Southwest Skin Specialists, Llc Dba

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 review of accuracy checks for frozen biopsies for 2020 and interview with the facility personnel, the laboratory failed to indicate the correct diagnosis for 3 out of 3 frozen biopsy specimens sent to a qualified dermatopathologist for assessment of diagnostic accuracy. Findings include: 1. The frozen biospy slides including the following session numbers (ZBG20-0005, ZBG20-0006 and ZBG20-0007) indicated the diagnosis as "clear" on the accuracy assessment sheet for each of the frozen biopsy slides that were read by the physician providing the primary diagnosis. 2. The dematopathologist participating as the reviewer of the slides for accuracy signed the form indicating agreement with the diagnosis for all 3 frozen biopsies. 3. The diagnostic assessments provided by the primary reader of the slides and the agreement indicated by the reviewer of the slides were diagnostic assessments for Mohs surgery slide reading, not for Frozen Biopsy dermatopathology diagnostic assessments. 4. The facility personnel acknowledged that the primary diagnostic assessments and subsequent diagnostic reviews for accuracy were incorrect for frozen biopsies as indicated on the accuracy assessment form. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 review of accuracy checks presented for review for Mohs surgery slide reading for 2017 and 2018 and interview with the facility personnel, the laboratory failed to follow policies regarding the diagnostic comparison of the randomly selected cases read by the Mohs surgeon at the surveyed laboratory with that of another Mohs surgeon from an outside CLIA certified lab . Findings include: 1. Each case selected only included the pathology diagnosis not the Mohs diagnosis for the Mohs surgeon at the lab surveyed. Each comparative case indicated the Mohs diagnosis for the surgeon from the other CLIA certified lab. 2. None of the 23 diagnostic evaluations matched between the two surgeons since the diagnostic evaluations were for two different tests. 3. There was no documented comments or