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 2018 - 2019 API (American Proficiency Institute) proficiency testing (PT) records, personnel records, and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed moderate complexity testing on patients. This was noted on six of seven surveys. The findings include: 1. A review of API attestation statements revealed Testing Personnel (TP) #2 had signed as the only "Personnel performing the testing" on five out six 2018-2019 Hematology surveys, and one of one 2019 Chemistry surveys. None of the testing had been performed by TP #3. 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 11/16/2017). TP #3 received training on the new Chemistry analyzer on 8/6/2019. [The 2019 Event #3 Chemistry survey was performed on 9/4/2019.] 3. During an interview on 12/19/2019 at 12:35 PM, TP #2 confirmed she had performed all the proficiency testing as the lead testing personnel, however TP #3 had performed some rerun testing on critical PT samples. The surveyor then reviewed the attestation statements which instructed personnel performing the testing to sign in the appropriate section and specify the samples run. Only TP #2 had signed as the testing personnel. The surveyor explained all testing personnel included on the CMS-Form 209 (Laboratory Personnel Report) should periodically participate in proficiency testing performance. 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 --