Honorhealth Cancer Care

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the Technical Consultant (TC-1), 3 out of 3 test reports failed to include the correct laboratory address where the testing was performed. Findings include: 1. The laboratory performs patient testing in the specialty of hematology, with an approximate annual test volume of 39,018. 2. Three out of three test reports reviewed during the survey (#5516813, 6932121 and 5380116) failed to include the correct laboratory address where the testing was performed. 3. At the time of the survey conducted on April 23, 2025, the laboratory address listed in the CLIA database for CLIA# 03D0680709 was 3621 N Wells Fargo Ave, Scottsdale, AZ 85251. 4. The test reports indicated above listed the resulting lab as "Honorhealth Cancer Care, 3501 N Scottsdale Rd Ste 300, Scottsdale, AZ 85251." 5. The TC-1 interviewed on 4/23/25 at 10:21 AM confirmed that the laboratory address listed on the test reports referenced above was not correct. 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 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the severity and number of deficiencies cited for quality control practices identified during the survey conducted on February 24, 2021, it was determined that the laboratory failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for patient testing performed by the laboratory in the specialty of Hematology. See D5445 and D5791 for findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures 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 4 -- This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) records, review of patient test reports and interview with the Technical Consultant, the laboratory failed to perform control procedures using the frequency established by the laboratory. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing in the specialty of Hematology on the Sysmex XN-450 analyzer with an approximate annual test volume of 16,900. 2. The laboratory's established policy titled, "Quality Control VGPCCN- Osborn" states, "No patient test should be reported unless QC for that test is complete and correct". The policy lists the frequency and level of QC for the Sysmex XN-450 as each day of patient testing, using 3 levels of controls (Low, Normal, High). 3. Review of patient test report (sample# 1015407369) from testing performed on 8/23 /2019 and lack of QC documentation from that date indicated the laboratory failed to perform QC testing for the Sysmex XN-450 (Low, Normal or High) on 08/23/2019. Approximately 26 patient tests were performed that day. 4. Review of patient test report (sample# 1018689491) from testing performed on 3/20/2020 and lack of QC documentation from that date indicated the laboratory failed to perform QC testing for the Sysmex XN-450 (Low, Normal or High) on 03/20/2020. Approximately 21 patient tests were performed that day. 5. The exact number of days from January 1, 2019 through the date of the survey conducted on February 24, 2021 in which QC was not performed each day of patient testing could not be determined at the time of the survey. 6. The technical consultant confirmed that the laboratory failed to perform control procedures as required for CBC testing on the dates indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) documentation, Quality Control (QC) records, and interview with the technical consultant, the laboratory failed to identify problems associated with Quality Control performance. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing in the specialty of Hematology on the Sysmex XN-450 analyzer with an approximate annual test volume of 16,900. 2. The laboratory performs a monthly review, specific to QC, titled, "VGPCCN Hematology Monthly Review", for testing performed on the Sysmex XN- 450 analyzer. The monthly QC review consists of a checklist to include: QC Parallel Lot Study Complete, Background Checks printed and reviewed, Supply/Reagent Inventory Complete, Instrument Maintenance Complete, Equipment Failure or Service- printed and reviewed, QC printed and reviewed, Notable QC issues and

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of