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 surveyor review of laboratory records and interview with the histology director, the laboratory did not document special stain quality control reactions for one of two cases reviewed. Findings include: 1. Review of laboratory records for two cases with special or immunohistochemical stains (patient one and two) showed no recorded quality control reactions for the PAS (Periodic acid-Schiff) stain for patient one. 2. Interview with the histology director (staff A) on February 12, 2021 at 11:15 AM confirmed the testing personnel did not document the quality control reactions for the PAS stain for case one. 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 --