Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on the review of proficiency testing records and an interview with the technical consultant (September 27, 2018, 12:35 P.M.), the laboratory failed to test a proficiency sample the same number of times as a patient sample. Findings include: a. For the 2018 American Proficiency Institute (API) first testing event (Q1) event, for the Complete Blood Count (CBC) test sample 1 had a Hemoglobin of 5.8 g/dL (which the laboratory defines as a critical value). The sample was not retested. b. The technical consultant affirmed that the above proficiency sample should have been retested, but was not. c. The laboratory testing personnel reportedly will be performing approximately 75 CBC tests per month, even though the laboratory failed to retest a proficiency sample that had an analyte which had a critical value. D5779