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 direct observations, review of current, approved standard operating procedures (SOPs), as well as interview with the Testing Person (TP), the laboratory failed to remove from inventory expired reagents in the Mohs processing laboratory. FINDINGS: 1. The surveyor's observations in the Mohs processing laboratory confirmed on September 5, 2024, at approximately 11:00 A.M. the following reagents were not removed from inventory as required by the Mohs Procedure Manual SOP, "Quality Control Policies and Documentation". a. CDI Tissue Marker Dye Red, lot: 22047, expiration: February 28, 2024, was stored in an overhead cabinet in the Mohs processing laboratory. b. CDI Tissue Marker Dye Green, lot: 22098, expiration: April 30, 2024, was stored in an overhead cabinet in the Mohs processing laboratory. c. CDI Tissue Marker Dye Black, lot: 9092, expiration: April 2021, was stored in an overhead cabinet in the Mohs processing laboratory. d. CDI Tissue Marker Dye Yellow, lot: April 30, 2024, was stored in an overhead cabinet in the Mohs processing laboratory. 2. TP informed the surveyors that the respective expired tissue marker dyes were utilized for patient specimen processing. Approximately 1587 patient specimens were processed utilizing the respective expired reagents. 3. TP confirmed the findings on September 5, 2024, at approximately 11:30 A.M. 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 --