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 2019, 2020 and 2021. Findings include: 1. No documentation was presented for review during the survey conducted on January 4, 2022 to indicate the laboratory verified the accuracy of Mohs testing at least twice annually during 2019, 2020 and 2021. 2. The facility personnel confirmed that the laboratory failed to verify the accuracy of Mohs testing at least twice annually during 2019, 2020 and 2021. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 240. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and interview with the facility personnel, the laboratory failed to perform and document monthly quality assessment activities related to the verification of accuracy for testing performed by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory. Findings include: 1. The laboratory performs Mohs testing under the sub- specialty of Histopathology, with an approximate annual test volume of 240. 2. The laboratory's established policy states, "To verify our accuracy for MOHS test we make sure that we send our case to a different Dermatopathologist or Pathologist to re- read our cases to maintain the accuracy of our reading...Cases for re-read will be done twice a year, for 2 cases a year." 3. The laboratory performs and documents a monthly QA checklist to include the monitoring of Proficiency Testing. The laboratory performs the verification of accuracy (see above #2) in lieu of Proficiency Testing. 4. No documentation was presented for review during the survey to indicate the laboratory monitored the verification of accuracy during the monthly QA review performed during 2019, 2020 and 2021. 5. The facility personnel confirmed that the laboratory's monthly QA processes failed to monitor and correct errors found, which were related to the performance of the verification of accuracy. -- 2 of 2 --