Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records, a review of the PT Policy, and an interview with the Corporate Office Manager, the laboratory failed to ensure the December 2022 PT had documentation of review upon return of the results. This affected one of one PT activity performed in 2022. The findings include: 1. A review of the December 2022 PT revealed no evidence of review upon return of the results. The surveyor noted no documentation of the findings from the "Peer Reviewing Dermatopathologist", thus the laboratory failed to document whether there were any discrepancies between the Dermatopathologist and the MOHS surgeon's findings. (Refer to D5417.) 2. A review of the policy, "MOHS Histopathology & Proficiency Testing Policy" under "Procedure" revealed, "...The histological findings of the Peer Reviewing Physician will be compared with the Mohs surgeon's diagnosis." 3. During an interview on 5/4/2023 at approximately 1:30 PM the Corporate Office Manager, the surveyor reviewed and confirmed the above findings. . 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 Proficiency Testing (PT) records, a review of the PT Policy, 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 -- an interview with the Corporate Office Manager, the laboratory: (I) failed to perform one of two PT activities due in 2022, and (II) failed to ensure the December 2022 PT was valid and completed as per policy. The findings include: (I) 1. A review of the policy, "MOHS Histopathology & Proficiency Testing Policy" under "Procedure" revealed, "...Proficiency testing is to be sent out and returned by June 30th and December 31st each year." "...The slides from each Mohs case will be sent ... for review by a Dermatopathologist." 2. A review of MOHS patient logs revealed patient testing began on 9/7/2021. 3. A review of the PT records revealed no slides were sent out for PT review the first half of 2022. 4. During an interview on 5/4/2023 at 1:05 PM, the Corporate Office Manager confirmed the above findings. (II) 1. A review of the policy, "MOHS Histopathology & Proficiency Testing Policy" under "Procedure" revealed, "...The slides will be reviewed by a dermatopathologist (the "Peer Reviewing Physician") for a blind review to test for accuracy of the Mohs surgeon's diagnostic criteria...". "...The histological findings of the Peer Reviewing Physician will be compared with the Mohs surgeon's diagnosis." 2. A review of the December 2022 PT entitled "Quality Assurance", revealed the following: a) Accession numbers for five MOHS cases b) The MOHS surgeon's histological findings for the slides (under "Pathologist's Review") [Refer to interview below] c) The original diagnoses (BCC [Basal Cell Cancer] or SCC [Squamous Cell Cancer] under "Results"). There were no MOHS Maps attached or other information for the December 2022 PT. 3. During an interview on 5/4/2023 at approximately 1:30 PM, the surveyor asked about the MOHS surgeon's results and the comparison with the Dermatopathologist's results. The Corporate Office Manager stated the MOHS surgeon's results were under the Pathologist's Review column on the form. The surveyor asked, "Then where are the Pathologist's findings?" The Manager stated the Pathologist did not have room to write his findings, and signed on the bottom of the form with the date 1/9/2023. The Manager further stated if there had been a discrepancy the pathologist would have signed Form 4.6-CP-L 1015A. The surveyor noted the blank form with no evidence of survey details to indicate it was forwarded with this PT event, or evidence the Dermatopathologist had seen this form. 4. As the interview continued on 5/4/2023, the surveyor reviewed the PT Policy with the Manager, noting the laboratory had included the MOHS's surgeon's results, even though the Dermatopathologist was supposed to perform a "blind review". Next, the laboratory failed to ensure the Dermatopathologist was able to document his findings, so the laboratory could perform a comparison of the results. The surveyor explained the December 2022 PT was invalid because the laboratory had failed to follow their policy. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --