Hospital Pharmacist to Plead Guilty to Attempting to Spoil Hundreds of COVID Vaccine Doses

A Wisconsin pharmacist has agreed to plead guilty to charges filed today in federal court that he attempted to render hundreds of doses of COVID-19 vaccine ineffective.

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    In Crime News
    A dual Venezuelan-Italian citizen who controlled multiple companies via U.S. based bank accounts was charged in an indictment returned Tuesday for his role in laundering the proceeds of inflated contracts that were obtained by making bribe payments to officials at Venezuela’s state-owned and state-controlled energy company Petróleos de Venezuela S.A. (PDVSA).
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  • GAO Audits Involving DOD: Status of Efforts to Schedule and Hold Timely Entrance Conferences
    In U.S GAO News
    GAO began 42 new audits that involved the Department of Defense (DOD) in the third quarter of fiscal year 2020. Of the 42 requested entrance conferences (i.e., initial meetings between agency officials and GAO staff) for those audits, DOD scheduled 41 within 14 days of notification and held all 42 entrance conferences within 30 days of notification. Scheduling was delayed for one entrance conference, which was scheduled 21 days after notification, because DOD and GAO were working to reach agreement on the primary action officer, which is the appropriate office or component within the department that coordinates DOD's response to the audit. The entrance conference was held 8 days after it was scheduled. Entrance conferences allow GAO to communicate its audit objectives and enable agencies to assign key personnel to support the audit work. GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO evaluates the extent to which DOD scheduled entrance conferences within 14 days of receiving notice of a new audit, consistent with GAO's agency protocols, and held those conferences within 30 days. This is the third of four quarterly reports that GAO will produce on this topic for fiscal year 2020. In the first two quarterly reports, GAO found that DOD had improved its ability to meet the protocol target. GAO analyzed data on GAO audits involving DOD and initiated in the third quarter of fiscal year 2020 (April 1, 2020, through June 30, 2020). Specifically, GAO identified the number of notification letters requesting entrance conferences that were sent to DOD during that time period. GAO determined the number of days between when DOD received the notification letter for each new audit and when DOD scheduled the entrance conference and assessed whether DOD scheduled entrance conferences within 14 days of notification, which is the time frame identified in GAO's agency protocols. GAO also determined the date that each requested entrance conference was held by collecting this information from the relevant GAO team for each audit and assessed whether DOD held entrance conferences for new audits within 30 days of notification, which was the time frame identified in the mandate for this review For more information, contact Elizabeth Field at (202) 512-2775 or Fielde1@gao.gov.
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    In Crime News
    On Thursday, a federal court in the Southern District of Florida held two individuals, as well as the company they allegedly co-own, in contempt for violating a preliminary injunction that restricted their tax preparation activities. The court’s order notes defendants “admit that sufficient evidence exists to hold them in contempt of court for violating the preliminary injunction.”
