Kurt Vernon Md Pa (Pathology Lab)

Summary Statement of Deficiencies 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 review of laboratory policies and procedures, the absence of 2024 and 2025 competency records, and interview with the Practice Administrator on 02/24/2026, the Laboratory Director (LD) failed to perform the required yearly competency assessments for Testing Personnel (TP #1) for 2024, and the Clinical Consultant (CC #2) and General Supervisors (GS #1 and GS #2) for 2024 and 2025. Findings: Review of the laboratory policy and procedure "Competency Testing 17.0" page 1 revealed, "Competency testing is required after 6 months of initial training and once a year thereafter." Review of laboratory "Competency Testing" records revealed the absence of yearly competency assessments for the following positions: TP #1 - 2024 CC #2 - 2024 and 2025 GS #1 - 2024 and 2025 GS #2 - 2024 and 2025 During interview at approximately 2:55 p.m. the Practice Administrator confirmed no 2024 yearly competency assessment available for review for TP #1, no 2024 and 2025 yearly competency assessments available for review for the CC and both GS's. At approximately 2:58 p.m. she said they were completed but could not locate them. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of laboratory maintenance records and interview with testing personnel (TP #1) 05/22/24, the laboratory failed to document maintenance as defined in the laboratory policy for the Milestone KOS Processor. Findings: Review of laboratory policy "Tissue Processing Using the Milestone KOS Processor" revealed the following maintenance and/or function protocols: 1. Under "SAFETY/PPE"...."The filters will be replaced every six months." 2. Under "PROCEDURE" ..."Prowave should be changed every other week or sooner if the color of the solution turns pink." 3. Under "QUALITY CONTROL"..."A Dailly QC log of all reagents and paraffin changes will be kept. The checklists will be marked with a check mark with those reagents or paraffin stations that have been changed and the technician initials....The paraffin wax and the processing solutions will be changed on a bi-weekly basis or more depending on case load." Interview with TP #1 at approximately 11:00 a.m. confirmed the laboratory was not documenting the maintenance protocols defined in the laboratory policy for the Milestone KOS Processor. She stated they do not keep that log. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --