Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Through a review of the Aptima Panther System instructions for use, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform contamination monitoring as required by the manufacturer. Survey findings include: A. The Aptima Panther System instructions for use were reviewed. The instructions for use state, "Intervals for contamination monitoring should be established based on each laboratory's practices and procedures." B. The surveyor requested the contamination monitoring protocol and documentation. None was provided. C. In an interview, at 1:20 p.m. on 5/18/2022, employee #7 (as listed on the Employee Identification Worksheet) stated that the laboratory did not have a contamination monitoring protocol and that the laboratory had not monitored for contamination. 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 --