Summary:
Summary Statement of Deficiencies 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 record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to follow its policy to perform weekly contamination checks for 8 (March 2021 to November 2021) of 8 months reviewed. Findings include: 1. A review of the laboratory's "Quality Control Monitoring" policy revealed a section titled "Weekly Environmental Controls" stating, "On a weekly basis, environmental checks will be performed by swabbing equipment and surfaces in the laboratory with a sterile swab to check for contamination." 2. A review of the laboratory's documentation revealed a lack of environmental contamination checks performed weekly. 3. An interview on 11/30/21 at 1:50 pm with the LD confirmed the laboratory had not performed weekly environmental contamination checks according to their policy. 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 --