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 and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 7/16/26 at 2:20pm, two (of two) containers of "Vitros Chemistry Calibrator Kit 2 3mL" (Ortho-Clinical Diagnostics, lot: 02141-B1, CD906321P, expiration date 2026-07-01) were observed in the laboratory, available for use beyond the expiraton date. B) In an interview on 7/16/26 at 2:21am the technical consultant confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on policy, lack of documentation and an interview, the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in analytic systems. Findings include: A. Policy titled "Quality Assessment Program" states "