Summary:
Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a surveyor's review of quality control records and an interview with the Dermapathologist/laboratory director at the time of this survey, the laboratory director failed to review and document the quality control acceptability of the staining characteristics of the Hematoxylin & Eosin (H&E) stain, special stain Periodic Acid Schiff (PAS) stain on each day of reading. FINDINGS: 1. The Dermapathologist /laboratory director confirmed on November 1, 2019 at approximately 11:30 AM, findings that the Dermapathologist failed to review and document the quality control acceptability of the staining characteristics of the H&E stain and special stain (PAS) from June 1, 2018 through survey date. 2. Approximately 350 patients' histopathology slides were read and reported during above time frame. 3. The Dermapathologist failed to record the stain's quality as acceptable or unacceptable on the Aurora Diagnostic slide stain worksheet that accompanies each set of slides for the above time period. 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 --