Still hard to share

Nearly a year ago, the Agency for Healthcare Research and Quality began implementing regulations for its patient-safety organization program—touted as a way for providers to share information and learn from problems. So far, however, the technology has not been finessed enough to really enable that sharing, according to the PSOs.

Some 68 organizations have been designated as AHRQ-approved PSOs since last November, when the agency first explained the criteria they needed to meet under interim guidelines. The agency recently released a set of common formats as well as the standardized definitions and data elements that it will require providers and PSOs to use if they report information to the agency. The formats currently are meant for acute-care hospitals only, with later versions planned for other types of healthcare facilities.

In addition to the nascent formats, providers have been slow to contract with PSOs to conduct patient-safety work, a trend that has continued since early this year (March 23, p. 10). Advocates for the system say the PSOs provide a level of protection at the federal level, so providers who previously might have been afraid that the information they reported could be used against them in a lawsuit can be assured the data are off-limits. But things are still in the early stages, says Ronni Solomon, executive vice president and general counsel at the ECRI Institute. “This is still really new,” she says. ECRI, which provides healthcare research and consulting, runs a “component patient-safety organization,” which is a group separate from the parent company. ECRI PSO was one of the first 10 to be designated last year.

Despite the desire to ensure information can be shared electronically, the AHRQ common formats currently are in paper form. Addressing that is only the first step in setting up an infrastructure of shared definitions of safety events and an eventual electronic data-sharing system, says William Munier, a physician who is director of the Center for Quality Improvement and Patient Safety at AHRQ.

The agency is working on writing technical specifications that will automate the data elements now defined in the paper forms while creating the electronic rules for submitting information to AHRQ. It hopes to release those in the first quarter of next year. By the end of 2010 AHRQ hopes to have information collected in an aggregated database from participating PSOs, which would populate the database with the information they gather in their work with providers.

Under the law that established PSOs, there are eight specific activities an organization must perform, such as collecting and analyzing patient-safety work products, implementing security measures to protect that product and developing information and providing feedback to providers, and assisting in helping them use that feedback.

The paper forms give a description of the types of patient-safety events that should be reported and defines the data elements providers should give in reporting those events. For example, the form for reporting an error involving a medical device asks for the type of device, how it was involved in the event, whether the error came from the device operator, and a number of specifications about the manufacturer, model and serial number of the device.

Those descriptions and data elements were developed internally after the agency researched an inventory of current reporting systems—including state systems; other federal agency systems such as the Centers for Disease Control and Prevention's National Healthcare Safety Network; and the University HealthSystem Consortium's database of academic research centers, Munier says. “It was a jumping-off point,” he says.

But the descriptions were ultimately established after AHRQ received more than 900 comments and realized stakeholders all had their own ideas of what a safety event entailed, Munier says. “The common formats really had to be useful,” which means clinically valid, efficient and able to provide immediate feedback.

But PSOs are not waiting for AHRQ to complete its work before they design their own data-sharing programs. All involvement with PSOs is voluntary, under the law that created them, and the PSOs themselves are not required to report their work into AHRQ's national database. Because they don't have to report at the national level, PSOs do not have to follow the common formats.

Still, that remains AHRQ's goal, Munier says. That national database will allow quality researchers to find trends, identify problems in the system that lead to errors and find ways to improve the system. “It's very definitely the ultimate goal, to be interoperable.”

The creation of PSOs has been years in the making. Rules to implement the law establishing them, the Patient Safety and Quality Improvement Act of 2005, were not finalized until this year. While the proposed regulations were being hammered out in 2008 by HHS, AHRQ—urged by advocacy groups that wanted to get a jump-start on patient-safety work—released its interim guidelines so that organizations could at least begin to comply with the requirements to be designated a PSO.

The final regulations were set in January when HHS published the official rule for how PSOs would collect and analyze safety information.

Since then, some providers have signed up with PSOs, but not in the numbers that advocates might have hoped for. There is no federal funding for the PSO program, and providers most likely will have to pay to work with various PSOs.

