Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dazzling Dermatology PLLC on April 23, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 the procedure manual, peer review records, and interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain, at least twice annually in 2023 and 2024. Findings: 1. Review of the procedure titled, Chapter 7 Quality Control (QC), Quality Assurance (QA), and Proficiency Testing, noted "Proficiency testing for the reading and interpretation (professional component) of H&E slides will be completed using peer review system. An outside board certified dermatologist pathologist and/or Mohs surgeon will review two (2) H&E specimens for diagnosis concordance. This will be completed twice (2 times) annually with results documented." 2. Review of the peer review recorded showed peer review for 2023 and 2024 for Testing Personnel A (Laboratory Director) was performed on 03/10/2025. 3. During an interview on 04/23 /2025 at 2:20 PM, the Laboratory Director acknowledged peer review of the slides was not done twice per year. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient 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 -- identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the procedure manual and Dermatopathology Reports, and interview, the laboratory failed to report where the technical component was performed and failed to include gross description of the surgical tissue for three of three (#1, #2, #3) Dermatopathology Reports reviewed. Finding: 1. Review of the procedure titled Chapter 4 Operating Procedures and Reporting Results noted, "All laboratory test reports must contain the results, units of measure, normal ranges, reporting technician, date, time, and name and address of testing facility." 2. Review of the Dermatopathology Reports revealed the laboratory failed to include technical component was also performed where the grossing was performed. 3. Review of the Gross Description section in the Dermatopathology Report revealed gross description of the surgical tissue was not included in the reports. 4. During an interview on 04/23 /2024 at 2:25 PM, the Laboratory Director stated the Dermatopathology Report was given to patients if requested. 5. During an interview on 04/23/2024 at 2:25 PM, the Laboratory Director acknowledged the Dermatopathology Reports did not indicate where the technical component was performed and did not include the gross description of the surgical tissue. -- 2 of 2 --