Story County Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on October 5, 2026. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, High Complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing 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 -- events in the subspecialty of compatibility testing. The laboratory had unsatisfactory scores for 2026 events 1 and 2. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (100% or greater) for two consecutive testing events in the subspecialty, compatibility testing. The findings include: 1. For 2026 event 1, the laboratory received an unsatisfactory performance score of 60% for the subspecialty, compatibility testing. 3. For 2026 event 2, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2026 events 1 and 2), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of coagulation records and observations of the coagulation analyzer and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 09/27/22, the laboratory fails to meet the hematology (coagulation) requirements for test system/equipment/reagent verification as specified in the standard D5411. 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 review of coagulation studies, observations of the coagulation analzyer and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 9/27/22, the laboratory failed to establish a new normal patient mean and program the correct normal patient mean into the coagulation analyzer for lot number 564610, expiration date 01/20/2025 of prothrombin time reagent. The findings include: 1. The laboratory starting using lot 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 -- number 564610, expiration date 1/20/2025 of prothrombin time reagent on 7/20/22. 2. At the time of the survey, the laboratory had a normal patient mean of 10.1 programmed into the coagulation analyzer. The laboratory had established a normal patient mean of 10.1 for a previous lot number of reagent (Lot 549788). 3. Laboratory personnel #1 confirmed that the laboratory had not established a normal patient mean for lot number 564610 of prothrombin time reagent. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Ortho blood bank dispense maintenance records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:45 pm on 09/27/22, the laboratory failed to perform weekly Ortho blood bank dispenser checks weekly for ten out of 13 weeks from 4/1/2022 - 6/30 /2022. The findings include: 1. The Ortho blood bank dispenser maintenance log stated the laboratory must weekly clean the dispenser. 2. The laboratory performed the weekly dispenser cleaning on 4/5/2022, 5/3/2022, and 6/6/2022. 2. At the time of the survey, the laboratory did not have documentation of cleaning the dispenser for the week of 4/11/22, 4/18/22, 4/25/22, 5/9/22, 5/16/22, 5/23/22, 5/30/22, 6/13/22, 6/20/22 and 6/27/22. 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of chemistry records, the Laboratory Test List and Annual Volume report, and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 11:30 am on 09/27/2022, the laboratory failed to perform comparison evaluations for three out of three semiannual time periods from 1 /1/2021 - 9/27/2022 for the analytes: glucose, creatinine, blood urea nitrogen, sodium, potassium, and chloride. The findings include: 1. The laboratory performed the analytes: glucose, creatinine, blood urea nitrogen, sodium, potassium, and chloride on both the Dimension chemistry analyzer and the i-STAT analyzer. 2. At the time of the survey, the laboratory did not perform comparison evaluations between the Dimension chemistry analyzer and the i-STAT analyzer for the above listed analytes. -- 2 of 2 --