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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with a technical consultant, the laboratory did not verify accuracy for six of thirty-one ungraded proficiency testing results in 2019 and 2020. Findings include: 1. Review of API Chemistry Miscellaneous PT records showed the laboratory did not evaluate the accuracy for one of one ungraded opiate result for event one in 2019. Further review of API Hematology PT records showed the laboratory did not evaluate the accuracy for five of thirty ungraded "Educational Blood Cell Identification" results in 2019 and 2020. 2. Interview with a technical consultant, Staff A, on January 21, 2021 at 9:40 AM, confirmed the laboratory did not evaluate the accuracy for six of thirty-one ungraded PT results in 2019 and 2020. This is a repeat deficiency from June 17, 2008. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --