Text

IP 71130.08 Fitness for Duty Program
	ML17263A609
Person / Time
Issue date:	10/22/2018
From:	Eric Wharton; NRC/NSIR/DSO/SOSB
To:	;
	Eric Wharton, 301-287-3621
Shared Package
ML17262A696, ML18295A018	List:
References
	CN 18-035
	Download: ML17263A609 (129)
	v • d • e

NRC INSPECTION MANUAL NSIR/DSO INSPECTION PROCEDURE 71130.08 FITNESS-FOR-DUTY PROGRAM Effective Date: January 1, 2019 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 licensees 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 licensees 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 10 CFR Part 26 (Subpart I) 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 licensees 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 licensees 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).

Issue Date: 10/22/18 1 71130.08

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 and FFD procedures, the access authorization provisions that adjudicate FFD authorization under Subpart C of Part 26, and sanctions under Subpart D of Part 26. 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) pre-access drug testing records, or sample at least 20 percent of the total personnel that had a pre-access drug and alcohol test in the last month), the inspector(s) should adhere as closely as possible to the numbers identified in the guidance. Should a compliance concern arise, the inspector(s) may expand the minimum sample number to aid in determining the extent of the condition.

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. Since 2014, all licensees and other entities have submitted 10 CFR 26.717 data to the NRC using 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 the information received in the annual FFD program performance submissions in an Excel spreadsheet data format. This data will facilitate the evaluation of site-specific performance across years to identify if emerging trends warrant attention (e.g., increases in subversion attempts; any post-event positive results; a high number of 24-hour reportable events). The Excel format can reduce inspector time obtaining individual files from the NRCs Agencywide Documents Access and Management Issue Date: 10/22/18 2 71130.08

System (ADAMS), and the aggregated format of the information can assist in a more time-effective evaluation (auto-filtering of data, key word searches).

The FFD program office in NSIR can provide the inspector(s) with all original FFD program performance report submittals (i.e., ARFs and SPTFs). In addition, the application that the FFD program office uses to process the e-reports for data analysis, renames each Portable Document Format (PDF) file received to include the year of report, the e-form type (SPTF or ARF), the licensee 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 spent 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 site-specific 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 Web site:

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 licensees 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 licensees 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 licensees FFD policy statement and FFD procedures. The onsite inspection should focus on the licensees implementation of the FFD policy statement and FFD procedures, and compliance with 10 CFR Part 26.

b. Review a sample of testing records (pre-access; random; for-cause; post-event; follow-up), 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 made under 10 CFR 26.719(c) on significant FFD policy violations, programmatic failures, and drug and alcohol testing errors submitted to the NRC 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 73, Appendix B).

Issue Date: 10/22/18 3 71130.08

f. The results of any 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 NRCs FFD program staff 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 collectors 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). This IP does not include a visit to the licensees U.S. Health and Human Services (HHS)-certified laboratory, but multiple IP requirements do evaluate laboratory performance, as well as the licensees 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. Pre-access (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))

Issue Date: 10/22/18 4 71130.08

Specific Guidance.

The inspector(s) should interview the FFD program manager to confirm the managers 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. Pre-access

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, have had their test results reviewed by the MRO and interviews conducted.

1. Pre-access (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., custody-and-control forms (CCFs), verified test results) to confirm compliance for each test type:

1. Pre-access (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 pre-access 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.

Issue Date: 10/22/18 5 71130.08

(c) The inspector(s) should evaluate the method used by the licensee to ensure that all individuals meeting the criteria specified in 10 CFR 26.4(f) are subject to pre-access drug and alcohol testing.

(1) Is the determination based on specific job titles assigned?

(2) Is the determination based on specific activities (within a job title)?

(3) Are all individuals subject to pre-access testing regardless of activity performed?

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 the 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).

(c) 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.

(d) Evaluate if any subversion attempts were identified by for-cause testing, especially instances where a specimen temperature was out of range or subversion paraphernalia was discovered. These observations would suggest that the individual was able to obtain cheating paraphernalia prior to arriving for testing. The SPTFs submitted each year under 10 CFR 26.717, include a section providing detailed information on each subversion attempt.

Issue Date: 10/22/18 6 71130.08

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 licensees 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 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?

(e) 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. Follow-up (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 follow-up testing requirements established by the SAE for a sample of individuals in the follow-up testing program. For these individuals, review all follow-up tests (CCFs, MRO-verified drug test results, alcohol test results). The inspector(s) should evaluate if the licensee is complying with the follow-up testing plan Issue Date: 10/22/18 7 71130.08

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 indicated that over 75 percent of subversion attempts occur at pre-access testing, a predictable testing event. If subversion attempts were observed on random, for-cause, post-event, or follow-up 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 would suggest that the individual was able to obtain cheating paraphernalia prior to arriving for testing). The SPTF submitted each year under 10 CFR 26.717 includes 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 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 Issue Date: 10/22/18 8 71130.08

(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 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months ; 0.02 and in work status at least 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months ).

b. Verify that the licensees 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.

c. Verify that the licensees 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 licensees 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 industrys 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.

Issue Date: 10/22/18 9 71130.08

b. Verify that the licensee has established management actions that must be taken when an individual shows indications that he or she may not be fit to perform his or her duties safely and competently. (10 CFR 26.77)

Specific Guidance.

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

2. 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 licensees 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))

Issue Date: 10/22/18 10 71130.08

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 licensees 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 policy statement?

Also, if the FFD policy has been updated since the last inspection, confirm that subject individuals have been notified of the policy update.

d. Verify that the licensees 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 over-the-counter 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; Issue Date: 10/22/18 11 71130.08

4. Prohibits the consumption of alcohol, at a minimum, within an abstinence period of 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months preceding the individuals arrival at the licensees facility, and during the period of any tour of duty;

5. Conveys that abstinence from alcohol for 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months 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 individuals 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 individuals responsibility to report legal actions, as defined in 10 CFR 26.5;

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

11. The individuals responsibility to report FFD concerns; and

12. The management of fatigue for security officers.

e. Verify that the licensees 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.

If the licensee conducts limit of detection (LOD) testing of dilute specimens, as permitted by 10 CFR 26.163(a)(2), 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:

Issue Date: 10/22/18 12 71130.08

(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 individuals 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 individuals ability to perform his or her duties safely and competently. The procedure must require that individuals who have a FFD concern about another individuals behavior shall contact the personnel designated in the FFD policy or FFD procedures to report the concern;

5. The process to be followed when a security officer makes a self-declaration that he or she is not fit to perform his or her 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))

Issue Date: 10/22/18 13 71130.08

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 licensees 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 licenses audit program needs improvement and or revised auditing approaches/strategies.

3. The inspector(s) should verify that the licensee is conducting audits on a 12-month 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 HHS-certified 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 HHS-certified laboratory as a result of audit findings.

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

Issue Date: 10/22/18 14 71130.08

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 individuals 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) staffs;

4. Knowledge of the EAP services available to the individual;

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

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

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

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

9. Ability to observe and detect performance degradation, indications of impairment, or behavioral changes; Issue Date: 10/22/18 15 71130.08

10. Knowledge of the individuals 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 licensees 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 licensees 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 licensees 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 individuals 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.

Issue Date: 10/22/18 16 71130.08

k. Verify, through a review of records, that the licensee effectively implements a pre-access 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.

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

b. Verify that an MRO review is performed on all positive, adulterated, substituted, dilute, and invalid specimen test results received from the HHS-certified laboratory.

(10 CFR 26.185(a), (c), and (f) - (n))

Note: the MRO may permit his or her 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 HHS-certified 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 HHS-certified 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 HHS-certified laboratory within 5 business days after the laboratory receives each specimen for testing.

(10 CFR 26.169(a))

Issue Date: 10/22/18 17 71130.08

Specific Guidance.

The inspector(s) should verify that the MRO is receiving drug test results from the HHS-certified 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 donors specimen).

e. Verify that the MRO completes his or her review and notifies the licensees designated representative within 10 business days of receiving: (1) any positive, adulterated, substituted, or invalid test result from the HHS-certified laboratory; and (2) in instances where no legitimate medical explanation for the test result(s) exist(s).

(10 CFR 26.185(p))

Specific Guidance.

No inspection guidance.

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 licensees positive test decision.

g. Verify the licensees 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 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months , or 0.02 percent BAC and the individual was in work status for at least 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months ). (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.

The inspector(s) should administer the Urine Collection Questionnaire (Attachment 1) and Breath Collection Questionnaire (Attachment 2) to evaluate the compliance of the licensees 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 Issue Date: 10/22/18 18 71130.08

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 all samples contained in this section.

Note: While 10 CFR Part 26 permits the use of alcohol screening devices that test oral fluid (i.e., saliva), the Breath Collection Questionnaire (Attachment 2) only covers alcohol testing of breath specimens. If alcohol testing of saliva is performed by the licensee, in addition to delivering the Breath Collection Questionnaire, the inspector(s) also should evaluate the specimen collection process for saliva testing. To verify collector compliance, obtain the instructions provided by the test manufacturer and evaluate via a mock collection if 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), (b), and (c) to conduct initial and confirmatory 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) and (e).

c. Verify that the alcohol testing specimen collection process is conducted in accordance with the requirements in subpart E of 10 CFR Part 26. (10 CFR 26.89, 10 CFR 26.91, 10 CFR 26.93, 10 CFR 26.95, 10 CFR 26.97, 10 CFR 26.99, 10 CFR 26.101, and 10 CFR 26.103)

d. Verify that the drug testing specimen collection process is conducted in accordance with the requirements in subpart E of 10 CFR Part 26. (10 CFR 26.89, 10 CFR 26.105, 10 CFR 26.107, 10 CFR 26.109, 10 CFR 26.111, 10 CFR 26.113 (as applicable),

10 CFR 26.115, 10 CFR 26.117, and 10 CFR 26.119)

e. Verify that the specimen collectors used by the licensee meet the collector qualification requirements in subpart E of 10 CFR Part 26. (Urine collectors - 10 CFR 26.85(a);

Alcohol collectors - 10 CFR 26.85(b))

02.08 Sanctions and Substance Abuse Expert Interview.

The inspector(s) should administer the Substance Abuse Expert Questionnaire (Attachment 4) to evaluate the training and credentials of the SAE, the SAEs knowledge of the treatment and follow-up testing requirements associated with FFD program policy violations, and the SAEs 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.

Issue Date: 10/22/18 19 71130.08

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 (HHS-certified 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))

(b) The assay and cutoff level for each drug has been certified in writing by a forensic toxicologist per 10 CFR 26.31(d)(1)(i)(D).

3. If the licensee chooses to conduct special analyses on dilute specimens (i.e., LOD testing), verify that the process is implemented as described in 10 CFR 26.163(a)(2). This only pertains to testing at an HHS-certified laboratory.

Specific Guidance.

The inspector(s) should review drug and validity testing results provided by the licensees testing facility (as applicable) and the HHS-certified 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 HHS-certified laboratory to confirm the drug testing program used by the licensee (substances tested, cutoff levels used, validity tests performed, etc.).

4. If the licensee performs LOD testing on dilute specimens, ensure that the laboratorys test results and MRO review are consistent with the requirements in Issue Date: 10/22/18 20 71130.08

10 CFR 26.163(a)(2). Request from the licensee the CCF, MRO-verified result, and laboratory results for each test where LOD testing was performed.

b. Verify that the licensee is conducting validity testing at an HHS-certified laboratory for all urine specimens as described in 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 licensees FFD policy to ensure that it specifies that validity testing is to be performed on all urine specimens. Review the HHS-certified laboratory contract to ensure that validity testing is being performed in accordance with 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. That 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 HHS-certified laboratory for testing. (10 CFR 26.137(e)(5))

3. The licensee is receiving from the LTF, testing information 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. That the LTF is reporting testing program errors. (10 CFR 26.137(f))

Specific Guidance.

The inspector(s) should verify the following elements of the LTFs 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 HHS-certified 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 HHS-certified laboratory.

Issue Date: 10/22/18 21 71130.08

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.

d. For each HHS-certified laboratory used by the licensee to conduct testing on urine specimens, ensure that:

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

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

Specific Guidance.

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

1. That each laboratory used is listed on the current list of HHS-certified laboratories available at http://www.workplace.samhsa.gov.

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

e. Verify the following about the blind performance test samples (BPTSs) that the licensees FFD program is submitting to the HHS-certified 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. That all BPTSs used by the licensee are certified by the supplier and formulated as specified in 10 CFR 26.168(g) and (h).

4. That the licensee is submitting all BPTSs in a manner such that each sample is indistinguishable to laboratory personnel from a donors specimen.

(10 CFR 26.168 (i))

Specific Guidance.

Inspector(s) should evaluate the following about the BPTSs submitted to the HHS-certified 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.

Issue Date: 10/22/18 22 71130.08

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

(1) the total number of donor specimens tested at the HHS-certified laboratory; (2) 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 HHS-certified laboratory that it uses for drug and validity testing of specimens?

4. Ask the licensee to explain who reviews the BPTS test results from the HHS-certified 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 licensees 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 licensees staff to explain how it completes the CCF for a BPTS. Review the CCFs for a sample of BPTSs submitted for testing. Verify that the CCF was completed as though it were a donor sample.

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).

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)

Tier III 02.10 Reviews.

FFD Events and Logs. 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 Reviews. 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 in 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))

Issue Date: 10/22/18 23 71130.08

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 that the licensee provide 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 his/her 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 licensees 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 entitys 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))

Issue Date: 10/22/18 24 71130.08

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 licensees 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 time period of the inspection review. The inspector(s) should evaluate if the random testing pool is updated effectively. In particular, does the random selection pool list NOT include any individual who has been granted authorization, and does the selection pool include any 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 Issue Date: 10/22/18 25 71130.08

to testing); and (2) how frequently random lists are generated (if the employees 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 7-day 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.

Issue Date: 10/22/18 26 71130.08

(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 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 Issue Date: 10/22/18 27 71130.08

demands would prevent an individual from immediately reporting for testing, the individual is to report as soon as he or she is notified.

(b) The licensee may not notify an individual for testing until they can proceed for testing (e.g., notifying an individual when he or she starts shift that he or she must appear for a test at the end of shift is not appropriate).

(c) The inspector(s) should evaluate if the established time period 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?

7. 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) Interview the MRO using the MRO Questionnaire (Attachment 3).

(b) Validate through reviews of the 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.

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)

Issue Date: 10/22/18 28 71130.08

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 individuals 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 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 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 individuals 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.

Issue Date: 10/22/18 29 71130.08

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 licensees 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. Thirty-day 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 licensees 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 there 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 Issue Date: 10/22/18 30 71130.08

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 licensees internal documentation and through discussions with relevant staff that each report was made to NRC within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 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 licensees testing facility (as applicable), the HHS-certified laboratory, and any other errors that could adversely affect the integrity of the testing program. The inspector(s) should verify through the licensees 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. The annual summary report published each year by the NRC on FFD program performance 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.

Issue Date: 10/22/18 31 71130.08

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

Specific Guidance.

The inspector(s) should review the licensees 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, custody and control forms, 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 licensees or other entitys 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 From 892) submitted to the NRC under 10 CFR 26.203(e).

Issue Date: 10/22/18 32 71130.08

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, he or she is unable to perform his or her 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, he or she is unable to perform his or her 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 21 inspection requirements, and nominal range of 36 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 (28), and Tier III inspection requirements (6),

for a total of 42 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 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months for the inspection of the minimum range of inspection requirements, and approximately 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 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, Federal Register, Volume 73, No. 62, dated March 31, 2008, and as updated.

Available on the NRC Web Site at: https://www.nrc.gov/reading-rm/doc collections/cfr/

part026/full-text.html.

Issue Date: 10/22/18 33 71130.08

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/druginfo/ds.shtml.

A current list of HHS-certified laboratories is available at: https://www.samhsa.gov/workplace/

resources/drug-testing/certified-lab-list. The list of certified laboratories and also is published each month in the Federal Register.

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) 03-01, Nuclear Power Plant Access Authorization Program, July 2014 (ADAMS Accession No. ML14199A645).

The annual summary reports published by the NRC on 10 CFR 26.717 FFD program performance data is available at the NRC Web Site: https://www.nrc.gov/reactors/

operating/ops-experience/fitness-for-duty-programs/performance-reports.html.

END : Urine Collection Questionnaire : Breath Collection Questionnaire : Medical Review Officer Questionnaire : Substance Abuse Expert Questionnaire : Blind Performance Test Sample Submissions : Revision History for IP 71130.08 Issue Date: 10/22/18 34 71130.08

Attachment 1 - Urine Collection Questionnaire 10 CFR Part 26 URINE COLLECTION QUESTIONNAIRE Licensee Contact Person Inspection Date Inspector This Urine Collection questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the urine collection procedures at a licensees or other entitys specimen collection site. Each question is accompanied by potential answers and the relevant requirement(s) in 10 CFR Part 26, Subpart E.

Issue Date: 10/22/18 Att1-1 71130.08

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 Question Section Numbers A. Observing the Collector (Mock Collection) A1 - A28 B. Knowledge of Collection Procedures B1 - B28 C. Observing the Facility D1 - D4 Issue Date: 10/22/18 Att1-2 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A1 Did the collector Yes. § 26.89(b)(1) states:

positively identify the No. Acceptable identification includes photo-identification donor [i.e., the inspector] Other: issued by a licensee or other entity who is subject to by photo identification his part, or by the Federal, State, and local before beginning the government. Licensees and other entities may not collection process? accept faxes or photocopies of identification.

A2 Did the collector require Yes. § 26.89(b)(4) states:

the donor to sign a No. The collector shall ask the donor to sign a consent-to-consent form? Other: testing form.

