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Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records, as well as interviews with the Clinical Director (CD) and Testing Personnel (TP), the laboratory failed to complete the attestation statement provided by the PT program, signed by the analyst and Laboratory Director (LD), documenting that PT samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the PT event. FINDINGS: 1. There no was documentation of LD signature and date of signature on the American Proficiency Institute (API) attestation statements for the 2023 Third Event, 2024 Third Event, and 2025 First Event. 2. It was noted the LD name was handwritten on the API attestation form in the space provided for the LD signature by the TP for the 2023 Third Event. It was also noted the TP name was written in the space provided for the LD signature on the API attestation form for the 2024 Third Event. 3. The CD and TP confirmed the findings on August 13, 2025, at approximately 11:45 A.M. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel training and competency assessment records, Standard Operating Procedures (SOPs), as well as interview with the CD, the laboratory failed to establish and approve written policies and procedures to assess employee and, if applicable, consultant competency. FINDINGS: 1. There was no documentation of annual Clinical Consultant (CC) and Technical Consultant (TC) competency assessment performance. 2. The current, approved SOPs did not include instructions for performing such activity. 3.. The CD confirmed the findings on August 13, 2025, at approximately 11:30 A.M. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on lack of PT records as well as interviews with the CD and TP, the laboratory failed to retain, document review, and evaluate PT summary reports. FINDINGS: 1. There was no documentation of PT summary report for the 2023 Second Event. 2. The CD and TP confirmed the findings on August 13, 2025, at approximately 11:45 A.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the third event 2020, all three events of 2021 and 2022, American Proficiency Institute (API) records and attestation forms, analyzer printouts, API test result forms and API summary test reports, the laboratory failed to maintain signed copies of the attestation forms and API test summary reports. FINDINGS: 1. The laboratory director failed to sign and date the attestation forms for the following test events: a. Third event of 2020; first and third event of 2021; all three events in 2022; and first event of 2023. 2. The testing person #1 confirmed during interview on 3/27 /2023 at 11:00 A.M. that the laboratory director failed to sign and date the attestation forms. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the personnel files for testing personnel #1 and #2, lack of six- month and annual competency evaluation, SOP for competency evaluation and an interview with testing person #1, the laboratory director failed to follow the establish competency evaluation policy regarding the six-month and annual for the first year of employment. FINDINGS: 1. The Competency evaluation policy states, "Each individual performs require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. o Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. o Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples. o Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. o Follow the laboratory's established

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory's temperature records and an interview with the testing person, the laboratory failed to include expected refrigerator and freezer temperature ranges on the daily log sheet used to monitor the temperatures for both refrigerator/freezers, located in the infusion area. FINDINGS: 1. The testing person confirmed on November 18, 2020 at approximately 3:00 PM, that the laboratory failed to include the expected refrigerator and freezer temperature ranges on the daily log sheet used to monitor the temperatures. a) Refrigerator/freezer #1 is used to store control, calibration material and proficiency testing specimens. b) Refrigerator/freezer #2 is used to store pharmaceuticals material for patient infusion. 2. The nursing staff did record the temperatures daily from 1/10/2019 through survey date. However, surveyor could not verify if these recorded temperatures were within the expected ranges. 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 --