Medical Malpractice: The Role of Patient Safety Initiatives
Released: 2006-07-14T00:00:00

Background

Medical malpractice and malpractice insurance continue to be issues of great concern tophysicians, consumers, legislators, and others. (1) Most of the discussion about the rising cost of malpracticeinsurance has centered on limiting the damage awards in malpractice suits. Some attention has beengiven to insurance market reforms. A third, related area that has received less consideration inmalpractice discussions is patient safety.

Patient safety refers to the panoply of rules, practices, and systems related to the preventionof patient injury, also known as "adverse events." Intrinsic to patient safety efforts are strategies toprevent medical errors; i.e., the use of an incorrect medical treatment or the failure of a specifictreatment to achieve the intended result. (2) While patient safety and medical errors have generated a great dealof discussion in the media and in legislatures in the past several years, such discussion typically hastaken place separately from the vigorous debates concerning malpractice litigation. Legislationconsidered during the 109th Congress has been no exception. S. 544 , the Patient Safetyand Quality Improvement Act of 2005, established a system for the voluntary submission andanalysis of medical error data. Similar to other medical error reporting bills in recent years, itprohibited use of error data in administrative, civil, and criminal proceedings. S. 544became P.L. 109-41 on July 29, 2005. However, medical liability issues are addressed in otherlegislation -- specifically, H.R. 5 / S. 354 , the Help Efficient, Accessible,Low-Cost, Timely Healthcare (HEALTH) Act of 2005; S. 22 , the Medical Care AccessProtection Act of 2006; and S. 23 , the Healthy Mothers and Healthy Babies Access toCare Act. (3) All of thesebills focus on tort reform as the solution to increasing malpractice premiums. (4)

The separation of patient safety concerns from medical malpractice issues has not alwaysbeen the case. During the first malpractice insurance "crisis" in the mid-late 1970s, California passeda pioneering bill, the Medical Injury Compensation Reform Act (MICRA), which includedprovisions not only limiting damage awards and other legal reforms, but also strengthening patientsafety and physician disciplinary activities. But the controversy over damage awards eclipsed thoseother topics, and subsequent state and federal legislative activity centered on reforming malpracticetort law.

This dynamic was repeated during the second malpractice insurance "crisis" during themid-late 1980s. Another spate of malpractice tort reforms were proposed and debated, separate fromthe proposals related to health care quality and the mostly academic discussions concerning patientsafety. Through most of the 1990s, patient safety issues did not command widespread legislativeattention, despite research that found that medical errors caused significant health and financialproblems for the individuals injured, their families, and the nation as a whole.

It wasn't until a 1999 Institute of Medicine study on medical errors, which avoided includingdiscussion about the malpractice insurance controversy, that the issue of patient safety finallyreached national prominence. Since publication of that report, the intense media attention helpedpropel patient safety issues to the forefront of health care debates and legislative proposals. Giventhe interest in patient safety and observations by some that the nation is in the midst of its thirdmalpractice insurance "crisis," some federal and state legislators have developed proposals to addressthese issues. Therefore, it may be appropriate to consider these issues collectively, and re-visit therole patient safety initiatives could play in the prevention of both medical errors and medicalmalpractice.

The link between malpractice and medical error has its detractors. Some health careobservers refer to studies that found that the majority of malpractice claims filed do not involvenegligent medical care. (5) In other words, the majority of patients who file malpractice claims have suffered medical injuries,but not of the type that would be "legally compensable" on the grounds of provider negligence. (6) Moreover, a seminal medicalerrors study showed that many lawsuits are won by patients even though expert reviewers cannotestablish any evidence of negligence. At the same time, only a small proportion of patients whoseinjuries are caused by negligence actually end up filing a malpractice claim. Some observers citethe gap between malpractice claims and provider negligence as evidence of a faulty litigation systemin need of reform. Thus, they support solutions that target the legal system, such as malpractice tortreforms. (7)

Other observers argue that the emphasis on liability and damage awards negatively impactsthe patient-provider relationship which, in turn, affects malpractice claims. A number of studieshave shown that communication breakdowns lead to patient frustration and anger, which increasesthe likelihood of litigation. (8) Some health care observers assert that the collapse incommunication and trust, in addition to a health care delivery system in which time spent providingservices has been compressed, adds an unhealthy, antagonistic component to modern medicine. They conclude that this adversarial element acts as a significant barrier to quality improvement andpatient safety efforts.

Such an assessment was reflected in an editorial by several well-respected patient safetyresearchers who observed that the threat of malpractice liability to deter bad medical care has "hadlimited impact on reducing patient injuries." (9) Indeed, the variety of disciplines involved in this debate (i.e.,medicine, insurance, law, government) speaks to the complexity of the issues. It follows that anymeaningful discussion about them necessitates a thorough analysis, including an analysis of patientsafety.

Patient Safety and Medical Errors

While concern about patient injuries is not new, data about adverse events was sparse andlimited until fairly recently. A small, pioneering study looked at a sample of 23 California hospitalsin 1974. (10) Thatanalysis found that nearly 5% of hospitalizations involved injuries to patients. Extrapolating fromthe number of hospitals in the sample to all CA hospitals, the study investigators estimated that therewere 140,000 patient injuries in that state alone in 1974. A more comprehensive study wasundertaken in 1991, largely in response to the lack of robust patient injury data, by members of theHarvard Medical Practice Study (HMPS) Group. The group analyzed 1984 data from over 30,000discharges at 51 New York hospitals and more than 67,000 litigation records, and the study isconsidered to be the most influential patient injury study. The HMPS found that the proportion ofhospitalizations involving medical injuries was around 4%. Lucian L. Leape, one of the HMPSinvestigators, later extrapolated from the NY data and estimated that 180,000 individuals diedannually in the U.S. as a result of medical injury. He noted that this was equivalent to "threejumbo-jet crashes every 2 days." (11) In 1992, a subset of the HMPS investigators conducted avalidation study by reviewing 15,000 discharges from a sample of 28 hospitals in Colorado and Utah. The findings of the CO-UT study largely corroborated those of the NY study.

