The public release of an audit last week that found some troubling lapses in oversight tarnished New York's pioneering tracking system for accidental deaths, injuries and other medical mishaps at hospitals and clinics.
State Comptroller Alan Hevesi and Health Commissioner Antonia Novello said some needed reforms to the New York State Patient Occurrence Reporting and Tracking System, or NYPORTS, were already in place as they jointly released the audit. But the frank appraisal of the widely heralded 6-year-old system pointed to potholes that can rattle similar efforts nationwide that are just getting under way. It also illustrated that despite the national push for mandatory reporting systems, state regulators don't have much stomach for punitively enforcing them.
The firestorm that followed the audit's release also demonstrated that the public's hunger for quality-improvement data doesn't show any signs of diminishing soon.
"I think it's clear that New York state has done more than just about any other state in the country with the public reporting of adverse and sentinel events," said David Schulke, executive vice president of the American Health Quality Association, which represents quality-improvement associations in every state. "What this shows is that hospitals are still going to be accountable and that the public is going to insist on them being accountable even as they work to improve."
Lesson to be learned
If there is a lesson to be learned by other states that are contemplating their own mandatory tracking systems, it's that simply launching an exemplary program isn't enough: It must be painstakingly administered and monitored to deliver its promised value to the healthcare system and patients, Hevesi said.
"This is a very important program and a very good program that can save lives. Our problem in New York was not initiation of the program. It was some failures in implementation. The system that was put in place will save lives. It just has to be monitored and implemented correctly," Hevesi said.
Among other things, the audit found that state regulators were lax in holding hospitals to prescribed timelines for reporting adverse events, and that health officials had cited or fined merely a handful of the hundreds of facilities that had failed to comply with its mandatory reporting requirements. Health officials also rarely held noncompliant hospitals accountable by insisting that they write corrective action plans, the auditors said. As a result, information on the database, which was designed as a quality-improvement tool for medical facilities and health officials, was incomplete, according to the auditors.
State health officials bristled at the criticism, stating that total incident reporting increased by 62% from 1999 to 2001, even though in 2001 Novello was furious over hospitals' shoddy compliance with the reporting system and threatened to seek stiffer penalties (Feb. 19, 2001, p. 33). The situation has improved considerably since then without the need for higher fines, health officials said, and the program is a model for others throughout the country.
"To paint the NYPORTS system as anything other than a great success is a gross mischaracterization," said Robert Kenny, a spokesman for the state Department of Health. "No other state in the nation comes close to providing the quality-of-care surveillance and patient protections that New Yorkers have in NYPORTS. ... The story here, really, is that we are making an already tremendous resource even better."
New York hospitals and clinics have been required by law to report certain adverse events to the state health department since 1985 and are subject to a $2,000 fine per reporting violation. The paper-based system was upgraded to the Internet-based NYPORTS system in 1998, the first of its kind in the country. It was designed to simplify and improve adverse-event reporting by creating a statewide database that could be used by medical facilities and the health department to improve patient care. The 263 hospitals and approximately 1,350 clinics that fall under the system's purview are required to classify adverse events as most serious or less serious. Under the law, hospitals and clinics must report the most serious occurrences within 24 hours, and they must submit a report within 30 days to be entered in the NYPORTS database.
The auditors found that medical facilities did a relatively good job of reporting the not-so-serious events and a bad job of reporting the serious ones. Medical facilities reported a total of 65,822 occurrences during the audit period from Jan. 1, 2001, through May 21, 2003. Of a total 5,777 most serious occurrences that should have been reported, 84% missed the 24-hour deadline. Auditors also found that 11% of the investigation reports (264 out of 2,505) that should have been subsequently submitted were not, and nearly half of the late reports were more than a year late. Meanwhile, during the audit pe-riod, only 20 citations were issued and two facilities were fined for noncompliance.
The 24-hour requirement is important so "immediate correction" can be made, Hevesi said. "The lesson is to put a system in place that is thoughtful and effective, but then monitor it to make sure that all the participants are doing the job they are supposed to do in a timely and effective manner."
State health officials quarreled with the auditor's assessment of the reporting timeliness, saying the law that the health department actually uses offers longer time frames that start from the day the facility first becomes aware of the occurrence. Also, rather then taking a strict "stick" approach to enforcement, health officials noted that they instituted a patient-safety grant program that supports healthcare providers who develop innovative patient-safety initiatives, many of which are utilizing NYPORTS data. The program has awarded $1 million in grants to five hospitals and one clinic since 2002, Kenny said.
NYPORTS' difficulties with hospital compliance were validated by the experience of the Pennsylvania Health Care Cost Containment Council, which since 1989 has been collecting data on every hospital admission in the state-about 1.8 million admissions per year. Beginning Jan. 1, hospitals have been under a new mandate to report hospital-acquired infections, said Joe Martin, a council spokesman. For the first quarter of the year, hospitals reported 2,253 such infections, he said. But the council found a vast discrepancy when it compared that data with secondary infections under uniform billing data-56,966 infections-many of which would likely be hospital-acquired, according to Martin.
"Despite the fact that there are people that want to have this stuff immediately, it takes time to get people invested and it takes time to get compliance," Martin said.
Though under state statute the council has the authority to slap noncompliant hospitals with fines of $10,000 per day, it "has not felt the need to impose that sanction in 14 years," Martin said. The council publishes a list of unresponsive hospitals in the reports; the threat of media attention seems to be enough incentive to drive compliance, he said.
In June, Pennsylvania also began rolling out a mandatory medical-error reporting system under the guise of the Patient Safety Authority, a state agency established by the state Legislature in 2002. The authority looked at NYPORTS and others before the system was "customized to what we felt would work for Pennsylvania," said Laurie Baker, the authority's spokeswoman. The authority plans to issue quarterly advisories of trends and observations gleaned from the database, she added. New York has done much the same, issuing dozens of alerts on topics such as electrosurgical burns and fire occurrences and magnetic resonance imaging safety, Kenny said.
New Jersey also has studied NYPORTS as it gears up to implement on Oct. 23 the state's first Patient Safety Act, which was passed by the Legislature in April. New York has "been considered the national leader among states," said Marilyn Dahl, the New Jersey deputy commissioner for healthcare quality and oversight.
Unlike NYPORTS, the New Jersey tracking system will be mandatory only for the most serious occurrences and will be voluntary for less serious events as well as "near misses," Dahl said. Policy stipulates that hospitals that are not in compliance could be subjected to $5,000-per-day fines, but "We don't want the first message to be that we're planning on fining you. We want the message to be that we're creating a confidential environment in which you can feel comfortable telling us about when things go wrong so that we can make healthcare safer for patients," she said.
The Greater New York Hospital Association defended the NYPORTS program, noting that there was a steep learning curve involved in understanding all the requirements. "I think NYPORTS works to a great extent. ... As a mandatory system, it does a very good job. Is it perfect? No," said Lorraine Ryan, the GNYHA's special counsel for regulatory and professional affairs.
NYPORTS, like any reporting system, is a work in progress, said Jeannie Cross, a spokeswoman for the Healthcare Association of New York State, which like the GNYHA, serves on a NYPORTS task force. "The value for hospitals from NYPORTS is getting data and analyses back from the system," Cross said. "This has improved, but further improvement is needed."
The NYPORTS audit experience sends out a cautionary lesson that the public won't stand for a lot of excuses when it comes to implementing quality programs, Schulke said. "Even when there is a pretty well-thought-out system to receive reports and make sure people are acting on it, people are not going to take it on faith that things get done," he said.
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