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 reviews of the Complete Blood Count (CBC) Quality Control (QC) records for the Sysmex XP-300 analyzer and an interview with the Technical Consultant (TC), the laboratory utilized expired QC materials prior to patient testing. The surveyor noted the three levels of expired CBC QC materials were used for 16 of the 31 days in May 2025. The findings include: 1. A review of the CBC QC records revealed the laboratory had utilized the three levels of CBC QC, Lot numbers 5021 (Low, Normal, High levels), Expiration date of 4-30-2025 for the following days in 2025, May 1-2; May 5-9; May 12-16; May 20-22, and May 27. 2. The TC stated 14 patient testing and results reported when the expired QC materials were utilized. 3. During the exit conference on 08-27-2025 at approximately 12:24 PM, TC confirmed the above findings. 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 --