Honorhealth Cancer Care

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of humidity records for review from January-May 2024, review of the manufacturer's environmental specifications for the Sysmex XN 450 hematology analyzer and interview with the Technical Consultant (TC-1), the laboratory failed to monitor and document the ambient humidity of the room where the instrument is utilized for patient testing on 54 out of 101 testing dates. Findings include: 1. The laboratory utilizes the Sysmex XN 450 analyzer to conduct patient testing in the specialty of Hematology with a reported annual test volume of 70,548. 2. The manufacturer's environmental specifications for the Sysmex XN 450 analyzer list an operating relative humidity range of 20%-85%. 3. The laboratory failed to provide documentation demonstrating the ambient humidity of the room where the analyzer is utilized was monitored and recorded on each day of patient testing for 54 out of 101 testing dates during the timeframe of January 2, 2024 through May 8, 2024. 4. The TC-1 interviewed on 4/22/25 at 10:46 AM confirmed the laboratory failed to monitor and document the ambient humidity on each day of patient testing as indicated above. D5781

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with the Technical Consultant (TC-1), the laboratory failed to follow their established policy to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. Findings include: 1. The laboratory performs patient testing on the Sysmex XN-450 hematology analyzer. Test results and patient-specific data are electronically interfaced from the analyzer to EPIC, the Laboratory Information System (LIS). 2. The laboratory's Patient Test Management policy states, "The Sysmex 450 has a bi- directional interface with EPIC, allowing the patient unique identification number to cross to the instrument and the results cross from the instrument back to EPIC. This interface will be checked yearly for proper result transmittal from the analyzer to EPIC as part of the QA program." 3. No documentation from 2021 and 2022 was presented for review to indicate the laboratory followed the policy referenced above to ensure patient test results and patient-specific data are accurately and reliably electronically interfaced from the Sysmex XN-450 analyzer to EPIC. 4. The TC-1 interviewed on October 11, 2023 at 1:45 PM confirmed the laboratory failed to follow their established policy to verify the accuracy of patient test results and patient- 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 -- specific data which are electronically interfaced from the Sysmex XN-450 analyzer to EPIC during 2021 and 2022. 5. The laboratory performs approximately 20,046 patient tests annually under the specialty of Hematology -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2018 and interview with the technical consultant, (A) the testing personnel failed to sign the PT attestation statement for the first event of 2018 and (B) the laboratory director failed to sign the PT attestation statements for the first and second testing events of 2018 in a timely manner. Findings include: 1. The laboratory began patient testing in the specialty of Hematology in March 2018, with an approximate annual test volume of 3,500. The laboratory participated in three Proficiency Testing events during 2018. A2. The PT attestation statement presented for review for the first event of 2018 lacked the testing personnel's signature. A3. The technical consultant confirmed that the attestation statement indicated above was not signed by the testing personnel. B2. The PT attestation statements presented for review during the survey for the first and second events of 2018 were not signed by the laboratory director's designee until February 11, 2019. B3. The laboratory submitted the PT records for the first event of 2018 to the PT Agency on March 21, 2018. B4. The laboratory submitted the PT records for the second event of 2018 to the PT Agency on July 27, 2018. B5. The technical consultant confirmed that the PT attestation statements indicated above were not signed by the laboratory director's designee until February 2019. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of temperature documentation for review and interview with the technical consultant, the laboratory failed to document the (A) humidity and (B) room temperature of the laboratory where patient testing is performed and the analyzer reagents are utilized and stored. Findings include: 1. The laboratory began Complete Blood Count (CBC) testing in March 2018 under the specialty of Hematology, with an approximate annual test volume of 3,500. 2. The laboratory performs patient testing on the Sysmex XN450 analyzer which has a humidity requirement of 30% - 85%, as stated in the manufacturer's operating manual. A3. No documentation was presented for review during the survey conducted on February 22, 2019 to indicate the laboratory monitored and documented the humidity of the laboratory where patient testing was performed from March 2018 through the date of the survey. A4. The technical consultant confirmed that the laboratory failed to monitor and document the humidity of the room where patient testing is performed. B3. No documentation was presented for review during the survey conducted on February 22, 2019 to indicate the laboratory monitored and documented the room temperature of the laboratory where patient testing is performed and analyzer reagents are utilized and stored from March 2018 through the date of the survey. B4. The manufacturer's acceptable temperature range listed on the Sysmex reagents used for the analyzer is 2 - 30 degrees Celsius. B5. The technical consultant confirmed that the laboratory failed to monitor and document the room temperature where patient testing is performed and the analyzer reagents are utilized and stored. 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, laboratory policies and procedures and interview with the technical consultant, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the repeat performance of Complete Blood Count (CBC) testing performed on the Sysmex XN450 analyzer. Findings include: 1. Review of patient test records (sample #1010661400) for CBC testing performed on 10/10/2018 indicated the specimen was tested on the Sysmex XN450 analyzer five different times between 8:27am and 8:39am. Each run resulted in the following instrument results/flag codes: 08:27am, Thrombocytopenia; 08:29am, no results measured; 08:31am, Thrombocytopenia; 08:36am, Thrombocytopenia, PLT Clumps?; 08:39am, Thrombocytopenia. 2. During the survey conducted on February 22, 2019, the surveyor and the technical consultant directly observed the "Action -- 2 of 3 -- Codes" found on the analyzer for Thrombocytopenia which stated, "Follow Protocol". 3. No established protocol or policy was presented for review to indicate the laboratory had established a process for testing personnel to follow in the event that the analyzer generates a flag code or other error message during the testing process, including but not limited to, the number of times the sample is repeated and steps to take to determine which test results are released. 4. The technical consultant confirmed the laboratory did not have an established policy and procedure in place at the time of the survey with regard to flagged and/or repeated specimens. -- 3 of 3 --