Ochsner Laird Hospital

Summary Statement of Deficiencies D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the "Administration of Blood Components" policy in the facility's Blood Transfusion Manual, review of patients' electronic medical records and laboratory transfusion records, and lack of documentation of review of blood administration records, the facility failed to ensure that the "Administration of Blood Components" policy, for preventing transfusion reactions, was followed, in order to promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory. Findings include: 1. The facility's "Administration of Blood Components" policy states, "Obtain pre-transfusion vital signs. After the initial 15 minutes, obtain another set of vital signs, and document the information in EPIC. The next set of vital signs that are required to be entered in EPIC is at the end of the transfusion." Review of the facility's Blood Transfusion Manual revealed no policy to ensure the "Administration of Blood Components" policy was followed for blood component transfusions. 2. Review of patients' electronic medical records and laboratory transfusion records revealed no documentation of review of administration of blood components, to promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory. 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 D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient test reports in the electronic medical record (EMR) of test results from the Siemens Dimension EXL chemistry system, Sysmex XS-1000i hematology analyzer, Stago STA-Compact coagulation system, and Siemens Clinitek Advantus urine analyzer and confirmation by the technical consultant, the laboratory's record system does not include the identity of the personnel who performed patient testing, since the automatic verification function was put in use on 7/1/21 for the laboratory information system to automatically verify results that meet the laboratory's criteria and transmit them to the EMR. Findings include: Review of patient test reports in the EMR of test results from the Siemens Dimension EXL chemistry system, Sysmex XS-1000i hematology analyzer, Stago STA-Compact coagulation system, and Siemens Clinitek Advantus urine analyzer revealed the patient test reports do not include the identity of the personnel who performed patient testing when the laboratory information system automatically verifies results and transmits them to the EMR. The technical consultant confirmed that the laboratory's record system does not include the identity of the personnel who performs the test, when the laboratory information system automatically verifies results and transmits them to the EMR. The technical consultant confirmed the automatic verification function was put in use 7/1/21 for the analyzers listed above and turned off for the Siemens Dimension EXL chemistry system from 7/14/21 until 8/24/21. 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 --