THE HEKTOEN INSTITUTE OF MEDICINE, LLCNon-Profit

Assistance Listing, Federal Agency, and Program Name - 93.088, U.S. Department of Health and Human Services, Advancing System Improvements for Key Issues in Women's Health 93.323, U.S. Department of Health and Human Services, Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) 93.592, U.S. Department of Health and Human Services, Family Violence Prevention and Services/Discretionary and COVID - 19 Family Violence Prevention and Services/Discretionary 93.837, U.S. Department of Health and Human Services, Cardiovascular Disease Research (Research and Development Cluster) Federal Award Identification Number and Year - 93.088 ASTWH220110 (2023 and 2024) 93.323 - 32680012K (2024) 93.592 - 90EV0516 (2021); 90EV0530 (2023); ; 90EV0544 (2024) 93.837 - U01HL146245 (2024) Pass through Entity - 93.088 N/A 93.323 - Illinois Department of Public Health 93.592 - N/A 93.837 - N/A Finding Type - Material weakness and material noncompliance with laws and regulations Repeat Finding - Yes 2024-001 Criteria - Per 2 CFR 200.303(a), nonfederal entities must establish and maintain effective internal controls over the federal award that provides reasonable assurance that the nonfederal entity is managing the federal award in compliance with federal statutes, regulations, and the terms and conditions of the federal award. These internal controls should be in compliance with the guidance in Standards for Internal Control in the Federal Government, issued by the Comptroller General of the United States, or the Internal Control Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Per 2 CFR 200.318(a), the nonfederal entity must have and use documented procedures, consistent with state, local, and tribal laws and regulations and the standards of this section, for the acquisition of property or services required under a federal award or subaward. The nonfederal entity's documented procurement procedures must conform to the procurement standards identified in §§200.317 through 200.327. The LLC has established in its internal procurement policies and procedures that a minimum of 3 quotes must be obtained for purchases made under informal, simplified acquisition procedures. Per 2 CFR 200.318(i), the nonfederal entity must maintain records sufficient to detail the history of procurement. These records will include, but are not necessarily limited to, the following: rationale for the method of procurement, selection of contract type, contractor selection or rejection, and the basis for the contract price. Condition - Controls were not sufficient to ensure that the history of procurement decisions was documented, as required by 2 CFR 200. Additionally, controls were not sufficient to ensure checks for suspension and debarment were documented before entering into covered transactions with third parties. Questioned Costs - unknown If questioned costs are not determinable, description of why known questioned costs were undetermined or otherwise could not be reported We are unable to predictably quantify, had federal procurement standards been followed, which portion of activity presented on the SEFA under these contracts would be in question. Identification of How Questioned Costs Were Computed N/A Context - 93.088 - Management was unable to provide evidence that three out of three contractors tested was checked for suspension and debarment in advance of entering into a covered transaction. 93.323 - Management was unable to provide evidence that three out of three contractors tested was checked for suspension and debarment in advance of entering into a covered transaction. 93.592 - Management was unable to provide evidence that four out of four contractors tested was checked for suspension and debarment in advance of entering into a covered transaction. 93.837 - Of the four contracts tested, management was unable to produce records sufficient to detail the history of procurement for one contract. Additionally, for that same contractor, management was unable to provide evidence that the third party was checked for suspension and debarment in advance of entering into a covered transaction. Because we were able to confirm via a check of the Excluded Parties Listing that the contractors noted above were not suspended or debarred, no questioned costs related to this noncompliance were identified. Cause and Effect - Newly revised procurement policies and procedures implemented during the last month of the fiscal period under audit were not in place during the time of the contract acquisitions noted above, and therefore a lack of internally established procurement documentation practices resulted in material noncompliance with federal procurement standards. Recommendation - We recommend that management continue to follow and formalize its procurement policies and procedures to demonstrate how the LLC will achieve compliance with federal procurement standards identified in §§200.317 through 200.327. Additionally, we recommend management retain documented evidence that its policies and procedures were followed to ensure compliance with federal procurement standards. Views of Responsible Officials and Corrective Action Plan - Management will continue to strengthen internal controls through the revised Procurement Policy, enhanced documentation requirements, and clarified approval procedures. A centralized tracking database has been implemented to document sanctions, suspension, and debarment checks, as well as other required verifications based on the nature of each purchase or service. These procedures are required prior to entering into covered transactions and are monitored through dual staff reviews. Management believes that ongoing monitoring and consistent enforcement of these procedures will ensure compliance and prevent recurrence.

