Patient safety laboratories: States pave the way for a national effort
■ From the need for confidentiality to the advantages of voluntary disclosure, state error reporting laws offer lessons for federal lawmakers.
By Joel B. Finkelstein — Posted Jan. 3, 2005
Congress has struggled unsuccessfully for several years to pass patient safety legislation, failing again in the final months of 2004. But while the federal government has remained stuck, many states have forged ahead.
Five years after the splash made by the Institute of Medicine's report on medical errors, "To Err Is Human," state patient safety laws have paved the way for a national effort to collect and analyze medical error data in a way that makes sense and provides useful information for hospitals and physicians.
Twenty states have some form of medical error reporting law, including Florida and New Jersey, which enacted new measures last year, and Connecticut, which refined its existing law.
"A lot of states have identified patient safety as an area of importance," said Paul Schyve, MD, senior vice president for the Joint Commission on Accreditation of Healthcare Organizations. "It is on the radar screen for states ... something they would like to improve."
Although polls suggest that this work has been largely unseen by the public, the efforts have established the foundation for a new phase in which safety will become a collaborative effort between both doctors and patients.
"What's really exciting is we have patient advocacy groups who are training patients themselves how to be more responsible for their own safety," said Matthew Rice, MD, chief medical officer at Northwest Emergency Physicians in Federal Way, Wash., and a board member of the National Patient Safety Foundation.
As that happens, the discussion increasingly will move into the national arena. Federal legislation got hung up over minor differences between House and Senate versions last year, but those bills will be reintroduced this year and rank high on the health care agenda.
That legislation would establish national standards for collecting and protecting information on medical errors. It also would set criteria for credentialing the organizations responsible for analyzing and disseminating error information.
Most state laws require the reporting of mistakes that lead to serious injury or death, although a few have now developed voluntary systems for less serious events. The federal proposals emphasize reporting of events across the spectrum, including slips that don't lead to harm -- so-called "near misses."
Despite that difference, the national effort is likely to benefit from the states' experiences. And, in turn, states can build on their efforts with new access to standardized, national data, experts said.
Setting the right tone
While most states require physicians and/or hospitals to report serious medical errors, some stakeholders say that might not be the most effective way to encourage compliance.
"There's no place that I know of that has adopted a mandatory reporting law that the physicians have felt comfortable with," Dr. Rice said.
Many of the mandatory reporting laws were passed shortly after the IOM report. At the time, states seemed to adopt a more punitive than educational patient-safety approach.
"That's the kind of environment that we have had for many years and the environment that I think the federal legislation is clearly trying to change, and I would say most of the state reporting systems are also trying to create a different environment," Dr. Schyve said.
With or without a law, physicians feel bad when they make an error that hurts a patient, Dr. Schyve said. But laws can create an atmosphere in which physicians feel like they are being judged for their failures, and that discourages them from owning up to their mistakes. "When you have a situation in which the doctor or the nurse feels inhibited from telling a patient who has been harmed through an error, 'I'm sorry this happened to you,' you know that there is something that is not working right in the system," he said.
"It is not conducive to bringing forth the kind of information that would really help us improve safety," Dr. Schyve added. "Many of the states have come to recognize that can be a counterproductive approach."
As states begin to expand their patient safety systems to include more types of errors and smaller institutions, such as surgical centers, some have made such reporting voluntary, experts said.
For example, both Florida's and New Jersey's recently passed laws establish voluntary, anonymous reporting systems to collect and analyze information on near misses. Federal legislation includes only voluntary reporting requirements and has been supported by the AMA and other medical societies.
"Voluntary reporting will bring forth more information," said Donald J. Palmisano, MD, immediate past president of the AMA.
Most states also have come to realize that information must be protected from certain uses. Nineteen of the 20 states with reporting laws have included confidentiality provisions barring collected data from being used in litigation against physicians or hospitals, a policy supported by the AMA. California, the only state without explicit protections, requires reporting only medication-related errors.
All the states require that identifying information be removed from data before it is made public.
"We need to have an atmosphere where you can have a candid conversation with your peers, with experts," Dr. Palmisano said. Fear of medical liability lawsuits has made that atmosphere difficult to achieve, he added.
Working the data
Another important lesson from state patient safety programs is how to produce more useful information from the data.
"The systems have definitely been improving in their ability to analyze data and to feed it back," said Jill Rosenthal, a project manager with the National Academy for State Health Policy.
For example, Pennsylvania has created an electronic reporting system that allows facilities to look at their own error rates and compare them with statewide rates. The system also produces safety alerts and other helpful reports for the medical community. "It's a really strong research-based system that keeps an open line of communication with the medical community," said Chuck Moran, spokesman for the Pennsylvania Medical Society.
Providing useful information for physicians and others will be the true test of patient safety efforts, experts said.
"It doesn't do any good to just collect data," Dr. Palmisano said. "The data has to be analyzed by experts, and there has to be feedback to the individuals involved with the error to tell them how to change the system to prevent the error from happening again."
If physicians see the fruits of reporting, they will be more inclined to participate.
"There will be a trial period to see whether data is submitted and then used appropriately," Dr. Rice predicted. "And that will open up a floodgate of people who really want to make patient safety a prime concern to submit data."
If and when federal legislation passes, the groundwork laid by the states could offer the basic infrastructure for a national system of patient safety organizations, as defined by the federal bills. Both public and private institutions are currently filling these data collection and dissemination roles and can be expected to make the transition into federally recognized organizations.
A national law also would help standardize reporting definitions and classifications, something the states would have a hard time achieving on their own, Rosenthal said.
Added Dr. Schyve, "Whether there is ever a single federal database, which there probably won't be, the real question is can we collect and record the data in such a way that for all practical purposes when you want to study something and learn from it, you have a virtual [national] database."
Involving all care settings
Despite the progress made on the state level, much of the focus has been on hospitals and other large institutions. Solo or group practice physicians largely have been overlooked.
"The psychology of reporting may be different in a small practice versus a large organization," Dr. Schyve said. "We have much less data about what kind of errors do occur and how frequently they occur outside the hospital setting."
But evidence is mounting that information from those doctors is an important aspect in tracking problems. Experts have found that many errors occur not as a single mistake but a sequence of oversights, mixed messages and gaps in the system, especially during transitions as patients are admitted to a hospital or nursing facility, or after being released.
"If we really want to make health care safer, ultimately it means we have to look across the entire continuum of care for where errors occur and where things can be changed to prevent those errors," Dr. Schyve said.
Even though savings can be gained from avoiding errors, no one has yet shown physicians in the community how they can cost effectively pursue patient safety measures, experts said.
Health information technology is often cited as one way to reduce errors. But capital investment is still beyond the means of many small practices.
"Everyone is saying let's have an electronic medical record, but who's going to pay for that?" Dr. Palmisano asked.
States are learning that regulation can get them only so far, that working directly with the medical community on solutions is essential, experts said.
Such relationships also could benefit from a ground-up movement within medicine to place a greater emphasis on patient safety.
"Five years ago you never really saw medical schools or residency programs talk much about this," Dr. Rice said. "Now there is research being done; there are different academic centers; there are different focuses by nurses, doctors, pharmacists on the safety issue. And that is the beginning of training a whole generation of individuals as to the importance of safety and incorporating it early in their careers so it becomes a natural consideration."