A3 Did the collector explain Yes. § 26.89(b)(4) states:

the collection process to No. The collector shall explain the testing procedure to the the donor and show the Other: donor, show the donor the form(s) to be used, and ask donor the form(s) to be the donor to sign a consent-to-testing-form.

used?

A4 Did the collector require No. § 26.89(b)(4) states:

the donor to list all Yes. The donor may not be required to list prescription prescription and over-the- Other: medications or over-the-counter preparations that he counter medications or she has recently used.

recently used?

A5 Did the collector direct Yes. § 26.105(a) states:

the donor to remove any No. The collector shall ask the donor to remove any outer garments (e.g., Other: unnecessary outer garments, such as a coat or jacket, jacket, coat, or hat) and which might conceal items or substances that the to leave personal donor could use to tamper with or adulterate his or her belongings such as urine specimen. The collector shall ensure that all purses and briefcases personal belongings such as a purse or briefcase with the outer garments? remain with the outer garments outside of the room or stall in which the urine specimen is collected.

Issue Date: 10/22/18 Att1-3 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A6 Did the collector direct Yes. § 26.105(b) states:

the donor to empty his or No. The collector shall also ask the donor to empty his or her pockets and display Other: her pockets and display the items in them to enable the items in them to the collector to identify items that the donor could use ensure that there are no to adulterate or substitute his or her urine specimen.

items present that could The donor shall permit the collector to make this be used to adulterate the observation.

specimen?

A7 If the collector identifies Yes. § 26.105(b) states:

nothing that the donor No. If the collector identifies nothing that the donor could could use to adulterate or Other: use to adulterate or substitute the specimen, the donor substitute the specimen, may place the items back into his or her pockets.

is the donor allowed to place the items back into his or her pockets?

A8 Did the collector allow the Yes. § 26.105(a) states:

donor to keep his/her No. The donor may retain his or her wallet.

wallet? Other:

A9 After the donor has Yes. § 26.105(c) states:

removed any outer No. The collector shall instruct the donor to wash and dry clothing and displayed Other: his hands before urinating.

the contents of his or her pockets, did the collector instruct the donor to wash and dry his/her hands?

A10 Are collection containers Yes. § 26.105(e) states:

sealed, and did the donor No. The collector may select, or allow the donor to select, or collector remove the Other: an individually wrapped or sealed collection container sealed wrapper in the from the collection kit materials. Either the collector or presence of both? the donor, with both present, shall unwrap or break the seal of the collection container.

Issue Date: 10/22/18 Att1-4 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A11 Did the collector assure Yes. § 26.105(e) states:

that the donor takes No. With the exception of the collection container, the nothing from the Other: donor may not take anything from the collection kit into collection kit into the the room or stall used for urination.

room used for urination except the collection container?

A12 Was the donor then Yes. § 26.105(d) states:

required to remain in the No. After washing his or her hands, the donor shall remain presence of the collector Other: in the presence of the collector and may not have (with no access to water, access to any water fountain, faucet, soap dispenser, soap or other adulterating cleaning agent, or other materials that he or she could agents) until entering the use to adulterate the urine specimen.

privacy enclosure to provide the specimen?

Issue Date: 10/22/18 Att1-5 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A13 Did the collector ensure Yes. § 26.87(e) states:

that the privacy enclosure No, the privacy enclosure was not The following steps must be taken to deter the dilution was secure for use: properly secured. and adulteration of urine specimens at the collection (1) All sources of clear Other: site:

water were eliminated (1) Agents that color any source of standing water in and or secured, the stall or room in which the donor will provide a (2) Possible specimen specimen, including, but not limited to, the toilet bowl contaminants were or tank, must be placed in the source of standing removed (e.g. aerosol water, so that the reservoirs of water are neither yellow cans; cleaning agents, nor colorless; etc.); and (2) There must be no other source of water (e.g., no (3) All places where shower or sink) in the enclosure where urination paraphernalia could be occurs, or the source of water must be rendered hidden were secured or unusable; and removed (e.g., garbage (3) Chemicals or products that could be used to cans, cabinets)? contaminate or otherwise alter the specimen must be removed from the collection site or secured. The collector shall inspect the enclosure in which urination will occur before each collection to ensure that no materials are available that could be used to subvert the testing process.

A14 Did the water in the toilet Yes. § 26.87(e) states:

(and any other source of No. The following steps must be taken to deter the dilution standing water, including Other: and adulteration of urine specimens at the collection the toilet tank if it is not site:

secured) contain an (1) Agents that color any source of standing water in agent that ensures the the stall or room in which the donor will provide a water is neither yellow specimen, including, but not limited to, the toilet bowl nor colorless? or tank, must be placed in the source of standing water, so that the reservoirs of water are neither yellow nor colorless; Issue Date: 10/22/18 Att1-6 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A15 After the donor provided Yes. § 26.107(c) states:

the urine specimen to the No. After the donor has provided the urine specimen and collector, did the collector Other: submitted it to the collector, the donor shall be inspect the toilet bowl and permitted to wash his or her hands. The collector shall collection area and then inspect the toilet bowl and room or stall in which the flush the toilet? donor voided to identify any evidence of a subversion attempt, and then flush the toilet.

A16 Once the donor provided Yes. § 26.109(a) states:

thea urine specimen to No. Licensees and other entities who are subject to this the collector, did the Other: subpart shall establish a predetermined quantity of collector verify that the urine that donors are requested to provide when minimum quantity of urine submitting a specimen. At a minimum, the was provided (at least predetermined quantity must include 30 milliliters (mL) 30 mL for a single to ensure that a sufficient quantity of urine is available collection; or at least for initial and confirmatory validity and drug tests at an 45 mL for a split HHS-certified laboratory, and for retesting of an aliquot specimen)? of the specimen if requested by the donor under

§ 26.165(b). The licensees or other entitys predetermined quantity may include more than 30 mL, if the testing program follows split specimen procedures, tests for additional drugs, or performs initial testing at a licensee testing facility. Where collected specimens are to be split under the provisions of this subpart, the predetermined quantity must include an additional 15 mL.

Issue Date: 10/22/18 Att1-7 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A17 Did the collector, within Yes. § 26.111(a) states:

4 minutes of receiving the No. Immediately after the donor provides the urine specimen, measure the Other: specimen to the collector, including specimens of less specimen temperature than 30 mL but greater than 15 mL, the collector shall (using the temperature measure the temperature of the specimen. The strip attached to the temperature measuring device used must accurately collection container or reflect the temperature of the specimen and not some other means)? contaminate the specimen. The time from urination to temperature measurement may not exceed 4 minutes.

If the temperature of a urine specimen is outside the range of 90°F to 100°F (32°C to 38°C), that is a reason to believe the donor may have altered or substituted the specimen.

A18 Did the collector Yes. § 26.111(b) states:

determine if the color or No. Immediately after the donor provides a urine clarity of the urine Other:; specimen, including specimens of less than 30 mL but specimen was unusual? equal to or greater than 15 mL, the collector shall also inspect the specimen to determine its color and clarity and look for any signs of contaminants or adulteration.

The collector shall note any unusual findings on the custody-and-control form.

A19 For split specimen At least 30 mL into Bottle A, and § 26.113(b)(2) states:

collections. at least 15 mL into Bottle B. The collector, in the presence of the donor and after Less than the minimum required determining specimen temperature as described in What quantity of urine amount(s). § 26.111(a), shall split the urine specimen. The was poured into Bottle A Other: collector shall pour 30 mL of urine into Bottle A and a and Bottle B by the minimum of 15 mL of urine into Bottle B. If the collector? quantity of urine available for Bottle B is less than 15 mL, the collector shall pour the remaining urine into Bottle B and forward the specimens in Bottles A and B to the HHS-certified laboratory for drug and validity testing.

Issue Date: 10/22/18 Att1-8 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A20 Did the collector securely Yes. § 26.117(c) states:

place tamper-evident No. The collector shall place an identification label seals on each container? Other: securely on each container. The label must contain the date, the donors specimen number, and any other identifying information provided or required by the FFD program. The collector shall also apply a tamper-evident seal on each container if it is separate from the label. The specimen bottle must be securely sealed to prevent undetected tampering.

A21 Did the collector then Yes. § 26.117(c) states:

apply an identification No, the donor wrote some or all of The collector shall place an identification label label with the date, the the information on the labels securely on each container. The label must contain donors specimen before the collector applied the the date, the donors specimen number, and any other number, and any other label(s) to the container(s). identifying information provided or required by the FFD identifying information No, all information was not program. The collector shall also apply a tamper-provided or required by included on the labels. evident seal on each container if it is separate from the the FFD program over Other: label. The specimen bottle must be securely sealed to each specimen prevent undetected tampering.

container?

A22 Did the collector instruct Yes. § 26.117(d) states:

the donor to initial each No. The donor shall initial the identification label(s) on the specimen container label Other: specimen bottle(s) for the purpose of certifying that the only after the seal(s) were specimen was collected from him or her.

affixed to the bottle(s) and label(s) were dated by the collector?

Issue Date: 10/22/18 Att1-9 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A23 Did the collector keep the Yes. § 26.117(a) states:

donor's collection No. Both the donor and the collector shall keep the container within his/her Other: donors urine specimen(s) in view at all times before view from the point when the specimen(s) are sealed and labeled. If any the urine specimen was specimen or aliquot is transferred to another container, received from the donor the collector shall ask the donor to observe the to the time the specimen transfer and sealing of the container with a tamper-container was sealed? evident seal.

A24 After the specimen Yes. § 26.117(d) states:

container labels are No. The donor shall initial the identification label(s) on the initialed by the donor, did Other: specimen bottle(s) for the purpose of certifying that the the collector direct the specimen was collected from him or her. The collector donor to read and sign shall also ask the donor to read and sign a statement the statement on the on the custody-and-control form certifying that the custody-and-control form specimen(s) identified as having been collected from (CCF) certifying that the the donor is, in fact, the specimen(s) that he or she specimen(s) identified as provided.

having been collected from the donor is, in fact, the specimen(s) that he or she provided?

A25 After the donor signed the Yes. § 26.117(e) states:

certification statement, No. The collector shall complete the custody-and-control did the collector complete Other: form(s) and shall certify proper completion of the the CCF and certify collection.

proper completion of the collection?

A26 After completing the CCF, Yes. § 26.117(i) states:

did the collector package No. Collection site personnel shall ensure that a custody-the sealed specimen Other: and-control form is packaged with its associated urine container(s) with the specimen bottle.

CCF?

Issue Date: 10/22/18 Att1-10 71130.08

A. Urine Collection, Observing the Collector (Mock Collection)

Num. Question Answer NRC Regulation(s)

A27 Only applies if using a Yes. § 26.117(i) states:

licensee testing facility No. The shipping container was Unless a collection site and a licensee testing facility not acceptable. are co-located, the sealed and labeled specimen If the collection site and Other: bottles, with their associated custody-and-control licensee testing facility forms that are being transferred from the collection site are not co-located, did to the drug testing laboratory must be placed in a the collector place the second, tamper-evident shipping container. The sealed and labeled second container must be designed to minimize the specimen bottles with the possibility of damage to the specimen during shipment associated CCF in a (e.g., specimen boxes, shipping bags, padded mailers, tamper-evident container, or bulk insulated shipping containers with that designed to minimize the capability), so that the contents of the shipping possibility of damage to containers are no longer accessible without breaking a the specimen during tamper-evident seal.

shipment?

A28 Did the collector have Yes. § 26.89(d) states:

only one donor under No. In order to promote the security of specimens, avoid his/her supervision at one Other: distraction of the collector, and ensure against any time until the collection confusion in the identification of specimens, a collector process was completed shall conduct only one collection procedure at any (i.e., specimen was given time. For this purpose, a urine collection collected, the urine procedure is complete when the urine specimen specimen container was container has been sealed and initialed, the chain-of-sealed and initialed, the custody form has been executed, and the donor has CCF was completed and departed the collection site.

the donor departed the collection site)?

[This concludes the mock collection section of the questionnaire]

Issue Date: 10/22/18 Att1-11 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B1 What actions must you I notify FFD program § 26.89(a) states:

take if a donor does not management. When an individual has been notified of a requirement arrive for a scheduled No action is taken on my part, its for testing and does not appear at the collection site test? the responsibility of someone within the time period specified by FFD program else. procedures, the collector shall inform FFD program I dont know. management that the individual has not reported for Other: testing. FFD program management shall ensure that the necessary steps are taken to determine whether the individuals undue tardiness or failure to appear for testing constitutes a violation of the licensees or other entitys FFD policy. If FFD program management determines that the undue tardiness or failure to report for testing represents an attempt to subvert the testing process, the licensee or other entity shall impose on the individual the sanctions in § 26.75(b). If FFD program management determines that the undue tardiness or failure to report does not represent a subversion attempt, the licensee or other entity may not impose sanctions but shall ensure that the individual is tested at the earliest reasonable and practical opportunity after locating the individual.

Issue Date: 10/22/18 Att1-12 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B2 What steps are taken if a Other than for a pre-access test, § 26.89(b)(2) states:

donor arrives without a (1) proceed with the collection; If the donor cannot produce acceptable identification photo ID? and then (2) contact FFD program before any testing that is required under this part other management, and do not allow than pre-access testing, the collector shall proceed the donor to leave the collection with the test and immediately inform FFD program site until his or her identity has management that the donor did not present acceptable been established. identification. When so informed, FFD program Continue with the testing process. management shall contact the individuals supervisor We take a digital photograph of to verify in-person the individuals identity, or, if the the donor and email it to the FFD supervisor is not available, take other steps to program manager for establish the individuals identity and determine confirmation. whether the lack of identification was an attempt to I dont know. subvert the testing process. The donor may not leave Other: the collection site except under supervision until his or her identity has been established.

B3 For a donor without a Yes, but only the supervisor of the § 26.89(b)(2) states: If the donor cannot produce photo ID, can another donor. acceptable identification before any testing that is licensee employee verify Yes, the collection site will accept required under this part other than pre-access testing, the identity of the donor? verification of identity from any the collector shall proceed with the test and other employee (i.e., a non- immediately inform FFD program management that supervisor) of the licensee. the donor did not present acceptable identification.

When so informed, FFD program management shall I dont know. contact the individuals supervisor to verify in-person Other: the individuals identity, or, if the supervisor is not available, take other steps to establish the individuals identity and determine whether the lack of identification was an attempt to subvert the testing process. The donor may not leave the collection site except under supervision until his or her identity has been established.

Issue Date: 10/22/18 Att1-13 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B4 During the collection If it appears to have been brought § 26.105(b) states: The collector shall also ask the process when a donor is with the intent to subvert the test, donor to empty his or her pockets and display the directed to display the contact the MRO or FFD program items in them to enable the collector to identify items items in his or her manager. If not, secure the item that the donor could use to adulterate or substitute his pockets - what steps are and continue with the normal or her urine specimen. The donor shall permit the taken if you identify a collection procedure. collector to make this observation. If the donor refuses material that could be Notify FFD program management. to show the collector the items in his or her pockets, used to tamper with a Secure the items until after the this is considered a refusal to test. If an item is found specimen? collection. that appears to have been brought to the collection I dont know. site with the intent to adulterate or substitute the Other: specimen, the collector shall contact the MRO or FFD program manager to determine whether a directly observed collection is required. If the item appears to have been inadvertently brought to the collection site, the collector shall secure the item and continue with the normal collection procedure. If the collector identifies nothing that the donor could use to adulterate or substitute the specimen, the donor may place the items back into his or her pockets.

B5 If a donor refuses to Document the actions in the § 26.89(c) states:

cooperate with the remarks section of the CCF and If the donor refuses to cooperate in the collection collection process, what contact FFD program procedures, the collector shall inform FFD program do you do? management. management to obtain guidance on the actions to be I dont know. taken.

Other:

Issue Date: 10/22/18 Att1-14 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B6 How do you secure the Secure water sources and other § 26.87(e) states:

collection site to prevent potential adulterants, add coloring The following steps must be taken to deter the dilution a donor from tampering agent to the toilet water and other and adulteration of urine specimens at the collection with or adulterating a standing water sources. site:

specimen? There is nothing special that (1) Agents that color any source of standing water in needs to be done. the stall or room in which the donor will provide a I dont know. specimen, including, but not limited to, the toilet bowl Other: or tank, must be placed in the source of standing water, so that the reservoirs of water are neither yellow nor colorless; (2) There must be no other source of water (e.g., no shower or sink) in the enclosure where urination occurs, or the source of water must be rendered unusable; and (3) Chemicals or products that could be used to contaminate or otherwise alter the specimen must be removed from the collection site or secured. The collector shall inspect the enclosure in which urination will occur before each collection to ensure that no materials are available that could be used to subvert the testing process.

B7 If a donor is clearly and Document the observed conduct § 26.107(b) states:

unequivocally attempting on the CCF and contact FFD The collector shall pay careful attention to the donor to adulterate or substitute program management for during the entire collection process to note any their urine specimen, direction on whether to perform a conduct that clearly indicates an attempt to tamper what steps do you take? directly observed collection. with a specimen (e.g., substitute urine is in plain view Conduct a directly observed or an attempt to bring an adulterant or urine substitute collection without contacting FFD into the private area used for urination). If any such management. conduct is detected, the collector shall document the I dont know. conduct on the custody-and-control form and contact Other: FFD program management to determine whether a directly observed collection is required, as described in

§ 26.115.

