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 lack of documentation provided by the laboratory from the proficiency testing (PT) organization and interview with the laboratory personnel, the laboratory failed to evaluate the results of the PT samples for the 3rd event of 2018 for Total Protein testing compared to the results supplied by the PT organization. Findings include: 1. The laboratory received an unsatisfactory score of 0 for the third event of 2018 for Total Protein testing since the PT results were not submitted to the PT organization by the deadline. 2. The laboratory provided a