The Reward and Risk of Expediting COVID-19 Testing and Vaccine Development

U.S. scientists are working quickly to develop new tests and vaccines to identify and combat COVID-19. They have already developed 3 kinds of tests and begun development on numerous potential vaccines.

Developing a new test or vaccine, however, is a complex process. With the reward of quick work also comes risks. Today’s WatchBlog looks at both when it comes to moving rapidly to fight the coronavirus.

COVID-19 testing

In response to the COVID-19 pandemic, the Food and Drug Administration (FDA) has streamlined its regulatory process to get more tests into the hands of medical providers. For example, by using its emergency use authorization authority, FDA has already allowed the use of more than 60 tests.

The figure below shows how the 2 most common kinds of tests–molecular and serology–can detect whether someone is currently infected or has been exposed to the virus that causes COVID-19. For example, a molecular test detects the presence of the virus’s genetic material. Serology tests detect the presence of antibodies, which are specific proteins made in response to an infection. Antibodies can be found in the blood of people who have been exposed to the virus.

COVID-19 vaccines

FDA can also use its emergency authority—combined with approaches like Fast Track (a process designed to speed up the review and approval of new therapies for the treatment and prevention of serious or life-threatening conditions such as COVID-19)— to move potential vaccines into clinical trials faster than usual. This could help shorten the amount of time needed to develop a vaccine, helping save lives and accelerate economic recovery.

The figure below shows the differences between traditional vaccine development and a potential accelerated timeline.

Note: This graphic was updated on May 28, 2020 to show that phases of vaccine development overlap and clarify accelerated timeline dates.

Risks of moving too quickly

While responding quickly has its benefits, there are also risks.

Accelerating vaccine development could result in less time spent on evaluating the safety of the vaccine. Some patients could experience serious adverse effects. Shortening the timeline could also mean that scientists learn less about the potential range of adverse effects.

Moving quickly to authorize and distribute tests may increase risks associated with their accuracy. As a result, there is the potential that some tests could show patients have not been exposed to or infected by the virus that causes COVID-19 when they actually have been. In addition, while tests may be developed quickly, their widespread use could be limited by the availability of supplies required to conduct testing safely, including swabs and personal protective equipment.

Finding the right balance between speed and safety, accuracy, and effectiveness is challenging. It requires careful assessment and may need to be adjusted over time.

Want to know more? Check out our Science & Tech Spotlights on COVID-19 Testing and COVID-19 Vaccine Development. GAO has a broad portfolio of work on the federal government’s response to and preparedness for infectious diseases, viruses, and biological threats including ZikaEbolaAvian Influenza, and H1N1.

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A Snapshot of Government-wide Contracting for FY 2019 (infographic)

From health care to helicopters, the government spends about 40% of its discretionary spending on contracts for goods and services.

In FY 2019, the federal government spent more than $586 billion on these contracts, an increase of over $20 billion from FY 2018. This increase is largely driven by spending on services for national defense. Our infographic shows more details on how federal contracting dollars are spent across the federal government—including which agencies obligated the most funds, what they bought, and whether the contracts were competed. Trends for FY 2019 remain largely the same as FY 2018 and do not reflect spending on COVID-19 response in 2020.


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The Watchdog is Afoot!

Sherlock Holmes might be literature’s most famous detective, but he can still surprise you. For example, did you know that in the original books by Sir Arthur Conan Doyle, Sherlock never actually said “Elementary, my dear Watson”?

May 22 is Sherlock Holmes Day. To celebrate, today’s WatchBlog highlights some little-known facts about our own investigators and analysts in GAO’s Forensic Audits and Investigative Service team—and the surprising things they’ve found in recent years.

Exposing fraud

In The Adventure of the Greek Interpreter, Mycroft Holmes is introduced as Sherlock’s older brother—and a government auditor. Holmes credits his brother with being the “most indispensable man in the country.” While we know that Mycroft probably did more than audit the government’s books, we’ll still take the compliment.

Our analysts do provide important insight into fraud in federal programs. For instance, they’ve found fraud risks in the Student and Exchange Visitor Program—such as “sham” schools that help students get visas to live in the U.S. without requiring that they attend classes.

