Ichordx, Inc

Summary Statement of Deficiencies D0000 Off-site revisit survey, May 19, 2026, found the deficiencies cited during the January 15, 2026 on-site survey are corrected and the laboratory is in compliance with 42 CFR Part 493 Requirements for Laboratories. 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 review of laboratory policies and procedures, the absence of competency records for 2025, and interview with the Laboratory Director (LD) on 01/15/2026, the LD failed to perform the required annual competency assessments for the General Supervisors (GS #1 and GS #2) and Technical Supervisor (TS #2) for 2025. Findings: Review of laboratory policy, "Personnel Policy - Laboratory" section 6.13.5 page 6, revealed "...ongoing competency assessments...semi-annually in the first year after training...annually therafter." Review of laboratory procedure, "Training & Competency Assessment Procedure" section 3 page 2, revealed "Evaluating competency...semi-annually for the first year after completion of initial training and annually therafter..." Review of laboratory competency records revealed the absence of 2025 annual competency assessments for the following laboratory positions: GS #1 - 2025 GS #2 - 2025 TS #2 - 2025 During interview at approximately 3:46 p.m. the LD confirmed the absence of 2025 competencies for GS #1, GS #2, and TS #2. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and 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 2 -- supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records for 2024, 2025, and 2026, and interview with the Laboratory Director (LD) 01/15/2026, the LD failed to specify in writing the duties and responsibilities for the Clinical Consultant (CC) involved with the daily operation of the laboratory and testing process. Findings: Review of personnel records for 2024, 2025, and 2026 revealed the absence of a job description for the CC position. During interview at approximately 2:02 p.m. the LD confirmed no position description available for the CC. -- 2 of 2 --

Summary Statement of Deficiencies D5791 Based on quality assessment policies and procedures record review and interview with laboratory personnel on February 28, 2024 at 1:00 pm, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. Findings included: a. According to the laboratory's written protocol titled "Generation of Patient Reports in DNAnexus (TSM-STP-7, ver #3)," section 8, Acceptance Criteria, described the laboratory's criteria for acceptability of various quality control parameters. These quality control parameters included acceptance criteria for the positive quality control results and array call rates, and review of concordance results, GSA controls analysis charts, and potential report generation errors. b. On February 28, 2024 at 1:15 pm, laboratory personnel confirmed that the laboratory maintained no written quality assessment policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified for the quality control activities described in the laboratory's written protocol titled "Generation of Patient Reports in DNAnexus (TSM-STP-7, ver #3)." c. According to laboratory records, the laboratory performed and reported approximately 247 patient tests annually involving the use of this written protocol. 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 --