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 2021. Findings include: 1. No documentation was presented for review during the survey conducted on July 14, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of histopathology specimens at least twice annually during 2021. 2. The laboratory's established policy titled "Proficiency Testing (#PP12-050)" states, "Three or more cases (slides) will be pulled randomly out of the file at minimum of twice annually." 3. At approximately 11:00am on 7/14 /22, the facility personnel interviewed confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2021. 4. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 2,549. 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 --