Arizona Arthritis & Rheumatology Associates

Summary Statement of Deficiencies D0000 An recertification survey was performed on July 13, 2026. The facility was found to be NOT in compliance with the following CLIA conditions for specialties /subspecialties surveyed for 42 CFR: 493.1487 - Laboratory Testing Personnel (High Complexity) D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of 2026 competency evaluation documentation, review of the CMS- 209, Laboratory Personnel form, review of patient test reports and interview with the technical consultant (TC) on 7/13/26 at 11:00 AM, the technical consultant failed to perform an annual competency evaluation for TP-2 in 2026, specific to testing performed on the Gold Standard Diagnostics Thunderbolt analyzer. Findings include: 1. Annual competency documentation reviewed for TP-2 from 1/06/26 revealed the competency evaluation was performed to assess the competency of a CLA (Certified Lab Assistant), not a testing personnel. The CLA competency form included only the evaluation of: "1.) Direct observation of routine patient preparation, if applicable, specimen handling, processing and testing; 2.) Completion of instrument maintenance as permitted; and 3.) Review of CLA efficiency and performance." 2. The CMS-209, Laboratory Personnel form presented for review on 7/13/26 listed 3 testing personnel including TP-2 who is listed as a testing personnel for moderate complexity testing. 3. Patient test reports reviewed during the survey indicated that TP-2 performed moderate complexity testing as follows: - Anticitrulline Ab (CCP) testing performed by TP-2 on 9/18/25 on the Gold Standard Diagnostics Thunderbolt analyzer (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 4 -- #2) - Anti-DNA (dsDNA) testing performed by TP-2 on 2/20/26 on the Gold Standard Diagnostics Thunderbolt analyzer (Patient #3) 4. The TC interviewed on 7/13/26 at 11: 00 AM acknowledged that the competency evaluation documentation for TP-2 from 1 /06/26 failed to evaluate the competency of TP-2 for moderate complexity testing as required under 493.1413(b)(i) through 493.1413(b)(vi). D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) (b)(8)(ii) Monitoring the recording and reporting of test results; This STANDARD is not met as evidenced by: Based on review of semiannual competency evaluations from December 2024, review of 2 out of 2 patient test reports for testing performed on the Quanta-Lyser 3000 analyzer and interview with the Technical Supervisor (TS) on 7/13/26 at 11:00 AM, the TS failed to evaluate the recording and reporting of test results generated from the Quanta-Lyser 3000 analyzer during the semiannual competency evaluation for 1 out of 3 testing personnel (TP-2) who perform high complexity testing in the subspecialty of general immunology. Findings include: 1. The laboratory began high complexity testing in the subspecialty of general immunology on the Quanta-Lyser 3000 analyzer in June 2024, with a reported annual test volume of 694,572. 2. The annual competency evaluation completed by the TS on 12/05/24 for TP-2 for testing performed on the Quanta-Lyser 3000 analyzer failed to include the evaluation of recording and reporting of test results. 3. Review of the personnel records for 1 out of 3 testing personnel revealed the laboratory failed to have academic credentials to qualify TP-2 for high complexity testing performed on the Quanta-Lyser 3000 analyzer. See D6171 4. Two out of two patient test reports (Patient #2 and Patient #3) from the Quanta-Lyser 3000 analyzer revealed TP-2 performed and resulted patient testing on 2/24/26 and 9/18/25. 5. TS interviewed on 7/13/26 at 11:00 AM acknowledged the competency evaluation referenced above for TP-2 listed "N/A" for monitoring the recording and reporting of test results on the Quanta-Lyser 3000 analyzer. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of semiannual competency evaluations from December 2024, review of 2 out of 2 patient test reports for testing performed on the Quanta-Lyser 3000 analyzer and interview with the Technical Supervisor (TS) on 7/13/26 at 11:00 AM, the TS failed to evaluate the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples during the semiannual competency evaluation for 1 out of 3 testing personnel (TP-2) who perform high complexity testing in the subspecialty of general immunology. Findings include: 1. The laboratory began high complexity testing in the subspecialty of general immunology on the Quanta-Lyser 3000 analyzer in June 2024, with a reported annual test volume of 694,572. 