The Institute of Medicine Report

The analyses from the NY and CO-UT studies formed the bulk of the evidence on which theInstitute of Medicine (IOM) based its patient safety recommendations, outlined in the 1999 report, To Err is Human: Building a Safer Health System . (12) The report's findings immediately seized the attention ofmainstream news media. Along with dramatic stories about individuals seriously harmed by errors,the IOM Report placed medical errors in the forefront of health care discussions. Most of theattention focused on the IOM's estimate of the number of deaths that could be attributed to errors,between 44,000 and 98,000 annually. In addition, the report estimated that the cost to the nation ofall preventable adverse events was $17 billion a year.

But beyond those dramatic statistics, the IOM Report emphasized a need to move away fromblaming individual providers and focus instead on preventing errors via safer health care systems. The IOM concluded that medical errors generally are the result of many variables. Since blaminga single person does nothing to change those contributing variables, the same error could occur overand over again. Thus, enhancing patient safety requires a systemic approach in order to makechanges to system conditions that lead to errors in the first place. In effect, this conclusionbroadened the medical errors discussion to include the characteristics of health care delivery systemsthat contribute to the prevalence of adverse events. Also, this groundbreaking approach toaddressing errors was seen as an opportunity for lessening the adversarial quality in patient-providerrelationships engendered by the malpractice liability debate.

Patient Safety Initiatives

Soon after publication of the IOM's findings, strategies to reduce medical errors were putforth from both public and private sector entities. For example, 34 medical error-related bills wereintroduced in state legislatures in the year following the release of the IOM Report. The proposalsaddressed a broad spectrum of related issues, such as adverse event reporting, reduction ofmedication errors, system-wide analysis, and public disclosure of information. (13) At the federal level,then-President Clinton charged an interagency task force to inventory current federal efforts toreduce errors and outline action items for future implementation. Three months later, the task force'sreport endorsed many of the IOM's recommendations and enumerated a diverse set of strategies foraddressing them. (14) Some of those strategies included allocating funds to establish a patient safety center within theAgency for Healthcare Research and Quality (AHRQ), implementing reporting systems at a numberof federal agencies, and developing new labeling standards to prevent medication errors.

In the private sector, one of the more visible responses was establishment of the voluntaryLeapfrog Group (Leapfrog). Founded by the Business Roundtable, an association of CEOs fromleading corporations, Leapfrog's mission is to mobilize purchasers of health insurance to alert healthcare providers that progress in patient safety would be rewarded with preferential use. As a first step,Leapfrog recommended three specific standards for comparing hospital performance: computerphysician order entry, evidence-based hospital referral, and intensive care unit physicianstaffing. (15) It alsodeveloped and conducted the Leapfrog Hospital Quality and Safety Survey. The survey querieshospitals about their adherence to specific quality standards, including the three original measuresrecommended by Leapfrog. (16)

Physician-Focused Initiatives

Some patient safety advocates point out that medical malpractice claims and awards are nota reliable gauge of an individual physician's competence. As discussed earlier, only a smallpercentage of patients who experience medical injuries end up filing malpractice claims, and of thosewho do file claims a majority did not experience injuries that meet the legal definition fornegligence. Therefore, even the most conscientious physicians face uncertainty as to whether theywill be sued, and negligent physicians may not be held accountable through the legal system. (17)

In addition, questions remain as to whether the prior experience of being sued or the threatof possible litigation make physicians practice medicine more safely. Some studies point out thata "large body of research has accumulated showing that medical malpractice liability causes doctorsto practice defensive medicine." (18) The premise underpinning defensive medicine is that the fearof liability and the potential negative outcomes associated with malpractice claims lead physiciansto administer additional health care treatments or avoid high-risk services primarily to reduce theirliability risk. The implication is that defensive medicine results in either an increase in overallspending for health care that may not be medically necessary, or a decrease in access to certainservices or for certain patients. Detractors suggest that the growth of cost-conscious managed carehas limited physicians' ability to provide care that provides marginal medical benefit. They arguethat empirical studies on defensive medicine have produced mixed findings, with "most failing todemonstrate any real impacts on medical practice arising from higher malpractice premiums or priorexperience of being sued." (19) Another issue for consideration is that many physicians may notface the full financial consequences of their professional conduct. Most physicians are insuredagainst medical malpractice, and premiums for professional liability insurance are not adjusted toreflect provider experiences with malpractice claims or other disciplinary actions, (i.e., malpracticepremiums are not "experience rated").

How then can patient safety be improved with the individual provider in mind? Some havesuggested that serious deviations from quality care can be addressed by strengthening licensure andaccreditation requirements, and modifying physician disciplinary procedures. Others recommenda less-punitive, less-adversarial approach of assessment, feedback, and ongoing professionaleducation.

Licensing and Disciplining of Physicians

The regulation of physician licensure and standards for appropriate physician conduct hastraditionally been the responsibility of the states. Through the licensure process states ensure thatall licensed physicians have appropriate education and training, and hold providers accountable tothe recognized standards of professional conduct. Under each state's Medical Practice Act, theresponsibility for physician licensure and discipline rests with the state medical boards. (20)

State Medical Boards. Any disciplinary sanctions imposed by state medical boards are reported to the Federation of State Medical Boards, medicalcredentialing societies, and appropriate government agencies, including the National PractitionerData Bank (see below for more details). State medical boards also can assist the public by disclosingthe current status of a physician's license, any disciplinary actions, or, in some instances, any pendingcharges. Many state boards have increased consumer accessibility to this information by making itavailable online. For example, Massachusetts passed a pioneering law in 1996 making informationabout physicians' disciplinary activities, malpractice payments, and criminal convictions availableto the general public. Other states, including California, Georgia, New York, Virginia, andWashington, now offer similar online physician profiles.

Some consumer groups believe, however, that the state medical boards are not doing anadequate job of protecting the public from negligent physicians, and that the number of doctorsdisciplined is low compared with the number believed to be providing substandard care. They havevoiced concern regarding the boards' reliance on consumers to bring unprofessional conduct to theirattention. Moreover, some observers question the effectiveness of state medical boards in thedisciplining of physicians because doctors themselves make up the majority of those boards. Otherobservers counter that medical boards are not given adequate resources to respond to the largenumber of complaints that they receive. They assert that boards lack sufficient funding, authority,and information to be able to act in an appropriate and timely manner. Boards also may not be ableto respond quickly, they say, because formal actions against physicians must follow a strict processof complaint, investigation, and hearing.

