Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment policy and records and confirmed by laboratory personnel identifiers #3 and #4 (refer to the Laboratory Personnel Report) at approximately 4:00 pm on 03/29/2018, the laboratory director failed to ensure that the quality assessment policy established specific quality assessment activities and a frequency for monitoring these activities. The findings include: 1. Laboratory personnel identifiers #3 and #4 stated that the laboratory intended to perform five patient chart audits every six months. Personnel identifiers #3 and #4 also confirmed that the laboratory's quality assessment policy did not specifically establish that the laboratory would perform patient chart audits or the frequency with which it would perform them. 2. Review of quality assessment records indicated that the laboratory performed five patient chart audits every six months (April and October) in 2015. At the time of the survey, personnel identifiers #3 and #4 confirmed that the laboratory did not perform chart audits every six months in 2016 and 2017. 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 --