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  • Aviation Sanitation: FDA Could Better Communicate with Airlines to Encourage Voluntary Construction Inspections of Aircraft Galleys and Lavatories
    In U.S GAO News
    Most commercial aircraft undergo voluntary inspections to ensure that galleys and lavatories are constructed and assembled to meet the Food and Drug Administration's (FDA) sanitation standards, according to industry representatives. Twenty-seven percent of the inspections FDA conducted between fiscal years 2015 and 2019 found objectionable conditions. But in nearly all of these instances, the conditions identified, such as the need for additional sealant in areas where there was a gap or seam, were corrected by the airline or aircraft manufacturer during the inspection. However, some regional airline representatives told GAO that their aircraft do not receive these construction inspections, either because larger airlines with which they have contracts told them the inspections were unnecessary or because they did not believe the inspections were relevant to them. FDA provides these inspections free of charge, upon request of aircraft manufacturers or airlines, and aircraft passing inspection receive a certificate of sanitary construction. Representatives of one aircraft manufacturer said they view the certificate as beneficial because their customers see it as a guarantee that the aircraft was constructed in a way that decreases the likelihood of microbial contamination, pests, and insects. While the construction inspections are important, they are not required, and FDA does not proactively encourage airlines to request them. By developing a process for communicating directly to all U.S.-based commercial airlines, including regional airlines, to encourage them to receive construction inspections, FDA could better ensure that aircraft meet FDA sanitation standards to protect passenger health. An Airline Representative Applying Additional Sealant in Response to an FDA Inspection FDA faces several challenges in providing construction inspections and is taking steps to address these challenges. For example, the demand for inspections by manufacturers and airlines is unpredictable, and FDA inspectors are responsible for inspections at multiple locations. To help mitigate these challenges, officials we interviewed from four FDA field offices said they usually request advance notice from industry to allow the agency time to allocate the necessary resources for construction inspections. Voluntary construction inspections are the primary mechanism by which FDA oversees compliance with its required sanitation standards for the construction of aircraft galleys and lavatories. A report accompanying the House 2019 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill included a provision for GAO to review FDA's process for ensuring proper sanitation in aircraft galleys and lavatories. This report (1) examines the extent to which aircraft are inspected to ensure compliance with FDA's sanitation standards, and (2) discusses challenges FDA faces in providing aircraft inspections and how FDA is addressing such challenges. GAO reviewed FDA guidance, interviewed FDA officials in headquarters and four selected field offices with high volumes of construction inspections, conducted site visits to meet with FDA inspectors, and interviewed representatives of selected aircraft manufacturers and airlines. GAO recommends that FDA develop a process for communicating directly with all U.S.-based commercial airlines to encourage them to request construction inspections. FDA generally agreed with our recommendation. For more information, contact Steve Morris (202) 512-3841 MorrisS@gao.gov.
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  • Federal Contracting: Actions Needed to Improve Department of Labor’s Enforcement of Service Worker Wage Protections
    In U.S GAO News
    The Department of Labor (DOL) completed over 5,000 Service Contract Act (SCA) cases, which for many resulted in the awarding of back wages to federally contracted security guards, janitors, and other service workers, in fiscal years 2014 through 2019, according to available data. DOL enforces the SCA, which was enacted to protect workers on certain types of federal service contracts. DOL found SCA violations—primarily of wage and benefit protections—in 68 percent of cases. Employers across a range of service industries agreed to pay around $224 million in back wages (see figure for examples). Sixty cases resulted in debarment—a decision to prevent an employer from being awarded new federal contracts for 3 years. DOL's strategic plan emphasizes optimizing resources for resolving cases using all available enforcement tools. However, DOL does not analyze its use of enforcement tools, such as debarment or employer compliance agreements. Therefore, DOL may lack a complete picture of how it uses resources on different strategies for resolving SCA cases, as well as the effectiveness of these enforcement strategies. Back Wages Paid for SCA Cases in Example Industries, Fiscal Years 2014-2019 Note: Mail haul refers to surface mail transportation by contract carriers. Values are adjusted for inflation and expressed in fiscal year 2019 dollars using the Gross Domestic Product Price Index from the U.S. Department of Commerce, Bureau of Economic Analysis. DOL reported various challenges to enforcing the SCA, including difficulty communicating with contracting agencies. For example, DOL officials told GAO that poor communication with contracting agencies—particularly with the U.S. Postal Service (USPS)—can affect and delay cases, though USPS officials told GAO they were unaware of any communication gaps. Without addressing communication issues between USPS and DOL, USPS's implementation and DOL's enforcement of the SCA may be weakened. GAO found that contracting agencies may face SCA implementation challenges, including not having key information about SCA debarments and violations from DOL. When recording SCA debarments, DOL does not always include the unique identifier for an employer so that contracting agencies can accurately identify debarred firms. DOL also does not have a process that consistently or reliably informs contracting agencies about SCA violations by employers. Without improved information sharing by DOL, an agency may award a contract to an employer without being aware of or considering its past SCA violations. The SCA ensures that service workers on certain federal contracts receive pay and benefits that reflect current employment conditions in their locality. From fiscal years 2014 through 2019, the U.S. government obligated over $720 billion on service contracts covered under the SCA. GAO was asked to review SCA implementation and enforcement. This report examines (1) what available data reveal about past SCA cases, (2) what challenges DOL reports facing in enforcing the SCA, and (3) how contracting agencies implement the SCA. GAO analyzed DOL and federal procurement data for fiscal years 2014 through 2019, the most recent years available; reviewed a nongeneralizable sample of contract performance assessments; examined practices at three agencies selected to represent a range of contracting services and agency size; interviewed DOL officials; and reviewed relevant federal laws, policy, and guidance. GAO is making six recommendations, including that DOL analyze its use of enforcement tools; that DOL and USPS implement written protocols to improve communication with each other; and that DOL improve its information sharing with contracting agencies on SCA debarments and investigation outcomes. DOL and USPS generally concurred with the recommendations. For more information, contact Thomas M. Costa at (202) 512-7215 or costat@gao.gov.
