Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ALIVE AND WELL COMMUNITY PARTNERS LLC on March 06, 2026 to March 09, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited are as follows: D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to establish a policy to be onsite at least once every six months, with at least 4 months between the minimum two on-site visits and documenting the onsite visits during the year 2025 until March 06, 2026. Findings included: 1- Review of the procedure manual signed by the LD on 11/13/2025 revealed that it did not specify when the LD must be onsite and document the visits. The laboratory started reporting patient results as on January 28, 2026. 2- During interview on 03/06/2025 at approximately 2:03 PM, the technician confirmed that there was no policy to monitor the LD visits to the laboratory and how to document the visits. 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 --