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Open Recommendations (17 total)

Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact

GAO-20-341
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)
Open – Partially Addressed
The Department of Health and Human Services concurred with this recommendation. As of June 2021, CDC stated that it has worked to encourage voluntary reporting to the Antibiotic Use and Resistance module. CDC also noted that it seeks to extend geographic coverage of AR data and will include caveats about data representativeness in its reports. In April 2022, CDC told us they are continuing to work with CMS to explore options to increase reporting and encourage reporting to the Antibiotic Use and Reporting module. Finally, CDC noted that assessing representativeness was delayed due to the pandemic but will revisit this effort. On August 10, 2022, the Centers for Medicare and Medicaid Services finalized a rule in collaboration CDC to require reporting to the Antibiotic Use and Resistance Module by certain eligible hospitals. This rule represents a significant step forward in collecting more comprehensive data to enable assessments of antibiotic resistance of public health importance. However, there remain exemptions to required reporting that may limit the representativeness of regional or national assessments. In April 2023, CDC stated it expects to have the participation rates to conduct regional and national assessments of antimicrobial resistance in hospitals, once the rule is fully implemented, but have not provided any documentation to support that conclusion. We will update the status of this recommendation as we receive additional information.

Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact

GAO-20-341
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3 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)
Open – Partially Addressed
The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. As of June 2021, CDC has taken some actions to address antibiotic-resistant gonorrhea, including publishing a report on a new type of resistant gonorrhea in the United States and evaluating new tests for resistant gonorrhea. In April 2022, CDC officials stated they are developing methods to create national estimates to account for possible biases within CDC's surveillance system, including constructing mathematical models to assess representativeness of surveillance data for both national and other populations of interest. In April 2023, CDC stated it recently published a paper on assessing the national representativeness of estimates of antimicrobial resistant gonorrhea in U.S. men. We will update the status of this recommendation as we receive additional information.
Centers for Disease Control and Prevention The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)
Open
The Department of Health and Human Services generally concurred with this recommendation. As of June 2021, in a recent CDC publication on a variety of antibiotic-resistant infections in U.S. hospitals, data presented include confidence intervals and the report included discussion of key limitations in interpreting the data. However, CDC did not yet incorporate this sort of analysis into its consolidated Threats Reports, and the publication did not include information on all CDC-identified antibiotic resistant threats. Further, the publication is limited in scope to hospital patient infections and thus represents a subset of antibiotic resistant infections in the United States. In April 2022, CDC officials stated they are continuing discussions on the next consolidated Threats Report. They noted that efforts were dramatically impacted and delayed by the pandemic. As of August 2023, CDC did not provide any further updates. We will update the status of this recommendation as we receive additional information.
Centers for Disease Control and Prevention The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)
Open
The Department of Health and Human services concurred with this recommendation. As of June 2021, CDC stated that it is committed to updating the Threats Report at regular intervals and have begun planning for the next iteration. CDC noted that it will continue exploring reasonable timeframes for such reports given potential disruption such as the COVID-19 pandemic. In April 2022, CDC officials stated that planning is ongoing for the next report to be released in the coming years and that they plan to develop a more established plan for updates to this report. They are also assessing best options given impacts on antibiotic surveillance activities affected by the pandemic. In April 2023, CDC noted they published an interim report describing the impacts of the pandemic on antimicrobial resistance in the United States. We will update the status of this recommendation as we receive additional information.

Food Safety: CDC Could Further Strengthen Its Efforts to Identify and Respond to Foodborne Illnesses

GAO-21-23
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The Director of the Centers for Disease Control and Prevention should implement a program performance assessment system for its multistate foodborne illness outbreak investigations, including setting performance goals, assessing progress toward achieving those goals with performance measures, and conducting program evaluations. (Recommendation 3)
Open – Partially Addressed
CDC officials have taken some steps to develop goals and objectives for addressing foodborne, waterborne, and environmentally transmitted infections and to incorporate them into their strategic plan. Specifically, CDC began a project in 2021 to design and implement an outbreak performance management system. CDC said that the initial version of this performance evaluation system should be finalized by 2022. CDC plans to incorporate all data sources needed for the performance evaluation system into SEDRIC, the System for Enteric Disease Response, Investigation, and Coordination, a cloud-based platform that facilitates collaborative investigations of multistate outbreaks of enteric disease by federal, state, and local partners. As of February 2022, this work has not yet been completed.

Small Business Research Programs: Agencies Should Further Improve Award Timeliness

GAO-22-104677
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The Director of the Centers for Disease Control and Prevention should evaluate the effectiveness of steps taken to improve SBIR award timeliness and take any necessary additional steps in order to consistently meet SBA award timeliness guidelines. (Recommendation 7)
Open – Partially Addressed
HHS agreed with this recommendation. According to an April 2022 HHS letter responding to our report as well as additional information provided by the Centers for Disease Control and Prevention (CDC), the CDC stated its intent to take steps to identify the organizational processes, systems, and policies that may offer opportunities for increased efficiencies. CDC also stated it had modified the roles and responsibilities of staff engaged in the SBIR program and provided documentation of these roles and responsibilities, as of November 2021. In May 2023, CDC reported to GAO that it had changed its SBIR funding process with an aim to increase applicant volume for its SBIR awards, and thereby, to improve award timeliness. CDC also reported that it had conferred with a cross-HHS workgroup resulting in recommendations for process measures to improve timeliness. In December 2023, we obtained and analyzed publicly available CDC award data for FY22. Our analysis indicated that CDC did not meet SBA's award timeliness guidelines in FY22. Further, in combination with prior fiscal years, CDC has not met SBA's timeliness guidelines in at least 3 of the preceding 5 years based on available data. Going forward, we will follow up to obtain data on CDC award timeliness in subsequent fiscal years to determine if actions the agency has taken have resulted in it being able to consistently meet SBA's award timeliness guidelines.

COVID-19: HHS Agencies' Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives

GAO-22-104457
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention As CDC finalizes its plans for an after action review related to its COVID-19 vaccine distribution and communication efforts, the Director of the Centers for Disease Control and Prevention should ensure the agency obtains feedback during the life cycle of the response from key stakeholders, including state and local health officials, and incorporates their perspectives as it conducts its review. (Recommendation 1)
Open
CDC concurred with this recommendation. As of April 2023, HHS/CDC had no updates for this recommendation. We will continue to monitor the agency's actions in this area.

COVID-19: HHS Agencies' Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives

GAO-22-104457
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The Director of the Centers for Disease Control and Prevention should share relevant findings of its after action review related to vaccine distribution and communication with key stakeholders, such as state and local health officials, and other federal agencies, as appropriate. (Recommendation 2)
Open
CDC concurred with this recommendation. In November 2021, CDC agreed the agency should share relevant findings with key stakeholders, as appropriate, from its after action review once completed. As of April 2023, HHS/CDC had no updates for this recommendation. We will continue to monitor the agency's actions in this area.

Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference

GAO-22-104613
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The CDC Director should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference. (Recommendation 1)
Open
As of April 2023, HHS was updating its departmental scientific integrity policy and its operating divisions, including the CDC, were also updating their individual scientific integrity policies. The updated policies will include specific provisions prohibiting political interference and will establish procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference. In April 2023, HHS plans to submit its draft scientific integrity policy for review by the White House Office of Science and Technology Policy. HHS then plans to finalize its policy by February 2024 and will make the policy publicly available on its website.

Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference

GAO-22-104613
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1 Open Recommendations
Agency Affected Recommendation Status
Centers for Disease Control and Prevention The CDC Director should ensure that CDC employees and contractors performing scientific activities are trained on how to report allegations of political interference in scientific decision-making. (Recommendation 2)
Open
As of April 2023, HHS was updating its departmental scientific integrity policy and its operating divisions were also updating their individual scientific integrity policies. The updated policies will include specific provisions prohibiting political interference and will establish procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference. Following publication of the updated departmental scientific integrity policy by February 2024, HHS will develop scientific integrity training for employees, contractors, and other persons covered by the policy. This training will describe HHS's policies and procedures related to scientific integrity, including how to recognize, avoid, and report potential political interference.
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