Satellite Med, Llc

Summary Statement of Deficiencies D6022 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 the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's quality assurance (QA) plan, review of monthly quality control (QC) records, lack of

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the personnel records and interview with the Laboratory supervisor, determined the Technical Consultant failed to document competency assessments for five of five testing personnel for 2019 and 2020. The findings include: 1. Review of five of five testing personnel records, reveiled the Technical Consultant failed to perform Competency Assessments for 2019 and 2020. 2. Interview with the Laboratory Supervisor on April 16, 2021 at 9am confirmed the Technical Consultant failed to perform Competency Assessments for 2019 and 2020. 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 --