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 from 2017 and interview with the facility personnel, the laboratory director failed to sign the PT attestation statement. Findings include: 1. The laboratory participates in PT for testing performed in the specialty of Hematology. The laboratory's approximate annual test volume is 51,600. 2. The PT attestation statement presented for review for the second event of 2017 lacked the director's signature. 3. The facility personnel confirmed that the PT attestation statement indicated above was not signed by the laboratory director. 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 --