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Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on January 24, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of September 7, 2021 and December 19, 2022, a review of the quality control records for the Sysmex XP300 hematology analyzer, and an interview with the Laboratory Technical Consultant, the laboratory failed to retain the calibration and quality control records for at least two years. Findings include: 1. A random patient audit of six patients tested between the dates September 7, 2021 and December 19, 2022 revealed that the instrument calibration certificate and the quality control records for the Sysmex XP 300 Hematology Analyzer were not available onsite, and could not be retrieved for review for the date of September 7, 2021. 2. The Technical Consultant stated that the records were not available onsite for review at the time of the survey , and that it was believed that the records were discarded during an interview conducted on January 24, 2023 at approximately 2:30 PM. The laboratory performs approximately 78000 hematology tests 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 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 9, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of May 6, 2019 and May 14, 2021, a review of the laboratory maintenance and quality control records for the Sysmex XP300 hematology analyzer, and an interview with the Laboratory Technical Consultant, the laboratory failed to retain the maintenance logs and the quality control records for at least two years. Findings include: 1. A random patient audit between the dates of May 6, 2019 and May 14, 2021 revealed that the quality control records for the Sysmex XP300 hematology analyzer were not available onsite and could not be retrieved for review for the date of May 6, 2019. 2. A random patient audit between the dates of May 6, 2019 and May 14, 2021 revealed that the maintenance records for the Sysmex XP300 hematology analyzer were not available and could not be retrieved for review for the dates of May 6, 2019, and for July 2, 2019. 3. The Technical Consultant stated that the records were not available onsite for review at the time of the survey during an interview conducted on June 9, 2021 at approximately 2:45 PM. The laboratory performs approximately 78000 hematology tests 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 4 -- 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) 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 D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on February 7, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing results for testing years 2017 and 2018 and an interview with the laboratory area manager, the laboratory failed to review and document