Patient Safety Organizations: Building a Safer Healthcare System

The surge of voluntary regional and national initiatives to improve patient safety demonstrates the momentum building to unite the healthcare community. Recently, the Institute for Healthcare Improvement’s 100,000 and 5 Million Lives Campaigns enrolled thousands of hospitals in a concerted effort targeting patient safety. Regionally, states such as Maryland have established networks to encourage peer-to-peer collaboration and learning. Now, the federal government has set the groundwork for a national network of organizations working to reduce harm to patients.

The 1999 Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System prompted widespread concern among the healthcare community and the general public. It revealed that healthcare in the United States is not as safe as it could be, and that medical errors result in as many as 98,000 hospital-related deaths each year. The report, which addressed a number of areas, called on providers to work together to create a safer healthcare system. One critical topic addressed by the IOM was the reporting and analysis of adverse events — injury caused by medical care (AHRQ PSNet) — and the need to capture data that would help to reduce the potential for patient harm.

So, what has happened in the past 10 years? What progress have we made in this area?

During the last decade, multiple organizations have worked diligently to encourage clinicians to share and report data on patient safety events. There have been, however, two primary obstacles to achieving this goal. One is the fear of disclosure. Physicians, other clinicians, and healthcare organizations often have been reluctant to participate in peer review of patient safety events for fear of legal liability, professional sanctions, or injury to their reputations. A second issue is that patient safety event reports have not been standardized to allow meaningful aggregation of data and sharing across different institutions. An insufficient number of reports translates to a paucity of meaningful data, making it difficult to identify and mitigate underlying patterns of causal factors (AHRQ, n.d.4).

There has been a growth of national state, and local initiatives to encourage reporting and analysis of adverse events. At the federal level, Congress passed the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) designed to expand voluntary reporting (AHRQ, n.d.1). It establishes Patient Safety Organizations (PSOs) that work with providers to study and improve their patient safety systems (Clancy, 2008). In Maryland, the Maryland Patient Safety Center (MPSC) offers a comprehensive set of patient safety interventions that bring attention to issues and solutions. In addition to a voluntary near miss and adverse event reporting system that examines regional needs and patterns, participating organizations access educational programs and improvement initiatives.

Creating a Network of Patient Safety Organizations
The Patient Safety Act of 2005 is national legislation intended to:

  • encourage voluntary, provider-driven initiatives to improve the safety of healthcare through the establishment of legal protections to ensure that providers who report patient safety information do not incur new legal liability;
  • promote rapid learning about the underlying causes of risk and harm in the delivery of healthcare; and
  • share those findings widely, thus speeding the pace of improvement (AHRQ, n.d.3).

A key element of the Act is the creation of PSOs, which are designed to improve the quality and safety of healthcare by providing a feedback cycle to evaluate and learn from reported events. By voluntarily reporting patient safety events to a PSO, healthcare organizations will be able to share data on patient safety events without fear of legal discovery.

Participating providers will become part of a national network designed to reduce the incidence of events that adversely affect patients. The law, in essence, creates uniform, national protections and standards to replace the current patchwork of state regulations.

Privacy provisions in the Act reinforce the protection of this sensitive information. The Office for Civil Rights, within the Department of Health and Human Services, is responsible for enforcing protections of the Patient Safety Act. The Patient Safety Act provides two types of protections:

  1. Confidentiality protections are key to voluntary reporting; breaches of these provisions may result in civil money penalties.
  2. Privilege protections are enforced by the judicial system; these provisions limit or forbid the use of protected information in criminal, civil, administrative, or other proceedings (AHRQ, n.d.2).

By providing both protections, PSOs offer a secure environment where clinicians and healthcare organizations can collect, aggregate, and analyze data to identify and reduce risks and hazards associated with patient care.

To date, there are 54 federally-listed PSOs in 24 states. Organizations that are eligible to become PSOs include: public or private entities, profit or not-for-profit organizations, provider organizations such as hospital chains, and others that may establish special components to serve as PSOs. Regardless of organization type, PSOs all share the goal of improving the safety and quality of healthcare delivery. To be a PSO, an organization must, among other steps:

  • Be focused on patient safety and quality, with the primary activity being patient safety.
  • Collect data in a standardized manner and then analyze the patient safety work product.
  • Develop and disseminate information regarding improving patient safety, including recommendations, protocols, and best practices.
  • Use the patient safety work product for encouraging a culture of safety and providing feedback/assistance to minimize patient risk.
  • Preserve confidentiality and security.
  • Involve qualified staff.
  • Operate an evaluation and feedback system.
  • Have a bona fide contracts with providers within each 24-month period.

One thing that the legislation does not offer PSOs is funding. With federal PSOs still in their infancy, different models are emerging of how PSOs will fund their operations. Models include payment from healthcare providers for PSO services, foundation and grant support, donations and contributions, and, perhaps in some cases, state-level financing.

