ML24059A170: Difference between revisions

From kanterella
Jump to navigation Jump to search
(StriderTol Bot insert)
 
(StriderTol Bot change)
 
Line 18: Line 18:
{{#Wiki_filter:Dustin T. Hamman Director Nuclear Regulatory Affairs
{{#Wiki_filter:Dustin T. Hamman Director Nuclear Regulatory Affairs


February 28,                                           2024 000335
February 28, 2024 000335


U.S. Nuclear Regulatory Commission Attn: NRC Document Control Desk Washington, DC 20555-0001
U.S. Nuclear Regulatory Commission Attn: NRC Document Control Desk Washington, DC 20555-0001


==Subject:==
==Subject:==
Docket           No.           50-482:                               Electronic Submittal of Annual Fitness for Duty Program Performance Report and Annual Fatigue Report for 2023
Docket No. 50-482: Electronic Submittal of Annual Fitness for Duty Program Performance Report and Annual Fatigue Report for 2023


Commissioners and Staff:
Commissioners and Staff:


The enclosed documents contain Wolf Creek Nuclear Operating Corporation                                       s                       (WCNOC)   2023 Annual Fitness for Duty (FFD) program performance data and Annual Fatigue Report               .         This submittal meets the requirements of   10 CFR 26.203, 10 CFR 26.717 and 10 CFR 26.719.     In accordance with 10 CFR 26.11, copies of the reported information are also enclosed with this report for the appropriate regional office and Senior Resident Inspector.
The enclosed documents contain Wolf Creek Nuclear Operating Corporation s (WCNOC) 2023 Annual Fitness for Duty (FFD) program performance data and Annual Fatigue Report. This submittal meets the requirements of 10 CFR 26.203, 10 CFR 26.717 and 10 CFR 26.719. In accordance with 10 CFR 26.11, copies of the reported information are also enclosed with this report for the appropriate regional office and Senior Resident Inspector.


This letter contains no commitments. If you have any questions concerning this matter, please contact me at (620) 364-                                                                 4204.
This letter contains no commitments. If you have any questions concerning this matter, please contact me at (620) 364-4204.


Sincerely,
Sincerely,
Line 37: Line 37:
DTH/nwl
DTH/nwl


Enclosure I:   2023                                                                 Fatigue Assessment and Report (2 pages)
Enclosure I: 2023 Fatigue Assessment and Report (2 pages)
Enclosure II: 2023                                                                 FFD Report and Attachment (12                                             pages)
Enclosure II: 2023 FFD Report and Attachment (12 pages)


CC: S. S. Lee (NRC), w/e J. D. Monninger (NRC), w/e G. E. Werner (NRC), w/e Senior Resident Inspector (NRC), w/e Licensing Correspondence -           RA 24-000335, w/e
CC: S. S. Lee (NRC), w/e J. D. Monninger (NRC), w/e G. E. Werner (NRC), w/e Senior Resident Inspector (NRC), w/e Licensing Correspondence - RA 24-000335, w/e


P.O. Box 411                       l Burlington, KS 66839           l 620-364-                     8831
P.O. Box 411 l Burlington, KS 66839 l 620-364-8831


Enclosure I t                 o 000335
Enclosure I t o 000335


2023     Fatigue Assessment and Report (This enclosure contain   s 2   pages)
2023 Fatigue Assessment and Report (This enclosure contain s 2 pages)


NRC FFD Program Performance Data Reporting System 10 CFR Part 26, Subpart I                 -
NRC FFD Program Performance Data Reporting System 10 CFR Part 26, Subpart I -
Managing Fatigue
Managing Fatigue


Attachment This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic F atigue Management form.
Attachment This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic F atigue Management form.


Analysis of Waiver Assessment Data:
Analysis of Waiver Assessment Data:
One work hour waiver completed for 202 3.
One work hour waiver completed for 202 3.
Waiver 11/2/2023 ONLINE Waiver issued to ensure minimum                                       NSO and fire brigade staffing due to sick callout.
Waiver 11/2/2023 ONLINE Waiver issued to ensure minimum NSO and fire brigade staffing due to sick callout.
Waiver request initiated f           or an operator to extend shift for 1             additional hour until relief could report. This extension would exceed work hours by 1 hour   in regards to greater than 16 work hours in any 24-                         hour period and greater than 26 work hours in any 48-hour period. Waiver for individual was initiated and approved by management.
Waiver request initiated f or an operator to extend shift for 1 additional hour until relief could report. This extension would exceed work hours by 1 hour in regards to greater than 16 work hours in any 24-hour period and greater than 26 work hours in any 48-hour period. Waiver for individual was initiated and approved by management.
Individual performed work satisfactory and relieved in 1-               hour time frame when relief arrived. No concerns noted in review of the waiver documentation or fatigue assessment documentation.
Individual performed work satisfactory and relieved in 1-hour time frame when relief arrived. No concerns noted in review of the waiver documentation or fatigue assessment documentation.


Analysis of Fatigue Assessment Data:
Analysis of Fatigue Assessment Data:
Six fatigue assessments were completed in 2023.
Six fatigue assessments were completed in 2023.
#1 Post event 1/23/2023                                                 ONLINE
#1 Post event 1/23/2023 ONLINE
#2 For cause 6/8/2023                                                 ONLINE
#2 For cause 6/8/2023 ONLINE
#3 For cause 7/10/2023                         ONLINE
#3 For cause 7/10/2023 ONLINE
#4 Post event 7/16/2023                         ONLINE
#4 Post event 7/16/2023 ONLINE
#5 For cause 8/8/2023 ONLINE
#5 For cause 8/8/2023 ONLINE
#6 Waiver 11/2/2023 ONLINE Condition reports were validated to be initiated for fatigue assessments within the corrective action program. In review of responses within fatigue assessments individuals involved did not describe or document any issues with fatigue or work hours that could have contributed to the event. The waiver initiated in operations                                         for minimum staffing met regulatory and procedure requirements. No issues were identified from operations management for individual                       working additional work hours to maintai n staffing.
#6 Waiver 11/2/2023 ONLINE Condition reports were validated to be initiated for fatigue assessments within the corrective action program. In review of responses within fatigue assessments individuals involved did not describe or document any issues with fatigue or work hours that could have contributed to the event. The waiver initiated in operations for minimum staffing met regulatory and procedure requirements. No issues were identified from operations management for individual working additional work hours to maintai n staffing.


