Honorhealth Complete Care Paradise Valley

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 4, 2025, 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 College of American Pathologists (CAP) proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events 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 -- in the subspecialty of Routine Chemistry and the regulated analytes, Carbon Dioxide (CO2), Creatinine, Sodium (Na) and Urea Nitrogen (BUN) in 2025 resulting in an initial unsuccessful performance. Refer to D2096 and D2097. 1. The laboratory's PT performance was unsatisfactory for the second event of 2025 as indicated below: - Routine Chemistry - 15% -CO2 - 0% -Creatinine -0% -Na -0% -BUN -0% 2. The laboratory's PT performance was unsatisfactory for the third event of 2025 as indicated below: - Routine Chemistry - 66% -CO2 - 0% -Creatinine -0% -Na -60% - BUN -0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 College of American Pathologists (CAP) PT records from 2025, the laboratory failed to achieve satisfactory performance (80%) for two of three consecutive testing events for the regulated analytes, Carbon Dioxide (CO2), Creatinine, Sodium (Na), and Urea Nitrogen (BUN). Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2025 event 2, CO2 0% 2025 event 2, Creatinine 0% 2025 event 2, Na 0% 2025 event 2, BUN 0% 2025 event 3, CO2 0% 2025 event 3, Creatinine 0% 2025 event 3, Na 60% 2025 event 3, BUN 0% 2. A review of the proficiency testing scores from CAP (2025) confirmed the above findings. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing 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 College of American Pathologists (CAP) PT records from 2025, the laboratory failed to achieve satisfactory performance (80%) for two of three consecutive testing events in the subspecialty of Routine Chemistry. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2025 event 2, subspecialty of Routine Chemistry 15% 2025 event 3, subspecialty of Routine Chemistry 66% 2. A review of the proficiency testing scores from CAP (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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and College of American Pathologists (CAP) 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 College of American Pathologists (CAP) 2025-2 and 2025-3, evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 3 of 3 --

Summary Statement of Deficiencies 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: D6003- failure to 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. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; and (b)(2)(ii)(B) Have at least 20 CE credit hours in 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 -- laboratory practice that cover the laboratory director responsibilities defined in 493. 1407; or (b)(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or (b)(3)(i)(B) Hold an earned doctoral degree; and (b)(3)(i)(B)(1) Have at least 16 semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or (b)(3)(i)(B)(2) An approved thesis or research project in biology/chemistry /MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(3)(ii) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in 493.1407; and (b)(3)(ii)(A) Be certified and continue to be certified by a board approved by HHS; and (b)(3)(ii)(B) Have had at least 1 year of experience directing or supervising nonwaived laboratory testing; or (b)(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(B)(2) Have at least 16 semester hours of additional graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science; or (b)(4)(i)(C)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(C)(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science coursework and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(4) (ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing; and (b)(4)(iii) Have at least 1 year of supervisory laboratory experience in nonwaived testing; and (b)(4)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407; or (b)(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(5)(i) (B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either- (b)(5)(i)(B)(1) 48 semester hours of medical laboratory science or medical laboratory technology courses; or (b)(5)(i)(B)(2) 48 semester hours of science courses that include- (b)(5)(i)(B)(2)(i) 12 semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; and (b) (5)(i)(B)(2)(ii) 12 semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (b)(5)(i)(B)(2)(iii) 24 semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination; and (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing; and (b)(5)(iii) Have at least 2 years of supervisory laboratory experience in nonwaived testing; and (b)(5)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407. (b)(6) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of moderate complexity testing under this section if they were qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on lack of a qualified laboratory director at the time of the survey conducted on 5/13/25 and interview with the Technical Coordinator (TC-2), the laboratory failed assign a qualified laboratory director to manage and direct the laboratory personnel and the performance of moderate complexity tests. Findings include: 1. During the -- 2 of 3 -- onsite survey conducted on 5/13/25, it was determined that the laboratory director listed in the CMS database for CLIA# 03D2284901 at the time of the survey was no longer affiliated with the laboratory since September 2024 2. The laboratory failed to provide notification of a change in laboratory director within 30 days of the change, as required under C.F.R.493.51(a)(4). 3. The TC-2 interviewed on 5/13/25 at 10:00 AM confirmed the laboratory failed to provide notification of a laboratory director change within 30 days of the change, and failed to have qualified laboratory director from September 2024 through the date of the onsite survey. -- 3 of 3 --