Butler County Health Care Center

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on surveyor review of quality control records, patient testing records, lack of Individualized Quality Control Plan (IQCP), and interview with the laboratory manager the laboratory failed to performed quality control (QC) each day of patient testing on Human Chorionic Gonadotropin (HCG), serum testing from 9/18/2025 - 12 /30/2025. 1. Review of HCG, serum QC records and patient testing records from 9/18 /2025 - 12/30/2025, revealed QC was performed with new test kit lot and new test kit box. 2. Interview with the laboratory manager on 1/6/2026 at 11:47 AM confirmed the laboratory did not perform QC each day of patient testing from 9/18/2025 - 12/30 /2025. 3. Interview with the laboratory manager on 1/6/2026 at 11:47 AM confirmed the laboratory did not have an IQCP in place for HCG, serum 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 1 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test report and interview with the general supervisor the laboratory failed to have the test report date on the test report. Findings are: 1. Review of one patient test report for compete blood count and chemistry panel for collection date of 1/2/2020 revealed collection date and collection time but no report date on the test report. 2. Interview with the general supervisor on 1/9/2020 at 2:10 PM confirmed no test report date was indicated on the test report. 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 --