The Federation of State Medical Boards (FSMB), a private, non-profit association of statemedical boards, has worked to improve state medical practice acts and the effectiveness of theboards. The FSMB has also developed the Federation Physician Data Center; a repository forformal actions taken and reported against physicians by regulatory and licensing entities throughoutthe United States and some other countries. Information on medical malpractice settlements orclaims is not collected. Reporting to the FSMB is voluntary and only actions that can be legallyreleased or are a matter of public record are included in the Data Center. Beginning in 2001, FSMBreports on disciplinary actions against physicians became available to the public. (21)

National Practitioner Data Bank. Establishedunder the Health Care Quality Improvement Act of 1986 ( P.L. 99-660 ) and made operational inSeptember 1990, the National Practitioner Data Bank (NPDB) is a central repository for informationabout physicians, dentists, and, in some cases, other health care professionals. It contains reports on: medical malpractice payments; actions taken by a state Board of Medical Examiners to suspend orrevoke a practitioner's license; and actions taken by a hospital or other health care entity to limit orrevoke clinical privileges. The intent of the data bank is to improve the quality of health care byencouraging hospitals, state licensing boards, and other health care entities to identify and disciplinethose who engage in unprofessional conduct, and to restrict the ability of incompetent providers tomove from state to state without disclosure or discovery of prior adverse actions taken against them. While hospitals are the only health care entities with mandatory requirements for querying the databank, NPDB information is available to state licensing boards, professional societies, certain federalagencies, and others as specified in the statute. NPDB information is not available to the generalpublic.

Some legislators and consumer groups have advocated for the public release of NPDBinformation. They argue that the public has the right to know about adverse actions against healthcare providers in their communities. Others, however, question the quality of the NPDB data. According to a comprehensive Government Accountability Office (GAO) report, (22) under-reporting may bea severe problem, and so the completeness and accuracy of the NPDB information are an openquestion. Health care practitioners also oppose the public disclosure of NPDB information forliability and professional reasons. They assert that the NPDB data can be easily misunderstood bylaypersons. For example, they say, a simple comparison of malpractice payments made byphysicians in different specialties would be misleading, since some medical specialties typically havehigher rates of malpractice suits than other specialities. The same can be said about certain doctorswho take on riskier cases than their colleagues. Also, a data bank entry showing a payment for amalpractice claim does not necessarily indicate negligent care. It is possible this was a case in whichthe physician was not negligent, some assert, but settled out of court in order to avoid the costs andpublicity associated with a lengthy trial.

Public Disclosure of Reported Information. Theconcern that many providers voice against making NPDB data public is the same one they expressabout participating in reporting systems in general. Their concern is rooted in the assumption thatsuch information, whether it be about medical errors, adverse events, or disciplinary actions, will beused against them professionally. At a time when malpractice insurance is becoming increasinglyexpensive and difficult to find in some regions and for certain specialities, providers may believethey are being asked to disclose sensitive information with no guarantee of legal, administrative, orprofessional protection. In addition, opponents of public disclosure argue that it creates strongdisincentives for openness and candor in the reporting system, thereby reducing the value of theinformation gathered. Disclosure proponents argue that placing medical practitioners on publicnotice creates strong incentives for quality improvement and assures consumers that, at a minimum,a mechanism is in place to identify serious errors and negligent providers. Moreover, theycharacterize physicians' fear about liability as unwarranted. For example, proponents of publicreporting say that physicians in states that have posted disciplinary actions on the Internet arereporting that they have seen no negative impact from making this information public. (23)

Provider Education, Feedback, and Practice Guidelines

The Institute of Medicine's report, Health Professions Education: A Bridge to Quality ,emphasizes that oversight and reporting must be part of an integrated approach to improving patientsafety that includes ongoing professional development. They recommend enabling health careproviders to maintain up-to-date skills and competence through an approach that includes evaluationand feedback by peers, medical boards, certification bodies, and employers. (24)

Some reporting systems, particularly those conducted by managed care organizations(MCOs), are designed to furnish performance information to the participating providers on how theirpractice compares with their peers or with accepted practice guidelines. Practice guidelines providerecommendations about appropriate medical care, and are designed to outline the range of treatmentsfor a given clinical situation. Such guidelines are developed from research findings about theeffectiveness of certain medical therapies and practices, and expertise from practicing physicians. The Omnibus Budget Reconciliation Act of 1989 ( P.L. 101-239 ) provided funding for thedevelopment of clinical practice guidelines and authorized the establishment of the Federal Agencyfor Health Care Policy and Research (AHCPR). (25) AHCPR ceased internal development of clinical practiceguidelines in 1996, and now -- as the reauthorized Agency for Healthcare Quality and Research --supports external researchers in the creation and dissemination of evidence-based medical care.

Medical professional societies, research groups, and private-sector firms also have developedpractice guidelines. In addition, MCOs and other health care entities have increasingly used practiceguidelines and outcomes assessment (i.e., analysis of the impact of certain treatments or procedureson patient health) to monitor and direct the way physicians deliver health care. There is someconcern, however, about the effect of practice guidelines on changing physician behavior. One studyfound that U.S. physicians follow recommended "best practices" for diagnosis and treatment ofadults only about 55% of the time. (26) Some have urged that increased compliance with guidelinesshould be combined with other efforts to improve health care quality, such as better reporting of thequality of care, greater use of Internet technology and decision-support tools, increased patientinvolvement, and providing financial incentives for investment in quality-improvementinfrastructure. (27)

Studies have shown that clinical guidelines are most effective when delivered by a "respectedpeer or 'opinion leader.'" (28) Many physicians believe that other physicians are the mostappropriate individuals to assess the quality of care delivered, and provide counseling or additionaleducation. Peer review may be conducted at different levels: peer-to-peer, at individual hospitals,or through outside organizations such as the Quality Improvement Organizations (QIOs), whichcontract with the Medicare program to monitor beneficiaries' quality of care. (29)

The success of feedback to medical practitioners also depends on the confidentiality, timeliness, and quality of the feedback, as well as provider immunity from administrative and legalreprisals. Similar to the public disclosure debates, supporters of confidentiality and immunity inprovider feedback initiatives say that such assurances are necessary to move away from the "blamegame" and encourage reporting. Detractors say that such features support a solely internal systemof monitoring that is inadequate for proper intervention and enforcement.

