Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 the laboratory's policies, the laboratory's accuracy assessment records from 2023, and staff interview, the laboratory failed to have documentation of performing one of two twice annual accuracy assessments for Mohs slide interpretations in 2023. Findings include: 1. A review of the laboratory's policy titled 'Mohs Lab Proficiency Testing Procedure' revealed the following: "Four Mohs cases are randomly selected twice a year to be pulled and reviewed by an outside board- certified dermatopathologist." 2. A review of the laboratory's accuracy assessment records revealed the laboratory performed one accuracy assessment in July 2023. The laboratory failed to have documentation of verifying the accuracy of the Mohs slide interpretations a second time in 2023. 3. In an interview on 1/5/24 at 9:25 a.m. in the laboratory, after review of the records, the medical assistant confirmed the above findings. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. 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 a review of the laboratory's annual competency assessments and staff interview, the laboratory failed assess problem solving skills for one of one annual competency assessment performed for Mohs slide interpretations in 2023. Findings include: 1. A review of the laboratory's annual competency assessments performed in 2023 revealed the laboratory failed to assess problem solving skills for testing person #1 for Mohs slide interpretations. 2. In an interview on 1/5/24 at 9:40 a.m. in the laboratory, after review of the records, the medical assistant confirmed the above findings. -- 2 of 2 --