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 a review of the 2018 - 2020 CAP (College of American Pathologists) proficiency testing (PT) records and interview with the Testing Personnel #1 (listed on Form CMS-209), the laboratory failed to ensure attestation statements for two out of eight surveys were signed by the Laboratory Director (LD) and Testing Personnel (TP). The findings include: 1. A review of the CAP PT records revealed no signatures of the Laboratory Director and Testing Personnel on the attestation statements for the following surveys: A) 2019-FH2-B Hematology Event: No LD or TP B) 2020-FH2-A Hematology Event: No LD or TP 2. In an interview on 12/8/2020 at 12:43 PM, TP #1 reviewed the PT records with the surveyor, and confirmed the above noted findings. . 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on a review of CAP (College of American Pathologists) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to participate in one out of three proficiency testing events in 2019. The findings include: 1) A review of the CAP PT records for the 2019 FH2-B Hematology survey event revealed results were due on or before 5/28/2019. However the laboratory failed to submit the PT results within this timeframe, and received a score of 0% due to "failure to participate". 2) In an interview on 12/8/2020 at 12:45 PM, TP #1 stated that she had run the CAP samples on 5/16/2019 at 10:06 AM, however she had failed to submit the results on time. . 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 the 2018 - 2020 CAP (College of American Pathologists) proficiency testing (PT) records and an interview with Testing Personnel #1 and #2, the surveyor determined the laboratory failed to document reviews of eight of eight of the returned survey evaluations results, and further failed to document