Piedmont Plastic Surgery & Dermatology - Hickory

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 verification records, and interview with the Mohs histotechnologist on 7/19 /2023, the laboratory failed to verify the accuracy of their Mohs testing at least twice a year during 2020, 2021, and 2022. Findings: Review of the laboratory's Biannual Proficiency Testing policy revealed in "Section I. Scope/Purpose...Four cases will be randomly selected twice a year for review." Review of the laboratory's 2020, 2021, and 2022 Mohs verification records revealed peer review verifications were performed on the following dates: 8/19/2020, 5/5/2021, and 9/15/2022. During an interview at approximately 11:30 a.m., the Mohs histotechnologist confirmed verification activities were not performed twice a year during 2020, 2021, and 2022. 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 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 observation, records review, and staff interview on 6/28/19, the laboratory failed to discard materials that had exceeded its expiration date and was available for use. Findings: 1. At 9:20 a.m. the surveyor observed a bottle HealthLink 20% KOH, Lot #: 171211, that had expired on 2018-05-01 located on the north hallway on the shelf above the microscope. 2. The Mohs Tech indicated during interview at 9:20 a. m., that the Nursing Clinical Team Manager is responsible for this testing area and the manager failed to notice the expired material. 3. The review of the KOH Testing log revealed that approximately 28 patient test were performed using the expired HealthLink 20% KOH. 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 --