U.S. Department of Health and Human Services 
Office of Inspector General 
HHSs Suspension and 
Debarment Program Helped 
Safeguard Federal Funding, 
But Opportunities for 
Improvement Exist 
Suzanne Murrin 
Deputy Inspector General 
January 2022, OEI-04-19-00570   U.S. Department of Health and Human Services 
Office of Inspector General 
Report in Brief 
January 2022, OEI-04-19-00570 
Key Terms  HHSs suspension and debarment program 
Awarding agencies award 
helped safeguard Federal funding, but 
Department of Health and Human 
Services (HHS) fundse.g., grants and  opportunities for improvement exist 
contracts. 
Non-awarding entities within HHS do  
What OIG Found 
not fund awards, but often have  Key Takeaway 
Between fiscal years (FYs) 2015 and 2019, 
oversight responsibilities.  These 
Most suspension and  86 percent of referrals that HHS entities 
entities include the Office of Inspector 
debarment referrals resulted in  made to ORIC resulted in suspension, 
General (OIG), the Office of Recipient 
actions to protect Federal  debarment, or other administrative action 
Integrity Coordination, the Office of 
to protect Federal programs  and funds.  
Research Integrity, and the Office of  programs and funds, but HHS 
Nearly one-third of  debarments involving 
General Counsel.  also has opportunities  to 
grants had preceding suspensions.   ORIC 
Suspensions  are preliminary,  improve the timeliness, 
does not have complete guidance about 
immediate actions that exclude  efficiency, and effectiveness of 
the circumstances in which immediate 
persons from receiving new funds.  its suspension and debarment 
action (i.e., suspension) may be 
Debarments  are final determinations   program.  
appropriate while it awaits a debarment 
that exclude persons from receiving   
from the SDO.  Most of the referrals for 
new funds for a specified time. 
suspension or debarment came from HHS 
Referrals for suspension or debarment 
non-awarding entities; many HHS awarding agencies made no referrals during  
are made by  awarding agencies and 
the 5-year period we reviewed.  Suspension  and debarment actions often missed 
non-awarding entities if they suspect 
ORICs internal timeliness goals.  Delays resulted in part from ongoing criminal or 
awardee misconduct. 
appeals proceedings and challenges in obtaining necessary information about  
The Office of  Recipient Integrity 
the person referred for suspension or debarment.  Other factors that affected the 
Coordination (ORIC) receives referrals 
timeliness, efficiency, and effectiveness of this program were (1) vacancies and 
and manages the HHS suspension and 
turnover at both the staff and senior leadership levels; (2) a limited system for 
debarment program.  ORIC is part of 
case management and tracking of referrals; and (3) incomplete guidance 
HHSs Office of the Assistant Secretary 
regarding the use and documentation of corrective actions for what are known as 
for Financial Resources.  
fact-based referrals (as distinguished from conviction-based referrals).   
The suspension and debarment 
official (SDO)part of ASFR
What OIG Recommends and How the Agency Responded 
determines if any suspension  or 
To improve the timeliness, efficiency, and effectiveness of HHSs suspension and 
debarment action should be 
debarment program, we recommend that HHSs Office of the Assistant Secretary 
implemented.  
for Financial Resources (1) take steps to ensure that the program has more 
consistent senior leadership  and sufficient staffing; (2) improve the case  
Why OIG Did This Review 
management  and tracking of referrals; (3) develop and disseminate guidance 
As HHS is the largest Federal grant-
regarding how to prepare and submit complete referrals; and (4) conduct 
making agency ($531 billion in 2019) 
outreach and provide additional training to HHS awarding agencies that make  
and  the fourth-largest Federal 
few or  no referrals.  ASFR concurred with  all four of our recommendations.  
contracting agency ($39 billion in 
2019), it is important for it to have a 
How OIG Did This Review 
robust suspension and debarment 
We analyzed  multiple data sources to describe the outcomes, sources, and 
program.  If bad actors or poor 
timeliness of suspension and debarment referrals during our review period, 
performers are not prevented from 
FYs 2015 through 2019.  We also identified factors that  may  have affected the 
receiving additional Federal awards in  
timeliness, efficiency, and effectiveness of  HHSs suspension  and debarment 
a timely  manner, beneficiaries of public 
program.  For example, we reviewed referral data and surveyed awarding 
health and human services  programs 
agencies and  non-awarding entities.  We  also  interviewed ORIC and the SDO.  
may suffer and taxpayer funds may be 
misused.     
TABLE OF CONTENTS 
 
 
BACKGROUND ................................................................................................................................................ 3  
FINDINGS....................................................................................................................................................... 13  
From FY 2015 through 2019, 86 percent of suspension and debarment referrals resulted in actions to 
protect Federal Programs and funds ............................................................................................................................... 13  
HHS non-awarding entities were the sources of most referrals for suspension and debarment, while 
many HHS awarding agencies made no referrals .......................................................................................................15  
Suspension and debarment actions often missed ORICs internal timeliness goals ..................................... 17  
Delays resulted in part from ongoing criminal or appeals proceedings and challenges in obtaining 
necessary respondent information ...................................................................................................................................18  
Opportunities exist to improve the timeliness, efficiency, and effectiveness of HHSs suspension and 
debarment program .............................................................................................................................................................. 19  
CONCLUSION AND RECOMMENDATIONS.......................................................................................... 23  
Take steps to ensure that HHSs suspension and debarment program has more consistent senior 
leadership and sufficient staffing ...................................................................................................................................... 23  
Improve the case management and tracking of referrals .......................................................................................24  
Develop and disseminate guidance regarding how to prepare and submit complete referrals .............. 24  
Conduct outreach and provide additional training about the suspension and debarment program to 
HHS awarding agencies that make few or no referrals ............................................................................................ 25  
AGENCY COMMENTS AND OIG RESPONSE ........................................................................................ 26  
APPENDICES .................................................................................................................................................. 27  
Appendix A: Detailed procedures for suspensions and debarments .................................................................. 27  
Appendix B: Additional information on referrals received during our review period ................................... 29  
Appendix C: Annual funding amounts (in billions) for grants and contracts, by awarding agency ........ 30  
Appendix D:  Agency Comments ...................................................................................................................................... 31  
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 33  
Acknowledgments ..................................................................................................................................................................33  
Contact ........................................................................................................................................................................................ 33  
ABOUT THE OFFICE OF INSPECTOR GENERAL. ................................................................................... 34  
ENDNOTES................................................................................................................................................... 35  
   
BACKGROUND  
OBJECTIVES 
1.   To describe the outcomes, sources, and timeliness of referrals within the 
Department of Health and Human Services (HHS) for suspension and 
debarment.  
2.   To identify factors that may affect the timeliness, efficiency, or effectiveness 
of HHSs program for suspension and debarment. 
 
As HHS is the largest grant-making agency in the Federal Government ($531 billion in 
fiscal year (FY) 2019) and the fourth-largest contracting Federal agency ($39 billion in 
FY 2019), it is important for HHS to have a robust suspension and debarment 
program.1,2  If bad actors or poor performers are not prevented from receiving 
additional Federal awards in a timely manner, beneficiaries of public health and 
human services programs may suffer and taxpayer funds may be misused.   
OIG has not previously evaluated HHSs suspension and debarment program to 
assess timeliness, efficiency, or effectiveness.  A 2014 Government Accountability 
Office (GAO) report found that HHS had taken steps to implement components of an 
effective suspension and debarment program, such as having dedicated staffing; a 
system for case management and tracking; and training.    
Now is an opportune time for HHS to consider how well its suspension and 
debarment program is working and identify opportunities for improvement.  In 
January 2021, the Office of Management and Budget designated HHS as the Quality 
Service Management Office for grants across the Federal government.  The Quality 
Service Management Office works across all Federal awarding agencies to modernize, 
automate, and standardize the processes and systems for grants management.  
Therefore, this evaluation is well-positioned to provide information for awarding 
agencies in HHS as well as across the Federal Government to use as agencies 
continue to improve their oversight of awards funding.   
Suspensions and debarments protect the integrity of Federal 
programs  
Suspension and debarment programs help protect the integrity of Federal grants, 
contracts, and other covered transactions by ensuring that the Federal government 
does business only with responsible persons.3, 4, 5, 6  (Regulations define a person as 
any individual, corporation, partnership, association, unit of government, or legal 
entity.)  Suspensions and debarments are one of many optional and discretionary 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 3     
administrative actions7 that Federal departments may take against a person that is not 
presently responsiblei.e., a person that demonstrates a lack of honesty, a lack of 
integrity, or an unacceptable level of performance.  Suspension and debarment 
actions are based on a persons present responsibility to handle Federal funds.  
Generally, suspension or debarment action is initiated when an awarding agency or 
other entity (e.g., Office of Inspector General, or OIG) submits a referral to a Federal 
departments program for suspension and debarment.  Within HHS, the Office of 
Recipient Integrity Coordination (ORIC) receives referrals for suspension and 
debarment.  
Suspensions and debarments are not mutually exclusive; a Federal department may 
pursue a suspension (a preliminary decision) while also pursuing a debarment (a final 
determination).  When a Federal department decides to pursue a suspension or 
debarment against a person, that person is known as a respondent.  Typically, the 
end goal is to debar a respondent.  However, if a Federal department cannot initially 
meet the higher evidentiary standard required for debarment, or if it concludes that 
immediate action is necessary to protect the Federal government, it may first pursue a 
suspension.  Below, Exhibit 1 provides an overview of suspensions and debarments, 
including the definitions, timeframes, and levels of evidence needed for each.8  
Exhibit 1: Overview of suspensions and debarments 
  Suspensions  Debarments  
Definition  
Preliminary decision that a  Final determination that a 
respondent is not presently  respondent is not presently 
responsible and is  responsible and is unable to 
temporarily ineligible to  obtain new awards for a  
obtain new awards, pending  specific period 
the completion of legal 
proceedings  
General 
Typically does not exceed  Typically does not exceed 
Timeframe  
12 months  3 years  
Evidence   (1) Must have adequate 
Must conclude, based on a
evidence that there 
higher evidentiary standard 
may be cause for 
(i.e., preponderance of the 
debarment  
evidence), that the 
(2) Must conclude that 
respondent has engaged in
immediate action is 
conduct that warrants 
necessary to protect 
debarment  
the Federal 
governments interest 
Source: Adapted from Federal Law Enforcement Training Center, National Suspension and Debarment Training 
Program Student Handbook FY 2014.  Federal Acquisition Regulation  and Nonprocurement Common Rule. 
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OEI-04-19-00570  Background | 4     
 
