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 2016-2018 American Association of Bioanalysts (AAB) proficiency testing records and an interview with the center manager, the surveyor determined the Laboratory Director failed to ensure Chemistry results for one of two surveys in 2016 was submitted within the timeframes specified by the proficiency testing program. The findings include: 1. A review of the 2016 second quarter survey revealed a score of 0% (percent) due to no data received. 2. In an interview on 7/3 /2018 at 12:25 PM, the center manager confirmed that the survey results for the second quarter in 2016 were not submitted to the proficiency testing program within the specified time frame. Jeremy Westry, 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 --