Dermatology Associates Of Georgia Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on October 23, 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: 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: A review of 2023 - 2025 Proficiency Testing Records confirmed that the Laboratory Director failed to enroll in an approved Proficiency Program for the MOHS Testing Procedure. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 WSLI Proficiency Testing Records confirmed that the labortory was not enrolled in a proficiency testing program or peer-to-peer testing program. 2. An exit interview, in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that the Laboratory Director failed to enroll in an approved Proficiency Program for MOHS Testing Procedure. D3011 FACILITIES CFR(s): 493.1101(d) 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 -- 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: A tour of the laboratory and a review of the current procedure manual confirmed that the Laboratory Director failed to ensure all safety procedures and accessibility to safety equipment were available, to the testing personnel, in the clinical laboratory. THE FINDINGS INCLUDE: 1. A review of current procedure manual revealed that all safety procedures were not available, to testing personnel, on the date of survey, October 23. 2025. 2. A tour of the laboratory confirmed that the safety shower was blocked by a fire safety cabinet and multiple boxes. The clean eyewash station was mounted on the dirty sink in use for the disposal of biohazard waste. 3. An exit interview, in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that the Laboratory Director failed to ensure all required safety procedures and the accesibility to safety equipment were available to testing personnel in the laboratory. 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. This STANDARD is not met as evidenced by: A review of the 2023 - 2025 Personnel Records confirmed that competencies on the Technical Supervisors were not performed. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records revealed that the required competencies for Technical Supervisor 1 and Technical Supervisor 2, (as listed on Form 209 Laboratory Personnel Report) were not performed. 2. An exit interview, in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that the required competencies on the Technical Supervisors were not completed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: A review of Maintenance Records, Personnel Records, Quality Control Records, Temperature/ Humidity Records, and Proficiency Testing Records for 2023 - 2025 confirmed that the laboratory failed to implement or perform quality assurance reviews of all laboratory records. THE FINDINGS INCLUDE: 1. A review of 2023 -2025 Maintenance Records, 2023 - 2025 Personnel Records, 2023 - 2025 Quality Control Records, 2023 - 2025 Temperature/ Humidity Records, and 2023 - 2025 Proficiency Testing Records confirmed that quality assurance reviews were not -- 2 of 4 -- performed. 2. An exit interview, in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that the laboratory failed to implement or perform quality assurance reviews of all laboratory records. 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: A tour of the laboratory revealed that the clinical laboratory testing personnel were using expired reagents for patient testing and patient specimen collection. THE FINDINGS INCLUDE: 1. A tour of the laboratory revealed that SurgiPath Clearium Mounting Media, which expired on February 02, 2023, remained in use on the date of survey, October 23, 2025. 2. A tour of the laboratory confirmed that Becton Dickinson Lithium Heparin Vacutainer Tubes, that expired on June 30, 2025, remained in use, on the date of survey, October 23, 2025. 3. An exit interview, in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that expired reagents, remained in use, by clinical laboratory testing personnel, on the date of survey, October 23, 2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records confirmed that Testing Personnel failed to perform and/ or document maintenance as required by the manufacturer or implement laboratory microscope use protocol procedures. THE FINDINGS INCLUDE: 1. A review of the Microscope Use Protocol Procedure listed the following maintenance performed: - Cleaning of the microscope stage and microscope oculars weekly - Grounding Check to be performed weekly - Calibration of the ocular micrometer annually 2. A review of the Microscope Use Protocol Procedure Item #6 states that "Every action is documented on the Maintenance Record Form. 3. A review of the Leica CM1850 UV Cryostat Manual pp. 38 - 47 lists the following required maintenance: DAILY MAINTENANCE o Remove waste oWear protective gear WEEKLY MAINTENANCE " Disinfect surfaces o Use UVC disinfection o Defrost ANNUAL OR PROFESSIONA MAINTENANCE " Full cleaning and inspection o Check refrigeration system o Inspect and clean parts o Replace seals and lines 4. A review of the Sakura Tissue Tek II User Manual lists the following required maintenance: DAILY MANITENANCE " Wipe the exterior of the sterilizer o Wipe the door gasket and mating surfaces " Inspect the door and dam gaskets for damage. " Drain the reservoir and refill with clean distilled water. o Clean the trays and tray rack " Clean the exterior and gaskets MONTHLY MAINTENANCE " Autoclave prompted maintenance cycle every 28 5. The documentation of completion of the required manufacturers performance, of the items listed above, was not evident in the review of the 2023 - 2025 Microscope Maintenance Logs. 6. Maintenance performance on the -- 3 of 4 -- Safety Shower was not performed in the review of the 2023 - 2025 maintenance records. 