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


Webinar Discussion Topics
Webinar Discussion Topics Introduction Annual FFD reporting data (10 CFR 26.717 and 26.417)
* Introduction
FFD electronic reporting forms (drug and alcohol only)
* Annual FFD reporting data (10 CFR 26.717 and 26.417)
Common reporting errors and guidance Questions Slide2
* FFD electronic reporting forms (drug and alcohol only)
* Common reporting errors and guidance
* Questions Slide 2


Annual FFD Program Performance Data
Annual FFD Program Performance Data Part 26 reporting requirements:  
* Part 26 reporting requirements:
- 26.717 (Operating power reactors; Category I fuel cycle facilities)
  - 26.717 (Operating power reactors; Category I fuel cycle facilities)
- 26.417(b)(2) (Power reactors under construction)
  - 26.417(b)(2) (Power reactors under construction)
Due to the NRC before March 1 after calendar year end Includes information such as:  
* Due to the NRC before March 1 after calendar year end
- Random testing rate
* Includes information such as:
- Substances tested and testing cutoff levels used
  - Random testing rate
- Populations tested (licensee employees, contractor/vendors)
  - Substances tested and testing cutoff levels used
- Conditions for testing (pre-access, random, for-cause, etc.)
  - Populations tested (licensee employees, contractor/vendors)
- Substances identified  
  - Conditions for testing (pre-access, random, for-cause, etc.)
- Subversion attempts by type
  - Substances identified
- Management actions Slide3
  - Subversion attempts by type
  - Management actions Slide 3


FFD Electronic Reporting Forms (E-forms)
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):
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) -
Annual Reporting Form for Drug and Alcohol Tests (ARF) -
NRC Form 891 (One ARF is completed for each site)
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)
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:
Slide4 Latest forms available for download at the NRC website:
http://www.nrc.gov/reactors/operating/ops-experience/
http://www.nrc.gov/reactors/operating/ops-experience/
fitness-for-duty-programs/submit-ffd-reports.html Slide 4
fitness-for-duty-programs/submit-ffd-reports.html


FFD E-forms - Use and Advantages
FFD E-forms - Use and Advantages Voluntary use, first available for calendar year 2009 reporting All sites using since 2014 Advantages:  
* Voluntary use, first available for calendar year 2009 reporting
- Adaptive form functions (fields appear/disappear based on entries)
* All sites using since 2014
- Built in validations improve data quality
* Advantages:
- In form guidance (pop-up text boxes)  
    - Adaptive form functions (fields appear/disappear based on entries)
- 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 Slide5 FFD e-forms periodically updated (e.g., to improve form completion speed, data uniformity, correct bugs) -- Feedback is ALWAYS welcome
    - 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
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)
* 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/)
* 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.
* Once OMB approves the information collection, a new expiration date is assigned, and the date will be updated on the SPTF and ARF.
Slide6
Slide 6


NRC Receipt Reviews of FFD Program Performance Reports
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:
* Performed by NRC FFD team to ensure that information is accurate and complete
- New staff completing forms
* Data quality has been improving as FFD e-form use has increased
- New reporting circumstance not previously encountered
* Likely reasons for reporting inconsistencies:
- 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 Slide7
  - 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
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)
* Unlocked Forms
Unique Reference ID Deleting an FFD E-form EIE General Form Submissions Slide8
* 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 &
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.
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.
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
Slide9 Best practice: Prior to submitting files to the NRC, open each e-form and confirm that the Locked button is visible


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:
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
- 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:
- 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
- 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:
- SPTF: 4 Pre-Access, 4 Random, 2 Followup = 10 results Slide10 Reasons identified for reporting inconsistencies:
* Same SPTF submitted more than once (duplicate file)
Same SPTF submitted more than once (duplicate file)
* Some SPTFs not received by the NRC
Some SPTFs not received by the NRC Two SPTFs submitted for same event (double reporting)
* Two SPTFs submitted for same event (double reporting)
Unlocked SPTFs  
* Unlocked SPTFs Slide 10


Reporting Error Multiple SPTFs for the Same Event
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:
* 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 1 = out of acceptable temperature range (negative)
- Specimen 2 = collected under direct observation (positive)
    - 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 Slide11 Remember this:
* 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)
Submit only one SPTF per FFD testing violation (not per specimen)
* One individual one SPTF
* One individual one SPTF
* One individual one Reason for Testing Slide 11
* One individual one Reason for Testing


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.
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
Slide12 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
* 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)
Reporting Errors HHS-Certified Laboratories (ARF)
: 1) Not including city and state for the laboratory Needed because some labs have multiple locations, for example:
: 1) Not including city and state for the laboratory Needed because some labs have multiple locations, for example:
  - Alere (Gretna, LA; Richmond, VA)
- Alere (Gretna, LA; Richmond, VA)
  - LabCorp (Houston, TX; Research Triangle Park, NC; Southhaven, MS)
- LabCorp (Houston, TX; Research Triangle Park, NC; Southhaven, MS)
  - Quest Diagnostics (Lenexa, KS; Norristown, PA; Tucker, GA)
- Quest Diagnostics (Lenexa, KS; Norristown, PA; Tucker, GA)
: 2) Not providing a response for both HHS-certified laboratory fields Remember this:
: 2) Not providing a response for both HHS-certified laboratory fields Slide13 Remember this:
* Include City and State for each HHS-certified laboratory
* 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)
* 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:
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 Slide14 SPTF reporting, things to remember:
* Choose Dilute for Test Validity
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)
* 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)
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
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?  
* 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
  - Supervisor
- Licensed Operator
  - Licensed Operator
- FFD Program Personnel
  - 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).
  - SSNM Transporter
Slide15
* 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)
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
* 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]
[See next slide for descriptions of maintenance associated labor categories]
Slide 16
Slide16 Use of the Other labor category primarily reflected maintenance activities that could have been characterized under Maintenance (general facility) or Facility support.


