Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services form 209- Laboratory Testing Personnel (CMS 209), testing personnel records, patient data logs and interview with the technical consultant, the laboratory director failed to ensure testing personnel number two received training prior to performing patient testing for activated clotting time (ACT) in 2017. The findings include: 1) Review of the CMS 209 revealed the name of testing personnel number two. This testing personnel was new since the last survey date. 2) Review of testing personnel number two personnel records revealed the following: Document labeled as "Hemochron Initial Training Test" dated 6.21.2017. Competency assessment checklist marked as 6 month with an evaluation date of 6.21.2017. 3) Review of the ACT master results log revealed testing personnel number two began performing patient testing on 4.21.2017 with 15 patient tests performed before the first documented training and competency assessment. 4) Interview with the technical consultant on February 4, 2019 at 12:15 pm confirmed the laboratory director failed to ensure testing personnel number two had documented training prior to performing patient ACT testing in 2017. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --