High containment laboratories: recent incidents of biosafety lapses – US Government Accountability Office – 16 July 2014

Posted on July 22, 2014. Filed under: Occupational Hlth Safety, Pathology | Tags: |

High containment laboratories: recent incidents of biosafety lapses – US Government Accountability Office – 16 July 2014

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Electronic health record programs: Participation Has Increased, but Action Needed to Achieve Goals, Including Improved Quality of Care – GAO [US] – March 2014

Posted on March 10, 2014. Filed under: Clin Governance / Risk Mgmt / Quality, Health Informatics | Tags: |

Electronic health record programs: Participation Has Increased, but Action Needed to Achieve Goals, Including Improved Quality of Care – GAO [US] – March 2014

Government Accountability Office

“What GAO Recommends

GAO recommends that HHS develop a comprehensive strategy to better ensure the reliability of CQM data collected using EHRs and develop and use outcome-oriented performance measures to monitor progress toward goals. HHS agreed data reliability and performance monitoring are important but neither agreed nor disagreed with GAO’s reco

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Drug Shortages: public health threat continues, despite efforts to help ensure product availability – GAO – February 2014

Posted on February 12, 2014. Filed under: Pharmacy | Tags: , |

Drug Shortages: public health threat continues, despite efforts to help ensure product availability – GAO – February 2014

Drug Shortages Continue to Vex Doctors – New York Times – 10 February 2014

“Despite efforts by the Obama administration to ease shortages of critical drugs, shortfalls have persisted, forcing doctors to resort to rationing in some cases or to scramble for alternatives, a government watchdog agency said on Monday. The number of annual drug shortages — both new and continuing ones — nearly tripled from 2007 to 2012.

In recent years, drug shortages have become an all but permanent part of the American medical landscape. The most common ones are for generic versions of sterile injectable drugs, partly because factories that make them are aging and prone to quality problems, causing temporary closings of production lines or even entire factories.

The analysis by the United States Government Accountability Office, released Monday, was required by a 2012 law that gave the Food and Drug Administration more power to manage shortages. The watchdog agency was designated to evaluate whether the F.D.A. had improved its response to the problem, among other things.

The accountability office concluded that the F.D.A. was preventing many more shortages now than in the past — 154 potential shortages in 2012 compared with just 35 in 2010 — but that the total number of shortages has continued to grow. In 2012, the number of drugs in short supply, both new and long-term, was 456, the report said, up from 154 in 2007. Such drugs now include the heart medicine nitroglycerin, and cisatracurium, which is used to paralyze muscles during surgery and for patients on ventilators.

“We are at a public health crisis when we don’t have the medicines to treat acutely ill patients and we don’t have the basics like intravenous fluids,” said Erin Fox, a drug expert at the University of Utah whose data was used in the analysis. The most acute shortage now is that of basic IV fluids, she said.”

… continues on the site

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National Preparedness: Countermeasures for Thermal Burns – GAO – 22 February 2012

Posted on February 29, 2012. Filed under: Disaster Management | Tags: |

National Preparedness: Countermeasures for Thermal Burns – GAO – 22 February 2012

Summary

Extract

“The Department of Health and Human Services (HHS) is the federal agency primarily responsible for identifying and supporting the development and acquisition of the medical countermeasures needed to prevent or mitigate potential health effects from exposure to chemical, biological, radiological, and nuclear (CBRN) agents and other terrorist threats. In addition to identifying these countermeasures, including those for thermal burns, HHS also has responsibility for engaging with industry to research and develop them and, ultimately, for acquiring them for the U.S. Strategic National Stockpile (SNS), if appropriate.”

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Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices – GAO [US] – 13 January 2012

Posted on February 9, 2012. Filed under: Health Economics, Health Technology Assessment | Tags: , |

Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices – GAO [US] – 13 January 2012

Government Accountability Office

full text

“What GAO Found

From 2004 through 2009, expenditures for hospital IMD procedures increased from $16.1 billion to $19.8 billion, an increase of 4.3 percent per year—a rate equal to that of Medicare spending for other hospital procedures. While cardiac and orthopedic procedures accounted for nearly all IMD-related expenditures, orthopedic procedures accounted for most of the increase in such expenditures during this period. Utilization increased at a faster rate for orthopedic devices and accounted for the majority of changes in expenditures for IMD procedures during the period.

The information GAO obtained on the amounts hospitals paid for selected IMDs showed substantial variation.”

