Audit 359249

FY End
2024-12-31
Total Expended
$18.90M
Findings
4
Programs
1
Year: 2024 Accepted: 2025-06-19
Auditor: Rsm US LLP

Organization Exclusion Status:

Checking exclusion status...

Findings

ID Ref Severity Repeat Requirement
565386 2024-001 Significant Deficiency - I
565387 2024-001 Significant Deficiency - I
1141828 2024-001 Significant Deficiency - I
1141829 2024-001 Significant Deficiency - I

Programs

ALN Program Spent Major Findings
93.103 Food and Drug Administration Research $11.09M Yes 1

Contacts

Name Title Type
EBVDJ7R7AY35 Tariq Bahich Auditee
2028046648 Jeri Fleming Auditor
No contacts on file

Notes to SEFA

Title: Basis of Presentation Accounting Policies: Expenses reported on the Schedule are reported on the accrual basis of accounting. Such expenditures are recognized following the cost principles contained in the Uniform Guidance, wherein certain types of expenditures are not allowable or are limited as to reimbursement. De Minimis Rate Used: N Rate Explanation: Indirect costs allocated to awards for the year ended December 31, 2024, were based on a rate negotiated with the Organization’s cognizant federal agency, the Department of Health and Human Services. The Organization does not utilize the 10% de minimis indirect cost rate per CFR 200.414. The accompanying schedule of expenditures of federal awards (the Schedule) includes the federal award activity of Medical Device Innovation Consortium (the Organization) under programs of the federal government for the year ended December 31, 2024. The information in this Schedule is presented in accordance with the requirements of Title 2 U.S. Code of Federal Regulations Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance). Because the Schedule presents only a selected portion of the operations of the Organization, it is not intended to and does not present the financial position, changes in net assets, or cash flows of the Organization.
Title: Summary of Significant Accounting Policies Accounting Policies: Expenses reported on the Schedule are reported on the accrual basis of accounting. Such expenditures are recognized following the cost principles contained in the Uniform Guidance, wherein certain types of expenditures are not allowable or are limited as to reimbursement. De Minimis Rate Used: N Rate Explanation: Indirect costs allocated to awards for the year ended December 31, 2024, were based on a rate negotiated with the Organization’s cognizant federal agency, the Department of Health and Human Services. The Organization does not utilize the 10% de minimis indirect cost rate per CFR 200.414. Expenses reported on the Schedule are reported on the accrual basis of accounting. Such expenditures are recognized following the cost principles contained in the Uniform Guidance, wherein certain types of expenditures are not allowable or are limited as to reimbursement.
Title: Indirect Cost Rate Accounting Policies: Expenses reported on the Schedule are reported on the accrual basis of accounting. Such expenditures are recognized following the cost principles contained in the Uniform Guidance, wherein certain types of expenditures are not allowable or are limited as to reimbursement. De Minimis Rate Used: N Rate Explanation: Indirect costs allocated to awards for the year ended December 31, 2024, were based on a rate negotiated with the Organization’s cognizant federal agency, the Department of Health and Human Services. The Organization does not utilize the 10% de minimis indirect cost rate per CFR 200.414. Indirect costs allocated to awards for the year ended December 31, 2024, were based on a rate negotiated with the Organization’s cognizant federal agency, the Department of Health and Human Services. The Organization does not utilize the 10% de minimis indirect cost rate per CFR 200.414.

