Honorhealth Cancer Care

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records from 2023 and interview with the Technical Consultant (TC-1), the laboratory failed to participate in the third testing event of 2023 for Hematology resulting in unsatisfactory performance and a score of 0 for the testing event, and the laboratory failed to suspend patient testing during that time period. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing on patient specimens under the specialty of Hematology with an annual reported test volume of 51,738. 2. The laboratory reported a PT sample issue to the PT provider, American Proficiency Institute (API), for Hematology samples received by the laboratory for the third testing event of 2023. 3. The laboratory failed to participate in the third testing event of 2023 for Hematology, resulting in unsatisfactory performance and a score of 0 for that testing event. 4. The laboratory failed to suspend patient testing during the time frame allotted for testing and reporting proficiency testing results during the third testing event of 2023 for Hematology. 5. The TC-1 interviewed on 1/11/2024 at 1:00 PM confirmed the 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 -- laboratory failed to participate in the third testing event of 2023 for Hematology resulting in unsatisfactory performance and a score of 0 for that testing event, and failed to suspend patient testing during that timeframe. -- 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 review of Proficiency Testing (PT) reports for 2019 and 2020 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Cell ID or WBC Diff, under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2019 for the regulated analyte, Cell ID or WBC Diff, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the 1st event of 2020 for the regulated analyte, Cell ID or WBC Diff, with a score of 64%. D2128 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, Cell ID or WBC Diff, for the 2nd event of 2019 and 1st event of 2020. See D2016 for findings. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, Cell ID or WBC Diff, for the 2nd event of 2019 and 1st event of 2020 resulting in unsuccessful PT performance. See D2016 for findings. 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, Cell ID or WBC Diff. See D2016 and D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of laboratory policy, lack of instrument function check records for review and interview with the technical consultant, the laboratory failed to perform and document background counts on the Sysmex XN-450 hematology analyzer each day prior to patient testing. Findings include: 1. The laboratory began patient testing on the Sysmex XN-450 hematology analyzer on June 19, 2018, with an approximate annual test volume of 16,900. The laboratory tests patient specimens on approximately 20 days a month. 2. The laboratory's policy, "Operating Procedure" includes 5 steps involved in the Start-Up Procedure: Visual Inspection of the analyzer /system/reagents, Turning ON the entire system, Log on to the XN-450, Analyzer Self- Checks and Analyze Quality Control Material. The Analyzer Self-Checks include initialization of the mechanical parts; Rinse; Temperature Stabilization; Background Check (up to 3 times). The background check must be within acceptable limits as defined in the the procedure. 3. The Background Log reviewed during the survey indicated the laboratory failed to perform the background check each day of patient testing. The background log listed a passing background check for only 8 days in July 2018, 7 days in August 2018, 5 days in September 2018, and 9 days in October 2018. 4. The technical consultant confirmed that the laboratory failed to produce evidence of 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 -- background counts performed each day of patient testing during the time frames indicated above. 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 review of the laboratory's test reports and interview with the facility personnel, the laboratory failed to indicate the correct facility name on the test report. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing on patient specimens in the specialty of Hematology, with an approximate annual test volume of 16,900. On the date of the survey conducted on May 22, 2019, the laboratory name listed is the CMS Database for CLIA# 03D2026177 was Virginia G Piper Cancer Center Network North Scottsdale. 2. Three out of three patient test reports reviewed during the survey (#1010469447, 1011967312 and 1013667059) were missing the name of the laboratory where the CBC testing was performed. Each patient test report listed the name of the laboratory as Honor Health Scottsdale Oncology. 3. The facility personnel confirmed that the correct laboratory name was missing from the test reports indicated above. -- 2 of 2 --