Cornerstone Medical Group

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 13, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following 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 the American Proficiency Institute (API) proficiency testing (PT) evaluation reports and an interview with testing personnel (TP), the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 21, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the review of the Sysmex XP-300 (serial number A5095) calibration documents and testing personnel interview, the laboratory failed to calibrate the analyzer at the frequency required by the manufacturer. Findings: 1. Review of the available calibration documents revealed calibration was performed : June 2020, December 2020, January 2022, June 2022. 2. No calibration was performed in 2021 or December 2022. The over due calibration has not been performed to date. 3. Letter from the manufacturer field service representative stated : "The calibration was due June 22, 2021 but was not completed until January 2022". 4. Interview with testing personnel #1 (CMS 209) in the lab on 3/21/23 at 2 PM, confirmed the findings. 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 -- D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on the review of the Sysmex XP-300 (serial number A5095) calibration documents and testing personnel interview, the laboratory technical consultant failed to ensure the calibrations were performed on the analyzer at the frequency required by the manufacturer. Refer to D 5437 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 20, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of reporting SARS-CoV-2 documents and subsequent staff interview, the laboratory failed to meet the specific requirements for reporting SARS-CoV-2 test results during the Public Health Emergency, to the Secretary. Findings include: 1. Review of SARS-CoV-2 testing logs reveals the lack of documentation for the required reporting of SARS-CoV-2 patient results for the Right Sign COVID-19 IgG/ IgM Rapid Test kit utilized by the lab. 2. Interview with staff #4 (CMS 209 form) on 04/20/21 at approximately 12:15 PM in the back office reception area confirmed the lab was not reporting results to the Secretary. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to perform and document external QC on the Right Sign COVID-19 IgG/ IgM Rapid Test kit. Findings include: 1. No QC documents were available to review on the Right Sign COVID-19 IgG/ IgM Rapid Test kit at the time of survey. 2. . Interview with staff #4 (CMS 209 form) on 04/20/21 at approximately 12:15 PM in the back office reception area confirmed the lab was not performing external QC on the aforementioned test kit. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 8, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) attestation statements for 2017 and 2018, the laboratory failed to ensure all testing personnel (TP) particiapated in the PT testing. Findings include: 1. Review of the proficiency testing (PT) attestation statements for 2017 and 2018 revealed all of the testing events were performed by staff #4 (CMS 209). 2. Interview with staff #4 (CMS 209) on 1/8/19 at approximately 4 PM in the spare office, confirmed she performed all of the 2017-2018 PT testing. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require