==
==
Conclusions:==
Conclusions:==
The results of the annual fatigue management program effectiveness review determined Wolf Creek is effective in controlling the work hours of individuals subject to work hour controls.
The results of the annual fatigue management program effectiveness review determined Wolf Creek is effective in controlling the work hours of individuals subject to work hour controls.


Line 78: Line 77:
Enclosure II to 000335
Enclosure II to 000335


2023 FF     D Report and Attachment (This enclosure contain   s 12 pages)
2023 FF D Report and Attachment (This enclosure contain s 12 pages)
FFD Program Performance Data Reporting System NRC Form 891, Annual Reporting Form for Drug and Alcohol Tests
FFD Program Performance Data Reporting System NRC Form 891, Annual Reporting Form for Drug and Alcohol Tests


(submit using the NRC EIE General Submission portal)
(submit using the NRC EIE General Submission portal)
APPROVED BY OMB: CLEARANCE NO. 3150-0146                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             EXPIRES: 09/30/2024 Estimated burden per response to comply with this collection request is 106 hours. This form is a voluntary means of reporting the information required under 10 CFR 26.417(b)(2) and 26.717. The information is required by the NRC to obtain on an annual basis site specific fitness-for-duty (FFD) program performance data on drug and alcohol programs from licensees and other entities. Send comments regarding burden estimate to the FOIA, Library, and Information Collections Branch (T-6 A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@NRC.gov, and the OMB reviewer at: OMB Office of Information and Regulatory Affairs, (3150-0146), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; e-mail: oira_submission@omb.eop.gov. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
APPROVED BY OMB: CLEARANCE NO. 3150-0146 EXPIRES: 09/30/2024 Estimated burden per response to comply with this collection request is 106 hours. This form is a voluntary means of reporting the information required under 10 CFR 26.417(b)(2) and 26.717. The information is required by the NRC to obtain on an annual basis site specific fitness-for-duty (FFD) program performance data on drug and alcohol programs from licensees and other entities. Send comments regarding burden estimate to the FOIA, Library, and Information Collections Branch (T-6 A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@NRC.gov, and the OMB reviewer at: OMB Office of Information and Regulatory Affairs, (3150-0146), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; e-mail: oira_submission@omb.eop.gov. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
: 1) All fields required unless marked 'optional'
: 1) All fields required unless marked 'optional'
: 2) Use of Adobe Reader 8 or later is required                                                                                                                                                                                                                                                                         Submission
: 2) Use of Adobe Reader 8 or later is required Submission
: 3) Mouse over fields for additional information                                                                                                                                                                                                                                                                       Update
: 3) Mouse over fields for additional information Update


Facility                                                                                                                                                                                                                                                                                               Period of Report Wolf Creek [50-482]                                                                                                                                                                                                                                                                                                         2023
Facility Period of Report Wolf Creek [50-482] 2023


Tests Conducted in the Calendar Year
Tests Conducted in the Calendar Year


Reason For Testing                                                                                                                                                                                                                                                                   Total Number of Tests Conducted                                                                                                                                                                                                                                                                                                                                     Total Number of Positive, Adulterated, Licensee Employees                                                                                                                                                                 Contractors/Vendors Substituted, and Refusal to Test Results
Reason For Testing Total Number of Tests Conducted Total Number of Positive, Adulterated, Licensee Employees Contractors/Vendors Substituted, and Refusal to Test Results


Pre-Access                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     83 217                                                                                                                                                                                                   3
Pre-Access 83 217 3


Random                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               420                                                                                                                                                                                                                                                                                                                                                                                                                               79                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       1
Random 420 79 1


For Cause                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     2                                                                                                                                                                                                                                                                                                                                                                                                                                       2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       1
For Cause 2 2 1


Post-Event                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               2                                                                                                                                                                                                                                                                                                                                                                                                                                       0                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       0
Post-Event 2 0 0


Followup                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   21                                                                                                                                                                                                                                                                                                                                                                                                                                       3                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       1
Followup 21 3 1


Total (Calculated)       528 301                                                                                                                                                                                               6
Total (Calculated) 528 301 6


FFD Program Random Testing Population and Rate Average number of                                                                                                         Average number of                                                                                                           Total size of the random testing pool                                                                                                                                         Annual random testing percentage licensee employees                                                                                                       contractors/vendors                                                                                                         throughout the period (Calculated)                                                                                                                                           achieved for the testing pool
FFD Program Random Testing Population and Rate Average number of Average number of Total size of the random testing pool Annual random testing percentage licensee employees contractors/vendors throughout the period (Calculated) achieved for the testing pool


730                                                                                                                       215                                                                                                                                                                             945                                                                                                                                                                       52.8
730 215 945 52.8


Laboratory Testing
Laboratory Testing


Does your program use a Licensee Testing Facility?   No                                                                                                                                                                                                                                                                               HHS-Certified Laboratory Clinical Reference Laboratory (Primary)
Does your program use a Licensee Testing Facility? No HHS-Certified Laboratory Clinical Reference Laboratory (Primary)


