Kodiak Area Native Association

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of 2022 patient test log and interview with the laboratory director, the laboratory did not test, at a minimum, two levels of external control material to monitor the accuracy and precision of the Quidel QuickVue One-Step HCG Combo assay each day of patient testing. Findings include: 1. The 2022 patient log for HCG tests revealed patient HCG tests performed on 1/19/22, 1/21/22, 4/21/22, 5/4/22, 6/7 /22, 6/17/22, 7/13/22, 7/19/22, 9/1/22, 9/13/22, 9/27/22, 10/11/22, 10/20/22, and 11/28 /22 with no corresponding external control documentation. 2. The laboratory director confirmed on 11/2/22 at 12:00 PM the external controls were not run on the days patients were tested. 3. The laboratory reported performing 17 serum HCG tests annually. 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 D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation and Lab Director Interview, the laboratory failed to follow manufacturer's instructions for SARS-CoV-2 testing on the Cepheid GeneXpert. Findings: 1. The laboratory was using the Cepheid GeneXpert for SARS-CoV- 2testing. 2. On 3/30/2021 at 11:00 am it was observed that patient samples were pooled prior to running on the GeneXpert. 3. The GeneXpert Instructions for Use states "Authorized laboratories using your product will use your product as outlined in the Xpert Xpress SARS-CoV-2 Instructions for Use - For Use with GeneXpert Dx or GeneXpert Infinity systems. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use the Xpert Xpress SARS-CoV-2 test are not permitted." 4. The laboratory began pooling specimens on 10/13/2020 and discontinued the pooling practice at the time of the survey. 5. The laboratory performs approximately 4500 SARS-CoV-2 tests annually. 6. The laboratory director confirmed these findings on 3 /30/2021 at 12:00 pm. 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 D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation and Lab Director Interview, the laboratory failed to follow manufacturer's instructions for SARS-CoV-2 testing on the Cepheid GeneXpert. Findings: 1. The laboratory was using the Cepheid GeneXpert for SARS-CoV- 2testing. 2. On 3/30/2021 at 11:00 am it was observed that patient samples were pooled prior to running on the GeneXpert. 3. The GeneXpert Instructions for Use states "Authorized laboratories using your product will use your product as outlined in the Xpert Xpress SARS-CoV-2 Instructions for Use - For Use with GeneXpert Dx or GeneXpert Infinity systems. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use the Xpert Xpress SARS-CoV-2 test are not permitted." 4. The laboratory began pooling specimens on 10/13/2020 and discontinued the pooling practice at the time of the survey. 5. The laboratory performs approximately 4500 SARS-CoV-2 tests annually. 6. The laboratory director confirmed these findings on 3 /30/2021 at 12:00 pm. 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 --