“Patient safety” is “freedom from accidental injury due to medical care, or medical errors.”

“Medical error” is  “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim…

[including] problems in practice, products, procedures, and systems.”   Institute of Medicine

This is the first part of a two part article that will outline the role that preventable medical accidents, injuries and diseases play in the rising cost of health care, summarize the current state of efforts to improve patient safety, and detail some changes that could be made in public policy, health care financing and health care regulation that could make a real difference both in lives and money saved.  Part 1 will provide information on the scope of the patient safety issue and summarize the current state of efforts to reduce medical errors including actions taken in Virginia.  Part 2 will suggest further actions that could be taken in Virginia to make health care safer, save lives and reduce health care costs.

The national conversation on patient safety began with the publication in 1999 of “To Err is Human: Building a Safer Health Care System” by the Quality of Health Care in America Committee of the Institute of Medicine (“To Err” or the IOM Report). 

The IOM report shocked the nation with conclusions like this:

• “At least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies. Even using the lower estimate, preventable medical errors in hospitals exceed attributable deaths to such feared threats as motor-vehicle wrecks, breast cancer, and AIDS.” These numbers make medical error the 8^th leading cause of death in this country.
• Medical errors “have been estimated to result in total costs (including the expense of additional care necessitated by the errors, lost income and household productivity, and disability) of between $17 billion and $29 billion per year in hospitals nationwide.”
• Additional costs are imposed on society by medical errors including costs associated with “lost worker productivity, reduced school attendance by children, and lower levels of population health status.”

Where are we now?  The sad fact is that in the almost six years since the report was published not enough has happened to reduce the number of deaths or the consequent health care and other societal costs.  While the medical community has gone from denying the widespread nature of the patient-safety problem before the publication of “To Err” to accepting the importance of investments in improving patient safety, we are nowhere near achieving the goal set out in the report of a 50% reduction in medical errors in five years.

 In fact, the situation may be getting worse instead of better.  A study cited in the second annual report on Patient Safety in American Hospitals released by Health Grades in May 2005 reports that “patient-safety adverse” events increased among Medicare beneficiaries between 1995-2003.  Among other findings, Health Grades determined that “hospital-acquired infections rates worsened by approximately 20 percent from 2000 to 2003 and accounted for 9,552 deaths and $2.60 billion, almost 30 percent of the total excess cost related to the patient safety incidents.”

To put the number of deaths from medical errors in perspective, the lower end of the estimated number of preventable deaths caused by medical error, 44,000 per year, is the equivalent of 110 Boeing 747’s crashing annually and killing all on board.  As the 2005 Health Grades report points out, “This also equates to three fully loaded jumbo jets crashing every other day for the last five years.” Can anyone question whether the public would tolerate that kind of death rate in the airline industry?

Speaking at the Commonwealth Fund Quality Improvement Colloquium: Patient Safety Five Years After To Err is Human in November 2004, Robert M. Wachter, MD, a leading authority on patient safety, gave this reason why we have not made more progress:

We have not yet found the right mix of financial, educational, research, regulatory, organizational, and cultural activities and forces to catalyze the far-greater investment (in money, time, and attention) that will be needed to make health care significantly safer.

In 2001 following publication of the IOM report, the federal government announced $50 million in grants for research into medical errors and patient safety.  The Agency for Healthcare Research and Quality now has a safety budget of $60 million, but this pales in comparison to what the federal government invests in innovation.  The NIH research budget for innovation is 500 times greater than the safety budget.

Virginia has taken some steps to address the patient-safety issue since To Err was published, but it is unclear what the effect of these actions has been.

The Virginians for Improving Patient Care and Safety (VIPC&S) is a voluntary public-private partnership that was formed shortly after the publication of the report. VIPC&S now includes public agencies including the Virginia Department of Health along with representatives of doctors, hospitals, health insurance purchasers, and health insurance companies and associations.  No representatives of patients or individual consumers of medical services are currently listed among the membership of the VIPC&S although the AARP was listed as a member at one time.  http://www.vipcs.org/all_aboutus.htm  

VIPC&S adopted core principles for addressing the IOM report in June 2000.  A principle goal of the organization is to ensure that any patient safety reporting system adopted in Virginia does not involve public reporting of safety data.  VIPC&S believes that any data reporting system must insure “strict confidentiality of individual reports” and the use of data for “learning and improvement rather than punishment.”

In advocating a confidential reporting system, VIPC&S is generally aligned with the views of hospital executives. Hospital leaders have concerns about the impact of mandatory, nonconfidential reporting systems on hospital internal reporting, lawsuits, and overall patient safety. While hospital leaders generally favor disclosure of patient safety incidents to involved patients, fewer would disclose incidents involving moderate or minor injury to state reporting systems.  80% say that names of hospitals and professionals involved should be confidential.

A 2000 Study by Virginia Joint Commission on Health Care recommended changes in Virginia law to encourage voluntary reporting of patient safety data to patient safety organizations like VIPC&S.  The Virginia Code was amended to provide civil immunity to those providing data to such organizations.  Virginia also has in place a mandatory reporting program for certain health professions that requires hospital administrators and others to report unprofessional or unethical conduct of professional incompetence that has been strengthened recently. 

There is also a patient level data reporting system, in place since 1993, that requires reporting of  “external cause of injury” by hospitals.  This data, aggregated by the Virginia Health Information is coded in a manner that permits some analysis of the incidence of medial error, but no regular public reports are made from this data.  An analysis by the staff of the General Assembly’s Joint Health Care Commission in 2000 concluded “for the years 1997 and 1998, surgical misadventures and adverse drug effects occur in a small, but perhaps slightly increasing percentage of inpatient hospitalizations.”  The staff also highlighted some limitations of the data and found that “greater evaluation is warranted concerning whether the VHI patient level data base could be used, either in its present form or with some modification, as the basis for greater screening and surveillance, from a public health and health care purchasing perspective, of adverse medical events and medical errors in Virginia.”

Virginia has not expanded its mandatory reporting system or published any analysis of existing data on medical errors since the Joint Health Care Commission study in 2000.  Despite a recommendation by the AARP in response to the staff’s draft report, there is no annual report to the public regarding the efforts of VIPC&S to gain improvements in patient safety or any other public report and analysis of patient safety data that would permit the public to track Virginia’s progress toward the IOM report goal of reducing medical errors by 50%.

It is clear that more can and should be done to enhance patient safety and to reduce medical errors and preventable accidents and injuries to patients in hospitals.  Part 2 of this article will address some policy options under consideration in Congress and in other states along with those recommended by the Joint Commission on Accreditation of Health Care Organizations.