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 one of two Histopathology tissue marking materials was 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 1:00 p.m. on 10/14/21. 2. One expired bottle of tissue marking dye was observed as present and available for use during the tour of the laboratory. See below. Platinum Line Tissue Marking Dye Lot (Color) Expiration date 77490 (Black) 01/2020 3. The laboratory performed approximately 150 Mohs procedures annually as indicated on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form CMS-116 completed for the 10/14/21 survey. 4. In an interview at 1:05 p.m. on 10/14 /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 --