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 review of the laboratory's 2018 and 2019 American Proficiency Institute (API) proficiency testing (PT) documentation and interview, the laboratory failed to verify the accuracy of hematology and microbiology analytes that were assigned a ungraded proficiency testing score. Findings Include: 1. Review of the laboratory's 2018 and 2019 API PT documentation for hematology and microbiology found the following ungraded results: Hematology/Coagulation: 2018 - 2nd Event: Received "Grade" of "Not Graded" Blood Cell Identification: BCI-13, BCI-14, BCI-10 Microbiology 2018 - 2nd Event: Received "Grade" of "Not Graded" Molecular Resist. Genes-Blood: BCP-07 Microbiology 2019 - 1st Event Received "Grade" of "Not Graded" Urine Identification: UR-03 2. Review of the laboratory's PT review and