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 review of the laboratory's proficiency testing (PT) records, and interview with the Technical Supervisor (TS) on November 7, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the routine chemistry analyte Alanine Aminotransferase (ALT) for the second PT event of 2025. The findings included: 1. The laboratory participated in College of American Pathologists (CAP) proficiency testing (PT) program for routine chemistry using the Siemens Dimension analyzer. According to the CAP evaluation report, the laboratory received an unsatisfactory score of 20% for ALT in Q2-2025. 2. On November 7, 2025, at approximately 10:30 am the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on September 5, 2025, stated that the laboratory performed approximately 8888 routine chemistry tests including ALT annually. Thus, the accuracy and reliability of patient test reports cannot be determined. 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 --