Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and parasitology test requisitions record review on November 9, 2018, the laboratory failed to have written or electronic requests for patient Giardia and/or Cryptosporidium antigen testing from an authorized person. Findings included: a. It was the practice of the laboratory to perform patient Giardia and Cryptosporidium antigen testing on patient specimens. b. For 8 (accession numbers H1152672, T1117629, H1182379, M117555, W133012, S1168240, T1215411, and W159256) of 8 patient Giardia and/or Cryptosporidium antigen tests performed and reported between January 1, 2018 and June 30, 2018, the laboratory failed to maintain written or electronic requests from an authorized person. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of