… continues

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Antibiotics. FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information – GAO – January 2012

Posted on February 2, 2012. Filed under: Pharmacy | Tags: , , |

Antibiotics. FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information – GAO – January 2012

“What GAO Found

FDA has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints. FDA designates certain drugs as “reference-listed drugs” and the sponsors of these drugs play an important role in ensuring the accuracy of drug labels. Reference-listed drugs are approved drug products to which generic versions are compared. As of November 2011, FDA had not yet confirmed whether the breakpoints on the majority of reference-listed antibiotics labels were up to date. FDA contacted sponsors of 210 antibiotics in early 2008 to remind sponsors of the importance of maintaining their labels and requested that they assess whether the breakpoints on their drugs’ labels were up to date. Sponsors were asked to submit evidence to FDA showing that the breakpoints were either current or needed revision. As of November 2011, over 3.5 years after FDA contacted sponsors, the agency had not yet confirmed whether the breakpoints on the labels of 70 percent, or 146 of the 210 antibiotics, were up to date.”  … continues

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Health care quality measurement: HHS should address contractor performance and plan for needed measures – GAO – US Government Accountability Office – January 2012

Posted on January 23, 2012. Filed under: Clin Governance / Risk Mgmt / Quality | Tags: , |

Health care quality measurement: HHS should address contractor performance and plan for needed measures – GAO – US Government Accountability Office – January 2012

“What GAO Found
National Quality Forum (NQF) has made progress on projects under its contract activities, as of August 2011. Specifically, NQF has completed or made progress on 60 of 63 projects. For example, NQF has completed projects to endorse measures related to various topics, including nursing homes. However, for more than half of the projects, NQF did not meet or did not expect to meet the initial time frames approved by HHS.”  … continues

“GAO recommends HHS: (1) use all monitoring tools required under the contract to help address NQF’s performance, (2) complete testing of retooled measures, and (3) comprehensively plan for its quality measurement needs. HHS neither agreed nor disagreed with these recommendations.”

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Information Technology: Critical Factors Underlying Successful Major Acquisitions – US Government Accountability Office – 21 October 2011

Posted on November 23, 2011. Filed under: Health Informatics | Tags: |

Information Technology: Critical Factors Underlying Successful Major Acquisitions – US Government Accountability Office – 21 October 2011

Summary

“Planned federal information technology (IT) spending has now risen to at least $81 billion for fiscal year 2012. As GAO has previously reported, although a variety of best practices exists to guide their successful acquisition, federal IT projects too frequently incur cost overruns and schedule slippages while contributing little to mission-related outcomes. Recognizing these problems, the Office of Management and Budget (OMB) has launched several initiatives to improve the oversight and management of IT investments. GAO was asked to identify (1) federal IT investments that were or are being successfully acquired and (2) the critical factors that led to the successful acquisition of these investments. To do this, GAO interviewed agency officials from selected federal departments responsible for each investment. In commenting on a draft of GAO’s report, three departments generally agreed with the report. OMB and the other departments either provided minor technical comments, or stated that they had no comments at all.

According to federal department officials, the following seven investments were successfully acquired in that they best achieved their respective cost, schedule, scope, and performance goals: (1) Department of Commerce’s Decennial Response Integration System; (2) Department of Defense’s Global Combat Support System-Joint, Increment 7; (3) Department of Energy’s Manufacturing Operations Management (MOMentum) Project; (4) Department of Homeland Security’s Western Hemisphere Travel Initiative; (5) Department of Transportation’s Integrated Terminal Weather System; (6) Department of the Treasury’s Customer Account Data Engine 2 (CADE 2); and (7) Department of Veterans Affairs’ Occupational Health Record-keeping System. Department officials identified nine common factors that were critical to the success of three or more of the seven investments: (1) Program officials were actively engaged with stakeholders; (2) Program staff had the necessary knowledge and skills; (3) Senior department and agency executives supported the programs; (4) End users and stakeholders were involved in the development of requirements; (5) End users participated in testing of system functionality prior to formal end user acceptance testing; (6) Government and contractor staff were stable and consistent; (7) Program staff prioritized requirements; (8) Program officials maintained regular communication with the prime contractor; and (9) Programs received sufficient funding. Officials from all seven investments cited active engagement with program stakeholders as a critical factor to the success of those investments. Agency officials stated that stakeholders regularly attended program management office sponsored meetings; were working members of integrated project teams; and were notified of problems and concerns as soon as possible. Implementation of these critical factors will not necessarily ensure that federal agencies will successfully acquire IT systems because many different factors contribute to successful acquisitions. Nonetheless, these critical factors support OMB’s objective of improving the management of large-scale IT acquisitions across the federal government, and wide dissemination of these factors could complement OMB’s efforts.”

