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 review of quality control (QC) staining records and interview with the Histotechnologist, the laboratory failed to document the negative control for Immunohistochemical (IHC) stains performed in 2019, 2020, and 2021. Findings include: 1. On the day of survey 09/15/2021 review of IHC Staining records revealed, IHC negative control was not documented in 2019, 2020 and 2021 2. The Histotechnologist confirmed the finding above on 09/15/2021 around 09:20 a.m. 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 --