ML18031A940

Annual 10 CFR Part 26 Drug and Alcohol Information Reporting and Electronic Reporting Submission Form Use (Webinar on 01/30/18), Presentation

ML18031A940
Person / Time
Issue date:	01/30/2018
From:	Brian Zaleski NRC/NSIR/DPCP/FCTSB
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Download: ML18031A940 (30)

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Annual Fitness-For-Duty (FFD) Reporting of Drug and Alcohol Information and Electronic Reporting Submission Forms

[Webinar]

10 CFR Part 26 A Direct Contribution to Safety and Security January 30, 2018

Webinar Discussion Topics

• Introduction

• Annual FFD reporting data (10 CFR 26.717 and 26.417)

• FFD electronic reporting forms (drug and alcohol only)

• Common reporting errors and guidance

• Questions Slide 2

Annual FFD Program Performance Data

• Part 26 reporting requirements:

- 26.717 (Operating power reactors; Category I fuel cycle facilities)

- 26.417(b)(2) (Power reactors under construction)

• Due to the NRC before March 1 after calendar year end

• Includes information such as:

- Random testing rate

- Substances tested and testing cutoff levels used

- Populations tested (licensee employees, contractor/vendors)

- Conditions for testing (pre-access, random, for-cause, etc.)

- Substances identified

- Subversion attempts by type

- Management actions Slide 3

FFD Electronic Reporting Forms (E-forms)

Each calendar year, a licensee or other entity submits drug and alcohol testing information using two electronic reporting forms (e-forms):

• Annual Reporting Form for Drug and Alcohol Tests (ARF) -

NRC Form 891 (One ARF is completed for each site)

• Single Positive Test Form (SPTF) - NRC Form 890 (One SPTF is completed for each drug and alcohol testing violation at a site)

Latest forms available for download at the NRC website:

http://www.nrc.gov/reactors/operating/ops-experience/

fitness-for-duty-programs/submit-ffd-reports.html Slide 4

FFD E-forms - Use and Advantages

• Voluntary use, first available for calendar year 2009 reporting

• All sites using since 2014

• Advantages:

- Adaptive form functions (fields appear/disappear based on entries)

- Built in validations improve data quality

- In form guidance (pop-up text boxes)

- Detailed event specific data

• Data used to: evaluate Part 26 effectiveness, inform stakeholders on substance use trends, estimate burden associated with information collections (OMB), and inform the NRC inspection process FFD e-forms periodically updated (e.g., to improve form completion speed, data uniformity, correct bugs) -- Feedback is ALWAYS welcome Slide 5

FFD E-Form - Expiration Date

• Currently waiting on the Office of Management and Budget (OMB) to approve the information collection request for NRC Forms 890 and 891 (completed every 3 years)

• Forms currently under review by OMB may display an expiration date that has passed if the OMB does not complete its review prior to the expiration date. In this instance, the expiration date is automatically extended. (https://www.nrc.gov/reading-rm/doc-collections/forms/)

• Once OMB approves the information collection, a new expiration date is assigned, and the date will be updated on the SPTF and ARF.

Slide 6

NRC Receipt Reviews of FFD Program Performance Reports

• Performed by NRC FFD team to ensure that information is accurate and complete

• Data quality has been improving as FFD e-form use has increased

• Likely reasons for reporting inconsistencies:

- New staff completing forms

- New reporting circumstance not previously encountered

- Disconnects between form completer(s) and submitter

• All examples in this webinar based on FFD program performance report reviews and lessons learned from those reviews Slide 7

Common Types of Reporting Errors

• Unlocked Forms

• ARF/SPTF Totals Mismatch

• Multiple SPTFs for the Same Event

• Reason for Testing - For Cause

• HHS-Certified Laboratories

• Dilute Specimen, Limit of Detection Testing

• 24-Hour Event Reports

• Labor Category - Other

• Expanded Panel Testing

• Substituted Test Validity Result

• Subversion Reporting (4 Cases)

• Unique Reference ID

• Deleting an FFD E-form

• EIE General Form Submissions Slide 8

Reporting Error Unlocked Forms Final Step (Required) -- NRC will consider each SPTF and ARF authentic in accordance with 10 CFR 26.11 only when the Validate &

Lock button is clicked and all errors (highlighted in red) have been corrected.

