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 observation, lack of documentation, and proficiency testing result information from the laboratory unit, the laboratory failed to authorize the proficiency testing program to release information. Findings include: The surveyor attempted to look up proficiency testing results for the laboratory before the survey, and there were no results available on the Center for Medicare and Medicaid Services (CMS) reports. The laboratory unit verified that they did not have this laboratory on their College of American Pathologists (CAP) proficiency testing list. Review of proficiency testing results on 01/04/19 at 10:00 a.m. revealed that the laboratory was enrolled in proficiency testing with the CAP with successful scores over the past two years. During an interview with the laboratory supervisor at 11:30 a.m. on 01/04/19, she was not aware that results were not authorized to be released. 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 --