Consumers Union, nonprofit publisher of Consumer Reports, strongly supports House Bill 821, by Delegates Summers, Howard, and V. Turner. HB821 will require acute care hospitals in Maryland to report incidences of medical harm to the department of health, which will use the data to create a public report.
Since 2003, Consumers Union has conducted a national campaign advocating for public disclosure of information about patient safety in hospitals and other settings. Public disclosure informs people about health care outcomes and motivates health care providers to do more to prevent medical harm. The Safe Patient Project (www.SafePatientProject.org ) covers numerous issues relating to medical harm including health care-acquired infections, drug safety, medical errors and physician accountability.
MEDICAL HARM IS A SIGNIFICANT PROBLEM
Medical harm is a significant problem in American hospitals. Millions of patients are harmed every year while receiving medical treatments. Over the past decade, numerous lists of harmful events have been developed by the National Quality Forum (NQF) and various federal and state programs. The NQF list – commonly called the “never events” list but officially named “serious reportable events” – is the most commonly referred to list. It includes 28 events and is periodically updated. Events cover surgical errors (such as surgery on the wrong patient, the wrong body part or leaving a foreign object in the body), care management (such as medication errors, blood errors, maternal or infant deaths during normal deliveries, serious bed sores), product or device related events (such as contaminated drugs, death due to intravascular air embolism in the use of an IV), environmental events (such as electrical burns, falls, electric shocks), and criminal and patient protection issues (such as abduction of a patient, sexual assault of a patient, suicide).
Recent studies, discussed below, took a broader view, looking at all harm resulting from medical care.
While the harm spans all providers – hospitals, doctors, dialysis centers, nursing homes and outpatient surgical centers – most of what we know of this harm is about hospitals. The impact on patients varies – from minor harm to years of recovery to death. People who are harmed lose their jobs, their houses, their health insurance. They may go bankrupt trying to pay subsequent medical bills, debt they would not have had they not been harmed by a health care provider.
We don’t really know how many hospital patients are harmed each year because there is no national effort to collect this information. And we don't know how many are harmed in Hawaii because there is no statewide effort to document this problem.
More than ten years ago, the Institute of Medicine (IOM) estimated that annually 98,000 patients lost their lives due to medical harm. That estimate included hospital-acquired infections and certainly was an underestimate, since the current estimate is that infections alone kill 99,000 hospital patients each year. The IOM report sounded an alarm to the country, calling for sweeping changes to the health-care system to improve patient safety (defined by the IOM as “freedom from accidental injury”) and for a measurable improvement in patient safety, stating “it would be irresponsible to expect anything less than a 50% reduction in errors over five years.”
Despite an initial flurry of activity following the report, progress slowed once the media moved on to the next crisis. When the IOM published a follow-up report in March 2001, the release barely registered. By 2004, the deadline for the IOM’s goal of a 50% reduction in errors, no national medical error reporting bills had been passed and the initial outrage surrounding the report had faded. Movement towards systematic change to the health-care system remained “frustratingly slow.” For a more thorough examination of the landscape ten years after this IOM report, see “To Err Is Human, To Delay Is Deadly.”
The IOM panel recommended two separate national reporting systems: A mandatory and public reporting system designed to encourage accountability, (i.e. creating external pressure for change) and a voluntary and confidential system designed to facilitate learning about errors. But only the voluntary confidential system is in place (begun almost 10 years after the report). This is a network of private entities that hospitals can contract with to help them analyze harmful events that occur in their facilities and to hopefully to learn how to prevent similar events in the future.
In 2010, two landmark studies revealed no significant progress in improving the safety of hospital patients since the IOM’s report. The studies have rocked the confidence of experts in the field who have assumed piecemeal efforts to prevent medical harm were having an overall effect on improving patient safety. One study, by the US Health and Human Services Office of Inspector General, found that one in seven Medicare patients endure long-term and serious harm from hospital care. The other, published in the New England Journal of Medicine (NEJM), had similar findings - one in four hospital patients are harmed. This study was done in North Carolina where there has been a high level of engagement in efforts to improve patient safety during the six years covered by the study; despite this work, the surprising findings showed little evidence that harm had decreased substantially over that 6-year period. North Carolina requires no public reporting or public accountability for medical harm. Translating harm to one in four hospital patients nationally amounts to approximately nine million people each year. Since we have estimates that two million hospital-acquired infections occur annually, that means seven million patients are harmed in other ways. Both studies looked at all harm – from minor to major – and both emphasized the need for the system to focus on a broader array of events than the National Quality Forum list. The OIG estimated that 44 percent of this harm identified was preventable. The NEJM study found 63% preventable and made the important point that what is “preventable” changes constantly as new ways to keep patients safe are tried and measured.