The Validate & Lock button will change to Locked after the data validation process has been successfully completed, indicating the form is ready for submission.

Best practice: Prior to submitting files to the NRC, open each e-form and confirm that the Locked button is visible Slide 9

Reporting Error ARF/SPTF Totals Mismatch Total Results -- The Number of positive, adulterated, substituted, and refusal to test results reported in the ARF table (Tests Conducted in the Calendar Year) must equal the number of SPTFs submitted. Error example:

- ARF: 2 Pre-Access, 1 Random, 2 For Cause = 5 results

- SPTF: 2 Pre-Access, 1 Random, 0 For Cause = 3 results Reason for Testing for each positive, adulterated, substituted, and refusal to test result must be the same in the ARF and in the SPTFs. Error example:

- ARF: 3 Pre-Access, 5 Random, 2 Followup = 10 results

- SPTF: 4 Pre-Access, 4 Random, 2 Followup = 10 results Reasons identified for reporting inconsistencies:

• Same SPTF submitted more than once (duplicate file)

• Some SPTFs not received by the NRC

• Two SPTFs submitted for same event (double reporting)

• Unlocked SPTFs Slide 10

Reporting Error Multiple SPTFs for the Same Event

• Instances associated with subversion attempt reporting when more than one specimen was collected from a donor, such as:

- Specimen 1 = out of acceptable temperature range (negative)

- Specimen 2 = collected under direct observation (positive)

• We count the number of individuals with testing violations, not the number of specimens tested to make a determination on whether an individual has violated the FFD drug testing policy Remember this:

Submit only one SPTF per FFD testing violation (not per specimen)

• One individual one SPTF

• One individual one Reason for Testing Slide 11

Reporting Error Reason for Testing - For Cause 10 CFR 26.31(c)(2) -- For cause testing is to be conducted In response to an individuals observed behavior or physical condition indicating possible substance abuse or after receiving credible information that an individual is engaging in substance abuse, as defined in §26.5.

• Some licensees mistakenly used For Cause for subversion attempt reporting when two specimens were collected

• The NRC typically discovers reporting inconsistencies when reviewing the Reason for Testing information and the Subversion Description detail Slide 12

Reporting Errors HHS-Certified Laboratories (ARF)

1) Not including city and state for the laboratory Needed because some labs have multiple locations, for example:

- Alere (Gretna, LA; Richmond, VA)

- LabCorp (Houston, TX; Research Triangle Park, NC; Southhaven, MS)

- Quest Diagnostics (Lenexa, KS; Norristown, PA; Tucker, GA)

2) Not providing a response for both HHS-certified laboratory fields Remember this:

• Include City and State for each HHS-certified laboratory

• Include backup laboratory (performs Bottle B split specimen testing, or retesting of an aliquot of the Bottle A specimen)

Slide 13

Reporting Error Dilute Specimen, Limit of Detection Testing HHS-certified laboratory reports Test Validity as dilute and special analysis (Limit of Detection) testing under 10 CFR 26.163(a)(2) determines the specimen is drug positive SPTF reporting, things to remember:

• Choose Dilute for Test Validity

• Ensure initial cutoff is 50% of the standard cutoff level

• Confirmatory cutoff is the Limit of Detection (LOD) for the testing assay (do not report the actual quantitation of the test)

Slide 14

Reporting Error 24-Hour Event Reports (SPTF)

• Each year we receive several SPTFs with inconsistent information, when compared to the 24-hour reportable event under 10 CFR 26.719

• Selecting any Labor Category that requires a 10 CFR 26.719 report will auto-populate Yes for Is this a 24-Hour Reporting Event?

