Research on Health Costs, Quality, and Outcomes (HCQO) (continued)

Patient Safety

FY 2009 Authorization: Title III and IX and Section 937(c) of the Public Health Service Act.

Allocation Method: Competitive Grant/co-operative agreement, Contracts, and Other.

1. Congress appropriated $41,889,000 for Patient Safety Threats and Medical Errors (which includes $17,304,000 for Healthcare-Associated Infections) and $7,000,000 for the Patient Safety Organizations.

A. Program Description and Accomplishments

The Patient Safety Program comprises two key components: (1) coordination of support for the creation, synthesis, dissemination, implementation, and use of knowledge about patient safety threats and medical errors and (2) operation of a program to establish Patient Safety Organizations (PSOs), which are a fundamental element of the Patient Safety and Quality Improvement Act (Patient Safety Act) of 2005. The Patient Safety Act provided needed protection (privilege) to providers throughout the country for quality and safety review activities. The Act promotes increased patient safety event reporting and analysis, as event information reported to a PSO is protected from disclosure in medical malpractice cases. This legislation is anticipated to support and spur advancement of a culture of safety in health care organizations across the country. AHRQ administers the provisions of the Patient Safety Act dealing with PSO operations. The Department of Health and Human Services (HHS) has issued regulations to implement the Patient Safety Act, which authorizes the creation of Patient Safety Organizations. The final rule became effective on January 19, 2009.

The Patient Safety Program's goal as stated historically is to prevent, mitigate, and decrease the number of medical errors, patient safety risks and hazards, and quality gaps associated with health care and their harmful impact on patients. The Program funds grants, contracts, and interagency agreements (IAAs) to support projects that identify the threats; identify and evaluate effective practices; educate, disseminate, and implement to enhance patient safety and quality; and maintain vigilance.

The Patient Safety Program, which formally commenced in FY 2001, began with AHRQ awarding $50 million for 94 new projects aimed at reducing medical errors and improving patient safety. Throughout the past 8 years, AHRQ has funded many additional projects and initiatives in a number of areas of patient safety and health care quality. As a result, a large body of research continues to emerge, and numerous surveys, reporting and decision support systems, training and technical assistance opportunities, taxonomies, publications, tools, and presentations are available for general use. AHRQ has addressed these patient safety issues independently and in collaboration with public and private sector organizations.

Some relevant research findings and projects related to Patient Safety include:

Research Grants

• Through a study funded by AHRQ for which preliminary findings are currently available, it is estimated that 95 percent of hospitals have some type of reporting system. This is based on a nationally representative sample of 2,000 hospitals with an 81 percent survey response rate. Only about 12 percent of the respondents had a fully computerized system. (FY 2005 funding = $165,909.) Plans include a repeat survey of hospitals to update this estimate during FY 2009.
• In FY 2005, 17 Partnerships in Implementing Patient Safety two-year grants were awarded to assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. The majority of these grants are completed and the resultant tool kits are in the process of being made available to the public and/or further tested in different environments to identify what easily works and what challenges are faced by providers in implementing these safe practice intervention tool kits. (FY 2005 and FY 2006 funds = $4.7 million.)
• In September 2008, AHRQ awarded $3,708,799 for 13 risk-informed intervention grants. These 3-year projects build on previously funded risk assessment projects funded by AHRQ and support risk-informed development and implementation of safe practice interventions that have the potential of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care in the ambulatory setting. The objectives of the projects are to: (1) identify, develop, test, and implement safe practice interventions in ambulatory care settings, and (2) share the findings and lessons learned about the challenges and barriers to developing and implementing these interventions through toolkits. (Source: https://www.ahrq.gov/qual/risk08.htm.)

