Unity Health White County Oncology

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 the 2025 CMS Casper Reports 0153D, 096D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin (TBILI). Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2025 CMS Casper Reports 0153D, 096D, and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte TBILI. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte TBILI in the second proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte TBILI in the third proficiency testing event of 2025. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test TBILI. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: . Through a review of the new instrument validation documentation dated 12/7/2021 for the Alcor MiniSED Analyzer, lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to have the director approve validation procedures to ensure they are adequate to determine the accuracy, precision, and other pertinent performance characteristics as evidenced by: A. A review of the validation documentation for the Alcor MiniSED Analyzer dated 12/7/2021, revealed the validation procedures were not approved and signed by the Laboratory Director. B. In an interview on 6/13/2022 at 1:30 p.m., laboratory employee #1 (as listed on CMS form 209) confirmed the validation procedures for the Alcor MiniSED Analyzer were not approved or signed by the Laboratory Director. 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 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through a review of the CMS-209 form, personnel rcords,a lack of documentation, and interviews with laboratory staff, it was determined the technical consultant failed to evaluate the competency of one of two testing personnel. Survey findings follow: A) Review of the CMS 209 form revealed that the laboratory staff member, identified as number four on the CMS 209 form, was listed as a testing personnel. B) Review of personnel records for testing personnel, identified as number four on the CMS 209 form, revealed that in the years of 2018 and 2019 documents titled "Annual Comptency for Clinical Laboratory Manager" did not address the competency required for performing the laboratory tests identified on the CMS 116 form submitted for the laboratory, did not specify the six required elements for evaluating the competency of testing personnel, and was intialed as being performed by the clinic administrator. C) Review of the CMS 209 form revealed that the clinic adminsitrator was not included as the technical consultant. D) Upon request, the laboratory could not produce competency evaluations performed by the technical consultant for the years of 2018 and 2019 for the testing personnel identified as number 4 on the CMS 209 form. E) In an interview at appriximately 10:15 AM on 11/6/19, the laboratory technical consultant, identified as number 1 and the testing personnel identified as number 4 on the CMS 209 form, confirmed that the testing personnel identified above performed moderately complex laboratory procedures and that annual competencies had not been evaluated by the technical consultant. 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 --