Van Diest Medical Center

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the Clostridium difficile Individualized Quality Control Plan (IQCP) and quality control (QC) records and confirmed by interview with the General Supervisor (GS) at 12:27 pm on 8/21/2025, the laboratory failed to perform a positive and negative control for one out of one new lot numbers of Clostridium difficile test kits in March 2025 . The findings include: 1. The Clostridium difficile IQCP stated that positive and negative QC would be performed with each new lot number and shipment of test kits. 2. On 3/2/2025, Patient A had Clostridium difficile testing performed using test kit lot number 0824258, expiration date 6/1/2026. 3. The General Supervisor confirmed at the time of the survey, the laboratory did not perform QC for lot number 0824258, expiration date 6/1/2026 of Clostridium difficile test kit. 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 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 Sysmex CA Series coagulation reagent verification records and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at 11:47 am on 08/17/2023, the laboratory failed to verify the manual calculation of the international normalized ratio (INR) for one out of one lot number of prothrombin time reagent (lot number 564631, expiration 09/22/2025). The findings include: 1. The laboratory began using prothrombin time reagent lot number 564631 (expiration 09/22/2025) on 05/25/2023. 2. At the time of the survey, the laboratory did not have documentation of a manual check of the INR calculation from the instrument for prothrombin reagent lot number 564631. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of an Individualized Quality Control Plan (IQCP), review of quality control (QC) records, and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at 1:12 pm on 08/17/2023, the laboratory failed to perform a positive and negative control each day of patient testing for the Clostridium difficile Quik Chek Complete test system. The findings include: 1. The laboratory performed a positive and negative control with each new lot and shipment of tests for the Clostridium difficile Quik Chek Complete test system. 2. Laboratory personnel identifier #5 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the Clostridium difficile Quik Chek Complete test system. 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 the laboratory test volume forms and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at 1:21 pm on 08/17 /2023, the laboratory failed to perform twice annual comparison testing for three out of three time periods from 01/01/2022 - 08/17/2023 for the following tests: Clostridium difficile, urine drug screen panel, and white blood cell (WBC) count. The findings include: 1. The laboratory performed Clostridium difficile testing using both the BioFire and Clostridium difficile Quik Chek Complete test systems. 2. The laboratory performed urine drug screen panel testing using two MedtoxScan Profile V test systems. 3. The laboratory performed WBC count testing using both the Sysmex xs-1000i and Hemocue WBC test systems. 4. At the time of the survey, the laboratory did not have documentation of comparison testing for Clostridium difficile, urine drug screen panel, and WBC count testing from 01/01/2022 - 08/17/2023. D5781

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 analyte, automated white blood cell differential, for two consecutive testing events: 2022 events 2 and 3 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 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 (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, automated white blood cell (WBC) differential, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 8% for 2022 testing event 2 and 4% for 2022 testing event 3. -- 2 of 2 --