Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2021 and interview with the Office Administrator, the laboratory failed to ensure the Laboratory Director (LD) and the testing personnel (TP) signed and dated the attestation form for PT. Findings include: 1. Upon review of the PT records for event #1 for Rh factor testing in 2021, the attestation page was blank. 2. The Office Administrator confirmed that she was unaware that this document was required for all PT events. 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 --