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    In Crime News
    An indictment returned by a federal grand jury in Washington, D.C. was unsealed on May 20, 2021, charging the Republic of Chad’s former Ambassador to the United States and Canada and Chad’s former Deputy Chief of Mission for the United States and Canada with soliciting and accepting a $2 million bribe from a Canadian start-up energy company, and conspiring to launder the bribe payment in order to conceal its true nature.
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  • Justice Department Applauds Passage of the Criminal Antitrust Anti-Retaliation Act
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    A former U.S. resident and taxpayer was sentenced in the Southern District of New York to four years in prison for wire fraud, tax fraud, money laundering, false statements, and other charges.
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    Two individuals were charged in an indictment that was unsealed today for their alleged participation in a scheme to obtain, through multiple fraudulent loan applications, more than $1.7 million in COVID-19 relief guaranteed by the Small Business Administration through the Paycheck Protection Program (PPP) under the Coronavirus Aid, Relief and Economic Security (CARES) Act.
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  • Justice Department Files Lawsuit Against Village of Airmont, New York, for Zoning Restrictions that Target the Orthodox Jewish Community
    In Crime News
    The Justice Department today announced that it filed a lawsuit against the Village of Airmont, New York, alleging that it violated the Religious Land Use and Institutionalized Persons Act (RLUIPA) by targeting the Orthodox Jewish community through zoning ordinances restricting religious schools and home synagogues, and by enforcing its zoning code in a discriminatory manner to prevent Orthodox Jews from using their property consistent with their faith. 
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    “Four federal judges and three family members have been killed since 1979. These horrific tragedies must stop,” Judge David W. McKeague told the Judicial Conference of the United States today.
