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 lack of documentation and interview with the Medical Assistant (MA), the laboratory failed to document the Hematoxyline and Eosin (H&E) quality control (QC) reactions everyday of patient testing in Histopathology from 06/29/2021 through date of survey. Findings include: 1. On the day of survey, 07/26/2023 at 9:17am, the laboratory could not provide documentation of QC for H&E staining for everyday of patient testing from 06/29/2021 to date of survey. 2. The laboratory's annual volume for Histopathology is 460. (CMS-116) 3. The MA confirmed the above findings around 9:45 am. 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 --