Dermatology Associates Of Georgia Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 18, 2025. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and review of the WSLH Proficiency reports, the laboratory failed to maintain satisfactory proficiency testing (PT) 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 -- participation for Mycology in 2025 events 1 & 2, resulting in an initial unsuccessful participation for Mycology. Refer to D 2046 D2046 MYCOLOGY CFR(s): 493.827(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of WSLH proficiency reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events (2025 events 1 & 2), resulting in an initial unsuccessful participation for Mycology. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Mycology on the following: 2025 Event 1 Mycology Score 60% 2025 Event 2 Mycology Score 0% 2. A review of the laboratory's WSLH Reports confirmed the laboratory failed Mycology with the aforementioned scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review WSLH reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the WSLH 2025 events 1 & 2 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Mycology in two consecutive testing events, resulting in the initial unsuccessful participation for Mycology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 06, 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: 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 Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT), it was revealed there was no peer reviews performed twice annually or proficiency testing (PT) from a CMS approved agency to test the competency of PPM testing personnel in 2022 - January 2024. Findings: 1. A review of WSLH (PT) documents revealed the absence of (PT)s for PPM (KOH) testing or KOH peer reviews for testing personnel #s 4 - 9 (CMS 209) in 2022 - January 2024. 2. An interview with the lab lead, in the review room, at approximately 3:00 PM, on 02/06 /2024 confirmed the absence of PT records or peer review documentations for (TPs #s 4 - 9 CMS 209) 2022 - January 2024. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 -- This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) document review and staff interview, the laboratory failed to document ALL quality assessment activities on a monthly or quarterly basis that cover pre-analytic, analytic and post analytic phases of laboratory testing in 2022 - January 2024 in the specialty of Histopathology. Findings: 1. Review of the daily maintenance logs revealed Quality Control (QC) and Plate Sterility logs for Dermatophyte Test Medium (DTM) testing were NOT reviewed by the Technical Supervisor (TS) in 2022 - January 2024. 2. An interview,with the lab lead, on 02/06 /2024, at approximately 3:30 PM, in the review room, confirmed the lack of standard quality oversite of the laboratory by the Technical Supervisor (TS) 2022 - January 2024. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on document review and interview with the lead MA , the Lab Director (LD) failed to ensure that Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory from 2022 - January 2024, as required by the Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Review of Standard Operating Procedures (SOP), Proficiency Testing (PT)/ Peer Review guidelines for KOH PPM testing and maintenance logs revealed the Lab Director falied to ensure ALL Quality Assurance (QA) activities were maintenaned 2022 - January 2024. 2. An interview with the laboratory's lead MA, in the review room, on 02/06/2024, at approximately 3:00 PM, confirmed the lab director failed to ensure proper oversight of the laboratory to solve problems as they occurred in 2022 - January 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 26, 2022. 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the Laboratory Tour and staff interview, the Laboratory failed to ensure that the Fire Extinguisher's were checked for safety from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. The Findings include: 1. During the Laboratory Tour observation of the Fire Extinguisher revealed that the last maintenance check was on September 2020. 2. During an interview with Testing Personnel #2(CMS 209) on May 26, 2022 at approximately 1:45 PM, confirmed that the Laboratory did not maintenace the Fire Extinguisher for safety since September 2020. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency test(PT) documents and staff review, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- failed to perform required correction action for PT results for unacceptable /unsatisfactory evaluations. The Findings include: 1. American Academy of Family Physicians(AAFP) PT document review revealed there was no correction action for the Urinalysis Microscopy Skin Scrap for PT testing in 2021 Event C. 2. During an interview with the Testing Personnel #2(CMS-209) on May 26, 2022 at approximately 2:50 PM, it was confirmed that the TP and LD failed to document a correction action for the PT in 2021 for Event C. 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 and staff interview, the laboratory failed to ensure reagents must not be used after their expiration date as required. Findings include: 1. Observation during the laboratory tour on May 26, 2022 at approximately 1:30 PM, revealed a bottle of Potassium Hydroxide (KOH) 10 percent reagent on the laboratory counter near the microscope which had expired on 12-31-2022. Observation during the same tour at 1:30 p.m. on 1/23/2020 revealed there was no replacement available at the time of survey. 2. During an interview with the Testing Personnel#2(CMS-209) in the hallway of the facility, on May 26, 2022 at approximately 1:30 M, confirmed the KOH solution in use had expired on 12-30-2021, and there was no replacement available at the time of survey. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 12, 2019. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to ensure all TP who routinely perform moderate complexity laboratory testing participate in testing of PT samples as required. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed the same TP, who is no longer employed by the facility, performed the Dermatophyte Screen (Mycology) and Skin Scraping (Urinalysis - Potassium Hydroxide) for the following PT events: 2018 -- Events B and C; 2019 -- Events A, B, and C. 2. An interview with the back office medical assistant on 11/12/2019 in the breakroom at approximately 1: 00 p.m. confirmed the same TP performed the aforementioned PT testing for 2018 and 2019. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to retain all PT documents as required. required. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed there was no attestation statement for 2018 Event A for Dermatophyte Screen and Skin Scraping. 2. An interview with the back office manager in the breakroom on 11/12/2019 at approximately 1:00 p.m. confirmed the lack of attestation documentation for the aforementioned PT event. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) documents and staff interview, the laboratory failed to perform required