Infinity Health

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 1:42 pm on 02/26 /2024, the laboratory director and testing personnel failed to attest to the routine integration of PT samples into the patient workload for three out of six PT events from 01/01/2022 - 12/31/2023. The findings include: 1. For 2022 events 2 and 3, the laboratory director did not sign the hematology/coagulation PT attestation statements. 3. For 2023 event 1, the laboratory director and testing personnel did not sign the the hematology/coagulation PT attestation statement. 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 D5783

Summary Statement of Deficiencies 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:00 am on 03 /22/2018, the laboratory failed to indicate the address of the testing facility for two out of two patient test reports (patient identifiers A and B) from October and November 2018. The findings include: 1. Patient identifier A had a complete blood cell count performed on 10/05/2017. 2. Patient identifier B had a complete blood cell count performed on 11/01/2017. 3. The patient test reports indicated the name of the facility performing the test. However, the patient test reports did not include the address of the testing facility. 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 --