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: D5417 Based on direct observation and interview with the Quality Assurance Associate (QAA), the laboratory failed to remove from inventory expired patient specimen processing materials as required by current, approved standard operating procedures. FINDINGS: 1. The surveyor's observations confirmed on May 10, 2024, at approximately 11:30 A.M. the following patient specimen urine cytology transport containers were not removed from inventory as required by the standard operating procedures: a. 125 units of 50% Reagent Alcohol Specimen Transport Containers; Lot#: 163745; expiration: March 31, 2024. b. It was noted that the respective patient specimen processing materials were removed from inventory during the survey in partial satisfaction of this requirement. c. The QAA confirmed on May 10, 2024, at approximately 11:30 A.M. that the respective expired patient specimen transport cups were not utilized for patient specimen processing. d. The QAA confirmed the findings on May 10, 2024, at approximately 11:30 A.M. 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 --