Hospital-Focused Initiatives

With the majority of medical error studies based on inpatient data and the IOM Report'semphasis on addressing system failures, most patient safety initiatives thus far have focused onhospitals. An abundance of solutions have been proposed, such as reporting hospital performance,disseminating clinical protocols, and adopting innovative technology to aid hospitals in the creationof a "culture of safety." This endeavor was further energized by the implementation of patient safetystandards by the nation's largest hospital accrediting body, the Joint Commission on Accreditationof Healthcare Organizations (JCAHO). The JCAHO standards stressed not only a hospital's role inthe prevention of medical errors, but also its responsibility for disclosing to patients when they havebeen harmed by such errors.

Reporting of Medical Errors

Patient safety studies and initiatives emphasize the importance of "transparency" in healthcare delivery. Communication is the principal medium through which transparency concerns areaddressed, and one of the key features of a patient safety-based communication strategy is a systemfor reporting adverse events. (30)

Lessons from the Airline Industry. Some of theearly thinking on this issue borrowed ideas from other industries, particularly aviation. In the airlineindustry, pilots, controllers, and others can submit information to the Aviation Safety ReportingSystem (ASRS), which is administered by the National Aeronautics and Space Administration(NASA). (31) The ASRSis a system for reporting "near misses;" that is, incidents that do not result in accidents butnonetheless violate standard practices or rules. The system also analyzes the root causes of nearmisses, and communicates the findings to those involved as well as others working under similarconditions. Such a design is considered useful for identifying possible hazards and developingsolutions to prevent accidents. Key characteristics of the ASRS are that it operates independentlyof any regulatory body, is completely confidential, and reporters are given immunity fromretribution. In more than 30 years of existence, ASRS has received and processed more than 600,000reports, and many aviation experts credit ASRS with helping to greatly increase commercial aviationsafety. However, it is important to note that the ASRS does not deal with incidents that result inpassenger injury or aircraft damage. Serious aviation accidents are investigated by the NationalTransportation Safety Board under a different system. Moreover, pilots have extra incentive toperform flawlessly since a major mistake puts them in as much immediate danger as theirpassengers.

The dual-system arrangement for addressing near misses and serious errors in aviationparallels the IOM's recommendation for two-tier medical error reporting. The IOM recommendedestablishing a mandatory reporting system to hold hospitals and other health care facilitiesaccountable for errors that lead to serious injury or death. It also encouraged the development ofvoluntary, confidential systems for reporting no harm events (a medical error that has been carriedout but does not result in injury), minimal harm events, and near misses. Analysis of suchinformation could then be used to identify system vulnerabilities and develop preventive strategies.

Mandatory vs. Voluntary Reporting. There aremany ideas among stakeholders regarding the design of a health care reporting system, includingwho should report and what they should report. A key area of discussion is whether a reportingsystem should mandate participation or be voluntary. (32)

The primary purpose of a mandatory reporting system is to hold providers accountable byensuring that serious mistakes are reported and investigated, and that appropriate follow-up actionis taken. Medical practitioners that continue unsafe practices risk citations, penalties, sanctions,suspension or revocation of licenses, and possible public exposure and loss of business. However,the focus on collecting adverse event data and disciplining individual providers bypasses the majorityof errors; errors that are caused or exacerbated by poorly designed health care delivery systems.

According to the IOM, voluntary reporting systems play a "valuable role in encouragingimprovements in patient safety." (33) Experience from ongoing voluntary reporting efforts have shownthat such systems are helpful in identifying errors that occur on such an infrequent basis that theywould be difficult to detect by any one single health organization, and error trends or patterns thatallude to system problems that may affect all health care organizations. Identification of such eventscould facilitate the development of strategies to prevent more serious errors from occurring. Nevertheless, key criticisms against voluntary systems are that due to their very design,under-reporting is a constant concern, and such systems are inadequate for addressing egregiousmedical errors.

Examples of Health Care Reporting Programs. Both private and public entities have implemented patient safety reporting programs. For example,in 1996 JCAHO implemented its Sentinel Event Policy (SEP). (34) This policy outlinesJCAHO's expectations for how health care organizations should address sentinel events; i.e., medicalevents involving death or severe physical and/or psychological injury. The SEP instructsorganizations to identify sentinel events, complete a thorough analysis of the root causes of thoseevents, implement strategies to reduce their prevalence, and track the effectiveness of thosestrategies. The policy also encourages health care organizations to share their findings with JCAHO,in order for it to pass on those "lessons learned" to others. As of April 2006, JCAHO has released36 alerts that describe different types of serious medical events and suggest ways to prevent them. The alerts also include statistics on the prevalence of these medical events, but do not name specifichospitals.

With respect to the states, 28 have passed legislation or issued regulations mandating thereporting of adverse events or medical errors in hospitals. (35) The reporting requirements vary widely. For instance, statemandates differ in what health facilities are required to do with reported information: review reportsabout medical violations, share information with patients, disseminate evidence-based, error-prevention protocols, etc. In general, the quality and quantity of information collected aremajor concerns. Only a few states get enough information to conduct proper analyses, and some ofthe information reported is not useful. But a few states are able to conduct analyses and use thefindings in their role as regulator. (36)

"Honesty Policies". While most of the attentionpaid to better communication has centered on reporting systems, a few health care entities haveimplemented programs that directly engage individuals injured by medical errors. "Honesty policies"have been instituted in a small minority of hospital and health care systems to encourage providersand staff to admit that they have committed errors. In addition, these institutions offer compensationto injured patients to pay for medical treatment or cover lost income. Such practices, however, areuncommon. Providers typically resist disclosure of adverse medical events. (37) Supporters of honestypolicies assert that such policies help maintain openness and trust in patient-provider relationships,which may diffuse potentially volatile situations. Others argue that these policies elicit declaredadmissions of guilt, thereby exposing medical practitioners to even greater liability.

