Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on January 4, 2023. K Wade Foster MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 record review, and interview, the laboratory failed to provide documentation showing the Acetic Acid used on 05/06/2021 and the 95% Alcohol used from 11/04 /2021 to 08/04/2022 in their Hematoxylin and Eosin Staining (H&E) was not expired prior to patient testing. Findings: Review of the "H and E Staining Set-up Rotation Record" showed on 05/06/2021 the Acetic Acid listed lot #31911515 with expiration date of 04/30/2021. Review of the Mohs log showed there were 15 surgical procedures performed on 05/06/2021. Review of the "H and E Staining Set-up Rotation Record" showed on 10/07/2021 the 95% Alcohol listed lot #1910918 with expiration date of 10/21/2021. A new lot number of 95% Alcohol was not listed until 08/04/2022 and the dates of surgical procedures in between had ditto marks. Review of the Mohs logs showed surgical procedures were performed on patients on the following dates 11/04/2021 - 11 surgical procedures 12/02/2021 - 11 surgical procedures 01/06/2022 - 9 surgical procedures 02/03/2022 - 9 surgical procedures 03 /03/2022 - 13 surgical procedures 04/07/2022 - 16 surgical procedures 05/05/2022 - 11 surgical procedures 06/02/2022 - 8 surgical procedures 07/07/2022 - 9 surgical procedures Review of the "H and E Staining Set-up Rotation Record" showed on 08 /04/2022 the 95% Alcohol listed lot #1933809 with expiration date of 06/10/2022. Review of the Mohs log showed there were 11 surgical procedures performed on 08/04 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 -- /2022. On 01/04/2023 at 10:45 AM, the Mohs Technician/Lab Supervisor acknowledged the form listed expired reagents. -- 2 of 2 --