Training Programs

• The Patient Safety Improvement Corps (PSIC) is a partnership program between AHRQ and the Department of Veterans Affairs (VA). The primary goal is to improve patient safety by providing to teams of hospital and other staff, including patient safety officers and those responsible for patient safety reporting and analysis, as well as, intervention initiatives the knowledge and skills necessary to:
  • Conduct effective investigations of reports of medical errors (e.g., close calls, errors with and without patient injury) by identifying their root causes with an emphasis on underlying system causes.
  • Prepare meaningful reports on the findings.
  • Develop and implement sustainable system interventions based on report findings.
  • Measure and evaluate the impact of the safety intervention (i.e., that will mitigate, reduce, or eliminate the opportunity for error and patient injury).
  • Ensure the sustainability of effective safety interventions by transforming them into standard clinical practice.
• The PSIC program content includes a number of topics, tools, and methods designed to help participants reduce medical error and improve patient safety (e.g., patient safety science, human factors, root cause analysis, health care failure mode and effects analysis, probabilistic risk assessment, medical error reporting and analysis, measurement, evaluation, communication, leading and sustaining organizational change, safety culture assessment, high reliability organizations' characteristics and operations, TeamSTEPPS™ team training, mistake-proofing in the delivery of health care, just culture, and other topics such as the Patient Safety and Quality Improvement Act of 2005, patient safety organizations, patient safety indicators, and the National Healthcare Quality and National Healthcare Disparities Reports). (Source: https://www.ahrq.gov/about/psimpcorps.htm.)
• Each year, PSIC exceeded the target number of organizations targeted for training. With the fourth class, the PSIC has trained a team in every State in the United States. Additionally, AHRQ produced a PSIC DVD that provides a self-paced, modular approach to training individuals involved in patient safety activities at the institutional level. This interactive, 8-module DVD provides information on the investigation of medical errors and their root causes; identification, implementation, and evaluation of system-level interventions to address patient safety concerns; and steps necessary to promote a culture of safety within a hospital or other health care facility. (FY 2009 funding for PSIC = $300,000.)
• It has been an expectation that "graduates" from the PSIC program will both use their PSIC training to become change agents in their home organizations and go on to implement as well as train others using the knowledge, skills, and patient safety improvement techniques delivered in their PSIC training. For example, as a result of participating in the PSIC, the State of Maine, in 2008 and 2009, is attempting to train all hospitals in the use of TeamSTEPPS. The Connecticut Hospital Association and team members from the Connecticut Department of Public Health have also studied Connecticut's adverse event reporting system. This effort helped the Department of Public Health's Quality in Health Care Advisory Committee, which developed formal recommendations to enhance the effectiveness of the State's adverse event reporting system. The Committee's recommendations were incorporated in legislation enacted by the Connecticut legislature in May 2004. In October 2005, the New York State Department of Health rolled out their PSICbased training program including more than 700 people from the State's free-standing diagnostic and treatment centers (e.g., Ambulatory Surgery Centers, End Stage Renal Disease Dialysis Centers, Community Healthcare Centers) and selected Department of Health clinics. In Georgia, the Georgia Hospital Association (GHA) developed their PSIC based on GHA's staff participation in the 2004-2005 PSIC program. The GHA PSIC used 5 two-day face-to-face workshops, 8 Webinars, and 4 networking audio conferences. This training enabled the GHA PSIC program attendees to go back to their organizations, train additional staff, and implement patient safety improvement programs.

Resources/Tools

• AHRQ also supports the AHRQ Patient Safety Network (AHRQ PSNet). It is a national Webbased resource featuring the latest news and essential resources on patient safety. The site offers weekly updates of patient safety literature, news, tools, and meetings ("What's New"), and a vast set of carefully annotated links to important research and other information on patient safety ("The Collection"). Supported by a robust patient safety taxonomy and Web architecture, AHRQ PSNet provides powerful searching and browsing capabilities, as well as the ability for diverse users to customize the site around their interests (My PSNet). In addition, AHRQ funds the WebM&M (Morbidity and Mortality Rounds on the Web). WebM&M is an online journal and forum on patient safety and health care quality. This site features expert analysis of medical errors reported anonymously by readers, interactive learning modules on patient safety ("Spotlight Cases"), Perspectives on Safety, and forums for online discussion. Use of these sites has increased over the past 3 years, from approximately 57,000 Web sessions in April 2005, to more than 190,000 in April 2008. (Funding for the PSNet and WebM&M total $1.3 million in FY 2009.)
• In their 1999 report on medical errors, the Institute of Medicine (IOM) suggested that systemic failures were important underlying factors in medical error and that better teamwork and coordination could prevent harm to patients. The IOM recommended that health care organizations establish team training programs for personnel in critical care areas such as emergency departments, intensive care units, and operating rooms. As a follow up, AHRQ, in partnership with the Department of Defense, developed a teamwork training program, TeamSTEPPS™. It is an evidence-based teamwork system aimed at optimizing patient outcomes by improving communication and other teamwork skills among health care professionals. It includes a comprehensive set of ready-to-use materials and training curricula necessary to integrate teamwork principles successfully into an organization's health care system. TeamSTEPPS™ is presented in a multimedia format, with tools to help a health care organization plan, conduct, and evaluate its own team training program. It includes five components: (1) an instructor guide; (2) a multimedia resource kit including a CD-ROM and DVD with 9 video vignettes about how failures in teamwork and communication can place patients in jeopardy, and how successful teams can work to improve patient outcomes; (3) a spiral-bound pocket guide; (4) PowerPoint® presentations; and (5) a poster that tells staff that the organization is adopting TeamSTEPPS™. In addition, AHRQ has a technical assistance contract in place to support those interested in implementing TeamSTEPPS™. TeamSTEPPS National Implementation continues to grow and expand. As of the end of FY 2008, the project has trained or registered 651 individuals for TeamSTEPPS Master Trainers representing 147 different organizations across the United States. TeamSTEPPS is now part of the 9th Scope of Work for Quality Improvement Organizations (QIOs). All QIOs have received initial Master Team Training. To date, Master Trainers reported that they have trained 4,780 individuals from 119 organizations. (Technical assistance in FY 2008 and FY 2009.)

