Summary:
Summary Statement of 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: Review of the CMS Report 155, proficiency testing records and interview of facility personnel found that the laboratory failed to achieve satisfactory performance ( a score of 80% or higher) for the analyte Red Blood Cell (RBC) in one of five Hematology proficiency testing events between the 3rd testing event of 2016 and the 1st testing event of 2018. The findings included: 1. Review of the CMS report 155 Individual Laboratory Profile found a result of 60% submitted by the proficiency testing agency for the analyte RBC in the 2017 3rd testing event. 2. Review of the American Proficiency Institute (API) proficiency testing records for 2016, 2017 and 2018 (three events per year) found that the laboratory attained a score of 60% for the analyte RBC in the 2017 Hematology 3rd testing event. The laboratory submitted unacceptable results for specimens HEM-12 and HEM-14. 2. Interview of Testing person one on the CMS report 209 Laboratory Personnel report 209 confirmed the above scores were attained and that the laboratory consulted with the manufacturer regarding service once the failure was identified. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Review of proficiency testing records and interview of facility personnel found that 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 -- the laboratory failed to retain all proficiency testing records for at least two years. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for Chemistry found that the laboratory failed to retain results for five of six testing events between the 2016 3rd Chemistry testing event and the 2018 2nd testing event. The laboratory failed to retain the original results for Bilirubin tested on the Reichart Unistat bilirubinometer. 2. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on July 11, 2018 at 09:40 AM confirmed that the Reichert Unistat did not have a printer. The laboratory did not record proficiency results on the patient log used to record patient results, and did not retain the result submission form used to record the proficiency testing results. 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: Review of proficiency testing records policies and procedures and interview of facility personnel found that the laboratory failed to document proficiency testing evaluation and verification activities when Red blood cell (RBC) analyte failures occurred in the 2017 Hematology 3rd testing event. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records between 2016 3rd testing event and 2018 1st testing event (three testing events per year) found that the laboratory failed to document the evaluation of test results and