Avera Holy Family Hospital

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 and Annual Volume report, proficiency testing records, and confirmed by interview with general supervisor identifier #1 (GS #1) at 9:00 am on 01/07/2025, the laboratory failed to verify the accuracy of urine sediment examinations performed on the Beckman Coulter DxU 840m Iris test system twice annually for two out of two time periods from 05/01/2024 - 12/31/2024. The findings include: 1. The laboratory began using the Beckman Coulter DxU 840m Iris test system to perform urine sediment examinations in May 2024. 2. At the time of the survey, GS #1 confirmed the laboratory did not enroll in proficiency testing or perform twice annual accuracy testing for urine sediment examinations performed on the Beckman Coulter DxU 840m Iris test system by another method from 05/01/2024 - 12/31/2024. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List and Annual Volume report and 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 -- confirmed by interview with general supervisor identifier #1 (GS #1) at 2:08 pm on 01 /07/2025, the laboratory failed to perform comparison testing twice annually for two out of two time periods from 05/01/2024 - 12/31/2024 for urine sediment examinations. The findings include: 1. The laboratory began using the Beckman Coulter DxU 840m Iris test system to perform urine sediment examinations in May 2024. 2. GS #1 stated the laboratory also performs urine sediment examinations by manual microscopy method. 3. At the time of the survey, GS #1 confirmed the laboratory did not perform comparison testing for urine sediment examinations from 05/01/2024 - 12/31/2024. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of blood culture bottle media quality control (QC) certificates and lot numbers, expiration dates and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 02/09/2023, the laboratory failed to retain blood culture bottle media quality control certificates for four out of four lot numbers of blood culture bottles currently in use. Additionally, the laboratory failed to retain blood culture bottle lot numbers, expiration dates for all blood culture bottles used prior to the current lot numbers. The findings include: 1. At the time of the survey, the laboratory had in use the following lot numbers, expiration dates of blood culture media: *Bact/alert PF plus lot number 0004101300, expiration date 10 /04/23, *Bact/alert PF plus lot number 0004101076, expiration date 06/24/23, *Bact /alert SN lot number 0001059330, expiration date 9/21/23, and *Bact/alert SA lot number 0001059232, expiration date 8/17/23. 2. The laboratory did not retain the media QC certificates for the above lot numbers, expiration dates of blood culture bottles. 3. The laboratory did not document lot numbers and expiration dates of blood culture bottles used on patients prior to the above lot numbers, expiration dates of blood culture bottles. 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9: 15 am on 05/20/2021, the laboratory director failed to attest to the routine integration of PT samples into the patient workload for five out of six proficiency testing events (2019 events 1 and 2; 2020 events 1, 2 and 3) from 1/1/2019 - 12/31/2020. The findings include: 1. For 2019 event 1, the laboratory director did not sign the following PT attestation statement: miscellaneous chemistry. 2. For 2019 event 2, the laboratory director did not sign the following PT attestation statements: immunology /immunohematology and core chemistry. 3. For 2020 event 1, the laboratory director did not sign the following PT attestation statement: microbiology. 4. For 2020 event 2, the laboratory director did not sign the following PT attestation statements: miscellaneous chemistry and microbiology. 5. For 2020 event 3, the laboratory director did not sign the following PT attestation statements: hematology/coagulation, immunology/immunohematology, and SARS-CoV2. 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 --