Suspensions and debarments are prospective (forward-looking) only, meaning that 
the respondent can continue current awards but cannot obtain new ones for a fixed 
term.  In addition, suspensions and debarments have a government-wide reciprocal 
effect, meaning that respondents who are suspended or debarred by one Federal 
department are generally ineligible for awards from other Federal departments.9  In 
this way, a Federal department that suspends or debars a respondent is helping to 
protect not just its own program integrity, but also those of other Federal 
departments that might fund that same respondent.  
Conviction-based and fact-based debarments  
In addition, there are two types of debarments: conviction-based and fact-based.  
Conviction-based debarments can be initiated based on a criminal conviction or civil 
judgment.  Once the conviction or civil judgment occurs, the conviction-based 
debarment may occur relatively quickly because the evidentiary threshold has likely 
already been established by the conviction or judgment.  In contrast, fact-based 
debarments generally take longer than conviction-based debarments because they 
rely on a development of facts (e.g., search warrants, audit findings, or failures to 
disclose) to support the debarment rather than a judicial conviction or judgment.  
Causes for suspension and debarment 
The Federal Acquisition Regulations and the Nonprocurement Common Rule specify 
several potential causes for suspension and debarment.  These include fraud, theft, 
forgery, tax evasion, serious violations of a government contract (e.g., willful failure to 
perform or a history of unsatisfactory performance), or any other cause of a serious 
or compelling nature that impacts the respondents integrity.10  Additionally, 
regulations note that Federal departments should exclude persons that are not 
presently responsible, but the regulations do not define this term.11   
Federal departments have discretion on when to pursue suspensions or debarments.  
That is, the existence of one of the causes for suspension or debarment (e.g., 
a conviction for theft) does not require Federal departments to suspend or debar the 
person.  Instead, Federal departments are directed to consider (a) the seriousness of 
the act or any aggravating factors and (b) any mitigating factors or actions the 
respondent has taken to address potential causes for suspension or debarment.  To 
that end, Federal departments are responsible for establishing procedures for 
reporting, investigating, and referring potential suspension and debarment cases to 
their respective Suspension and Debarment Officials.   
 
 
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OEI-04-19-00570  Background | 5     
Major actors involved in HHSs suspension and debarment 
program  
Each Federal departments suspension and debarment program involves different 
actors responsible for protecting Federal funds against bad actors and poor 
performers.  HHSs suspension and debarment program involves several key actors: 
the HHS Operating Divisions (OpDivs) and Staffing Divisions (StaffDivs) that fund and 
oversee awards; ORIC (under the Assistant Secretary for Financial Resources (ASFR); 
and the HHS Suspension and Debarment Official (also under ASFR).  These actors are 
responsible for protecting the integrity of both grant and contract dollars.  
Awarding agencies (HHS OpDivs and StaffDivs that fund and oversee awards).  
HHS OpDivs and StaffDivs, such as the National Institutes of Health (NIH) and the 
Health Resources and Services Administration (HRSA), are responsible for monitoring 
the awards that they fund.  Generally, when OpDivs and StaffDivs suspect misconduct 
and decide to pursue suspension and debarment, they refer the respondent for 
suspension and/or debarment.  (The OpDiv  or StaffDiv making the referral is 
thereafter referred to as a referring entity.)   
Non-awarding entities (i.e., entities that do not fund persons referred for 
suspension and/or debarment).  Non-awarding entities may also serve as referring 
entities.  These entities often have oversight responsibilities within HHS and include 
OIG, ORIC, the Office of Research Integrity, and the Office of General Counsel (OGC).  
See Exhibit 2 for how these non-awarding entities involvement may lead to 
suspension or debarment referrals.   
Exhibit 2: HHS non-awarding entities involved in suspension and debarment 
OIG  OIG initiates investigations or audits of fraud, waste, and abuse 
that may generate suspension or debarment referrals as a result 
of hotline complaints; OIGs audit or evaluation work; or 
referrals of suspected misconduct from awarding agencies. 
ORIC  ORIC, which is a part of ASFR, manages HHSs suspension and 
debarment program.  (ASFR  provides advice and guidance to 
the Secretary on all aspects of budget, financial management, 
grants, and acquisition management.)  ORIC conducts 
environmental scanning to identify misconduct that could serve 
as the basis of a suspension or debarment referral.  In this way, 
ORIC is also  a referring entity. 
Office of Research  The Office of Research Integritypart of the Office of the 
Integrity   Assistant Secretary for Health (OASH)reviews and monitors 
research misconduct investigations conducted by applicant and 
awardee institutions and intramural research programs.  The 
Office of Research Integrity may submit suspension and/or 
debarment referrals to address research misconduct and 
protect Federal programs and funds. 
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OEI-04-19-00570  Background | 6     
OGC  OGC provides representation and legal advice on a wide range 
of issues for HHS.  In doing so, OGC may refer a person for 
suspension and/or debarment. 
 
Referring entities use their discretion on whether or when to pursue suspensions or 
debarments versus other administrative remedies.  Some referring entities have their 
own corrective-action escalation processes that involve imposing other administrative 
actions before pursuing suspension or debarment, depending on the gravity of the 
offense.  Because suspensions and debarments are among the tools in the program 
integrity toolbox, referring entities may decide to pursue other, less severe corrective 
actions that enable them to continue working with the person while they correct the 
behavior through various components of the agreement (e.g., ethics training).  For 
example, both the Administration for Children and Families (ACF) and OASH reported 
that they pursue suspension and debarment only when all other remedies or 
corrective actions have been exhausted and those actions have not corrected the 
misconduct.  In addition to or instead of these corrective-action escalation processes, 
some referring entities may also consult with OGC when deciding whether and when 
to pursue suspension or debarment.  
When submitting a referral, the referring entity should include all relevant information 
in the referral and recommend the appropriate action (e.g., suspension, debarment, 
other administrative action).   
ORIC.  When ORIC receives the referral, it reviews the included information to 
determine whether it is accurate and complete.  ORIC follows up with the referring 
entity for clarifications and additional documentation, as needed.  Then, ORIC 
develops an action referral memorandum for the Suspension and Debarment Official 
(SDO).  ORIC handles all formal correspondence with the respondent and serves as 
the point of contact for entities making referrals for suspension or debarment.  ORIC 
is also responsible for reporting its actions annually to the Interagency Suspension 
and Debarment Committee.  This committee collects information from suspension 
and debarment programs across the Federal government and reports its findings to 
Congress annually. 
SDO.   Within HHS, the SDO is not a part of ORIC.  Instead, the HHS SDO is the Deputy 
Assistant Secretary for the Office of Acquisitions within ASFR.  As such, the HHSs SDO 
has responsibilities other than suspension and debarment.  The SDO is the deciding 
official for any suspension or debarment action.  Specifically, the SDO must sign any 
notices of action and final decisions.  Once ORIC compiles the action referral 
memorandum, the SDO decides whether to suspend or debar a respondent and ORIC 
then implements any such action.  The SDO must provide a written decision to either 
take or decline action against a respondent.  See Exhibit 3 for an organization chart of 
major actors in HHSs suspension and debarment program.   
 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 7    Exhibit 3: Organization of major actors in HHSs suspension and debarment 
program  
Source: OIG analysis  of HHS suspension and debarment program, July 2021.  
HHSs suspension and debarment process 
When ORIC receives a referral from a referring entity, it will gather evidence and 
present it to the SDO.  The SDO then reviews the evidence and decides what, if any, 
action to take.  If the SDO decides to take action, ORIC will then implement the action.  
As such, ORIC sends a notice of action to the respondent and enters the action into 
the General Services Administrations  (GSAs) System for Award Management, a 
governmentwide database containing information on all individuals or organizations 
debarred, suspended, declared ineligible, or excluded from Federal awards.  Exhibit 4 
provides an overview of how ORIC and the SDO work together during the suspension 
and debarment process.  Appendix A contains more detailed information on 
suspension and debarment procedures. 
 
