Southeastern Dermatology Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Southeastern Dermatology on 09/25/2025 - 09/30/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 record review and interview the Laboratory failed to verify the accuracy of KOH (Potassium Hydroxide) and Scabies testing at least twice a year for 1 (2024) out of 2 years reviewed (2024-2025). Findings Included: 1. Review of the CMS 209 (signed by the Laboratory Director on 09/25/2025) revealed that there were 3 Testing Personnel (TP) who performed KOH and Scabies testing in 2024. 2. Review of peer reviews for 2024 revealed: 2a. TP#A only had 1 KOH and 1 Scabies peer review in 2024. 2b. TP#C only had 1 Scabies peer review in 2024. 3. Interview on 09/25/2025 at 11:00 AM the Lab Supervisor confirmed that there were no other peer reviews for 2024. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- 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 record review and interview, the Technical Consultant failed to perform competency evaluations on 4 out of 4 Testing Personnel who performed moderately complex testing for 2 out of 2 years (2024-2025). Findings Included: 1. Review of the CMS 209 (signed by the Laboratory Director 09/25/2024) revealed 4 Testing Personnel (TP) for moderately complex testing. 2. Review of competency evaluations revealed no competency evaluations for 2 years (2024-2025) for TP#A, TP#B, and TP#C. TP#D did not start until 01/2025 and was missing the 6 month competency evaluation. 3. Interview on 09/25/2025 at 11:00 AM the Lab Supervisor confirmed that there was no competency evaluations for the moderately complex TP. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to develop a policy or provide evidence of the required onsite visits for 3 of 3 month period reviewed (01/2025-09/2025). Findings Included: 1. Review of records revealed no policy regarding the Laboratory Director being onsite every 6 months and no evidence of visits for 01/2025 to 09/2025. 2. Interview on 09/25/2025 at 1:30 PM the Lab Supervisor confirmed that they do not have a policy regarding the mandatory visits or documentation of the visits. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 10, 2023 at Southeastern Dermatology, Inc., a clinical laboratory. The laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. 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: Based on record review and interview with Testing Person (TP) #B, the laboratory failed to ensure that 1 of 2 Histotechnologists had an annual competency for 2022. This is a repeat deficiency from the survey on June 16, 2021. The findings include: A review of personnel records for TP #B revealed an annual competency for 2021 and 2023 but no competency was found for 2022. An interview with Testing Person #B on April 10, 2023 at 1:00 pm confirmed an annual competency was not performed or documented in 2022 for TP #B. 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 record review and interview, the laboratory failed to verify the accuracy of Mycology, Parasitology, and Virology testing at least twice annually for 1 of 2 years 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 -- reviewed for 4 of 4 moderate complexity Testing Personnel. (Testing Personnel #D, #E, #F, and #G) The findings include: A review of personnel records found no peer reviews for KOH (Potassium Hydroxide), Scabies, Tzanck tests for 2022. A review of the policy titled, "Quality Assurance Protocol", noted PPM quality assurance is performed semi-annually. An interview with Testing Person #B on April 10, 2023, at 1:00 pm, confirmed Testing Personnel #D, #E, #F, and #G did not verify the accuracy at least twice annually for the tests KOH, Scabies, or Tzanck for 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Southeastern Dermatology Inc. clinical laboratory is in compliance with the 42 CFR Part 493, Requirements for Laboratories. A CLIA recertification survey was conducted 06/16/2021. 44394 An announced CLIA recertification survey was conducted at Southeastern Dermatology Inc on 6/16/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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: Based on record review and interview with testing personnel (TP) A, the laboratory failed to ensure that two (TP F and TP G) of seven (TP A, TP B, TP C, TP D, TP E TP F, and TP G) testing personnel did not complete annual competencies for the year of 2020. Findings included: Record review revealed both TP F and TP G were missing competency for scabies competencies for 2020. Record review of the Monthly Laboratory Quality Assurance Checklist revealed Personnel Policies were all checked off as completed for the months of August 2020 and October 2020. Interview on 6/16/2021 at 1420 with TP A confirmed competencies were not complete or not perfrormed on four of the seven testing personnel. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with testing personnel (TP) A, the laboratory failed to ensure that expired reagents were not utilized for testing. The laboratory was utilizing expired KOH (Potassium Hydroxide) for patient testing since July 25, 2020. A total of 464 patients were tested with expired KOH. The findings included: During the tour of the lab on 6/16/2021 at 1600 it was observed that the KOH reagent bottle (lot #1820403 ) was expired on July 25, 2020. Record review of the Monthly Laboratory Quality Assurance Checklist revealed that "All reagents that exceeded their expiration date were discarded" had been checked with a Y for the months of August 2020, October 2020, January 2021, February 2021, March 2021, April 2021, and May 2021. Review of patient logs revealed 61 patients were tested in August of 2020, 43 patients were tested in September of 2020, 74 patients were tested in October of 2020, 49 patients were tested in November of 2020, 26 patients were tested in December of 2020, 28 patients were tested in January of 2021, 51 patients were tested in February of 2021, 43 patients were tested in March of 2021, 48 patients were tested in April of 2021, 23 patients were tested in May of 2021, and 18 patients were tested through June 16, 2021. During interview on 6/16/2021 at 1600 with TP A, it was confirmed that the KOH reagent bottle was dated to expire July 25, 2020. -- 2 of 2 --