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 direct observation, review of Quality Control (QC) records, control material manufacturer's specifications, Standard Operating Procedures (SOPs), as well as interview with the Laboratory Director (LD), the laboratory failed to remove from inventory control materials that exceeded their expiration date. FINDINGS: 1. The surveyor's observations confirmed on August 26, 2025, at approximately 11:00 A.M. the following control materials were not removed from inventory as required by the current, approved SOPs and manufacturer's specifications. a. Control Material, Boule Multi-Parameter Assayed Hematology Control, lot: 22503, expiration: August 12, 2025. 2. LD informed the surveyor that the respective expired control materials were utilized for patient specimen processing. Approximately four patient specimens were processed utilizing the respective expired control materials on August 13, 2025. 3. LD confirmed the findings on August 26, 2025, at approximately 11:00 A.M. D5783