Issue Date: 10/22/18 Att1-15 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B8 If a donor provides a Send the specimen to the § 26.111(d) states:

specimen that appears HHS-certified laboratory for Any specimen of 15 mL or more that the collector adulterated (e.g., altered testing. suspects has been diluted, substituted, or adulterated, color, odor of bleach), Contact FFD program and any specimen of 15 mL or more that has been what do you do with the management for direction. collected under direct observation under paragraph (c) specimen? Discard the specimen. of this section, must be sent directly to the I dont know. HHS-certified laboratory for initial and, if required, Other: confirmatory testing, and may not be subject to initial testing at a licensee testing facility.

B9 If the temperature of a Send the specimens to the § 26.111(a) states:

urine specimen is outside HHS-certified laboratory for Immediately after the donor provides the urine the acceptable range, testing. specimen to the collector, including specimens of less what do you do with the Contact FFD program than 30 mL but greater than 15 mL, the collector shall specimen? management for direction. measure the temperature of the specimen. The Discard the specimen. temperature-measuring device used must accurately Continue with the collection. reflect the temperature of the specimen and not I dont know. contaminate the specimen. The time from urination to Other: temperature measurement may not exceed 4 minutes.

If the temperature of a urine specimen is outside the range of 90 F to 100 F (32 C to 38 C), that is a reason to believe the donor may have altered or substituted the specimen.

§ 26.111(d) states:

Any specimen of 15 mL or more that the collector suspects has been diluted, substituted, or adulterated, and any specimen of 15 mL or more that has been collected under direct observation under paragraph (c) of this section, must be sent directly to the HHS-certified laboratory for initial and, if required, confirmatory testing, and may not be subject to initial testing at a licensee testing facility.

Issue Date: 10/22/18 Att1-16 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B10 If the color or clarity of a Note the observations on the § 26.111(b) states:

urine specimen is remarks line of the CCF, and send Immediately after the donor provides a urine unusual, what do you do? the specimen to the HHS-certified specimen, including specimens of less than 30 mL but laboratory for testing. equal to or greater than 15 mL, the collector shall also Contact FFD program inspect the specimen to determine its color and clarity management for direction. and look for any signs of contaminants or adulteration.

Discard the specimen. The collector shall note any unusual findings on the Continue with the collection. custody-and-control form.

I dont know.

Other: § 26.111(d) states:

Any specimen of 15 mL or more that the collector suspects has been diluted, substituted, or adulterated, and any specimen of 15 mL or more that has been collected under direct observation under paragraph (c) of this section, must be sent directly to the HHS-certified laboratory for initial and, if required, confirmatory testing, and may not be subject to initial testing at a licensee testing facility.

Issue Date: 10/22/18 Att1-17 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B11 If the individuals behavior Yes, but only after receiving § 26.111(c) states:

clearly indicates an direction from FFD management. If there is reason to believe that the donor may have attempt to dilute, No, if sufficient information on a attempted to dilute, substitute, or adulterate the substitute, or adulterate subversion attempt is obtained specimen based on specimen temperature or other the specimen, is a direct (e.g., subversion paraphernalia), observations made during the collection, the collector observation collection the FFD program manager could shall contact the designated FFD program manager, required? stop the collection process. who may consult with the MRO, to determine whether I dont know. the donor has attempted to subvert the testing Other: process. . . .

§ 26.115(a) states:

The following circumstances constitute the exclusive grounds for performing a directly observed collection:

(1) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate medical explanation for the result; (2) The donor has presented, at this collection, a urine specimen that falls outside the required temperature range; (3) The collector observes conduct clearly and unequivocally indicating an attempt to dilute, substitute, or adulterate the specimen; and (4) A directly observed collection is required under

§ 26.69.

Issue Date: 10/22/18 Att1-18 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B12 Can a donor voluntarily Yes. § 26.111(c) states:

specimen submit a No. If there is reason to believe that the donor may have second sunder direct I dont know. attempted to dilute, substitute, or adulterate the observation if the Other: specimen based on specimen temperature or other collector suspects the first observations made during the collection, the collector specimen was altered shall contact the designated FFD program manager, (e.g., unusual who may consult with the MRO, to determine whether appearance, odor, etc.)? the donor has attempted to subvert the testing process or whether other circumstances may explain the observations. The FFD program manager or MRO may require the donor to provide a second specimen as soon as possible under direct observation. In addition, the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered or substituted the specimen.

B13 What steps must be Receive approval from FFD § 26.115(b) states:

taken prior to initiating an program manager or MRO. Before collecting a urine specimen under direct observed collection? Proceed with the collection observation, the collector shall obtain the agreement of without any contact with the FFD the FFD program manager or MRO to obtain a urine program manager or MRO. specimen under direct observation. After obtaining Contact FFD program agreement, the collector shall ensure that a specimen management for direction. is collected under direct observation as soon as I dont know. reasonably practicable.

Other:

Issue Date: 10/22/18 Att1-19 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B14 When conducting a No, the collector must watch the § 26.115(f)(2) states:

directly observed urine exit from the donors body The observer shall watch the donor urinate into the collection, is it sufficient directly into the collection collection container. Specifically, the observer shall for you to see the donors container. watch the urine go from the donors body into the back or side? Yes. collection container.

I dont know.

Other:

B15 If the donor refuses to Describe the donors actions in § 26.115(g) states:

allow a required directly the remarks section of the CCF If a donor declines to allow a directly observed observed collection, what and notify FFD program collection that is required or permitted under this do you do? management. This action is a section, the donors refusal constitutes an act to refusal to test. subvert the testing process.

Contact FFD program management for direction.

I dont know.

Other:

B16 What should you do if you Notify FFD program management. § 26.115(h) states:

learn that a directly I dont know. If a collector learns that a directly observed collection observed collection Other: should have been performed but was not, the collector should have been shall inform the FFD program manager, or his or her performed, but was not? designee. The FFD program manager or designee shall ensure that a directly observed collection is immediately performed.

Issue Date: 10/22/18 Att1-20 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B17 If the donor is unable to Offer the donor up to 40 oz. of § 26.109(b)(1) states:

provide a specimen of at fluid over 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months or until a The collector shall encourage the donor to drink a least 30 milliliters (mL), specimen is collected. reasonable amount of liquid (normally, 8 ounces of what is done? Contact FFD program water every 30 minutes, but not to exceed a maximum management. of 40 ounces over 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months ) until the donor provides a I dont know. specimen containing at least 30 mL. The collector Other: shall provide the donor with a separate collection container for each successive specimen.

B18 How does the collector We keep a log of the amount of § 26.109(b)(1) states:

measure the amount of water provided and the time The collector shall encourage the donor to drink a fluid provided to the provided. For example, we reasonable amount of liquid (normally, 8 ounces of donor? provide the donor with 8 oz. water every 30 minutes, but not to exceed a maximum bottles of water. of 40 ounces over 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months ) until the donor provides a We provide the donor with a cup specimen containing at least 30 mL. The collector and permit them to fill it at the shall provide the donor with a separate collection water cooler, but we do not container for each successive specimen.

measure how much water is consumed.

We allow a donor to consume a beverage that they brought to the collection site, but do not measure the amount consumed.

Other:

B19 After providing a Document the donor actions in the § 26.89(c) states:

specimen of less than remarks section of the CCF, and If the donor refuses to cooperate in the collection 30 mL, if the donor contact FFD program procedures, the collector shall inform FFD program refuses to provide a new management. management to obtain guidance on the actions to be specimen, or leaves the I dont know. taken.

collection site before the Other:

process is complete, what do you do?

Issue Date: 10/22/18 Att1-21 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B20 If the donor cannot Terminate the collection process, § 26.109(b)(3) states:

provide a sufficient document in the remarks section If the donor has not provided a specimen of at least specimen within 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months of the CCF the situation, and 30 mL within 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months of the first unsuccessful attempt of the first unsuccessful notify the FFD program manager to provide a specimen of the predetermined quantity, attempt, what do you do? or MRO. the collector shall discontinue the collection and notify Ask my supervisor the FFD program manager or MRO to initiate the shy Contact FFD program bladder procedures in § 26.119.

management for direction.

I dont know.

Other:

B21 What do you do with a We place the specimen in the § 26.117(j) states:

specimen that has not refrigerator until shipped, so the Specimens that have not been shipped to the been shipped to the temperature does not rise above HHS-certified laboratory or the licensee testing facility HHS-certified laboratory 6 C or 42.8 F. within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of collection and any specimen that is or the licensee testing We refrigerate all specimens until suspected of having been substituted, adulterated, or facility within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of shipment to the laboratory. tampered with in any way must be maintained cooled specimen collection? I dont know. to not more than 6°C (42.8°F) until they are shipped to Other: the HHS-certified laboratory.

B22 If the initial specimen is Both specimens. § 26.111(d) states:

out of temperature range, Only the second, observed Any specimen of 15 mL or more that the collector and a second specimen specimen. suspects has been diluted, substituted, or adulterated, is collected under direct Only the first, out of temperature and any specimen of 15 mL or more that has been observation, which range specimen. collected under direct observation under paragraph (c) specimen(s) are sent to Contact FFD program of this section, must be sent directly to the the lab? management for direction. HHS-certified laboratory for initial and, if required, I dont know. confirmatory testing, and may not be subject to initial Other: testing at a licensee testing facility.

Issue Date: 10/22/18 Att1-22 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B23 If you believe that the Both specimens. § 26.111(d) states:

donor has tampered with Only the second specimen Any specimen of 15 mL or more that the collector the initial specimen, and (i.e., the observed specimen). suspects has been diluted, substituted, or adulterated, a second specimen is Only the initial specimen (i.e., the and any specimen of 15 mL or more that has been collected under direct tampered-with specimen). collected under direct observation under paragraph (c) observation, which Contact FFD program manager of this section, must be sent directly to the specimens are sent to the for direction. HHS-certified laboratory for initial and, if required, lab? I dont know. confirmatory testing, and may not be subject to initial Other: testing at a licensee testing facility.

B24 What do you do with a Discard it, unless the specimen § 26.109(b)(4) states:

specimen of insufficient shows signs of tampering, Neither the donor nor the collector may combine quantity (less than adulteration, or the temperature or specimens. The collector shall discard specimens of 30 mL)? color was out of range. If so, less than 30 mL, except if there is reason to believe contact FFD program that the donor has diluted, adulterated, substituted, or management and send the otherwise tampered with the specimen, based on the sample to the HHS-certified collectors observations of the donors behavior during laboratory. the collection process or the specimens Discard it. characteristics, as specified in § 26.111. If the Send it to the lab. collector has a reason to believe that a specimen that Contact FFD program is 15 mL or more, but less than 30 mL, has been management for direction. diluted, adulterated, substituted, or altered, the I dont know. collector shall prepare the suspect specimen for Other: shipping to the HHS-certified laboratory and contact FFD program management to determine whether a directly observed collection is required, as described in

§ 26.115.

Issue Date: 10/22/18 Att1-23 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B25 If a specimen has been Take both the specimen(s) and § 26.117(g) states:

collected but not yet CCF(s) with me or secure them. If the involved collector momentarily leaves his or her packaged for transfer, Leave the specimen(s) with workstation, the sealed specimens and custody-and-and you momentarily another authorized collector. control forms must be secured or taken with him or have to leave your I dont know. her.

workstation, what do you Other:

do with the sealed specimen(s) and CCF(s)?

B26 In the exceptional event Visually inspect the facility, add a § 26.87(f) states: In the exceptional event that a that a non-dedicated coloring agent to the water in the designated collection site is inaccessible and there is facility (public restroom or toilet, assure that undetected an immediate requirement to collect a urine specimen, hospital examining room) access is prevented, and post including, but not limited to, an event investigation, is used for a collection limited access signs or assign an then the licensee or other entity may use a public rest (e.g., post-event test): individual to ensure no room, onsite rest room, or hospital examining room unauthorized personnel are according to the following procedures:

How do you secure the present during the collection (1) The facility must be secured by visual inspection to location used for testing? process. ensure that no unauthorized persons are present, and I dont know, Ive never conducted that undetected access (e.g., through a rear door not a collection under these in the view of the collector) is impossible. Security circumstances. during the collection may be maintained by restricting Other: access to collection materials and specimens. In the case of a public rest room, a sign must be posted or an individual assigned to ensure that no unauthorized personnel are present during the entire collection procedure to avoid embarrassment of the donor and distraction of the collector.

Issue Date: 10/22/18 Att1-24 71130.08

B. Urine Collection, Knowledge of Collection Procedures Num. Question Answer NRC Regulation(s)

B27 In the exceptional event Stand directly outside the stall (if § 26.87(f)(3) states:

that a non-dedicated multi-stall restroom) or outside the A collector of the same gender as the donor shall facility (public restroom or door to the room (if a single accompany the donor into the area that will be used hospital examining room) restroom). for specimen collection, but remain outside of the stall, is used for a collection Stand inside the stall or restroom. if it is a multi-stalled rest room, or outside of the door (e.g., post-event test): I dont know, Ive never conducted to the room, if it is a single rest room, in which the a collection under these donor will provide the specimen. If a collector of the Where do you (or a circumstances. same gender is not available, the collector shall select different collector of the Other: a same-gender person to accompany the donor. This same gender as the person shall be instructed on the collection procedures donor) go while the donor specified in this subpart and his or her identity must be is in a multi-unit stall or documented on the custody-and-control form.

single restroom?

B28 In the exceptional event Inspect the toilet bowl and area § 26.87(f)(4) states:

that a non-dedicated and then flush the toilet. After the collector has possession of the specimen, facility (public restroom or Inspect the toilet bowl and area. the collector shall inspect the toilet bowl and area to hospital examining room) Flush the toilet. ensure that there is no evidence of a subversion is used for collections I dont know, Ive never conducted attempt and shall then flush the toilet. The collector (e.g., post-event test): a collection under these shall instruct the donor to participate with the collector circumstances. in completing the chain-of-custody procedures.

What do you do after the Other:

collection?

Issue Date: 10/22/18 Att1-25 71130.08

C. Urine Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

C1 Was the urine collection Yes. § 26.87(c) states:

site prepared for the No. Staff at the collection site Contracts for collection site services must permit inspection team, and did were unable to produce all representatives of the NRC, licensee, or other entity to the vendor cooperate with required records. conduct unannounced inspections and audits and to the inspection team and No. Staff at the collection site obtain all information and documentation that is facilitate the inspection provided the requested records, reasonably relevant to the inspections and audits.

process, including but did not participate in a mock producing the required collection.

records? Other:

C2 Is the facility used for Yes. § 26.87(d)(2) states:

urine collections securely No. Licensees and other entities shall take the following maintained at all times? Other: measures to prevent unauthorized access to the collection site that could compromise the integrity of the collection process or the specimens:

(1) Unauthorized personnel may not be permitted in any part of the designated collection site where specimens are collected or stored; (2) A designated collection site must be secure. If a collection site is dedicated solely to specimen collection, it must be secure at all times. Methods of assuring security may include, but are not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied; and (3) If a collection site cannot be dedicated solely to collecting specimens, the portion of the facility that is used for specimen collection must be secured and, during the time period during which a specimen is being collected, a sign must be posted to indicate that access is permitted only for authorized personnel.

Issue Date: 10/22/18 Att1-26 71130.08

C. Urine Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

C3 Are only authorized Yes. § 26.87(d)(1) states:

personnel permitted in No. Unauthorized personnel may not be permitted in any any area of the Other: part of the designated collection site where specimens designated collection site are collected or stored.

where urine specimens are collected and stored?

C4 Is security of the Yes. § 26.87(d)(2) states:

collection materials and No. A designated collection site must be secure. If a completed specimens Other: collection site is dedicated solely to specimen within the collection site collection, it must be secure at all times. Methods of maintained at all times? assuring security may include, but are not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied.

C5 Does the collection site Yes. § 26.87(b) states:

provide for donor No. The collection site must provide for the donors visual privacy? Other: privacy while the donor and collector are viewing the results of an alcohol test, and for individual privacy while the donor is submitting a urine specimen, except if a directly observed urine specimen collection is required. Unauthorized personnel may not be present for the specimen collection.

C6 Does this collection site Yes. § 26.115(e) states:

have procedures in place No, there are a few times when The collector shall ensure that the observer is the to ensure that a same- the collection site could not same gender as the individual. A person of the gender collector is conduct an observed collection. opposite gender may not act as the observer under available for observed No, this collection site cannot any conditions. The observer may be a different collections? collect a urine specimen under person from the collector and need not be a qualified direct observation procedures. collector.

Other:

Issue Date: 10/22/18 Att1-27 71130.08

C. Urine Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

C7 Have each of the urine Adequate training was conducted § 26.85(a) states:

collectors received and records were produced. Urine collectors shall be knowledgeable of the training in accordance Training was not conducted. requirements of this part and the FFD policy and with 10 CFR Part 26 Training was conducted, but procedures of the licensee or other entity for whom regulations? certificates were not found for all collections are performed, and shall keep current on collectors. any changes to urine collection procedures. Collectors

[Examine training Other: shall receive qualification training that meets the records]. requirements of this paragraph and demonstrate proficiency in applying the requirements of this paragraph before serving as a collector. At a minimum, qualification training must provide instruction on the following subjects:

(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the custody-and-control form; (2) Methods to address problem collections, including, but not limited to, collections involving shy bladder and attempts to tamper with a specimen; (3) How to correct problems in collections; and (4) The collectors responsibility for maintaining the integrity of the specimen collection and transfer process, carefully ensuring the modesty and privacy of the donor, and avoiding any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate.

Issue Date: 10/22/18 Att1-28 71130.08

C. Urine Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

C8 Were the personnel files Yes. § 26.85(e) states:

for the urine collectors No, some required information Collection site personnel files must include each complete? was missing. individuals resume of training and experience; Other: certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports, if any; results of tests to establish employee competency for the position he or she holds, including, but not limited to, certification that collectors are proficient in administering alcohol tests consistent with the most recent manufacturers instructions for the instruments and devices used; and appropriate data to support determinations of honesty and integrity conducted under § 26.31(b).

