Summary:
Summary Statement of Deficiencies D0000 An unannounced, onsite, focused complaint survey was conducted at Weirton Medical Center on July 22, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed and the complaint was found to be Substantiated. The laboratory was determined to be out of compliance with the following Standard of the CLIA regulations under 42 CFR 493, Requirements for Laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures, Hologic Panther analyzer reports, testing personnel (TP) records, lack of documentation, interview with the laboratory director (LD), and exit interview with the LD and administration team, the laboratory failed to document the training, semi annual competency assessment (CA), and/or annual CA for 5 of 5 testing personnel (TP) performing testing on the Hologic Panther in Microbiology for 2024 and 2025. Findings: 1. Review of Weirton Medical Center Policy and Procedure Manual identified the "Laboratory Competency Assessment" policy which states "during the first year of an individual's duties, competency will be assessed semi-annually" and "after an individual has performed their duties for one year, competency will be assessed annually." The policy states "New employees have a 90 day orientation period to successfully complete items on their respective training checklists." 2. Review of the Hologic Panther Activity Log Reports identified that 5 individuals (TP1, TP2, TP3/GS, TP4, TP5) had performed HPV testing on the instrument between 12/2024 and date of survey. 3. Review of 2024 and 2025 TP records identified a lack of documented training and/or competency assessments for HPV testing on the Hologic Panther, as follows: a. TP1 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- released results 4/30/2025- no training checklist or CA could be located b. TP2 released results 5/13/2025- no training checklist or CA could be located c. TP3/GS released results 4/2/2025- training checklist completed 3/12/2024, no CA could be located d. TP4 released results 5/25/2025- no training checklist or CA could be located e. TP5 released results 12/2024- no training checklist or CA could be located 4. During an interview with the laboratory director (LD), 7/23/25 at 10:30 AM, the LD stated the training checklists and/or competency assessments for the 5 testing personnel operating the Hologic Panther could not be located. 5. An exit interview with the LD and laboratory administration, 7/22/25 at 11:35 AM, confirmed the lack of documented training and competency assessments for the TP performing patient testing on the Hologic Panther in 2024 and 2025. -- 2 of 2 --