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, review of thermometer calibration records and Standard Operating Procedures (SOPs), as well as interview with the Testing Personnel (TP), the laboratory failed to perform and document thermometer calibration. FINDINGS: 1. The most recent calibration of the Thomas Scientific thermometer, Model: 9337T07, serial number (SN): 221228574, utilized for monitoring room temperature and humidity of the Mohs processing laboratory, expired February 8, 2024. There was no documentation of calibration performance since expiration. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The TP confirmed the findings on December 12, 2024, at approximately 4:00 P.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 --