Vascular Institute Of The Midwest

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on review of i-Stat thermal probe records, review of the i-Stat operator's guide, and confirmed by interview with Testing Personnel #1 (TP #1) at 9:45 am on 11/20 /2025, the laboratory failed to perform and document thermal probe function checks on the i-Stat analyzer every six months for one out of four time periods from 01/01 /2024- 11/20/2025. The findings include: 1. The laboratory used an i-Stat test system to perform the following tests: protime, activated clotting time (ACT), pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), lactate, sodium, potassium, chloride, carbon dioxide, glucose, ionized calcium, blood urea nitrogen, creatinine, and hematocrit. 2. The i-Stat operator's guide stated that a thermal probe check must be performed every six months. 3. Review of the laboratory's i-Stat records indicated that the laboratory last performed a thermal probe check on 06/18 /2024. 4. At the time of the survey, TP #1 confirmed the laboratory did not perform thermal probe checks at any other time from 01/01/2024- 11/20/2025. 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 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 proficiency testing records and reports, the laboratory failed to successfully participate in a proficiency testing program for the specialty, hematology, for two consecutive proficiency testing events: 2022 events 1 and 2 (refer to D2131). D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- 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 proficiency testing reports and records, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events for the specialty, hematology; the laboratory received unsatisfactory performance scores of 60% for 2022 testing event 1 and 33% for 2022 testing event 2. The findings include: 1. The laboratory received an unsatisfactory performance score of zero for 2022 testing event 1 for the analyte, prothrombin time. 2. The laboratory received unsatisfactory performance scores of zero for 2022 testing event 2 for the analytes, hematocrit and hemoglobin. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the Laboratory Test List and Annual Volume form, proficiency testing records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:10 pm on 11/16/2021, the laboratory failed to enroll in an approved proficiency testing (PT) program for the analytes, sodium, potassium, chloride, calcium, glucose, blood urea nitrogen, carbon dioxide, creatinine, and hematocrit, for two out of two years from 2020-2021. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not enroll in PT for the analytes, sodium, potassium, chloride, calcium, glucose, blood urea nitrogen, carbon dioxide, creatinine, and hematocrit in 2020 and 2021. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of performance specification records and confirmed by Laboratory Personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2: 45 pm on 11/16/2021, the laboratory failed to verify the performance specifications of accuracy, precision, and reportable range for the Abbott iStat test system. The findings include: 1. The laboratory began using the Abbott iStat test system to perform activated clotting time (ACT) testing in October 2021. 2. At the time of the survey, the laboratory did not have performance specification records for the Abbott iStat test system. -- 2 of 2 --

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 #3 (refer to the Laboratory Personnel Report) at approximately 9: 45 am on 8/16/2019, the laboratory director and testing personnel failed to attest to the routine integration of PT samples into the patient workload by signing PT attestation statements for two out of five proficiency testing events (2019 events 1 and 2) from 01 /01/2018 - 8/16/2019. The findings include: 1. For 2019 testing event 1, the laboratory director and testing personnel did not sign the PT attestation statements for the arterial blood gas, activated clotting time and Prothrombin time PT modules. 2. For 2019 testing event 2, the laboratory director did not sign the PT attestation statement for the Prothrombin time PT module. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: 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 -- Based on review of the i-STAT operator's guide and confirmed by laboratory personnel identifier #3 (refer to Laboratory Personnel Report) at approximately 10:30 am on 08/16/2019, the laboratory failed to perform and document function checks of the thermal probe every six months for three out of three time periods from 01/01 /2018 - 8/16/2019. The findings include: 1. The i-STAT operator's manual states that a thermal probe check must be performed on the i-STAT analyzer every six months. 2. At the time of the survey, the laboratory did not have records indicating the thermal probe had been checked from 01/01/2018 - 08/16/2019. 3. Laboratory personnel identifier #3 confirmed that the laboratory did not know the thermal probe needed to be checked every six months, and that the laboratory had not performed the thermal probe check from 01/01/2018 - 8/16/2019. -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of written or electronic test requests and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2: 40 pm on 03/08/2018, the laboratory failed to have a written or electronic test request for two out of two patients (patient identifiers A and B) having activated clotting time (ACT) testing performed in January and February 2018. The findings include: 1. Patient identifier A had two ACT tests performed on 02/07/2018. 2. Patient identifier B had an ACT test performed on 01/16/2018. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have a written or electronic test request for ACT testing performed on patient identifiers A and B. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 493.1253. (7) Control procedures. (8)