Intermountain West Jordan Clinic

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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory failed to achieve successful PT scores for the American Proficiency Institute (API) PT for Cell I.D. or WBC Diff testing for three out of four PT events in 2022 and 2023 (events 1 and 2 in 2022 and events 1 in 2023). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores from the American Proficiency Institute (API) and email communications with the laboratory director, the laboratory failed to meet successful PT participation for Cell I.D. or WBC Diff for events 1 and 2 in 2022 and for event 1 in 2023. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 8/25/2023, at 11:00 AM, revealed the Cell I.D. or WBC Diff testing scores for 2022 event 1 was 32%, for 2022 event 2 was 0% and for 2023 event 1 was 0%. 2. Email received from the laboratory director on 8/17/2023, at 9:18 AM, confirmed the subsequent unsuccessful proficiency testing scores for Cell I.D. or WBC Diff. 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory director failed to provide overall management of the laboratory by failing to ensure accurate PT testing and reporting for the Cell I.D. or WBC Diff. See D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory failed to meet successful PT participation for the Cell I.D. or WBC Diff. Findings include: 1. A review if the CMS-155 Individual Laboratory Profile on 8/25/2023, at 11:00 AM, revealed the American Proficiency Institute (API) PT for Cell I.D. or WBC Diff testing scores for 2022 event 1 was 32%, for 2022 event 2 was 0%, for 2023 event 1 was 0%. 2. Email received from the laboratory director on 8/17/2023, at 9:18 AM, confirmed the subsequent unsuccessful proficiency testing scores for Cell I. D. or WBC Diff. -- 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 a routine desk review of the CMS-155 report for proficiency testing performance and email from the laboratory technical consultant, the laboratory failed to achieve satisfactory performance scores for Cell I.D or WBC Diff testing for two out of three events in 2022. (Event 1 and 2) See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores from the American Proficiency Institute (API) and email communications with the laboratory technical consultant, the laboratory failed to achieve a score of 80% for Cell I.D. or WBC Diff for Events 1 and 2 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/03/2022, at 1:00 pm, revealed the Cell I.D. or WBC Diff testing scores for 2022, Event 1 was 32% and Event 2 was 0%. 2. Email received from the laboratory technical consultant on 10/04/2022, at 04:24 pm, confirmed two consective unsuccessful proficiency scores for Cell I.D. or WBC Diff testing due to technical errors while running the samples. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation and confirmation by the technical consultant, the laboratory failed to retain testing personnel signed attestation statements for 4 of 6 American Proficiency Institute (API) complete blood count (CBC) testing events for at least two years. Findings include: 1. Proficiency testing records review failed to include signed attestation statements affirming they performed API CBC proficiency test samples in the same manner and frequency as patient tests are performed for the 3rd API event of 2017; and all three events of 2018. 2. In an interview conducted on 09/03.2019 at approximately 11:00 A.M. the technical consultant confirmed that testing personnel had not signed the attestation statements for 4 testing events mentioned above and that they were not available currently to make the attestation that proficiency tests were performed as patient CBC 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 --