Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) records, monthly QC data, Standard Operating Procedures (SOPs), as well as interview with the Technical Consultant (TC), the laboratory failed to ensure QC control material results met the laboratory's acceptability criteria before reporting patient test results. FINDINGS: 1. QC results were unacceptable for Progesterone, Follicle Stimulating Hormone, Luteinizing Hormone, Prolactin, Prostate Specific Antigen, Thyroid Stimulating Hormone, Vitamin D, Folate, and Free Thyroxine analytes. 2. There was no documentation of repeated QC performance prior to patient specimen testing and results reporting. 3. This is contrary to instructions indicated in the current, approved SOPs that "no specimens are to be tested or reported when controls and instrument calibration are unacceptable." 4. Approximately 121 patients were tested with unacceptable QC results for the respective analytes. 5. The TC confirmed the findings on April 30, 2025, at 12:00 P.M. D5783