Our investigators have also looked into fraud in the Head Start program. Investigators attempted to enroll fictitious children at 15 Head Start centers using information that should have disqualified their applications—like pay stubs that exceeded income requirements. We found potential fraud at 5 of these centers, such as schools doctoring our applications to exclude disqualifying information.

Masters of disguise

Sherlock Holmes often disguised himself during investigations. For instance, he played the part of a drunken, out-of-work groom to get into Irene Adler’s house in A Scandal in Bohemia.

Our investigators don’t wear disguises, but they have gone undercover for operations. For example, GAO was asked to look into whether the campuses at the National Institute of Standards and Technology—a U.S. national laboratory that conducts research on sensitive areas like bioscience and manufacturing—were secure. But our investigators were able to gain unauthorized access to various areas of these campuses in Maryland and Colorado.

Hot tips

Sherlock Holmes relies on the public to bring him interesting cases. Case in point: in The Hound of the Baskervilles, Dr. James Mortimer asks Sherlock Holmes for advice after his friend (Sir Charles Baskerville) is found dead in the park near his house.

Like Sherlock, GAO also needs help from the public. In addition to our regular efforts to investigate fraud, we have been tasked by Congress to monitor the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act for fraud. To help us with these efforts, we are turning to the public for help identifying fraud, waste, or abuse.

You can report any of your concerns related to fraud in federal programs or the CARES Act to GAO’s FraudNet using:

  • Our online reporting portal
  • Via email at
  • Or by calling our hotline at 1-800-424-5454

Due to the coronavirus pandemic, FraudNet staff are working remotely to maintain social distancing. As a result, we strongly encourage you to submit your concern online so we may provide a more timely response.

To learn more about our intrepid investigators, check out our website.

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Protecting Nursing Home Residents from Infections like COVID-19.

Recent COVID-19 related deaths at nursing homes have raised concerns about the health and safety of the nation’s 1.4 million residents living in these facilities.

In today’s WatchBlog, we look at the federal role in protecting nursing home residents and our recent report that identified ongoing gaps in this effort that pre-date the coronavirus pandemic. 

Nursing home infection control

There are about 15,500 nursing homes in the United States. Federal standards require that these facilities establish and maintain infection prevention and control programs.

While the Centers for Medicare & Medicaid Services is responsible for ensuring that these facilities have programs and safety measures in place,  it relies on state agencies to conduct surveys and investigations of facilities to ensure nursing homes comply with federal standards.

Deficiencies in meeting these standards can include situations where, for example, nursing home staff did not regularly use proper hand hygiene or failed to implement preventive measures during an infectious disease outbreak like isolating sick residents. Many of these practices can be critical to preventing the spread of infectious disease, including COVID-19.

What we found

Our review of nursing homes, which pre-dated the COVID-19 pandemic, looked at data from Medicare & Medicaid and showed that infection prevention and control deficiencies were widespread among most nursing homes and often persistently found over multiple years. Infection prevention and control were the most commonly cited deficiencies in surveyed nursing homes. Between 2013 and 2017, 82% (13,299) of nursing homes were cited with an infection prevention control deficiency in one or more years. About 48% (6,327) of those nursing homes had multiple consecutive years of citations for deficiencies.

In each individual year from 2013 through 2017, the percent of surveyed nursing homes with an infection prevention and control deficiency ranged from 39 percent to 41 percent. In 2018 and 2019, we found that this continued with about 40 percent of surveyed nursing homes having an infection prevention and control deficiency cited each year.

We also found that in each year from 2013 through 2017, 99% of the infection prevention and control deficiencies were classified by state surveyors as “not severe.” As a result Medicare & Medicaid enforcement actions against nursing homes were only taken for 1% of these deficiencies. Furthermore, 67 percent of these infection prevention and control deficiencies classified as “not severe” did not have any enforcement actions imposed or implemented, and 31 percent had enforcement actions imposed but not implemented—meaning the nursing home likely had an opportunity to correct the deficiency before an enforcement action was imposed.

To learn more about our findings, tune in to our podcast with John Dicken, a director in our Health Care team.

The figure below shows the number of nursing homes with cited deficiencies in multiple years, between 2013 and 2017.

Note: CMS restructured its deficiency code system beginning on November 28, 2017, and, due to these coding changes, we did not analyze CMS data cited by surveyors from November 28, 2017, through December 31, 2017. Percentages may not add to 100 due to rounding.

