Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of documentation for the daily slide control quality, and an interview with the MOHS Surgical Technician, the surveyor determined the laboratory failed to assess and document the slide stain quality each day of patient testing from February 2018 till the day of the survey. The findings include: 1. During the entrance interview and tour of the laboratory at approximately 10:15 AM on 2/20/2020, the MOHS Technician included Histopathology as the only non-waived testing for this CLIA certificate. The Laboratory Director read and interpreted slides prepared from frozen sections specimens collected during MOHS surgical procedures. 2. A review of the laboratory procedure manual under, "QUALITY ASSURANCE" [QA], revealed "The first case submitted to the Mohs lab which consists of NORMAL tissue will be stained for H&E [Hematoxylin and Eosin], documented on the control sheet as the QA. ...". 3. A review of the Histopathology records revealed no documentation of the daily slide stain quality. 4. During an interview on 2/20/2020 at 12:00 PM, when asked about the slide quality control (QC), the MOHS Tech stated if there was a problem, he fixed it right away. The MOHS Tech also provided the surveyor with the H&E stainer maintenance log, however the surveyor explained this was not what she was requesting. 5. As the interview continued on 2/20/2020 at approximately 12:05 PM, the surveyor explained, it is the responsibility of the testing personnel (i.e. 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 -- Director performing the reading) to assess and document the slide QC each day of patient testing, as per procedure. The Mohs Tech confirmed they had not documented the slide QC results. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --