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 from the American Proficiency Institute and interview with staff on 03/12/2019 and 03/13/2019, the laboratory failed to ensure attestation statements were signed by the testing personnel and laboratory director on one of three chemistry testing events in 2017 and one of three chemistry testing events in 2018. Findings include: Attestation statements for the performance of blood gas analytes (pH, pCO2, pO2) were not signed for the third testing event of 2017 and the second testing event of 2018 . Testing Personnel acknowledged in an interview at 11:00 AM on 03/12/2019, the facility failed to have a system in place to ensure attestation sheets were signed by the laboratory director and testing personnel to attest to the integration of the proficiency samples into the routine patient workload. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 personnel records and staff interview on 03/12/2019 and 03/13 /2019, the Technical Supervisor failed to ensure four of seven newly-hired individuals were trained to perform blood gases on the IL GEM 3500 blood gas instrument prior to patient testing and reporting results. Findings include: Testing Personnel #6 was hired 03/22/2018. There was no evidence of initial training on the IL GEM 3500. Testing Personnel #7 was hired 08/04/2017. There was no evidence of initial training on the IL GEM 3500. Testing Personnel #11 was hired 08/02/2017. There was no evidence of initial training on the IL GEM 3500. Testing Personnel #12 was hired 03 /2018. There was no evidence of initial training on the IL GEM 3500. Testing Personnel acknowledged in an interview at 10:40 AM on 03/12/2019, the laboratory failed to have a system in place to ensure all new-hired individuals receive training for the laboratory services performed prior to patient testing and reporting of results. -- 2 of 2 --