Help from the Cares Act

The Coronavirus Aid, Relief, and Economic Security (CARES) Act has provided $200 million to CMS to prevent, prepare for, and respond to the coronavirus. Of that money, Congress has directed CMS to use at least $100 million on nursing home facilities in localities where the coronavirus has spread. Further, since the COVID-19 pandemic, HHS has taken a number of actions, including targeting nursing home inspections on infection prevention and control, providing new guidance for nursing homes, and enhancing reporting of nursing home infections.

To learn more about these issues, as well as how the federal government is responding to COVID-19, check out our website.

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Our plan to save the government tens of billions of dollars through reducing fragmentation, overlap and duplication.

The federal government has made an unprecedented financial response to the COVID-19 (coronavirus) pandemic. At the same time, opportunities exist for achieving tens of billions of dollars in financial savings and improving the efficiency and effectiveness of a wide range of federal programs in other areas.

Today we released our 10th annual report on opportunities to reduce spending and address fragmentation, overlap, and duplication within the federal government. Over the past decade, our annual reports have helped the federal government improve operations and save about $429 billion. Today’s WatchBlog explores.

How reducing fragmentation, overlap, and duplication saves taxpayer money

Since 2011, we’ve been reporting on ways the government can be more efficient and save taxpayers’ money by looking for agencies and programs that:

  • work on similar or different parts of the same goal (fragmentation)
  • have similar goals or provide similar services (overlap)
  • work on the same activities or provide the same services (duplication)

Our new report includes 168 new actions that Congress or agency leaders can take to improve the efficiency and effectiveness of government in 29 new areas and in 10 existing areas.

For example:

  • Improved coordination and communication between the Department of Health and Human Service’s Office of the Assistant Secretary for Preparedness and Response and its emergency support agencies—including the Federal Emergency Management Agency and Departments of Defense and Veterans Affairs—could help address fragmentation and ensure the effective provision of public health and medical services during a public health emergency.
  • The U.S. Navy could save billions of dollars by improving its acquisition practices and ensuring that ships can be efficiently sustained.
  • The U.S. Army Corps of Engineers and the U.S. Coast Guard could address fragmentation and better communicate lessons learned in contracting following a disaster.
  • The Internal Revenue Service could save billions of dollars by improving its efforts to prevent identity theft refund fraud.
  • The Government National Mortgage Association’s (Ginnie Mae) operations and risk management could be more efficient and effective, reducing costs or enhancing federal revenue by tens of millions of dollars annually.
  • By implementing a process to monitor orders and resolve outstanding reimbursements, the Department of Defense could recover millions of dollars in overdue repayments for sales made to foreign partners.

Fully addressing new actions and those that remain open from our prior reports could lead to tens of billions of dollars in additional financial benefits. Want to find out more? Check out our Action Tracker to explore the hundreds of other actions we’ve identified.

Find out more about our new report by tuning into our podcast with Director Jessica Lucas-Judy.

Some examples of previously identified actions that could save billions

  • The Department of Energy may be able to reduce certain risks by adopting alternative approaches to treat some of its low-activity radioactive waste, potentially saving tens of billions of dollars.
  • Medicare could save billions of dollars annually if Congress equalized the rates Medicare pays for certain health care services (payment rates currently vary by location).
  • Unless the Department of Energy can demonstrate demand for new Advanced Technology Vehicles Manufacturing loans and viable applications, Congress may wish to consider rescinding all or part of the remaining credit subsidy appropriations—potentially saving more than $4 billion.
  • If the Department of the Interior improved management of federal oil and gas resources, $1.7 billion could be saved over 10 years.

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F-35: DOD’s Next Top Gun Aircraft Needs More Time and Attention

The F-35 Joint Strike Fighter jet is critical to national—and international—security. But its stealth technology, advanced sensors, and networking capabilities don’t come cheap: it’s the most expensive weapon program in U.S. military history.

Several partner countries have contributed funds and agreed to buy jets, while a number of other countries have signed on to purchase them through the Department of Defense’s foreign military sales.

The F-35 program has been delivering jets since 2007, but full-rate production—to meet the demand for jets—can’t start until the program is ready. We’ve been updating Congress regularly on the program’s readiness, including the cost, schedule, and other risks it faces.

