Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at K Wade Foster MD PA on June 12, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on interview and review of quality control and surgical case logs, the laboratory failed to use non-expired reagents in their Hematoxylin and Eosin (H&E) stain for staining patient's histopathology slides from 06/19/2024 to 07/12/2024. Findings: 1. Review of the H and E Staining Set-up and Rotation Record log noted above the name of the form, "Do not use expired reagents!!" 2. Review of the H and E Staining Set-up and Rotation Record log listed the Bluing Solution lot #12316024 expired on 06/14 /2024, and Bluing Solution lot #2331003 expired on 10/11/2024 and was opened on 07 /17/2024. 3. Review of the Mohs Log Clermont 2024 log revealed there were eight surgical procedures done on 06/19/2024, 20 surgical procedures done on 06/28/2024, ten surgical procedures done on 07/02/2024, and 20 surgical procedures done on 07/12 /2024. 4. During an interview on 06/12/2025 at 11:45 AM, the Laboratory Supervisor confirmed the new lot number of Bluing Solution was listed as being opened on 07/17 /2024. 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 --