Clinical Standards in Hospital Settings

Medical guidelines generally are developed with a particular health condition in mind andindividual providers as the target audience. However, given the increased awareness about medicalerrors caused by weaknesses in health care systems, there is more attention being paid to theapplication of clinical standards to hospitals. For instance, AHRQ developed a set of QualityIndicators (QIs) to measure the level of quality associated with the medical care being delivered inhospitals. One of the components that make up the QIs is a set of Patient Safety Indicators (PSIs). The PSIs provide information on potential inpatient adverse events, such as accidental puncture,obstetric trauma, transfusion reaction, etc. AHRQ encourages hospitals to use the PSIs to assesspatient safety at their facilities.

IHI's 100,000 Lives Campaign: A Hospital QualityInitiative. In December 2004, the Institute for Healthcare Improvement (IHI)launched a major effort to save 100,000 lives in American hospitals over an 18-month period oftime. Dr. Donald Berwick, President and CEO of IHI, stated that this significant outcome could beachieved easily if hospitals focused on implementing only six evidence-based interventions that areknown to improve health care. The six quality improvement interventions that are a focus of the100,000 Lives Campaign include the deployment of rapid response teams, prevention of adverseevents, improved care for heart attacks, prevention of surgical site infection, prevention of centralline-associated infections, and prevention of ventilator-acquired pneumonia. Hospitals that choseto participate in the 100,000 Lives Campaign had to commit to implementing one or more of thesesix interventions.

The 100,000 Lives Campaign hoped to enroll 2,000 hospitals in its effort, but to date hasenrolled more than 3,000 hospitals (this represents about 75% of all hospital beds in the UnitedStates). IHI touted its campaign as successful, and announced on June 14, 2006, that it hadsurpassed its goal of saving 100,000 lives by 22,300. Key components of this campaign include"node" hospitals, which lead the initiative at the regional or state level; national partners, whichprovide the initiative with visibility and exposure; and "mentor hospitals," those hospitals that havedemonstrated success with a specific intervention and therefore act as mentors to other hospitals bysharing what they have learned. Participation in the campaign was entirely voluntary, no financialincentives were provided, and no regulatory mandates were leveraged to achieve either participationor cooperation. (38)

Information Technology

Another area on which a great deal of attention is focused is information technology (IT). Many observers believe that the health care system lags behind other industries in utilizing suchtechnology and should incorporate these innovations at multiple levels in order to enhance patientsafety. The IOM's report , Crossing the Quality Chasm: A New Health System for the 21st Century ,concluded that IT's role in the future of health care delivery is key, and the automation of health caretransactions is fundamental to the prevention of medical errors. (39)

Proposed IT Initiatives. The applicability andpotential benefits of IT to health care are immense. Supporters recite a litany of uses:patient-physician communication via e-mail, bar-coding of pharmaceuticals, instantaneous retrievaland sharing of patient records, etc. Some e-health care pioneers tout the savings in time andresources, in addition to a reduction in medical errors, resulting from IT investments.

A number of public and private-sector organizations, to varying degrees, have incorporatedIT into their policies, programs, and operations. For example, President Bush in his 2006 State ofthe Union address expressed his desire to reduce medical errors through wider adoption ofinformation technologies. Moreover, included in the President's FY2007 budget request is $169million for health IT initiatives to improve quality and reduce errors, among other objectives. (40)

For more than 20 years, the Department of Veterans Affairs (VA) has developed and operatedthe Veterans Health Information Systems and Technology Architecture (VISTA). VISTA is anintegrated health information system that incorporates diverse functions ranging from managingpatient records to providing decision-support tools to handling billing. It can be accessed at each ofthe VA's 1,400 facilities. According to the VA, such connectivity and use of performance measureshave led to both increases in efficiency and reductions in medical errors. (41)

The Food and Drug Administration (FDA) issued a final rule on February 26, 2004 thatrequired bar codes on labels for pharmaceuticals and biological products, in order to reduce theprobability of errors that cause adverse medical events. The FDA estimated that the rule wouldprevent nearly a half-million drug and transfusion errors over the next two decades. (42)

A related strategy to reduce adverse drug events comes from the private-sector LeapfrogGroup. One of the three measures that form the core of its hospital performance monitoring effortsis implementation of computer physician order entry (CPOE) systems. Such systems allowphysicians to order medications electronically and alerts them to possible prescribing errors.

In addition to government officials and health care practitioners, corporate managersrecognize the benefit of adopting technology for patient safety enhancement. For example, theHealth Information and Management Systems Society, a health care IT member organization,conducts an annual survey of chief information officers (CIOs) at integrated delivery systems,multi-hospital systems, and stand-alone healthcare facilities from around the country. The latestsurvey results revealed that half of CIOs cited reduction of medical errors and promotion of patientsafety as one of their top priorities for 2006. (43)

Technology Implementation Considerations. While the potential benefits from IT are great, so are the implementation challenges. One of thechief challenges relates to the up-front investment. For instance, the FDA's drug bar code policyrequires hospitals to spend an estimated $7-plus billion on necessary equipment. (44) In addition, there are costsassociated with training staff, maintaining a technical assistance capacity, and updating systems andapplications. There also are other less tangible but nonetheless considerable barriers to IT adoption,including data privacy, system security, and overall reliability. Perceptions of value depend heavilyon how those concerns are addressed. And, lastly, culture also plays a substantial role. Familiarityand comfort with electronic systems affect how well consumers, providers, insurers, and payors willrespond to e-health care efforts.

Impact of Patient Safety Programs

The specific challenges associated with IT adoption reflect the larger concerns regardingadoption of patient safety programs in general. Individual initiatives have resulted in promisingoutcomes, but the overall impact of these efforts has been mixed. To some degree, this is the casebecause implementation has not been as pervasive as initial intentions suggested, and also becausenot enough research has been done to identify, enumerate, and assess patient safety efforts.

Selected Results from the Field

While it would be very difficult to provide a comprehensive, quantitative assessment of theimpact of patient safety programs, some insight can be gleaned from individual, private-sectorinitiatives, as well as public efforts. It is important to note that the results of specific programs arehighly dependent on the environment in which they operate, the target audience, and the level ofresources provided.

