Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 the surveyor's review of the laboratory's policy and procedure, the College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with the director of operations (DOO), laboratory manager (LM), testing personnel 1 (TP1), and testing personnel 2 (TP2) on August 4, 2026, the laboratory failed to attain at least 80 percent acceptable responses for the Total Bilirubin analyte for the first PT event of 2026 (Q1 2026). The findings include: 1. The surveyor reviewed the laboratory's policy and procedure and the CAP PT documentation and found that the laboratory obtained an unsatisfactory score of 60 percent for the Total Bilirubin analyte for the Q1-2026 event. 2. During an interview on August 4, 2026, at approximately 9:20 a.m., the DOO, LM, TP1 and TP2 confirmed that the laboratory obtained the unsatisfactory score as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 283 patient samples annually including the time when the laboratory obtained unsatisfactory scores for Total Bilirubin during the Q1-2026 event. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy and procedure, College of American Pathologists (CAP) proficiency testing (PT) records, lack of