States wanting to follow the lead of the six that have enacted legislation supporting creation of state patient safety centers to help address the problem of medical errors should be sure there is clear legislative authority, coordinate center activities with other state activities, and begin by focusing on creating a safety culture. That conclusion is from a report from the National Academy for State Health Policy that examined the models in use in the six states.
IOM report spurred effort
Report author Jill Rosenthal tells State Health Watch the effort grew out of the 1999 Institute of Medicine (IOM) report that documented 98,000 deaths per year in the United States due to medical errors. "The IOM recommended two types of reporting systems: state mandatory reporting for serious adverse events and a voluntary system for near misses. The safety centers are a way of implementing the voluntary reporting," she notes.
The report says that all six patient safety centers studied — Florida, Maryland, Massachusetts, New York, Oregon, and Pennsylvania — are legislatively authorized or endorsed in some manner. That authorization distinguishes them from other state or public/private patient safety programs or coalitions.
Four of the centers are housed within their state governments, while two are outside of but still have legislatively authorized affiliations with the state governments. But Ms. Rosenthal says that whether a center is housed within or outside of state government does not alone dictate how a center interfaces with that government. More important is the authorizing legislation and how it describes the working relationship between the center and the government.
Mission statements are similar
Although patient safety centers may have different governing structures, operations, and activities, they are similar in their mission statements — all six have statements on improving, ensuring, or promoting patient safety. Ms. Rosenthal says the most universal function, common to all six centers surveyed, is to educate providers about best practices to improve patient safety. Other common roles include identifying causes of patient safety problems, fostering a culture of safety, developing collaborative relationships among patient safety stakeholders, and educating consumers about patient safety.
Five of the six states with centers have separate mandatory reporting systems for serious adverse events, and those systems are housed in state regulatory agencies. Several centers have access to the data in those systems and will assist with their analysis. Three of the states chose to develop within their patient safety centers a voluntary reporting system for less serious errors, intended to complement the mandatory systems already in place.
According to Ms. Rosenthal, center officials face a number of challenges, including the level and reliability of funding and staffing levels. Also, despite efforts to carefully separate patient safety center activities from regulatory processes in many states, providers may be hesitant to participate in some patient safety center activities, especially reporting, due to fear of publicity or negative repercussions, even though the patient safety center data systems offer strong protections.
The report says the state patient safety centers are charged with promoting patient safety through a variety of activities that vary by state but may include:
- educating health care providers and patients on processes that may reduce future occurrences of adverse events;
- developing systems of near miss and/or adverse-event data reporting, collection, analysis, and dissemination to improve the quality of health care;
- fostering creation of safety cultures to identify and determine causes of adverse events and near misses;
- informing consumers about patient safety issues;
- serving as a clearinghouse for development, evaluation, and dissemination of best practices;
- promoting ongoing collaboration between the public and private sectors;
- coordinating state agency initiatives.
Most patient safety centers are governed by a board of directors (Florida, Massachusetts, Oregon, and Pennsylvania), but membership on the boards is quite distinct, Ms. Rosenthal says. Boards can include representatives of various stakeholder groups including providers (Oregon and Pennsylvania) or their associations (Florida), consumer groups and purchasers (Florida and Oregon), and medical insurers (Florida and Oregon), among others. Boards in Oregon and Pennsylvania are appointed by the governor and legislature.
Florida’s law specifies which stakeholder groups may appoint board members, including the state hospital association, practitioner associations, and payers.
Because the Massachusetts center is a state government agency, its board contains three secretary-level state officials. Centers in Maryland and New York are overseen by their center executive officials. Four of the five centers with boards include state government representatives. Several states also have advisory committees or councils that support the work of the centers.
Various ways to fund centers
Financial support for patient safety centers comes primarily from fees, grants, and appropriations. Florida and New York are supported through legislative appropriations, while Oregon and Pennsylvania rely on fees.
Pennsylvania has a dedicated Patient Safety Trust Fund supported by an annual surcharge on licensing fees for facilities subject to the enabling legislation’s reporting requirements. Oregon’s center may levy fees on eligible participants. Maryland’s center will be funded for its first three years through contributions from the Maryland Hospital Association and the Delmarva Foundation.
Future funding may come from grants. Massachusetts is relying on a combination of state monies and a grant from the federal Agency for Healthcare Research and Quality.
While all six centers plan to focus on hospitals, other commonly mentioned facilities include ambulatory surgery centers (Florida, Massachusetts, Oregon, and Pennsylvania), long-term care facilities (Florida, Maryland, Massachusetts, and Oregon), and birthing centers (Oregon and Pennsylvania).
New York and Oregon specifically mention serving health care professionals. Some center activities may focus on a particular type of provider. Thus, educational activities, reporting systems, and legal protections may be designed to address the needs and concerns of specific providers. New York, for example, prepared a toolkit to help reduce overprescribing of antibiotics and distributed it to pediatricians, family practitioners, and other appropriate primary care providers.
As the six patient safety centers ramp up, staffing levels are modest, the survey shows, with much of the work conducted through contracts.
The most universal functions, common to all six centers, are to educate providers about best practices to improve patient safety, promote collaboration between the public and private sectors, and inform consumers on patient safety issues.
Ms. Rosenthal says other activities that the majority of centers propose to do include recommending statewide goals and tracking progress, fostering creation of a culture of safety and learning, reviewing and promoting patient safety research, promoting collaboration between state and federal initiatives, and implementing a reporting system.
Unique data collection tactics
The types of data and methods of collection and analysis used by the centers vary. Ms. Rosenthal says some interesting and unique activities of patient safety centers include:
- Florida will examine ways to reward providers who implement evidence-based medical practices and will recommend core competencies in patient safety for health professional curricula.
