Summary:
Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was conducted on 04/23/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 review of laboratory's policies/procedures, laboratory's records and staff interview, the laboratory director failed to define protocols/requirements for documentation of laboratory director's on-site visits, and to document two of two required visits in 2025. Findings included: 1. Review of laboratory's policies /procedures revealed the laboratory did not have protocols in place defining the requirements of laboratory director's on-site visits, including performing activities that are part of the laboratory director responsibilities, or how the visits were to be documented. 2. Review of laboratory's records revealed the laboratory did not have documentation of laboratory director's on-site visits, including documentation of fulfillment of laboratory director's responsibilities, for two of two visits required in 2025. 3. In an interview on 04/23/2026 at 1300 hours in the laboratory, the facility's General Supervisor (as indicated on submitted Form CMS 209) confirmed the findings. 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 --