 
 
 
 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 8   Exhibit 4: Overview of Suspension and Debarment Process Within HHS 
 
Source: OIG analysis  of ORICs May 2014 Discretionary Suspension and Debarment Program Guidance. 
Although suspensions and debarments follow similar processes, there are differences.   
Respondents have fewer due-process rights for suspensions than for debarments.  
Suspensions go into effect immediately, without giving respondents an opportunity 
to contest them, whereas respondents have the opportunity to contest proposed 
debarments before they take effect.12    
To ensure that respondents rights are limited only in appropriate cases, a suspension 
is meant to be used only in cases where the SDO has cause to believe that immediate 
action is necessary to protect Federal interests.  The SDO has broad discretion to 
determine which cases warrant suspension.  For example, the SDO may determine 
that suspensions are appropriate, as outlined in the regulations, based on the nature 
of the misconduct, potential business relationships, or involvement with a program of 
the Federal government (e.g., knowledge that the respondent has recently applied for 
another Federal award).13  The referring entity may request a suspension, or the SDO, 
in consultation with ORIC, may also determine that a suspension is warranted without 
a specific request from the referring entity.  
The debarment process varies depending on the type of award (i.e., grants vs. 
contracts).  Specifically, notices of proposed debarments made under the Federal 
Acquisition Regulation (i.e., involving contracts) have the same impact on the 
respondent as a suspension.14  That is, once the SDO signs the notice of proposed 
debarment, those respondents become temporarily ineligible to receive additional 
government funding.  Conversely, notices of proposed debarments made under the 
Nonprocurement Common Rule (i.e., involving grants) have no impact on the 
respondents ability to obtain new awards.  That is, those respondents do not become 
temporarily ineligible to receive additional government funding unless there was a 
preceding suspension or until the SDOs final determination to implement the 
debarment.   
A referral for suspension or debarment may result in a variety of outcomes.  Referrals 
that do not result in suspension or debarment may be terminated by the SDO or 
result in another administrative action.  The SDO may terminate a referral because of 
a lack of evidence, because of a lack of timeliness in ORICs processing of the referral, 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 9   or because the respondent has remedied the misconduct to the Departments 
satisfaction.  The SDO may pursue other administrative actions when it is in the best 
interest of HHS not to suspend or debar the respondent.  For example, when a 
respondent is the only person that can provide a certain good or service in a specific 
geographic area, an administrative agreement allows HHS to more closely monitor 
the respondent while beneficiaries can still access the respondents goods or services.  
Additionally, if the respondent presents evidence that raises a genuine dispute over 
facts relevant to the suspension or debarment, the SDO must conduct additional 
proceedings to resolve those facts.  Exhibit 5 shows the possible outcomes of a 
referral within HHS.  
Exhibit 5:  Suspension and Debarment Referral Outcomes Within HHS  
 
Source: OIG analysis  of the Federal Acquisition Regulation and Nonprocurement Common Rule, July 2021.  
Timeliness of suspension and debarment actions 
ORIC has developed internal timeliness goals for certain actions to protect the 
integrity of HHS awards.  Specifically, ORIC stated that suspensions should take no 
longer than 60 days to implement from receipt of the referral.  Further, ORIC stated 
that conviction-based debarments should take no longer than 100 days to implement 
from receipt of the referral.  While regulations do not specify how long suspensions or 
conviction-based debarments should take to implement, these actions should be as 
timely as possible so as to prevent bad actors and poor performers from receiving 
additional Federal funds. 
 
 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 10    
Components of effective suspension and debarment programs  
GAO and the Interagency Suspension and Debarment Committee (ISDC) have 
identified factors that contribute to the effectiveness of suspension and debarment 
programs.15  These bodies note that the numbers of suspensions and debarments are 
not always indicative of an effective program.16  Instead, GAO and the ISDC have 
focused on the following factors in assessing program effectiveness:  
   Dedicated staffing.  Active suspension and debarment programs have a dedicated 
suspension and debarment program with full-time staff and commitment from 
the agencys senior officials.  Additionally, strong suspension and debarment 
programs need to have one SDO and a focused program.  If a program has an 
SDO with many other responsibilities, suspension and debarment may become a 
lower priority.  Further, suspension and debarment programs need to have buy-in 
from the top to show that suspension and debarment is a priority.   
   Case management and tracking.  An effective program has a case management 
process and uses a referral tracking system.  The review process should be open 
and streamlined to optimize program resources.  Further, Federal departments 
may use a system or database to track where referrals are in the review process 
and ensure that any necessary followup is completed.17  Additionally, as a 
program processes a referral, an effective programs staff should be responsive to 
referring entities and other investigative/legal stakeholders.  Staff could also 
proactively communicate status updates during the referral review process and 
facilitate regular meetings among key stakeholders.18    
   Guidance and training.   An effective program trains its staff to follow consistent 
practices and develops detailed written guidance, policies, and procedures to 
share with referring entities.  It also provides formal training to key stakeholders 
on how to identify and refer respondents for potential suspension or 
debarment.19   
Methodology 
We analyzed multiple data sources to describe the outcomes, sources, and timeliness 
of referrals and to identify factors that may affect the timeliness, efficiency, and 
effectiveness of HHSs suspension and debarment program during our period of 
review, FYs 2015 through 2019 (i.e., October 1, 2014, through September 30, 2019).  
To describe the outcomes, sources, and timeliness of referrals, we used 
(1) information from ORICs system for case management and tracking; (2) referral 
documentation from ORICs SharePoint site; and (3) publicly available electronic data 
from GSAs System for Award Management.  
To identify factors that may affect the timeliness, efficiency, and effectiveness of the 
program, we (1) reviewed ORICs suspension and debarment data; (2) interviewed 
ORIC staff; and (3) surveyed all of the 26 HHS OpDivs and StaffDivs that funded 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 11     
awards (i.e., grants or contracts) during our review period.20   We used previous work 
(e.g., GAO and ISDC reports) to help inform interview and survey questions.  We 
reviewed selected case files to determine reasons for delays in implementing 
suspensions and debarments. 
As we proceeded with data collection and analysis, we followed up with ORIC and/or 
survey respondents to request additional information and documentation, as needed.    
Limitations  
In some instances, data from ORICs system for case management and tracking were 
missing.  In these instances, we attempted to complete or clarify such information 
using GSAs System for Award Management or additional records from ORIC.  For 
example, in some instances, it was not clear when ORIC received the referral.  In those 
cases, we used the date the referral first appeared in ORICs system for case 
management and tracking as the referral date.  As a result, our timeliness analysis may 
underestimate the length of time it took to implement certain actions.  Additionally, 
ORICs system for case management and tracking crashed in 2016 and subsequently 
experienced some data loss, which we were unable to quantify.  In select cases, our 
numbers may not coincide with ISDC reports from the same period because ORIC was 
not able to recover all of the data and files that the ISDC used to create its reports, 
and therefore was not able to provide us with all of those data and files.  
For data that were not missing in the tracking system, we relied on what was captured 
in ORICs tracking system and did not independently verify such data.   
Standards 
We conducted this study in accordance with the Quality Standards for Inspection and  
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency.   
 
 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Background | 12     
FINDINGS 
From FY 2015 through 2019, 86 percent of suspension and 
debarment referrals resulted in actions to protect Federal 
Programs and funds 
Of the 221 referrals that ORIC received during our period of review, 86 percent 
(191 referrals) resulted in action to protect Federal programs and funds (i.e., 
suspension, debarment, or other administrative action).21  The remaining referrals 
were either terminated or were pending action (i.e., pending suspension, pending 
debarment, or pending another type of administrative action) as of September 30, 
2019.  Exhibit 6 shows the types of actions for referrals during our review period.  See 
Appendix B for additional information about the referrals that ORIC received from 
FY 2015 through FY 2019.    
Exhibit 6:  86 percent of referrals that ORIC received resulted in action to 
protect Federal programs and funds. 
 
