Dermatology Associates Of Georgia, Llc

Summary Statement of Deficiencies 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 WSLH (Wisconsin State Laboratory Of Hygiene) Proficiency Testing records review and staff interview, the laboratory failed to have successful performance in two out of three PT events in 2025. Findings: 1. WSLH (PT) documents review revealed the laboratory scored a 0% in event #1 and 0% in event #3 on Dermatophyte (DTM) screening in the subspecialty of Mycology in 2025. 2.) An interview with the office manager on 03/03/2026 in the breakroom at approximately 12:25 PM confirmed the aformentioned findings on (PT) testing in 2025. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 WSLH (Wisconsin State Laboratory Of Hygiene) PT records review and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 17, 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: D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient log review and staff interview, the laboratory failed to perform required quality control (QC) for all testing. Findings include: 1. Patient log rview revealed Potassium Hydroxide (KOH) QC was not performed for 2017(October through December), 2018, and 2019 thus far. 2. An interview with the office manager in a conference room on 9/17/2019 at approximately 1:00 p.m. confirmed the lack of QC for KOH testing for the aforementioned dates. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. 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 CONDITION is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the technical supervisor (TS) failed to perform annual competencies on TP as required. Findings include: For details refer to D6120 D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 testing personnel (TP) document review and staff interview, the technical supervisor (TS) failed to perform annual competencies on TP as required. Findings. 1. TP competency document review revealed the TS failed to perform annual competencies for the following TP in 2018 and 2019 thus far: (CMS 209) Staff #4, Staff #5, Staff #6, and Staff f#7. 2. An interview with the office manager in a conference room on 9/17/2019 at approximately 1:00 p.m. confirmed there were not annual competencies performed on TP in 2018 and 2019 thus far. This is a repeat deficiency -- 2 of 2 --