Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2022017829, was conducted on January 13, 2023 at Sea Level Labs, LLC. The facility was not in compliance with 42 CFR 493, Requirement for clinical laboratories. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on direct observation and interview with laboratory manager and Testing Personnel (TP #A), the laboratory failed to keep food and drink materials separate from the Polymerase Chain Reaction (PCR) testing environment. Findings include: Observation of the laboratory refrigerator on 1/13/2023 at approximately 7:00 pm, revealed a pint of milk and a bottle of Dasani drinking water inside the patient sample /reagent refrigerator. Observation of the laboratory desk area on 1/13/2023 at approximately 7:10 pm, that is within 5 -6 feet from the PCR testing environment, revealed a used coffee cup, a closed lunch container, and a large coffee creamer jug. Interview with laboratory manager and TP #A on 1/13/2023 at 7:40 pm, confirmed there were drinks and food containers in the laboratory. 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 --