Summary:
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 lack of documentation, staff interview, and review of policy and procedure, the laboratory failed to ensure the microscopic evaluation of dermatological histopathology slides was performed twice annually for 2 of 2 years reviewed (2023, 2024). The findings were: 1. Review of the facility's documentation showed no evidence the accuracy of internally processed specimens had been verified twice yearly as required. 2. Review of the "Quality Assessment Manual and Forms" policy showed "...In addition to the responsibilities described above, when applicable, the Laboratory Director is responsible for maintaining or ensuring that designated employees maintain the following laboratory systems and components...of this manual...Comparison of Test Results". Further review of the facility's documentation showed no evidence a policy and procedure had been developed related to the verification of test accuracy. 3. Interview with the laboratory director on 6/26/25 at 9: 35 AM revealed the accuracy of the evaluation of dermatological histopathology slides had not been completed as required. 4. Interview with the office manager on 6 /26/25 at 10:04 AM confirmed a policy and procedure had not been developed. 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 --