Source: OIG analysis  of ORIC files from FY 2015 to FY 2019. 
Two referrals initially resulted in a proposal for debarment involving contracts; such a 
proposal has the same effect as a suspension.  However, these two referrals were later 
terminatedfor one referral, because the respondent provided credible information 
that disputed material facts, and for the other referral, because the respondent died. 
A small portion of referrals (11 referrals) were terminated without any preceding 
suspension or debarment action.  These referrals were terminated because the legal 
case serving as the cause for debarment was dismissed (three referrals), the 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Findings | 13     
respondents provided credible information that  disputed material facts (two referrals), 
the Office of Small and Disadvantaged Business Utilization advised against taking 
action (two referrals), the SDO determined that grant funds were not harmed by the 
respondents actions (one referral), OGC  advised that the facts did not meet the 
necessary evidentiary threshold (one referral), or the respondent died (one referral). 
Finally, 19 referrals were pending action as of September 30, 2019.  ORIC received 
these referrals but was still processing them by the end of FY 2019, when our review 
period ended.  Of these pending referrals, 13 had been received in 2019, 2 had been 
received in 2018, and 4 had been received in 2017.   
Of the 130 debarments involving grants, nearly one-third had 
preceding suspensions, but ORIC does not have complete 
guidance about the circumstances in which immediate actions 
may be appropriate  
Of the 134 debarments that ORIC implemented during our review period, almost all 
(130) involved grants and nearly one-third (39) had a preceding suspension.  In the 
cases with a preceding suspension, the SDO determined that immediate action was 
necessary to protect Federal interests.  These suspensions prevented the respondents 
from obtaining new Federal awards while ORIC processed the debarment.  
Debarments with a preceding suspension took a median of 811 days for ORIC to 
implement, with an average of 761 days and a range of 168 to 973 days. 
The remaining two-thirds of the debarments involving grants (91 debarments) did not 
have a preceding suspension.  As a result, respondents in these cases remained 
eligible to receive new Federal funding until the debarment was implemented, unless 
the awarding agency chose not to award new Federal funds to the respondent for 
other reasons.  For example, awarding agencies may choose not to give new awards 
to applicants with certain criminal convictions or civil actions.22  From the time ORIC  
received the referral to the implementation of the debarment, these 91 debarments 
took a median of 182 days for ORIC to implement, with an average of 249 days and a 
range of 20 to 1251 days.23  Of these 91 debarments, almost all (83 debarments) were 
conviction-based.24    
For cases involving contracts, proposed debarments have the same effect as a 
suspension, once the respondent receives the notice of proposed debarment.  During 
our review period, ORIC implemented four debarments involving contracts.  From the 
time ORIC received the referral to the time it sent the notice of proposed debarment, 
these referrals took a median of 199 days for ORIC to implement, with an average of 
222 days and a range of 12 to 477 days.25    
ORIC does not have guidance that includes all of the circumstances outlined in 
regulations in which the SDO may determine that suspensions are appropriate (e.g., 
the nature of the misconduct or potential business relationships), and the SDO made 
different decisions about whether to suspend respondents in circumstances that 
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OEI-04-19-00570  Findings | 14     
appeared similar.26  ORIC reported that suspensions are most often based on 
indictments but also stated that each decision to suspend a respondent should be 
grounded upon the unique facts of a matter.  ORIC stated that when the SDO is 
determining whether to suspend a respondent, the SDO may also work with OGC or 
request additional information from the referring entity. 
HHS non-awarding entities were the sources of most referrals 
for suspension and debarment, while many HHS awarding 
agencies made no referrals  
Non-awarding entities at four HHS offices (i.e., OIG, ORIC, the Office of Research 
Integrity, and OGC) were the sources of 84 percent of all referrals to ORIC from 
FY 2015 through FY 2019.  Only four awarding agenciesNIH, HRSA, OASH, and the 
Substance Abuse and Mental Health Services Administration (SAMHSA)also 
submitted referrals during our review period.  No other awarding agency submitted 
suspension or debarment referrals during our review period, despite ORICs hosting 
annual, but optional, training on suspension and debarment.  See Exhibit 7 for the 
percentages of referrals by source from FY 2015 to FY 2019.  See Appendix B for a 
more detailed breakdown of referrals by source and basis (i.e., conviction-based or 
fact-based). 
Exhibit 7: 84 percent of referrals in FYs 20152019 came from non-awarding 
entities. 
 
Source: OIG analysis  of FY 20152019 ORIC data, 2021. 
* ORI is OASHs  Office of Research Integrity. 
** Non-HHS referring entities were the General Services Administration (two referrals), the Department of the Treasury 
(one referral), and the Department of Homeland Security (one referral).  In these cases, the referring entity found that 
the respondent had received HHS  funding  and referred the respondent to  ORIC for  suspension and debarment  
consideration.   
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OEI-04-19-00570  Findings | 15     
Although awarding agencies in HHS are not required to pursue suspension and 
debarment, the proportion of referrals from non-awarding entities raises questions 
about potential missed opportunities among these awarding agencies for additional 
suspension and debarment referrals.  In particular, the fact that so many referrals are 
coming from non-awarding entities rather than from awarding agencies raises 
questions about whether the awarding agencies are doing enough to identify bad 
actors or poor performers.  In addition, those awarding agencies that did not submit 
referrals during our review period were among the HHS awarding agencies with the 
highest dollar values of funds awarded during this same timeframe.  See Exhibit 8 for 
a comparison of HHS awarding agencies with the highest award funding amounts, as 
well as the source and number of their referrals from FYs 2015 through 2019.  See 
Appendix C for detailed funding amounts from all HHS awarding agencies. 
Exhibit 8: Top 10 HHS awarding agencies by total HHS award funding and 
corresponding numbers of referrals by referral source, FYs 20152019 
Awarding Agency  Total HHS Awards  Number of  Number of 
Funded, FY 2015  Referrals From  Referrals from 
Through 2019 (in  Non-Awarding  Awarding  
Billions)  Entities  Agency  
Administration for Children  $271.2  95  0 
and Families (ACF)  
NIH   $147.6   29  20 
Centers for Disease Control  $59.0  8  0 
and Prevention (CDC) 
HRSA   $47.8   18  7 
SAMHSA   $22.0   10  2 
Indian Health Service (IHS)  $16.0   19  0 
Administration for  $10.1  1  0 
Community Living (ACL) 
Centers for Medicare and  $9.2*   1*  0* 
Medicaid Services (CMS)  
Food and Drug  $7.5  4  0 
Administration (FDA) 
Assistant Secretary for  $6.4  1  0 
Administration (ASA) 
TOTAL  $596.8   186   29  
Source: OIG analysis  of FY 20152019 HHS award data, 2021. 
* This  figure does not include grants  awarded through  entitlement programs (i.e., Medicaid  and the Childrens Health 
Insurance Program).  Additionally, referrals are for suspensions and  debarments only and do not include Medicare and 
Medicaid program exclusions, which have similar results (i.e., limiting the ability to conduct business  with the Federal 
government).   From FY 2015 through 2019, approximately 15,700 individuals and/or businesses were excluded from 
conducting business with the  Medicare and Medicaid program.  HHS OIG, List of Excluded Individuals/Entities (LEIE) 
Downloadable Databases 06-2021 Updated LEIE Database, Accessed at  
https://oig.hhs.gov/exclusions/exclusions_list.asp  on July 21, 2021.  
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OEI-04-19-00570  Findings | 16     
Suspension and debarment actions often missed ORICs internal 
timeliness goals     
ORICs implementation of suspensions and debarments often did not meet ORICs 
established internal timeliness goals of 100 days for conviction-based debarments 
and 60 days for suspensions.  Most of the debarments implemented during our 
review period (110 of 134 debarments) were conviction-based (i.e., were based on a 
criminal conviction or civil judgement).  Of these conviction-based debarments, 
82 percent (90 of 110 debarments) took longer than ORICs goal of 100 days from 
receiving the referral to implementing the debarment.  Conviction-based debarments 
during our review period took a median of 205 days to implement, with an average of 
326 days and a range of 20 to 946 days.  See Exhibit 9 for more information about 
how long conviction-based debarments took to implement during our review period.  
Exhibit 9:  Three-fourths of conviction-based debarments implemented 
during our review period did not meet ORICs 100-day goal. 
 
Source: OIG analysis  of FY 20152019 ORIC data, 2021 
Nearly half of the 75 suspensions (34) implemented during our review period did not 
meet ORICs internal goal of 60 days from referral received to suspension 
implemented.27  These 75 suspensions took a median of 46 days for ORIC to 
implement, with an average of 82 days and a range of 0 to 702 days.  See Exhibit 10 
for more information about how long suspensions took to implement during our 
review period. 
 
