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 accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2020. Findings include: 1. No documentation was presented for review during the survey conducted on February 10, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of histopathology specimens at least twice annually during 2020. 3. The facility personnel confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2020. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 2,100. The laboratory began patient testing on April 1, 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 --