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 interview with the 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 TP confirmed the findings on December 3, 2024, at approximately 11:30 A.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)