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 record review and interviews with the Administrative Director (AD), General Supervisor (GS) #4 and GS#11, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte partial pressure of oxygen (pO2) for the second PT event in 2023 in the specialty of Chemistry. This deficient practice had the potential to affect 10,227 out of 10,227 patient pO2 test results from the second PT event on 09/17/2023 to the first PT event in 2024. Findings Include: 1. Review of the laboratory's "Proficiency Testing Policy", approved by the Laboratory Director via signature and date on 04/28/2023 and provided on the date of the inspection, found the following statements: "Unacceptable results are evaluated for PT and APT by laboratory director or delegate with appropriate