Chi Health Nebraska Heart

Summary Statement of Deficiencies D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory manager and laboratory director, the laboratory failed to document hematoxylin and eosin stain quality for the nine frozen section histopathology tests performed in 2024. Findings are: 1. No documentation was found that hematoxylin and eosin stain quality was performed in 2024. 2. The laboratory performed nine frozen section histopathology tests in 2024. 3. Interview with the laboratory manager and laboratory director on 2/4 /2025 at 2:15 PM, confirmed the laboratory did not have documentation of hematoxylin and eosin stain quality for 2024. D5805 TEST REPORT CFR(s): 493.1291(c) (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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory test reports and interview with the lab manager and laboratory director the laboratory failed to have the name and address of the laboratory location where the test was performed on two out of two histopathology frozen section laboratory reports reviewed. Findings are: 1. Review of the two histopathology frozen section laboratory reports from 7/23/2024 and 11/18/2024 did not indicate the name and address of the laboratory where the frozen section testing was performed. 2. Interview with the lab manager and laboratory director on 2/5/2025 at 2:15 PM , confirmed the laboratory test reports did not include the name and address of the laboratory where the frozen section testing was performed. -- 2 of 2 --

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 proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte partial oxygen (pO2) blood gas. See D2088. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from College of American Pathologists (CAP), the laboratory failed to achieve successful performance for the analyte, partial oxygen (pO2) blood gas, in two out of three testing events. Findings are: 1. 2020 second event, analyte - pO2 blood gas, score 20% 2. 2021 first event, analyte - pO2 blood gas, score 60% -- 2 of 2 --