Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Consultant (TC), the laboratory failed to document evaluation activities of unacceptable proficiency testing (PT) results. Findings Include: 1. Review of 3 of 3 of the laboratory's 2017 College of American Pathologists (CAP) Hematology/Coagulation PT records, provided on the date of the inspection, revealed the submitted RDW (red blood cell distribution width) results for sample HEM-3 in the first testing event of 2017 were unacceptable. Documentation of the laboratory's result evaluations were not found. 2. The Surveyor requested the laboratory's CAP PT evaluation documentation of the unacceptable results from the TC. The TC was unable to provide any evaluation documentation for the unacceptable PT results on the date of the inspection. The interview occurred on 03 /28/2018 at 1:56 PM. 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 --