 
 
 
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OEI-04-19-00570  Findings | 17     
Exhibit 10: Nearly half of suspensions implemented during our review period 
did not meet ORICs 60-day goal. 
 
Source: OIG analysis  of FY 20152019 ORIC data, 2021 
Delays resulted in part from ongoing criminal or appeals 
proceedings and challenges in obtaining necessary respondent 
information 
For referrals that took longer to process, delays often stemmed from ongoing criminal 
or appeals proceedings or difficulty in obtaining information from or about 
respondents.  Some actions were delayed by simultaneous criminal or appeals 
proceedings.  For example: 
   Seizure of Evidence by Criminal Investigations.  Conviction-based suspensions 
and debarments often happen at the same time as criminal investigations.  In 
one instance, a respondents lawyer stated that the respondent could not 
provide evidence to dispute the suspension because investigators had seized 
such documents.  The lawyer therefore requested an extension, which delayed 
the subsequent suspension.  This case resulted in a suspension during our 
review period, but as of September 30, 2019, it had been pending debarment 
for 1141 days.28    
   Research Misconduct Appeals Process.   When the Office of Research Integrity
the HHS office that handles cases of research misconductrefers a case to 
ORIC for suspension or debarment action, the respondent may pursue an 
appeal process to dispute the Office of  Research Integritys findings.  Because 
the research misconduct is the basis of the suspension or debarment referral, 
if an appeal is filed, ORIC cannot move forward until the HHS Departmental 
Appeals Board rules on the basis of the Office of Research Integritys findings.  
For example, the longest fact-based debarment took 1251 daysover 
3 yearsto implement because the respondent requested a hearing with the 
Departmental Appeals Board.  The board took nearly 2 years to provide ORIC 
with a summary judgment.29    
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OEI-04-19-00570  Findings | 18     
   Delayed Criminal Proceedings.  Although indictments often serve as the basis 
for suspensions, the SDO must wait until the respondent is convicted to 
proceed with a conviction-based debarment.  However, the criminal 
proceedings against a respondent can take a long time.  In one instance, a 
respondent was convicted nearly 19 months after being indicted.  This case 
took 809 days from receipt of referral received to implementation of the 
debarment.30    
Additionally, ORIC reported that often it must go back and forth with a respondent 
multiple times to obtain information necessary to implement a suspension or 
debarment.  In these cases, respondents may continue to provide additional 
information to dispute the cases against them.  We found several instances of actions 
that resulted in these types of delay, including: 
   Show-Cause Letters.  In some cases in which ORIC is considering suspension or 
debarment action, it may choose to first send a show-cause letter to the 
respondent.  A show-cause letter gives the respondent an opportunity to 
present evidence as to why HHS should not begin formal suspension or 
debarment proceedings.  One case began with a referral for a fact-based 
debarment.  On receipt of the referral, ORIC first decided to send the 
respondent a show-cause letter to gather more information.  In response to 
the show-cause letter, the respondent continued to provide additional 
information, which significantly lengthened the time it took ORIC to ultimately 
implement the suspension.  This case took 702 days from receipt of referral to 
implementation of the suspension. 
   Difficulty Finding Respondents Address.  ORIC policies require ORIC to send 
every notice of action to the respondent via certified mail with a return-receipt 
request.  In at least one instance, the referral did not contain the respondents 
current address and the notice of action to the respondent was returned to 
ORIC multiple times as not being deliverable.  As a result, ORIC used 
additional resources to locate the appropriate mailing address for the 
respondent, which delayed action.  This case took 133 days from receipt of 
referral to implementation of the debarment. 
Opportunities exist to improve the timeliness, efficiency, and 
effectiveness of HHSs suspension and debarment program 
ORICs timeliness, efficiency, and effectiveness in processing referrals have also been 
affected by several internal factors:  staffing vacancies and turnover; limitations with 
the system for case management and tracking; and incomplete guidance on what 
should be included in a high-quality fact-based referral.  
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OEI-04-19-00570  Findings | 19     
Vacancies and turnoverat both the staff and senior leadership 
levels of the suspension and debarment programcreate 
challenges  
From FY 2015 through 2019, ORIC faced a high rate of staff vacancies and turnover.  
Staff vacancies reduce the number of referrals that ORIC can process and increase the 
time it takes to process each referral.  In addition, high turnover reduces the amount 
of time that ORIC can spend on processing referrals because staff must dedicate 
limited resources to onboarding and training new personnel.   
ORIC faced a high rate of staff vacancies during our review period, limiting its ability 
to process referrals.  Specifically, as of November 2020, only one current employee 
had been with ORIC longer than 1.5 years.  When ORIC is fully staffed, it consists of 
four employees.  However, ORIC reported that it was frequently not fully staffed 
during our review period, and at certain points only had one or two employees.  ORIC 
worked to temporarily fill vacancies by bringing on detailees throughout the 5-year 
period of our review (i.e., it brought on two detailees for 4 and 6 months, 
respectively).   
Additionally, the SDO changed often during our review period.  Specifically, seven 
different people served as HHSs SDO from  FY 2015 through FY 2019, with an average 
tenure of less than 9 months.  Further, HHSs SDO as of November 2020, who began 
serving in this role in August 2019, reported that because of his other job 
responsibilities, he spent less than 10 percent of his time on suspension and 
debarment activities.  The SDO serves as the Senior Procurement Executive for HHS, 
so his other job responsibilities include serving as the contracting authority for all 
HHS OpDivs; handling other Executive Branch and Office of Management and Budget 
interests in acquisitions; and overseeing policy and data systems pertaining to 
contracting.   
Limitations in ORICs system for case management and tracking 
add administrative burden and hinder effective communication  
ORICs current system for case management and tracking is a semistructured Excel 
spreadsheet that does not consistently track all aspects of referral data.  ORIC lacks 
policies and procedures as to which referral data are required to be entered into its 
system, which may contribute to the variation as to which aspects of referral data are 
entered.  Additionally, shortcomings in ORICs system for case management and 
tracking limit the effectiveness and efficiency of communication within ORIC and 
between ORIC and its referring entities.   
Inconsistent data entry.  ORICs current tracking system does not require that all 
referral data be captured or uniformly tracked across referrals.  That is, certain 
characteristics of referrals are clearly defined and consistently entered (e.g., the 
referring entity and the awarding agency), whereas other aspects (e.g., dates of action, 
communication with the respondent) are not clearly defined and/or are entered either 
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OEI-04-19-00570  Findings | 20     
inconsistently or not at all.  Additionally, only one analyst can work in the tracking 
system at a time.  ORIC stated that this makes version control a significant challenge, 
as multiple analysts may try to input their own data in various versions of the Excel 
worksheet that must later be merged manually.  Further, ORIC is required to report to  
the Interagency Suspension and Debarment Committee (ISDC) the number of actions 
it takes; the ISDC then reports those actions annually to Congress.  Therefore, ORIC 
needs to have a system that has well defined fields, contains data that is entered 
consistently among staff, and is accurate, so that it can accurately track the volume, 
progress, and status of its caseloads and ensure that the numbers it reports to the 
ISDC are correct.     
Lack of policies and procedures.  ORIC does not have current policies or 
procedures detailing how staff should enter and track important case information and 
milestones.  Although ORIC reported to us that its standard operating procedures 
provide such instructions, these instructions reference an old tracking system that has 
not been used since 2016.  ORICs standard operating procedures show how to record 
certain kinds of datafor example, multiple respondents from referrals that stem 
from the same instance of misconductinto the previous tracking system, but these 
steps are not applicable for ORICs current tracking system.  Because there are no up-
to-date procedures indicating how multiple respondents associated with the same 
case should be tracked, there is variation across staff as to how they enter this 
information into the tracking system.  That is, it is not immediately clear how many 
respondents are associated with the same case.  This can make it difficult for ORIC to 
determine the number of respondents or the number of actions associated with that 
particular entry, as actions are tracked at the respondent level outside of the tracking 
system (e.g., in ORICs reports to the ISDC).  
Communication challenges.  The current system for case management and 
tracking poses communication challenges that limit efficiency and effectiveness.  For 
example, only ORIC has access to the system, so it must communicate with referring 
entities outside of the system to gather information necessary to process the referral 
and then must manually input relevant information from referring entities into the 
system.  In addition, according to ORIC, it would improve program efficiency and 
effectiveness if ORIC had a system with a central repository that automatically 
captured complete and consistent information and tracked correspondence with 
referring entities.  Although ORIC periodically sends out versions of its tracking 
system to update stakeholders on referral progress, stakeholders cannot update the 
system itself by adding requested documentation.  As a result, the current system for 
case management and tracking does not allow for centralized communication with 
referring entities. 
Because ORIC lacks a centralized information management system to automatically 
communicate with referring entities, it must find other waysoften more 
burdensome onesto communicate with referring entities and obtain necessary 
referral information.  For instance, ORIC reported that when it has to follow up with a 
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OEI-04-19-00570  Findings | 21     
referring entity, it must internally coordinate any referral followup to ensure that 
analysts are informed of any such updates. 
Most referring entities that pursued suspension and debarment during our review 
period reported being satisfied with ORICs communication and assistance after 
sending a referral.  However, most respondents reported needing to follow up with 
ORIC multiple times, most often to (1) request information about the timeline of 
ORICs action and (2) provide additional information at ORICs request.  Although 
ORICs following up with referring entities is an important and necessary part of 
