Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to acheive satisfactory testing performance for Direct Bilirubin. This was noted for two out of five Proficiency Testing events reviewed for the specialty of Chemistry. The findings include: 1. A review of Medical Laboratory Evaluation (MLE) proficiency testing reports revealed the following scores: A. 2023 M2 - Direct Bilirubin 40% B. 2023 M3 - Direct Bilirubin 60% 2. During an interview on 4/16/2024 at 2:40 PM, Testing Personnel #1 confirmed the laboratory to have ongoing failures with Direct Bilirubin PT despite attempts to correct the issue. 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 --