We’ll look at our most recent update in today’s WatchBlog.

Can They Build It Right?

The contractor building the “airframes” (jet bodies) says it’s ready. We found that the program is on track to meet 6 of the 8 leading practices for manufacturing readiness. But the remaining 2 practices are key to preventing future quality issues that would add to the $428 billion overall cost of the program.

  • Production processes should consistently lead to a high quality product without defects or rework. The contractor is still changing some of its processes, and not always following its established processes well. In 2018, the Air Force found corrosion between the surface panels and the frame because the contractor didn’t apply primer when it attached the panels. In 2019, a mechanic found titanium fasteners in an area of the aircraft where the design calls for stronger fasteners.  
  • The product should meet its goals for reliability and maintenance time. Over 500 F-35s that are in the field now aren’t meeting their reliability goals—they’re more likely than expected to be in maintenance rather than available for operations.

Can They Build Enough?

There are already parts shortages and supply chain issues that make it hard to increase production. In April 2019, F-35s in the field weren’t meeting users’ requirements, largely because of trouble getting spare parts.

In July 2019, Turkey—an international partner—was suspended from the program. The program was ordered to stop placing parts orders with Turkish suppliers after March 2020, which means that they had to find new suppliers for 1,005 airframe and engine parts while also increasing production. The program found new suppliers by the end of 2019, but it may still be hard to ensure that they can meet the increased demands of full-rate production.

Is It Ready for Emerging Threats?

The F-35’s computer systems are due for an upgrade to help them address emerging threats. There has been substantial cost and schedule growth in this modernization effort. DOD now expects it to cost $12.1 billion—an increase of $1.5 billion since May 2019.

Also, the program had planned to deliver 8 new capabilities in 2019, but it has only delivered 1 so far. Delivery of the remaining 65 capabilities was delayed and is now expected to take another 2 years, through 2024.

We made 5 recommendations to help DOD address some of these production and modernization risks. Check them out in our report.

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COVID-19 Potential Impact on Prisons’ Populations and Health Care Costs

Recent reports of COVID-19 (coronavirus) outbreaks in prisons have raised concerns about health risks for inmates, and the availability and cost of care in prisons. The Federal Bureau of Prisons currently cares for about 143,000 inmates in 122 facilities.

In today’s WatchBlog, we look at steps the Federal Bureau of Prisons has taken to address health concerns, and our work on inmate health and healthcare costs.

Prison inmates may face higher health risks from COVID-19

Social distancing is meant to promote health and prevent the spread of COVID-19. But in prisons, people are in close contact and cannot practice social distancing—potentially allowing the coronavirus to spread more quickly. Inmates may be more at risk of exposure as a result.

In addition, the health profiles of many prisoners put them at higher risk for severe illness and higher mortality rate if infected with the virus. According to the Centers of Disease Control (CDC), people of any age—and older adults, in particular—who have serious underlying medical conditions may be at higher risk for severe illness from COVID-19. During our review of factors that contributed to higher Bureau health care costs, we found that the prison population includes:

  • Older inmates — In 2016, about 12% of Bureau inmates were 55 years of age or older. Our analysis found that the average age of inmates increased each year from fiscal years 2009 to 2016. If this trend continued, it is likely that a higher percentage of inmates are of an age that puts them more at risk of serious health issues if they contract COVID-19.
  • Inmates have relatively poorer health— During our review of the Bureau’s healthcare costs, officials said that inmates generally enter the system with more acute health needs due to limited access to care. Inmates also tend to have higher rates of infectious diseases—such as hepatitis C and HIV/AIDS from engaging in risky behavior like substance abuse—and chronic conditions such as cancer that can persist throughout incarceration. For example, the Bureau estimated that there were approximately 20,000 inmates infected with hepatitis C. Similarly, rates of chronic health and infection disease are 7 times higher for inmates than that of the general population, according to the Council of State Governments Justice Center. Underlying health conditions have been connected with COVID-19 related hospitalizations and deaths.

How is the Bureau protecting prison inmates?