building a strong case, it can lengthen the amount of time it takes to process a 
referral.  In part because of its limited system for case management and tracking, 
ORIC may have limited capacity to address the competing needs of meeting its 
internal timeliness goals while also communicating vital information toand 
receiving vital information fromreferring entities.   
Guidance is needed regarding the use and documentation of 
corrective actions for fact-based referrals   
Although fact-based referrals generally take longer to process because they rely on a 
development of facts, ORIC told us that these referrals can take longer for additional 
reasons.  Specifically, suspension and debarment regulations do not include 
information on which documents should be included in fact-based referrals.  In 
addition, ORIC said thatfor referring entities that have a process for escalating 
corrective actionsa high-quality fact-based referral should include documentation 
that the referring entity followed that process.  This documentation demonstrates that 
the referring entity tried to correct the misconduct before sending the referral and 
helps establish a pattern of behavior that demonstrates that the person is not acting 
in a presently responsible manner.  However, awarding entities do not all follow the 
same corrective-action escalation processes.   
ORIC reported that not all referring entities include documentation in their referrals to 
show that they followed their own corrective-action escalation processes.  As a result,  
ORIC was unable to suspend or debar several respondents.   
When we reviewed ORICs guidance materials for developing a referral for suspension 
and debarment, we did not find language that instructed referring entities to 
documentwhen they submit a referralthat they had followed their respective 
corrective-action escalation process.  While ORICs guidance materials do include a list 
of potential documents for referring entities to consider including in the referral, the 
guidance does not distinguish between what should be included for a conviction-
based referral versus a fact-based referral.   
Materials from an optional training state that referrals for fact-based debarments 
should show documentation and analysis of progressive corrective action(s) as 
appropriate.  These training materials do not provide information on when these 
supporting documents are appropriate.    
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OEI-04-19-00570  Findings | 22    CONCLUSION AND RECOMMENDATIONS 
HHSs suspension and debarment program works to protect Federal programs and 
funds, but HHS has opportunities to improve the timeliness, efficiency, and 
effectiveness of the program.  For example, most referrals from FYs 2015 through 
2019 resulted in suspension, debarment, or other administrative action to safeguard 
Federal funds.  However, most of the referrals came from non-awarding entities, such 
as OIG.  Many HHS awarding agencies did not submit any referrals during our 5-year 
review period, even though ORIC hosted annual training on suspension and 
debarment.  This may indicate that these awarding agencies missed opportunities to 
use suspension and debarment as program integrity tools.   
Further, if ORIC does not process referrals in a timely manner, bad actors may remain 
eligible for government funding until the SDO decides to suspend or debar a 
respondent.  During our review period, suspension and debarment actions were often  
not timely.  Factors that contributed to delays were ongoing criminal or appeals 
proceedings and challenges in obtaining necessary respondent information frequently 
contributed to delays.  Internal factors that also affected the timeliness, efficiency, and 
effectiveness of this program were (1) vacancies and turnover at both the staff and 
senior leadership levels; (2) a limited system for case management and tracking; and 
(3) incomplete guidance regarding the use and documentation of corrective actions 
for certain referrals (i.e., for fact-based referrals as opposed to conviction-based 
referrals). 
As the home for HHSs suspension and debarment program and the new Quality 
Service Management Office for grants across the Federal government, ASFR is 
uniquely positioned to address these vulnerabilities to help protect the integrity of 
Federal programs and funds.   
We offer the following recommendations to improve the timeliness, efficiency, and 
effectiveness of HHSs suspension and debarment program. 
We recommend that ASFR:  
Take steps to ensure that HHSs suspension and debarment 
program has more consistent senior leadership and sufficient 
staffing 
As our findings note, seven different people served as HHSs SDO from FY 2015 
through FY 2019, with an average tenure of less than 9 months.  ASFR should take 
steps to promote more stable leadership of this critical function and to ensure that 
the SDO is able to devote sufficient attention toamong the SDOs other 
responsibilitiessuspension and debarment activities.  ORIC  also experienced 
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OEI-04-19-00570   Conclusion and Recommendations | 23    
frequent turnover and staff vacancies.  ASFR should take steps to recruit and maintain 
sufficient staff in ORIC to effectively manage the referrals that ORIC receives and for 
ORIC to implement suspensions and conviction-based debarments within its 
established timeliness goals.   
Improve the case management and tracking of referrals 
ASFR should establish policies and procedures for uniform data entry into structured 
fields.  These procedures should include how to enter data into the tracking system 
and how often analysts should update the progress of cases.  
ASFR should also assess the costs and benefits of adopting a new system for case 
management and tracking to reduce the likelihood of human error, decrease 
the amount of time that analysts spend entering data, and improve the quality of 
tracked data.  A new system for case management and tracking that is more 
centralized and that contains structured, well-defined fields would help ensure that 
data are complete and would allow ORIC to  better track referrals and their progress; 
communicate the status of referrals to referring entities; and ensure efficiency and 
accuracy when conveying performance metrics to the ISDC for annual reports to 
Congress.   
Develop and disseminate guidance regarding how to prepare 
and submit complete referrals  
Additionally, ASFR should work with referring entities to develop more detailed 
guidance on the necessary components of a high-quality fact-based referral.  
Specifically, ASFR should provide more detailed guidance on the circumstances in 
which documentation of following a corrective-action escalation process must be 
included in the referral, and under what circumstances (if any) referring entities should 
deviate from their corrective-action escalation processes to address egregious 
misconduct.  For example, ASFR could distinguish in its guidance what documents to 
include for a conviction-based referral versus a fact-based referral.  In addition, for 
fact-based referrals, the guidance could detail what documentation is helpful in 
demonstrating that the awarding entity has followed its corrective-action escalation 
process, how it has done so, and if it has not done so, why.  The guidance could also 
provide more information on what types of information from referring entities would 
help inform the SDOs decisions about whether immediate action via suspension is 
warranted in a given case (e.g., nature of the misconduct, potential business 
relationships).     
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OEI-04-19-00570   Conclusion and Recommendations | 24    
Conduct outreach and provide additional training about the 
suspension and debarment program to HHS awarding agencies 
that make few or no referrals  
To ensure that HHS awarding agencies are aware of and know the circumstances in 
which suspension and debarment may be best suited to address misconduct, ASFR 
should develop additional training for awarding agencies that make few or no 
referrals.  In doing so, ASFR should consider soliciting awarding agencies input in 
developing this training to ensure that it covers how suspension and debarment fits 
into the agencies specific oversight processes.  Finally, ASFR could require that HHS 
grant and contract staff take this training on a regular basis (e.g., annually). 
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OEI-04-19-00570   Conclusion and Recommendations | 25    
AGENCY COMMENTS AND OIG RESPONSE 
ASFR concurred with all four of our recommendations. 
ASFR concurred with our recommendation to take steps to ensure that HHSs 
suspension and debarment program has more consistent senior leadership and 
sufficient staffing.  ASFR noted that it will initiate a review to address staffing levels in 
HHSs suspension and debarment program. 
ASFR concurred with our recommendation to improve the case management and 
tracking of referrals.  ASFR stated that it has secured funding for a case management 
system and that the estimated deployment date of that system is March 29, 2022. 
ASFR concurred with our recommendation to develop and disseminate guidance 
regarding how to prepare and submit complete referrals.  ASFR stated that it has 
reviewed its suspension and debarment guidance materials and has consolidated 
them into a single document with an updated template regarding how to prepare and 
submit referrals.  ASFR indicated that this guidance document is expected to be 
released in late January 2022.  
Lastly, ASFR concurred with our recommendation to conduct outreach and provide 
additional training about the suspension and debarment program to HHS awarding 
agencies that make few or no referrals.  ASFR stated that it conducts outreach to HHS 
awarding agencies through various channels, including the Executive Committee on 
Grants Administration Policy and Head of Contracting Activity communities.  ASFR 
announces and registers suspension and debarment training through the Federal 
Acquisition Institutes Cornerstone on Demand training system, which is used across 
awarding agencies.  Additionally, ASFR will continue to consider strategies to 
encourage referrals from awarding agencies that make few or no referrals. 
We appreciate ASFRs commitment to address these important issues.  OIG 
encourages ASFR to continue strengthening HHSs suspension and debarment 
program and protect the integrity of Federal funds.  We encourage ASFR to 
consideras part of its efforts to conduct outreach and provide additional training to 
awarding agencies that make few or no referralssoliciting awarding agencies input 
in developing this training and to consider requiring that HHS grant and contract staff 
take suspension and debarment training on a regular basis (e.g., annually).  Doing so 
would help ensure that appropriate HHS staff are aware of suspension and debarment 
as program integrity tools.  
For the full text of ASFRs response, see Appendix D.  
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OEI-04-19-00570   Agency Comments and OIG Response | 26    
APPENDICES 
Appendix A: Detailed procedures for suspensions and 
debarments 
Appendix A-1: Suspensions and debarments under the Federal 
Acquisition Regulation  
Source: OIG analysis  of Federal Acquisition Regulation, 2021.  This flow chart shows a respondent that  is both  
suspended and debarred, which is not always the outcome  of a referral.  A respondent  may be suspended or debarred 
only, or the referral may be terminated earlier in the process.  
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570   Appendix A | 27    Appendix A-2: Suspensions and debarments under the 
Nonprocurement Common Rule 
 
