ML23019A072
| ML23019A072 | |
| Person / Time | |
|---|---|
| Issue date: | 01/17/2023 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| ML23019A068 | |
| Download: ML23019A072 (1) | |
Text
Annual Fitness-For-Duty (FFD) Program Performance Reporting of Drug and Alcohol Testing Information under 10 CFR Part 26 Lessons Learned, Best Practices, and Use of NRC Forms 890 and 891 January 17, 2023 (Webinar)
Webinar Discussion Topics Opening Remarks FFD reporting requirements (10 CFR 26.717 and 26.417)
FFD electronic reporting forms (NRC Forms 890 and 891)
Lessons Learned and Best Practices Question and Answer Session Slide2
Annual FFD Program Performance Reporting Requirements 10 CFR 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 - 26.717(e)
Information to be reported under 26.717(b) includes items such as:
Random testing rate Substances tested and testing cutoff levels used Populations tested (licensee employee, contractor/vendor)
Conditions for testing (pre-access, random, for-cause, etc.)
Substances identified Subversion attempts (number by type)
Summary of management actions Slide3
FFD Electronic Reporting Forms (E-forms)
Each calendar year, a licensee or other entity submits drug and alcohol (D&A) testing information for each site using two electronic reporting forms (e-forms):
- NRC Form 890, Annual Reporting Form for Drug and Alcohol Tests (ARF):
One ARF completed per site.
- NRC Form 891, Single Positive Test Form (SPTF):
One SPTF completed for each D&A testing violation per 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 All sites using FFD e-forms since 2014, available to use since 2009 Advantages:
Adaptive form functions (fields appear/disappear based on entries)
Built in validations improve data quality In form guidance (pop-up text boxes appears if hold mouse over fields)
Detailed event specific data Data used to:
Evaluate Part 26 effectiveness, trending Inform stakeholders on substance use trends Inform NRC inspection process Estimate burden for 3-year Part 26 information collection extensions (Office of Management and Budget)
Slide5 FFD e-forms periodically updated (e.g., improve form completion speed, data uniformity, bugs fixes) -- Feedback is ALWAYS welcome
NRC Receipt Reviews of FFD Program Performance Reports Performed by NRC to ensure information is accurate and complete Data quality has significantly improved with FFD e-form use Likely reasons for reporting inconsistencies:
- New staff completing forms
- New reporting circumstance not previously encountered
- Disconnects between form completer(s) and submitter(s)
Slide6
Common 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 Slide7 All examples based on FFD program performance report reviews and lessons learned from those reviews
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 Slide8 Best practice: Before submitting files to the NRC, open each e-form, scroll to the bottom, and confirm the Locked green button is displayed
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. For example:
ARF: Pre-Access (13), Random (6), Followup (2) = 21 results
- SPTF: Pre-Access (12), Random (6), Followup (2) = 20 results Reason for Testing - Must be the same for each D&A test result and refusal to test reported in the ARF and in the SPTFs. For example:
ARF: Pre-Access (15), Random (3), Followup (1) = 19 results
- SPTF: Pre-Access (14), Random (4), Followup (1) = 19 results Slide9 Typical reasons for reporting inconsistencies:
Same SPTF submitted more than once (uploaded same file twice)
Same SPTF Unique Reference ID but different data (copy/paste issue)
Inconsistent Reason for Testing selected in SPTF and ARF Missing SPTF(s) (if use sequential Unique Reference ID - easy to identify; e.g., ABC-2021-01; ABC-2022-02; ABC-2022-03; ABC-2022-05)
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 Slide10 Remember this:
Submit only one SPTF per FFD testing violation (not per specimen)
- One individual one SPTF
- One individual one Reason for Testing
[Over time, this reporting error has declined considerably]
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.