Blind Performance Test Sample Supplier(s)     ElSohly Laborat ory                                                                                                                                                                                                                                                                                                                         HHS-Certified Laboratory Quest Laboratory (Lenexa, KS)
Blind Performance Test Sample Supplier(s) ElSohly Laborat ory HHS-Certified Laboratory Quest Laboratory (Lenexa, KS)
(Backup)
(Backup)


Special Analyses Testing Results                                                                                                                                                                                                                                                                                                                                                                         Total Number of Specimens
Special Analyses Testing Results Total Number of Specimens
          - 26.163(a)(2) and 26.717(b)(2)                                                                                                                                       Total Number of "Dilute" Specimen Test Results (Optional)                                                                                                                                                     (Special Analyses Testing Conducted)                                                                                                                                                                   1
- 26.163(a)(2) and 26.717(b)(2) Total Number of "Dilute" Specimen Test Results (Optional) (Special Analyses Testing Conducted) 1


Substances Tested Did your program only test for NRC-required substances AND at the NRC-specified minimum cutoff levels? Yes
Substances Tested Did your program only test for NRC-required substances AND at the NRC-specified minimum cutoff levels? Yes


Annual Report Form (version 1.11.0 - November 2022)                                                                                                                                                                                                                                 - Page 1 of 2 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           NRC Form 891 Additional Substances Tested
Annual Report Form (version 1.11.0 - November 2022) - Page 1 of 2 - NRC Form 891 Additional Substances Tested


Summary of Management Actions - 26.717(b)(8)
Summary of Management Actions - 26.717(b)(8)
Summarize actions implemented to improve FF D program performance. As applicable, reference in the topic description audit repor ts, 30-day reports, and/or corrective action reports. If reporting information on more than three topics, select "Others" for Topic 3 to report any additi onal topics.
Summarize actions implemented to improve FF D program performance. As applicable, reference in the topic description audit repor ts, 30-day reports, and/or corrective action reports. If reporting information on more than three topics, select "Others" for Topic 3 to report any additi onal topics.


Topic 1                                                   Topic 1 Description Policies and Procedures                                   CR # 10024690 NRC Green NCV - Fitness For Duty Policy did not provide specific guidance for employees to report directly to FFD testing as soon as reasonably prac ticable once notified of a random test.
Topic 1 Topic 1 Description Policies and Procedures CR # 10024690 NRC Green NCV - Fitness For Duty Policy did not provide specific guidance for employees to report directly to FFD testing as soon as reasonably prac ticable once notified of a random test.
NRC Inspection Report 2023-401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.
NRC Inspection Report 2023-401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.
Actions taken to correct this deficiency and strengthen the FFD program -
Actions taken to correct this deficiency and strengthen the FFD program -
Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practi cable verbiage, so individual s are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified. There was no reportability.
Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practi cable verbiage, so individual s are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified. There was no reportability.
1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and t he Director of Nuclear Maintenance on June 07, Add an additional Topic                               2023. All FFD / FM Policy hard copy documents were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was pub lished in the Wolf Creek News on June 21, 2023 Topic 2                                                   Topic 2 Description Blind Performance Test Samples                           CR # 10023241 - Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access Screening was notified a blind per formance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected. In discussion with the MRO staff at Coffey County Hospital it is belie ved the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.
1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and t he Director of Nuclear Maintenance on June 07, Add an additional Topic 2023. All FFD / FM Policy hard copy documents were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was pub lished in the Wolf Creek News on June 21, 2023 Topic 2 Topic 2 Description Blind Performance Test Samples CR # 10023241 - Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access Screening was notified a blind per formance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected. In discussion with the MRO staff at Coffey County Hospital it is belie ved the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.
Actions taken - Access Screening conducted an ex tensive investigation and found the unexpected Blind Result was a result of human error. We foun d substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30-day report.
Actions taken - Access Screening conducted an ex tensive investigation and found the unexpected Blind Result was a result of human error. We foun d substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30-day report.
After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate the possibility of human error in the future. The improvement Add an additional Topic                               suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screeni ng. CCH MRO Staff will continue to order the blind Topic 3                                                   Topic 3 Description Other(s)                                                 CR # 10022895 - Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed.
After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate the possibility of human error in the future. The improvement Add an additional Topic suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screeni ng. CCH MRO Staff will continue to order the blind Topic 3 Topic 3 Description Other(s) CR # 10022895 - Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed.
Upon investigation it was confirmed the MRO did not follow 10 CFR 26.119. 10 CFR 26.119(c) states Please elaborate:                                         "The physician who conducts this evaluation shall make one of the following determinations:
Upon investigation it was confirmed the MRO did not follow 10 CFR 26.119. 10 CFR 26.119(c) states Please elaborate: "The physician who conducts this evaluation shall make one of the following determinations:
CR # 10024692 - 2023 NRC FFD Inspection                   (1) A medical condition has, or with a high degree of probability could have, precluded the donor from Minor Violation Training. Collector training             providing a sufficient amount of urine; or contained incorrect information regarding the             (2) There is an inadequate basis for determining that a medical condition has, or with a high degree of use of temperature strips.                               probability could have, precluded the donor from providing a sufficient quantity of urine."
CR # 10024692 - 2023 NRC FFD Inspection (1) A medical condition has, or with a high degree of probability could have, precluded the donor from Minor Violation Training. Collector training providing a sufficient amount of urine; or contained incorrect information regarding the (2) There is an inadequate basis for determining that a medical condition has, or with a high degree of use of temperature strips. probability could have, precluded the donor from providing a sufficient quantity of urine."
The NRC Inspection Report 2023-401                       Actions taken - Access Screening c onducted a meeting with the Coffey County Hospital MRO Chief of proposed an NRC-Identified Minor Violation of             Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We 10 CFR 26.85(a)(1), which requires each                   discussed 10 CFR 26.119(c). Since this individual did not have a medical condition which precluded them to provide a sample the determination by th e MRO should have been considered a refusal to test as per 10 CFR 119(g)(2). The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expec tations moving forward. Access Screening provided copies of
The NRC Inspection Report 2023-401 Actions taken - Access Screening c onducted a meeting with the Coffey County Hospital MRO Chief of proposed an NRC-Identified Minor Violation of Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We 10 CFR 26.85(a)(1), which requires each discussed 10 CFR 26.119(c). Since this individual did not have a medical condition which precluded them to provide a sample the determination by th e MRO should have been considered a refusal to test as per 10 CFR 119(g)(2). The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expec tations moving forward. Access Screening provided copies of


