Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of analyzer quality and control calibration records, standard operating procedures (SOPs), as well as interviews with the Technical Consultant (TC) and Testing Personnel (TP), the laboratory failed to retain analyzer quality control and calibrator assay information sheets for minimum two years. FINDINGS: 1. There was no documentation of Sysmex pocH-100i analyzer quality control and calibrator assay information sheets for calendar year 2023. 2. The current, approved SOPs did not include instructions for retaining such analyzer records for minimum two years. 3. The TC and TP confirmed the findings on December 3, 2024, at approximately 2:00 P.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 --