Summary:
Summary Statement of Deficiencies 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 observation and interview with laboratory personnel, the laboratory failed to ensure 6 of 7 Histopathology tissue marking materials were not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 1:10 p.m. on 06/17/21. 2. Expired tissue marking materials were observed as present and available for use during the tour of the laboratory. See below. Surgipath Tissue Marking & Margin Dye Lot (Color) Expiration date 08102016 (Black) 08/2017 2012016 (Violet) 07/2017 110818 (Yellow) 11/08/19 052120 (Blue) 05/21/21 063020 (Orange) 06/2017 042120 (Red) 04/21/21 3. The laboratory performed approximately 350 Mohs procedures annually as indicated on the Form CMS-116 completed for the 06/17/21 survey. 4. In an interview at 1:20 p.m. on 06/17/21, TP1 confirmed the above finding. 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 --