Summary:
Summary Statement of Deficiencies 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 the 2017 - 2019 MLE (Medical Laboratory Evaluation) proficiency testing (PT) records, personnel records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely performed moderate complexity Hematology testing on patients. This was noted on seven of seven surveys reviewed. The findings include: 1. A review of MLE attestation statements revealed Testing Personnel (TP) #1 and #2 had performed all the testing on the surveys performed from 5/16/2017 through 5/15/2019 (the most current survey). None of the PT testing had been performed by TP #3, #4, or #5. 2. A review of the personnel files revealed TP #3 was full time, and had been qualified to perform moderate complexity Hematology testing since the previous survey (on 4/11 /2017). TP #4 and #5 were hired and trained on 2/19/2018 and 4/24/2017 respectively. 3. During an interview on 6/6/2019 at 10:25 AM, the Technical Consultant was asked if the laboratory had rotated the Hematology proficiency testing among all personnel who routinely performed patient CBC (Complete Blood Count)testing. The Technical Consultant confirmed TP #3, #4, and #5 were full-time and had performed CBC testing on patients; however they generally performed nursing duties, and had not performed PT in the last two years. The surveyor explained the laboratory must ensure all testing personnel included on the CMS-Form 209 (Laboratory Personnel Report) must periodically participate in the performance of proficiency testing. Thus the above noted findings were confirmed. SURVEYOR ID# 32558 Licensure and Certification Surveyor 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 --