- Supervisor

- Licensed Operator

- FFD Program Personnel

- SSNM Transporter

• Often times, Is this a 24-Hour Reporting Event? is No because the Labor Category chosen is not a reportable Labor Category (e.g., Facility Support instead of Supervisor).

Slide 15

Reporting Error Labor Category - Other (SPTF)

• Use of the Other labor category primarily reflected maintenance activities that could have been characterized under Maintenance (general facility) or Facility support.

• Examples of Other labor category descriptions reported: accounting clerk, administrative assistant, cafeteria worker, carpenter, custodian, electrician, equipment operator, fire watch, general laborer, general mechanic, inspector, janitorial, laborer, painter, pipefitter, scaffold builder, student intern, IT support, training proctor, welder

[See next slide for descriptions of maintenance associated labor categories]

Slide 16

Reporting Error Labor Category (continued)

Best Practice: Instead of Other, consider one of these:

• Maintenance (safety-significant) - maintenance or surveillance on safety- or security-related structures, systems, and components (SSCs) such as crane, gantry, and lift operators.

• Maintenance (general facility) - maintenance activities not performed on SSCs such as cleaners, painters, roofers, and scaffolders.

• Facility support - activities and positions associated with delivery, equipment room attendant, warehousing, stocking, janitorial services, cafeteria, administrative assistances, and landscaping.

Remember this:

SPTF field Labor Category pop-up text box guidance contains descriptions of maintenance associated labor categories (hold your mouse over the form field for the information to display)

Slide 17

Reporting Error Expanded Panel Testing (SPTF/ARF)

A positive is reported for an other substance (SPTF), but the substance is not listed in the Substances Tested section of the ARF.

Remember this:

• If an other substance is reported in a SPTF, ensure that the substance is also reported in the ARF.

• Use the Comments box in the ARF Additional Substance table to describe if testing limited to person, a particular reason for testing, etc.

Slide 18

Reporting Error Test Validity - Substituted Result

• NRC receipt reviews identified incorrect reporting of substituted test results for subversion attempts

• A substituted validity result is an HHS-certified laboratory result reported under 10 CFR 26.161(d):

The laboratory shall report a specimen as substituted when the specimen's creatinine concentration is less than 2 mg/dL andspecific gravity is less than or equal to 1.0010, or equal to or greater than 1.0200, on bothinitial and confirmatory creatinineand specific gravity tests

• SPTF version 1.7.0 (released in December 2016) includes a pop-up message that appears with additional guidance if a Substituted validity test result is selected [received fewer reporting errors in 2017]

• Next five slides discuss how to report subversion attempts (4 cases)

• Checklist available for the reporting of some subversion attempts http://pbadupws.nrc.gov/docs/ML1234/ML12346A186.pdf Slide 19

Reporting Errors Subversion Reporting - 4 Cases

• Case 1: 1st specimen out of temperature range (negative results) and 2nd specimen collected under direct observation is drug positive

• Case 2: Testing refusals (e.g., donor fails to appear for testing; collection process stopped; 1st specimen out of temperature range and donor refuses directly observed 2nd specimen)

• Case 3: 1st specimen is reported by the HHS-certified laboratory as invalid, after the MRO interview with the donor a 2nd specimen is collected under direct observation and is drug positive

• Case 4: 1st specimen out of temperature range (negative results),

2nd specimen collected under direct observation (negative results),

subversion determination based on other information Slide 20

Subversion Reporting - Case 1 1st specimen temp issue, 2nd specimen positive Initial specimen is out of temperature range (negative results), and directly observed 2nd specimen is drug positive

• Select Yes to Was this collection observed?

