Summary:
Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the AAB (American Association of Bioanalysts) proficiency testing (PT) records and an interview with Testing Personnel #1, the Office Manager, and the Laboratory Director, the surveyor determined the laboratory failed to submit results for the 2020-Event Q1 Nonchemistry survey before the cutoff date. This was noted on one out of seven 2018-2020 AAB survey events reviewed. The findings include: 1. A review of the PT records revealed results for the 2020-Event Q1 Nonchemistry (Hematology) survey were due on or before 02/19/2020. A review of Hematology records revealed the instrument was down and patient testing was suspended from 02/06/2020 to 02/29/2020. However, the laboratory failed to notify the PT program (AAB) of the problem within the time frame for submitting PT results; the laboratory scored 0%, with the code "NR" (Not reported to AAB) for this survey. 2. During an interview conducted on 03/23/2021 at 3:15 PM, Testing Personnel #1, the Office Manager, and the Laboratory Director confirmed the above noted findings, stating however that AAB proficiency program was notified before the survey was due; the surveyors requested documentation of the notification to AAB. 3. On 3/26/2021 the laboratory submitted additional documentation to CLIA via e-mail. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The AAB records showed the laboratory failed to submit a valid reason for not performing the survey before the cutoff date. In a 3/29/2021 email, the Laboratory Director stated the Testing Personnel entered a comment, but probably forgot to save it. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of 2018-2020 AAB (American Association of Bioanalysts) proficiency testing (PT) records and an interview with Testing Personnel (TP) #1 and the Laboratory Director, the laboratory failed to implement and document