Arthritis Centers Of Texas

Summary Statement of Deficiencies D0000 An onsite initial survey was conducted on 07/23/2026, and standard level deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS) 116 form, proficiency testing (PT) 2026 records (1st and 2nd events) and staff interview, the laboratory director failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 2 events in 2026. Findings included: 1. Review of CMS-116 form submitted at time of survey (07/23/2026) revealed the laboratory tested the following unregulated immunology analytes not offered by a PT company: a. EL-aCL b. EL-B2GPI 2. Review of laboratory proficiency testing records in 2026 (Event 1), revealed the following: "Attestation Statement The individual testing or examining samples and the laboratory director must attest to the routine integration of the samples into the laboratory work load using the laboratory's routine methods." Further review of the PT records revealed the laboratory failed to document attestation for routine integration of PT samples into the patient workload, for one of two events in 2026 (Event 1). 3. In an interview on 07/23/2026 at 10:26 AM, the General Supervisor (GS-1) confirmed the laboratory director failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 2 events in 2026. Word Key EL-aCL- Elisa Anticardiotropin EL-B2GPI- Elisa Beta2 Glycoprotein 1 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each 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 -- of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on inspector observation, review of laboratory policy, verification studies, patient final reports, and confirmed in interview, the laboratory failed to ensure acceptable sample stability during transport prior to testing patient samples for 104 of 104 patients randomly reviewed in March and April 2026. Findings included: 1. In a tour of the facility located in Dallas Texas on 07/23/2026 at 09:10 AM, the surveyor observed one DSX Automated Elisa System Analyzer (SN:00032143) available for patient testing. During the tour, the General Supervisor (GS-1) stated patient samples were received from a sister location in Richardson Texas. 2. Review of patient policies, "Antinuclear Antibodies (DSX Automated Elisa System) (Measurements of levels by ELISA)" (approved by the laboratory director on 01/10/2026) revealed the following specimen stability requirements for all ELISA testing: " ...II. Specimen Collection and handing ...Unseparated blood can be stored at 18-25 C for 24 hours before the separation of serum. For separation of the serum, the sample is centrifuged for 10 minutes at 2000 rpm. Serum samples are removed from the clot and placed in a labeled container and refrigerated (2-8 C)." 3. Review of laboratory ELISA verification studies (approved by the laboratory director on 01/10/2026) revealed the laboratory failed to document transport studies of patient specimens from the Richardson location to ensure specimen stability for the above acceptable temperatures. 4. Random review of patient final reports in March and April 2026, revealed the following patient specimens received from the Richardson location for testing: a. March: 50 ELISA patient specimens B. April: 54 ELISA patient specimens 5. In an interview on 07/23/2026 at 10:15 AM, the General Supervisor (GS-1) stated temperatures of samples were not monitored during or after transportation from the Richardson Texas location. This confirmed the laboratory failed to ensure acceptable sample stability during transport prior to testing patient samples for 104 of 104 patients randomly reviewed in March and April 2026. Word Key C- Celsius Rpm- Revolutions per minute D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient final reports, laboratory information system (LIS), and confirmed in interview, the laboratory failed to document the testing location on patient final reports for 50 of 50 patients randomly reviewed in March 2026. Findings -- 2 of 3 -- included: 1. Random review of patient reports and the laboratory information system in March 2026 revealed the laboratory failed to document the testing address of the facility for 50 of 50 patients tested. 2. In an interview on 07/23/2026 at 11:01 AM, the General Supervisor (GS-1), after review of the above documentation and LIS, confirmed the laboratory failed to document the testing location on patient final reports for 50 of 50 patients randomly reviewed in March 2026. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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: Revisit 05/13/2019 Based on review of manufacturer's instructions, laboratory policies, quality control and patient data, the laboratory director failed to provide overall management and direction, as evidenced by: 1. The laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for preanalytic phase of testing. Refer to D6007. 2. The laboratory director failed to ensure that the quality control program was established and maintained to assure the quality of laboratory services provided. Refer to D6020. 3. The laboratory director failed to ensure the laboratory had documentation that evaluated patient test results in an unacceptable system run and after performing test system adjustments for chemistry QC (quality control). Refer to D6022. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of 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 -- testing; This STANDARD is not met as evidenced by: Revisit 05/13/2019 Based on review of manufacturer's instructions, laboratory's policy, and patient data, the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for preanalytic phase of testing, as evidenced by: 1. The laboratory failed to follow manufacturer's for establishing a stability for patient complete blood count (CBC) specimens prior to testing on the Sysmex KX-21N analyzer. Refer to D5311-II 2. The laboratory failed to ensure synovial fluid specimens collected included all information according to the lab policy. Refer to D5311-III 3. The laboratory failed to have a system in place to ensure that specimens were collected, processed, and stored according to manufacturer's instructions for specimens submitted to the laboratory for testing from an outside clinic. Refer to D5317 -- 2 of 2 --