West Suburban Center For Arthritis

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of the laboratory's temperature logs and procedures, and interview with the technical consultant, the laboratory did not define an acceptable temperature range that was consistent with the manufacturer's acceptable range for three of three Abbott Architect chemistry reagents stored at room temperature. Findings include: 1. Review of laboratory's temperature logs showed no established room temperature range for the main laboratory area where reagents and supplies were stored. 2. Review of laboratory procedures showed albumin, calcium, and creatinine testing reagents for the Abbott Architect chemistry analyzer were to be stored at 15-30 C. 3. Interview with the technical consultant on February 3, 2025, at 3: 00 PM confirmed the laboratory had not defined an acceptable range for reagents stored at room temperature. 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 --

Summary Statement of Deficiencies 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, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory policies and procedures and interview with the technical supervisor, the laboratory did not establish a procedure defining the method and frequency requirements for assessment of testing personnel and supervisory employee competence. Findings include: 1. Review of laboratory procedures showed no evidence of a procedure for assessing employee competence that identified the frequency of evaluation or the elements required for evaluation of testing and supervisory personnel. 2. Interview with the technical supervisor on January 31, 2023 at 10:30 AM confirmed the laboratory did not establish a procedure for assessing employee competence that defined the method and frequency of evaluation. 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) 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 -- 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 D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the "Verification Report and Data" reports for the QUANTA Lyser automated processor and interview with the technical supervisor, the laboratory did not perform and document the function checks required by the manufacturer after the verification performed on May 14, 2018 expired on September 29, 2018. Findings include: 1. Review of the QUANTA Lyser "Verification Report and Data" reports showed the most recent record available was from testing performed on May 14, 2018. The report shows the results expired on September 29, 2018. 2. Interview with the technical supervisor on January 31, 2019 at 12:30 PM confirmed no records were available showing the laboratory completed the manufacturer's required function checks for the QUANTA Lyser processor since May 14, 2018. 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 --