7. An exit interview, conducted in the office, with the Office Manager, on October 23, 2025, at 1:00pm, confirmed that testing personnel failed to perform and/ or document maintenance as required by the manufacturer. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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: A tour of the Laboratory facility, a review of the current Procedure Manual, Maintenance Records, Personnel Records, Quality Control Records, Temperature/ Humidity Records, Proficiency Testing Records for 2023 - 2025, confirmed that the Laboratory Director failed to provide overall oversight of laboratory operations. Refer to Tags: D2000, D3011, D5209, D5291, D5417, and D5429 for details. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 25, 2023. 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: 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

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 29, 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 proficiency test (PT) document review and staff interview, the laboratory failed to enroll in a PT program that meets the required (five sample) CLIA criteria. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed the laboratory received and tested only one PT sample for Microbiology Potassium Hydroxide (KOH) skin scraping for the following PT events: 2018 -- all three events; 2019 -- First event (2019-A). 2. An interview with an office manager in a medical office on 5/29/2019 at approximately 1:45 p.m. confirmed the aforementioned lack of required PT samples tested. REPEAT DEFICIENCY D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(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 4 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload 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 director (LD) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Academy of Family Physicians (AAFP) document review revealed the laboratory failed to produce an attestation statement signed by the LD and testing personnel for the following Clinical Microbiology Potassium Hydroxide (KOH) and Dermatophyte Screen PT events: 2017 -- Off-schedule/Reinstatement PT event; 2017-C, 2018 -- all three PT events; 2019-A. 2. An interview with an office manager in a medical office on 5/29/2019 at approximately 1:45 p.m. confirmed the failure of the laboratory to produce attestation statements signed by the LD and testing personnel for the aforementioned PT events. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of mycology quality control documents and staff interview, the laboratory failed to perform required media quality control. Findings include: 1. Dermatophyte Test Medium (DTM) QC document review revealed the labaoratory failed to check each batch of DTM media for its ability to support or inhibit growth for the following dates: 2017 -- June through December; 2018, 2019 thus far. 2. Dermatophyte Test Medium (DTM) QC document review revealed the labaoratory failed to check each batch of DTM media for sterility for the following dates: 2017 -- June through December; 2018, 2019 thus far. 3. An interview with the clinic manager on 5/29/2019 at approximately 1:45 p.m. in a medical office confirmed the aforementioned lack of QC of DTM media. 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 proficiency test (PT) documents and staff interview, the laboratory director (LD) failed to provide overall management and direction of the laboratory as required. Findings include: For detailed refer to D6015 and D6018 -- 2 of 4 -- D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) 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 review of proficiency test (PT) documents and staff interview, the laboratory director (LD) failed to ensure the laboratory was enrolled in an HHS approved PT program for the testing performed. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed the laboratory received and tested only one PT sample, instead of the five samples required, for Microbiology Potassium Hydroxide (KOH) skin scraping for the following PT events: 2018 -- all three events; 2019 -- First event (2019-A). 2. An interview with an office manager in a medical office on 5/29/2019 at approximately 1:45 p.m. confirmed the aforementioned lack of required PT samples for each PT event. 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