Finding Details

Procurement, Suspension and Debarment Federal agency: U.S. Department of Health and Human Services Program: Continuation of the National Evaluations System for Health Technology Coordinating Center Assistance listing number: 93.103 Federal award identification number and year: • 2U01FD006292-06 2024 • 3U01FD006292-06S1 2023 Criteria: 2 CFR 200.318 states non-federal entities must have and use documented procurement procedures that conform to 2 CFR 200.317 through 200.327. 2 CFR 200.214 states non-Federal entities are subject to the non-procurement debarment and suspension regulations implementing Executive Order 12549 and 12689, 2 CFR Part 180. The regulations in 2 CFR part 180 restrict awards, subawards, and contracts with certain parties that are debarred, suspended, or otherwise excluded from or ineligible for participation in Federal assistance programs or activities. 2 CFR 200 requires adequate documentation of compliance with 2 CFR 200.214. Condition and context: The Organization established policies and procedures over suspension and debarment, including checking all vendors against the government suspension and debarment listing. The policies and procedures for suspension and debarment were being followed however the evidence of the search on sam.gov was not retained. A sample of five vendors with a total contract value of $8,528,526 was selected from a population of twelve. Cause: The Organization’s management did not retain evidence of compliance with the above criteria regarding suspension and debarment due to oversight. Effect: The Organization’s documentation was lacking evidence of tracking vendors for suspension and debarment. Questioned costs: None Repeat finding: No Recommendation: We recommend management updates its policies and procedures to ensure adequate supporting documentation of suspension and debarment verification is maintained. Views of Responsible Officials: Management agrees with the finding. See corrective action plan.
Procurement, Suspension and Debarment Federal agency: U.S. Department of Health and Human Services Program: Continuation of the National Evaluations System for Health Technology Coordinating Center Assistance listing number: 93.103 Federal award identification number and year: • 2U01FD006292-06 2024 • 3U01FD006292-06S1 2023 Criteria: 2 CFR 200.318 states non-federal entities must have and use documented procurement procedures that conform to 2 CFR 200.317 through 200.327. 2 CFR 200.214 states non-Federal entities are subject to the non-procurement debarment and suspension regulations implementing Executive Order 12549 and 12689, 2 CFR Part 180. The regulations in 2 CFR part 180 restrict awards, subawards, and contracts with certain parties that are debarred, suspended, or otherwise excluded from or ineligible for participation in Federal assistance programs or activities. 2 CFR 200 requires adequate documentation of compliance with 2 CFR 200.214. Condition and context: The Organization established policies and procedures over suspension and debarment, including checking all vendors against the government suspension and debarment listing. The policies and procedures for suspension and debarment were being followed however the evidence of the search on sam.gov was not retained. A sample of five vendors with a total contract value of $8,528,526 was selected from a population of twelve. Cause: The Organization’s management did not retain evidence of compliance with the above criteria regarding suspension and debarment due to oversight. Effect: The Organization’s documentation was lacking evidence of tracking vendors for suspension and debarment. Questioned costs: None Repeat finding: No Recommendation: We recommend management updates its policies and procedures to ensure adequate supporting documentation of suspension and debarment verification is maintained. Views of Responsible Officials: Management agrees with the finding. See corrective action plan.
Procurement, Suspension and Debarment Federal agency: U.S. Department of Health and Human Services Program: Continuation of the National Evaluations System for Health Technology Coordinating Center Assistance listing number: 93.103 Federal award identification number and year: • 2U01FD006292-06 2024 • 3U01FD006292-06S1 2023 Criteria: 2 CFR 200.318 states non-federal entities must have and use documented procurement procedures that conform to 2 CFR 200.317 through 200.327. 2 CFR 200.214 states non-Federal entities are subject to the non-procurement debarment and suspension regulations implementing Executive Order 12549 and 12689, 2 CFR Part 180. The regulations in 2 CFR part 180 restrict awards, subawards, and contracts with certain parties that are debarred, suspended, or otherwise excluded from or ineligible for participation in Federal assistance programs or activities. 2 CFR 200 requires adequate documentation of compliance with 2 CFR 200.214. Condition and context: The Organization established policies and procedures over suspension and debarment, including checking all vendors against the government suspension and debarment listing. The policies and procedures for suspension and debarment were being followed however the evidence of the search on sam.gov was not retained. A sample of five vendors with a total contract value of $8,528,526 was selected from a population of twelve. Cause: The Organization’s management did not retain evidence of compliance with the above criteria regarding suspension and debarment due to oversight. Effect: The Organization’s documentation was lacking evidence of tracking vendors for suspension and debarment. Questioned costs: None Repeat finding: No Recommendation: We recommend management updates its policies and procedures to ensure adequate supporting documentation of suspension and debarment verification is maintained. Views of Responsible Officials: Management agrees with the finding. See corrective action plan.
Procurement, Suspension and Debarment Federal agency: U.S. Department of Health and Human Services Program: Continuation of the National Evaluations System for Health Technology Coordinating Center Assistance listing number: 93.103 Federal award identification number and year: • 2U01FD006292-06 2024 • 3U01FD006292-06S1 2023 Criteria: 2 CFR 200.318 states non-federal entities must have and use documented procurement procedures that conform to 2 CFR 200.317 through 200.327. 2 CFR 200.214 states non-Federal entities are subject to the non-procurement debarment and suspension regulations implementing Executive Order 12549 and 12689, 2 CFR Part 180. The regulations in 2 CFR part 180 restrict awards, subawards, and contracts with certain parties that are debarred, suspended, or otherwise excluded from or ineligible for participation in Federal assistance programs or activities. 2 CFR 200 requires adequate documentation of compliance with 2 CFR 200.214. Condition and context: The Organization established policies and procedures over suspension and debarment, including checking all vendors against the government suspension and debarment listing. The policies and procedures for suspension and debarment were being followed however the evidence of the search on sam.gov was not retained. A sample of five vendors with a total contract value of $8,528,526 was selected from a population of twelve. Cause: The Organization’s management did not retain evidence of compliance with the above criteria regarding suspension and debarment due to oversight. Effect: The Organization’s documentation was lacking evidence of tracking vendors for suspension and debarment. Questioned costs: None Repeat finding: No Recommendation: We recommend management updates its policies and procedures to ensure adequate supporting documentation of suspension and debarment verification is maintained. Views of Responsible Officials: Management agrees with the finding. See corrective action plan.