Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC) on 3/20 /2026, the laboratory failed to review and evaluate a proficiency testing (PT) sample result failure for one of six events in 2024 and 2025. Findings include: 1. On 03/20 /2026, record review of 2024 and 2025 proficiency testing (PT) records revealed the following sample failure: a. AQ-A Critical Care Blood Gas w/ Chemistry 2025 Event 1 - 80% Score. Incorrect response sample AQ-5 for PC02. 2. Surveyor record review 2025 AQ-PT records revealed no evidence of a review, evaluation, or