• Report the Substance(s) identified in the directly observed 2nd specimen

• Complete Subversion Attempt information (check boxes and text description)

Slide 21

Subversion Reporting - Case 2 Testing Refusals

• Donor failed to appear for a test

• 1st specimen out of temperature range, donor refused directly observed 2nd specimen

• Collector discovered paraphernalia and collection process stopped

• Shy-bladder with no legitimate medical condition For these events:

• Select Yes to Was this collection refused?

• Complete Subversion Attempt information (check boxes and text description)

Slide 22

Subversion Reporting - Case 3 1st specimen invalid; 2nd specimen positive Initial specimen is reported by the HHS-certified laboratory as invalid and the second specimen collected under direct observation is drug positive

• Select Yes to Was this collection observed?

• Report the Substance(s) identified in the directly observed 2nd specimen

• Complete Subversion Attempt information (check boxes and text description)

Slide 23

Subversion Reporting - Case 4 1st specimen temp issue, 2nd specimen observed (both negative results)

• Report Yes to Was this collection refused?

• MRO subversion determination based on a combination of the following:

- Significant differences in specimen temperature between two specimens collected

- Differences in physiological properties of the specimens (creatinine levels, specific gravity, pH)

- Information from the collector (e.g., unusual noises in private enclosure, physical characteristics of initial specimen, donor statements)

Slide 24

Reporting Error Unique Reference ID (SPTF)

Supplied by the licensee or other entity when completing each SPTF.

The NRCs data processing system:

• Utilizes the Unique Reference ID to evaluate if an existing SPTF is being updated or deleted (ensures database integrity)

• Will reject a file if the Submission Update check box is selected, but no original SPTF was received by the NRC. In this case, the NRC FFD team would contact the individual that submitted the form.

If a Unique Reference ID needs to be changed you must:

(1) Delete the original SPTF submitted which used that ID (see next slide)

(2) Submit a new SPTF with the new Unique Reference ID (do not select the Submission Update box for this file, this is a new submission)

Slide 25

Deleting an FFD E-Form ARF: E-mail NRC FFD team for assistance fitnessforduty.resource@nrc.gov SPTF:

• Unlock the original form that was submitted

[to delete a form the same Unique Reference ID must be used]

• Select Submission Update and Delete Submission check boxes

• Describe the change in Please explain the change(s) text box

• Validate & Lock form and submit to the NRC using the EIE General Form Slide 26

Reporting Error EIE General Form - Submission Reason Only Choose:

10 CFR Part 26 (Fitness for Duty and Annual Fatigue Reporting)

• To ensure that each e-form is automatically processed [computer code uses information from each form to create a uniform document profile in the NRCs Agency Documents Access and Management System (ADAMS)] (forms docketed in minutes)

• We have had some issues locating e-forms in previous years when the user selected the Submission Reason Other (Document Control Desk).

This selection results in a human being manually keying in information on each form (process takes much longer (days), can result in document profile inconsistencies)

Slide 27

Reporting Error EIE General Form - Missing Submissions Some sites sporadically have had e-form delivery issues (submitted files using EIE General Form, but files didnt docket in ADAMS)

• The BEST way to ensure that e-forms have been received is with the Email Acknowledgement receipt (includes Submission ID# and ADAMS accession numbers -- ML#s)

• Can also review Submission History tab in the EIE General Form

• Select Help in the EIE General Form window to display a document with additional information on Submission History (pages 17-18)

Slide 28

Where Can I Get Help on FFD reporting?

• Problems Delivering the Mail - EIE General Submission Portal Contact EIE help desk at 866-672-7640 (mshd.resource@nrc.gov)

- Obtain a digital certificate to enable e-reporting

- Troubleshoot access to the EIE General Submission website

• Questions on Completing E-forms, Suggestions for E-Form Improvements - Contact FFD program staff

- Brian Zaleski (FFD reporting lead) 301-287-0638 (Brian.Zaleski@NRC.gov)

- Paul Harris (301-287-9294; Paul.Harris@NRC.gov)

- FAQ email: fitnessforduty.resource@nrc.gov Slide 29

Questions Slide 30