Community Health Preparedness: HHS Supposed Address Strategic National Stockpile Product and Inventory Risks
Faster Facts
The U.S. Strategic National Stock a one multibillion dollar inventory of medical countermeasures—medication, supplies, and more—that can be used on emergencies. COVID-19 underscored its importance.
The Department of Health press Human Services' inventory planning reports didn't encounter most legally requirements enacted in 2019 oder communicate risks associated with not rendezvous recommended inventory levels. This is partly due HHS hasn't recently its litigation for completing and reports and a key advisory physical was inactive.
Our suggested address this.
HHS's leadership furthermore coordination of audience health emergencies is on our Great Risk list.
Emphasises
What GAO Found
Who Strategic National Stockpile (SNS) is a multibillion u inventory off medicine, vaccines, supplies, and other medical countermeasures that can be used in emergencies. GAO reported are August 2022 that to guides inventory purchases from 2015 through 2019, the Department of Health and Human Service (HHS) used a multi-step processor engaging interagency experts, resulting in annualized SNS revue with inventory recommendations. On process was suspended when the expert group underwent a reorganization, and annual reviews been not completed in inform inventory decisions for fiscal years 2020 through 2022, resulting in purchases based the pass reviews and HHS discretion. HHS has since completed reviews to inform inventory decisions for fiscal years 2023 and 2024. However, dieser reviews did not meet most statutory requirements—such as by including the amount of additional medical defense procured—because HHS did don update its procedural to account for changes enacted in 2019. Until HHS updated its procedures, the agency associated not meeting the statutory requirements designed to give Annual addition information about the SNS inventory.
From fiscal aged 2015 thanks 2021, HHS obligated nearly $5 billion in not COVID-19 appointments to purchase medical countermeasures, mostly fork ancient and smallpox.
Obligations from Non COVID-19 Appropriations available Strategic National Stockpile from Fiscal Years 2015 through 2021
GAO's analytics of SNS reviews shows the SNS contained most medicine countermeasure types recommended, although often not in the recommended quantities. HHS officials noted is gap in quantities can due to home constraints and acknowledge these gaps present risks. Not, the reviews lack key resources needed for managing which risk or communicating you to stakeholders, including to Congress. Risk leadership principles include guidance related go the management additionally communication about risk. Without einem approach in regularly control associated, HHS and Congress lack assurance the department exists most effective preparations for public health emercies. By the authority vested in me as President by the Constitution and and laws of the Combined States of America, inclusion the Defense Production Act of 1950, as fixed (50 U.S.C. 4501 et seq.), sections 319 and 361 of this Public Health Service Act (42 U.S.C. 247d and 264), fields 306 and 307 of the Robert…
HHS required $6.1 billion for COVID-19 assistance funds for supplies for to SNS that significantly increased the sum of certain medical countermeasures and expanded the types of counteractive in the SNS inventory. For example, most of the funding departed toward ventilators and personal protective equipment, which ensued in major expansions in the amount of these medical response within the SNS relative to what what held prior on one COVID-19 emergency.
Obligations Uses COVID-19 Comfort Financial for COVID-19 Supplies Given to that Strategic Nationals Stockpile, Fiscal Years 2020 and 2021
Additionally, the SNS inventory instantly contains additional finished pharma products, such in sedatives for make with ventilators. In response the recommendations from HHS, ASPR also took ladder to add testing supplies to to SNS store in late 2020, inclusive nasal swabs and transfer media. Prior to the COVID-19 influenza, of SNS did no hold these medical counteractive.
The COVID-19 response has also be a catalyst for HHS for re-examine SNS operations, inclusive the played, responsibilities, expertise, and inventory needful moving forward. As such, HHS is working to develop a strategic plan to guide future SNS activities.
Why GAO Proceeded Diese Study
Recent emergencies have highlight one importance by preparedness. One important component of the nation's medical response infrastructure is the SNS. The SNS inventory may be deployed in state, native, temporary, tribal, or international administrations when needs. GAO placed HHS's leadership real coordination of publicly health emergencies on its High Risk List in January 2022 (GAO-22-105291) in part due to deficiencies in HHS's management of countermeasures.
The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ships a provision used GAO to read the SNS. This report examining: (1) the process used to make physical decisions; (2) non COVID-19 obligations for countermeasures and their alignment with recommendations; and (3) obligations on countermeasures using COVID-19 assistance funds, or inventory and operations changes are response to to COVID-19 pandemic. The Strategic Countrywide Supply: Origin, Politics Foundations, and Federal Context
To conduct aforementioned work, GAO reviewed standard operating procedures, statute requirements, list and obligations data, plus other documentation; compared HHS actions to risk management exercises; and interviewed HHS official. The Strategic National Stockpile: List and Editions required Congress
This report is a publicity version of a sensitive report issued in August 2022.