THAT WAS THE LAST QUESTION. THANK YOU FOR YOUR TIME AND INPUT.

Issue Date: 10/22/18 Att1-29 71130.08

Attachment - 2 10 CFR Part 26 BREATH COLLECTION QUESTIONNAIRE Licensee Contact Person Inspection Date Inspector 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 licensees or other entitys specimen collection site. Each question is accompanied by potential answers and the relevant requirement(s) in 10 CFR Part 26, Subpart E.

Issue Date: 10/22/18 Att2-1 71130.08

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 collectors 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 collectors 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 Question Section Numbers A. Observing the Collector - Initial Breath Test (Mock Collection) A1 - A14 B. Knowledge of Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks B1 - B21 C. Knowledge of Collection Procedures - Non-Typical Specimen Collections C1 - C7 D. Observing the Facility D1 - D4 Issue Date: 10/22/18 Att2-2 71130.08

A. Breath Collection, Observing the Collector - Initial Breath Test (Mock Collection)

Num. Question Answer NRC Regulation(s)

A1 Did the collector positively identify Yes. § 26.89(b)(1) states:

the donor [i.e., the inspector] by No. Acceptable identification includes photo-photo identification before Other: identification issued by a licensee or other entity beginning the collection process? who is subject to his part, or by the Federal State, and local government. Licensees and other entities may not accept faxes or photocopies of identification.

A2 Did the collector require the donor Yes. § 26.89(b)(4) states:

to sign a consent form? No. The collector shall ask the donor to sign a Other: consent-to-testing form.

A3 Did the collector explain the Yes. § 26.89(b)(4) states:

collection process to the donor No. The collector shall explain the testing procedure and show the donor the form(s) to Other: to the donor, show the donor the form(s) to be be used? used, and ask the donor to sign a consent-to-testing-form.

A4 Immediately before collecting a Yes. § 26.93(a) states:

breath specimen, did the collector No. Immediately before collecting a specimen for ask the donor if he or she ate, Other: alcohol testing, the collector shall drank, belched, or put anything (1) Ask the donor whether he or she, in the past into their mouth? 15 minutes, has had anything to eat or drink, belched, or put anything into his or her mouth (including, but not limited to, a cigarette, breath mint, or chewing gum), and instruct the donor that he or she should avoid these activities during the collection process.

Issue Date: 10/22/18 Att2-3 71130.08

A. Breath Collection, Observing the Collector - Initial Breath Test (Mock Collection)

Num. Question Answer NRC Regulation(s)

A5 Did the collector then instruct the Yes. § 26.93(a) states:

donor that eating, drinking, Directions provided to the Immediately before collecting a specimen for belching, or putting anything into donor, but the collector did alcohol testing, the collector shall their mouth during the collection not document that the (1) Ask the donor whether he or she, in the past process should be avoided? directions were provided to 15 minutes, has had anything to eat or drink, the donor belched, or put anything into his or her mouth AND Other: (including, but not limited to, a cigarette, breath mint, or chewing gum), and instruct the donor that Did the collector document on the he or she should avoid these activities during the custody-and-control form (CCF) collection process.

that these instructions were (2) Explain that it is to the donors benefit to avoid provided to the donor? the activities listed in paragraph (a)(1) of this section during the collection process.

(3) Document that the instructions were communicated to the donor.

A6 After the donor states that he or As soon as possible. § 26.95(a) states:

she has not engaged in any of the Other: The collector shall perform the initial breath test activities requiring a waiting as soon as practical after the donor indicates that period, when does the collector he or she has not engaged in the activities listed perform the test? in § 26.93(a)(1) or after the 15-minute waiting period has elapsed, if required.

A7 Did the collector select, or allow Yes. § 26.95(b)(1) states:

the donor to select, an individually No. Select, or allow the donor to select, an wrapped or sealed mouthpiece Other: individually wrapped or sealed mouthpiece from from the testing materials? the testing materials.

A8 Did the collector then open the Yes. § 26.95(b)(2) states:

individually wrapped or sealed No. Open the individually wrapped or sealed mouthpiece in view of the donor Other: mouthpiece in view of the donor and insert it into and insert it into the EBT? the device as required by the manufacturers instructions.

Issue Date: 10/22/18 Att2-4 71130.08

A. Breath Collection, Observing the Collector - Initial Breath Test (Mock Collection)

Num. Question Answer NRC Regulation(s)

A9 Did the collector then instruct the Yes. § 26.95(b)(3) states:

donor to blow steadily and The collector only instructed Instruct the donor to blow steadily and forcefully forcefully into the mouthpiece for the donor to blow into the into the mouthpiece for at least 6 seconds or until at least 6 seconds or until the EBT mouthpiece. the device indicates that an adequate amount of indicated that an adequate Other: breath has been obtained.

amount of breath had been obtained?

A10 Did the collector then show the Yes. § 26.95(b)(4) states:

donor the displayed or printed test No. Show the donor the displayed or printed test result? Other: result.

A11 Did the collection site provide for Yes. § 26.87(b) states:

the donors visual privacy while No. The collection site must provide for the donors the donor and the collector were Other: visual privacy while the donor and collector are viewing the test result? viewing the results of an alcohol test, and for individual privacy while the donor is submitting a urine specimen, except if a directly observed urine specimen collection is required. Unauthorized personnel may not be present for the specimen collection.

A12 Did the collector then ensure that Yes. § 26.95(b)(5) states:

the test result record was No. Ensure that the test result record can be associated with the donor and Other: associated with the donor and is maintained maintained securely? secure.

[Guidance: Some EBTs print the result directly onto the CCF; other EBTs print the result onto a small receipt type piece of paper and the collector will affix it to the CCF with tamper-evident tape or by some other means.]

[Guidance: If an ASD or screening EBT is used (i.e., doesnt print a result), the collector will write the result onto the CCF.]

Issue Date: 10/22/18 Att2-5 71130.08

A. Breath Collection, Observing the Collector - Initial Breath Test (Mock Collection)

Num. Question Answer NRC Regulation(s)

A13 Did the collector have only one Yes. § 26.89(d) states:

donor under his or her supervision No. In order to promote the security of specimens, until the collection process was Other: avoid distraction of the collector, and ensure completed? against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time.

A14 Was the EBT used for the initial Yes. § 26.91(a) states:

test listed on the NHTSA No. Alcohol screening devices (ASDs), including Conforming Product List (CPL) of Other: devices that test specimens of oral fluids or breath alcohol screening devices? must be approved by the National Highway Traffic Safety Administration (NHTSA) and listed in the most current version of NHTSAs Conforming Record the EBT information here Products List (CPL) for such devices. An ASD and verify: that is listed in the NHTSA CPL may be used only for initial tests for alcohol, and may not be used for confirmatory tests.

§26.91(b) states:

Evidential breath testing devices listed in the NHTSA CPL for evidential devices that meet the requirements of paragraph (c) of this section must be used to conduct confirmatory alcohol tests, and may be used to conduct initial alcohol tests.

Issue Date: 10/22/18 Att2-6 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B1 Did the collection site have an Yes, all EBTs used at the § 26.91(b) states:

EBT compliant with 26.91(b) collection site can be used for Evidential breath testing devices listed in the for use for confirmatory confirmatory testing. NHTSA CPL for evidential devices that meet the alcohol testing? Yes, we have a separate EBT requirements of paragraph (c) of this section must that we use for confirmatory be used to conduct confirmatory alcohol tests, and testing. may be used to conduct initial alcohol tests. Note Record the EBT information No, we must transport the that, among the devices listed in the CPL for EBTs, here and verify: donor to another location to only those devices listed without an asterisk (*) may conduct confirmatory testing. be used for confirmatory alcohol testing under this No. subpart.

Other: § 26.91(c) states:

An EBT that is listed in the NHTSA CPL for evidential devices that has the following capabilities may be used for conducting initial alcohol tests and must be used for confirmatory alcohol tests under this subpart:

(1) Provides a printed result of each breath test; (2) Assigns a unique number to each completed test, which the collector and donor can read before each test and which is printed on each copy of the test result; (3) Prints, on each copy of the test result, the manufacturers name for the device, its serial number, and the time of the test; (4) Distinguishes alcohol from acetone at the 0.02 alcohol concentration level; (5) Tests an air blank; and (6) Permits performance of an external calibration check.

Issue Date: 10/22/18 Att2-7 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B2 What initial alcohol test result 0.02 % blood alcohol § 26.99 states:

requires confirmatory testing concentration (BAC) or greater. (a) If the initial test result is less than 0.02 percent to be conducted? Any BAC greater than 0.00. BAC, the collector shall declare the test result as Other: negative.

(b) If the initial test result is 0.02 percent BAC or higher, the collector shall ensure that the time at which the test was concluded (i.e., the time at which the test result was known) is recorded and inform the donor that a confirmatory test for alcohol is required.

B3 What do you do immediately Record the time the initial test § 26.99 states:

after an initial positive result result was known and inform (b) If the initial test result is 0.02 percent BAC or registers on the EBT? the donor that confirmatory higher, the collector shall ensure that the time at testing will be conducted. which the test was concluded (i.e., the time at which Other: the test result was known) is recorded and inform the donor that a confirmatory test for alcohol is required.

B4 How soon after receiving an As soon as possible, but no § 26.101(a) states:

initial positive test result is more than 30 minutes after the The confirmatory test must begin as soon as confirmatory testing conclusion of the initial test. possible, but no more than 30 minutes after the conducted on the donor? It doesnt matter. conclusion of the initial test.

I dont know.

Other:

B5 Can the same EBT used for Yes, if the EBT is on the § 26.101(d) states:

the initial breath test also be NHTSA CPL for confirmatory If an EBT that meets the requirements of used for the confirmatory testing. § 26.91(b) and (c) was used for the initial alcohol test? No. test, the same EBT may be used for confirmatory I dont know. testing.

Other:

B6 Before a confirmatory test is Yes. § 26.101(b)(1) states:

conducted, is an air blank No. In the presence of the donor, conduct an air blank required to be run on the Other: on the EBT before beginning the confirmatory test EBT? and show the result to the donor.

Issue Date: 10/22/18 Att2-8 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B7 Is it required that the collector Yes. § 26.101(b)(1) states:

show the air blank result to No. In the presence of the donor, conduct an air blank the donor? Other: on the EBT before beginning the confirmatory test and show the result to the donor.

B8 What reading must result 0.00 % BAC. § 26.101(b)(2) states:

from an air blank to proceed I dont know. Verify that the reading is 0.00. If the reading is with a confirmatory test? Other: 0.00, the test may proceed.

B9 If the EBT does not display a Take the EBT out of service § 26.101(b)(3) states:

0.00 result after two and proceed with the collection If the reading on the second air blank is 0.00, the consecutive air blanks, what using another EBT. test may proceed. If the reading is greater than do you do? Cancel the test and notify the 0.00, take the EBT out of service and proceed with FFD program manager. the test using another EBT. If an EBT is taken out I dont know. of service for this reason, the EBT may not be used Other: for further testing until it is found to be within tolerance limits on an external check of calibration.

B10 If the same EBT is used for Yes, a new mouthpiece is used § 26.101(b)(4) states:

confirmatory testing that was for each breath alcohol Open an individually wrapped or sealed used for initial testing, is a collection. mouthpiece in view of the donor and insert it into new mouth piece used? No. the device as required by the manufacturers Other: instructions.

B11 After the mouthpiece is Read the unique test number § 26.101(b)(5) states:

inserted into the EBT, what displayed on the EBT, and Read the unique test number displayed on the do you do before collecting ensure the donor reads the EBT, and ensure that the donor reads the same the specimen? same number. number.

Read the unique test number displayed on the EBT.

I dont know.

Other:

Issue Date: 10/22/18 Att2-9 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B12 After the test result is Show the donor the result, § 26.101(b)(7) states:

displayed on the EBT, what is record the result, and Show the donor the result displayed on or printed the next step? document the time the result by the EBT, record the result, and document the was known. time at which the confirmatory test result was Mentioned one or two of the known.

three required actions.

I dont know.

Other:

B13 What BAC level for a Any result that is 0.04% BAC or § 26.103(a) states:

confirmatory alcohol test is greater is a positive result. A A confirmed positive test result for alcohol must be considered a positive result? positive test result also may be declared under any of the following conditions:

determined based on the hours (1) When the result of the confirmatory test for that that donor has been in alcohol is 0.04 percent BAC or higher; work status for results less than (2) When the result of the confirmatory test for 0.04% BAC. The FFD program alcohol is 0.03 percent BAC or higher and the donor manager determines in these had been in a work status for at least 1 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months at the cases if an individual is time the initial test was concluded (including any positive. breaks for rest, lunch, dental/doctor appointments, Any result that is 0.04% BAC or etc.); or greater. (3) When the result of the confirmatory test for The collector notifies the FFD alcohol is 0.02 percent BAC or higher and the donor program manager of all had been in a work status for at least 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months at the confirmatory alcohol test time the initial test was concluded (including any results. breaks for rest, lunch, dental/doctor appointments, I dont know. etc.).

Other:

Issue Date: 10/22/18 Att2-10 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B14 After a confirmed positive Yes. § 26.91(e)(4) states:

alcohol test result, does the No, we only conduct external In order to ensure that confirmed positive alcohol collection site perform an calibration checks at the test results are derived from an EBT that is external calibration check on interval specified by the EBT calibrated, the licensee or other entity shall the EBT in the presence of manufacturer quality assurance implement one of the following procedures:

the donor? plan (QAP). (i) If an EBT fails any external check of calibration, Other: cancel every confirmed positive test result that was obtained using the EBT from any tests that were conducted after the EBT passed the last external calibration check; or B15 If the answer to question B14 Take the EBT out of service (ii) After every confirmed positive test result is NO, skip this question. and, as soon as practicable, obtained from using an EBT, conduct an external conduct another initial and check of calibration of the EBT in the presence of What action is taken if an confirmatory test on a different the donor. If the EBT fails the external calibration EBT fails an external EBT. check, cancel the donors test result and conduct calibration check performed Take the EBT out of service. another initial and confirmatory test on a different immediately after a confirmed Contact FFD program EBT as soon as practicable.

positive test result? management.

I dont know.

Other.

B16 What do you do if an EBT Take the EBT out of service, § 26.91(e)(3) states:

fails an external calibration contact the FFD program If an EBT fails an external check of calibration, the check? manager to cancel every licensee or other entity shall take the EBT out of confirmed test result that was service. The EBT may not be used again for obtained using the EBT after alcohol testing under this subpart until it is repaired the EBT passed its last external and passes an external calibration check.

calibration check.

Take the EBT out of service.

Contact FFD program management.

I dont know.

Other:

Issue Date: 10/22/18 Att2-11 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B17 Who is qualified to do Record the individual(s) names, § 26.91(e)(5) states:

calibration checks at the verify when evaluating the external Inspection, maintenance, and calibration of the collection site? calibration check log, and confirm EBT must be performed by its manufacturer or a when reviewing training records. maintenance representative or other individual who is certified either by the manufacturer or by a State health agency or other appropriate State agency.

B18 Does the collection site use Yes and adequate records § 26.91(e)(1) states:

the most current QAP for the were produced. Licensees and other entities shall implement the EBT? Unable to verify because the most recent version of the manufacturers collection site could not present instructions for the use and care of the EBT Verify that the collection site a copy of the QAP for review. consistently with the quality assurance plan has a copy of the QAP. submitted to NHTSA for the EBT, including No, the QAP is not the most performing external calibration checks no less Record the EBT model and current version submitted to frequently than at the intervals specified in the QAP version: NHTSA by the EBT manufacturers instructions.

manufacturer.

Other:

Issue Date: 10/22/18 Att2-12 71130.08

B. Breath Collection, Knowledge of the Collection Procedures - Confirmatory Alcohol Testing and External Calibration Checks Num. Question Answer NRC Regulation(s)

B19 Is the external calibration Yes § 26.91(e)(2) states:

device used for calibration No. When conducting external calibration checks, listed on the NHTSA CPL for Other: licensees and other entities shall use only Calibrating Units for Breath calibration devices appearing on NHTSAs CPL for and Alcohol Tests? Calibrating Units for Breath Alcohol Tests.

[Make sure that the calibration device is not expired (gas cylinders list an expiration date).]

B20 Is the collection site Yes, EBT calibration is § 26.91(e)(1) states:

performing the calibration conducted in accordance with Licensees and other entities shall implement the checks at the specified the manufacturer QAP. most recent version of the manufacturers interval in the QAP? No, the calibration records instructions for the use and care of the EBT demonstrate that the collection consistently with the quality assurance plan

[Evaluate the records of the site has not calibrated the EBT submitted to NHTSA for the EBT, including external calibration checks in accordance with the performing external calibration checks no less performed on the EBT used manufacturer QAP. frequently than at the intervals specified in the for the alcohol test.] manufacturers instructions.

B21 Are inspection, maintenance, Yes. § 26.91(e)(5) states:

and calibration of EBTs No. Inspection, maintenance, and calibration of the performed by manufacturer, Other: EBT must be performed by its manufacturer or a maintenance representative, maintenance representative or other individual who or other individual who is is certified either by the manufacturer or by a State certified either by the health agency or other appropriate State agency.

manufacturer or by a State health agency or other appropriate State agency?