STATES’ RESPONSE TO MEDICAL HARM
Twenty-seven states and the District of Columbia now require public reporting of certain hospital-acquired infections and these hospital-specific reporting laws have stimulated more activity around infection prevention than this nation has seen for decades. However, the reporting of other types of medical harm currently in place fails to create external pressure for change. In most cases hospital-specific information is confidential and under-reporting of errors is not curbed by systematic validation of the reported data.
Currently, 26 states require hospitals to report certain types of medical harm, but only 10 require reporting this information by hospital. Without hospital-specific information, key elements for stimulating change are missing: public accountability and hospitals’ awareness of their records and of their peers.
Fairly steady criticism has been leveled at underreporting in these state-reporting systems, which often do not include enforcement provisions and rely on weak protocols to validate the accuracy of the reports. More than half of states with reporting systems acknowledged that underreporting occurs in their system. Validation, generally through random chart audits or regular comparison to claims and billing data, counters systematic underreporting by participants. As of January 2008, only three states reported performing on-site audits to validate compliance. (Sixteen states reported using more limited validation techniques.) For example, Minnesota, a state that has been reporting for several years, looks at death records and consumer complaints as a measure of accuracy. Validation programs must be active, ongoing and funded to be effective. The New York City Comptroller recently reported that the state was not sufficiently enforcing or funding its reporting system, stating the ability of the state program “to more broadly improve the quality of care and reduce unnecessary costs has been seriously compromised” by these shortcomings.
Also, a 2010 series in the Seattle Times clearly illustrated the problems arising from narrowly defining “harm” in a way that ensures most harm will not be reported. One article told of a man who entered the hospital for a simple outpatient arthroscopic shoulder surgery and, according to state investigation records, sustained brain damage and died due to nursing errors, including a misadministration of pain medication. This was clearly a case of preventable medical harm but the harm did not fit into any definitions under Washington state reporting law. These are the issues that both reports from the Office of Inspector General and the NEJM pointed to in their conclusions – we need a system that identifies all preventable harm, not just those that fit into a narrow definition.
SB705 addresses these issues with provisions such as requiring validation with data available to the state, assessing fines against hospitals that fail to report within a certain time frame, and publishing the information on each hospital’s record. The published information cannot identify any patients or employees of the hospital.
PUBLIC REPORTING IMPROVES SAFETY
Facility specific reporting is essential to facilitating accountability, and when this report uses the term “public” reporting, we refer to facility-specific reporting. Consider if Consumer Reports tested 50 cars and found some performed well and others unsafe, but refused to reveal which cars were which. The public would not be served by such evaluation. Error information is not useful unless it is publicly tied to the entity where the harm occurred.
Minnesota is one state that publishes facility-specific information about patient harm on a state Minnesota Department of Health website. Seventy-two percent of Minnesota facilities surveyed in 2008 felt that the Minnesota error reporting law made them safer than they had been when reporting began in 2003. One respondent said, “(Our) focus was always on patient safety, however now safety efforts are better understood by more of our staff and we prioritize this work ahead of other work. Data is helping us to create more sense of urgency for this work.”
For decades, some states have reported hospital-specific quality of care information to the public, and in those states, hospitals are more motivated to improve their outcomes. Research shows the lowest performing hospitals are the most motivated to change.
New York was among the first states to compare hospital mortality for coronary artery bypass grafts (CABG). When the early reports were issued, hospitals with substantially higher mortality rates responded by examining their surgical systems and identifying areas of improvement. Winthrop University Hospital on Long Island fared poorly among heart programs, so it hired a renowned cardiologist to overhaul its program, hired additional staff, and created a new database system to monitor quality of care. Within two years, the cardiac program had one of the state's lowest mortality rates.
Public reporting of hospital infection rates is a relatively new activity, but some improvement is becoming visible in states requiring such reporting. In Pennsylvania, over a two year period in which the same measures were reported, the number of infections dropped by almost eight percent statewide. While not all hospitals reduced their infections, most did. Also, in New York’s third year of reporting, many hospitals showed a decrease in certain surgical infections between 2006 and 2009, with 39% of hospitals reported zero infections for hip surgery. Also, significant reductions were documented in NY for central line associated bloodstream infections.
House Bill 821 will significantly improve the safety of Maryland's hospitals. We urge you to support its passage. Please contact me if you have any questions.
Campaign Manager, Safe Patient Project
512-477-4431 ext 115