Sioux Center Health

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 proficiency testing records, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:45 am on 06/26/2024, the laboratory failed to verify the accuracy twice annually for the analyte, total iron binding capacity (TIBC), for four out of four time periods from 06/01/2022 - 06/26/2024. The findings include: 1. The laboratory began performing TIBC testing in June 2022. 2. At the time of the survey, the laboratory had not verified the accuracy of the analyte from 06/01/2022 - 06/26/2024. 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 proficiency testing records and the Laboratory Test List & Annual Volume form and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 8:50 am on 8/25/2022, the laboratory failed to verify the accuracy for testosterone and potassium hydroxide (KOH) testing twice annually for 3 out of 3 time periods from 1/1/2021 - 8/30/2022. The findings include: 1. Testing personnel #1 confirmed the laboratory performed testosterone and KOH testing. 2. At the time of the survey, the laboratory had not enrolled in proficiency testing for testosterone or KOH testing. Additionally, the laboratory had not verified the accuracy of either tests by a different method. 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 9: 50 am on 11/10/2020, the laboratory failed to perform a self evaluation of ungraded PT scores for three out of six PT testing events in 2019-2020 (2019 events 1 and 3 and 2020 event 1). The findings include: 1. For 2019 testing event 1, the laboratory received ungraded PT test scores for the following: *2019 Hematology and Coagulation 1st event- urine sediment (specimen US-02) *2019 Microbiology 1st event- susceptibility testing- ampicillin/sulbactrum (specimen UR-01) *2019 Microbiology 1st event- susceptibility testing- cefuroxime (specimen UR-01) 2. For 2019 testing event 3, the laboratory received ungraded PT test scores for the following: *2019 Microbiology 3rd event- stool culture (specimen SC-02) 3. For 2020 testing event 1, the laboratory received ungraded PT test scores for the following: *2020 Hematology and Coagulation 1st event- fecal leukocytes (specimen FW-01) 4. At the time of the survey, the laboratory did not have additional documentation or