Chase County Community Hospital

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, lack of Individualized Quality Control Plan (IQCP), interview with the laboratory manager, and email from the laboratory manager, the laboratory failed to performed quality control (QC) each day of patient testing lactoferrin, using the Techlab Leuko EZ Vue, from 1/20/2025 - 12/1 /2025. Findings: 1. Review of Techlab Leuko EZ Vue QC records from 1/20/2025 - 12 /1/2025, revealed QC was performed on 10/8/2025. 2. Interview with the laboratory manager on 1/27/2026 at 10:28 AM confirmed the laboratory did not have an IQCP in place for lactoferrin, using the Techlab Leuko EZ Vue. 3. Interview with the laboratory manager on 1/27/2026 at 10:28 AM confirmed the laboratory did not perform QC each day of patient testing from 1/20/2025 - 12/1/2025. 4. Email from the laboratory manager received on 1/28/2026, confirmed the laboratory tested 9 patients for lactoferrin, using the Techlab Leuko EZ Vue in 2025. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) 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 -- (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's blood bank procedure manual, and interview with the laboratory director the laboratory failed to have "Transfusion Reaction Protocol" signed by the laboratory director at time of survey. Findings: 1. Interview with the laboratory director on 1/28/2026 at 10:10 AM, confirmed the laboratory did not have "Transfusion Reaction Protocol" signed at time of survey. -- 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's list of tests performed and interview with general supervisor, in 2019 the laboratory failed to enroll in an approved proficiency testing program for Human Chorionic Gonadoptropin, qualitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed forty four moderate complexity Human Chorionic Gonadoptropin, qualitative serum in 2019. 2. Interview with general supervisor on 1/30/2020 at 11:23 AM confirmed the laboratory had not enrolled in proficiency testing for moderate complexity Human Chorionic Gonadoptropin, qualitative serum in 2019. 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 --