 40 inspection requirements. The inspection of the nominal range of inspection requirements is the target range for this sample and should be completed to the extent practicable.

The nominal range of inspection requirements for this IP is defined as Tier I inspection requirements (8), Tier II inspection requirements (26), and Tier III inspection requirements (6), for a total of 40 inspection requirements.

The frequency at which this IP is to be conducted is triennially (i.e., once every 3 years).

# 71130.08-04	RESOURCE ESTIMATE

The resource estimate for the completion of this procedure consists of approximately 16 hours for the inspection of the minimum range of inspection requirements, and approximately 24 hours for the inspection of the nominal range of inspection requirements. The sample size for this procedure is one.

# 71130.08-05	REFERENCES

10 CFR Part 26 Final Rule, *Federal Register*, Volume 87, No. 224, November 22, 2022, is available at: https://www.govinfo.gov/content/pkg/FR-2022-11-22/pdf/2022-24903.pdf

10 CFR Part 26 Final Rule, *Federal Register*, Volume 73, No. 62, March 31, 2008, is available at: https://www.govinfo.gov/content/pkg/FR-2008-03-31/pdf/E8-4998.pdf

10 CFR Part 26 is available at the Electronic Code of Federal Regulations (eCFR) Website: https://www.ecfr.gov/current/title-10/chapter-I/part-26

A current list of controlled substances (Schedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812]) is available at: https://www.dea.gov/drug-information/drug-scheduling

A current list of HHScertified laboratories (urine and oral fluid) is published each month in the *Federal Register* and is available at:  https://www.samhsa.gov/workplace/drug-testing- resources/certified-lab-list

National Highway Traffic Safety (NHTSA) Conforming Products List (CPL) for evidential breath testing devices (67 FR 62091; October 3, 2002, and subsequent amendments). A current list of approved devices is available at: https://www.transportation.gov/odapc/approved-evidential-breath-testing-devices

Nuclear Energy Institute (NEI) 0301, Nuclear Power Plant Access Authorization Program, Revision 3, May 2009 (non-public)

Regulatory Guide (RG) 5.89, “Fitness-For-Duty Programs for Commercial Power Reactor and Category I Special Nuclear Material Licensees,” Revision 0, November 2022 (ML20143A034)

The annual summary reports published by the NRC on 10 CFR 26.717 FFD program performance data are available at the NRC Web Site: https://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/performance-reports.html.

END

Attachments:Attachment 1: Urine Collection QuestionnaireAttachment 2: Breath Collection QuestionnaireAttachment 3: Medical Review Officer QuestionnaireAttachment 4: Substance Abuse Expert QuestionnaireAttachment 5: Blind Performance Test Sample SubmissionsAttachment 6: Revision History for IP 71130.08

Issue Date: 01/23/24		1	71130.08

Issue Date: 01/23/24	1	71130.08

Attachment 1: Urine Collection Questionnaire

10 CFR Part 26

URINE COLLECTION QUESTIONNAIRE

This Urine Collection questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the urine collection procedures at a licensee’s or other entity’s specimen collection site. Each question is accompanied by potential answers and the relevant requirement(s) in 10 CFR Part 26, Subpart E.

INSTRUCTIONS:

The Urine Collector questionnaire is divided into three sections.

Section A (Observing the Collector – Mock Collection) is to be completed by the inspector during a mock specimen collection. The inspector is to direct the collector to treat the inspector as an employee who has just arrived for a test. At the point in the collection when the collector requests the inspector to provide a specimen, the inspector will direct the collector to fill the specimen collection cup with water and assume the “specimen” is acceptable (in appearance and temperature). The full specimen collection process must be observed by the inspector. The inspector must also enter the private collection area to assess security measures.

Section B (Knowledge of Collection Procedures) is to be completed after the mock collection. The inspector will ask the collector questions about the procedures to be followed during typical and atypical collections.

Section C (Observing the Facility) consists of questions to be completed by the inspector based on observations made regarding the specimen collection facility.

Table of Contents

Issue Date: 01/23/24	Att1-1	71130.08

Attachment 2: Breath Collection Questionnaire

10 CFR Part 26

BREATH COLLECTION QUESTIONNAIRE

This Breath Collection questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the breath alcohol testing procedures at a licensee’s or other entity’s specimen collection site. Each question is accompanied by potential answers and the relevant requirement(s) in 10 CFR Part 26, Subpart E.

INSTRUCTIONS:

The Breath Collection questionnaire is divided into four sections. 

Section A (Observing the Collector – Initial Breath Test (Mock Collection)) is to be completed by the inspector during a mock breath collection. The inspector is to direct the collector to treat the inspector as an employee who has arrived for both a urine and breath alcohol test. The inspector is to participate in the complete collection process for the initial alcohol test (including providing a breath specimen).

Section B (Knowledge of Collection Procedures – Confirmatory Alcohol Testing and External Calibration Checks) is a question and answer segment of the inspection to evaluate the collector’s knowledge on conducting confirmatory alcohol testing. In this section, the inspector will ask the collector questions. An evaluation of the evidential breath testing device (EBT) external calibration capabilities (i.e., a verification that the EBT is functioning correctly) also will be assessed.

Section C (Knowledge of Collection Procedures – Non-Typical Specimen Collections) is a question and answer segment of the inspection to evaluate the collector’s knowledge of how to address non-typical situations that might arise during a breath alcohol test.

