A multifacited approach to improve patient safety, prevent medical errors and resolve the professional liability crisis

American Journal of Obstetrics and Gynecology (2006) 194, 1160–7

www.ajog.org

A multifacited approach to improve patient safety, prevent medical errors and resolve the professional liability crisis Louis Weinstein, MD Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, PA Received for publication November 14, 2005; accepted December 15, 2005

KEY WORDS Patient safety Professional liability

The current professional liability crisis is the third in the last 30 years. Similarities of the 3 crises are the rising cost of professional liability insurance and a diminishing number of sources available to purchase coverage. Proposed tort reform with caps on noneconomic damages and attorney contingency fees is a back end approach and will do little to solve this crisis or prevent future ones. The current situation can only be solved by placing an increased emphasis on improving patient safety and elimination of all preventable medical errors. A national electronic medical record must be developed and rapid response teams need to be available in most hospitals. The protective devices of privileged communication and peer review are counterproductive and must be eliminated. Full and prompt disclosure of any medical error or injury needs to be made. Physicians must be taught proper communication skills and the importance of teamwork. Providers with frequent patient, nursing or medical staff complaints must be critically reviewed. The present system of risk management needs to move from a reactive position to a role of being proactive for both patient and physician. Claims management should offer the patient early compensation when appropriate and pursue a vigorous defense when medical care is adequate. Experts should be identified who will render fair, unbiased reviews of medical care with all of their findings being disclosed. Similar experts need to devise clear, concise, evidenced based standards of care for common medical conditions. Ó 2006 Mosby, Inc. All rights reserved.

Something deeply hidden had to be behind things. dAlbert Einstein 1879-1955

Issues surrounding professional liability in medicine have been present for many years, but only recently has medical malpractice, because of the high cost of liability Presented at the Twenty-Fourth Annual Meeting of the American Gynecological and Obstetrical Society, September 29–October 1, 2005, Victoria, British Columbia, Canada. Reprints are not available from the author. 0002-9378/$ - see front matter Ó 2006 Mosby, Inc. All rights reserved. doi:10.1016/j.ajog.2005.12.024

insurance, become a major focus for health care providers. During this time interval, there have been 3 periods labeled as ‘‘malpractice crises.’’ Physicians dealt with the crises of 1973 and 1974 and 1985 by passing on the increased cost of liability insurance to health care consumers. Minimal effort was made to address the underlying problems of preventable medical errors and an unsafe healthcare system. The current crisis is different because of the inability of the physician or institution to pass on the increased costs of liability insurance and the major emphasis of the public, industry, and

Weinstein government on improving patient safety and preventing medical errors. The availability of liability insurance is primarily an economic issue, as most physicians can obtain coverage but at a premium that makes it less likely that they can continue their current practice. The emphasis of most physicians and medical professional societies has been on seeking tort reform with the imposition of noneconomic damage caps and contingency fee limits. The purpose of tort reform has been on reducing liability for medical errors and not on preventing errors. Both Studdert et al1 and Kessler et al2 have demonstrated that the pursuit of tort reform over the last 30 years has had minimal results with little attention paid to improving the quality of medical care and the safety of the health care system. The tort reform currently being pursued has not been linked to newer developments in evidenced-based medicine or the increasing number of preventable medical errors and these contrary positions cannot be reconciled.3 An attempt at federal tort reform, the HEALTH Act of 2003 (help efficient accessible low-cost timely healthcare) has stalled in congress several times and is unlikely to pass in the future. The name of the act is ironic as health care is often not timely, clearly not efficient, and certainly not low cost. Nothing in the Act addresses the issues of patient safety and preventable medical errors. If the federal government is truly committed to improving patient safety, it should mandate and assist in the funding of a national electronic medical record. Patient safety and quality of care are adversely affected on a daily basis by the common occurrence of missing clinical information.4 A national electronic medical record will immediately improve patient safety, dramatically increase efficiency, and decrease costs with the likelihood of a decrease in liability actions. Tort reform supporters cite the passage in 1976 of MICRA (Medical Injury Compensation Reform Act) in California with the resultant effect being that liability insurance rates have risen at slower pace than that of other states. The noneconomic damage cap of $250,000 is important for tort reform but is unfair to the injured patients as it has not been adjusted for inflation since its passage. The tort reform represented by MICRA is in reality an insurance reform act. Caps will have little effect on frivolous lawsuits, as the amount of money involved in these types of suits is usually below the cap. Although the limits on attorney contingency fees may be the most important part of MICRA, this is 1 of the major blocks to passage of tort reform as the majority of politicians who would vote at the national level are attorneys. The problem with any type of tort reform is that it is a back end approach. No evidence exists that it addresses the real issues: preventable medical errors, improved patient safety, full disclosure of all adverse events, and subquality practitioners. These issues have