Tracking and Reducing Medical Errors. TheAgency for Healthcare Research and Quality (AHRQ) submitted an interim report to the SenateAppropriations Committee that included how health care facilities track and record medical errors,and discussed how such information may be used to increase patient safety. (45) Hospitals and other healthcare facilities used a variety of approaches in their efforts to reduce errors. These approaches includenot only investments in technology and development of patient safety procedures, but also lesswell-known but equally important strategies, such as changes in organizational culture, involvementof key leaders, and education of providers. Such a breadth of activities underscored the necessityof implementing a comprehensive approach to reduce medical errors, instead of relying on a singlestrategy (e.g., information technology). For instance, to assist hospital efforts to enhance patientsafety, AHRQ developed a survey, with both private and public partners, to measure "organizationalconditions that can lead to adverse events and patient harm." (46)

Publicizing Hospital Performance Data. Overall,the research on the impact of publicizing hospital performance measures shows mixed results. Somefindings show that patient mortality decreased after hospital performance data was released, whereasother findings showed no effect. While these studies were not necessarily focused on the preventionof medical errors, they still provide some indication of how similar programs may affect patientsafety efforts in general.

One study of a hospital reporting system in Wisconsin highlighted some of the commonconcerns involved in such efforts. (47) The study assessed the impact of disclosing the findings fromthe "QualityCounts" report, which compared the performance of 24 hospitals. In this study, somehospitals' performance data was made public; other hospitals' data was not publicized. The endresults provided some evidence of the value of publicizing performance data to encourage qualityimprovement activities. For example, hospitals with low scores for obstetric and cardiac care, whoseresults were made public, were later involved in the most quality improvement efforts. In contrast,the hospitals whose performance was not made public had the lowest level of quality improvementactivity. Not surprisingly, the analysis also found that making performance data public generatedfeelings of distrust and anger among the participating hospitals. All of the hospitals had a slightlynegative view of public reporting in general, although they differed with respect to how they thoughtsuch reporting would affect their public image. As to be expected, hospitals with higher scores weremore likely to assert that their public image would be helped, while those with lower scores weremore likely to assert that their image would be hurt.

Disclosing Medical Errors to Injured Patients. Anecdotal evidence suggests a positive impact of "honesty policies" on the reduction of malpracticeclaims. The Veterans Affairs medical center in Lexington, Kentucky regularly is held up as a modelfor such policies. The Lexington center chose to adopt the practice after dealing with two costlymalpractice cases. Since then center administrators claim that their policy has led to savings, partlydue to decreased legal expenses. Also, the center did not experience a deluge of malpracticelitigation as initially feared. Copic Cos., a malpractice insurer in Denver, had similar experiences.Copic's policy directs providers to report medical complications and adverse events. Copic respondswithin 72 hours with offers to compensate the patient for medical expenses related to injuries causedby errors and lost wages. According to Copic, this policy has led to a reduction in the number ofclaims and smaller claim payments.

Despite these promising outcomes, some observers urge caution. They assert that patientsmay not receive adequate compensation without the assistance of legal counsel. Furthermore, thesepolicies are not adequate mechanisms for addressing very serious medical errors (e.g., patientdeaths). Others point out that it would be inaccurate to generalize the experience of the Lexingtoncenter to the general population. They assert that VA patients generally are older men with finiteresources; individuals who may have limited expectations and a lower-than-average inclination tosue. (48)

Using Information Technology in Health CareDelivery. Individual efforts to utilize information technology in health caregenerally have increased the quality of health care. For example, in order to overcome the lack ofspecialists in a rural area in California, some providers use e-mail to consult with specialistselsewhere. A Spokane, Washington medical center built an IT system to provide 24-hour pharmacistcoverage for review of all medication orders. A heart institute in Kansas City, Missouri, iselectronically linked to a larger medical system that allows institute staff to remotely monitor cardiacpatients at each of the system's care locations.

Specific IT initiatives also have enhanced patient safety. For instance, one study found thatthe rate of serious medication errors fell more than 50% when computerized prescribing systemswere used. (49) Yet,despite the enthusiasm expressed by some experts for the use of IT in health care, the adoption ofsuch technology has progressed slowly, especially in smaller medical settings. For example, "morethan 90 percent of medical practices with fewer than 50 doctors do not make significant use ofIT." (50)

Barriers to the Adoption of Patient Safety Programs

Cultural Issues. Just as there are numeroussolutions proposed to enhance patient safety, so to are there numerous barriers to implementing thosesolutions. Part of the reason why more has not been done is cultural. Some say medicine is aconservative discipline that does not change easily. Providers, especially physicians, place greatvalue on their professional autonomy and expertise. In an environment such as this, efforts to changeday-to-day practice patterns by outsiders may be met with resistance. Cultural barriers apply notonly to providers, but to other players in the health care system. For instance, proponents ofpublicizing patient safety information note the central role of the consumer. But study after studyhas shown that the vast majority of consumers generally do not seek out, use, or understand theinformation being made available to the public. (51)

Limited Resources. There are also resource issuescontributing to the lack of progress in conducting patient safety efforts. The cost of investing inequipment, staff, and supplies are of paramount concern. (52) For example, state mandatory reporting systems are hamperedby insufficient funding. The budgets for many state programs are small relative to theirresponsibilities, and some recently-enacted programs have not been implemented because of lackof funds. Some observers also point out that federal reimbursement does not take into accountmedical error rates or implementation of error reduction measures, so there is little incentive forproviders to enhance patient safety. Unless a "business case" can be made for the potential savingsresulting from patient safety initiatives, cost will continue to be a substantial barrier to such efforts. Some organizations have launched individual initiatives to address the financial feasibility concernsexpressed by health care providers. For example, in April 2003, a coalition of providers, plans,purchasers, and others launched "Bridges to Excellence," whose mission is to reward high-qualityhealth care. (53) In thepublic sector, HHS announced on July 10 of that same year the launch of a demonstration that wouldprovide bonuses to hospitals that perform well on selected quality-of-care standards. (54) More recently, S. 1932 , the Deficit Reduction Act of 2005, includes provisions for the Secretary ofHHS to develop a plan for value-based purchasing under the Medicare program beginning inFY2009. (55) Theseinitiatives are indicative of the growing interest in pay for performance in health care. (56)

Additional resource concerns focus on the time and effort needed to design, implement, andmaintain patient safety programs, including training staff. Some argue that this detracts from timethat could be spent on direct health care. However, others counter that these efforts are a moreefficient use of time and money in the long run.

