Dermatology Partners - N Wilmington

Summary Statement of Deficiencies D0000 D0000 A Recertification Survey was conducted on August 1, 2025 at approximately 1: 00 PM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on laboratory document review and interview, the laboratory failed to retain records for peer-review proficiency testing (PT). This was noted for 3 out of 5 events reviewed. Findings included: Review of the records for the peer-review PT conducted to satisfy the requirement for twice-yearly accuracy verification revealed that results for the first event of 2023 and both events of 2024 were not available for review Review of the "Proficiency Testing" section of the "Policies and Procedures" manual, approved by Laboratory Director (LD) #1 on 08/01/2025, revealed the following statement: "Results of each Proficiency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records." During an interview on 08/01/2025 at 1:30 PM, Senior Director of Clinical Development (SDCD #8) stated that the laboratory moved the previous month, and the records could not be located; they may have been inadvertently discarded. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 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 -- This STANDARD is not met as evidenced by: Based on laboratory record review and interview, the laboratory failed to maintain copies of the monthly Quality Assurance (QA) checklists for two years. This was noted for 21 out of 24 months reviewed. Findings included: Review of the QA monthly checklists revealed completed checklists for 01/2023, 05/2025 and 06/2025. However, the QA monthly checklists for the remainder of 2023 and all of 2024 were not available for review. Review of the "Quality Assurance Policy" section of the "Policies and Procedures" manual, approved by Laboratory Director (LD) #1 on 08/01 /2025, revealed the following statement: "Any discrepancies found in the checklist for the month will be documented on a lab error form and kept in the manual for 2 years." During an interview on 08/01/2025 at 2:05 PM, Senior Director of Clinical Development (SDCD) #8 stated that the laboratory moved the previous month, and the missing QA checklists could not be located; they may have been inadvertently discarded. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial survey was conducted on February 7, 2023 at approximately 09:15 am at Dermatology Partners - N. Wilmington. The laboratory was surveyed according to 42 CFR part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Specific deficiencies 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: documentation and interview, the laboratory failed to perform Proficiency Testing (PTs) as required. Findings include: 1. At approximately 9:25 am on February 7, 2023 during document review, there was no second Proficiency Testing performed by the Testing Personnel (TP) in 2022. A PT was performed by the TP in January 2022, but none was performed or documented for the remainder of 2022 as required. 2. During the interview with the Laboratory Manager (LM), the LM confirmed that no second PT for 2022 was documented for the TP. 3. At the end of the survey at approximately 10:20 am no documentation could be provided as required for a second PT in 2022 by the TP. 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 --