Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at North Pinellas Children's Medical Center Inc on 11/22/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 review of American Proficiency Institute (API) proficiency testing results for white blood cell differential, which includes granulocytes, lymphocytes, and monoctyes, erythrocytes (red blood cells - RBC), hematocrit, hemoglobin, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentrate (MCHC), mean corpuscular volume (MCV), platelet count, and red blood cell distribution width (RDW), and interview with the Office Manager, the Laboratory failed to score at least 80% for one (3rd testing event 2018) out of four (2nd, 3rd testing events in 2018 and 1st, 2nd testing events in 2019) hematology proficiency events reviewed. Findings included: Review of the API 3rd proficiency testing event in 2018 revealed a score of 73% for White Blood Cell differential. Interview on 11/22/2019 at 11:30 AM with the Office Manager confirmed the proficiency testing failure. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results for hematology and interview with the Office Manager, the Laboratory failed to have documented