Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of hematology proficiency testing (PT) records since the last survey on 4-5-16, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, personnel records, and interview with the technical consultant on 2-15-18 at 10: 00 a.m., proficiency testing was not rotated between Technical Consultant/Testing Personnel #1 and Testing Personnel #2, who performed hematology testing during this time frame. Findings include: Review of the CMS 209 personnel form and hematology PT records since the last survey on 4-5-16 revealed Technical Consultant /Testing Personnel #1, listed on the CMS 209 personnel form, performed all five of the PT events since 4-5-16, and Testing Personnel #2 did not perform any proficiency testing. Review of personnel records revealed Testing Personnel #2 was trained to perform hematology testing in January 2016. In an interview on 2-15-18 at 10:00 a. m., the technical consultant confirmed that Testing Personnel #2 began performing patient hematology testing in January 2016. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of the patient test log, quality control (QC) printouts from the Horiba Medical ABX Micros 60 hematology analyzer from 8-1-17 through 12-28-17, and hematology test reports in patients' charts, the laboratory failed to document performance of at least two levels of hematology control on 8-21-17, when hematology test results were reported on two patients. Findings include: Review of the patient test log, QC printouts from the Horiba Medical ABX Micros 60 hematology analyzer from 8-1-17 through 12-28-17, and hematology test reports in patients' charts revealed no documentation of performance of at least two levels of hematology control on 8-21-17, when hematology test results were reported on Patients #2710 and #7454. -- 2 of 2 --