Kbmo Diagnostics

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 record review and confirmed through an interview with the Technical Supervisor (TS) the laboratory did not have an ongoing mechanism to evaluate the TS and General Supervisor (GS) based on their CLIA responsibilities. Findings Include: 1. Record review on 5/28/2025 of the laboratory's 2023, 2024 and 2025 to date personnel competency records revealed the laboratory did not have documented competency evaluation for the TS and GS based on their CLIA responsibilities. 2. Record review on 5/28/2025 of the laboratory's, Policy and Procedure Manual revealed, the laboratory did not have a policy in place to evaluate the TS and GS based on their CLIA responsibilities. 3. During staff interview on 5/28/2025 at 11:30 AM with the TS, the TS confirmed the laboratory does not have a policy to evaluate the TS and GS based on their CLIA responsibilities and they were not assessed. 4. The laboratory performs 4,452,170 tests annually in the specialty of Diagnostic Immunology. D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the 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 -- original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor (TS) the laboratory failed to indicate the final patient test report was a corrected report. Finding include: 1. Record review on 5/28/2025 of the laboratory's documentation of 2 incorrect patient reports revealed; "Patient 1 and Patient 2 had the wrong FIT-132 blood spot reports on August 16, 2024." 2. Record review on 5/28/2025 of the two final patient test reports of the above patients, containing corrected test results revealed the test report did not indicate the fact that the results were corrected. 3. Staff interview on 5/28/2025 at 12:15 PM with the TS confirmed the above findings. 4. The laboratory performs 4,452,179 tests annually in the specialty of Diagnostic Immunology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the KBMO Diagnostics laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on procedural review and interview, the laboratory failed to adequately evaluate their system that twice a year evaluated and defined the relationship between multiple analyzers performing the same type of testing as evidenced by the following: a) The laboratory performs testing on three Chromate plate readers performing general immunology and routine chemistry testing. b) The laboratory's procedure for plate reader correlation stated that, "Plate reader data must be compared twice per year, at minimum, and the degree of correlation must be assessed". c) The general supervisor confirmed in an interview on 5/27/21 at 10:25 AM that cross comparison correlations between the three plate readers had not been performed for calendar years 2019 and 2020. 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 D0000 A CLIA recertification survey was conducted for the KBMO Diagnostics laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish performance specifications for one (1) of one (1) newly implemented test systems not subject to FDA clearance as evidenced by the following: Zonulin: Specificity A review of validation studies for the Zonulin assay revealed that the laboratory failed to perform specificity studies as part of the validation. The technical supervisor stated in an interview on 2/27/19 at 9:59 a.m. that specificity studies had not been included as part of the validation. The laboratory performs 2,560 Zonulin assays annually. 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 --