Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/14/2020. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director or designee failed to sign a proficiency testing attestation statement for 1 of 7 events. Findings include: (1) On 10/14/2020, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following for 1 of 7 events: (a) First 2019 Hematology Event - The attestation statement had not been signed by the laboratory director or designee. (2) The surveyor reviewed the findings with the technical consultant. The technical consultant stated on 10/14/2020 at 02:15 pm, the attestation statement had not been signed by the laboratory director or designee. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- 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 records and interview with the technical consultant, the laboratory failed to participate in 1 of 7 proficiency testing events. Findings include: (1) On 10/14/2020, the surveyor reviewed proficiency testing records for 2019 and 2020 and identified the laboratory attained a 0% score for the analytes Red Blood Cell Count, Hematocrit, Hemoglobin, White Blood Cell Count, Platelet Count, and White Blood Cell Differential, for the third 2019 Hematology Event, due to a failure to participate; (2) There was no documentation in the laboratory records to indicate what occurred for the laboratory to not participate; (3) The surveyor reviewed the records with the technical consultant and asked if