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 observation and an interview with the Laboratory Director (LD), the laboratory failed to replace five out of five Tissue Marking Dyes after they had exceeded their expiration dates. The Laboratory processes approximately 200 Histopathology specimens per year. Findings include: 1. An observation of the laboratory's reagents and stains on 08/02/2023 at approximately 10:30 AM, revealed five bottles of Tissue Marking Dyes had exceeded their expiration dates. A) Color black, lot number: 087387, expiration date: 09/30/2021. B) Color green, lot number: 088372, expiration date: 10/31/2021. C) Color red, lot number: 089147, expiration date: 08/31/2021. D) Color blue, lot number: 089149, expiration date: 10/31/2021. E) Color yellow, lot number: 089145, expiration date: 10/31/2021. 2. An interview with the LD at on 08/02/2023 at approximately 11:15 AM, confirmed that the five Tissue Marking Dyes had expired and had been used for the inking process for Mohs specimens. 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 --