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Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy – GAO [US] – 31 October 2011

Posted on November 3, 2011. Filed under: Public Hlth & Hlth Promotion | Tags: , |

Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy – GAO [US] – 31 October 2011

Source: Government Accountability Office

“Recommendations for Executive Action

Recommendation: In order to help build and maintain a national biosurveillance capability in a manner that accounts for the particular challenges and opportunities of reliance on state and local partnerships, the Homeland Security Council should direct the National Security Staff to ensure that the national biosurveillance strategy (1) incorporates a means to leverage existing efforts that support nonfederal biosurveillance capabilities, (2) considers challenges that nonfederal jurisdictions face in building and maintaining biosurveillance capabilities, and (3) includes a framework to develop a baseline and gap assessment of nonfederal jurisdictions’ biosurveillance capabilities as part of its implementation of our previous recommendation for a national biosurveillance strategy.

Agency Affected: Executive Office of the President: Homeland Security Council

Status: In process”

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Improved Oversight and Compliance Needed for Physician Credentialing and Privileging Processes – US GAO – January 2010

Posted on January 7, 2010. Filed under: Medicine | Tags: |

Improved Oversight and Compliance Needed for Physician Credentialing and Privileging Processes – US GAO – January 2010   –  United States Government Accountability Office

GAO Highlights

“Why GAO Did This Study

VA has policies to ensure that physicians have appropriate qualifications and clinical abilities through the processes of credentialing, privileging, and continuous monitoring of performance. Results of a VA investigatory report in 2008 cited deficiencies in the Marion, Illinois, VA medical center’s (VAMC) credentialing and privileging processes and oversight of its surgical program. This report examines VA’s policies and guidance to help ensure that information about physician qualifications and performance is accurate and complete, VAMCs’ compliance with selected VA credentialing and privileging policies, and their implementation of VA policies to continuously monitor performance. GAO reviewed VA’s policies, interviewed VA officials, and reviewed a judgmental sample of 30 credentialing and privileging files at each of six VAMCs that GAO visited. GAO selected the files to ensure inclusion of highly paid specialties, newly hired physicians, and other physician characteristics. GAO selected the judgmental sample of six VAMCs based on geographic balance and other factors.

What GAO Recommends

GAO recommends that VA develop a formal mechanism to systematically review VAMC credentialing and privileging files and performance monitoring for compliance with VA policies. VA agreed with GAO’s findings and recommendations.”

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Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to Be Addressed – US GAO – 29 July 2009

Posted on July 31, 2009. Filed under: Infectious Diseases, Influenza A(H1N1) / Swine Flu | Tags: , |

Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to Be Addressed – Statement of Bernice Steinhardt Director, Strategic Issues, US Government Accountability Office – 29 July 2009  30p.

Why GAO Did This Study

As the current H1N1 outbreak underscores, an influenza pandemic remains a real threat to our nation. Over the past 3 years, GAO conducted a body of work, consisting of 12 reports and 4 testimonies, to help the nation better prepare for a possible pandemic. In February 2009, GAO synthesized the results of most of this work and, in June 2009, GAO issued an additional report on agency accountability for protecting the federal workforce in the event of a pandemic. GAO’s work points out that while a number of actions have been taken to plan for a pandemic, including developing a national strategy and implementation plan, many gaps in pandemic planning and preparedness still remain.

This statement covers six thematic areas: (1) leadership, authority, and coordination; (2) detecting threats and managing risks; (3) planning, training, and exercising; (4) capacity to respond and recover; (5) information sharing and communication; and (6) performance and accountability.

What GAO Recommends

This statement discusses the status of GAO’s prior recommendations on the nation’s planning and preparedness for a pandemic. Key open recommendations concern the need to exercise the shared federal leadership roles for a pandemic, address planning gaps at all levels of government and in the private sector, and monitor and report on agencies’ plans to protect their workers.”

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Hospital Emergency Departments: Crowding Continues to Occur, and Some Patients Wait Longer than Recommended Time Frames – US Government Accountability Office – April 2009

Posted on June 11, 2009. Filed under: Emergency Medicine | Tags: |

Hospital Emergency Departments: Crowding Continues to Occur, and Some Patients Wait Longer than Recommended Time Frames – US Government Accountability Office – April 2009 report  GAO-09-347 – 58 p.

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