Source: OIG analysis of Nonprocurement Common Rule, 2021.  This  flow chart shows a respondent that  is  both 
suspended and debarred, which is not always the outcome of a referral.  A respondent may  be suspended or  debarred  
only, or the referral may be terminated earlier in the process.  
 
 
 
 
 
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OEI-04-19-00570   Appendix A | 28     
Appendix B: Additional information on referrals received during 
our review period  
Exhibit B-1: Number of referrals for suspension and debarment action submitted to ORIC, 
FYs 20152019, by referring entity 
Referring  Number of referrals  Total number of  Percentage of total 
entity  referrals   referrals  
  2015  2016   2017  2018  2019      
OIG  57  23  14  27  19  140  64% 
ORIC  0  30  3  2  0  35  16% 
NIH  14  5  1  0  0  20  9% 
OASH  4  2  3  3  0  12  5% 
HRSA  0  6  0  0  1  7  3% 
Non-HHS  1  0  3  0  0  4*  2% 
SAMHSA  0  2  0  0  0  2  <1% 
OGC   0  0  1  0  0  1  <1% 
Total   76  68  25  32  20  221  100%  
Source: OIG analysis of FY 20152019 ORIC data, 2021. 
*Two of these referrals came from the General Services Administration, one came from the Department of Treasury, and another came from 
the Department  of Homeland Security.  
 
Exhibit B-2: Number of conviction-based and fact-based referrals for suspension and 
debarment action submitted to ORIC, FYs 20152019, by referring entity 
Referring  Number of conviction-based  Number of fact-based  Total 
entity  referrals   referrals*  referrals  
OIG  116  24  140 
ORIC  32  3  35 
NIH  1  19  20 
OASH  0  12  12 
HRSA  3  4  7 
Non-HHS  1  3  4 
SAMHSA  0  2  2 
OGC  1  0  1 
Total  154  68  221 
Source: OIG analysis of FY 20152019 ORIC data, 2021. 
*The referrals sent by  OASH include those from the Office of Research Integrity that were based on findings of research misconduct.   In this  
table, referrals based  on research misconduct are  included in the column for fact-based referrals.  
 
 
 
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OEI-04-19-00570  Appendix B | 29     
Appendix C: Annual funding amounts (in billions) for grants and 
contracts, by awarding agency 
Awarding  FY 2015   FY 2016   FY 2017   FY 2018   FY 2019   Total Funding  
Agency  FYs 2015-2019 
ACF  $52.6   $51.4  $56.7  $52.2  $58.3   $271.2  
NIH  $28.8   $28.3  $27.3  $29.7  $33.4   $147.6  
CDC1  $11.4   $12.9  $12.0  $11.4  $11.4   $59.0  
HRSA   $9.0   $9.2  $9.4  $9.9   $10.2   $47.8  
SAMHSA   $3.5   $3.7  $3.9  $5.4  $5.5   $22.0  
IHS2  $0.7   $3.3  $3.5  $4.0  $4.5   $16.0  
ACL3  $2.0   $1.9  $1.9  $2.0  $2.2   $10.1  
CMS4   $2.3   $2.5  $1.2  $1.2  $1.9   $9.2  
FDA5  $1.3   $1.2  $1.6  $1.6  $1.7   $7.5  
ASA6  $2.0   $2.0  $0.4  $0.8  $1.3   $6.4  
ASPR7  $0.8   $1.2  $0.2  $0.6  $1.7   $4.5  
OASH  $0.4   $0.4  $0.4  $0.4  $0.4   $2.0  
AHRQ8  $0.4   $0.3  $0.3  $0.3  $0.3   $1.6  
OIG  $0.0   $0.0  $0.0  $0.0  $0.0   $0.1  
ASPE9  $0.0   $0.0  $0.0  $0.0  $0.0   $0.0  
ONC10  $0.0   $0.0  $0.0  $0.0  $0.0   $0.0  
HHS/OS11  $0.0   $0.0  $0.0  $0.0  $0.0   $0.0  
TOTAL12   $115.2  $118.3   $118.8   $119.7  $133.0   $604.9  
Source: OIG analysis  of FY 20152019 data on  contracts and Federal assistance, 2021. 
1 Centers for Disease Control and Prevention 
2 Indian  Health Service  
3 Administration  for Community Living   
4 Centers for Medicare and Medicaid Services.  This figure does not include grants awarded  through entitlement programs (i.e., Medicaid and 
the Childrens Health Insurance  Program).      
5  Food and Drug Administration  
6 Assistant Secretary for Administration   
7 Assistant Secretary for Preparedness and Response  
8  Agency  for Healthcare  Research and Quality   
9 Assistant Secretary for Planning and Evaluation  
10 Office of the National Coordinator for Health  Information Technology  
11 Department of Health and Human Services / Office of the Secretary  
12 Values  in  this row do not sum  to  totals because of  rounding.  
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OEI-04-19-00570  Appendix C | 30     
Appendix D:  Agency Comments   
 
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OEI-04-19-00570  Appendix D | 31    
 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Appendix D | 32     
ACKNOWLEDGMENTS AND CONTACT 
Acknowledgments 
Margaret Naughton served as the team leader for this study.  Others in the Office of 
Evaluation and Inspections who conducted the study include Victoria Coxon and 
Brianna Weldon.  Office of Evaluation and Inspections staff who provided support 
include Kevin Farber, Kevin Manley, and Christine Moritz.    
This report was prepared under the direction of Dwayne Grant, Regional Inspector 
General for Evaluation and Inspections in the Atlanta regional office; Evan Godfrey, 
Deputy Regional Inspector General; and Jaime Stewart, Assistant Regional Inspector 
General.  
Contact 
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found 
on the OIG website at oig.hhs.gov.  
Office of Inspector General 
U.S. Department of Health and Human Services 
330 Independence Avenue, SW 
Washington, DC 20201  
 
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OEI-04-19-00570  Acknowledgments and Contact | 33    
ABOUT THE OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 
95-452, as amended, is to protect the integrity of the Department of Health and 
Human Services (HHS) programs, as well as the health and welfare of beneficiaries 
served by those programs.  This statutory mission is carried out through a nationwide 
network of audits, investigations, and  inspections conducted by the following 
operating components: 
The Office of Audit Services (OAS)  provides auditing services for HHS, 
either by conducting audits with its own audit resources or by overseeing audit work 
done by others.  Audits examine the performance of HHS programs and/or its 
grantees and contractors in carrying out their respective responsibilities and are 
intended to provide independent assessments of HHS programs and operations.  
These audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS.  
The Office of Evaluation and Inspections (OEI)  conducts national 
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable 
information on significant issues.  These evaluations focus on preventing fraud, waste, 
or abuse and promoting economy, efficiency, and effectiveness of departmental 
programs.  To promote impact, OEI reports also present practical recommendations 
for improving program operations. 
The Office of Investigations (OI)  conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, operations, and 
beneficiaries.  With investigators working in all 50 States and the District of Columbia, 
OI utilizes its resources by actively coordinating with the Department of Justice and 
other Federal, State, and local law enforcement authorities.  The investigative efforts 
of OI often lead to criminal convictions, administrative sanctions, and/or civil 
monetary penalties. 
The Office of Counsel to the Inspector General (OCIG) provides 
general legal services to OIG, rendering advice and opinions on HHS programs and 
operations and providing all legal support for OIGs internal operations.  OCIG 
represents OIG in all civil and administrative fraud and abuse cases involving HHS 
programs, including False Claims Act, program exclusion, and civil monetary penalty 
cases.  In connection with these cases, OCIG also negotiates and monitors corporate 
integrity agreements.  OCIG renders advisory opinions, issues compliance program 
guidance, publishes fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities. 
HHSs Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570   About OIG | 34     
ENDNOTES 
 
