Southside Dermatology, Pllc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/21/2024. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and testing person number nine at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of written policies and procedures and interview with the laboratory director, the laboratory failed to follow written procedures for the Quality Assurance Program for the review period of April 5, 2023 through the current date. Findings include: (1) On 11/21/2024 at 11:00 am, a review of the laboratory's written procedure "Quality Assurance Program" stated, "This procedure manual is reviewed by the laboratory director annually and at other times as required by major changes in procedure or other circumstances affecting laboratory performance of test"; (2) A review of records from April 5,2023 through the current date identified that a policy review had not been performed between April 5, 2023 and November 21, 2024; (3) Interview with the laboratory director on 11/21/2024 at 11:00 am confirmed that the laboratory had not followed it's written procedure for for reviewing the quality assurance program. 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 D0000 The recertification survey was performed on 04/05/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with histotechnician #1 and histotechnician#2 at the conclusion of the survey. 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 a review of records and interview with histotechnician #1 and histotechnician #2, the laboratory failed to verify the accuracy of KOH and Scabies testing at least twice annually during the review period of June 2021 through the current date. Findings include: (1) On 04/05/2023 at 09:20 am, histotechnician stated to the following testing was performed: (a) KOH (Potassium Hydroxide) testing as a PPM (Provider Performed Microscopy) procedure; (b) Scabies testing as a PPM procedure. (2) A review of records from June 2021 through the current date identified no evidence the testing had been verified for accuracy twice annually during the review period; (3) The records were reviewed with histotechnician #1 and histotechnician #2. Both stated on 04/05/2023 at 11:45 am, the testing had not been verified for accuracy at least twice annually. 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 D0000 The recertification survey was performed on 11/13/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, clinical consultant #2, the histotechnologist, and the surgical assistant during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the laboratory director and clinical consultant #2, the laboratory failed to verify the accuracy of slide interpretations at least twice annually. Findings include: (1) On 11/13/2020 at 10:00 am, the laboratory director and clinical consultant #2 stated to the surveyor, the laboratory began performing microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from dermatologic biopsies and tissues removed during Mohs surgery on 12/18 /2018; (2) On 11/13/2020 at 11:30 am, the laboratory director stated to the surveyor the accuracy of the microscopic interpretations was performed by sending cases (slides and maps) to a physician at a local reference laboratory for evaluation; (3) The surveyor reviewed records for 2019 and to date in 2020, and identified the accuracy of the slide interpretations had not been verified twice annually in 2019. The testing had not been verified for accuracy prior to 12/02/2019; (4) The surveyor reviewed the records with the laboratory director and clinical consultant #2. Both stated on 11/13 /2020 at 11:45 am, the accuracy of the slide interpretations had not been verified twice in 2019. 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 --