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As of January 31, 2023, there are 4840 open recommendations that still need to be addressed. 471 of these are priority recommendations, those that we believe warrant priority attention. Learn more about our priority designation on our Recommendations page.

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1 - 19 of 19 Recommendations, including 3 Priority Recommendations

Public Health Preparedness: HHS Should Address Strategic National Stockpile Requirements and Inventory Risks

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3 Open Recommendations
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response The Assistant Secretary for Preparedness and Response should update procedures for how SNS reviews will be conducted in accordance with statutory requirements, including a description of the roles and responsibilities of its interagency partners in the development of the SNS reviews. (Recommendation 1.)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Office of the Assistant Secretary for Preparedness and Response The Assistant Secretary for Preparedness and Response should develop and document an approach—whether through the standard operating procedures for the SNS reviews or some other mechanism—for ensuring that MCMs under consideration for SNS procurement receive the same consideration regardless of whether they received development funding from BARDA, in accordance with statutory requirements. (Recommendation 2.)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Office of the Assistant Secretary for Preparedness and Response The Assistant Secretary for Preparedness and Response should develop and document an approach for regularly managing the risks associated with the gaps between SNS MCM inventory levels and recommended quantities. Such an approach, which could occur as part of the SNS reviews, should clearly prioritize risks, track progress made in addressing the risks, and estimate resources needed to address risks. This approach should involve communicating this information to key decision makers, including Congress. (Recommendation 3.)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

COVID-19: Current and Future Federal Preparedness Requires Fixes to Improve Health Data and Address Improper Payments

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1 Open Recommendations
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response The Assistant Secretary for Preparedness and Response within the Department of Health and Human Services should conduct a workforce assessment of its Innovation and Industrial Base Expansion Program Office to determine the critical skills and competencies needed to support and sustain the office, and develop corresponding workforce strategies to address those needs. See the Public Health Industrial Base Expansion enclosure. (Recommendation 12)
Open – Partially Addressed

The Administration for Strategic Preparedness and Response (ASPR) agreed with GAO's recommendation. (Note: In July 2022, the Secretary of Health and Human Services elevated ASPR to an operating division within the department. Prior to this, ASPR was known as the Office of the Assistant Secretary for Preparedness and Response). In December 2022, ASPR provided information on recent efforts taken to begin to address the recommendation. Specifically, ASPR used a third-party contractor to assess needs and related gaps in the size and composition of the agency's acquisition workforce. The assessment

COVID-19: Continued Attention Needed to Enhance Federal Preparedness, Response, Service Delivery, and Program Integrity

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2 Open Recommendations
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response To improve the nation's preparedness for a wide range of threats, including pandemics, the Office of the Assistant Secretary for Preparedness and Response should develop and document plans for restructuring the Public Health Emergency Medical Countermeasures Enterprise. These plans should describe how the Assistant Secretary will ensure a transparent and deliberative process that engages interagency partners in the full range of responsibilities for the Public Health Emergency Medical Countermeasures Enterprise outlined in the Pandemic and All-Hazards Preparedness and Innovation Act of 2019, including the annual Strategic National Stockpile Threat-Based Reviews. These plans should also incorporate GAO's leading practices to foster more effective collaboration, while ensuring that sensitive information is appropriately protected. See the Strategic National Stockpile enclosure. (Recommendation 3)
Open – Partially Addressed

In June 2021, HHS concurred with this recommendation. In January 2022, HHS developed plans and analyses to support the reformed PHEMCE, which it relaunched in February 2022. In September 2022, HHS reported that it was hiring staff to support the PHEMCE, including by continuing to develop and implement new operating procedures. Further, in October 2022 HHS released the 2022 PHEMCE Strategy and Implementation Plan that provides information on the structure and goals of the PHEMCE as well as an implementation timeline. As of January 2023, HHS reported that it was continuing to work to fully

Office of the Assistant Secretary for Preparedness and Response To improve organizational accountability, the Office of the Assistant Secretary for Preparedness and Response should implement records management practices that include developing and maintaining, and securing documentation related to Public Health Emergency Medical Countermeasures Enterprise activities and deliberations, including those related to the Strategic National Stockpile. Documentation should include information such as the factors considered, the rationale for the action or decision, and the final outcomes of the Public Health Emergency Medical Countermeasures Enterprise processes. See the Strategic National Stockpile enclosure. (Recommendation 4)
Open

In June 2021, HHS concurred with this recommendation. In January 2022, HHS reported that it was working to implement our recommendation by developing standard operating procedures for recording, transmitting, and archiving information related to PHEMCE activities including its meeting notes, recommendations, decisions, and deliberations. HHS noted it was harmonizing these procedures with the proposed organizational structure and business processes of the restructured PHEMCE, which held its first meeting in February 2022. Further, HHS reported that it is working in collaboration with the Office

COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention

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2 Open Recommendations
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response To improve the nation's response to and preparedness for pandemics, the Assistant Secretary for Preparedness and Response should establish a process for regularly engaging with Congress and nonfederal stakeholders?including state, local, tribal, and territorial governments and private industry?as the Department of Health and Human Services refines and implements a supply chain strategy for pandemic preparedness, to include the role of the Strategic National Stockpile. (Recommendation 1)
Open

HHS generally agreed with our recommendation, while noting that the term "engage" is vague and unclear, and that they regularly engage with Congress and nonfederal stakeholders. HHS added that improving the pandemic response capabilities of state, local, tribal, and territorial governments is a priority. In September 2022, HHS noted that ASPR's Office of External Affairs engages, informs, and educates ASPR external stakeholders including public and private, state, local, territorial and tribal partners, academia, and members of Congress. However, no additional information was provided on the

Office of the Assistant Secretary for Preparedness and Response The Assistant Secretary for Preparedness and Response, in coordination with the appropriate offices within the Department of Health and Human Services, should accurately report data in the federal procurement database system and provide information that would allow the public to distinguish between spending on other transaction agreements and procurement contracts. (Recommendation 7)
Open – Partially Addressed

ASPR agreed with our recommendation, and as of April 2021, ASPR officials stated that they have discussed within ASPR the need to consistently identify other transaction agreements in the Federal Procurement Data System (FPDS) and explored how their contract writing system may interface with the FPDS other transaction agreement module in the future. In September 2022, ASPR officials stated that they have requested a field be added to their contract writing system to enable the identification of OTA awards, and that they expect this feature to be accessible in October 2022 . We will continue to

Defense Production Act: Opportunities Exist to Increase Transparency and Identify Future Actions to Mitigate Medical Supply Chain Issues:

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1 Open Recommendations
1 Priority
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response
Priority Rec.
This is a priority recommendation.
The HHS Assistant Secretary for Preparedness and Response should identify how DPA and similar actions will be used to increase domestic production of medical supplies going forward. This could be included in HHS's 180-day effort to identify and mitigate vulnerabilities for essential medicines, medical countermeasures, and critical inputs that is required to support Executive Order 13944, which is aimed at reducing reliance on foreign manufacturers of medical supplies. (Recommendation 2)
Open

HHS agreed with this recommendation but has not taken any actions as it is currently evaluating the potential use of DPA authorities to respond to future pandemics and national emergencies. As of January 2023, we continue to wait for agency updates. We will update this recommendation when we receive additional information.

Public Health Preparedness: HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders

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5 Open Recommendations
1 Priority
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response ASPR should develop an NDMS responder workforce target that aligns with the goals and objectives in ASPR's forthcoming strategic plan. (Recommendation 1)
Open

HHS officials agreed with this recommendation. In October 2022, ASPR officials noted that the agency's 2022-2026 strategic plan was in final development. In December 2022, ASPR publicly released its 2022-2026 strategic plan. GAO considers this recommendation open until GAO receives and reviews supporting documentation provided by ASPR demonstrating alignment of ASPR's NDMS responder workforce target with the goals and objectives in ASPR's strategic plan.

Office of the Assistant Secretary for Preparedness and Response
Priority Rec.
This is a priority recommendation.
ASPR should develop an NDMS responder workforce target that accounts for the critical skills and competencies that are needed to meet current and future programmatic results, such as a workforce target that considers (1) a nationwide event or multiple concurrent events, (2) the needs of at-risk individuals, and (3) the availability of other medical responders. (Recommendation 2)
Open

HHS officials agreed with this recommendation. In October 2022, ASPR officials stated that its NDMS responder workforce target was based on several studies over many years and post major deployments. Such assessments were completed between 2007 and 2015, using the worse-case scenarios to define response requirements. These requirements then informed the maximum effort of what would be needed for the NDMS workforce, including the workforce needed to support two large-scale catastrophic events at the same time. GAO considers this recommendation open until GAO receives documentation of the

Office of the Assistant Secretary for Preparedness and Response ASPR should develop strategies to fill gaps to achieve its revised workforce target. (Recommendation 3)
Open

HHS officials agreed with this recommendation. In October 2022, ASPR officials stated that ASPR is working to increase its NDMS responder workforce to meet its overall goal of 6,290 NDMS personnel (to comprise 69 NDMS response teams). According to officials, as of October 28, 2022, NDMS has 3,965 responders available for rostering. Officials stated that the fiscal year 2023 President's Budget request proposes an additional $50 million above fiscal year 2022 NDMS funding levels to, in part, support hiring additional NDSM responders. GAO considers this recommendation open until ASPR provides

Office of the Assistant Secretary for Preparedness and Response ASPR should develop a process to evaluate the web-based and in-person training provided to NDMS responders using GAO-identified key practices for evaluating training. (Recommendation 4)
Open

