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 surveyor observation and staff interview the laboratory failed to ensure reagents did not exceed the manufacturer's recommended expiration date when used for patient testing. Findings include: 1. Surveyor observation of the MOHS tissue marking dye on 2/5/18 at 10:00 AM revealed the following materials are in use. a. Blue dye with lot # 042825 expired on 9/30/2017 b. Yellow dye with lot # 042824 expired on 10/31/17 c. Red dye with lot # 42665 expired on 10/31/17 d. Green dye with lot # 43665 expired on 9/30/17 2. Staff interview with the laboratory director on 2 /5/18 at 10:30 AM confirmed the above findings. 3. The laboratory performs 216 MOHS procedures annually. 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 --