Slide11 Some licensees mistakenly selected 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)
- 2) Not providing a response for both HHS-certified laboratory fields Slide12 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 (SPTF)
Dilute Specimen, Limit of Detection (LOD) Testing HHS-certified laboratory reports Test Validity as Dilute and special analysis LOD testing under 10 CFR 26.163(a)(2) determines the specimen is drug positive Slide13 Things to remember:
Choose Dilute for Test Validity Ensure initial cutoff is 50% of the standard cutoff level Confirmatory cutoff is the LOD for the testing assay (do not report the actual quantitation of the test)
Reporting Error 24-Hour Event Reports (SPTF)
Typically receive a few SPTFs each year with inconsistent information from that provided in the 24-hour event report made under 10 CFR 26.719 Inconsistency is often because the Labor Category chosen is not the reportable Labor Category (e.g., Facility Support instead of Supervisor)
Slide14 Things to remember:
Always select the Labor Category that required the 24-hour report (i.e., Supervisor, Licensed Operator, FFD program personnel, SSNM Transporter)
The SPTF auto-populates Yes for Is this a 24-hour reportable event when a 10 CFR 26.719 reportable labor category is chosen If a Licensed Operator is also a Supervisor, report Licensed Operator
Reporting Error Labor Category - Other (SPTF)
Example Other labor category descriptions:
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 Slide15 Other labor category primarily selected when Maintenance (general facility) or Facility support would be appropriate Next slide provides descriptions for maintenance associated labor categories Are we missing any helpful Labor Categories?
Let us know
Reporting Error Labor Category (continued)
Best Practice: Instead of Other, consider one of these:
Maintenance (general facility) - maintenance activities not performed on safety-or security-related structures, systems, and components (SSCs)
(e.g., cleaners, painters, roofers, scaffolders)
Facility support - activities and positions associated with delivery, equipment room attendant, warehousing, stocking, janitorial services, cafeteria, administrative assistants, landscaping, etc.
Slide16 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 in a SPTF, but the substance is not listed in the Substances Tested section of the ARF.
Slide17 Remember this:
If an Other substance is tested (either reported in a SPTF for a positive OR not), ensure that the substance is reported in the ARF.
Use the Comment 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 occasionally identify the incorrect reporting of substituted test results for subversion attempts Slide18 Next five slides discuss how to report subversion attempts (4 cases)
The following pop-up message will appear with additional guidance if a Substituted result is selected for Test Validity
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, and 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 Slide19
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)
Slide20
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 Slide21 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)
Slide22
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 privacy enclosure, physical characteristics of initial specimen, donor statements)
Slide23
Reporting Error Unique Reference ID (SPTF)
Supplied by the licensee or other entity when completing each SPTF.
Slide24 If a Unique Reference ID needs to be changed you must:
(1) Delete the original SPTF submitted that used that ID (see next slide)
(2) Submit a new SPTF with the new Unique Reference ID (this is a new submission, do not select Submission Update box)
The NRCs data processing system:
Uses the Unique Reference ID to identify 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 will contact the individual that submitted the form.
Deleting an FFD E-Form SPTF:
Unlock the original form submitted to the NRC
[to delete a form the same Unique Reference ID must be used]
Select Submission Update and Delete Submission check boxes Describe why deleting the SPTF in Please explain the change(s) text box Validate & Lock form and submit to the NRC using the EIE General Form ARF: E-mail/call the NRC FFD team for assistance Slide25
Reporting Error: EIE General Form, New Submission selection Slide26 Only Choose >>> New Fitness for Duty (Part 26) Submission This selection ensures that the e-form(s) are automatically processed
[computer code uses information in 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 New General Form Submission. This choice directs the forms to be docketed by a human being who manually enters information on each form to docket the file in ADAMS (process takes much longer (days) and can result in document profile inconsistencies)
Reporting Error: EIE General Form, PII In File Name or Document Title Slide27
EIE General Form - Submission Confirmation Slide28 1.Emailreceipt 2.CheckSubmissionHistoryinEIE
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 (digital certificate is locally based on one computer)
- 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)
- FAQ email: fitnessforduty.resource@nrc.gov Slide29
Questions Slide30