Liability and Professional Concerns. A third setof barriers are prompted by concerns about professional and legal liability. As was mentionedearlier, some of the resistance to error reporting and public disclosure is born from the fear that suchactivities would make providers more vulnerable to claims of malpractice. Therefore, individualpractitioners and hospitals remain cautious about implementing programs that potentially could beused against them in the courtroom, on the career ladder, and in the marketplace. For instance, theMassachusetts Group Insurance Commission (GIC), the entity that provides health insurancecoverage and other benefits to the state's employees, dependents, and annuitants, ordered its healthplans to collect health care quality information based on Leapfrog's safety standards. GIC's intentionwas to use this data for hospital comparisons. Most of the GIC hospitals refused to provide theinformation. Hospital administrators declared that their respective institutions were working atimproving patient safety, but were concerned about the specific questions being asked. AMassachusetts hospital association spokesman noted that hospitals thought that the Leapfrogstandards were too narrowly defined, and that they preferred an approach that took into account theprogress that had already been made at individual institutions. (57)

Lack of Patient Safety Research

In addition to implementation barriers, the difficulty in assessing the impact of errorprevention efforts also relates to the lack of research in this area. Three of the most highly-regardedexperts on patient safety concluded that health care studies have focused on biomedical research fordecades. In contrast, "error prevention -- especially the systems issues that underlie a greatproportion of patient injury -- is a young field, which has commanded the attention of only a smallnumber of researchers and, until recently, has received little funding." (58) To illustrate, the $84million requested in the President's FY2007 budget to support AHRQ's patient safety efforts isequivalent to the single largest investment in this area by the federal government. However, thatappropriation amounted to less than one-half of 1% of the comparable budget request for theNational Institutes of Health.

Federal and State Patient Safety Activities

Congressional interest in activities at the federal and state levels has evolved from genericquality issues to concerns related specifically to medical errors and patient safety. As part of thisevolution, the development and implementation of legislative proposals has varied in scope, focus,and purpose.

Federal Legislation

Since the states traditionally play the role of regulator of provider behavior, the federalgovernment's presence historically has been small. But there was growing realization in the latter1970s and throughout the 1980s that the need for quality improvement in health care was sopervasive and severe that efforts of individual states could benefit from federal initiatives. In the1980s, Congress passed a number of legislative proposals designed to address health care qualitythrough a variety of mechanisms. Those mechanisms included state reporting systems, a nationaldata bank, Medicare peer review, and practice guidelines. In general, the proposals focused on theperformance of individual providers and generic quality issues. (59) Legislation to addresssystem problems specifically relating to patient safety issues did not come to fruition until the releaseof the IOM's To Err is Human report.

Several patient safety bills were introduced in the 106th Congress to address the issues raisedin the IOM Report. Many Members from both chambers and parties expressed support for patientsafety legislation, and introduced bills to develop guidelines for error reporting, establish a federalquality improvement center, and fund demonstration projects, among other initiatives. However,patient safety was overshadowed by other legislative priorities and all six stand-alone bills failed towin passage. The only federal action taken on this issue was a $50 million appropriation to theAgency for Health Care Research and Policy (later reauthorized as AHRQ) to support medical errorsresearch. (60) Most ofthe patient safety legislation first introduced in the 106th Congress was reintroduced in the 107th. Once again, not much legislative action took place.

During the 108th Congress, a number of patient safety bills were introduced. H.R. 663 , the Patient Safety and Quality Improvement Act, was the bill that receivedthe most legislative attention and enjoyed broad bipartisan support. H.R. 663 proposedthe establishment of a voluntary reporting system and provided civil and administrative protectionsfor certain types of documents and communications termed "patient safety work products." OnMarch 12, 2004, the House passed H.R. 663 by a vote of 418-6. On the Senate side, theHELP Committee took up S. 720 . The Senate bill was broadly similar to theHouse-passed legislation. S. 720 also established a voluntary system for the reporting ofmedical errors to patient safety organizations. But there were a few differences between S.720 and H.R. 663. The key difference was that the Senate bill provided greaterprotection for providers who submitted medical error information. Under S. 720, thesubmitted information was shielded from use not only in civil and administrative proceedings, butin criminal actions as well (with exception). On July 22, 2004, the Senate incorporated S.720 in H.R. 663 as an amendment, and passed H.R. 663 by unanimousconsent.

During the first session of the 109th Congress, Senator Jeffords introduced S. 544 , the Patient Safety and Quality Improvement Act of 2005. S. 544 was identical to theSenate-passed patient safety bill, S. 720 . It established a system for the voluntarysubmission and analysis of medical error data, and prohibited the use of patient safety data inadministrative, civil, and criminal proceedings. The Senate amended and passed S. 544unanimously on July 21, 2005. Six days later, the House voted overwhelmingly to pass the bill. S.544 became P.L. 109-41 on July 29, 2005. (61)

While the majority of patient safety and medical malpractice bills address problems relatedto only one of these issues, a few bills have included provisions that address both issues. Forexample, S. 1337 would authorize the HHS Secretary to award grants to states todevelop, implement, and evaluate alternatives to tort litigation for the purposes of resolvingmalpractice claims and utilizing patient safety data. Each state must demonstrate how the alternativeapproach encourages prompt and fair resolution of malpractice claims, promotes disclosure ofmedical errors, increases patient safety, and preserves access to medical malpractice insurance. Another bill, S. 1784 , would establish the Office of Patient Safety and Health CareQuality to administer the National Medical Error Disclosure and Compensation (MEDIC) Program. This new federal program would analyze information submitted by program participants aboutmedical errors and patient safety events, provide grants for the development and implementation ofprograms to disclose medical errors to patients, and require program participants to offer to negotiatewith individuals injured by medical errors for some level of compensation. The bill also includesprovisions for a number of separate studies to analyze provider accountability within the health caresystem, factors related to medical liability premiums, and cases that were not negotiated through theprogram. A couple of other bills also introduced during the 109th Congress ( H.R. 3359 and H.R. 3378 ) use a comprehensive approach that addresses multiple issue areas, suchas tort reform, mediation, insurance reform, medical errors reporting, and physician supply.

