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: Item 1: Based on surveyor observation of blood collection supplies and interview with laboratory personnel, staff A, the laboratory had thirty-nine of fifty serum separator (SST) blood collection tubes available for patient use in the specimen collection areas that were expired. Findings include: 1. Observation of blood collection supplies on August 26, 2021 at 11:40 AM revealed thirty-nine of fifty SST tubes had expired on May 31, 2021. 2. Interview with staff A on August 26, 2021 at 11:40 AM confirmed thirty-nine of fifty SST tubes expired on May 31, 2021 and were available for use for patient testing in the specimen collection areas. Item 2: Based on surveyor observation of microbiology culture media and interview with laboratory personnel, staff A, the laboratory had three of three blood agar plates available for use for patient testing in the microbiology culture set up area of the laboratory that were expired. Findings include: 1. Observation of microbiology culture set up area on August 26, 2021 at 11: 35 AM revealed three of three blood agar plates had expired on August 25, 2021. 2. Interview with staff A on August 26, 2021 at 11:35 AM confirmed three of three blood agar plates expired on August 25, 2021 and were available for use for patient testing in the culture set up area of the laboratory. 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 --