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 a review of Hematology quality control and quality assurance records, and an interview with Testing Personnel #1 (TP #1), the surveyor determined the laboratory failed to ensure expired quality control material was not utilized beyond the expiration date. Patient testing continued on 12/21/17, although the quality control material used, expired on 12/20/17. This affected one day of quality control testing of fourteen months of records, reviewed by the surveyor. The findings include: 1. A review of the quality control records (including the manufacturer's assay information sheets) revealed all three levels of the quality control [low, lot #0710; normal, lot #0711 and high, lot #0712], used on 12/21/2017 with patient testing, had expired on 12 /20/17. 2. In an interview with TP #1 on 1/09/19 at 11:30 AM, the testing personnel confirmed expired quality control material had been used (also noted in the quality assurance reviews), and no