Summary:
Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of Certification and Surveyor Provider Enhanced Reporting (CASPER) records and College of American Pathologists (CAP)proficiency testing (PT) results, and interview with the reference laboratory manager, the laboratory did not authorize the proficiency test program to release to Health and Human Services (HHS) the laboratory's proficiency test results. Findings include: 1. Review of the CASPER report 0155D (Individualized Laboratory Profile) for the laboratory on February 10, 2021 shows no proficiency testing data available for review for the regulated analytes. 2. Review of the CAP PT records showed the report for the laboratory did not include the Clinical Laboratory Improvement Amendments (CLIA) identification number for the laboratory. 3. Interview with the reference laboratory manager, Staff A, at 9:30 AM, confirmed the laboratory did not provide the CLIA identification number to the PT provider to authorize the program to release the laboratory's results to HHS. 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 --