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Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on 01/15/2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: 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. This STANDARD is not met as evidenced by: Based on lack of annual microscope maintenance document, review of the policy and procedure manual (SOP), and subsequent inteview with the lab director, the laboratory failed to perform and document microscope annual maintenance. Findings include: 1. Review of the microscope maintenence documents of 2023, 2024, & 2025 revealed there was no annual maintenance document available for the Nikon ECLIPSE 50i or the Olympus CH-B145-T-2 microscopes for the year of 2024. 2. Review of the SOP revealed microscope maintenence was to be done weekly and annually. 3. An interview with the laboratory director on 1/15/25 in the breakroom at 12:00 p.m. confirmed the lack of annual maintenance for the laboratory microscopes for the year of 2024. 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 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 27, 2023. 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: 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 lack of testing personnel peer review documents and lab director interview, the laboratory failed to verify at least twice annually the accuracy of Potassium Hydroxide (KOH) testing performed. Findings: 1. The lack of testing personnel documents revealed twice annual peer reviews were not performed for KOH testing in 2021, 2022, and 2023 thus far. 2. Interview with the laboratory director in the lab on 2 /27/2023 at 1:59 PM, confirmed the finding. 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 Procedure manual (SOP) review and interview with the lab director (LD), 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 -- the laboratory failed to have an approved written procedure for Potassium Hydroxide (KOH). Findings: 1. SOP review revealed the laboratory did not a written procedure for KOH. 2. Interview with the LD in the lab on 2/27/2023 at 1:59 PM confirmed the lack of the aforementioned procedure. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and lab director interview, the laboratory failed to perform and document QC on potassium hydroxide (KOH) slides. Findings: 1. No QC documents were available to review on KOH slides at the time of survey. 2. Interview with the lab director on 02/27/2023 at 1:39 PM in the lab, confirmed controls were not performed on KOH slides . D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on training and competency document review and interview with the lab director, the lab director failed to ensure the testing personnel receive the appropriate training and competency for potassium hydroxide (KOH) testing performed. Findings: 1. No KOH training documents were available for the years 2021, 2022, or 2023 to date. 2. No KOH competency documents were available for the years 2021, 2022, or 2023 to date. 3. Interview with the lab director in the lab on 02/27/2023 at 1:59 PM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Provider Performed Microscopy (PPM) Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 4, 2020. 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: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) logs, observation during the laboratory tour, review of laboratory test package insert, and staff interview, the laboratory failed to follow current manufacturer instructions for the waived test performed by the laboratory. Findings include: 1. Review of waived test package insert and observation during the laboratory tour on 2/04/2020 at approximately 1:00 p.m. revealed there were no required QC logs available at the time of survey for Human Chorionic Gonadotropin (Consult Diagnostics) for 2019 and 2020 thus far. 2. An interview with the lab director in the lab at approximately 1:00 p.m. on 2/04/2020 confirmed the lack of QC documents for the aforementioned waived test for 2019 and 2020 thus far. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 review of the procedure document, the lack of testing personnel (TP) documents, and subsequent staff interview, the laboratory failed to establish a policy and procedure to assess TP competency as required. Findings include: 1. Review of the procedure document revealed there was no policy and procedure to assess TP competency available at the time of survey. 2. Lack of TP competency documents revealed there was no annual competency performed for 2 of 2 Staff (CMS 209) for 2019, and 2020 thus far. 3. An interview with the lab director (LD) in the lab on 2/4 /2020 at approximately 1:15 p.m. confirmed the lack of a TP competency policy and procedure at the time of survey. During the same interview, the LD confirmed there were no competency documents available at the time of survey for 2 of 2 Staff (CMS 209) for the aforementioned dates. 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 on laboratory document review and staff interview, the laboratory failed to perform and document equipment maintenance activities as required. Findings include: 1. Laboratory document review revealed there were no routine maintenance documents available at the time of survey for the A/O single ocular microscope for 2019 and 2020 thus far. 2. An interview with the laboratory director on 2/04/2020 in the lab at approximately 1:00 p.m. confirmed the lack of routine maintenance for the laboratory microscope for the aforementioned dates.. -- 2 of 2 --