HHS officials agreed with this recommendation. As of October 2022, ASPR officials continue to work on implementing this recommendation. The fiscal year (FY) 2023 President's Budget request proposes an additional $50 million above fiscal year 2022 NDMS funding levels. According to ASPR officials, if funded at the specific requested level, NDMS will be able to evaluate training and make required adjustments based on collective feedback. At current levels, and if funding is not provided as requested, NDMS is unable to implement these actions. GAO will continue to monitor ASPR's action in this

Office of the Assistant Secretary for Preparedness and Response ASPR should develop a process or approach to prioritize various in-person training needs for its NDMS responders while taking into account budget constraints. (Recommendation 5)
Open

HHS officials agreed with this recommendation. As of October 2022, ASPR officials continue to work on implementing this recommendation. ASPR officials stated that in August 2022 NDMS conducted its first in-person training summit to provide hands-on training for responders, focusing on new hires to ensure basic skill sets to conduct post-disaster response operations. Over 1,400 NDMS personnel received training on new equipment, field and life support equipment, and classroom training on emerging threats, aeromedical evacuation, and disaster medicine. According to ASPR officials, the benefits of

Disaster Response: HHS Should Address Deficiencies Highlighted by Recent Hurricanes in the U.S. Virgin Islands and Puerto Rico

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5 Open Recommendations
1 Priority
Agency Recommendation Status
Office of the Assistant Secretary for Preparedness and Response As ASPR finalizes its federal patient movement framework, the agency should exercise the framework with its National Disaster Medical System (NDMS) partners to ensure that patients evacuated through NDMS will be consistently tracked from the start of their evacuation. (Recommendation 2)
Open

The U.S. Department of Health and Human Services (HHS) concurred with the recommendation GAO made in September 2019. As of January 2023, HHS stated that the federal patient movement framework was exercised via a real-world event in 2020 in support of COVID-19 response operations originating in Asia. HHS's Air Medical Evacuation teams, which are part of the National Disaster Medical System (NDMS), directly supported 39 flights, moving over 2,000 individuals who tested positive for COVID-19, individuals under observation, or individuals who were asymptomatic. According to HHS officials, all

Office of the Assistant Secretary for Preparedness and Response ASPR should put controls in place to ensure data on all NDMS evacuated patients are complete and accurate. (Recommendation 3)
Open

HHS officials concurred with this recommendation. In February 2022, ASPR officials stated that they hired a nurse consultant into NDMS who is the lead for the case management program. As of January 2023, according to officials, NDMS is in the process of exploring opportunities to develop case management teams. It also implemented a contract solution for case management and receives case management support from the Public Health Service. In addition, officials stated that the contract including the Joint Patient Assessment and Tracking System (JPATS), would be opened for competition in 2022

Office of the Assistant Secretary for Preparedness and Response
Priority Rec.
This is a priority recommendation.
ASPR should work with support agencies to develop and finalize memorandums of agreement that include information on the capabilities and limitations of these agencies to meet ESF#8 core capabilities. (Recommendation 5)
Open

In its comments on the draft report and subsequently in May 2021 and January 2023, the U.S. Department of Health and Human Services (HHS) stated it did not concur with this September 2019 recommendation. In its most recent comments, HHS responded that the National Response Framework articulates how ESFs operate during incident response, and that further agreements are not needed to outline functions and responsibilities. In addition, HHS stated it does not plan to develop a list of capabilities because capabilities can change, and due to the structure of the National Response Framework, all

Office of the Assistant Secretary for Preparedness and Response ASPR should develop a strategy demonstrating how it ESF#8 core capabilities can be provided through HHS and ESF#8 support agencies if DOD's capacity to respond is limited. (Recommendation 6)
Open

The U.S. Department of Health and Human Services (HHS) concurred with this September 2019 recommendation. In May 2021 and subsequently in January 2022 and January 2023, HHS officials stated that the Assistant Secretary for Preparedness and Response (ASPR) has implemented some changes to its response procedures since the issuance of GAO's report. For example, HHS officials stated that ASPR developed an Incident Response Framework that articulates how ASPR engages with its ESF#8 partners, including the establishment of an action officer-level group chaired by ASPR. HHS officials stated that this

Office of the Assistant Secretary for Preparedness and Response ASPR should take steps to ensure the perspectives of key external parties are incorporated in the development of HHS's after-action reviews, following future ESF#8 activations. (Recommendation 7)
Open

The U.S. Department of Health and Human Services (HHS) concurred with the recommendation GAO made in September 2019. As of January 2023, HHS officials stated that, since GAO's last update, the Assistant Secretary for Preparedness and Response's (ASPR's) Exercise Evaluation and After Action Team has a standing corrective action collaboration with the Centers for Disease Control and Prevention as well as the Federal Emergency Management Agency's Continuous Improvement Program to share data and observations for collaborative events and responses. HHS officials stated that, as conditions warrant

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