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, patient log review, and interview with the office manager, the laboratory was using mycobiotic media that exceeded the manufacturer's expiration date for 1 of 3 lots used from 2017 to 2019. Findings include: 1. An observation on 5/2 /19 at 9:18 am by the surveyor during the laboratory tour revealed a lot of Troy Biological Mycobiotic Agar (1805210) had expired on 2/21/29 and was in use. 2. A review of the patient testing log showed 11 cases had been tested since the current lot of mycobiotic media exceeded the 2/21/19 expiration date. 3. In an interview on 5/2 /19 at 9:18 am, the office manager acknowledged the mycobiotic media was expired. 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 --