Summary:
Summary Statement of Deficiencies D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing records and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to ensure Hematology results for one of three 2017 surveys were submitted within the timeframes specified by the proficiency testing program. The findings include: 1. A review of the results from the 2017-Event #3 Hematology survey revealed 0% (percent) scores for all analytes due to failure to participate. 2. During an interview on 2/01/2018 at 10:45 AM, the Technical Consultant explained she had been training a new technical consultant who had failed to hit the "SUBMIT" button after entering and checking the results on API website. The Technical Consultant further stated no one had caught the error, and confirmed the laboratory had failed to submit their results within the timeframes specified by the proficiency testing program. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor 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 --