Quest Diagnostics Clinical Laboratories Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted from June 4, 2024 to June 5, 2024. Quest Diagnostic Clinical Laboratories Inc was not in compliance with 42 CFR 493, requirements for clinical laboratories. D6081 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(d) Each individual may direct no more than five laboratories. This STANDARD is not met as evidenced by: Based on the Centers for Medicare and Medicaid Services (CMS) Aspen website and interview, the Laboratory Director was the director of seven (#1 - #7) laboratories. Findings: Review of the CMS Aspen website, showed the Laboratory Director was the director for seven laboratories. On 06/04/2024 at 9:20 AM, the Technical Supervisor acknowledged the Laboratory Director was the director of seven laboratories. 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 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 31, 2019. Quest Diagnostics Clinical Laboratories Inc. was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to run proficiency testing (PT) samples the same number of times, as it routinely tests patient samples for 2019 1st event for the specialty of Urinalysis. Findings: Review of the College of American Pathologists (CAP) PT records showed that for the 1st event of 2019 there were two sets of handwritten urinalysis cell identification results. The attestation for the 1st event for 2019 was signed by Testing Personnel B and the first set of handwritten results had Testing Personnel B's name written on it . The second set of result had Testing Personnel A's name on it and was dated 5/14/19. The CAP submission date for PT results for the 2019 1st event was 5/28/19. During an interview on 10/30/19 at 12:15 PM, the Testing Personnel A stated that he performed the cell identification to use for their comparison study but was unaware he needed to wait until after the submission date. 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 --