Summary:
Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a lack of 2021 performance evaluations in employee files, a review of patient test reports, a review of the installation records for the Sight OLO Hematology analyzer, and an interview with the Laboratory Manager, the Technical Consultant failed to evaluate and document the competency of four of five testing personnel performing moderate complexity Hematology testing. The findings include: 1. A review of the validation documentation for the new Sight OLO Hematology analyzer revealed the instrument was installed in October 2020. 2. A review of patient test reports revealed the first patient CBC's (Complete Blood Counts) were performed and reported on 2/7/2021. 3. A review of personnel files for Testing Personnel #1, #2, #3, and #4 revealed no training or semi-annual competency assessments (due early to mid 2021) for personnel performing patient CBC's on the new Sight OLO Hematology analyzer. 4. During an interview with the Laboratory Manager on 9/28/2021 at 3:55 PM, the surveyor reviewed and confirmed the above noted findings. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on a lack of training documentation in employee files, a review of patient test reports, a review of the installation records for the Sight OLO Hematology analyzer, and an interview with the Laboratory Manager, the laboratory failed to ensure training for four of five testing personnel was performed and documented. The findings include: 1. A review of personnel files for Testing Personnel #1, #2, #3, and #4 revealed no training on the new Sight OLO Hematology analyzer installed in October 2020. 2. A review of patient test reports revealed the first patient CBC's (Complete Blood Counts) were performed and reported on 2/7/2021. 3. During an interview on 9 /28/2021 at 3:55 PM, the surveyor requested the training records for the testing personnel using the OLO. The Laboratory Manager stated some employees were trained when the OLO was installed, however she was unable to provide the documentation. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --