Brentwood Dermatology

Summary Statement of Deficiencies 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 a review of laboratory policy, split-sample testing logs, and staff interview, the laboratory failed to perform twice-yearly verification of accuracy for KOH fungal testing and scabies testing for three of three testing personnel (TP) in 2023 and 2024. The findings include: 1. A review of the Provider Performed Microscopy (PPM) Lab Manual revealed the following requirements: - "To evaluate and demonstrate proficiency, at least twice per year, split-sample testing is performed on at least two specimens for each test performed." - "Proficiency testing/split-sample testing duties will be rotated among all personnel who examine patient samples for PPM." 2. A review of the PPM Split-Sample Testing Log/Quality Assurance revealed that one of three TP in 2023 and three of three TP in 2024 failed to perform the twice-yearly testing. 3. An interview with the histology technician and the clinic manager on 05/16 /2025 at 11:30 a.m. confirmed the findings. 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 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 review of the Department of Health and Human Services Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), lack of policies available, personnel records, and staff interview, the laboratory failed to establish and follow policies and procedures to assess competency of testing personnel that perform provider performed microscopy (PPM) for potassium hydroxide (KOH) and parasitology patient testing resulting in no competency assessments for three of four providers that perform PPM testing in 2021, 2022, and 2023. The findings include: 1. Review of the CMS Form 209 revealed testing persons two, three, and four (three of four testing persons) that perform PPM KOH and parasitology patient testing. 2. Review of the laboratory's policy and procedure manuals revealed the laboratory did not have a personnel policy to assess competency for PPM KOH and parasitology testing procedures. 3. Review of the laboratory testing personnel records revealed testing persons two, three, and four did not have competency assessments for PPM KOH and parasitology patient testing. 4. Interview on 07/06/2023 at 12:00 with the office manager and laboratory histotechnician (non- testing) confirmed the laboratory failed to establish and follow a policy to assess competency for testing personnel that perform PPM KOH and parasitology patient testing. 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 --