- Massachusetts has developed a patient safety ombudsman program to work with patients, families, and consumers on patient safety-related problems and also plans to address health system and individual practitioner accountability.
- New York administers an award program to recognize patient safety leaders of various types of health care facilities and also will recommend statewide medical safety goals and will track the progress of health care providers in meeting those goals.
- Pennsylvania’s statute includes a provision for a discount in medical malpractice liability insurance premiums for facilities that can demonstrate a reduction in serious events following adoption of center recommendations.
Ms. Rosenthal says the IOM report envisioned mandatory reporting systems housed within state regulatory agencies for serious adverse events and nonregulatory voluntary reporting systems for near misses, with the two systems intended to complement each other. The first would provide data to assist government in holding facilities accountable, while the voluntary system would be a more collaborative mechanism to learn from mistakes.
Separate reporting systems
Five of the six states with centers have separate mandatory reporting systems — Florida, Maryland, Massachusetts, New York, and Pennsylvania — housed within state regulatory agencies for serious adverse events. Florida, Maryland, and Pennsylvania embraced the IOM’s vision by also developing a reporting system within their patient safety centers for less serious errors. Florida collects near miss data, while Maryland and Pennsylvania collect near misses and adverse events up to a specified threshold. Only Oregon has no mandatory reporting system; the Oregon Patient Safety Commission will be creating a voluntary reporting system for serious adverse events as part of its mission. Centers in Massachusetts and New York have authority to implement a voluntary reporting system but have chosen to focus on other activities. Massachusetts is considering developing a system in the future.
All of the patient safety centers plan to make some information available to the public. If the centers have reporting systems, they will publicly report only data patterns using aggregate de-identified data that do not name facilities. Maryland and Oregon also will provide information on which facilities are participating in the reporting systems. Only New York provides facility- and provider-specific outcome information (which is contained within its physician profiling system) and outcome measure reports. The accessibility of data from New York’s center may be attributed to its mission, which has a unique focus on improving public access to health care information and to the great consumer demand for information.
Patient safety centers will identify evaluation strategies and indicators, Ms. Rosenthal says, to measure their progress and submit their required reports. "Despite the difficulty of evaluating success, the centers have already made progress," she reports. "In all six states, the legislatures have recognized the serious issue of patient safety and made commitments to supporting patient safety centers. In some states, the legislature has committed resources. Stakeholders have collaborated to create governing and advisory bodies that represent diverse groups brought together to achieve common goals.
Legislative authorization key
Participants involved in the National Academy of State Health Policy survey recommended that states considering developing a patient safety center do it legislatively to create a public mandate for the center’s mission. Participants also acknowledged the importance of clear and consistent legislation, noting that inconsistencies and lack of clarity in some of the centers’ authorizing legislation delayed progress.
Patient safety centers are more likely to be successful, those surveyed said, if sponsors share a common vision. However, in creating a center governing structure, one meeting participant suggested balancing the desire to create an all-inclusive board with the need to create an efficient and effective board process.
Participants said patient safety center activities need to be coordinated with other state activities, rather than operating as standalone entities.
States recommended clarifying how the patient safety center differs from any existing patient safety coalition and then clearly examining and clarifying the relationship between the two entities.
Center officials recommended allocating sufficient time during center development to consider operational issues before starting on activities. Depending on the patient safety center’s anticipated role in collecting, analyzing, and disseminating data, centers may have complex infrastructure issues to consider. Ms. Rosenthal says data-flow processes can be more complex than expected.
Developing and putting into operation clear definitions of reportable events is a challenge for any reporting system, and may influence decisions regarding access to data.
Participants noted a need to educate the news media about reporting systems, especially conveying the message that an increase in reporting should be viewed as a success, as an indication of growing support for a coalition of safety. Increased reporting also provides data that will be useful for identifying root causes and potential solutions. Participants also recommended that centers reach out to the media before crises occur in hopes of ensuring enlightened reporting.
"With all of the potential areas of focus for state patient safety centers, it may be difficult for emerging centers to set priorities," Ms. Rosenthal writes. "Several participants suggest that centers begin by focusing on creating a patient safety culture. According to some participants, newly created centers should be cautious about focusing on data collection. Unless the data will add a particularly unique value, [they] may only contribute to the vast amount of data already available. Some questioned the need for additional reporting systems and whether centers should instead focus on implementation of best practices. However, according to one state, a reporting system can be useful in providing facility-specific and peer-specific feedback to help facilities target their quality improvement interventions," she continues.
Ms. Rosenthal notes that whether other states should create a patient safety center is an individual decision based on what else is going on in the state, what a center would do, and whether funding is available.
Questions raised by the survey, she says, include:
1. What role can/should the state play in a patient safety center? Is government responsible for quality improvement initiatives? Should government be involved?
2. What role can/should patient safety centers assume in data collection, analysis, and evaluation? Does it differ depending on whether the state already has a regulatory reporting system? Does every state need to develop its own voluntary system to track problems and identify best practices, or can states learn from other databases? Should centers focus on collecting data or implementing already identified best practices?
3. How can the centers address patient safety systems problems in addition to clinical processes of care? If most errors are the result of systems of care, how can provider education lead to improvement? Can centers provide training in leadership, culture of safety, and human factors in addition to clinical improvement? How can patient safety centers help states move from focusing only on avoiding mistakes to improving quality outcomes?
"The impact of state patient safety centers remains to be seen," Ms. Rosenthal says. "Despite the lack of rigorous indicators, patient safety centers ultimately will have to demonstrate gains in patient safety. If they are unable to do this, pressure will no doubt build from regulators, purchasers, and the public for more draconian measures," she adds.
[Contact Ms. Rosenthal at (207) 874-6524.]