Summary:
Summary Statement of Deficiencies D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain complete Histopathology quality control documentation of reagent lot numbers and expiration dates for 3 of 3 months reviewed in 2019. Findings Included: Record review of quality control documentation showed there was no record of lot numbers and expiration dates for the Hematoxylin and Eosin (H&E) staining reagents that were used on patient skin sample histopathology slides during processing. Interview with the office staff on 5/29/19 at 6:30 PM confirmed that the laboratory had not kept any quality control reagent logs showing documentation of the lot number and expiration dates for the H&E staining reagents. 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 --