Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of policies and procedures, proficiency testing records, patient test records and staff interview, the laboratory failed to follow it's own written policy when failures occurred in one of four Nonchemistry proficiency testing events. The findings included: 1. Review of the policy titled PROFICIENCY TESTING found: "Use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to help resolve and document failed proficiency testing." 2. Review of the American Association of Bioanalysts (AAB) proficiency testing records for 2022 and 2023 found that the laboratory obtained a score of 40% for Hematocrit in the Q3 Nonchemistry 2022 testing event. The laboratory did not use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to document