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(U) Rec. 1: The DoD OIG recommended that the Director of the Defense Health Agency work with the Program Executive Officer of the Program Executive Office, Defense Healthcare Management Systems to document and implement the process for identifying and collecting patient health data of DoD patients in the Military Health System in current and future registries within their purview in a written document, such as a standard operating procedure. The procedure should identify, at a minimum, the internal controls throughout the process, the relevant data sources, data fields, and diagnostic codes used in the computer scripts, and should be reviewed and approved when updates occur.

Rec. 2: The DoD OIG recommended that the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity and the Chief of the Joint Trauma System work with the Joint Trauma System contracting officer's representative to revise the quality assurance surveillance plan. The plan should include an appropriate sampling methodology for selecting patient health records from the Coronavirus Disease-2019 Registry to verify that the contractor is achieving the contract-required accuracy rate for entering patient data, and submit the revised quality assurance surveillance plan to the contracting officer.

Rec. 2: The DoD OIG recommended that the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity and the Chief of the Joint Trauma System work with the Joint Trauma System contracting officer's representative to revise the quality assurance surveillance plan. The plan should include an appropriate sampling methodology for selecting patient health records from the Coronavirus Disease-2019 Registry to verify that the contractor is achieving the contract-required accuracy rate for entering patient data, and submit the revised quality assurance surveillance plan to the contracting officer.

Rec. 3.a: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to update the contractor's rating in the contractor's performance assessment reports for contract W81XWH-22-C-0151 and contract W81XWH-20-P-0197, when feasible.

Rec. 3.b: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to recoup any of the $3.9 million in questioned costs paid for services that did not comply with the terms of contract W81XWH-20-P-0197, if feasible.

Rec. 3.c: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to recoup any of the $2.3 million in questioned costs paid for services that did not comply with the terms of contract W81XWH-22-C-0151.

Rec. 3.d: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to consider all available contract remedies for contract W81XWH-22-C-0151, including modifying and, if necessary, terminating and re-competing the contract, and take action to ensure that the Department receives full value for the funds it expends for contract W81XWH-22-C-0151.

Rec. 3.e: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to delegate an official to review the concerns identified in this report, including the actions of the contracting officials, and take administrative actions, as necessary. The review should include a determination on whether the contractor's performance assessment reports were accurate and make updates as necessary.

Rec. 3.e: If the contractor did not meet the 90 percent accuracy requirement, the DoD OIG recommended that the Chief of the Joint Trauma System work with the Senior Contracting Official of the U.S. Army Medical Research Acquisition Activity to delegate an official to review the concerns identified in this report, including the actions of the contracting officials, and take administrative actions, as necessary. The review should include a determination on whether the contractor's performance assessment reports were accurate and make updates as necessary.

(U) Rec. 4.a: The DoD OIG recommended that the Director of the Defense Health Agency work with the Chief of the Joint Trauma System establish and implement a process for selecting Coronavirus Disease-2019 events for entry into the Coronavirus Disease-2019 Registry to limit selection bias.

Rec. 4.b: The DoD OIG recommended that the Director of the Defense Health Agency work with the Chief of the Joint Trauma System to include a bias disclosure notice on all reports generated from the Coronavirus Disease-2019 Registry until the Coronavirus Disease-2019 Registry data represent the population of DoD patients who had a Coronavirus Disease-2019 event.

(U) Rec. 5.a: The DoD OIG recommended that the Assistant Secretary of Defense (Health Affairs) establish and implement a policy for developing and populating patient registries that aligns with the Department of Health and Human Services best practices, "Agency for Healthcare Research and Quality, Registries for Evaluating Patient Outcomes: A User's Guide," current edition.

(U) Rec. 5.b: The DoD OIG recommended that the Assistant Secretary of Defense (Health Affairs) conduct a review of all patient registries in the Military Health System to verify the reliability of data in each registry and implement corrective actions, as necessary.