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) records and interview with the Histotechnologist (HT), the laboratory failed to document a positive and negative reactivity every day of patient testing for Mart-1 antibody immunohistochemical (IHC) stain performed in 2020 and 2021. Findings include: 1. On the day of survey 01 /14/2022 at 10:22 a.m., review of stain QC records revealed, that a positive and negative controls were not documented for Mart-1 antibody immunohistochemical (IHC) stain in 2020 and 2021. 2. The laboratory performed the following number of special stains: - 2020: 33 IHC stains were performed. - 2021: 39 IHC stains were performed. 3. The HT confirmed the findings above on 1/14/2022 around 11:30 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 --