Person(s) Responsible for Information Provided Person 1 (required):
Person(s) Responsible for Information Provided Person 1 (required):


Mallory                                   Rosales                                   Senior Access Specialist                   mallory.rosales@evergy.com First Name                                 Last Name                                 Position Title                           Company Email Address Person 2 (optional):
Mallory Rosales Senior Access Specialist mallory.rosales@evergy.com First Name Last Name Position Title Company Email Address Person 2 (optional):


Sonya                                     Jones                                     Supervisor of Access Screening             sonya.jones@evergy.com First Name                                 Last Name                                 Position Title                           Company Email Address
Sonya Jones Supervisor of Access Screening sonya.jones@evergy.com First Name Last Name Position Title Company Email Address


Final Step (Required) - NRC will consider this form authentic in accordance with 10 CFR 26.11 only when the Validate & Lock button has been selected and all errors (i.e., those highlighted in red) have been corrected. The Validate & Lock button will change to Locked after the data validation process has been successfully completed and the form is ready for submission.
Final Step (Required) - NRC will consider this form authentic in accordance with 10 CFR 26.11 only when the Validate & Lock button has been selected and all errors (i.e., those highlighted in red) have been corrected. The Validate & Lock button will change to Locked after the data validation process has been successfully completed and the form is ready for submission.


Locked             Form Locked On: Feb 26, 2024 at 2:52:03 PM                                                               Save to Local PC           Print this Report
Locked Form Locked On: Feb 26, 2024 at 2:52:03 PM Save to Local PC Print this Report


Annual Report Form (version 1.11.0 - November 2022)                                                                                                                                                                                                                                 - Page 2 of 2 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           NRC Form 891 NRC FFD Program Performance Data Reporting 10CFR Part 26   -             FFD
Annual Report Form (version 1.11.0 - November 2022) - Page 2 of 2 - NRC Form 891 NRC FFD Program Performance Data Reporting 10CFR Part 26 - FFD


This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic             form.
This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic form.


FFD Summary of Management Actions Summarize actions implemented to improve FFD program performance
FFD Summary of Management Actions Summarize actions implemented to improve FFD program performance
Line 155: Line 154:
Topic 1: Policies and Procedure
Topic 1: Policies and Procedure


CR # 10024690 NRC Green NCV -             Fitness For Duty Policy did not provide specific guidance for empl oyees to report directly to FFD testing as soon as reasonably practicable once notified of a random test.
CR # 10024690 NRC Green NCV - Fitness For Duty Policy did not provide specific guidance for empl oyees to report directly to FFD testing as soon as reasonably practicable once notified of a random test.


NRC Inspection Report 2023-                                                 401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail     to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.
NRC Inspection Report 2023-401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.


Actions taken to correct this deficiency and strengthen the FFD program     -
Actions taken to correct this deficiency and strengthen the FFD program -


Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practicable verbiage, so individuals are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified.
Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practicable verbiage, so individuals are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified.
There was no reportability.
There was no reportability.


1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and the Director of Nuclear Maintenance on June 07, 2023. All FFD / FM Policy hard copy document     s were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was published in the Wolf Creek News on June 21, 2023 to inform site personnel the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing. The Access Screening share point was updated with the new FFD / FM Policy on June 07, 2023.
1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and the Director of Nuclear Maintenance on June 07, 2023. All FFD / FM Policy hard copy document s were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was published in the Wolf Creek News on June 21, 2023 to inform site personnel the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing. The Access Screening share point was updated with the new FFD / FM Policy on June 07, 2023.


2)Procedure AP 01A -001 (Fitness for Duty Program) was revised to align with 10 CFR 26.31(d)(2)(iii) requirements of reporting to the collection sit   e as soon as reasonably practicable within the time specified in the FFD policy.
2)Procedure AP 01A -001 (Fitness for Duty Program) was revised to align with 10 CFR 26.31(d)(2)(iii) requirements of reporting to the collection sit e as soon as reasonably practicable within the time specified in the FFD policy.


3)An article was published in the Wolf Creek News to communicate the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing.
3)An article was published in the Wolf Creek News to communicate the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing.
Line 174: Line 173:
Topic 2: Blind Performance Test Samples
Topic 2: Blind Performance Test Samples


CR # 10023241 -                         Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access S creening was notified a blind performance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected.       In discussion with the MRO staff at Coffey County Hospital it is believed the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.
CR # 10023241 - Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access S creening was notified a blind performance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected. In discussion with the MRO staff at Coffey County Hospital it is believed the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.


Actions taken -                                                 Access Screening conducted an extensive investigation and   found the unexpected Blind Result was a result of human error. We found substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30-                                                                                     day report.
Actions taken - Access Screening conducted an extensive investigation and found the unexpected Blind Result was a result of human error. We found substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30- day report.


