Honorhealth Cancer Care

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 6, 2026, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 the Certification and Survey Enhanced Reporting (CASPER) 155 report and the API-American Proficiency Institute, the laboratory failed to 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 -- successfully participate in two out of three consecutive testing events for the regulated analyte, Hematocrit (HCT), in 2025, resulting in an initial unsuccessful performance. Refer to D2130. 1. The laboratory's PT performance was unsatisfactory for the second event of 2025 as indicated below: -HCT (Non-Waived) -60% 2. The laboratory's PT performance was unsatisfactory for the third event of 2025 as indicated below: -HCT (Non-Waived) -0% D2130 HEMATOLOGY CFR(s): 493.851(f) (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 review of the CASPER 155 report and American Proficiency Institute (API) PT records from 2025, the laboratory failed to achieve satisfactory performance (80%) for two of three consecutive testing events for the regulated analyte, Hematocrit (HCT). Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2025 event 2, HCT (Non-Waived) 60% 2025 event 3, HCT (Non-Waived) 0% 2. A review of the proficiency testing scores from API (2025) confirmed the above 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: Based on a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and American Proficiency Institute (API) 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 proficiency testing desk review of the CASPER-0155 and American Proficiency Institute (API) 2025-2 and 2025-3, evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (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 review of the manufacturer's criteria for the relative humidity requirement for the environment where the Sysmex hematology analyzer is operated, the humidity range indicated on the laboratory's log sheets and interview with the facility personnel, the laboratory failed to follow the manufacturer's instructions for the humidity levels where the Sysmex hematology analyzer is operated. Findings include: 1. The laboratory performs patient testing on the Sysmex XN450 hematology analyzer, with an approximate annual test volume of 21,600. 2. The manufacturer's specifications for the relative humidity (RH) are between 20% and 85% with no condensation. 3. The laboratory's temperature logs indicated an acceptable humidity range of 0% - 80%. 4. The facility personnel acknowledged that the laboratory's established humidity range was not consistent with the manufacturer's requirements. 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 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 2017 for testing performed in the specialty of Hematology and interview with the technical consultant, the laboratory director failed to sign the PT attestation statements. Findings include: 1. The laboratory performs patient testing in the specialty of Hematology, with an approximate annual test volume of 32,400. 2. The PT attestation statements presented for review for the first testing event of 2017, second testing event of 2017 and third testing event of 2017 lacked the director's signature. 3. The technical consultant confirmed that the PT attestation statements indicated above were not signed by the laboratory director. 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- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 2017 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, WBC Differential, under the specialty of Hematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 1st event of 2017 for the regulated analyte, WBC Differential, with a score of 67%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, WBC Differential, with a score of 0%. D2128 HEMATOLOGY 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 review of