Section D (Observing the Facility) consists of questions to be completed by the inspector based on observations made regarding the specimen collection facility, a records review, and some questions that may require speaking to the collection site manager.

Table of Contents

Issue Date: 01/23/24	Att2-20	71130.08

Attachment 3: Medical Review Officer Questionnaire

10 CFR Part 26

Medical Review Officer Questionnaire

This questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the Medical Review Officer (MRO) supporting a licensee’s or other entity’s fitness-for-duty (FFD) program. Each question is accompanied by potential answers and the relevant requirements in 10 CFR Part 26, Subpart H. This questionnaire is divided into the following five sections:

Issue Date: 01/23/24	Att3-29	71130.08

Attachment 4: Substance Abuse Expert Questionnaire

10 CFR Part 26

Substance Abuse Expert Questionnaire

This questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the Substance Abuse Expert (SAE) supporting a licensee’s or other entity’s fitness-for-duty (FFD) program. Each question is accompanied by potential answers and the relevant requirement(s) in 10 CFR Part 26, Subpart H. This questionnaire is divided into the following two sections:

Issue Date: 01/23/24	Att4-12	71130.08

Attachment 5: Blind Performance Test Sample Submissions (10 CFR 26.168)

This attachment provides guidance for use by the inspector(s) when evaluating a licensee’s quarterly blind performance test sample (BPTS) submissions.

The BPTS submissions are a critical component of the quality assurance/quality control program that ensures the accuracy of HHScertified laboratory testing and MRO test result reviews.

Positive results are infrequent events for most sites (industry positive rate for all tests is well below 1 percent so most sites are seeing less than 1 positive in every 100 people tested).

The drug-testing panels used by NRC licensees differ from the majority of Federal workplace drug-testing programs. Therefore, NRC licensees and other entities cannot rely on the HHScertification of laboratories and performance testing process which is a part of the HHS laboratory certification and inspection process, in part, because: 

Testing cutoff variability - NRC cutoffs may be different than those used by other Federal workplace drug-testing programs.

No Federal workplace drug-testing program employs special analyses testing of specimens with dilute validity test results and specimens collected under direct observation conditions, as specified under 10 CFR 26.163(a)(2).

NRC licensees may test for additional substances based on local drug use trends.

The BPTS program validates the Medical Review Officer (MRO) review and MRO staff review of non-typical specimen test results (i.e., drug positive, adulterated, substituted, and dilute).

Many of the 30-day reportable events under 10 CFR 26.719 received each year by the NRC pertain to the testing of BPTSs.

The annual FFD program performance reports submitted under 10 CFR 26.717 also may contain information that a licensee did not meet the quarterly submission requirement for each BPTS type (e.g., did not submit the required number of adulterated BPTSs in the fourth quarter of the calendar year).

Attachment 5 provides information for the inspector(s) to evaluate compliance with the most common 10 CFR 26.168 quarterly BPTS requirement for a site following the initial 90-day period of any HHScertified laboratory contract.

The number of BPTSs submitted per quarter must be a minimum of 1 percent of all specimens tested (up to a maximum of 100) or 10 per quarter, whichever is greater. (10 CFR 26.168(a)(2))

Unless the FFD program tests more than 1,000 specimens in a quarter (rare event, maybe a three-unit operating site in outage conditions), 10 BPTSs would be submitted per quarter as follows:

Positive for one or more drugs or drug metabolites (10 CFR 26.168(b))(60 percent of 10 BPTSs per quarter = 6 BPTSs per quarter).

Include all drugs in the site's drug-testing panel in each quarter (the minimum NRC panel in 10 CFR 26.133 and 26.163 includes 14 substances: marijuana metabolite, cocaine metabolite, 4 amphetamines (AMP) (amphetamine, methamphetamine, methylenedioxyamphetamine (MDA), methylenedioxymethamphetamine (MDMA)), 7 opioids (codeine (COD), morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, oxymorphone), and phencyclidine).

If the site submits the minimum 6 BPTSs per quarter, this means that some BPTSs must contain more than one substance. Presently, no site only submits 6 BPTSs per quarter because of how BPTS suppliers formulate specimens.

2 BPTSs per quarter must be for marijuana metabolite. (10 CFR 26.168(b)(1))

In a minimum of two quarters per year, replace the PCP sample with another cocaine sample. (10 CFR 26.168(b)(2))

False negative challenge (10 percent of BPTSs per quarter, a minimum of 1 BPTS). This is a positive specimen that is formulated with a drug concentration closer to the testing cutoff level. (10 CFR 26.168(f))

Validity testing challenges (20 percent of BPTSs per quarter, a minimum of 3 BPTSs = 1 adulterated, 1 substituted, and 1 dilute). (10 CFR 26.168(e))

Negative test results (10 percent of BPTSs per quarter, must not contain a measurable amount of any drug or drug metabolites)

The table on the next page provides an example BPTS submission program for a site for one calendar year. While variability among sites will exist, what may be helpful to the inspector(s) is to evaluate the framework presented to ensure that the licensee is submitting the correct number and type of BPTS each quarter to meet the 10 CFR 26.168 requirements.

The example is divided into four quarters of the calendar year (i.e., January–March; April–June; July–September, and October–December). For each quarter, the BPTSs are sequentially numbered from 01 to 14.

Issue Date: 01/23/24	Att5-3	71130.08

Attachment 6: Revision History for IP 71130.08

Issue Date: 01/23/24	Att6-2	71130.08