Federal Agency Activities

The Secretary of Health and Human Services (HHS) was charged with promulgating rulespursuant to the Patient Safety and Quality Improvement Act of 2005 ( P.L. 109-41 ). This task wasgiven to the Agency for Healthcare Research and Quality (AHRQ) within HHS, and specifically tothe Center for Quality Improvement and Patient Safety within AHRQ. In March 2006, AHRQ helda series of public meetings to inform its rulemaking process. These meetings solicited feedback fromthe public on specific topical areas, including provider-patient safety organization (PSO)relationships, contracts and disclosures (March 8, 2006); the operation of a component PSO (62) (March 13, 2006); andsecurity and confidentiality issues (March 16, 2006). Although the meetings specifically asked forcomments relating to these topics, participants were generally encouraged to provide comments onany issue they believed was relevant to the rulemaking process. A broad range of stakeholders wasrepresented at the meetings, with an average of 200 participants at each meeting. (63)

The first meeting invited comments on provider-PSO relationships, disclosures, andcontracts. (64) ThePatient Safety and Quality Improvement Act provides for extensive privilege and confidentialityprotections for certain patient safety information, deemed patient safety work products. Specifically,information is afforded these protections if it is considered to be existing within a Patient SafetyEvaluation System (PSES). (65) In other words, this information is considered to be a patientsafety work product if it is created within the boundaries of a PSES. For this reason, AHRQ needsto provide clear guidance as to the boundaries and scope of a PSES to make clear what informationfalls under its aegis and therefore is protected. In addition, the statute requires entities pursuingcertification as a PSO to provide the Secretary with relevant information regarding their existingrelationships with health care providers that might constitute a conflict of interest, and AHRQ wasinterested in gathering information from the public regarding what type of relationships specificallywould trigger concerns about an entity's ability to perform independently as a PSO.

The second meeting focused on the issues arising during the operation of a component PSO(meaning an entity that is a component of another organization). Specifically, the statute hasadditional security-related requirements for component PSOs to ensure that privacy of the patientsafety work products it collects is not compromised. In particular, these requirements help to makecertain that protected information is not shared with the parent organization.

Finally, the third meeting solicited comment on broader issues relating to security andconfidentiality. Specifically, the statute allows for certain exceptions to the protection ofinformation, and AHRQ was interested in learning more about how this would affect existing clinicaloperations. In addition, since it is possible that a PSO might receive information about events thatare outside of any contractual relationship it has with a provider, AHRQ wanted feedback on howPSOs should handle such information. The agency also was interested in receiving commentsrelating to standards for de-identifying data and securing identifiable health information.

According to AHRQ, the information generated through these meetings has been analyzedby the agency but is not publicly available. The comments received highlighted several importantissues, which may be helpful to the agency as it moves forward. AHRQ is formulating a draft rule,and expects to release it in the immediate future. As this will be AHRQ's first operational program,and since the legislation raises a plethora of policy issues, a substantial amount of energy is beingdirected toward this effort. More information about these meetings can be found on AHRQ's websiteat http://www.ahrq.gov/about/pso06.htm .

State Activities

State activity in health care quality preceded the release of To Err is Human . A JCAHOsurvey found that at least a third of the states had implemented reporting systems by the late 1990s. The purpose of those reporting systems was mainly to collect information on patient injuries orissues related to health care facilities (e.g., structural problems). Most of the reports came fromhospitals and nursing homes, but some states also collected data from other facilities, such asambulatory care centers. These systems reportedly protected data confidentiality, though privacypolicies varied from state to state. Only a few states aggregated the information or conducted trendanalysis. The overall effectiveness of these programs was hampered by resource and datalimitations. (66)

On the issue of patient safety specifically, many state legislatures did not wait for their federalcounterpart to act. The number of patient safety-related bills introduced in the states tripled in theyear following the release of the IOM Report, then nearly doubled in the year after that. Out of the22 states that introduced bills in 2001 -- two years after the release of the IOM Report -- half of themwere introducing medical error legislation for the first time. However, during the 2005 legislativesessions, states made limited progress. Three states (Kentucky, Virginia, and Wyoming) "enactedlegislation to address medical errors and to improve patient safety in the first quarter of 2005." (67)

As previously noted, 28 states have some type of medical error reporting mandate in place. The requirements cover a spectrum of issues, such as the type of information to be reported, to whomthe information is submitted, and for what purpose. For example, Washington requires the reportingof medication-related errors, but New Jersey requires the reporting of "serious preventable adverseevents." Connecticut requires medical facilities to contract with patient safety organizations for datacollection and recommendations on improving patient safety. In contrast, New York requireshospitals to report infection rates, which are included in an annual report published by the stateHealth Department.

While federal medical malpractice legislation usually did not include patient safetyprovisions, there was some evidence that the link between the two issues has been made at the statelevel. For example, Pennsylvania passed bills in 2002 and 2003 that contained provisionsconcerning malpractice tort reform, insurance reform, and patient safety enhancement. Accordingto Governor Rendell, the comprehensive approach was an attempt to address concerns aboutmalpractice insurance and medical safety. (68) A couple of other states passed or debated similar bills that alsolinked those issues.

State Patient Safety Centers. A buddingmovement in the states is the creation of state patient safety centers. The common purpose of theseentities is to promote patient safety efforts within the state. Approaches, which vary by state, includeeducating consumers and providers about safety issues, developing systems for error reporting andanalysis, recommending patient safety goals to the state, and supporting collaboration among publicand private sector organizations. While it is too early to assess the impact of these centers, the statecommitment of authority and resources towards these centers lends legitimacy and expectation toefforts that primarily had been conducted on a voluntary basis (e.g., patient safety coalitions). Statepatient safety centers may yet play an active role in generating the systemic changes cited as key toenhancing patient safety. (69)