Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/25/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with histotechnician #2 at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the histotechnician, the laboratory failed to ensure that staining procedures were not performed with expired staining materials. Findings include: (1) At the beginning of the survey, the histotechnician stated to the surveyor, the laboratory performed H&E (Hematoxylin and Eosin) staining procedures on frozen sections of tissues obtained during Mohs surgical procedures. The tissue would then be observed microscopically; (2) The surveyor observed the current stains in use and identified the Hematoxylin stain (lot #81472) had a manufacturer's expiration date of August 2020 and was available for use; (3) The stain was shown to the histotechnician, who stated the expired stain was available for use. 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 --