Providence Seward Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 condition: successful participation [proficiency testing] D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the laboratory's 2025 American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the 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 -- general supervisor on 11/10/2025, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte High Sensitivity C-Reactive Protein (hs-CRP) and the subspecialty of General Immunology in two (2) out of three (3) General Immunology testing events resulting in unsuccessful PT Performance. See D2084, D2085 D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's 2025 American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the general supervisor on 11/10/2025, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte High Sensitivity C-Reactive Protein (hs-CRP) in two (2) out of three (3) General Immunology testing events resulting in unsuccessful PT Performance. Findings include: 1. Desk review of the laboratory's 2025 API PT records revealed hs-CRP scores of less that eighty (80) percent for the following General Immunology events: a. 2025 1st event - score of 0% b. 2025 2nd event - score of 0% 2. In an email and telephone interview with the general supervisor on 11/10/25, it was confirmed that the laboratory was unsuccessful in the PT events listed above. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's 2025 American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the general supervisor on 11/10/2025, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses the subspecialty of General Immunology in two (2) out of three (3) General Immunology testing events resulting in unsuccessful PT Performance. Finding include: 1. Desk review of the laboratory's 2025 API PT records revealed overall General Immunology scores of less that eighty (80) percent for the following testing events: a. 2025 1st event - score of 50% b. 2025 2nd event - score of 50% 2. In an email and telephone interview with the general supervisor on 11/10/25, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the cell washer maintenance log, patient testing log, and an interview with the general supervisor, the laboratory failed to perform cell washer function checks to ensure the cell washer is performing accurately and reliably 27 of 73 days patients were tested for ABO and Rh determinations, antibody screens, and compatibility testing in 2024 and up to 4/28/2025. Findings include: 1. A review of the cell washer maintenance logs and Immunohematology patient testing logs revealed that cell washer function checks were not documented on the following dates patients were tested. (1/26/24, 2/11/24, 3/8/24, 5/10/24, 5/14/24, 5/16/24, 5/26/24, 6/15 /24, 7/12/24, 7/20/24, 7/24/24, 7/27/24, 8/4/24, 8/13/24, 8/23/24, 8/24/24, 9/16/24, 11 /19/24, 11/20/24, 11/22/24, 11/23/24, 12/12/24, 1/4/25, 1/12/25, 2/27/25, 4/16/25, 4/23 /25) 2. The general supervisor confirmed these findings in an on-site interview on 4/28 /25 at 4:00 PM. 3. The laboratory reports performing approximately 250 Immunohematology tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must 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 -- be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on a review of Immunohematology alarm system records and an interview with the general supervisor, the laboratory failed to document alarm system checks for the Immunohematology refrigerator where blood products are stored in 2023 and 2024. Findings include: 1. A request was made to review documentation of the Immunohematology refrigerator high and low temperature alarm checks and documentation could not be provided for 2023 and 2024. 2. The laboratory receives and stores approximately 120 units of packed red blood cells per year. 3. On an on- site interview on 4/28/25 at 4:00 PM, the general supervisor confirmed the alarm system testing for the Immunohematology refrigerator was not documented in 2023 and 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 an interview with the general supervisor and lack of records, the laboratory failed to perform a comparison of test results in 2024 for Chloride, Creatinine, Glucose, Hematocrit, Hemoglobin, Potassium, Sodium, and Urea Nitrogen using the Abbott i-STAT Chem8+ cartridges and the Siemens Dimension chemistry and the Sysmex XN 550 Hematology analyzers. Findings include: 1. A request was made to review documentation of the comparison of test results for analytes run on the Abbott i-STAT Chem8+ cartridges, the Siemens Dimension, and the Sysmex XN 550 for 2024, and documentation could not be provided. 2. The general supervisor confirmed the test comparisons were not performed, in an on-site interview on 4/28/25 at 4:00 PM. 3. The laboratory reports performing approximately 51,000 routine chemistry and 17,000 hematology tests annually. -- 2 of 2 --

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. 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 quality control review of Medtox Urine Drug Screen tests and General Supervisor interview, the laboratory did not test, at a minimum two levels of external quality control (QC) material to monitor the accuracy and precision of the Medtox Urine Drug Screen tests in from September 2020 to survey date. Findings include: 1. QC records for the Profile-V MedtoxScan Drugs of Abuse test system showed external controls were performed weekly as indicated in the manufacturer's package insert. 2. The laboratory performs approximately 125 urine drugs screens annually. 3. The general supervisor confirmed these findings on 4/16/2021 at 14:30 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 --