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  • Public Health Preparedness: Information on the Use of Medical Reserve Corps Volunteers during Emergencies
    In U.S GAO News
    Almost all states have a network of health care volunteers—the Medical Reserve Corps—who can augment federal, state, and local capabilities in response to public health emergencies, such as those arising from wildfires and hurricanes, and infectious disease outbreaks. Having sufficient, trained personnel, such as these volunteers, is critical to a state's capability to respond and recover from public health emergencies. According to federal data, 48 states and the District of Columbia reported 102,767 health care volunteers in 838 Medical Reserve Corps units as of September 2019, with nurses making up 43 percent. Number of Medical Reserve Corps Volunteers by Type, as of September 2019 Note: These data illustrate 90 percent of total health care volunteers. The remaining five types volunteers each make up less than 5 percent of the total. Other Public Health Medical volunteers may include cardiovascular technicians, sonographers, and phlebotomists. Medical Reserve Corps volunteers in states included in GAO's review—Alabama, California, North Carolina, and New Mexico—were deployed in response to natural disasters in 2018 and 2019, migrants at the southern border in 2019, and COVID-19 in 2020. Department of Health and Human Services (HHS) documentation shows these volunteers performed a variety of health care activities, such as providing medical services, setting up and providing support at shelters, and distributing medical supplies. Volunteers from these four states and others also participated in the response to COVID-19 by supporting testing sites, collecting specimens, and performing administrative tasks, such as data entry. For example, one unit deployed four volunteers a day for 3 days to work alongside nurses at a drive-through testing site. In addition to responding to public health emergencies, volunteers participated in preparedness activities, such as an initiative to train the public on how to respond to emergencies. HHS oversees the Medical Reserve Corps program and has assisted units in developing their volunteer capabilities. For example, HHS funded the development of a checklist of activities that should occur during volunteer deployment such as re-verifying medical credentials; provided training to new unit leaders on developing, managing, and sustaining Medical Reserve Corps units; and issued generally accepted practices, such as periodically re-evaluating volunteer recruitment procedures. The Medical Reserve Corps consists of health care volunteers—medical and public health professionals—who donate their time to help strengthen a response to public health emergencies and build community resilience. These volunteers prepare for and respond to public health emergencies, which may include natural disasters—such as hurricanes and wildfires—as well as disease outbreaks, whether intentional or natural. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review states' use of health care volunteers during public health emergencies. This report describes (1) the number and type of Medical Reserve Corps volunteers; (2) the types of public health emergencies volunteers have participated in; and (3) how HHS has assisted in developing volunteer capabilities. To conduct this work, GAO analyzed data reported to HHS as of September 2019; reviewed HHS documentation on four states' use of volunteers, which GAO selected based on population, number of volunteers, and event; and interviewed officials from HHS who oversee the Medical Reserve Corps program. GAO plans to further examine how states have used health care volunteers to respond to public health emergencies, including COVID-19, and any associated challenges to doing so in a future report. GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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  • Transportation Research: Additional Actions Could Improve DOT’s Internal Collaboration and Reliability of Information on Research Activities
    In U.S GAO News
    The Department of Transportation (DOT) uses a multistep, centralized process to prioritize and select research activities it will fund. DOT's modal administrations—which focus on specific modes of transportation like air, rail, and highways—conduct and manage most of DOT's research. The modal administrations GAO spoke to used a variety of methods to prioritize and select research, including soliciting stakeholders' feedback on research needs. The Office of the Assistant Secretary for Research and Technology (OST-R) is responsible for reviewing this proposed research to ensure alignment with DOT's strategic plans and to prevent duplicative research efforts, as required by statute. DOT has multiple efforts to facilitate research collaboration both externally and internally, but in guidance to promote collaboration, OST-R did not incorporate all leading practices. Specifically, OST-R established topical-research working groups on 12 multimodal subject areas in October 2018 and issued accompanying guidance. This guidance incorporated some leading collaboration practices, such as directing working groups to identify leadership roles and relevant participants. However, the guidance did not incorporate two leading practices—defining and monitoring progress toward long-term outcomes and regularly updating and monitoring written agreements. Taking steps to ensure the working groups follow these practices could provide OST-R greater assurance that the groups coordinate their efforts effectively, better plan long-term research, and better position themselves to address future transportation challenges. OST-R has taken some steps to help ensure that its public database on DOT-funded research projects (the Research Hub) contains complete and accurate information, as required by DOT's data management policy; however, data reliability issues remained. For example, as of July 2019—the latest available data at the time of GAO's analysis—36 percent of records in the database were missing research partners' contact information, hindering the research community's ability to obtain current project details. Taking additional steps, such as providing instructions to the modal administrations on how to improve the completeness and accuracy of the information they give OST-R for the Research Hub, would help ensure the database is fulfilling DOT's intended purpose that it serve as a reliable source of information on the department's research portfolio. Examples of Research Activities on Advanced Driver-Assistance Systems and Connected Vehicles Funded by the U.S. Department of Transportation DOT's research activities are critical to DOT's mission to make the nation's transportation system safer and more efficient. To meet current research needs and prepare for emerging technologies, DOT partners with public and private entities. In fiscal year 2018, DOT funded about 2,300 partners and had a research budget exceeding $1 billion. GAO was asked to review DOT's research activities. This report addresses: (1) how DOT prioritizes and selects which research activities it will undertake; (2) the extent to which DOT facilitates research collaboration with external stakeholders and across the department; and (3) the extent to which DOT ensures its Research Hub database contains complete and accurate project information. GAO reviewed documents and analyzed data from DOT; observed DOT-funded research; interviewed DOT officials from OST-R and four selected modal administrations; and used GAO's leading collaboration practices to assess the extent of collaboration. GAO also interviewed 17 DOT research partners, including universities and associations. GAO recommends that OST-R (1) take steps to ensure the topical-research working groups follow all leading collaboration practices, and (2) take additional steps to ensure the information in the Research Hub is complete and accurate. DOT concurred with GAO's recommendations. For more information, contact Elizabeth Repko at (202) 512-2834 or repkoe@gao.gov.
