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 testing performed in the specialty of Hematology and interview with the facility personnel, the laboratory director and the individual testing the samples failed to sign the PT attestation statement. Findings include: 1. The laboratory performs patient testing in the specialty of Hematology, with an approximate annual test volume of 30. 2. The PT attestation statement presented for review for the third event of 2016 for Hematology lacked the director's signature and the testing personnel's signature. 3. The PT attestation statement presented for review for the first event of 2018 for Hematology lacked the director's signature. 4. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director and testing personnel. **This is a repeat deficiency from the previous inspections conducted on 6 /13/2014 and 6/01/2016. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of