In response to health concerns, the Bureau announced it would modify operations to help mitigate the spread of the coronavirus in prisons. As of May 2020, changes include:

  • Suspending all social and legal visits for 30 days unless a request for an in-person attorney visit is approved by the local institution,  and restricting the transfer of prisoners between facilities and systems (except in limited circumstances, such as federal or state court case processing)
  • Screening staff in areas where there is sustained transmission of the virus and at medical referral centers
  • Screening inmates newly arriving at a facility and quarantining those who were likely exposed to the virus
  • Testing and isolating inmates who show symptoms of COVID-19.
  • Maximizing social distancing, such as staggering meal and recreation times as much as is practicable
  • Granting certain eligible prisoners home confinement

What does this mean for the Bureau’s healthcare costs?

In our review of the Bureau’s health care costs, we found that medical services comprised 88% or $1.2 billion of the Bureau’s total health care obligations in 2016. The coronavirus could add to these costs. For example, the Bureau will need to purchase additional equipment and supplies, such a masks, gloves, thermometers, and ventilators. Total salaries and benefits expenditures could increase because Bureau medical staff may be needed to work overtime to screen for the virus and treat inmates. Further, outside medical care costs could increase if Bureau medical facilities are unable to manage the number of ill inmates and they must be sent to private physicians or hospital for care.

Check out our report to learn more about the factors that drive the Bureau’s healthcare costs and the initiatives it has in place to control them.

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A Critical Shortage of Nurses

Nurses are on the frontlines of the COVID-19 pandemic. Along with other health care workers, they face an increased demand for their services—which puts them at greater risk of catching coronavirus.

So, in honor of National Nurses Week (May 6 through May 12), we are taking a look at our work on shortages in the nursing and health care worker communities. We are also reviewing federal efforts to respond to these shortages, including through the CARES Act (Coronavirus Aid, Relief, and Economic Security Act).

Today’s WatchBlog explores.

The nursing workforce

Nurses are the largest component of the health care workforce. They provide much of the care for hospital patients and deliver most of the nation’s long-term care.

However, the U.S. has been facing a critical nursing shortage for years, partly due to increased demands on the health care system as baby boomers age. This is likely to be exacerbated by the growing demand for nurses during the COVID-19 pandemic.  

Federal agencies have been working to address this issue. Most federal funding to educate health care providers funds physician residencies through Medicare’s graduate medical education (GME) program. In 2018, GAO reported on Medicaid’s GME funding, and found that 9 and 10 states respectively, allowed the use of GME funding to train nurses and nurse practitioners. GAO recommended improving the data to help ensure that the government’s funds are being used effectively. In addition, in 2019, GAO reported on views regarding expanding the Medicare GME funding to nurse practitioners.

Help from the CARES Act

The CARES Act has provided funding to train and educate nursing students in areas with nursing shortages.

Additionally, the Department of Health and Human Services (HHS) funds the Nursing Education Loan Repayment Program, which helps repay education loans for registered nurses.

To learn more about these issues, as well as how the federal government is responding to COVID-19, check out our website.

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As COVID-19 aid arrives, be on the lookout for scams

[Correction—This blog has been corrected to indicate that FDA has approved a home test collection kit, as of May 8, 2020.]

As individuals, employers, and agencies await aid from the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act, they should also be on the lookout for scams. The CARES Act, signed into law on March 27, provides

  • funds for federal and state agencies to respond to the COVID-19 pandemic
  • loans and grants to assist businesses and hospitals
  • economic impact payments of up to $1,200 per individual based on income with an additional $500 per child.

The act also temporarily expands unemployment benefits, which have already been the subject of concerns about scams and fraud.

In today’s WatchBlog, we look at several types of scams that are already occurring or are possible during the COVID-19 pandemic—and federal agencies’ roles in protecting you from them.


On April 2, the IRS issued a warning about a surge in calls and email phishing attempts tied to economic impact payments to individuals. According to the IRS, the scammers’ calls emphasize the words “stimulus check” or “stimulus payment” and suggest they could help you receive payments faster if you provide personal and/or banking information.

In December, we reported on robocalls and how federal agencies enforce prevention laws for them. Robocallers often use a fake caller ID—a practice known as “spoofing”—to disguise their identities and gain credibility. Spoofing schemes have deceived people into providing financial information or buying falsely advertised products, costing the victims millions of dollars each year.

In our report, we looked at what federal agencies are doing to protect consumers. We found that the Federal Communications Commission, the Federal Trade Commission, and the Department of Justice are investigating and prosecuting scammers, educating the public, and supporting a new industry-developed system to detect spoofing.

