Summary:
Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory documentation, and interview, the laboratory failed to establish written policies and procedures to ensure transcription errors on Mohs slides are monitored, identified, and when needed, corrected, affecting one out of one patient. Findings include: 1. Direct observation on December 16, 2021 at 3:15 PM, surveyor observed the Mohs procedure date of 11/25/2019 written on six out of six (6) slides for Patient D2. 2. Review of the "Got Mohs" patient log showed 11 /25/2019 as the Mohs procedure date. 3. Review of the Patient D2 electronic medical record (EMR) and Mohs procedure Map showed that Patient D2 surgery was performed on 11/26/2019. 4. Interview on December 16, 2021 at 3:30 PM, Staff X1 and Staff X2 stated the laboratory did not have a process or procedure in place to monitor possible transcription errors that could occur during Histopathology slide production. 5. Staff X1 and Staff X2 confirmed the above findings on December 16, 2021 at 3:30 PM. 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 --