[Verify with the collection site management and through a records review]

Issue Date: 10/22/18 Att2-13 71130.08

C. Breath Collection, Knowledge of Collection Procedures - Non-Typical Collection Situations Num. Question Answer NRC Regulation(s)

C1 What actions must you take I notify the FFD program § 26.89(a) states:

if a donor does not arrive to management. When an individual has been notified of a take a scheduled test? We are not notified of when a requirement for testing and does not appear at the donor may arrive for a test. collection site within the time period specified by Other: FFD program procedures, the collector shall inform FFD program management that the individual has not reported for testing. FFD program management shall ensure that the necessary steps are taken to determine whether the individuals undue tardiness or failure to appear for testing constitutes a violation of the licensees or other entitys FFD policy. If FFD program management determines that the undue tardiness or failure to report for testing represents an attempt to subvert the testing process, the licensee or other entity shall impose on the individual the sanctions in § 26.75(b). If FFD program management determines that the undue tardiness or failure to report does not represent a subversion attempt, the licensee or other entity may not impose sanctions but shall ensure that the individual is tested at the earliest reasonable and practical opportunity after locating the individual.

Issue Date: 10/22/18 Att2-14 71130.08

C. Breath Collection, Knowledge of Collection Procedures - Non-Typical Collection Situations Num. Question Answer NRC Regulation(s)

C2 What steps are taken if a (1) Other than for a pre-access § 26.89(b)(2) states:

donor arrives without a test I proceed with the collection; If the donor cannot produce acceptable photo ID? (2) then I contact FFD program identification before any testing that is required management and do not allow under this part other than pre-access testing, the the donor to leave the collection collector shall proceed with the test and site until his or her identity has immediately inform FFD program management that been established. the donor did not present acceptable identification.

Continue with the testing When so informed, FFD program management shall process. contact the individuals supervisor to verify in-We take a digital photograph of person the individuals identity, or, if the supervisor the donor and email it to the FFD is not available, take other steps to establish the program manager for individuals identity and determine whether the lack confirmation. of identification was an attempt to subvert the I dont know. testing process. The donor may not leave the Other: collection site except under supervision until his or C3 For a donor without a photo Yes, but only the supervisor of her identity has been established.

ID, can another licensee the donor.

employee verify the identity Yes, the collection site will accept of the donor? verification of identity from any other employee (i.e., a non-supervisor) of the licensee.

I dont know.

Other:

C4 If a donor refuses to Document the action on the § 26.89(c) states:

cooperate with the remarks line of the CCF and If the donor refuses to cooperate in the collection collection process, what do contact FFD program procedures, the collector shall inform FFD program you do? management. management to obtain guidance on the actions to Contact FFD management and be taken.

receive guidance on actions to take.

Other:

Issue Date: 10/22/18 Att2-15 71130.08

C. Breath Collection, Knowledge of Collection Procedures - Non-Typical Collection Situations Num. Question Answer NRC Regulation(s)

C5 If for-cause drug and We always conduct alcohol § 26.93(b) states:

alcohol testing is being testing first when a drug and With the exception of the 15-minute waiting period, conducted, which test is alcohol tests are to be performed. if necessary, the collector shall begin for-cause performed first? Drug test. alcohol and/or drug testing as soon as reasonably Either or is fine. practical after the decision is made that for-cause Other: testing is required. When for-cause alcohol testing is required, alcohol testing may not be delayed by collecting a specimen for drug testing.

C6 What steps must be taken if Implement a 15-minute waiting § 26.93(a) states: . . . .

a donor states that he or period and explain that the initial (3) If the donor states that he or she has engaged she had eaten, drank, and, if needed, confirmatory in any of the activities listed in paragraph (a)(1) of belched, or put anything tests, will be conducted at the this section, inform the donor that a 15-minute into his or her mouth, end of the period. waiting period is necessary to prevent an 15 minutes prior to the initial Implement a waiting period of accumulation of mouth alcohol from leading to an breath test? uncertain length. artificially high reading. . . .

I dont know. (5) Explain that the initial and confirmatory tests, if Other: a confirmatory test is necessary, will be conducted at the end of the waiting period, even if the donor has not followed the instructions.

Issue Date: 10/22/18 Att2-16 71130.08

C. Breath Collection, Knowledge of Collection Procedures - Non-Typical Collection Situations Num. Question Answer NRC Regulation(s)

C7 If problems occur while The first successful collection. § 26.95(c) states: Unless problems in administering a breath test I dont know. administering the breath test require an additional that requires an additional Other: collection, only one breath specimen may be collection(s), which is the collected for the initial test. If an additional valid test result? collection(s) is required, the collector shall rely on the test result from the first successful collection to determine the need for confirmatory testing.

§ 26.101(c) states: Unless there are problems in administering the breath test that require an additional collection, the collector shall collect only one breath specimen for the confirmatory test. If an additional collection(s) is required because of problems in administering the breath test, the collector shall rely on the breath specimen from the first successful collection to determine the confirmatory test result. Collection procedures may not require collectors to calculate an average or otherwise combine results from two or more breath specimens to determine the confirmatory test result.

Issue Date: 10/22/18 Att2-17 71130.08

D. Breath Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

D1 Is the facility used for breath Yes, only authorized collection § 26.87(d)(2) states:

collections secure at all site staff are permitted in the Licensees and other entities shall take the times? areas where specimen following measures to prevent unauthorized access collections are conducted and to the collection site that could compromise the equipment and materials are integrity of the collection process or the specimens:

stored. All other persons are (1) Unauthorized personnel may not be permitted in escorted when entering secure any part of the designated collection site where areas in the collection site. specimens are collected or stored; No, unauthorized staff have (2) A designated collection site must be secure. If a access to the collection area, collection site is dedicated solely to specimen equipment, and/or materials at collection, it must be secure at all times. Methods times during the day. of assuring security may include, but are not limited Other: to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied; and (3) If a collection site cannot be dedicated solely to collecting specimens, the portion of the facility that is used for specimen collection must be secured and, during the time period during which a specimen is being collected, a sign must be posted to indicate that access is permitted only for authorized personnel.

Issue Date: 10/22/18 Att2-18 71130.08

D. Breath Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

D2 Has each breath collector Adequate training was conducted § 26.85(b) states:

received training in and records were produced. Alcohol collectors shall be knowledgeable of the accordance with Training was not conducted. requirements of this part and the FFD policy and 10 CFR 26.85? Training was conducted, but procedures of the licensee or other entity for whom certificates were not found for all collections are performed, and shall keep current on

[Examine training records] collectors. any changes to alcohol collection procedures.

Other: Collectors shall receive qualification training meeting the requirements of this paragraph and demonstrate proficiency in applying the requirements of this paragraph before serving as a collector. At a minimum, qualification training must provide instruction on the following subjects:

(1) The alcohol testing requirements of this part; (2) Operation of the particular alcohol testing device(s) [i.e., the alcohol screening devices (ASDs) or EBTs] to be used, consistent with the most recent version of the manufacturers instructions; (3) Methods to address problem collections, including, but not limited to, collections involving shy lung and attempts to tamper with a specimen; (4) How to correct problems in collections; and (5) The collectors responsibility for maintaining the integrity of the specimen collection process, carefully ensuring the privacy of the donor, and avoiding any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate.

Issue Date: 10/22/18 Att2-19 71130.08

D. Breath Collection, Observing the Facility Num. Question Answer NRC Regulation(s)

D3 Were the personnel files for Yes. § 26.85(e) states: Collection site personnel files the breath collectors Some required information was must include each individuals resume of training complete? missing. and experience; certification or license, if any; Other: references; job descriptions; records of

[Examine collector performance evaluations and advancement; personnel files] incident reports, if any; results of tests to establish employee competency for the position he or she holds, including, but not limited to, certification that collectors are proficient in administering alcohol tests consistent with the most recent manufacturers instructions for the instruments and devices used; and appropriate data to support determinations of honesty and integrity conducted under § 26.31(b).

D4 Was the collection site Yes. § 26.87(c) states: Contracts for collection site personnel prepared for the No, the collection site was not services must permit representatives of the NRC, inspection team, facilitate prepared for the inspection but licensee, or other entity to conduct unannounced the inspection process, and cooperated with the inspection inspections and audits and to obtain all information produce the required team and produced all required and documentation that is reasonably relevant to records? records. the inspections and audits.

No, the collection site was unable to produce all requested records.

No, the collection site staff did not cooperate with the inspection process.

Other:

THAT WAS THE LAST QUESTION. THANK YOU FOR YOUR TIME AND INPUT.

Issue Date: 10/22/18 Att2-20 71130.08

Attachment - 3 10 CFR Part 26 Medical Review Officer Questionnaire Licensee Contact Person Date Inspector This questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the Medical Review Officer (MRO) supporting a licensees or other entitys 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:

Question Section Numbers A. MRO Qualifications, Knowledge, and Affiliations A1 - A6 B. MRO Responsibilities and Test Results Review B1 - B11 C. MRO Staff Oversight and Activities C1 - C6 D. MRO Activities Associated with Test Results Reviews (Invalid, Adulterated, Substituted, Dilute, Medications D1 - D4 E. Retesting an Aliquot of a Single Specimen or Split-Specimen Testing E1 - E5 Issue Date: 10/22/18 Att3-1 71130.08

A. MRO Qualifications, Knowledge, and Affiliations Num. Question Answer NRC Regulation(s)

A1 Please describe your Medical Doctor (MD) § 26.183(a) states:

qualifications to serve licensed in the U.S. The MRO shall be a physician holding either a Doctor of as a MRO for an NRC- Doctor of Osteopathy (DO) Medicine or Doctor of Osteopathy degree who is licensed to regulated licensee licensed in the U.S. practice medicine by any State or Territory of the United under 10 CFR Part 26. Other: States, the District of Columbia, or the Commonwealth of Puerto Rico.

[Request a copy of the medical license from the MRO or the licensee or other entity]

A2 Have you passed an Yes. § 26.183(a) states:

examination No. By March 31, 2010, the MRO shall have passed an administered by a Other: examination administered by a nationally-recognized MRO nationally-recognized certification board or subspecialty board for medical MRO certification board practitioners in the field of medical review of Federally or subspecialty board mandated drug tests.

for medical practitioners in the field of medical review of Federally mandated drug tests?

[Request a copy of the training certificate]

Issue Date: 10/22/18 Att3-2 71130.08

A. MRO Qualifications, Knowledge, and Affiliations Num. Question Answer NRC Regulation(s)

A3 How do you keep up-to- I regularly review the NRC § 26.183(a) states:

date on the NRC drug FFD website for information The MRO shall be knowledgeable of this part and of the and alcohol testing on the regulation. FFD policies of the licensees and other entities for whom the regulations in I receive a newsletter that MRO provides services.

10 CFR Part 26? informs me of changes in the NRCs drug and alcohol testing regulations.

I have a copy of 10 CFR Part 26.

The licensees or other entitys staff provides me with any updates on the rule.

Other:

A4 Do you have a copy of Yes. § 26.183(a) states:

the licensees or other No. The MRO shall be knowledgeable of this part and of the entitys FFD program Other: FFD policies of the licensees and other entities for whom the policy? MRO provides services.

A5 How do you keep up-to- I receive information from § 26.183(a) states:

date on any changes to the FFD program manager The MRO shall be knowledgeable of this part and of the the FFD program if any changes are FFD policies of the licensees and other entities for whom the policy? implemented. MRO provides services.

I rely upon the policy that is provided to me by the FFD program.

Other:

Issue Date: 10/22/18 Att3-3 71130.08

A. MRO Qualifications, Knowledge, and Affiliations Num. Question Answer NRC Regulation(s)

A6 Are you an employee, No, I have no professional § 26.183(b) states:

agent of, or do you have or financial relationship with The MRO may not be an employee or agent of, or have any a financial interest in the the contracted operator of financial interest in, an HHS-certified laboratory or a contracted operator of the LTF or the HHS- contracted operator of a licensee testing facility for whom the the licensee testing certified laboratories. MRO reviews drug test results. Additionally, the MRO may facility (LTF) - if Yes, I have a financial not derive any financial benefit by having the licensee or applicable, and/or the interest or I am an other entity use a specific drug testing facility operating HHS-certified employee or agent of the contractor and may not have an agreement with such parties laboratories used by the contracted operator of the that may be construed as a potential conflict of interest.

FFD program? LTF or one of the HHS- Examples of relationships between laboratories and MROs certified laboratories. that create conflicts of interest, or the appearance of such Other: conflicts, include, but are not limited to:

(1) The laboratory employs an MRO who reviews test results produced by the laboratory; (2) The laboratory has a contract of retainer with the MRO for the review of the results produced by the laboratory; (3) The laboratory designated which MRO the licensee or other entity is to use, gives the licensee or other entity a slate of MROs from which to choose, or recommends certain MROs; (4) The laboratory gives the licensee or other entity a discount or other incentive to use a particular MRO; (5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory or (6) The laboratory permits an MRO, or an MROs organization, to have a financial interest in the laboratory.

Issue Date: 10/22/18 Att3-4 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B1 Describe your Review and interpret drug § 26.183(c) states: The primary role of the MRO is to responsibilities as an and validity test results review and interpret positive, adulterated, substituted, invalid, MRO for an NRC received from the licensee and at the licensees or other entitys discretion, dilute test licensee? testing facility and/or the results obtained through the licensees or other entitys HHS-certified laboratory. testing program and to identify any evidence of subversion of Conduct donor interviews for the testing process.

positive, adulterated, substituted, and invalid test § 26.111(c) states: If there is reason to believe that the results received from the donor may have attempted to dilute, substitute, or adulterate HHS-certified laboratory. the specimen based on specimen temperature or other Advise the licensee or other observations made during the collection, the collector shall entity on collection site contact the designated FFD program manager, who may issues related to possible consult with the MRO, to determine whether the donor has subversion attempts attempted to subvert the testing process or whether other

[§ 26.111(c)]. circumstances may explain the observations. The FFD Assist in shy-bladder program manager or MRO may require the donor to provide situations [§26.119]. a second specimen as soon as possible under direct Advise the collector observation. . . .

regarding a decision to proceed with an observed § 26.119 states: Determining shy bladder.

specimen collection (a) When a donor has not provided a specimen of at least

[§ 26.115(b)] 30 mL within the 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months permitted for urine collection, FFD All of the above. program personnel shall direct the donor to obtain, within 5 Other: business days, an evaluation from a licensed physician who is acceptable to the MRO and has expertise in the medical issues raised by the donors failure to provide a sufficient specimen. The MRO may perform this evaluation if the MRO has the appropriate expertise.

Issue Date: 10/22/18 Att3-5 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B1 § 26.115(b) states: Before collecting a urine specimen Cont under direct observation, the collector shall obtain the d agreement of the FFD program manager or MRO to obtain a urine specimen under direct observation. After obtaining agreement, the collector shall ensure that a specimen is collected under direct observation as soon as reasonably practicable.

B2 Explain the steps you The MRO stated the § 26.405(g) states: Licensees and other entities shall take as the MRO for a following three steps: provide for an MRO review of positive, adulterated, confirmatory positive, 1) Review the CCF and substituted, and invalid confirmatory drug and validity test adulterated, laboratory test results. results to determine whether the donor has violated the FFD substituted, dilute, or 2) Contact the donor to policy, before reporting the results to the individual invalid test result discuss the test results designated by the licensee or other entity to perform the received from the and evaluate if a suitability and fitness evaluations required under§ 26.419.

HHS-certified legitimate medical laboratory? explanation exists to § 26.185(a) states: The MRO shall review all positive, explain the result. adulterated, substituted, dilute, or invalid initial test results

3) Immediately notify the from the HHS-certified laboratory to determine whether the licensees or other donor has violated the FFD policy before reporting the entitys designated results to the licensees or other entitys designated official.

representative once an FFD policy violation is § 26.185(c) states: Before determining that a positive, determined. adulterated, substituted, dilute, or invalid test result or other Other: occurrence is an FFD policy violation and reporting it to the licensee or other entity, the MRO shall give the donor an opportunity to discuss the test result or other occurrence with the MRO, except as described in paragraph (d) of this section. After this discussion, if the MRO determines that a positive, adulterated, substituted, dilute, or invalid test result or other occurrence is an FFD policy violation, the MRO shall immediately notify the licensees or other entitys designated representative.

Issue Date: 10/22/18 Att3-6 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B3 As the MRO, are you No. § 26.185(b) states:

permitted to report Yes. Reporting of initial test results prohibited. Neither the MRO initial test results Other: nor MRO staff may report positive, adulterated, substituted, received from the dilute, or invalid initial test results that are received from the HHS-certified HHS-certified laboratory to the licensee or other entity.

laboratory to the licensee or other entity?

B4 For confirmatory Conduct a medical interview § 26.183(c)(1) states:

positive, adulterated, with the donor. In carrying out these responsibilities, the MRO shall substituted, and invalid Review the donors medical examine alternate medical explanations for any positive, test results, what history, including any adulterated, substituted, invalid, or, at the licensees or other method(s) do you use records that they might entitys discretion, dilute test result. This action may include, to examine alternate provide to me. but is not limited to, conducting a medical interview with the medical explanations? Review any other relevant donor, reviewing the donors medical history, or reviewing biomedical factors. any other relevant biomedical factors. The MRO shall review All of the above all medical records that the donor may make available when Other: a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.

