Arizona Arthritis & Rheumatology Associates

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 --