The Agency for Healthcare Research and Quality (AHRQ) administers the Patient Safety Act and approves PSO applications. AHRQ maintains a list of entities whose PSO certifications have been accepted. A list of certified PSOs is available at

The Journey to Safer Care: The Maryland Experience
The Maryland Patient Safety Center (MPSC) was among the first 25 organizations in the country to be listed as federal PSOs. In addition, MPSC has been designated as a patient safety organization through similar legislation at the state level. Being certified as a federal PSO enables the Center to build on its current set of programs, which target patient safety improvements in the Mid-Atlantic region. It strengthens and expands on the state protections embodied in Maryland’s “Patient Safety Act of 2001” that called for the establishment of the Maryland Patient Safety Center. Specifically, the Maryland Health Care Commission (MHCC), with input from the Department of Health and Mental Hygiene, studied the feasibility of reducing the number of preventable adverse medical events in Maryland. From this study emerged the recommendation to establish the MPSC as a key component of a state plan to improve patient safety.

Several subsequent actions catapulted the organization into being. First, the Maryland General Assembly endorsed this concept in 2003 by including a provision in legislation to allow the MPSC to have medical review committee status, thereby making the proceedings, records, and files of the MPSC confidential and not discoverable or admissible as evidence in any civil action. Second, the Maryland Hospital Association and the Delmarva Foundation were jointly selected to operate the Center for a 3-year period starting in January 2004, which was extended for two additional 1-year periods through December 2008.

In 2008, MPSC completed a strategic reorganization, becoming an incorporated non-profit organization with an ongoing collaboration with the Maryland Hospital Association and the Delmarva Foundation for Medical Care, Inc. A newly-designated fiduciary voluntary Board of Directors was established and recently completed a strategic long-term agenda for the Center. The Center received re-designation for the next 5 years from the MHCC, through 2014. These are critical and noteworthy achievements in the Center’s efforts to support Maryland’s relentless quest to provide safe and effective care for its citizens.

The vision of the MPSC is to make Maryland’s healthcare the safest in the nation by focusing on improving systems of care, reducing the occurrence of adverse events, and strengthening the culture of patient safety at Maryland healthcare facilities. With this goal in mind, the Center employs a robust, multi-faceted approach that has engaged more than 10,000 providers in improving care for patients across the healthcare spectrum by:

  • developing a grassroots model for building consensus to bolster patient safety in Maryland;
  • promoting a “culture of safety” that encourages system improvements rather than faulting individuals;
  • collecting, analyzing, and sharing appropriate information about adverse events and near misses;
  • developing and providing education for healthcare professionals, hospitals, and nursing home staff, including sharing “best practices” from Maryland and worldwide;
  • sponsoring patient safety breakthrough collaboratives, in intensive care, emergency departments, labor and delivery, and other settings, that bring together providers and national experts to focus on specific process improvements; and
  • leading applied research to find and implement safer processes and practices in Maryland.

As the Center has grown, efforts in each of these areas have built on and been informed by each other. Skills shared in educational programs reinforce the approaches used in collaborative programming and in the study of adverse events. Similarly, research on safety practices in the state, along with other special projects, help guide the Center in identifying and designing future programs. As a new PSO, MPSC will continue to employ this model to learn from and draw upon the information from the national network of PSOs.

For example, the MPSC’s SAFE from FALLS initiative, which began in 2008, was conceptualized based on data from the Center’s Adverse Event Reporting system. These data revealed that falls are among the predominant patient safety issues for facilities and patients, and result in the greatest injury to patients. Based on these data, MPSC convened a Falls Workgroup to design a cross-setting intervention. Currently 10 hospitals, 11 long-term care facilities, and 4 home health agencies are involved in a pilot program, with plans for a regional launch in fall 2009.

During its first 5 years, healthcare providers in the state have partnered with the Maryland Patient Safety Center to make patient safety a top priority. Signature achievements include:

  1. Receiving the 2005 John M. Eisenberg Patient Safety and Quality Award for national/regional innovation in patient safety.
  2. Engaging and training more than 10,000 healthcare professionals on safety strategies and tools that have transformed Maryland’s hospitals. In addition, the Center is working with 85% of Maryland hospitals in breakthrough collaborative programs.
  3. Improving outcomes and processes of care, including dramatic reductions in ventilator- associated pneumonia and catheter-related blood stream infections, during its Intensive Care Unit Collaborative, resulting in an estimated 140 lives saved and more than $40 million in avoided costs; the first statewide collaborative on reducing infant and maternal harm in labor and delivery; and other improvements related to methicillin-resistant Staphylococcus aureus (MRSA).
  4. Developing a safety center model that other states seek to learn from and emulate.

The Maryland Patient Safety Center continues to formulate new programs and initiatives in its quest to make Maryland healthcare the safest in the nation. This year, the Center is implementing new collaboratives and learning networks to actively engage patients as partners in patient safety and to address quality and safety issues in hospital nurseries.

MPCS is proud that, working together, the Maryland healthcare community has markedly reduced infections in hospital ICUs, improved care in the state’s emergency departments, and made great strides to reduce maternal and infant harm related to the birth process. Looking into the future, MPSC is confident that as a state-designated PSO and a federally listed PSO the Center will lead Maryland toward dramatic innovation and improvement in patient safety.