In July 2018 and March 2020, we reported on the IRS’s efforts to curb identify-theft as it relates to tax fraud on businesses and individuals. The IRS’s efforts have kept millions of tax return funds out of criminals’ hands, but we found that more could be done. To learn more, check out our recommendations.

Identity theft scams – FDIC and banking

On March 18, the Federal Deposit Insurance Corporation (FDIC) warned consumers of recent scams with impostors posing as agency representatives and asking for bank account information or cash. The FDIC notice reminded consumers that it does not send unsolicited correspondence or contact people via telephone asking for money or sensitive personal information, such as bank account information, credit and debit card numbers, Social Security numbers, or passwords.

Health supplement scams

In this time of COVID-19, beware of offers for “home” test kits and unknown “miracle” cures or vaccines. According to the U.S. Food and Drug Administration (FDA), COVID-19 is a new coronavirus infecting humans, so no FDA-approved vaccines are currently available to prevent or treat the virus. The FDA is working with vaccine and drug manufacturers to develop new vaccines and find drugs to treat COVID-19 as quickly as possible.

Meanwhile, the people and companies trying to profit from the pandemic are selling unproven and illegally marketed products that falsely claim to be effective against the coronavirus. For example, the FDA has identified unauthorized, fraudulent COVID-19 test kits being sold online. Currently, the only way to be tested for the coronavirus is by contacting your health care provider. FDA has approved a test collection kit, which allows people, with a doctor’s order, to take samples from their homes and mail them into a lab for testing.

In May 2017, we reported on the steps that the FDA and the FTC have taken to oversee false claims by health supplement companies. This report focused on memory supplements. In addition to false claims, in 2018, we found and reported that some health supplements’ ingredients might not match what is on the label.

For more detailed information about any of these scams, be sure to check out our reports.

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Is FEMA Ready to Respond to Emergencies?

Even before COVID-19, a rising number of natural disasters has meant an increased reliance by state, local, and tribal entities on federal funding and resources.

For instance:

  • The 2017 Hurricanes Harvey, Irma, and Maria affected 47 million people and are among the top 5 costliest hurricanes ever recorded.
  • Hurricanes Florence and Michael in 2018 caused nearly $50 billion worth of damage.
  • The Camp Fire in northern California in 2018 destroyed over 18,000 buildings and was the costliest and deadliest wildfire in California’s history.
  • Federal funding for disaster assistance has totaled at least $460 billion since 2005.

In today’s WatchBlog, we look at some of our latest work on FEMA’s readiness to respond to emergencies and how it could improve its efforts. You can also tune in to our podcast, the Watchdog Report, to learn more.

Time Line of Key Major Disasters during the 2017 and 2018 Disaster Seasons

Preparedness planning

FEMA uses the National Preparedness System to help assess the nation’s emergency preparedness. The system is meant to help prioritize the use of federal grants that are given to states and local communities to fill gaps in their capacity to respond to emergencies.

FEMA is taking steps to strengthen this system. For instance, it’s planning to collect more data on capabilities at the state, territory, and local levels. FEMA also plans to begin assessing the federal government’s capabilities.

However, we found that the agency has yet to determine what steps are needed to address capability gaps once they have been identified. We recommended it do so and inform key stakeholders, such as Congress, about what resources will be needed across all levels of government.

Hurricane Florence caused significant flooding in and around New Hanover County, North Carolina.

Disaster workforce staffing

We also looked at how well FEMA is staffed to respond to a crisis. During the 2017 and 2018 disaster seasons, FEMA deployed 14,684 and 10,328 personnel, respectively. FEMA employs a broadly skilled workforce of everything from social workers to engineers. But the agency has struggled with having enough people with the right skills needed to respond to crises.

FEMA matches field requests for positions using an automated system that identifies staff qualifications. However, we found that FEMA did not provide reliable staffing information to field officials to ensure its workforce was being used effectively. For example, during the 2017 and 2018 disaster seasons, some deployed FEMA staff who were designated as “qualified” did not have the skills or experience to effectively perform their positions.

We recommended that FEMA develop a plan to provide reliable staffing information to field officials.

To learn more about our work on FEMA, please check out our website.

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