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 for Mohs testing 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 February 17, 2023 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of histopathology specimens which are read during the Mohs procedure at least twice annually during 2021. 2. The facility personnel interviewed on 2/17/23 at approximately 10:10am confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2021. 3. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 313. 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 established quality assessment (QA) policies and procedures and 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 -- interview with the facility personnel, the laboratory failed to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 313. The laboratory performs the microscopic interpretation (reading/diagnosis) of histopathology specimens which are read during the Mohs procedure 2. The laboratory's established QA policy titled, Casa Grande - Laboratory Quality Assessment Proficiency Testing Policy, presented for review during the survey conducted on February 17, 2023 states, "At least twice annually, the clinic laboratory shall verify the accuracy of the test or the procedure by peer evaluation or through external proficiency testing examination." 3. The laboratory failed to follow the established QA policy indicated above as evidenced by the laboratory's failure to verify the accuracy of Mohs cases during 2021. 4. No QA documentation was presented for review during the survey to indicate the laboratory has an ongoing mechanism to routinely monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 5. The facility personnel interviewed on 2/17/23 at 10:25am confirmed that the laboratory failed to follow their established QA policy and procedure related to the frequency of accuracy verification for Mohs cases and confirmed that the laboratory's QA processes at the time of the survey failed to monitor, assess and correct problems as they occur in the general laboratory systems. -- 2 of 2 --