Premier 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 record review and interview with the Laboratory Director, the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination for TP1 (testing Personnel). The laboratory performs approximately 250 histopathology slide examinations annually. Findings include: 1. Record review revealed that the laboratory failed to verify the accuracy, at least twice annually, of their test system for histopathology slide examination for TP1 in the year 2023. 2. In an interview on 8/24/2024 at approximately 11:33 am, the Laboratory Director confirmed the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination. 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 D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on patient test reports review, patient test records review, and interview with staff, the laboratory failed establish a method to monitor, assess, and when indicated, correct problems identified in the post analytic systems. Findings include: 1. Test report review for case number PFM 17M- 00120 included documentation the procedure included a second stage. 2. Patient test records review for case number PFM 17M- 00120 included a Mohs map and slides corresponding to one stage of specimen collection and examination. 3. In an interview conducted on 04/09/2018, staff confirmed the laboratory lacked an established method to document test report accuracy review. 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 --