1 US Department of Health and Human Services Grants.  Accessed at https://www.hhs.gov/grants on April 23, 2021.   
2 In FY 2019 HHS awarded approximately $531 billion in grants and $39 billion in contracts according to HHSs Tracking 
Accountability in Government Grants System (TAGGS), Grants by OPDIV FY2019 report, and USASpending.gov, Object Class, 
Contractual Spending and Supplies, FY2019, respectively.   
3 Other covered transactions include loans or loan guarantees, subawards, subcontracts, insurance, and other assistance 
programs. 
4 The Federal Acquisition Regulation and Nonprocurement Common Rule provide parallel  suspension and debarment 
processes for contracts and nonprocurement  transactions (i.e., grants or other assistance), respectively.  The Federal 
Acquisition Regulation and the Nonprocurement Common Rule note that contractors and nonprocurement transaction 
persons are not presently responsible if they demonstrate a lack of honesty, integrity, and business performance.  48 CFR 
 9.406-2 and 9.407-2.  OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement), 
2 CFR  180.800.  The threshold for what is determined to be not presently responsible for all persons (including contractors) 
is left to the discretion of individual suspension and debarment programs.   
5 Although suspension and debarment actions are often referred to as exclusions, they are separate and distinct program 
integrity tools from health care exclusions enacted under Sections 1128 and 1156 of the Social Security Act. 
6 2 CFR  180.985 defines person as any individual, corporation, partnership, association, unit of government, or legal entity, 
however organized. 
7 Other administrative actions include administrative agreements and voluntary exclusions.  Administrative agreements 
generally allow a person to remain eligible for new awards but enable HHS to more closely monitor the person through 
predetermined stipulations.  Voluntary exclusions occur when a person agrees to be excluded (i.e., ineligible for future 
awards) in lieu of suspension and/or debarment.  Collectively, administrative actions aim to fix and prevent wrongdoing and 
recover award money inappropriately spent.  In contrast, civil or criminal actions may be pursued, in addition to or instead of 
administrative  actions, in more egregious cases of wrongdoing to recover funds or punish those persons.   
8 48 CFR  2.101 and 2 CFR  180.900 define adequate evidence as information sufficient to support the reasonable belief 
that a particular act or omission has occurred.  48 CFR  2.101 and 2 CFR  180.990 define preponderance of the evidence 
as proof by information that, compared that opposing it, leads to the conclusion that the fact at issue is more probably true 
than not.  
9 If a person is suspended or debarred, the person is not entirely prohibited from receiving new awards.  If a Department 
determines that the benefits of funding the person outweigh the risks, the Department can justify awarding new funds to the 
person despite the suspension or debarment and provide an exception or waiver to the person (Federal Acquisition 
Regulations 9.405(a) and 2 CFR  180.135). 
10 48 CFR  9.406-2 and 2 CFR  180.800. 
11 31 CFR  19.110 (b). 
12 Although proposed debarments under the Federal Acquisition Regulations also limit a respondents due process rights 
because they are effective without giving the respondent an opportunity to contest them, proposed debarments involving 
contracts have a higher evidentiary standard (preponderance of the evidence) than suspensions.   
13 2 CFR  180.705(c). 
14 In some cases, the SDO may still elect to impose a suspension on a respondent while processing the proposal for 
debarment.  In these cases, the SDO may identify that immediate action is necessary to protect Federal interests and act to 
 
HHSs  Suspension and Debarment Program  Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Endnotes | 35    
 
suspend the respondent but may not be able to meet the higher evidentiary standard required for the proposal for 
debarment until or unless it gathers more information.   
15 ISDC brings together suspension and debarment program staff across the Federal government to share best practices and 
increase transparency and consistency through training, engagement, and outreach.  Interagency Suspension and Debarment 
Committee.  FY 2018 873 Report.  October 2019.  
16 The ISDC, in particular, notes that the number of suspensions and debarments fluctuate from year to year because they are 
considered and used as necessary to protect the Federal governments business interests.  ISDC.  FY 2018 873 Report.  
October 2019. 
17  GAO.  Some Agency Programs Need Greater Attention, and Governmentwide Oversight Could Be Improved, GAO-11-739, 
August 2011.  GAO noted that Departments with active suspension and debarment programs included components of case 
management and tracking of referrals.  For example, the Department of Homeland Security had detailed policies and 
procedures for tracking cases in its database.  Immigration and Customs Enforcement used a case management system that 
allowed for tracking and followup on all referrals for consideration of suspension and debarment. 
18 GAO.  Agencies Have Taken Steps to Improve Suspension and Debarment Programs, GAO-14-513, May 2014.  GAO noted 
that several agencies have scheduled monthly standing meetings for coordination with relevant stakeholders. 
19 Ibid.  GAO noted that several agencies increased the number of suspension and debarment actions as a result of providing 
additional resources for training. 
20 We collected data on both grants and contracts from each awarding OpDiv and StaffDiv.  In some cases, this resulted in  
one unified survey response for one or more OpDivs or StaffDivs because the respondent reported being responsible for 
overseeing grants and contracts at multiple OpDivs or StaffDivs.  In other cases, this resulted in multiple responses for the 
same OpDiv or StaffDiv because separate offices are involved in overseeing grants and contracts for those OpDivs and 
StaffDivs.  Several smaller OpDivs and StaffDivs that awarded contracts opted to have the Assistant Secretary for 
Administrations Program Support Center complete the survey on their behalf because the Program Support Center handles 
their contracts.  In addition, we separately surveyed components within OIG that are involved in submitting suspension and 
debarment referrals.  OIG components we surveyed were the Office of Investigation, Office of Audit Services, and the Office 
of Counsel to the Inspector General.   
21 Other administrative actions included administrative agreements, show-cause letters, and voluntary exclusions.   
22 Although awarding agencies  are required to check whether an applicant has a history of any criminal or civil proceedings, 
the presence of such action alone does not automatically preclude the applicant from receiving new awards.  Specifically, the 
Federal Awardee Performance and Integrity System (FAPIIS)  is a Federal database that is intended to serve as a 
governmentwide source of information about the prior performance of Federal contractors, grantees, and cooperative 
agreement holders.  For any awardee receiving over $500,000 in grants or contracts, FAPIIS must include information on any 
criminal or civil proceeding, or award termination in the past 5 years.  Federal agencies are required to check FAPIIS prior to 
issuing an award, and they can use the information in deciding whether to fund new awards to applicants.  Further, the HHS 
Grants Policy Administrative Manual states that for new or renewal awards, the applicant must indicate in its application 
whether or not any of its principals have been (a) convicted within the preceding 3 years of any of the offenses listed in 2 CFR 
 180.800(a); (b) had a civil judgment rendered against the organization or the individual for one of those offenses within that 
time period; or (c) is presently indicted for, or otherwise criminally or civilly charged by a governmental entity (Federal, State,  
or local) with commission of any of the offenses listed in 2 CFR  180.800(a).  If the application does not indicate the existence 
of any of the above circumstances and the grants officials check of System for Award Management and other available 
information indicates that any of these circumstances do exist, this may be considered  a false certification and the 
OpDiv/StaffDiv may take action against an applicant on that basis.   
23 The case that took 1251 days was referred to ORIC for research misconduct.  The respondent requested a hearing with the 
HHS Departmental Appeals Board, which took nearly 2 years to provide ORIC with a summary judgment.   
24 Of these 83 debarments, 20 met ORICs 100-day goal.  
25  Of these debarments, two were conviction-based and neither met ORICs 100-day goal..    
 
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OEI-04-19-00570  Endnotes | 36    
 
26  ORICs guidance includes information about what is considered  not sufficient to demonstrate immediate action (i.e., merely 
stating that the respondents misconduct is serious and concluding that there is an immediate need).  The guidance also 
directs referring entities to consider whether the respondent may obtain new awards, which may be a basis for immediate  
action.  However, the guidance does not include other circumstances in which the SDO may determine that suspensions are 
appropriate, as outlined in the regulations.  Specifically, 2 CFR  180.705(c) directs the SDO to consider such things as the 
nature of the circumstances giving rise to a cause for suspension and potential business relationships. 
27 Over half of the 75 suspensions resulted in later debarment.  The suspensions that did not result in a debarment as of 
December 2019 were either terminated (12) or the debarment was still being considered (24).  
28 The suspension was for a grant.  
29 There was not a preceding suspension before the debarment in this case, and the debarment was for a grant.   
30 There was a preceding suspension before the debarment in this case, and the debarment was for a grant.    
HHSs  Suspension and Debarment Program  Helped Safeguard Federal Funding, But Opportunities for Improvement Exist 
OEI-04-19-00570  Endnotes | 37