Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Foundational Medical, LLC on March 18, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: 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 tours, review of procedures, and interviews, the laboratory failed to follow their safety protocol for two of two eyewash safety stations as observed on the date of inspection, March 18, 2026. Findings include: 1. During a tour of the laboratory on 3 /18/26 at 10 AM, the inspector noted no eye wash stations in the liquid chromatography mass spectrometry (LCMS) laboratory. 2. Review of the laboratory's procedures revealed a safety inspection procedure checklist (FMGLS-FORM-003c- 00) which included the following protocols to check as verified: Eyewash present, Eyewash Flushed, Eyewash Inspected/Tagged, Path to Eyewash is unobstructed, Eyewash is within 10-15 seconds of work area. The inspector noted that the above five protocols for laboratory eyewash safety checks were marked "YES" in the procedure manual. The inspector inquired regarding the location of the eyewash. The laboratory director (LD) stated on 3/18/26 at 12 noon, "there is no eyewash in our laboratory at the moment but the staff would be able to use two eyewash stations if needed. They are located in adjacent area where another laboratory rents space". 3. Tour of the adjacent space described above on 3/18/26 at 12:30 PM in order to observe the eyewash stations revealed that the path to the two safety stations would be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- obstructed for LCMS testing personnel and they were not within 10-15 seconds of the laboratory work area. 4. An exit interview with the primary testing personnel and LD on 3/18/26 at 2:30 PM confirmed the above findings. -- 2 of 2 --