Mercyone Ankeny Clinics

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume Form, proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4/7/2021, the laboratory failed to verify the accuracy at least twice annually for three out of three time periods (1/1/2020 - 4/7/2021) for the analyte, glycated hemoglobin. The finding include: 1. The Laboratory Test List & Annual Volume form included the analyte, glycated hemoglobin. 2. Review of the PT records from 2020 and 2021 revealed the laboratory did not perform PT for the analyte, glycated hemoglobin. 3. At the time of the survey, the laboratory did not have additional records indicating the twice annual verification of accuracy for the analyte, gylcated hemoglobin from 1/1/2020 - 4/7/2021. 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 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual volume form, proficiency testing (PT) records and confirmed by laboratory personnel identifier #7 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 12/11/2018, the laboratory failed to verify the accuracy of glycated hemoglobin testing at least twice annually for two out of two time periods from September 2017- September 2018. The findings include: 1. The Laboratory Test List & Annual Volume form included the analyte, glycated hemoglobin. 2. The laboratory installed and began using a new chemistry analyzer (Dimension EXL) in September 2017. 3. Personnel identifier #7 stated that the laboratory forgot to enroll in PT after the new install and did not perform PT for the analyte, glycated hemoglobin, from September 2017- September 2018. 4. At the time of the survey, the laboratory did not have additional records indicating the verification of accuracy for the analyte, glycated hemoglobin. 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 --