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 review of proficiency testing records since the last survey on 9/16/20 and confirmation by Testing Personnel #1, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory director failed to sign the attestation statements for all five hematology proficiency testing events since 9/16 /20, in order to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings include: Review of hematology proficiency testing records for Event 3 of 2020, Events 1, 2, and 3 of 2021, and Event 1 of 2022 revealed the laboratory director failed to sign the attestation statements for all five proficiency testing events, in order to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Testing Personnel #1, listed on the CMS 209 personnel form, confirmed these attestation statements were not signed by the laboratory director. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of quality control (QC) records and preventive maintenance records for the Horiba Medical ABX Micros 60 hematology analyzer, including temperature logs, since the last survey on 9/16/20 and confirmation by Testing Personnel #1 listed on the CMS 209 personnel form, the technical consultant failed to document review of QC records and maintenance records, including temperature logs, since 9/16/20, for the evaluation of the competency of the staff. Findings include: Review of quality control records for complete blood count (CBC) testing on the Horiba Medical ABX Micros 60 hematology analyzer and maintenance records, including refrigerator and room temperature logs, revealed no documentation of review of these records by the technical consultant since the last survey on 9/16/20. Testing Personnel #1, listed on the CMS 209 personnel form, confirmed that review of these records was not documented. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and personnel records since the last survey on 9/16/20, the technical consultant failed to evaluate and document the performance of Testing Personnel #3, responsible for moderate complexity testing, at least semiannually during the first year this individual tested patient specimens. Findings include: Review of the CMS 209 personnel form and personnel records since the last survey on 9/16/20 revealed Testing Personnel #3 had an initial competency assessment, for performing moderate complexity complete blood count (CBC) testing, by the technical consultant on 9/4/21. There was no documentation that the technical consultant had evaluated and documented the performance of Testing Personnel #3 semiannually, since this individual began patient CBC testing in September 2021. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and personnel records since the last survey on 9/16/20, the technical consultant failed to evaluate and document the performance of Testing Personnel #1 and #2, responsible for moderate complexity testing, at least annually, since 9/16/20. Findings include: Review of the CMS 209 personnel form and personnel records since the last survey on 9/16/20 revealed no documentation that the technical consultant had evaluated and documented the performance of Testing Personnel #1 and #2, responsible for moderate-complexity complete blood count (CBC) testing, at least annually since 9/16/20. -- 2 of 2 --