After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate th   e possibility of human error in the future. The improvement suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screening. CCH MRO Staff will continue to order the blind spec   imens through ElSohly, they will contact Access Screening to pick up the unpackaged blind specimens and then review the test results when theyre returned from CRL. Access Screening will be responsible for preparing the blind specimen for shipment. The st     rength gained in this change is only 1 blind specimen will be packaged on the designated day the blind is scheduled to be sent which can mitigate the possibility of h               uman error and eliminates the packaging all the blinds at one time as the MRO Staff was doing. This improvement in the process cuts down on the multiple steps used in the past between MRO Staff and Access                                           Screening.
After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate th e possibility of human error in the future. The improvement suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screening. CCH MRO Staff will continue to order the blind spec imens through ElSohly, they will contact Access Screening to pick up the unpackaged blind specimens and then review the test results when theyre returned from CRL. Access Screening will be responsible for preparing the blind specimen for shipment. The st rength gained in this change is only 1 blind specimen will be packaged on the designated day the blind is scheduled to be sent which can mitigate the possibility of h uman error and eliminates the packaging all the blinds at one time as the MRO Staff was doing. This improvement in the process cuts down on the multiple steps used in the past between MRO Staff and Access Screening.


Topic 3: Policies and Procedure
Topic 3: Policies and Procedure


CR # 10022895 -                         Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed. Upon investigation it was confirmed the MRO did not
CR # 10022895 - Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed. Upon investigation it was confirmed the MRO did not


follow 10 CFR 26.119. 10 CFR 26.119(c) states "The physician who conducts this evaluation shall make one of the following determinations:
follow 10 CFR 26.119. 10 CFR 26.119(c) states "The physician who conducts this evaluation shall make one of the following determinations:


(1) A medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficie nt amount of urine; or
(1) A medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficie nt amount of urine; or


(2) There is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine."
(2) There is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine."


Actions taken -                                     Access Screening                                                 conducted a meeting with the Coffey County Hospital MRO Chief of Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We discussed 10 CFR 26.119(c)   . Since this individual did not have a medical condition which precluded them   to provide a sample the determination by the MRO should have been considered a refusal to test as per 10 CFR 119(g)(2)     . The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expectations moving forward. Access                                           Screening provided copies of 10 CFR 26 handouts (26.119, 26.183, 26.185, & 26.187) for the MRO Chief of Staff to use for communicating the expectations going forward to our other MROs. Ensuring communication occurred to the other MROs was verified by calling the Director of Clinical Operations. All MROs have the documentation to understand the expectations.
Actions taken - Access Screening conducted a meeting with the Coffey County Hospital MRO Chief of Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We discussed 10 CFR 26.119(c). Since this individual did not have a medical condition which precluded them to provide a sample the determination by the MRO should have been considered a refusal to test as per 10 CFR 119(g)(2). The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expectations moving forward. Access Screening provided copies of 10 CFR 26 handouts (26.119, 26.183, 26.185, & 26.187) for the MRO Chief of Staff to use for communicating the expectations going forward to our other MROs. Ensuring communication occurred to the other MROs was verified by calling the Director of Clinical Operations. All MROs have the documentation to understand the expectations.
During this meeting it was discovered the dictation system has been significantly upgraded since this issue occurred. The MROs dictation is now imm ediate as opposed to previously having a 24-                                               hr. delay, closing the gap between when the evaluation occurs and Access Screening receiving the MRO determination. The MROs full dictation notes from 2021 to current were provided to Access Screening                                                     for review. The review did not identify any issues. Supplier Quality auditor initiated a Report of Non   -Compliance (RON
During this meeting it was discovered the dictation system has been significantly upgraded since this issue occurred. The MROs dictation is now imm ediate as opposed to previously having a 24-hr. delay, closing the gap between when the evaluation occurs and Access Screening receiving the MRO determination. The MROs full dictation notes from 2021 to current were provided to Access Screening for review. The review did not identify any issues. Supplier Quality auditor initiated a Report of Non -Compliance (RON
# 25471-                                                                       01) to Coffey County Hospital. The individual has now been correctly sanctioned. Access Screening also incorporated into the Water Intake process an informational sheet detailing the Water Intake and Shy Bladder Processes     and the possible consequences . When the Water Intake process is needed the collector will get out informational sheet have the donor read the sheet, ensure they have no ques     tions, and                                                                       have them sign the Water Intake form they understand the process and possible consequences.
# 25471- 01) to Coffey County Hospital. The individual has now been correctly sanctioned. Access Screening also incorporated into the Water Intake process an informational sheet detailing the Water Intake and Shy Bladder Processes and the possible consequences. When the Water Intake process is needed the collector will get out informational sheet have the donor read the sheet, ensure they have no ques tions, and have them sign the Water Intake form they understand the process and possible consequences.


Topic 4: Training
Topic 4: Training


CR # 10024692 -             2023 NRC FFD Inspection Minor Violation                           Training. Collector training contained incorrect information                                                   regarding the use of temperature strips.
CR # 10024692 - 2023 NRC FFD Inspection Minor Violation Training. Collector training contained incorrect information regarding the use of temperature strips.


The NRC Inspection Report 2023-                         401 proposed an NRC -Identified Minor Violation of 10 CFR 26.85(a)(1), which requires each collector shall be knowledgeable of the
The NRC Inspection Report 2023-401 proposed an NRC -Identified Minor Violation of 10 CFR 26.85(a)(1), which requires each collector shall be knowledgeable of the


requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed and shall keep current on any changes to the collection procedures for each specimen the individual is qualified to collect under this part. Specifically, the Licensee did not provi   de the correct training for measuring temperature of collections using the temperature strips used at the station.
requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed and shall keep current on any changes to the collection procedures for each specimen the individual is qualified to collect under this part. Specifically, the Licensee did not provi de the correct training for measuring temperature of collections using the temperature strips used at the station.


