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 a review of the test menu with the Laboratory Director (LD), a review of the Quality Assurance (QA) policies and procedures, a lack of QA records (accuracy verifications) and an interview with the LD, the surveyor determined the laboratory failed to ensure the accuracy of Histopathology and non-Gyn Cytology slide interpretation was verified at least twice annually. The findings include: 1. The Laboratory Director described the test menu as Histopathology and non-Gyn Cytology slide interpretation with rare peripheral blood smear readings. The slide preparation was done off-site. 2. A review of the policy and procedure manual included QA instructions to perform the review of slides per each pathologist, monthly. 3. There were no documentation of accuracy verifications to review, since the previous survey in June of 2017. 4. At 10:47 AM on 7/10/2019, the Laboratory Director stated the other pathologist had separated from the practice about two years prior to the survey. Additionally, the LD stated the two pathologists previously reviewed each other's slides. However, since the other's departure, there have been no QA verifications done. The LD further stated he had recently sent about three slides per month for the survey period (July 2017 - July 2019) to another group of pathologists, but no results have been returned. The surveyor discussed with the LD the CLIA requirement to verify the accuracy and document at least twice per year; and to not hold the slides for two years prior to sending them for peer review . 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 --