Arthritis Treatment Center

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) record for 2025 and 2026, the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing moderate complexity testing; 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- 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and AAB Medical Laboratory Evaluation (MLE) PT Hematology and Chemistry Module (CH) 2025 and 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 -- 2026 records, the laboratory failed to successfully participate for the analyte of WBC Differential and the analyte ALT/(SGPT). Refer to D2130 and D2096. 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 a proficiency testing (PT) desk review of CASPER 0155 report and AAB- MLE PT 2025 Chemistry Module (CH) Event 3 and 2026 Chemistry Module (CH) Event 1 records, the laboratory failed to achieve successful performance for the analyte ALT/(SGPT) in two out of three testing events. Findings include: 1. Review of the CASPER 0155 report revealed the following results: AAB-MLE Chemistry Module (CH) 2025-3rd Event the laboratory received an unsatisfactory score of 0% for ALT/(SGPT). AAB-MLE Chemistry Module (CH) 2026-1st Event the laboratory received an unsatisfactory score of 0% for ALT/(SGPT). 2. A review of the 2025 and 2026 AAB-MLE Proficiency Testing records confirmed the laboratory received the above results 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 a proficiency testing (PT) desk review of CASPER 0155 report and AAB- Medical Laboratory Evaluation (MLE) 2025 Hematology Cell ID Event 3 and 2026 Hematology Cell ID Event 1 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for two of three consecutive testing events in the specialty of Hematology for the analyte WBC Differential. Findings include: 1. Review of the CASPER 0155 report revealed the following results: AAB_MLE Hematology 2025-3rd Event the laboratory received an unsatisfactory score of 0% for WBC Differential. AAB-MLE Hematology 2026-1st Event the laboratory received an unsatisfactory score of 24% for WBC Differential. 2. A review of 2025 and 2026 AAB-Medical Laboratory Evaluation (MLE) Proficiency Testing records confirmed the laboratory received the above results. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and AAB-MLE -- 2 of 3 -- Chemistry Module (CH) and Hematology 2025 and 2026 PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 CASPER 0155 report and AAB-MLE Chemistry Module (CH) and Hematology 2025 and 2026 PT records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibration verifications every six months or, as appropriate, as evidenced by the following: a) A 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 -- review of hematology calibration records for calendar years 2018, 2019, and 2020 was performed on 11/4/20 at 10:49 AM. b) The review revealed that calibration verifications of at least 3 points was not performed once every six months complete blood count (CBC) analytes performed on the Beckman Coulter HMX analyzer. Records revealed that calibrations of the analyzer had only been performed once during calendar years 2018, 2019 and 2020 (calibrations performed 5/16/18, 7/9/19, and 1/8/20 respectively). c) General supervisor number one confirmed in an interview on 11/4/20 at 10:58 AM calibrations had not been performed every six months on the hematology analyzer. d) The laboratory performs approximately 9,516 CBCs annually. . D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on record review and interview the technical supervisor failed to ensure the establishment of the laboratory's test performance characteristics and that the verification of the test procedures performed were adequate for accuracy and precision when applicable, prior to implementing a hematology analyzer test procedures for patient testing and reporting: a) A review of validation documentation on 11/4/20 at 11:20 AM for the Sysmex XN 530 hematology analyzer implemented on 10/21/20 was performed. The review revealed that the technical supervisor failed to document a review and approval of all performance specifications that had been completed. There was no documented review of the within and day to day precision studies. b) The technical supervisor confirmed in an interview on 11/4/20 at 12:45 AM that he had not signed off on the precision studies. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Arthritis Trreatment Center Rheumatology Associates laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of any test or procedure it performs that is not included in subpart I of this part at least semiannually as evidenced by the following: a) The laboratory performs joint fluid analysis for white blood cell counts and crystals. The laboratory routinely compares white blood counts on joint fluids between two laboratory technologists for each patient sample tested. However, there is no cross comparison being performed for the crystal portion of the analysis. b) The fact that the crystal portion of the joint fluid analysis is not included in any accuracy procedure at least semiannually was confirmed by the general supervisor in an interview on 5/22/18 at 1:27 P.M.. The laboratory performs 1,167 joint fluid analyses annually. 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 --