Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 of Tosoh AIA-900 immunoassay system reagents stored in the laboratory refrigerator, interview with the technical consultant, and review of patient test results from the Tosoh AIA-900 immunoassay system, the laboratory failed to ensure that the Tosoh AIA-Pack Diluent Concentrate reagent, in use for five of five days, had not exceeded its expiration date, when used for performing PSA and testosterone tests. Findings include: 1. Observation of Tosoh AIA-900 immunoassay system reagents stored in the laboratory refrigerator on 3/9/2026 at 10:55 a.m. revealed the Tosoh AIA-Pack Diluent Concentrate reagent, Lot #F380078, expired on 2/28/2026. 2. In an interview on 3/9/2026 at 11:00 a.m., the technical consultant confirmed Tosoh AIA-Pack Diluent Concentrate reagent, Lot #F380078, which expired on 2/28/2026, was used for patient testing for five, of five, testing days from 3 /2/2026 through 3/6/2026. 3. Review of patient test results from the Tosoh AIA-900 immunoassay system revealed 62 patient PSA test results and 18 patient testosterone test results were reported from 3/2/2026 through 3/6/2026. 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 --