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: Review of proficiency testing records for 2016, 2017 and 2018 found the laboratory failed to document the review of proficiency testing results for five of five testing events in Hematology and four of five testing events in Microbiology (three events per year) . Findings included: 1. Review of American Proficiency Institute API) Proficiency testing records found that the laboratory failed to document the review of proficiency testing results for the following testing events: 2016 Hematology/ Coagulation - 2nd event 2016 Hematology/ Coagulation - 3rd event 2017 Hematology /Coagulation - 1st Event 2017 Hematology/ Coagulation - 2nd event 2017 Hematology/ Coagulation - 3rd event 2016 Microbiology - 3rd Event 2017 Microbiology - 1st Event 2017 Microbiology - 2nd event 2017 Microbiology - 3rd Event 2. Interview of testing person 1 listed on the CMS report 209 Laboratory Personnel Report conducted on February 28, 2018 at 10:55 AM confirmed that proficiency testing results had no documentation of review by the laboratory director. She went on to say that she "does not have her review them unless there is a failure." D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are 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 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require