Reporting Error Labor Category (continued)
Reporting Error Labor Category (continued)
Best Practice: Instead of Other, consider one of these:
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 (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.
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.
Facility support - activities and positions associated with delivery, equipment room attendant, warehousing, stocking, janitorial services, cafeteria, administrative assistances, and landscaping.
Remember this:
Slide17 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)
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)
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.
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:
Slide18 Remember this:
* If an other substance is reported in a SPTF, ensure that the substance is also reported in the ARF.
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.
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
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):
* NRC receipt reviews identified incorrect reporting of substituted test results for subversion attempts
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]
* A substituted validity result is an HHS-certified laboratory result reported under 10 CFR 26.161(d):
Slide19
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)
* 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
* Checklist available for the reporting of some subversion attempts http://pbadupws.nrc.gov/docs/ML1234/ML12346A186.pdf


Reporting Errors Subversion Reporting - 4 Cases
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 1: 1st specimen out of temperature range (negative results) and 2nd specimen collected under direct observation is drug positive
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),
* 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),
2nd specimen collected under direct observation (negative results),
subversion determination based on other information Slide 20
subversion determination based on other information Slide20


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
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?
* 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)
* Report the Substance(s) identified in the directly observed 2nd specimen
Slide21
* Complete Subversion Attempt information (check boxes and text description)
Slide 21


Subversion Reporting - Case 2 Testing Refusals
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 Slide22 For these events:
* Donor failed to appear for a test
Select Yes to Was this collection refused?
* 1st specimen out of temperature range, donor refused directly observed 2nd specimen
Complete Subversion Attempt information (check boxes and text description)
* 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
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?
* 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)
* Report the Substance(s) identified in the directly observed 2nd specimen
Slide23
* 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)
Subversion Reporting - Case 4 1st specimen temp issue, 2nd specimen observed (both negative results)
* Report Yes to Was this collection refused?
Report Yes to Was this collection refused?
* MRO subversion determination based on a combination of the following:
MRO subversion determination based on a combination of the following:
    - Significant differences in specimen temperature between two specimens collected
Significant differences in specimen temperature between two specimens collected Differences in physiological properties of the specimens (creatinine levels, specific gravity, pH)
    - 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)
    - Information from the collector (e.g., unusual noises in private enclosure, physical characteristics of initial specimen, donor statements)
Slide24
Slide 24


Reporting Error Unique Reference ID (SPTF)
Reporting Error Unique Reference ID (SPTF)
Supplied by the licensee or other entity when completing each SPTF.
Supplied by the licensee or other entity when completing each SPTF.
The NRCs data processing system:
The NRCs data processing system:
* Utilizes the Unique Reference ID to evaluate if an existing SPTF is being updated or deleted (ensures database integrity)
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.
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:
Slide25 If a Unique Reference ID needs to be changed you must:
(1) Delete the original SPTF submitted which used that ID (see next slide)
(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)
(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:
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
Unlock the original form that was submitted
[to delete a form the same Unique Reference ID must be used]
[to delete a form the same Unique Reference ID must be used]
* Select Submission Update and Delete Submission check boxes
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 Slide26
* 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:
Reporting Error EIE General Form - Submission Reason Only Choose:
10 CFR Part 26 (Fitness for Duty and Annual Fatigue Reporting)
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)
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).
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)
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
Slide27


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)
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)
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
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)
* Select Help in the EIE General Form window to display a document with additional information on Submission History (pages 17-18)
Slide28
Slide 28


Where Can I Get Help on FFD reporting?
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)
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
- Obtain a digital certificate to enable e-reporting
  - Troubleshoot access to the EIE General Submission website
- Troubleshoot access to the EIE General Submission website Questions on Completing E-forms, Suggestions for E-Form Improvements - Contact FFD program staff
* 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)
  - Brian Zaleski (FFD reporting lead) 301-287-0638 (Brian.Zaleski@NRC.gov)
- Paul Harris (301-287-9294; Paul.Harris@NRC.gov)
  - Paul Harris (301-287-9294; Paul.Harris@NRC.gov)
- FAQ email: fitnessforduty.resource@nrc.gov Slide29
  - FAQ email: fitnessforduty.resource@nrc.gov Slide 29


Questions Slide 30}}
Questions Slide30}}

Latest revision as of 02:52, 7 January 2025

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
To:
References
Download: ML18031A940 (30)
v • d • e


Text

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 Slide2

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 Slide3

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)

Slide4 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

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 Slide5 FFD e-forms periodically updated (e.g., to improve form completion speed, data uniformity, correct bugs) -- Feedback is ALWAYS welcome

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.

Slide6

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 Slide7

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 Slide8

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.

Slide9 Best practice: Prior to submitting files to the NRC, open each e-form and confirm that the Locked button is visible

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 Slide10 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

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 Slide11 Remember this:

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

  • One individual one SPTF
  • One individual one Reason for Testing

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.

Slide12 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

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 Slide13 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)

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 Slide14 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)

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).

Slide15

Reporting Error Labor Category - Other (SPTF)

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]

Slide16 Use of the Other labor category primarily reflected maintenance activities that could have been characterized under Maintenance (general facility) or Facility support.

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.

Slide17 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)

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.

Slide18 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.

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]

Slide19

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

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 Slide20

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)

Slide21

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 Slide22 For these events:

Select Yes to Was this collection refused?

Complete Subversion Attempt information (check boxes and text description)

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)

Slide23

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)

Slide24

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.

Slide25 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)

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 Slide26

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)

Slide27

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)

Slide28

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 Slide29

Questions Slide30

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