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: Through a review of 2020 Special Request/Daily Tissue Quality QC forms and an interview with laboratory staff, it was determined the laboratory failed to document reactivity of immunohistochemical (IHC) stains and failed to document all control procedures performed when IHC stains fail to react as expected. Survey findings include: A. During a review of randomly selected Special Request/Daily Tissue Quality QC forms from March, May, and August of 2020 it was determined that two out of fifty Special Request/Daily Tissue Quality QC forms reviewed were incomplete. B. The Special Request/Daily Tissue Quality QC form dated 5/13/2020 (case #C20-316) includes a comment in the sections titled Pathologist QC Review that states, "CMV positive control not working". The form includes a space to record