Issue Date: 10/22/18 Att3-7 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B5 Can you consider test No. § 26.183(c)(2) states:

results for specimens Yes, but only for testing The MRO may only consider the results of tests of that have not been conducted under Subpart K specimens that are collected and processed under this part, collected and which permits specimen including the results of testing split specimens, in making his processed under collections at a local hospital or her determination, as long as those split specimens have 10 CFR Part 26? or other facility in been stored and tested under the procedures described in compliance with U.S. DOT this part [10 CFR Part 26].

specimen collection requirements in § 26.405(e) states:

49 CFR Part 40. The specimen collection and drug and alcohol testing Other: procedures of FFD programs under this subpart [Subpart K]

must protect the donors privacy and the integrity of the specimen, and implement stringent quality controls to ensure that test results are valid and attributable to the correct individual. At the licensees or other entitys discretion, specimen collections and alcohol testing may be conducted at a local hospital or other facility under the specimen collection and alcohol testing requirements of 49 CFR Part 40 and subsequent amendments thereto.

B6 When attempting to Three attempts using the § 26.185(d)(3) states:

speak to a donor about day and evening telephone Reasonable efforts include, at a minimum, three attempts, a positive, adulterated, numbers reasonably spread spaced reasonably over a 24-hour period, to reach the donor substituted, or invalid out over a 24-hour period. at the day and evening telephone numbers listed on the test result, at a Fewer than three attempts in custody-and-control form.

minimum, what is a 24-hour period of time.

considered a Other:

reasonable effort to contact the individual?

Issue Date: 10/22/18 Att3-8 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B7 Under what three The MRO stated the three § 26.185(d) states:

circumstances may circumstances: The MRO may determine that a positive, adulterated, you verify that a 1) I made and documented substituted, dilute, or invalid test result or other occurrence is positive, adulterated, contact with the donor an FFD policy violation without having discussed the test substituted, dilute, or and the donor expressly result or other occurrence directly with the donor in the invalid test result is an declined to discuss the following three circumstances:

FFD policy violation test result. (1) The MRO has made and documented contact with the without discussing the 2) My staff or a licensee donor and the donor expressly declined the opportunity to test result directly with representative discuss the test result or other occurrence that may the donor? successfully made and constitute an FFD policy violation; documented contact with (2) A representative of the licensee or other entity, or an the donor and instructed MRO staff member, has successfully made and documented the donor to contact me contact with the donor and has instructed him or her to

[the MRO], and more contact the MRO, and more than 1 business day has than 1 business day has elapsed since the date on which the licensees elapsed. representative or MROs staff member successfully contact

3) After making all the donor; or reasonable efforts and (3) The MRO, after making all reasonable efforts and documenting the dates documenting the dates and time of those efforts, has been and time of those efforts, unable to contact the donor.

I have been unable to contact the donor.

I refer to 10 CFR Part 26 for non-typical circumstances to ensure that I follow the correct procedures.

Other:

Issue Date: 10/22/18 Att3-9 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B8 Can you as the MRO Yes, but only if the donor § 26.185(e) states:

modify your initial presents information within If the MRO determines that the donor has violated the FFD determination of an 30 days of my initial policy without having discussed the positive, adulterated, FFD policy violation for confirmed result that substituted, dilute, or invalid test result or other occurrence instances where a documents a legitimate directly with the donor, the donor may, on subsequent donor interview was reason that the donor was notification of the MRO determination and within 30 days of unable to be unable to contact me in a that notification, present to the MRO information conducted? timely manner. documenting the circumstances, including, but not limited to, Yes, at any point in the serious illness or injury, which unavoidably prevented the future. donor from being contacted by the MRO or a representative No. of the licensee of other entity, or from contacting the MRO in Other: a timely manner. On the basis of this information, the MRO may reopen the procedure for determining whether the donors test result or other occurrence is an FFD policy violation and permit the individual to present information related to the issue. The MRO may modify the initial determination based on an evaluation of the information provided.

B9 How many days does Within 10 business days of § 26.185(p) states:

10 CFR Part 26 permit receiving the result from the The MRO shall complete his or her review of positive, you as the MRO to HHS-certified laboratory. adulterated, substituted, and invalid test results and, in complete the review of Any time period less than instances when the MRO determines that there is no a positive, adulterated, 10 business days. legitimate medical explanation for the test result(s), notify the substituted, or invalid Other: licensees or other entitys designated representative within specimen test result? 10 business days of an initial positive, adulterated, substituted, or invalid test result.

Issue Date: 10/22/18 Att3-10 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B10 After completing your I or my staff notifies the § 26.185(p) states:

review of positive, licensees or other entitys The MRO shall notify the licensee or other entity of the adulterated, designated representative of results of his or her review in writing and in a manner substituted, and invalid the results in writing and by designed to ensure the confidentiality of the information.

test results, what telephone (using a communication method dedicated telephone number do you use to transmit for the contact).

the test result to the I or my staff transmits the licensee or other results in a manner entity? designed to ensure the confidentiality of the information (using a secure fax, secure website, contact via cell phone or dedicated telephone number)

Other:

Issue Date: 10/22/18 Att3-11 71130.08

B. MRO Responsibilities and Test Results Review Num. Question Answer NRC Regulation(s)

B11 What procedures must Request from the § 26.185(o) states:

you follow when HHS-certified laboratory the The MRO is responsible for reviewing drug test results from reviewing drug test quantitation of the test an individual whose authorization was terminated or denied results from an results and other information for a first violation of the FFD policy involving a confirmed individual whose necessary to determine positive drug test result and who is being considered for re-authorization was whether subsequent positive authorization. In order to determine whether subsequent terminated or denied confirmatory drug test positive confirmatory drug test results represent new drug for a first violation of results represent new drug use or remaining metabolites from the drug use that initially the FFD policy use or remaining resulted in the FFD policy violation, the MRO shall request involving a confirmed metabolites from the drug from the HHS-certified laboratory, and the laboratory shall positive drug test result use that initially resulted in provide, quantitation of the test results and other information and who is being the FFD policy violation. necessary to make the determination. If the drug for which considered for re- Other: the individual first tested positive was marijuana and the authorization? confirmatory assay for delta tetrahydrocannabinol carboxylic acid yields a positive result, the MRO shall determine whether the confirmatory test result indicates further marijuana use since the first positive test result, or whether the test result is consistent with the level of delta tetrahydrocannabinol-9-carboxylic acid that would be expected if no further marijuana use had occurred. If the test result indicates that no further marijuana use has occurred since the first positive test result, then the MRO shall declare the drug test result as negative.

Do you have staff that assists you in performing administrative functions?

If NO, skip the next section. of questions (C1-C6) on MRO Staff Oversight Activities.

Issue Date: 10/22/18 Att3-12 71130.08

C. MRO Staff Oversight and Activities Num. Question Answer NRC Regulation(s)

C1 Who is responsible for The MRO is directly responsible. § 26.183(d)(1) states:

overseeing the The licensee is directly responsible. MROs shall be directly responsible for all individual(s) performing The staff is responsible for their own administrative, technical, and professional activities of MRO staff functions? actions. individuals who are serving MRO staff functions while Other: they are performing those functions, and those functions must be under the MROs direction.

C2 What steps must your Assure that procedures being § 26.183 (d)(1)(ii) states:

staff take to protect the performed by MRO staff meet NRC An MROs responsibilities for directing MRO staff privacy of donor testing regulations and HHS and must include, but are not limited to, ensuring that information and professional standards of practice. (a) The procedures being performed by MRO staff records? Assure that data transmission is meet NRC regulations and HHS and professional secure (only between authorized standards of practice; staff using a dedicated telephone (b) Records and other donor personal information are number; secure fax line, secure maintained confidential by MRO staff and are not electronic communication). released to other individuals or entities, except as Assure that records and other donor permitted under this part; personal information are maintained (c) Data transmission is secure; and confidential by MRO staff and are (d) Drug test results are reported to the licensees or not released to other individuals or other entitys designated reviewing official only as entities (restricted access to required by this part.

hardcopy and electronic files).

Assure that drug test results are reported to the licensees or other entitys designated reviewing official only.

All of the above.

Other:

Issue Date: 10/22/18 Att3-13 71130.08

C. MRO Staff Oversight and Activities Num. Question Answer NRC Regulation(s)

C3 Does your staff receive, Yes. § 26.183(d)(2) states:

review, and report No. MRO staff may perform routine administrative negative drug test Other: support functions, including receiving test results, results to the licensees reviewing negative test results, and scheduling or other entitys interviews for the MRO.

designated (i) The staff under the direction of the MRO may representative? receive, review, and report negative test results to the licensees or other entitys designated representative.

C4 Does your staff review No. § 26.183(d)(2)(ii) states:

positive, adulterated, Yes, but my staff only reviews the The staff reviews of positive, adulterated, substituted, and invalid, CCF for errors. substituted, invalid, and, at the licensees or other test results? Other: entitys discretion, dilute test results must be limited to reviewing the custody-and control form to If yes, what specifically determine whether it contains any errors that may do they do? require corrective action and to ensure that it is consistent with the information on the MROs copy.

The staff may resolve errors in custody-and-control forms that require corrective action(s), but shall forward the custody-and-control forms to the MRO for review and approval of the resolution.

C5 Does your staff conduct No. § 26.183(d)(2)(iii) states:

interviews with donors Yes. The staff may not conduct interviews with donors to to discuss positive, Other: discuss positive, adulterated, substituted, invalid, or adulterated, dilute test results nor request medical information substituted, and invalid from a donor. Only the MRO may request and review test results and/or to medical information related to a positive, adulterated, request medical substituted, or invalid test result or other matter from information? a donor.

Issue Date: 10/22/18 Att3-14 71130.08

C. MRO Staff Oversight and Activities Num. Question Answer NRC Regulation(s)

C6 With whom is your staff Licensee FFD program personnel. § 26.183 (d)(2)(iv) states:

permitted to discuss My staff only can speak with Any MRO staff discussions of confirmed positive, confirmed positive, authorized FFD program personnel adulterated, substituted, invalid, or dilute test results adulterated, but they cannot review quantitative must be limited to discussions only with the licensees substituted, invalid, and test results or donor medical or other entitys FFD program personnel and may not dilute test results? information that I have collected as reveal quantitative test results or any personal part of the test result review medical information about the donor that the MRO process. may have obtained in the course of reviewing Other: confirmatory test results from the HHS-certified laboratory.

Issue Date: 10/22/18 Att3-15 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D1 What are the three The MRO listed the following § 26.185(f) states:

steps that you, as the three steps: (1) If the HHS-certified laboratory reports an invalid MRO, must take for a 1) Consult with the laboratory result, the MRO shall consult with the laboratory to specimen with an and determine if additional determine whether additional testing by another invalid test result testing at another HHS- HHS-certified laboratory may be useful in determining and from the HHS- certified laboratory may be reporting a positive or adulterated test result. If the MRO certified laboratory? useful to identify an and the laboratory agree that further testing would be adulterant or to obtain a useful, the HHS-certified laboratory shall forward the positive result. specimen to a second laboratory for additional testing.

2) Contact the donor and (2) If the MRO and the laboratory agree that further determine if an acceptable testing would not be useful and there is no technical medical explanation exists for explanation for the result, the MRO shall contact the the invalid result. donor and determine whether there is an acceptable

3) If no additional testing is medical explanation for the invalid result. If there is an conducted and no legitimate acceptable medical explanation, the MRO shall report to medical explanation exists for the licensee or other entity that the test result is not an the invalid test result, require FFD policy violation, but that a negative test result was that a second specimen be not obtained. If the medical reason for the invalid result collected as soon as practical is, in the opinion of the MRO, a temporary condition, the under direct observation. licensee or other entity shall collect a second urine I refer to 10 CFR Part 26 for non- specimen from the donor as soon as reasonably practical typical circumstances to ensure and rely on the MROs review of the test results from the that I follow the correct second collection. The second specimen collected for the procedures. purposes of this paragraph may not be collected under Other: direct observation. If the medical reason for the invalid result would similarly affect the testing of another urine specimen, the MRO may authorize an alternative method for drug testing. Licensees and other entities may not impose sanctions for an invalid test result due to a medical condition.

Issue Date: 10/22/18 Att3-16 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D1 (3) If the MRO and the laboratory agree that further contd testing would not be useful and there is no legitimate technical or medical explanation for the invalid test result, the MRO shall require that a second collection take place as soon as practical under direct observation. The licensee or other entity shall rely on the MROs review of the test results from the directly observed collection.

D2 What action must you Verify the drug test result as § 26.185(g)(1) states:

as the MRO take for positive and contact FFD If the HHS-certified laboratory reports that a specimen is a dilute specimen management. dilute and that drugs or drug metabolites were detected in with drug or drug Other. the specimen at or above the cutoff levels specified in this metabolites detected part or the licensees or other entitys more stringent cutoff at or above the levels, and the MRO determines that there is no legitimate specified cutoff level medical explanation for the presence of the drugs or drug with no legitimate metabolites in the specimen, and a clinical examination, if medical explanation? required under paragraph (g)(4) of this section, has been conducted, the MRO shall determine that the drug test results are positive and that the donor has violated the FFD policy.

Issue Date: 10/22/18 Att3-17 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D3 Does the licensee or Not applicable. § 26.185(g)(2) states:

other entity conduct Determine if the test result also If the . . . special analysis of dilute specimens permitted limit of detection is a refusal to test by considering in §26.163(a)(2) . . . are positive, the MRO determines (LOD) testing of if: that there is no legitimate medical explanation for the dilute specimens 1) The donor provided at this or presence of the drug(s) or drug metabolite(s) in the under §26.163(a)(2)? a previous collection a urine specimen, and a clinical examination, if required . . . has specimen that an HHS- been conducted . . . , the MRO shall determine whether If yes, what action certified laboratory reported the positive and dilute specimen is a refusal to test. If the must you take, as the as substituted, adulterated, or MRO does not have sufficient reason to believe that the MRO, if a donors invalid, and MRO review positive and dilute specimen is a subversion attempt, he specimen is dilute determined no adequate or she shall determine that the drug test results are and you confirm the technical or medical positive and that the donor has violated the FFD policy.

result as positive for explanation for the result. When determining whether the donor has diluted the a drug or drug 2) The donor presented a urine specimen in a subversion attempt, the MRO shall also metabolite at LOD? specimen of 30 mL or more consider the following circumstances, if applicable:

that was outside the required (i) The donor has presented, at this or a previous temperature range. collection, a urine specimen that the HHS-certified

3) The collector observed laboratory reported as being substituted, adulterated, or conduct indicating an attempt invalid to the MRO and the MRO determined that there is to dilute the specimen. no adequate technical or medical explanation for the Verify the drug test result as result; positive and contact FFD (ii) The donor has presented a urine specimen of 30 mL management. or more that falls outside the required temperature range, Other: even if a subsequent directly observed collection was performed; or (iii) The collector observed conduct clearly and unequivocally indicating an attempt to dilute the specimen.

Issue Date: 10/22/18 Att3-18 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D4 Before determining a I or a qualified designee must § 26.185(g)(4) states:

donor violation of the conduct a clinical examination for If the drugs detected in a dilute specimen are any opium, FFD policy, what signs of abuse of the opiate, or opium derivative (e.g., morphine/ codeine), or if procedure must you substance(s). the drugs or metabolites detected indicate the use of follow for a dilute No clinical examination is prescription or over-the-counter medications, before specimen positive for necessary if 6-AM is detected by determining that the donor has violated the FFD policy any opium, opiate, or the laboratory. I verify the test under paragraph (a) of this section, the MRO or his/her opium derivative result as positive in this case. designee, who shall also be a licensed physician with (e.g., morphine or All of the above. knowledge of the clinical signs of drug abuse, shall codeine), or drugs or Other: conduct the clinical examination for abuse of these metabolites that substances that is required in paragraph (j) of this section.

indicate the use of An evaluation for clinical evidence of abuse is not prescription or over- required if the laboratory confirms the presence of 6-AM the-counter (i.e., the presence of this metabolite is proof of heroin medications? use) in the dilute specimen.

D5 Is an MRO review No, my staff can review a dilute § 26.183(d)(1)(i) states: The staff under the direction of required for a dilute negative result. the MRO may receive, review, and report negative test negative specimen No, but I review all drug test results to the licensee's or other entity's designated result? results. representative.

Yes.

Other: § 26.185(g)(5) states: An MRO review is not required for specimens that the HHS-certified laboratory reports as negative and dilute. The licensee or other entity may not take any administrative actions or impose any sanctions on a donor who submits a negative and dilute specimen.

Issue Date: 10/22/18 Att3-19 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D6 What course of The MRO stated the correct two Substituted specimen action do you take as steps § 26.185(h)(1) states:

the MRO for a (1) Conduct an interview with If the HHS-certified laboratory reports a specimen as substituted or the donor to evaluate if substituted, the MRO shall contact the donor and offer the adulterated specimen legitimate medical evidence donor an opportunity to provide a legitimate medical test result received exists to explain the test result; explanation for the substituted result.

from the HHS- (2) Verify the test result as certified laboratory? substituted or adulterated if no § 26.185(h)(2) states:

legitimate medical evidence If the MRO determines that there is no legitimate medical exists. explanation for the substituted test result, the MRO shall Other: report to the licensee or other entity that the specimen was substituted.

Adulterated specimen

§ 26.185(i)(1) states:

If the HHS-certified laboratory reports a specimen as adulterated with a specific substance, the MRO shall contact the donor and offer the donor an opportunity to provide a legitimate medical explanation for the substituted result.

§ 26.185 (i)(2) states:

If the MRO determines that there is no legitimate medical explanation for the adulterated test result, the MRO shall report to the licensee or other entity that the specimen was adulterated.

Issue Date: 10/22/18 Att3-20 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D7 Who has the burden The donor has the burden of § 26.185(h)(1) states:

of proof regarding proof and must provide The burden of proof resides solely with the donor, who substituted or legitimate medical evidence to must provide legitimate medical evidence within adulterated test the MRO within 5 business days that he or she produced the specimen for results (the MRO or 5 business days of the specimen which the HHS-certified laboratory reported a substituted the donor)? collection date. result.

