Scholes Dermatology

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of patient reports, the laboratory Hematoxylin and Eosin (H&E) stain quality control (QC) calendar and an interview with the laboratory director (LD) on 12/4/2023, the laboratory failed to document QC each day of patient testing. The findings include: 1. A random review of patient reports, slides and the corresponding H&E QC identified that the laboratory failed document H&E stain quality on 6/21/23 and 1/24/2023. 2. An interview with the LD on 12/4/2023 at 9:41 am confirmed the above finding. 3. The laboratory reports performing 1200 dermatopathology tests annually. 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 a review of competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory director on 1/26/2022, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1451(b) (7)(8) for 2020 and 2021. The findings include: 1. A review of competency assessment records identified one (1) of two (2) testing personnel listed on the CMS 209 failed to have documentation of annual competency for KOH and tissue grossing which included the six parameters as listed in 493.1451(b)(8) for 2020 and 2021. 2. An interview with the laboratory director on 1/26/2022 at 10:22 confirmed the above finding. 3. The laboratory reports performing 1,800 KOH and histopathology tests annually. 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 --