Mankato Clinic At Daniels Health Center

Summary Statement of Deficiencies D0000 The Mankato Clinic at Daniels Health Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertifiication survey performed on May 13, 2025. The following standard-level deficiencies were cited: 493.1291 Test report D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with the laboratory personnel, the laboratory failed to ensure four of fifteen Urinalysis reference intervals were available to the authorized person responsible for using the test results. Findings are as follows: 1. The laboratory performed urinalysis testing as confirmed by Testing Personnel 1 during a tour of the laboratory at 10:06 a.m. on 5/13/25. 2. A Nikon Eclipse E2000 microscope was observed as present and available for use for urine microscopic examination during the tour. 3. Urine microscopic examination reference intervals were not established on a patient test report from 5/15/23. See below: Missing reference intervals: White blood cells /hpf Red blood cells /hpf Epithelial Cells /hpf Bacteria /hpf 4. In an interview at 1:09 p.m. on 5/13/25, the Technical Consultant (TC) confirmed the above findings. 5. The laboratory performed 1,131 urine microscopic exams since March 2023 as indicated by the TC in an email received at 12:42 p.m. on 5/15/25. 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 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. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to to establish and follow a procedure for the ongoing monitoring of the effectiveness of an Individualized Quality Control Plan (IQCP). Findings are as follows: 1. The laboratory performed qualitative serum HCG* testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 4/17/19 at 10:05 a.m. 2. A Beckman Coulter ICON 25 hCG Test kit was observed as present and available for use during the tour of the laboratory. 3. In an interview on 4/17/19 at 12:15 pm, TC1 confirmed that an IQCP to reduce the frequency of QC performance from each day of patient testing for qualitative serum HCG was established and implemented in 2016. 4. Annual reviews of the qualitative serum HCG IQCP for 2017 and 2018 were not found in laboratory records. The laboratory was unable to provide the documentation upon request. 5. In an interview on 4/17/19 at 12:15 pm, TC1 confirmed the above findings. *HCG = human chorionic gonadotropin . 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 --