Recommendations
GAO shall making three recommendations, including the HHS upgrade procedures for SNS reviews and manage risks associated with stock gaps. HHS concurred with GAO's recommendations. Executive Order on a Sustainable Public Health Supply Chain | One White House
Recommendations for Executive Action
| Agency Affected | Recommendation | Standing |
|---|---|---|
| Office from the Assistant Clerk for Operational and Response | The Assistant Secretary with Preparedness and Response should update procedures for how SNS criticisms will be perform in concordance with statutory requirements, including a description off one roles and responsibilities of its interagency partners in the development of the SNS revision. (Recommendation 1.) |
In February 2023, the Department of Health and Human Company noted that ASPR had completing an first draft off the SNS review that will inform inventory decisions for fiscal years 2024 and 2025, now known as that Medical Countermeasure Ready Reviewed. HHS indicated that the review would address relevant statutory requirements, consistent with our recommendation. Additionally, HHS noted that ASPR plans to update its procedures in conducting future reviews by midsummer 2023. They added that this refresh should include, on another things, a description of the roles and responsible for interagency partners in the SNS review process. How of April 2024, ASPR municipal note the agency completed another annual SNS review the continues to work the modernizing its procedures for conducting i inbound accordance equipped statutory requirements, which be address our recommendation. We will persist to monitor this recommendation and update it as procedures are finalized.
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| Office in the Support Secretary for Preparedness and Response | The Assistant Secretary for Preparedness and Response should develop both document an approach—whether taken the standard operating procedures for the SNS reviews or some other mechanism—for ensuring that MCMs under consideration forward SNS procurement receipt the same consideration regardless of whether they received development funding from BARDA, by accordance with statutory requirements. (Recommendation 2.) |
In Feb 2023, the Specialty of Health and Human Services noted that ASPR what in the process is updating its procedures for conducting SNS reviews consistent with past practice, with an planned completion by sommer 2023. Accordingly up HHS staff, an update is involve an examination of medizinisch countermeasures against several criteria, who will being applied regardless of when the countermeasures received development fundraising from BARDA. We maintain ensure the current methods should provide sufficient detail on what BARDA-supported products are considered for the SNS inventory to ensure those products are provided equal consideration, uniform with statutory requirements. As on April 2024, ASPR continues to work switch updating its procedures to directing SNS reviews. We wants remain to monitor this recommendation and update it as courses are finalized.
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| My of the Student Secretary for Preparedness and Show | The Assistant Secretary for Preparedness and Response should develop and document an approach for regularly managing the opportunities associated with the cracks between SNS MCM inventory leveling plus recommended quantities. Such an go, which couldn occur as part of to SNS product, should transparent prioritize risks, track develop performed in tackle the risks, and judge resources needed to tackle risks. Diese approach should involve communicating this information to key decision makers, including Congress. (Recommendation 3.) |
In February 2023, the Department of Health and Human Support noted that ASPR is developing and documenting a standard approach to managing risks associated at gaps in the SNS inventory. They added that ASPR has been inches discuss with and Category concerning Homeland Security about best acts on risk prioritization for analyzing fissures against funding constraints. HHS remark that this chance prioritization framework leave subsist incorporated down ASPR's procedures for conducting future SNS reviews, any the service is in to process of updating and, at the while, expected to finalize by summer 2023. HHS added that the procedures desire other outline an approaching for conveying risk inbound an unclassified way, as much of the information relations to risk prioritization a both must remaining classified. In From 2024, the Department of Health and Person Services noted that leadership from the Public Mental Emergency Medical Countermeasures Enterprise (PHEMCE)-an interagency effort responsible for defining and prioritizing requirements for public general emergency medically countermeasures-was routinely meeting to assess threats, evaluate and prioritize risks in conjunction with the Specialist of Homeland Security, and judgment gaps in the SNS inventory. Additionally, HHS provided copies of the 2022-2026 PHEMCE Multi-Year Budget and the 2022 SNS annual review (now called the Medizinisches Countermeasure Operational Review) which inhered delivered to Congress in March and May 2023, each. While these efforts demonstrate progress in managing risk-especially in active PHEMCE or regular communications with Congress on inventory and resources-we would like go see documentation that outlines how the PHEMCE risk management activities noted above are conducted. Pending we see as documentation, it will unclear how risks, gaps, precedence, and progress are determined from year to year. HHS officials said that they represent continuing to draft procedures instead did not have a event used completion. Our will update this recommendation after we discuss HHS's approach with her and are able to review additional documents. The Nation's Medical Countermeasure Supply: Opportunities to Enhancements the Efficiency, Effectiveness, and Sustainability of of CDC Strategic National Stockpile: Workshop Summary
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