Ogden Clinic Utah Hematology Oncology Layton

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 all enrolled hematology analytes for two out of three events in 2023. (Event 2 and 3) 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 (PT) 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 Hematology for Events 2 and 3 in 2023. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 02/13 /2024, at 1:00 PM, revealed all enrolled hematology analytes scores for 2023, Event 2 and 3 were 0%. 2. Email received from the laboratory technical consultant on 02/15 /2024, at 1:59 PM, confirmed two consecutive unsuccessful proficiency scores for all enrolled hematology analytes due to technical errors while submitting PT results to API. -- 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 American Proficiency Institute (API) performance summary review and confirmation from laboratory supervisor on 9/15/2021, the laboratory failed to achieve successful participation in two of three consecutive events for Platelet Count testing performance. 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 American Proficiency Institute (API) performance summary review and confirmation by laboratory supervisor on 09/15/2021, the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Platelet Count. Findings include: 1. API summary report included documentation that the laboratory failed two out of three consecutive testing events for Platelet Count (0% for third testing event of 2020 and 60% for second testing event of 2021). 2. Laboratory supervisor confirmed via email on 09/15/2021 that API testing samples were not tested before the closing date of the third testing event of 2020 and therefore results were not submitted to API. 3. Laboratory supervisor confirmed via email on 09/15 /2021 that the laboratory failed the Platelet Count for the second API testing event of 2021. -- 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: Based on new instrument verification documentation review, lack of documentation, and interview with staff, the director failed to sign and date the new blood cell counter reportable range verification for Abbott Emerald serial number 008335 installed on 12 /29/2020. The laboratory performed approximately 20,000 complete blood count tests per year. Findings include: 1. The laboratory director failed to sign and date the reportable range study as approved for use prior to reporting patient test results. 2. In an interview conducted on 01/25/2021 at approximately 3:50 P.M. staff confirmed the director's signature was missing from the reportable range study. 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 D5805 TEST REPORT CFR(s): 493.1291(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. This STANDARD is not met as evidenced by: Based on patient complete blood count (CBC) reports review and interview with staff, the laboratory failed to ensure tests reports included the name and address of the laboratory location where the CBC test was performed for 1 of 11 test reports reviewed. The laboratory reported approximately 10 to 20 CBC tests per day. Findings include: 1. Patient test reports review for patient 20525 tested on 07/12/2018 included a test location of South Ogden for the test that was performed at the Layton laboratory. 2. In an interview conducted on 08/28/2018 at approximately 2:45 P.M. testing staff stated the laboratory test system was recently interfaced into a common information system that included two locations where testing is performed. The test reports included the South Ogden location but not the Layton location. The information system failed to identify the location where the testing was performed. 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 --