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 twice annual test accuracy verification review, lack of documentation, and confirmation by the director, the laboratory failed to verify histopathology test accuracy at least twice annually in 2019. The laboratory performed approximately 25,000 histopathology diagnostic tests per year. Findings include: 1. Test accuracy verification documentation included records of performance on 04/02/2019, 01/07 /2020, and 09/10/2020. 2. The test accuracy verification record review lacked documentation of a second event in 2019. 3. In an interview conducted via telephone on 12/02/2020 at approximately 1:10 P.M. the director stated the 1st event of 2020 included testing performed in 2019. The director confirmed the review of the testing accuracy was not performed in 2019 but on 01/07/2020. 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 --