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  • Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas
    In U.S GAO News
    What GAO Found Nationwide data from the Centers for Disease Control and Prevention's (CDC) Pregnancy Mortality Surveillance System from 2011-2016, the most recent data available at the time of GAO's review, indicate that deaths during pregnancy or up to 1 year postpartum due to pregnancy-related causes—are higher in rural areas compared to metropolitan areas. See figure. CDC data also showed higher mortality in underserved areas (areas with lower numbers of certain health care providers per capita). Pregnancy-Related Mortality Ratios in Rural and Metropolitan Areas, 2011-2016 Note: Micropolitan areas include counties with populations of 2,500 to 49,999. Noncore areas include nonmetropolitan counties that do not qualify as micropolitan. GAO also analyzed the most recent annual data available from the Agency for Healthcare Research and Quality for 2016-2018 on severe maternal morbidity (SMM)—unexpected outcomes of labor and delivery resulting in significant health consequences. Nationwide, these data showed higher estimated rates of SMM in metropolitan areas (72.6 per 10,000 delivery hospitalizations) compared to rural areas (62.9 per 10,000). CDC and another Department of Health and Human Services (HHS) agency, the Health Resources and Services Administration (HRSA), fund several maternal health programs that aim to reduce maternal mortality and SMM, including some that target rural or underserved areas. CDC and HRSA collect program data, such as the percentage of women who received postpartum visits, to track progress in improving maternal health, but they do not systematically disaggregate and analyze program data by rural and underserved areas. By taking these actions, CDC and HRSA could help better ensure that program funding is being used to help address any needs in these areas. HHS has taken actions to improve maternal health through its funding of various programs and releasing an action plan in 2020. HHS also has two workgroups that aim to coordinate across HHS agencies on maternal health efforts, such as program activities that aim to reduce maternal mortality and SMM. Officials from HHS's two workgroups said they coordinated in developing the action plan, but they do not have a formal relationship established to ensure ongoing coordination. Officials from one of the workgroups noted that they often have competing priorities and do not always coordinate their efforts. By more formally coordinating their efforts, HHS's workgroups may be in a better position to identify opportunities to achieve HHS's action plan goal for reducing maternal mortality and objectives that target rural and underserved areas. Why GAO Did This Study Each year in the United States, hundreds of women die from pregnancy-related causes, and thousands more experience SMM. Research suggests there is a greater risk of maternal mortality and SMM among rural residents and that underserved areas may lack needed health services. GAO was asked to review maternal mortality and SMM outcomes in rural and underserved areas. This report examines, among other objectives, what is known about these outcomes; selected CDC and HRSA programs that aim to reduce these outcomes, as well as actions to collect and use relevant data; and the extent to which HHS is taking actions to improve maternal health and monitoring progress on its efforts. GAO analyzed HHS data, agency documentation, literature, and interviewed officials from a non-generalizable sample of three states and stakeholders to capture various perspectives.
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