The MRO has the burden of proof. § 26.185(i)(1) states:

Other: The burden of proof resides solely with the donor, who must provide legitimate medical evidence within 5 business days that he or she produced the adulterated result.

D8 What is the course of Verify the test result as negative. § 26.185(h)(3) states:

action if a legitimate Require a second specimen be If the MRO determines that there is a legitimate medical medical explanation collected under direct explanation for the substituted test result and no drugs or is verified by the observation. drug metabolites were detected in the specimen, the MRO for a Other: MRO shall report to the licensee or other entity that no substituted or FFD policy violation has occurred.

adulterated test result, and no drugs § 26.185(i)(3) states:

or drug metabolites If the MRO determines that there is a legitimate medical were detected in the explanation for the adulterated test result and no drugs or specimen? drug metabolites were detected in the specimen, the MRO shall report to the licensee or other entity that no FFD policy violation has occurred.

D9 Who must submit A physician experienced and § 26.185(h)(1) and (i)(1) state:

medical evidence to qualified in the medical issues Any medical evidence must be submitted through a support a legitimate involved. physician experienced and qualified in the medical issues medical explanation The donor. involved, as verified by the MRO.

for a substituted or Other:

adulterated specimen test result?

Issue Date: 10/22/18 Att3-21 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D10 If you as the MRO Yes, I or a qualified designee § 26.185(j)(1) states:

determine that no must conduct a clinical If the MRO determines that there is no legitimate medical legitimate medical examination to determine if the explanation for a positive confirmatory test result for explanation exists for donor has illegally used opium, opiates and before the MRO determines that the test a confirmatory an opiate, or an opium result is a violation of the FFD policy, the MRO or his/her positive result for derivative. designee, who shall also be a licensed physician with opiates, is a clinical No clinical examination is knowledge of the clinical signs of drug abuse, shall examination required necessary if 6-AM is detected, or determine that there is clinical evidence, in addition to the prior to reporting a the morphine or codeine positive confirmatory test result, that the donor has positive result? concentration is equal to or illegally used opium, an opiate, or an opium derivative greater than 15,000 ng/mL. (e.g., morphine/ codeine). This requirement does not All of the above. apply if the laboratory confirms the presence of 6-AM (i.e.,

Other: the presence of this metabolite is proof of heroin use), or the morphine or codeine concentration is equal to or greater than 15,000 ng/mL and the donor does not present a legitimate medical explanation for the presence of morphine or codeine at or above this concentration.

D11 Is consumption of No. § 26.185(j)(1) states:

food products a Yes. The MRO may not determine that the consumption of legitimate medical Other: food products is a legitimate medical explanation for the explanation for the presence of morphine or codeine at or above this presence of concentration.

morphine or codeine at or above 15,000 ng/mL?

Issue Date: 10/22/18 Att3-22 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D12 Is a determination of Yes, I must determine if clinical § 26.185 (j)(2) states:

clinical evidence of evidence of abuse exists for the If the MRO determines that there is no legitimate medical abuse needed prior substances detected or their explanation for a positive confirmatory test result for drugs to confirming a derivatives. other than opiates that are commonly prescribed or positive test result for No. I can confirm the test result included in over-the-counter preparations (e.g.,

drugs other than as positive. benzodiazepines in the first case, barbiturates in the opiates that are Other: second) and are listed in the licensees or other entitys commonly prescribed panel of substances to be tested, the MRO shall (e.g., determine whether there is clinical evidence, in addition to benzodiazepines) or the positive confirmatory test result, of abuse of any of included in over-the- these substances or their derivatives.

counter preparations (e.g., barbiturates)?

D13 What do you do as If clinical evidence of drug abuse § 26.185(j)(3) states:

the MRO if you is found, report to the licensee If the MRO determines that the donor has used another determine that a that the donor has violated the individuals prescription medication, including a donor has used FFD policy. medication containing opiates, and no clinical evidence of another individuals If no clinical evidence of drug drug abuse is found, the MRO shall report to the licensee prescription abuse is found, report to the or other entity that the donor has misused a prescription medication? licensee that the donor has medication. If the MRO determines that the donor has misused a prescription used another individuals prescription medication and medication. clinical evidence of drug abuse is found, the MRO shall All of the above. report to the licensee that the donor has violated the FFD Other: policy.

Issue Date: 10/22/18 Att3-23 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D14 Could use of a Yes. § 26.185(j)(4) states:

medication from a No. In determining whether a legitimate medical explanation foreign country Other: exists for a positive confirmatory test result for opiates or support a legitimate prescription or over-the-counter medications, the MRO medical explanation may consider the use of a medication from a foreign for a positive country.

confirmatory test result for opiates or prescription or over-the-counter medications?

Issue Date: 10/22/18 Att3-24 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D15 In determining There can be a legitimate § 26.185(j)(4) states:

whether a legitimate medical explanation only with The MRO shall exercise professional judgment medical explanation respect to a drug that is obtained consistently with the following principles:

exists for a positive legally in a foreign country. (i) There can be a legitimate medical explanation only with confirmatory test There can be a legitimate respect to a drug that is obtained legally in a foreign result for opiates or medical explanation only with country; prescription or over- respect to a drug that has a (ii) There can be a legitimate medical explanation only the-counter legitimate medical use. with respect to a drug that has a legitimate medical use.

medications, what Use of the drug can form the Use of a drug of abuse (e.g., heroin, PCP) or any other principles should you basis of a legitimate medical substance that cannot be viewed as having a legitimate adhere to when explanation only if it is used medical use can never be the basis for a legitimate considering the use consistently with its proper and medical explanation, even if the drug is obtained legally in of a medication from intended medical purpose. a foreign country; and a foreign country? All of the above. (iii) Use of the drug can form the basis of a legitimate Other: medical explanation only if it is used consistently with its proper and intended medical purpose.

D16 In determining No. § 26.185(j)(5) states:

whether a legitimate Yes. The MRO may not consider consumption of food medical explanation Other: products, supplements, or other preparations containing exists for a positive substances that may result in a positive confirmatory drug confirmatory drug test result, including, but not limited to supplements test result, may the containing hemp products or coca leaf tea, as a legitimate MRO consider the medical explanation for the presence of drugs or drug consumption of food metabolites in the urine specimen above the cutoff levels products, specified in § 26.163 or a licensees or other entitys more supplements, or stringent cutoff levels.

other preparations containing substances that may result in the positive result?

Issue Date: 10/22/18 Att3-25 71130.08

D. MRO Activities Associated with Test Result Reviews (Invalid, Adulterated, Substituted, Dilute,; Medications)

Num. Question Answer NRC Regulation(s)

D17 In determining No. § 26.185(j)(6) states:

whether a legitimate Yes, if the drug was legally The MRO may not consider the use of any drug medical explanation prescribed and used under State contained in Schedule I of section 202 of the Controlled for a positive law. Substances Act [21 U.S.C. 812] as a legitimate medical confirmatory test Other: explanation for a positive confirmatory drug test result, result exists, may the even if the drug may be legally prescribed and used under MRO consider the State law.

use of any Schedule I drug (i.e., listed in section 202 of the Controlled Substances Act

[21 U.S.C. 812])?

D18 If you determine a The MRO stated the three § 26.185(k) states:

legitimate medical actions: If the MRO determines that there is a legitimate medical explanation exists for 1) Report to the licensee or explanation for a positive confirmatory drug test result, a positive drug test other entity that no FFD and that the use of a drug identified through testing was in result, what actions policy violation has occurred. the manner and at the dosage prescribed, and the results must you take? 2) Evaluate the positive do not reflect a lack of reliability or trustworthiness, then confirmatory test result and the donor has not violated the licensees or other entitys medical explanation to FFD policy. The MRO shall report to the licensee or other determine if use of the drug entity that no FFD policy violation has occurred. The and/or the medical condition MRO shall further evaluate the positive confirmatory test poses a potential risk to result and medical explanation to determine whether use public health and safety. of the drug and/or the medical condition poses a potential

3) If a risk to public health risk to public health and safety as a result of the individual exists, ensure that a being impaired while on duty. If the MRO determines that determination of fitness is such a risk exists, he or she shall ensure that a performed. determination of fitness is performed.

Other:

Issue Date: 10/22/18 Att3-26 71130.08

E. Retesting an Aliquot of a Single Specimen or Split-Specimen Testing Num. Question Answer NRC Regulation(s)

E1 Who is authorized to The donor is the only individual that § 26.185(l) states:

request the reanalysis may request the MRO to direct such The MRO is also the only individual who may of an aliquot of a single testing. authorize a reanalysis of an aliquot of the original specimen or the The MRO is the only individual who specimen or an analysis of any split specimen analysis of the split can request such testing. (Bottle B) in response to a request from the donor specimen for a positive, The licensee is permitted to direct tested.

adulterated, such testing.

substituted, or invalid Other:

test result?

E2 If the testing performed Report an FFD policy violation to the § 26.185(n) states:

at the second HHS- licensee or other entity. After a second laboratory tests an aliquot of a single certified laboratory Other: specimen or the split (Bottle B) specimen, the MRO reconfirms the initial shall take the following actions if the second laboratorys test result, laboratory reports the following results:

what action do you take (1) If the second laboratory reconfirms any positive as the MRO? test results, the MRO may report an FFD policy violation to the licensee or other entity; (2) If the second laboratory reconfirms any adulterated, substituted, or invalid validity test results, the MRO may report an FFD policy violation to the licensee or other entity.

Issue Date: 10/22/18 Att3-27 71130.08

E. Retesting an Aliquot of a Single Specimen or Split-Specimen Testing Num. Question Answer NRC Regulation(s)

E3 If the testing performed Report that no FFD policy violation § 26.185(n) states:

at the second HHS- has occurred. After a second laboratory tests an aliquot of a single certified laboratory fails Report an FFD policy violation to the specimen or the split (Bottle B) specimen, the MRO to reconfirm the initial licensee or other entity. shall take the following actions if the second laboratorys test result, Other: laboratory reports the following results: . . . .

what action do you take (3) If the second laboratory does not reconfirm the as the MRO? positive test results, the MRO shall report that no FFD policy violation has occurred; or (4) If the second laboratory does not reconfirm the adulterated, substituted, or invalid validity test results, the MRO shall report that no FFD policy violation has occurred.

E4 Can you as the MRO Yes, I can request retesting at § 26.185(l) states:

request retesting of an second HHS-certified laboratory. Should the MRO question the accuracy or scientific aliquot of the original Yes, I can request retesting at the validity of a positive, adulterated, substituted, or specimen or the same HHS-certified laboratory. invalid test result, only the MRO is authorized to analysis of the split Other: order retesting of an aliquot of the original specimen specimen if you or the analysis of any split specimen (Bottle B) in question the accuracy order to determine whether the FFD policy has been of a positive, violated. Retesting must be performed by a second adulterated, HHS-certified laboratory. The MRO is also the only substituted, or invalid individual who may authorize a reanalysis of an test result? aliquot of the original specimen or an analysis of any split specimen (Bottle B) in response to a request from the donor tested.

Issue Date: 10/22/18 Att3-28 71130.08

E. Retesting an Aliquot of a Single Specimen or Split-Specimen Testing Num. Question Answer NRC Regulation(s)

E5 What is the appropriate Declare that a drug or validity test § 26.185(m) states:

course of action when result is not an FFD policy violation, Based on the review of inspection and audit reports, you as the MRO but that a negative test result was quality control data, multiple specimens, and other determine that a not obtained. pertinent results, the MRO may determine that a positive, adulterated, Request retesting of the original positive, adulterated, substituted or invalid test result substituted, or invalid specimen before making this is scientifically insufficient for further action and may test result is decision if warranted. declare that a drug or validity test result is not an scientifically If retesting is warranted, request that FFD policy violation, but that a negative test result insufficient? the reanalysis be performed by the was not obtained. In this situation, the MRO may same laboratory, or that an aliquot of request retesting of the original specimen before the original specimen be sent for making this decision. The MRO is neither expected reanalysis to another HHS-certified nor required to request such retesting, unless in the laboratory. sole opinion of the MRO, such retesting is Other: warranted. The MRO may request that the reanalysis be performed by the same laboratory, or that an aliquot of the original specimen be sent for reanalysis to another HHS-certified laboratory. The licensee testing facility and the HHS- certified laboratory shall assist in this review process, as requested by the MRO, by making available the individual(s) responsible for day-to-day management of the licensee testing facility or the HHS-certified laboratory, or other individuals who are forensic toxicologists or who have equivalent forensic experience in urine drug testing, to provide specific consultation as required by the MRO.

THAT WAS THE LAST QUESTION. THANK YOU FOR YOUR TIME AND INPUT.

Issue Date: 10/22/18 Att3-29 71130.08

Attachment - 4 10 CFR Part 26 SUBSTANCE ABUSE EXPERT QUESTIONNAIRE Licensee Contact Person Inspection Date Inspector This questionnaire may be used by the U.S. Nuclear Regulatory Commission (NRC) inspector when evaluating the Substance Abuse Expert (SAE) supporting a licensees or other entitys 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:

Question Section Numbers A. SAE Qualifications and Training A1 - A7 B. Services provided by the SAE B1 - B14 Issue Date: 10/22/18 Att4-1 71130.08

Num. Question Answer NRC Regulation(s)

A. SAE Qualifications and Training A1 Please describe your Licensed physician. § 26.187(b) states:

credentials to serve Licensed or certified social An SAE shall have at least one of the following as a substance worker. credentials:

abuse expert for an Licensed or certified (1) A licensed physician; NRC-regulated psychologist. (2) A licensed or certified social worker; licensee under Licensed or certified employee (3) A licensed or certified psychologist; 10 CFR Part 26. assistance professional (EAP). (4) A licensed or certified employee assistance Alcohol and drug abuse professional; or

[Request counselor certified by the (5) An alcohol and drug abuse counselor certified by the documentation to National Association of National Association of Alcoholism and Drug Abuse confirm Alcoholism and Drug Abuse Counselors Certification Commission or by the qualifications] Counselors Certification International Certification Reciprocity Consortium/Alcohol Commission. and Other Drug Abuse.

Alcohol and drug abuse counselor certified by the International Certification Reciprocity Consortium/Alcohol and Other Drug Abuse.

The individual does not meet the SAE credential requirement in 26.187(b).

A2 Describe your List the information provided § 26.187(c) states:

knowledge and here: Basic Knowledge. An SAE shall be knowledgeable in the clinical experience in following areas:

diagnosing and (1) Demonstrated knowledge of and clinical experience in treating alcohol and the diagnosis and treatment of alcohol and controlled controlled substance substance abuse disorders abuse disorders?

Issue Date: 10/22/18 Att4-2 71130.08

Num. Question Answer NRC Regulation(s)

A. SAE Qualifications and Training A3 How do you remain I regularly review the NRC FFD § 26.187(c) states:

up-to-date on the website for information on the Basic Knowledge. An SAE shall be knowledgeable in the NRC drug and regulation. following areas:

alcohol testing I receive a newsletter that (3) Knowledge of this part and any changes thereto.

regulations in informs me of changes in the 10 CFR Part 26? NRCs drug and alcohol testing regulations.

I have a copy of 10 CFR Part 26.

The licensee or other entitys staff provides me with any updates on the rule.

Other:

A4 Do you have a copy Yes. Understanding the specific testing requirements of a of the licensee or No. licensee or other entitys FFD program is a core other entitys FFD Other: component of the SAEs role because the NRC permits program policy? licensees and other entities to test at more stringent cutoff levels and for drugs in addition to those required in A5 How do you remain I receive information from the

§ 26.133 and §26.163.

up-to-date on the FFD program manager if any FFD program changes are implemented.

policies of the I rely upon the policy that is licensee or other provided to me by the FFD entity that you program.

provide services? Other:

Issue Date: 10/22/18 Att4-3 71130.08

Num. Question Answer NRC Regulation(s)

A. SAE Qualifications and Training A6 Describe the training List the information provided § 26.187(d) states:

that you have regarding qualification training: Qualification training. SAEs shall receive qualification received to comply I have not completed qualification training on the following subjects:

with the qualification training. (1) Background, rationale, and scope of this part; training requirement Other: (2) Key drug testing requirements of this part, including in § 26.187(d)? specimen collection, laboratory testing, MRO review, and problems in drug testing; Request: (3) Key alcohol testing requirements of this part, including The date specimen collection, the testing process, and problems in completed alcohol tests; qualification (4) SAE qualifications and prohibitions; training. (5) The role of the SAE in making determinations of fitness A copy of the and the return-to-duty process, including the initial certificate of evaluation, referrals for education and/ or treatment, the completion for any follow up evaluation, continuing treatment courses attended. recommendations, and the follow up testing plan; A description of (6) Procedures for SAE consultation and communication training(s) with licensees or other entities, MROs, and treatment attended if providers; available (web site (7) Reporting and recordkeeping requirements of this part; address, training and description). (8) Issues that SAEs confront in carrying out their duties under this part.

A7 After successfully 12 CPE hours over 3 years. § 26.187(e) states:

completing initial (Ask for certificate of completion, During each 3-year period following completion of initial qualification training, if applicable) qualification training, the SAE shall complete continuing how many I dont know but Id look the education consisting of at least 12 continuing professional professional information up in the regulations education hours relevant to performing SAE functions.

development hours after I take my qualification must you complete, training.

and over what period Other:

of time?

