Southern Dermatology

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 upon review of the laboratory's procedures, review of 2023 and 2024 maintenance logs and interview with Processor #2 on 5/9/24, the laboratory does not perform and document all automated stainer maintenance activities. Findings: Review of the Histopathology Mohs Micrographic Surgery procedure revealed in Section "E. Staining" that "...The entire linear stainer gets emptied and cleaned with 10% bleach solution about every month..." Review of 2023 and 2024 maintenance logs revealed no documentation of the stainer being emptied and cleaned with bleach solution. In interview at approximately 3:00 p.m. on 5/9/24, Processor #2 stated the following: 1. The stainer is cleaned with a bleach solution monthly. 2. This activity is not documented. 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 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 laboratory policy/procedure, lack of documentation and interview with HT (Histotech) 5/10/22, the laboratory failed to verify the accuracy of the KOH (Potassium Hydroxide)/Wet Prep testing and the Tzanck stain at least twice annually since June of 2019, approximately 3 years in which verification of accuracy was not performed. Findings: Review of laboratory policies and procedures revealed no documentation of a specific procedure for the verification of accuracy of the KOH /Wet Prep testing and the Tzanck stain. For example: Laboratory procedure "Quality Assessment Program" states "3. Ongoing Assessment:...The programs and methods used for Proficiency Testing and results of this testing will be evaluated by the Laboratory Director or an appropriate, designated staff member annually.". There was no documentation in the laboratory procedure manual of "programs and methods used for Proficiency Testing". Review of laboratory records revealed no documentation of a twice annual verification of accuracy for the KOH/Wet Prep testing and the Tzanck stain. Interview with HT at approximately 11:15 a.m. confirmed the laboratory had no procedures for the verification of accuracy for the KOH and Tzanck testing. She also confirmed the laboratory had no documentation of a twice annual verification of accuracy for the KOH and Tzanck testing. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)