Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to attain a score of at least 80 percent for the analyte of Blood Cell Identification for two of five proficiency testing samples in 2020 Hematology/Coagulation-2nd event. The findings were: 1. Review of the laboratory's API proficiency test results from 2020-2021 revealed the laboratory received an unacceptable score of 60 for the analyte of Blood Cell Identification in 2020 Hematology/Coagulation-2nd event. 2. Further review of the API proficiency test results for the 2020 Hematology/Coagulation-2nd event reveled two of five proficiency samples received unacceptable performance for the analyte of Blood Cell Identification resulting in a score of 60%. Sample:BCI-08 Reported Result: Immatur/abnorm, would refer Expected Result: Monocyte Sample:BCI-09 Reported Result: Neutrophil with toxic gran Expected Result: Neutrophil, segmented 3. An interview with the LD on 4/5/22 at 9:42 am in the float waiting room confirmed the above findings. Key: API=American Proficiency Institute LD-Laboratory Director 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 --