Aqua Dermatology Of Georgia , Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 25, 2025. 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: D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify, in writing the duties and responsibilities of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of laboratory testing. Findings include: 1. SOP review revealed the LD failed to specify in writing the duties and responsibilities of each person engaged in the performance of all phases of laboratory testing. No defined duties and responsibilities for the Lab Director, Clinical Consultant, Technical Supervisor, General Supervisor, or the Testing Personnel. 2. An interview with the clinical supervisor in the review room on 11/25/25 at 2:20 p.m. confirmed the SOP did not contain a duties and responsibilities policy and procedure for the aforementioned positions. 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 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 25, 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: D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Proficiency Testing (PT) and staff interview, the laboratory failed to perform Proficiency Testing (PT) for the speciality of Mycology (KOH). Findings include: 1. Review of Mycology log sheet documents revealed that PT was not performed in 2020. 2. During an interview with the Histotechnologist Coordinator, on January 25, 2022, at approximately 1:45 PM, in an office outside of the laboratory #2, confirmed PT was not performed for the specialty of Mycology in 2020. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to calibrate 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 2 -- Olympus BX41 microscope per the procedure manual. Findings include: 1. Observation during the lab tour revealed the last calibration on the Olympus BX41 microscope was in February 2018. 2. Observation during the lab tour revealed there was no calibration on the Lumeon microscope used for KOH readings. 3. During an interview with the Histotechnologist Coordinator on January 25, 2022, in an office outside of Laboratory #2, confirmed the microscope was not calibrated since February 2018. 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 review of the laboratory records, procedure manual (SOP), and staff interview, the laboratory director failed to ensure that the quality assessment(QA) programs are established and maintained to identify failures in quality. Findings include: 1. Review of the SOP revealed the lack of a written Quality Assessment (QA). 2. No QA documents were available to review on KOH preparation slides for 2020 at the time of survey. 3. During the interview with the Histotechnologist Coordinator on January 25, 2022, in an office outside of the #2 laboratory, confirmed the missing QA for 2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Validation survey was completed on May 23, 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: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on log sheet document review, policy and procedure manual (SOP) review , and staff interviews, the laboratory failed to enroll in an approved proficiency testing (PT) program for Mycology (KOH) or Histopathology. Findings include: 1. Review of Mycology log sheet documents revealed no evidence of PT being performed. 2. Review of Histopathology log sheet documents revealed no evidence of PT being performed. 3. Review of the SOP revealed no procedure for PT. 4. Interview with the histotechnologist coordinator and staff #4 (CMS 209) on 5/23/19 in the histotechnologist office at approximately 2:15 PM confirmed PT was not performed for Mycology or Histopathology. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance document review and staff interview, the laboratory failed to perform and document maintenance as defined by the manufacturer on the SCS BOND IHC. Findings include: 1. Review of BOND maintenance documents revealed monthly maintenance was not performed/documented: January 2018 - June 2018; August 2018- December 2018; or January 2019 - February 2019. 2. Interview with the histotechnologist coordinator on 5/23/19 at 2:35 PM in the histotechnologist office, confirmed the aforementioned monthly maintenance was not performed/documented. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on log sheet document review, policy and procedure manual (SOP) review , and staff interviews, the laboratory director (LD) failed to ensure the lab enrolled in an approved proficiency testing (PT) program for Mycology (KOH) or Histopathology. Findings include: 1. Review of Mycology log sheet documents revealed no evidence of PT being performed. 2. Review of Histopathology log sheet documents revealed no evidence of PT being performed. 3. Review of the SOP revealed no procedure for PT. 4. Interview with the histotechnologist coordinator and staff #4 (CMS 209) on 5/23/19 in the histotechnologist office at approximately 2:15 PM confirmed PT was not performed for Mycology or Histopathology. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel(TP) competency documents and staff interview , the technical supervisor (LD) failed to perform annual competency on all testing personnel. Findings include: 1. Review of TP competency documents revealed no documentation of competency being performed for 12 of 12 TP (CMS 209) for the year 2018. 2. Interview with the histotechnologist coordinator on 5/23/19 at 2:35 PM in the histotechnologist office, confirmed the competencies were not done in 2018. -- 2 of 2 --