Issue Date: 10/22/18 Att4-4 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B1 What are your Evaluate individuals who have § 26.187(g) states:

responsibilities as an violated the substance abuse Responsibilities and prohibitions. The SAE shall evaluate SAE? policy and make appropriate individuals who have violated the substance abuse education/ treatment referrals, provisions of an FFD policy and make recommendations follow-up testing, and aftercare concerning education, treatment, return to duty, follow up recommendations. [§ 26.187(g)] drug and alcohol testing, and aftercare. The SAE is not Make determinations of fitness an advocate for the licensee or other entity, or the for substance abuse related individual. The SAEs function is to protect public health issues. [§ 26.189(a)] and safety and the common defense and security by Other: professionally evaluating the individual and recommending appropriate education/treatment, follow-up tests, and aftercare.

§ 26.189(a)(1) states:

.An SAE who meets the requirements of § 26.187 may determine the fitness of an individual who may have engaged in substance abuse and shall determine an individuals fitness to be granted authorization following an unfavorable termination or denial of authorization under this part, but may not be qualified to assess the fitness of an individual who may have experienced mental illness, significant emotional stress, or other mental or physical conditions that may cause impairment but are unrelated to substance abuse, unless the SAE has additional qualifications for addressing those fitness issues Issue Date: 10/22/18 Att4-5 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B2 For follow-up testing, Yes, a minimum of 15 § 26.69(b) states:

does NRC require a unannounced tests to be Authorization after a first confirmed positive drug or minimum number of conducted at least quarterly over alcohol test result or a 5-year denial of authorization.

tests to be performed a period of 3 years. Random (6) If the individuals authorization was denied or AND over a specific and follow up tests count terminated unfavorably for a first confirmed positive drug period of time? towards the 15 test minimum. or alcohol test result and a licensee or other entity grants A minimum of 15 tests on an authorization to the individual, ensure that the individual is unannounced basis and at least subject to unannounced testing at least quarterly for three quarterly, but I can prescribe calendar years after the date the individual is granted more based on the individual authorization. Both random and follow-up tests, as case. defined in § 26.31(c), satisfy this requirement. Verify that No. the individual has negative test results from a minimum of Other: 15 tests distributed over the 3-year period.

B3 Under what The SAE stated the three § 26.187(g)(1) states:

circumstances is an circumstances in § 26.187(g)(1). The SAE is authorized to make determinations of fitness SAE authorized to o potentially disqualifying in at least the following three circumstances:

make a information is identified (i) When potentially disqualifying FFD information has determination of regarding an individual who been identified regarding an individual who has applied for fitness? has applied for authorization authorization under this part; o an individual has violated the (ii) When an individual has violated the substance abuse substance abuse provisions provisions of a licensees or other entitys FFD policy; and of the FFD policy (iii) When an individual may be impaired by alcohol, o an individual may be prescription or over-the-counter medications, or illegal impaired by alcohol, drugs.

prescription or over-the-counter medications, or illegal drugs The SAE did not state all three circumstances in § 26.187(g)(1).

Other:

Issue Date: 10/22/18 Att4-6 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B4 Are you qualified to Yes, I am a clinical psychologist § 26.189(a) states:

make a so I am qualified to evaluate A professional called on by the licensee or other entity may determination of mental illness, emotional stress, not perform a determination of fitness regarding fitness fitness for mental and cognitive or psychological issues that are outside of his or her specific areas of illness, emotional impairment from causes expertise. The types of professionals and the fitness issues stress, or other unrelated to substance abuse. for which they are qualified to make determinations of fitness mental or physical [see §26.189(a)(2)] include, but are not limited to, the following:

(1) An SAE who meets the requirements of § 26.187 may conditions that may Yes, I am a psychiatrist so I am determine the fitness of an individual who may have engaged cause impairment qualified to assess an individual in substance abuse and shall determine an individuals but are unrelated to taking psychoactive medications fitness to be granted authorization following an unfavorable substance abuse? consistently with one or more termination or denial of authorization under this part, but may valid prescription(s). [see not be qualified to assess the fitness of an individual who If the answer is yes, §26.189(a)(3)] may have experienced mental illness, significant emotional assess the Yes, I am a physician so I am stress, or other mental or physical conditions that may cause qualifications (MD, qualified to determine the fitness impairment but are unrelated to substance abuse, unless the psychologist, etc.). of an individual who may be ill, SAE has additional qualifications for addressing those fitness injured, fatigued, taking issues; medications in accordance with (2) A clinical psychologist may determine the fitness of an one or more valid prescriptions, individual who may have experienced mental illness, or using over-the-counter significant emotional stress, or cognitive or psychological medications. [see §26.189(a)(4)] impairment from causes unrelated to substance abuse:

No, I am specifically trained in (3) A psychiatrist may determine the fitness of an individual substance abuse related issues, who is taking psychoactive medications consistently with one but do not have appropriate or more valid prescription(s).

training to assess mental, (4) A physician may determine the fitness of an individual who may be ill, injured, fatigued, taking medications in emotional, or physical conditions accordance with one or more valid prescriptions or using that may cause impairment.

over-the-counter medications.

Other:

Issue Date: 10/22/18 Att4-7 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B5 Do you make If yes: § 26.189(c) states:

determinations of A face-to-face evaluation is A determination of fitness that is conducted for cause fitness for for-cause required. (i.e., because of observed behavior or a physical testing? I perform face-to-face condition) must be conducted through face-to-face evaluations for my work. interaction between the subject individual and the If yes, how do you By telephone. professional making the determination. Electronic means conduct the Other: of communication may not be used.

evaluation?

If no, skip to next question.

B6 May an individual or Yes. § 26.189(d) states:

the licensee or other No. Neither the individual nor licensees and other entities entity that you have Other: may seek a second determination of fitness if a issued a determination of fitness under this part has already been determination of performed by a qualified professional employed by or fitness for seek a under contract to the licensee or other entity. Unless the second professional who made the initial determination of fitness determination of is no longer employed by or under contract to the licensee fitness? or other entity, only that professional is authorized to modify the evaluation and recommendations. When reasonably practicable, licensees and other entities shall assist in arranging for consultation between the new professional and the professional who is no longer employed by or under contract to the licensee or other entity, to ensure continuity and consistency in the recommendations and their implementation.

B7 After you have made Yes. § 26.189(d) states:

an initial No. After the initial determination of fitness has been made, determination of Other: the professional may modify his or her evaluation and fitness, can you recommendations based on new or additional information modify your from other sources including, but not limited to, the subject evaluation and individual, another licensee or entity, or staff of an recommendations? education or treatment program Issue Date: 10/22/18 Att4-8 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B8 In providing services No. § 26.187(g)(2)(i) states:

as a SAE, can you Yes. To prevent the appearance of a conflict of interest, the refer an individual to Other: SAE may not refer an individual requiring assistance to his your private or her private practice or to a person or organization from practice? whom the SAE receives payment or in which the SAE has a financial interest. The SAE is precluded from making referrals to entities with whom the SAE is financially associated.

B9 In providing services No. § 26.187(g)(2)(i) states:

as a SAE, can you Yes. To prevent the appearance of a conflict of interest, the refer an individual to Other: SAE may not refer an individual requiring assistance to his a person or or her private practice or to a person or organization from organization from whom the SAE receives payment or in which the SAE has whom you receive a financial interest. The SAE is precluded from making payment or have a referrals to entities with whom the SAE is financially financial interest? associated.

Issue Date: 10/22/18 Att4-9 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B10 Are there any Yes: § 26.187(g)(2)(ii) states:

exceptions to the o A public agency (e.g., There are four exceptions to the prohibitions contained in NRC conflict of treatment facility) operated the preceding paragraph. The SAE may refer an interest provisions in by a state, county, or individual to any of the following providers of assistance,

§ 26.187(g)(2)? municipality regardless of his or her relationship with them:

o A person or organization (A) A public agency (e.g., treatment facility) operated by a under contract to the licensee state, county, or municipality; or other entity to provide (B) A person or organization under contract to the licensee alcohol or drug treatment or other entity to provide alcohol or drug treatment and/or and/or education services education services (e.g., the licensees or other entitys o The sole source of contracted treatment provider);

therapeutically appropriate (C) The sole source of therapeutically appropriate treatment under the treatment under the individuals health insurance program individuals health insurance (e.g., the single substance abuse inpatient treatment program; program made available by the individuals insurance o The sole source of coverage plan); or therapeutically appropriate (D) The sole source of therapeutically appropriate treatment reasonably treatment reasonably available to the individual (e.g., the available to the individual only treatment facility or education program reasonably (reasonably located within located within the general commuting area).

the general commuting area).

No Other:

Issue Date: 10/22/18 Att4-10 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B11 Explain the I maintain all records in Subpart K - § 26.411 Protection of information.

maintenance and accordance with HIPAA. (a) Licensees and other entities who collect personal security practices for I keep electronic records on a information about an individual for the purpose of the paper and computer that is password complying with this subpart shall establish and maintain a electronic records protected and only accessible by system of files and procedures to protect the personal you create related to me. information. FFD programs must maintain and use such your activities as an I maintain paper documents in a records with the highest regard for individual privacy.

SAE? locked file cabinet in my office (b) Licensees and other entities shall obtain a signed which is also locked when Im consent that authorizes the disclosure of the personal not working. information collected and maintained under this subpart Other: before disclosing the personal information, except for disclosures to the individuals and entities specified in

§ 26.37(b)(1) through (b)(6), (b)(8), and persons deciding matters.

B12 If an individual Yes, but only after I receive a § 26.37(d) states:

requests that you written request from the Protection of information. . . Upon receipt of a written provide a copy of individual or his or her request by the subject individual or his or her designated their treatment designated representative. representative, the FFD program, including but not limited records and/or Yes, but only after I receive a to, the collection site, HHS-certified laboratory, substance records on a signed information release and abuse expert (SAE), or MRO, possessing such records determination of then I only provide the records to shall promptly provide copies of all FFD records pertaining fitness, may you do the FFD program manager who to the individual, including, but not limited to, records so? then provides them to the pertaining to a determination that the individual has individual. violated the FFD policy, drug and alcohol test results, If yes, is there a No, the records that I create are MRO reviews, determinations of fitness, and management specific process that not to be released to the actions pertaining to the subject individual. . .

you follow? individual.

Other:

B13 Do you serve as an Yes. It is important to collect this information in situations where SAE for any other No. the individual is not adequately qualified to serve as an licensee or other Other: SAE. Also provides information on experience entity? level/workload.

Issue Date: 10/22/18 Att4-11 71130.08

B. Services provided by the SAE Num. Question Answer NRC Regulation(s)

B14 Did the SAE Yes. § 26.187(f) states:

cooperate with the No, the interview could not be Documentation. The SAE shall maintain documentation inspector and conducted because the SAE was showing that he or she currently meets all requirements of facilitate the unavailable to be interviewed. this section. The SAE shall provide this documentation on inspection process, No, the SAE was did not provide request to NRC representatives, licensees, or other including producing all requested documents. entities who are relying on or contemplating relying on the all required records? Other: SAEs services, and to other individuals and entities, as required by § 26.37.

THAT WAS THE LAST QUESTION. THANK YOU FOR YOUR TIME AND INPUT.

Issue Date: 10/22/18 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 licensees 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 HHS-certified 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 HHS-certification of laboratories and performance testing process which is a part of the HHS laboratory certification and inspection process, in part, because:

o Testing cutoff variability - NRC cutoffs may be different than those used by other Federal workplace drug testing programs o No Federal workplace drug testing program employs the dilute specimen testing process in 10 CFR 26.163(a)(2), to conduct drug testing to the limit of detection of the confirmatory drug test o 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). 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 HHS-certified 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))

Issue Date: 10/22/18 Att5-1 71130.08

Unless the FFD program tests more than 1,000 specimens in a quarter (fairly rare event, maybe a three unit operating site in outage conditions; or a reactor construction site),

10 BPTSs would be submitted per quarter as follows:

o 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 eight substances:

marijuana metabolite, cocaine metabolite, amphetamine, methamphetamine, codeine, morphine, 6-acetylmorphine, and phencyclidine).

If the site submits the minimum 6 BPTSs per quarter, this means that some BPTSs must contain more than one substance.

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))

o False negative challenge (10 percent of BPTSs per quarter, a minimum of 1 BPTS).

This is a positive specimen, just formulated closer to the testing cutoff level.

(10 CFR 26.168(f))

o 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))

o 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 amongst 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 10.

Issue Date: 10/22/18 Att5-2 71130.08

BPTS submissions for a site that tests 1,000 or fewer specimens per quarter BPTS Formulation Requirements Quarter 1 Quarter 2 Quarter 3 Quarter 4 (Jan - Mar) (Apr- Jun) (Jul - Sept) (Oct - Dec)

Positive BPTSs 01: Marijuana 01: Marijuana 01: Marijuana 01: Marijuana (6 per quarter) 02: Marijuana 02: Marijuana 02: Marijuana 02: Marijuana 03: AMP 03: AMP, MAMP 03: AMP 03: AMP, MAMP

- 2 Marijuana/quarter 04: COD, MOR, 6-AM 04: MOR, 6-AM 04: COD, MOR, 6-AM 04: MOR, 6-AM

- Replace PCP with 05: Cocaine 05: Cocaine 05: Cocaine 05: Cocaine Cocaine in 2 quarters 06: PCP 06: Cocaine 06: PCP 06: Cocaine (replaces PCP) (replaces PCP)

False Negative BPTS 07: MAMP 07: COD 07: MAMP 07 = COD (1 per quarter)

Validity Test BPTSs (3 per quarter) 08: Adulterated 08: Adulterated 08: Adulterated 08: Adulterated 1 Adulterated 09: Substituted 09: Substituted 09: Substituted 09: Substituted 1 Substituted 10: Dilute 10: Dilute 10: Dilute 10: Dilute 1 Dilute Notes:

6-AM: 6-acetylmorphine; AMP: amphetamine; COD: codeine; MAMP: methamphetamine; MOR: morphine Underlined substances in Positive BPTS row indicate multi-substance pairing with False Negative BPTS row Recommendations based on the BPTS submission example above:

While the same number sequence of each BPTS is presented in each quarter (01 through 10), it is NOT recommend that a site submit the specimens in the same order throughout the quarter (would add predictability, which could alert the laboratory that these are BPTSs).

For multi-substance positives, if submitted by the licensee, mix-up the types of substances in the BPTSs submitted. For simplicity of presentation in our example, we adjusted the two typical multi-substance positive specimen types with the false negative challenge o COD, MOR, 6-AM (adjust to COD and MOR, or MOR and 6-AM) with the other specimen as the false negative o AMP and MAMP (split such that one is used for the false negative) o Would recommend occasionally mixing in marijuana positives with another substance (we see this in the FFD program performance data) -- (e.g., marijuana and MAMP; marijuana and cocaine, marijuana and AMP; marijuana and COD)

Some dilutes should include a drug (most likely marijuana or cocaine), which is what we see in the FFD program performance report data received under 10 CFR 26.717.

Issue Date: 10/22/18 Att5-3 71130.08

Attachment 6 - Revision History for IP 71130.08 Commitment Accession Description of Changes Description of Comment Resolution Tracking Number Training Needed and Closed Feedback Number Issue Date and Completion Accession Number Change Notice Date (Pre-Decisional, Non-Public Information)

N/A ML0406806220 Issued N/A CN 04-007 02/19/2004 N/A ML071930354 This document has been revised to standardize N/A ML080030397 12/10/08 the sample size; include updates and feedback CN 08-035 from inspection and oversight; correct editorial errors; and convert the document to MS Word.

N/A ML093420748 This document has been revised to address the N/A ML093420756 01/07/10 changes to 10 CFR Part 26 that resulted from a CN 10-001 rulemaking; and in accordance with the ROP assessment process. This document has been revised in whole and therefore, changes are not identified in red font.

N/A ML13238A225 Inspection Procedure re-written to comply with N/A ML13270A261 12/19/13 IMC 0040 format and establish inspection CN 13-029 requirement range for procedure completion.

N/A ML14296A307 This document has been revised to address N/A ML15041A223 05/21/15 language clarification for 10 CFR 26.139(d) and CN 15-010 (e) requirement found in section 02.10 c. 3. of this IP; program applicability and minor administrative changes.

N/A ML16175A027 This document has been revised to adjust the N/A ML16189A070 09/30/16 resource estimate to reflect the nominal number CN 16-024 of inspection requirements as the target range for completion of this procedure as well as make minor administrative changes.

Issue Date: 10/22/18 Att6-1 71130.08

Commitment Accession Description of Changes Description of Comment Resolution Tracking Number Training Needed and Closed Feedback Number Issue Date and Completion Accession Number Change Notice Date (Pre-Decisional, Non-Public Information)

N/A ML17263A609 SOSB revised the 71130 series Inspection N/A ML17263A621 10/22/18 Procedures (IP) and associated Inspection CN 18-035 Manual Chapters (IMC) in response to Staff Requirements - SECY 16-0073 (Options and Recommendations for the Force-On-Force Inspection Program) and the March 2017 Assessment Team (Regions and HQ) review for redundancys and efficiencies of the 71130 series IPs for power reactors. Upon completion of a SUNSI review, the staff concluded that this document should be de-controlled. Consistent with the staffs SUNSI determination the portion markings were removed and the document was decontrolled. This revision also facilitated the removal of five requirements (Sections 02.03 a.;

02.05 a.; 02.05 c.; 02.06 b. and 02.11 a) from IP71130.01, Access Authorization, and the addition of those five requirements to IP71130.08, Fitness for Duty Program (Tier I item 02.03 c.; Tier II items: 02.05 i.; 02.05 j.;

02.05 k; and 02.05 l.). One redundant requirement also was eliminated from IP71130.08 (Tier II item 02.06).

Issue Date: 10/22/18 Att6-2 71130.08

ML17263A609

Text

Navigation menu

Search