Carolina Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA onsite recertification survey was conducted at the Carolina Dermatology Laboratory on March 12, 2026, by the South Carolina Department of Public Health (SC DPH), Bureau of Nursing Homes and Medical Services. The facility was found to be out of compliance with Medicare Condition 42 CFR Part 493. CLIA laboratory requirements. The following STANDARD LEVEL DEFICINCIES were found to be out of compliance: D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on reviewed records, lack of documentation, and staff interview, the laboratory failed to establish and/or document laboratory tests accuracy for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program for 1 out of 2 years reviewed (2024 and 2025). Findings included: 1. A review of 2025 professional evaluation records for laboratory director reveals a lack of documentation of verification of accuracy for unregulated testing program for histology high complexity testing. 2. The laboratory lacks sufficient documentation of blind testing/assessment of histology slides read by laboratory director and another peer professional for 2025. 3. In an interview on March 12, 2026, at 3:00 pm in the conference room/breakroom with consultant and testing personnel the above findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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: Based on records review, lack of documentation, and staff interview, the laboratory failed to establish and/or 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 for 2 out of 2 years reviewed (2024 and 2025). Findings included: 1. A review of policy and procedures titled Quality Assurance procedures reveals a. Once labs are received from outside reference labs if any errors occur, a log report will be documented. b. Quarterly review of 10 patients verifying accuracy and completeness No documentation was available on the day of inspection. 2. In an interview on March 12, 2026, at 3:00 pm in the conference room/breakroom with consultant and testing personnel the above findings were confirmed. 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: Based on direct observation, lack of documentation, and staff interview, the laboratory failed to ensure test systems and/or equipment being used to process histology tissue samples did not exceed their expiration or are of substandard quality for the 2 out of 2 years reviewed (2024 and 2025). Findings included: 1. During a tour of the laboratory on March 12, 2026, at 2:45 pm the surveyor observed: a. ThermoPro thermometer expired 11/31/2023 b. Mueller microwave oven for drying slides, lack maintenance sticker. 2. Surveyor request and the laboratory failed to provide verification of performance documentation on equipment used to process histology tissue. 3. In an interview on March 12, 2026, at 3:00 pm in the conference room/breakroom with consultant and testing personnel the above findings were confirmed. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 reviewed records, lack of documentation, and staff interview, the laboratory director failed to provide on-site regular interactions between him/herself and the lab -- 2 of 3 -- for 2 out of 2 years reviewed (2024 and 2025). Findings included: 1. A review of laboratory records reveals the lacks documentation of the laboratory director's on-site visits demonstrating the laboratory's continuous compliance with the assessment of overall quality assessment of laboratory operations. 2. The surveyor request and the laboratory failed to provide documentation of the laboratory director's documentation signed logs, minutes, or notes of observations. 3. In an interview on March 12, 2026, at 3:00 pm in the conference room/breakroom with consultant and testing personnel the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted on 8/28/2024. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific 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 with staff the laboratory failed to twice annually verify the accuracy of one of one moderately complex test in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: Potassium Hydroxide (KOH) testing. b. The laboratory was asked to provide documentation of verification of accuracy. No documentation was provided. c. An interview with the Practice Manager on 8/28/2024 at 12:10 PM in the breakroom confirmed these findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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, direct observations, and interview with staff the laboratory failed to establish an acceptable room temperature from 1/1/2022 to 8/28/2024. a. A review of the laboratory's Room Temperature & Humidity Log for 1/1/2022 to 8/28 /2024 revealed "Room Temperature Range 18 [degrees Celsius] to 35 [degrees Celsius] (64.4 [degrees Fahrenheit] to 95.0 [degrees Fahrenheit])". b. On 8/28/2024 at 8:30 AM the surveyor observed the following Tissue Marking Dyes (sampling): Orange, lot number 24071, Expiration date: 3/3/26, Storage Temperature 15-30 [degrees Celsius]; Red, lot number 24067, Expiration date: 3/31/26, Storage Temperature 15-30 [degrees Celsius]; Green, lot number 23289, Expiration date 10/31 /2025, Storage Temperature 15-30 [degrees Celsius]; blue, lot number 23345, Expiration date 12/31/2025, Storage Temperature 15-30 [degrees Celsius] c. An interview with the Practice Manager on 8/28/2024 at 12:20 PM confirmed these findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation and interview with staff the laboratory failed to label secondary reagent containers with storage requirements, or preparation/expiration dates. a. During the tour of the laboratory on 8/28/2024 at 8:30 AM the surveyor observed a manual slide stainer filled with staining reagents and a plastic container in a drawer labeled "10% Formalin". The reagents were not labeled with storage requirements or preparation/expiration dates. b. An interview with the laboratory Practice Manager on 8/28/2024 at 11:57 AM in the laboratory confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on record review and interview with staff the Technical Consultant failed to document the competency of two of two testing personnel in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: KOH testing. b. The laboratory was asked to provide a policy for the competency assessment. No policy was provided. c. The laboratory was asked to provide competency assessment for testing personnel that perform moderately complex testing. No documentation was provided. d. An interview with the Practice Manager on 8/28/2024 at 10:30 AM in the breakroom confirmed these findings. -- 2 of 2 --