Still, PSOs say they are ready for operation. ECRI PSO—whose parent company manages Pennsylvania's statewide error-reporting system—has been collecting information for some clients over the past few months, Solomon says. Its collection system is modeled after AHRQ's common formats, which ECRI supports. Creating the formats ensures everyone is talking the same language, and standardizing data collection is a “mammoth job,” she says.

While insurers and regulatory bodies are not allowed to be PSOs, nearly any other organization can be one, or may operate a separate group known as a “component PSO.” Of the organizations currently registered there are 41 component PSOs operated by a mix of not-for-profit groups and for-profit vendors, such as software developers. Some see it as a natural extension to the technology and consulting they already provide.

PSOs are the way for hospitals to use patient-safety information and really shift their operations to be more focused on quality, says Jim Bongiorno, president of HealthDataPSO, Farmington Hills, Mich., a component joint venture of consulting firm Medical Error Management and CCD Health Systems, a software developer. The PSO represents a chance to expand on the consulting that Medical Error Management provides.

“We're looking for a business extension, frankly,” says Bongiorno, who is also president of Medical Error Management. His PSO plans to focus on smaller hospitals and healthcare facilities that might not have the resources to conduct their own research. HealthData will provide the software and expects to align its applications with AHRQ's common formats.

Using a PSO adds value for providers as well, says Bongiorno, who previously worked in the automotive industry and saw the improvements that came after companies began to focus on quality and report on errors and product defects. Now that's just the way the auto industry does business, he says. “J.D. Power reports on all of it.”

Bringing that same level of focus to the healthcare industry is going to require providers to work with PSOs and use the analysis they can provide, Bongiorno says. But he's not sure that providers are motivated yet to invest time and money in such organizations. “If you're not committed to act on the information, it just increases the cost of doing business.”

UAB Health System in Birmingham, Ala., has created a PSO that was designated in January. The health system, which has seven owned or affiliated hospitals, is one of the few providers to have its own PSO. Marcus Montgomery, assistant vice president and chief patient safety officer at the UAB system, says that while AHRQ is on the right path with the common formats, the agency is having some “growing pains.”

UAB will be using software developed by the University HealthSystem Consortium academic medical alliance—which itself has established a PSO that follows AHRQ's common formats—to manage its PSO. All the hospitals in the system will be reporting information into the PSO. The not-for-profit UAB also plans to offer its PSO services outside the system to other hospitals, charging a subscription fee to cover operation costs, Montgomery says. The UAB PSO is not analyzing information yet but expects to begin in spring 2010 when the software is installed.

The UAB PSO is part of a larger program that includes two other components: research and a medical simulation center to conduct training for providers. With all three pieces, “we can re-create events and project what types will occur,” Montgomery says.

Montgomery says he's not surprised that more providers aren't involved yet in PSOs. “There's an expense to start this up,” he says, estimating it might cost an organization between $100,000 and 200,000 to start a PSO. And, to really conduct patient-safety analysis and put the information to use requires a cultural shift at many hospitals not used to disclosing internal problems. “Patient safety is still in its infancy,” he adds.

Still, just the fact that UAB is holding conversations with other facilities across the country about allowing the health system to see their data and provide feedback is a step forward for an industry that is learning to become more transparent, Montgomery says. “We're networking with one another and talking patient safety. That's something new.”

While hospitals aren't required at a federal level to use PSOs, that doesn't prohibit states from legislating their use. Missouri this year passed a law for its Medicaid program, saying hospitals must prove they are contracting with a PSO by January 2010. That law also says hospitals will not be reimbursed by the state for preventable errors and “never events” as outlined by the National Quality Forum and the CMS.

Missouri doesn't have a statewide reporting system for errors; the mandate for PSOs will ensure hospitals are reporting events and participating in strategies for improvement, according to the legislation.

The Missouri Center for Patient Safety's component PSO will be ready to go by the state deadline, says Becky Miller, executive director of the Jefferson City-based center. The PSO will focus first on the events outlined by the new state law and later develop the program in a phased-in approach, she says. “We kind of want to take this small because it's so new.” The state law does not require hospitals to work with any particular PSO.

The goal for hospitals in Missouri is the same goal that AHRQ has—finding paths toward better care, Miller says. That being the case, “there is a lot on healthcare providers' plates right now,” she adds. “Implementation is going to take a while.”

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