Actions Taken -             Access Screening reviewed the collector training material and removed the incorrect temperature strip training aide. The Fi   tness for Duty collector training material is now correct and in compliance with 10 CFR 26.85(a)(1). FFD / Access Screening verified procedure AI 01A -002, Fitness For Duty Screenings, aligns with the Fitness for Duty collector training material and they both align with the manufacturers recommendation on how to use and read the temperature strips.}}
Actions Taken - Access Screening reviewed the collector training material and removed the incorrect temperature strip training aide. The Fi tness for Duty collector training material is now correct and in compliance with 10 CFR 26.85(a)(1). FFD / Access Screening verified procedure AI 01A -002, Fitness For Duty Screenings, aligns with the Fitness for Duty collector training material and they both align with the manufacturers recommendation on how to use and read the temperature strips.}}

Latest revision as of 13:51, 5 October 2024

Annual Fitness for Duty Program Performance Report, and Annual Fatigue Report for 2023
ML24059A170
Person / Time
Site: Wolf Creek Wolf Creek Nuclear Operating Corporation icon.png
Issue date: 02/28/2024
From: Hamman D
Wolf Creek
To:
Document Control Desk, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response
References
000335
Download: ML24059A170 (17)


Text

Dustin T. Hamman Director Nuclear Regulatory Affairs

February 28, 2024 000335

U.S. Nuclear Regulatory Commission Attn: NRC Document Control Desk Washington, DC 20555-0001

Subject:

Docket No. 50-482: Electronic Submittal of Annual Fitness for Duty Program Performance Report and Annual Fatigue Report for 2023

Commissioners and Staff:

The enclosed documents contain Wolf Creek Nuclear Operating Corporation s (WCNOC) 2023 Annual Fitness for Duty (FFD) program performance data and Annual Fatigue Report. This submittal meets the requirements of 10 CFR 26.203, 10 CFR 26.717 and 10 CFR 26.719. In accordance with 10 CFR 26.11, copies of the reported information are also enclosed with this report for the appropriate regional office and Senior Resident Inspector.

This letter contains no commitments. If you have any questions concerning this matter, please contact me at (620) 364-4204.

Sincerely,

Dustin T. Hamman

DTH/nwl

Enclosure I: 2023 Fatigue Assessment and Report (2 pages)

Enclosure II: 2023 FFD Report and Attachment (12 pages)

CC: S. S. Lee (NRC), w/e J. D. Monninger (NRC), w/e G. E. Werner (NRC), w/e Senior Resident Inspector (NRC), w/e Licensing Correspondence - RA 24-000335, w/e

P.O. Box 411 l Burlington, KS 66839 l 620-364-8831

Enclosure I t o 000335

2023 Fatigue Assessment and Report (This enclosure contain s 2 pages)

NRC FFD Program Performance Data Reporting System 10 CFR Part 26, Subpart I -

Managing Fatigue

Attachment This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic F atigue Management form.

Analysis of Waiver Assessment Data:

One work hour waiver completed for 202 3.

Waiver 11/2/2023 ONLINE Waiver issued to ensure minimum NSO and fire brigade staffing due to sick callout.

Waiver request initiated f or an operator to extend shift for 1 additional hour until relief could report. This extension would exceed work hours by 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> in regards to greater than 16 work hours in any 24-hour period and greater than 26 work hours in any 48-hour period. Waiver for individual was initiated and approved by management.

Individual performed work satisfactory and relieved in 1-hour time frame when relief arrived. No concerns noted in review of the waiver documentation or fatigue assessment documentation.

Analysis of Fatigue Assessment Data:

Six fatigue assessments were completed in 2023.

  1. 1 Post event 1/23/2023 ONLINE
  1. 2 For cause 6/8/2023 ONLINE
  1. 3 For cause 7/10/2023 ONLINE
  1. 4 Post event 7/16/2023 ONLINE
  1. 5 For cause 8/8/2023 ONLINE
  1. 6 Waiver 11/2/2023 ONLINE Condition reports were validated to be initiated for fatigue assessments within the corrective action program. In review of responses within fatigue assessments individuals involved did not describe or document any issues with fatigue or work hours that could have contributed to the event. The waiver initiated in operations for minimum staffing met regulatory and procedure requirements. No issues were identified from operations management for individual working additional work hours to maintai n staffing.

==

Conclusions:==

The results of the annual fatigue management program effectiveness review determined Wolf Creek is effective in controlling the work hours of individuals subject to work hour controls.

Summary and Status of Corrective Actions:

The Corrective Action Program is adequately used to identify and correct concerns with compliance to the fatigue rule requirements

Enclosure II to 000335

2023 FF D Report and Attachment (This enclosure contain s 12 pages)

FFD Program Performance Data Reporting System NRC Form 891, Annual Reporting Form for Drug and Alcohol Tests

(submit using the NRC EIE General Submission portal)

APPROVED BY OMB: CLEARANCE NO. 3150-0146 EXPIRES: 09/30/2024 Estimated burden per response to comply with this collection request is 106 hours0.00123 days <br />0.0294 hours <br />1.752645e-4 weeks <br />4.0333e-5 months <br />. This form is a voluntary means of reporting the information required under 10 CFR 26.417(b)(2) and 26.717. The information is required by the NRC to obtain on an annual basis site specific fitness-for-duty (FFD) program performance data on drug and alcohol programs from licensees and other entities. Send comments regarding burden estimate to the FOIA, Library, and Information Collections Branch (T-6 A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@NRC.gov, and the OMB reviewer at: OMB Office of Information and Regulatory Affairs, (3150-0146), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; e-mail: oira_submission@omb.eop.gov. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.

