Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CSL Plasma Inc on 07/08 /2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 interview, the lab director failed to develop a policy or provide evidence of the required onsite visits for one of one six month period reviewed (01/2025 - 06/2025). Findings included: Review of records revealed no policy regarding the lab director being onsite every 6 months and no evidence of an onsite visit for 01/2025 to 06/2025. Interview with the Quality Manager on 07/08 /2025 at 1:30 p.m. confirmed the above. 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 --