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 identifier #2 (refer to the Laboratory Personnel Report) at approximately 3:45 pm on 02/15/2018, 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 identifier #2 stated that the laboratory intended to perform five patient chart audits each month. Personnel identifier #3 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 each month in 2015. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform monthly chart audits in 2016 and 2017. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 02/15/2018, the laboratory director failed to ensure that prior to testing patient specimens, all testing personnel performing moderate complexity testing received the appropriate training for one out of one new testing personnel (laboratory personnel identifier #7) hired in 2016. The findings include: 1. Review of personnel records revealed that the laboratory hired personnel identifier #7 in June 2016. 2. At the time of the survey, the laboratory did not have training records available for personnel identifier #7. -- 2 of 2 --