2. The semiannual competency evaluation completed by the TS on 12/05/24 for TP-2 for testing performed on the -- 2 of 4 -- Quanta-Lyser 3000 analyzer failed to include the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 3. Review of the personnel records for 1 out of 3 testing personnel revealed the laboratory failed to have academic credentials to qualify TP-2 for high complexity testing performed on the Quanta-Lyser 3000 analyzer. See D6171 4. Two out of two patient test reports (Patient #2 and Patient #3) from the Quanta-Lyser 3000 analyzer revealed TP-2 performed and resulted patient testing on 2/24/26 and 9/18/25. 5. TS interviewed on 7/13/26 at 11:00 AM acknowledged the competency evaluation indicated above for TP-2 listed "N/A" for the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples on the Quanta- Lyser 3000 analyzer. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the Technical Supervisor (TS) on 7/13/26 at 1:00 PM, the laboratory failed to have academic credentials required to qualify one out of three testing personnel for high complexity testing in the subspecialty of General Immunology. (Refer to D6065). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or -- 3 of 4 -- (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of personnel records, review of patient test reports for immunology testing performed on the Quanta-Lyser 3000 analyzer and interview with Technical Supervisor (TS) on 7/13/26 at 1:00 PM, the laboratory failed to provide documentation of academic credentials to qualify one out of three testing personnel (TP-2) for high complexity testing in the subspecialty of General Immunology. Findings include: 1. The laboratory began testing on the Quanta-Lyser 3000 analyzer in June 2024 and performs the following tests: RNP (Ribonucleoprotein) antibody, ANA (antinuclear antibody) screening and ANCA Vasculitides (Anti-neutrophil cytoplasmic autoantibody). The laboratory's reported test volume in the subspecialty of General Immunology is 694,572. 2. Review of personnel records for 1 out of 3 testing personnel revealed the laboratory failed to have academic credentials to qualify TP-2 for high complexity testing performed on the Quanta-Lyser 3000 analyzer. 3. Two out of two test reports for RNP testing indicated the RNP tests were performed by TP-2 as follows: Patient #2 performed on 9/18/25 and Patient #3 performed on 2/24/26. 4. The TS interviewed on 7/13/26 at 1:00 PM confirmed the laboratory failed to provide the required academic documentation to qualify TP-2 for high complexity testing, and acknowledged that TP-2 had performed patient testing on the Quanta-Lyser 3000 analyzer. -- 4 of 4 --

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 2021 and 2022 chemistry proficiency testing (PT) results and interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096; unsatisfactory performance in two out of three Total Bilirubin PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 chemistry proficiency testing (PT) results for 2021 and 2022 and interview with the technical consultant, the laboratory failed to achieve satisfactory performance for Total Bilirubin (TBIL) in two out of three PT events. Findings: 1. Review of chemistry PT results for the third event of 2021 revealed the laboratory obtained an unacceptable score of 60 percent for TBIL. 2. Review of chemistry PT results for the second event of 2022 revealed the laboratory obtained an unacceptable score of 20 percent for TBIL. 3. Interview with the technical consultant on July 13, 2023 at 11:30 AM confirmed the laboratory failed to achieve satisfactory performance for TBIL in two out of three testing events. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of correlation results for Ribonucleoprotein (RNP) antibodies tested on two Dynex DS instruments (DS1 and DS2) in August 2017 and interview with the technical supervisor, the laboratory failed to have a system in place in terms of policy and procedures that evaluates the comparison of the testing results received by both instruments to determine the acceptability of the difference in test values. Findings include: 1. The data presented for review indicated that the correlation between the instruments was deemed acceptable by the technical supervisor, but there was no criteria indicated in a policy and procedure that supported the acceptability of the comparison. 2. The technical supervisor acknowledged that there were no policies and procedures that defined the acceptable differences in test values for the correlation data. 3. The laboratory has several analytes that may be run on more than one instrument that require correlation studies. 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 --