Assistance Listing, Federal Agency, and Program Name - 93.837, U.S. Department of Health and Human Services, Cardiovascular Disease Research (Research and Development Cluster) Federal Award Identification Number and Year - 93.837 - U01HL146245 (2024) Pass through Entity - N/A Finding Type - Material weakness and material noncompliance with laws and regulations Repeat Finding - No Criteria - Per 2 CFR 200.303(a), nonfederal entities must establish and maintain effective internal controls over the federal award that provides reasonable assurance that the nonfederal entity is managing the federal award in compliance with federal statutes, regulations, and the terms and conditions of the federal award. These internal controls should be in compliance with the guidance in Standards for Internal Control in the Federal Government, issued by the Comptroller General of the United States, or the Internal Control Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Per 2 CFR 200.305(b)(3), when the reimbursement method is used, the Federal agency or pass through entity must make payment within 30 calendar days after receipt of the payment request unless the Federal agency or pass through entity reasonably believes the request to be improper. Condition - Controls in place were not sufficient to ensure subrecipients were paid consistently within 30 days of a request for reimbursement. Questioned Costs - N/A If questioned costs are not determinable, description of why known questioned costs were undetermined or otherwise could not be reported - N/A Identification of How Questioned Costs Were Computed - N/A Context - Out of a sample of 29 subrecipient disbursements tested, we noted 6 were not paid within 30 days of the LLC receiving the request for reimbursement. Cause and Effect - A lack of effective internal controls resulted in material noncompliance with this requirement. Recommendation - We recommend management establish robust controls over subrecipient activity to ensure the 30 day requirement is met. Views of Responsible Officials and Planned Corrective Actions - Management acknowledges the finding. Delays in approvals may occur due to multiple internal and external parties involved. To prevent recurrence, management will monitor all parties, issue email reminders with clear deadlines, and enforce timely processing to ensure compliance with the 30 day requirement.

Assistance Listing Number, Federal Agency, and Program Name -93.233/93.837, U.S. Department of Health and Human Services, Research and Development Cluster 93.323, U.S. Department of Health and Human Services, Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Federal Award Identification Number and Year - 93.233 - R01HL142116; 93.837 - U01HL146245 93.323 - 22680258J; 32680012K Pass-through Entity - 93.233 N/A (direct); 93.837 N/A (direct) 93.323 Illinois Department of Public Health (IDPH) Finding Type - Material weakness and material noncompliance with laws and regulations Repeat Finding - No Criteria - Per 2 CFR 200.303(a), nonfederal entities must establish and maintain effective internal controls over the federal award that provides reasonable assurance that the nonfederal entity is managing the federal award in compliance with federal statutes, regulations, and the terms and conditions of the federal award. These internal controls should be in compliance with the guidance in Standards for Internal Control in the Federal Government, issued by the Comptroller General of the United States, or the Internal Control Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Per 2 CFR 200.318(a), the nonfederal entity must have and use documented procedures, consistent with state, local, and tribal laws and regulations and the standards of this section, for the acquisition of property or services required under a federal award or subaward. The nonfederal entity's documented procurement procedures must conform to the procurement standards identified in §§200.317 through 200.327. Per 2 CFR 200.318(i), the nonfederal entity must maintain records sufficient to detail the history of procurement. These records will include, but are not necessarily limited to, the following: rationale for the method of procurement, selection of contract type, contractor selection or rejection, and the basis for the contract price. Per 2 CFR 200.324(a), the nonfederal entity must perform a cost or price analysis in connection with every procurement action in excess of the SAT, including contract modifications. The method and degree of analysis is dependent upon the facts surrounding the particular procurement situation; but, as a starting point, the nonfederal entity must make independent estimates before receiving bids or proposals. Condition - Controls were not sufficient to establish written policies and procedures surrounding procured contracts and to ensure that the history of procurement decisions was documented, as required by 2 CFR 200. Questioned Costs - Research and Development Cluster - unknown ELC - unknown Identification of How Questioned Costs Were Computed - N/A Context - Research and Development Cluster - For the four contracts tested, management did not maintain records sufficient to detail the history of procurement, rationale for the method of procurement, selection of the contract type, or basis of the contract price. Additionally, for the largest of the four contracts with activity of approximately $375,000, which is above the SAT established by FAR, management did not document its rationale for limiting competition, nor was management able to provide evidence that a cost-price analysis was performed. Finally, management has not formally documented an appropriate micropurchase or SAT threshold. ELC - For the three of the four contracts tested that were procured under noncompetitive means, management did not maintain records sufficient to detail the history of procurement, rationale for the method of procurement, selection of the contract type, or basis of the contract price. Further, for three out of four contracts tested under the Research and Development Cluster and all four contracts tested under ELC, management was unable to provide evidence that contractors were checked for suspension and debarment in advance of entering into a covered transaction. Because there was evidence that these contractors were not suspended or debarred, no questioned costs related to this noncompliance were identified. Cause and Effect - A lack of formal procurement policies and procedures, internally established procurement thresholds, or records in support of procurement decisions could result in material noncompliance with federal procurement standards. Recommendation - We recommend that management formalize procurement policies and procedures to demonstrate how the Institute will achieve compliance with standards identified in §§200.317 through 200.327. Additionally, we recommend management retain documented evidence that its policies and procedures were followed to ensure compliance with procurement standards. Views of Responsible Officials and Corrective Action Plan – Management agrees with the recommendation and will review the relevant guidance to ensure compliance. Necessary revisions will be made to the existing procurement policies and procedures in a timely manner to ensure that procurement decisions are documented, as required by 2 CFR Part 200.

Assistance Listing, Federal Agency, and Program Name - 93.918, U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA), Grants to Provide Outpatient Early Intervention Services with Respect to HIV Disease Federal Award Identification Number and Year - H76HA00107, 2022 Pass-through Entity - N/A Finding Type - Significant deficiency Repeat Finding - No Criteria - Per 2 CFR 200.303(a), non-federal entities must establish and maintain effective internal controls over the federal award that provides reasonable assurance that the non-federal entity is managing the federal award in compliance with federal statutes, regulations, and the terms and conditions of the federal award. These internal controls should be in compliance with the guidance in Standards for Internal Control in the Federal Government issued by the Comptroller General of the United States or the Internal Control Framework, issued by the Committee of Sponoring Organizations of the Treadwy Commission (COSO). Condition - Management did not have controls in place to ensure required reporting submissions to HRSA were reviewed for accuracy, completeness, and compliance with the terms and conditions prescribed by the funding agency by an individual other than the indvidual preparing the report. Questioned Costs - None Identification of How Questioned Costs Were Computed -Not applicable, as no questioned costs were identified. Context - During testing of the Institute's annual submission of its Federal Financial Report (FFR or SF-425), we noted the individual compiling the information also prepared the report without a secondary level of review. Cause and Effect - Though some elements of the report automatically populate from HRSA's Payment Management System, other key pieces of information are manually added to the report from underlying ledgers or other reports. Without a level of review in advance of the submission, information in the report could be materially mistated or out of compliance with HRSA's reporting requirements. Recommendation - We recommend management implement a level of review in advance of the report submission to ensure individuals who prepare reports are different from those who review and file the reports and to ensure reports are prepared in compliance with funding agency requirements. Views of Responsible Officials and Corrective Action Plan - Management concurs with the recommendation and will review the appropriate guidance and implement enhanced procedures for including secondary levels of review.