AHRQ Healthcare-Associated Infections (HAIs) Activities

The Agency has funded numerous projects to reduce HAIs, including MRSA infections. (Please note, in FY 2008 $5 million in funding for MRSA was funded under Crosscutting Activities.) Following are brief descriptions of some of these projects and initiatives.

• HAI ACTION Project. In September 2007, AHRQ awarded task orders to five Accelerating Change and Transformation in Organizations and Networks (ACTION) partners to mitigate HAIs at 34 hospitals. For 6 months, multidisciplinary teams at each hospital used AHRQsupported evidence-based tools for improving infection safety to facilitate changes in clinician behaviors and habits, care processes, and the safety culture. In addition, AHRQ has funded an assessment program, led by Indiana University, to coordinate project tasks and activities, provide technical assistance to the hospitals, and examine information gleaned from the project. Also, the Agency plans to develop an HAI project toolkit, which will include a case study for health care organizations interested in learning how the HAI project participants implemented infection safety training, the challenges they faced, and how they addressed them.
• Patient Safety Improvement Corps (PSIC) Fellowship Program on HAIs. The Patient Safety Improvement Corps (PSIC) is a partnership program between AHRQ and the Department of Veterans Affairs to improve patient safety by providing the knowledge and skills necessary to investigate medical errors and develop and evaluate sustainable system interventions to prevent them. The PSIC Fellowship Program on HAIs is a 1-day program to provide PSIC graduates with an overview of HAIs and to demonstrate different and successful approaches to prevention, reduction, or mitigation of HAIs from different perspectives including public and private hospital systems, communities, and regions.
• MRSA Collaborative Research Initiatives. In October 2007, Congress appropriated $5 million to AHRQ to identify and help suppress the spread of MRSA and related HAIs. Until then, the only large-scale study that had produced evidence on how to reduce serious HAIs and maintain that reduction was supported by AHRQ and carried out in 127 Michigan hospitals from 2003 to 2006. This new effort to reduce MRSA builds on that experience. In developing the action plan that AHRQ is funding, the Agency has worked in collaboration with the CDC and the Centers for Medicare & Medicaid Services (CMS). This action plan will use electronic and administrative data, surveillance, and implementation strategies to:
  • Reduce the burden of MRSA infections via novel interventions aimed at critical control points in a community/region.
  • Determine scope, risk factors, and control measures for hospital-acquired, community-onset MRSA infections.
  • Test methods to reduce hospitalization from community-acquired MRSA.
  • Understand the role of inter-facility MRSA transmission on overall infection rates.
  • Understand the role of nursing home transmission on overall rates and delineate interventions that are effective in reducing such transmission.
• Other proposed MRSA collaborative projects are as follows:
  • Reduction of Clostridium Difficile Infections in a Regional Collaborative of In-patient Health Care Settings.
  • Reducing the Overuse of Antibiotics by Primary Care Clinicians Treating Patients in Ambulatory and Long-term Care Settings.
  • Improving the Measurement of Surgical Site Infection (SSI) Risk Stratification and Outcome Detection.
  • Produce Rapid National, Regional and State-level Estimates of HAIs to Evaluate the Impact of Inter-Agency HAI Initiatives.
  • Reduction Of Infections Caused by Carbapenem Resistant Enterobacteriaceae (KPC producing organisms) Through Application Of Recently Developed CDC/HICPAC Recommendations

Patient Safety Act and PSOs

AHRQ, in conjunction with the Office of the Secretary and the Office of Civil Rights, has made significant progress in implementing the Patient Safety Act. On November 21, 2008, regulations to implement the Act were published, and the regulations became effective January 19, 2009. In addition, AHRQ has continued development of common definitions and reporting formats (Common Formats) to describe patient safety events. Promulgation of these Common Formats, which will allow aggregation and analysis of events collected by Patient Safety Organizations and national reporting annually on patient safety, was authorized by the Act. AHRQ announced the availability of Common Formats, v 0.1 beta, in a Federal Register notice at the end of August 2008.

Historically, the Patient Safety Program has concentrated most of its resources on evidence generation. While that activity continues to be important for AHRQ, increasingly, program support is moving more toward data development/reporting and dissemination/implementation as the Agency focuses on making demonstrable improvements in patient safety. This reporting and implementation focus has the advantage of providing a natural feedback loop that can highlight areas in which new evidence is most needed to address real quality and safety problems encountered by providers and patients. Additionally, most of the measures for the patient safety program have been modified to better reflect goals. The new measures, effective in FY 2008, are provided in the Performance Table below. The new measures better reflect an emphasis on implementation of evidence-based practices and reporting on their impact. Two of the measures also enable capture of information on two major new Agency initiatives (i.e., PSOs and HAIs).

Currently, only one Patient Safety measure has data to report for FY 2008. For measure 1.3.41, "Increase the number of tools that will be available in AHRQ's inventory of evidence-based tools to improve patient safety and reduce the risk of patient harm," a total of 73 tools are included in the inventory.

The Program took the following actions in 2008 to improve performance:

• Measuring the number of PSOs that become certified based on Patient Safety and Quality Improvement Act legislation. The list of certified PSOs is available on an ongoing basis as PSOs become listed.
• Establishing annual targets around the Patient Safety and Quality Improvement Act.
• Updating performance measures and targets. Patient Safety continues efforts to develop a data source to capture the use of AHRQ-supported tools. The program is writing a work assignment to identify and consolidate data collection into a single source.

The Patient Safety program underwent a program assessment in 2003, and was found to be performing adequately. The review cited improvements in the safety and quality of care as a strong attribute of the program. As a result of the program assessment, the program continued to take actions to prevent, mitigate and decrease the number of medical errors, patient safety risks and hazards associated with health care and their harmful impact on patients. The Patient Safety Program has also benefited from a robust effort aimed at evaluating the impact of projects that have been funded under this portion of AHRQ's budget. In April, summaries of the findings were published in a special issue of the journal Health Services Research. The contents include a description of the evaluation framework and approach, along with other articles that address AHRQ Contributions to patient safety knowledge, experiences with implementation research, the Patient Safety Improvement Corps, and trends and challenges in measuring safety outcomes.

B. Funding History

Funding for the Health Information Technology program during the last 5 years has been as follows:

C. Budget Request

The FY 2010 President's Budget Request level for Patient Safety Research is $48,889,000 the same level as the FY 2009 Omnibus Level. The Patient Safety Program is comprised of two research components: Patient Safety Threats and Medical Errors (including HAIs) and PSOs.

Patient Safety Threats and Medical Errors

The FY 2010 President's Budget Request level provides $41,889,000 million for patient safety threats and medical errors, including $17,304,000 for funds related to reducing Healthcare-Associated Infections (HAIs). This level will enable us to provide continued support for a number of ongoing research contracts, IAAs, and research grants including:

• The AHRQ PSNet and the AHRQ WebM&M, both of which have a growing user base and high levels of customer satisfaction based on annual customer satisfaction surveys.
• Patient safety grants focused on diagnostic error, ambulatory care patient safety intervention tool kit development, and CERTS pediatric patient safety.
• A follow-on effort to the PSIC "graduates" fellowship training.
• Patient safety evaluation activities.
• Patient safety implementation projects conducted through our ACTION program.
• TeamSTEPPS™ technical assistance
• Patient safety knowledge transfer projects

