Dermatology Of Athens

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 25, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 observation and staff interview, the laboratory failed to ensure that reagents were not used after they had exceeded their expiration date. Expired tissue marking dyes were found in the active testing area. Findings: 1. A tour of the laboratory on 9/25 /2026 at approximately 10:08 am revealed expired reagents, actively in use, on the laboratory countertop, in the the specimen preparation area, available for patient testing. Red Tissue Marking Dye ( Expired 10-31-2025) Orange Tissue Marking Dye ( Expired 11-30-2025) Green Tissue Marking Dye ( Expired 11-30-2025) Blue Tissue Marking Dye ( Expired 9-30-2025) Yellow Tissue Marking Dye ( Expired 4-30-2026) 2. An interview with the office manager, on 9/25/2026, at approximately 10:08 am, in the laboratory confirmed that all 5 tissue marking dyes had expired. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: \ Based on observation, record review and staff interview, the laboratory director failed to complete monthly quality arssurance ( QA) reviews of the Preanalytic, Analytic and Postanalytic processes to identify and fix problems in the laboratory, as required by the Clinical Laboratory Improvement Amendments. (CLIA). Findings: 1. A tour of the laboratory , on 9/25/2026 , at approximately 10:08 am revealed expired reagents, in use, on the laboratory countertop, in the specimen preparation area, available for patient testing. Red Tissue Marking Dye ( Expired 10-31-2025) Orange Tissue Marking Dye ( Expired 11-30-2025) Green Tissue Marking Dye ( Expired 11- 30-2025) Blue Tissue Marking Dye ( Expired 9-30-2025) Yellow Tissue Marking Dye ( Expired 4-30-2026) 2. An interview with the office manager, in the doctor's office, on 9/25/2026, at approximately 11:00 am, confirmed the laboratory director failed to complete monthly quality assurance (QA) review processes to identify and fix problems in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 19, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on personnel records review and interview with the office manager, the lab director failed to ensure that ALL pre analytic, analytic and post analytic Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory from August 2023 thru the date of survey September 19, 2024 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Personnel documents review revealed the lab director , who is also the (TS), had no proof that semi annual and annual competencies were performed on all testing personnel (TPs #s 6 and 7 CMS 209) from August 14, 2023 thru the day of survey September 19, 2024. 2. An interview with the laboratory's office manager, in the review room, on 09/19 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 -- /2024, at approximately 12:15 PM, confirmed the lab director , who is also the Technical Supervisor (TS), failed to ensure proper oversight of the laboratory from August 2023 thru the date of survey 9/19/2024. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on personnel records review and interview with the office manager, the laboratory failed to ensure that semi-annual and annual competencies for testing personnel (TPs) performing (PPM) testing from August 14, 2023 thru the date of survey September 19, 2024 were performed by the Technical Supervisor or Laboratory Director. Findings: 1. A review of Provider Performed Microscopy (PPM) training and competency assessment records revealed that TPs #s 6 and 7 (CMS-209 form) were signed off after training on August 14, 2023. There were no semi annual or annual competencies for either of the testing personnel by the Laboratory Director , who is the Technical Supervisor (TS). 2. An interview with the office manager, in the review room, at approximately 12:10 PM, on 09/19/2024, confirmed semi annual and annual competencies for TPs #s 6 and 7 (CMS -209 form ) were performed but not documented on day of survey 09/19/2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on October 20, 2022. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of