Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to evaluate "Not Graded" results obtained for Chemistry-Miscellaneous PT performed with the American Proficiency Institute (API) in the 1-2018 event. The finding includes: 1. The laboratory did not evaluate "Not Graded" for Opiates - sample UDS-02. 2. The OM confirmed on 10/30 /19 at 10:00 am that the laboratory failed to evaluate "Not Graded" results. 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 surveyor review of Personnel Files and interview with the Office Manager (OM), the Laboratory Director failed to have education documented for one of two 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 -- Testing Personnel on the date of the survey. The OM confirmed on 10/30/19 at 10:00 am the education record was not available for one TP. -- 2 of 2 --