1) All fields required unless marked 'optional'
2) Use of Adobe Reader 8 or later is required Submission
3) Mouse over fields for additional information Update

Facility Period of Report Wolf Creek [50-482] 2023

Tests Conducted in the Calendar Year

Reason For Testing Total Number of Tests Conducted Total Number of Positive, Adulterated, Licensee Employees Contractors/Vendors Substituted, and Refusal to Test Results

Pre-Access 83 217 3

Random 420 79 1

For Cause 2 2 1

Post-Event 2 0 0

Followup 21 3 1

Total (Calculated) 528 301 6

FFD Program Random Testing Population and Rate Average number of Average number of Total size of the random testing pool Annual random testing percentage licensee employees contractors/vendors throughout the period (Calculated) achieved for the testing pool

730 215 945 52.8

Laboratory Testing

Does your program use a Licensee Testing Facility? No HHS-Certified Laboratory Clinical Reference Laboratory (Primary)

Blind Performance Test Sample Supplier(s) ElSohly Laborat ory HHS-Certified Laboratory Quest Laboratory (Lenexa, KS)

(Backup)

Special Analyses Testing Results Total Number of Specimens

- 26.163(a)(2) and 26.717(b)(2) Total Number of "Dilute" Specimen Test Results (Optional) (Special Analyses Testing Conducted) 1

Substances Tested Did your program only test for NRC-required substances AND at the NRC-specified minimum cutoff levels? Yes

Annual Report Form (version 1.11.0 - November 2022) - Page 1 of 2 - NRC Form 891 Additional Substances Tested

Summary of Management Actions - 26.717(b)(8)

Summarize actions implemented to improve FF D program performance. As applicable, reference in the topic description audit repor ts, 30-day reports, and/or corrective action reports. If reporting information on more than three topics, select "Others" for Topic 3 to report any additi onal topics.

Topic 1 Topic 1 Description Policies and Procedures CR # 10024690 NRC Green NCV - Fitness For Duty Policy did not provide specific guidance for employees to report directly to FFD testing as soon as reasonably prac ticable once notified of a random test.

NRC Inspection Report 2023-401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.

Actions taken to correct this deficiency and strengthen the FFD program -

Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practi cable verbiage, so individual s are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified. There was no reportability.

1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and t he Director of Nuclear Maintenance on June 07, Add an additional Topic 2023. All FFD / FM Policy hard copy documents were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was pub lished in the Wolf Creek News on June 21, 2023 Topic 2 Topic 2 Description Blind Performance Test Samples CR # 10023241 - Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access Screening was notified a blind per formance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected. In discussion with the MRO staff at Coffey County Hospital it is belie ved the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.

Actions taken - Access Screening conducted an ex tensive investigation and found the unexpected Blind Result was a result of human error. We foun d substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30-day report.

After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate the possibility of human error in the future. The improvement Add an additional Topic suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screeni ng. CCH MRO Staff will continue to order the blind Topic 3 Topic 3 Description Other(s) CR # 10022895 - Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed.

Upon investigation it was confirmed the MRO did not follow 10 CFR 26.119. 10 CFR 26.119(c) states Please elaborate: "The physician who conducts this evaluation shall make one of the following determinations:

CR # 10024692 - 2023 NRC FFD Inspection (1) A medical condition has, or with a high degree of probability could have, precluded the donor from Minor Violation Training. Collector training providing a sufficient amount of urine; or contained incorrect information regarding the (2) There is an inadequate basis for determining that a medical condition has, or with a high degree of use of temperature strips. probability could have, precluded the donor from providing a sufficient quantity of urine."

The NRC Inspection Report 2023-401 Actions taken - Access Screening c onducted a meeting with the Coffey County Hospital MRO Chief of proposed an NRC-Identified Minor Violation of Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We 10 CFR 26.85(a)(1), which requires each discussed 10 CFR 26.119(c). Since this individual did not have a medical condition which precluded them to provide a sample the determination by th e MRO should have been considered a refusal to test as per 10 CFR 119(g)(2). The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expec tations moving forward. Access Screening provided copies of

Person(s) Responsible for Information Provided Person 1 (required):

Mallory Rosales Senior Access Specialist mallory.rosales@evergy.com First Name Last Name Position Title Company Email Address Person 2 (optional):

Sonya Jones Supervisor of Access Screening sonya.jones@evergy.com First Name Last Name Position Title Company Email Address

Final Step (Required) - NRC will consider this form authentic in accordance with 10 CFR 26.11 only when the Validate & Lock button has been selected and all errors (i.e., those highlighted in red) have been corrected. The Validate & Lock button will change to Locked after the data validation process has been successfully completed and the form is ready for submission.

Locked Form Locked On: Feb 26, 2024 at 2:52:03 PM Save to Local PC Print this Report

Annual Report Form (version 1.11.0 - November 2022) - Page 2 of 2 - NRC Form 891 NRC FFD Program Performance Data Reporting 10CFR Part 26 - FFD

This attachment provides the entire narrative as the NRC form has been created with boxes that scroll down, and when printed, the information prints very small due to the way the NRC has built the electronic form.

FFD Summary of Management Actions Summarize actions implemented to improve FFD program performance

Topic 1: Policies and Procedure

CR # 10024690 NRC Green NCV - Fitness For Duty Policy did not provide specific guidance for empl oyees to report directly to FFD testing as soon as reasonably practicable once notified of a random test.

NRC Inspection Report 2023-401 issued violation to Access Screening for 10 CFR 26.27(b) which requires the FFD policy be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.

Actions taken to correct this deficiency and strengthen the FFD program -

Compliance was restored on June 07, 2023, when Wolf Creeks FFD / FM Policy was updated to include as soon as reasonably practicable verbiage, so individuals are aware of 10 CFR Part 26 requirements when reporting for FFD tests once notified.

There was no reportability.

1)The FFD / FM Policy was updated on June 06, 2023, by Access Screening. The new revision was signed off by the Access Screening Supervisor and the Director of Nuclear Maintenance on June 07, 2023. All FFD / FM Policy hard copy document s were replaced with the new FFD / FM Policy revision on June 07, 2023. A site wide communication was published in the Wolf Creek News on June 21, 2023 to inform site personnel the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing. The Access Screening share point was updated with the new FFD / FM Policy on June 07, 2023.

2)Procedure AP 01A -001 (Fitness for Duty Program) was revised to align with 10 CFR 26.31(d)(2)(iii) requirements of reporting to the collection sit e as soon as reasonably practicable within the time specified in the FFD policy.

3)An article was published in the Wolf Creek News to communicate the changes made to the FFD / FM Policy when reporting for Fitness for Duty (FFD) testing.

4)The FFD Program Owner JFG was updated to include this CR to enhance knowledge of the 10 CFR Part 26 Regulation.

Topic 2: Blind Performance Test Samples

CR # 10023241 - Test Result Received for Blind Test Sample Not as Expected. On March 20, 2023, Wolf Creek Access S creening was notified a blind performance test provided by ElSohly and submitted to Clinical Reference Laboratory tested Substituted instead of PCP as expected. In discussion with the MRO staff at Coffey County Hospital it is believed the vials for PCP and Substituted were placed in bags with the incorrect Chain of Custody form. The Chain of Custody forms tie the vials to the expected result.

Actions taken - Access Screening conducted an extensive investigation and found the unexpected Blind Result was a result of human error. We found substantial evidence the lab did not make a mistake in testing and Elsohly, our blind manufacturer, did not make a mistake in what they sent us. With these findings, it was also determined this event does not require a 30- day report.

After reviewing the blind packaging process, Access Screening determined an improvement could be made to streamline and mitigate th e possibility of human error in the future. The improvement suggestion was presented by Access Screening to CCH MRO Staff to change the ownership of packaging the blinds for shipment to Access Screening. CCH MRO Staff will continue to order the blind spec imens through ElSohly, they will contact Access Screening to pick up the unpackaged blind specimens and then review the test results when theyre returned from CRL. Access Screening will be responsible for preparing the blind specimen for shipment. The st rength gained in this change is only 1 blind specimen will be packaged on the designated day the blind is scheduled to be sent which can mitigate the possibility of h uman error and eliminates the packaging all the blinds at one time as the MRO Staff was doing. This improvement in the process cuts down on the multiple steps used in the past between MRO Staff and Access Screening.

Topic 3: Policies and Procedure

CR # 10022895 - Shy Bladder Individual Not Properly Sanctioned. On 3/7/2023, during an external peer review a shy bladder concern was identified when a review of the individuals file was performed. Upon investigation it was confirmed the MRO did not

follow 10 CFR 26.119. 10 CFR 26.119(c) states "The physician who conducts this evaluation shall make one of the following determinations:

(1) A medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficie nt amount of urine; or

(2) There is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine."

Actions taken - Access Screening conducted a meeting with the Coffey County Hospital MRO Chief of Staff, Coffey County Hospital MRO Staff, and Supplier Quality auditor on March 21, 2023. We discussed 10 CFR 26.119(c). Since this individual did not have a medical condition which precluded them to provide a sample the determination by the MRO should have been considered a refusal to test as per 10 CFR 119(g)(2). The MRO stated he understood the mistake that was made, and he would ensure his MROs understand the expectations moving forward. Access Screening provided copies of 10 CFR 26 handouts (26.119, 26.183, 26.185, & 26.187) for the MRO Chief of Staff to use for communicating the expectations going forward to our other MROs. Ensuring communication occurred to the other MROs was verified by calling the Director of Clinical Operations. All MROs have the documentation to understand the expectations.

During this meeting it was discovered the dictation system has been significantly upgraded since this issue occurred. The MROs dictation is now imm ediate as opposed to previously having a 24-hr. delay, closing the gap between when the evaluation occurs and Access Screening receiving the MRO determination. The MROs full dictation notes from 2021 to current were provided to Access Screening for review. The review did not identify any issues. Supplier Quality auditor initiated a Report of Non -Compliance (RON

  1. 25471- 01) to Coffey County Hospital. The individual has now been correctly sanctioned. Access Screening also incorporated into the Water Intake process an informational sheet detailing the Water Intake and Shy Bladder Processes and the possible consequences. When the Water Intake process is needed the collector will get out informational sheet have the donor read the sheet, ensure they have no ques tions, and have them sign the Water Intake form they understand the process and possible consequences.

Topic 4: Training

CR # 10024692 - 2023 NRC FFD Inspection Minor Violation Training. Collector training contained incorrect information regarding the use of temperature strips.

The NRC Inspection Report 2023-401 proposed an NRC -Identified Minor Violation of 10 CFR 26.85(a)(1), which requires each collector shall be knowledgeable of the

requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed and shall keep current on any changes to the collection procedures for each specimen the individual is qualified to collect under this part. Specifically, the Licensee did not provi de the correct training for measuring temperature of collections using the temperature strips used at the station.

Actions Taken - Access Screening reviewed the collector training material and removed the incorrect temperature strip training aide. The Fi tness for Duty collector training material is now correct and in compliance with 10 CFR 26.85(a)(1). FFD / Access Screening verified procedure AI 01A -002, Fitness For Duty Screenings, aligns with the Fitness for Duty collector training material and they both align with the manufacturers recommendation on how to use and read the temperature strips.