In terms of performance measures, in FY 2007 the patient safety portfolio was able to provide a baseline for the number of U.S. health care organizations using AHRQ-supported tools to improve patient safety - 382 hospitals. The FY 2008 target for this measure is 439 hospitals, increasing to 504 hospitals in FY 2009. In addition, AHRQ intends to increase the number of tools that will be available in AHRQ's inventory of evidence-based tools to improve patient safety and reduce the risk of patient harm. FY 2007 efforts focused on developing a baseline measure. The FY 2007 baseline for the inventory of evidence-based tools is 61 - AHRQ goal is to develop and additional 7 tools in 2008 (for a total of 68), 8 additional tools in FY 2009 (for a total of 76), and 10 additional tools in 2010 (for a total of 86).

As part of ongoing efforts aimed at reducing and eliminating HAIs, AHRQ has helped to coordinate and execute the Department of Health and Human Services National Action Plan related to healthcare-associated infections. In FY 2009, $17,304,000 in additional funds were made available for work in this important area. A portion of the additional funds will expand a multi-State project (from 10 States to approximately 30 States) to apply the approach that proved to be successful in the Michigan Keystone project to prevent central line associated blood stream infections (CLABSI). Significant reductions in these infections were achieved through a comprehensive unit-based surveillance program (CUSP) in intensive care units. AHRQ will continue funding HAIs at $17,304,000 at the FY 2010 President's Budget Request level. Possible topics to be addressed as part of the HAI initiative include projects that focus on other infection sites (e.g., the urinary tract, lungs, surgical sites), hospital locations outside the ICU and other health care settings (e.g., nursing homes, outpatient clinics, etc.), as well as the prevention of additional types of infections (e.g., Clostridium difficile) and contributing factors such as antibiotic overuse.

Patient Safety Organizations (PSOs)

The Patient Safety and Quality Improvement Act (PSQIA) of 2005 amended the Public Health Service Act to foster a culture of safety in health care organizations. To encourage health care providers to work with PSOs, the Act (and implementing regulations) provides Federal confidentiality and privilege protections to deliberations carried out under the aegis of patient safety organizations. This legal protection of information voluntarily reported to PSOs will promote increased reporting and analysis of patient safety events and subsequent improvements in care. The Act prohibits the use of these analyses in civil, administrative, or disciplinary proceedings and limits their use in criminal proceedings. AHRQ is coordinating implementation of the Act as a science partner to PSOs and health care providers. The Agency's goals are to help advance the methodologies that identify the most important causes of threats to patient safety, identify best practices for addressing those threats, and share the lessons learned as widely as possible. Specific work to carry out the Act includes:

1. Promulgating regulations to implement the Act.
2. Developing systems to allow application by organizations to become PSOs.
3. Listing successful applicant organizations as PSOs.
4. Where appropriate, re-listing and de-listing PSOs.
5. Maintaining a database of PSO administrative information.
6. Providing technical assistance to PSOs.
7. Holding an annual meeting of PSOs.

Work related to patient safety event information includes:

• Specifying common definitions and reporting formats and disseminating it through notification in the Federal Register.
• Establishing systems to help PSOs de-identify information (data on an individual patient, reporter, provider, or institution).
• Developing a network of patient safety databases that will allow exchange of de-identified information among PSOs and reporting to AHRQ.
• Publication annually in AHRQ's National Healthcare Quality Reports information on national and regional statistics, including trends and patterns of health care errors.

Funding for this important Act will continue at the FY 2010 President's Budget Request at $7,000,000. This level of support will enable AHRQ, working with the Secretary, to support PSO operations in FY 2009, including publishing the list of operational PSOs. (See measure 1.3.40.)

D. Outputs and Outcomes Tables

Program: Patient Safety

Long-Term Objective: Within five years, providers that implement evidence-based tools, interventions, and best practices will progressively improve their patient safety scores on standard measures (e.g., Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), Hospital Survey of Patient Safety (HSOPS), Patient Safety Indicators (PSIs), and the Medical Office Survey on Patient Safety Culture.)

Return to Contents
Proceed to Next Section