Summary:
Summary Statement of Deficiencies D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the laboratory director, the laboratory director failed to employ a sufficient number of laboratory personnel with the appropriate training to accurately perform the volume of x-ray, phlebotomy, waived and non-waived testing performed. Findings: 1. Review of personnel records on June 24, 2025 showed the laboratory had two full-time, appropriately trained testing personnel that perform x-ray, phlebotomy, waived and non-waived testing. The laboratory performs approximately 4,420 waived and non-waived laboratory tests per year, approximately 3,600 x-rays per year and approximately 19,500 phlebotomies per year. 3. Interview with the laboratory director on June 24, 2025 at 10:00 AM confirmed the laboratory director failed to employ a sufficient number of laboratory personnel with the appropriate training to accurately perform the volume of x-ray, phlebotomy, waived and non-waived testing performed. 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 --