Summary:
Summary Statement of Deficiencies D0000 The following deficiency was cited as the result of a recertification survey on 11/20 /19 for 42 CFR part 493 Laboratory Requirements. 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 2018-2019 proficiency test records, and semi-annual pathology visit notes, the Laboratory Director failed to sign the attestation sheets for 5 of 15 test events. Findings are: A. Review of 2018-2019 proficiency test records revealed no signature by the laboratory director or a qualified designee (Technical Consultant) for 5 of 15 test events. 1. D-Dimer a. 2018-3; samples were tested on 10/24/18. b. 2019-3; samples were tested on 10/21/19. 2. CBC (Complete Blood Count) a. 2019-2; samples were tested on 05/14/19. b. 2019-3; samples were tested on 10/04/19. 3. Troponin a. 2019-2; samples were tested on 5/25/19. B. Review of 2018-2019 semi-annual pathologist visits revealed that the previous Laboratory Director noted 2 missing attestation statement signatures during her visit on 12/10/2018. She did not clarify which signatures were missing, the Testing Person or the Laboratory Director /designee. 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 --