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 of microbiology culture media, review of media logs and patient testing logs and interview with the laboratory director, the laboratory had eosin methylene blue (EMB) agar plates in the microbiology culture set up area of the laboratory that were expired and had been used for patient testing. Findings include: 1. Observation of microbiology culture set up area on January 30, 2023, at 2:45 PM revealed three of three EMB agar plates available for patient testing had expired on January 26, 2023. Further observation of the EMB media showed two boxes of EMB media in the refrigerator, both with the expiration date of January 26, 2023, with no additional EMB media available for use. 2. Review of media logs showed the EMB lot 580872 was received on January 11, 2023, put into use on January 26, 2023, and expired January 26, 2023. 3. Review of patient testing logs showed the following cultures set up after January 26, 2023: January 27, 2023: Patient 1 and Patient 2 January 30, 2023: Patient 3 and Patient 4 4. Interview with the laboratory director on January 30, 2023, at 2:48 PM confirmed the laboratory had EMB agar plates in the microbiology culture set up area of the laboratory that were expired and had been used for patient testing 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 --