Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/09/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the respiratory therapy supervisor at the conclusion of the survey. 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 a review of records and interview with the respiratory therapy supervisor, the laboratory failed to ensure that proficiency testing samples were tested by personnel who routinely performed patient testing for 7 of 7 events. Findings include: (1) On 06/09/2021 at 10:00 am, the respiratory therapy supervisor stated to the surveyor the laboratory performed Blood Gas (pH, pCO2, pO2) testing using the GEM Premiere 3000 analyzer; (2) The surveyor reviewed the Laboratory Personnel Report (Form CMS-209), that had been completed by the laboratory prior to the survey. The respiratory therapy supervisor stated to the surveyor at 10:30 am, 4 persons performed the above patient testing in the laboratory (respiratory therapy supervisor/testing person #1, testing person #2, testing person #3, and testing person #4); (3) The surveyor then reviewed proficiency testing records for the first 2019, second 2019, third 2019, first 2020, second 2020, third 2020, and first 2021 events and identified that 7 of 7 events had been tested by the same person (respiratory therapy supervisor/testing person #1); (4) The findings were reviewed with the respiratory therapy supervisor who stated on 06/09/2021 at 11:00 am, the proficiency testing samples had been tested by the respiratory therapy supervisor, as shown above. 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 -- D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the respiratory therapy supervisor, the laboratory failed to make appropriate reference ranges available for 1 of 1 patient report. Findings include: (1) On 06/09/2021 at 10:00 am, the respiratory therapy supervisor stated to the surveyor the laboratory performed venous Blood Gas (pH, pCO2, pO2) testing using the GEM Premiere 3000 analyzer; (2) The surveyor reviewed a patient report for venous Blood Gas testing performed on 05/30/2021 at 11: 22 am. The report did not include reference intervals for venous pH, pCO2, and pO2; (3) The surveyor reviewed the report with the respiratory therapy supervisor who stated on 06/09/2021 at 11:20 am, the patient report did not include reference intervals for venous Blood Gas testing. -- 2 of 2 --