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 laboratory document and CMS report review, the laboratory failed to ensure proficiency testing results for the sole regulated analyte were released to the Centers for Medicare and Medicaid Services (CMS) as required. Findings are as follows: 1. The laboratory performed Rh Factor blood testing as confirmed by the Regional Director of Health Services (RDHS) during a tour of the laboratory at 1:00 p. m. on 07/15/21. Rh Factor testing was implemented on 11/19/20 as indicated in laboratory records. 2. The laboratory participated in proficiency testing (PT) using the American Proficiency Institute (API) provider. API PT result documents from the 2020 3rd Immunohematology event and the 2021 1st Immunohematology event were reviewed on date of survey. 3. Rh Factor proficiency testing (PT) results were not included in the CMS CASPER Report 0096D, CLIA Application and Survey Summary. Rh Factor PT results were not found during additional CMS database review. 4. In an interview at 1:25 p.m. on 07/15/21, the RDHS confirmed the above finding. 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 --