Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. D6076 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, policies and procedures,maintenance procedures and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to monitor and prevent contamination when using the Hologic Aptima SARS-COV-2 Assay (Panther System) between June 2020 and September 2020. Findings included: 1. Review of the manufacturer's instructions for the Hologic Aptima SARS-COV-2 Assay (Panther System) (AWW-2149-001 rev. 002) found on page 14 D. Lab contamination monitoring protocol for the Panther system There are many laboratory specific factors that may contribute to contamination, including testing volume, workflow, disease prevalence and various other laboratory activities. These factors should be taken into consideration when contamination monitoring frequencies being established. Intervals for contamination monitoring should be established based on each laboratory's practices and procedures. 2. A review of the laboratory's own policy titled Aptima SARS-COV-2 Assay (Panther System) dated July 16, 2020 found: on page 16 of 21:" The Laboratory will monitor for contamination is part of routine QC. Results will be documented into the tests QC/maintenance logs.