1161 been present during all of the professional liability crises. The only rational solution to solving the professional liability crisis is to deal directly with the patient safety and medical error issues. A recent study analyzed 4 months of medical care in a 40-bed medical unit of a major teaching hospital.5 Adverse events were experienced by 8% of patients and 4% experienced near misses. Only 55% of adverse events, 34% of medical errors, and 31% of near misses were documented in the medical record. No hospital incident reports were filed in any of the events. Five years after the Institute of Medicine Report, progress in the prevention of medical errors and improvement in patient safety has been slow to nonexistent.6 The rapid advances in medical technology and the increasing workload secondary to staff reductions have markedly elevated the number of preventable medical errors.7 An attempt by the Agency for Healthcare Research and Quality to determine a national estimate for the improvement in patient safety by using existing measures has demonstrated little to no improvement since 1999.8 The number of deaths that occur each year in US hospitals appears to have doubled since the 1999 Institute of Medicine Report.9 Although the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has attempted to improve patient safety, medical errors and deaths have continued to increase. The JCAHO review of hospitals with the threat of loss of accreditation produces transient compliance in addressing patient safety issues.6 Historically after the review, the majority of hospitals return to ‘‘business as usual.’’ A major change in the culture of medicine is required to improve patient safety and prevent medical errors. The assumptions that must be addressed to change the culture are that medicine is extremely complex but can be mastered by one person, perfection is an obtainable goal for the individual, physicians are fierce supporters of autonomy, the leadership of the physician cannot be questioned, and that full open disclosure of all medical errors will increase liability actions. Lessons learned from the aviation industry are that a complex system like medicine requires teamwork, the captain cannot be the master of all systems, any member of the team can challenge another when safety is involved, information obtained about adverse events or near misses can be used to improve the system to prevent future occurrences, and full open disclosure increases public trust. These lessons are directly applicable to medicine and must be used to improve patient safety and prevent medical errors. The Institute for Healthcare Improvement has recently announced its 100,000 Lives campaign, an attempt to prevent 100,000 people dying from medical errors over the next 18 months.10 The 6 changes to be implemented that have been proven to prevent avoidable deaths are as follows: (1) availability of rapid response teams;

1162 (2) evidence-based care for acute myocardial infarction; (3) prevention of adverse drug events; (4) prevention of central line infections; (5) prevention of surgical site infections; and (6) prevention of ventilator associated pneumonia. In addition to the lives saved, a marked decrease in economic expenditures and liability actions will also result. When a patient is injured, the current tort system is inefficient, as it undercompensates and delays payments to victims of true medical negligence. The true incidence of medical negligence is 7 to 8 times greater than the number of patients initiating a lawsuit. Only 16% of the current number of lawsuits filed involves an injury because of medical negligence.11 Evidence exists that 3% to 4% of hospitalized patients experience an injury caused by medical care, with 25% of these injuries because of substandard care, yet most of these injured patients never initiate a legal action.12 The majority of the medical errors that occur are system errors, although individual nurses or physicians are often in place to prevent the problem. It has been documented that the office setting has a 10-fold increase in adverse events compared with the hospital, yet no system exists to address these errors.13 When one considers the number of patients that this represents and the effects on individuals and their families, it becomes obvious why the public is so enraged over the patient safety issue. In 2005, JCAHO released a white paper report that is a product of the Joint Commission’s Public Policy Initiative. Entitled ‘‘Health Care at the Crossroadsd Strategies for Improving the Medical Liability System and Preventing Patient Injury,’’ the document makes 3 major recommendations with numerous subrecommendations.14 The major recommendations are as follows: (1) pursue patient safety initiatives that prevent medical injury, (2) promote open communication between patients and practitioners, and (3) create an injury compensation system that is patient-centered and serves the common good. Before more energy is spent by practitioners and professional organizations on pursuing tort reform, they should evaluate this report and devise a strategy of change consistent with the recommendations.

Risk management The current system of risk management has minimal success in improving patient safety and decreasing medical errors. Risk managers are commonly senior nurses with minimal expertise in new technologies, have been away from clinical practice for a substantial period, are institutionally supported, and have little formal training in communication skills. The role of the risk management office is 3-fold. The first is loss prevention with resolution of claims at minimal cost to the institution. The second is management of the unresolved claim with assignment to a defense attorney whose prime

Weinstein directive is to protect the institution or insurance company. The third role is risk financing, which is to transfer away as much of the financial risk as possible to protect the institution or insurance carrier. An important function of the risk management office is collecting all the information about the occurrence. The information collected during the investigation is protected with no sharing with the injured party/family and minimal sharing with the involved physician(s). Usually, the only way for the patient to receive any information about their injury is through litigation. Compensation, even if appropriate, is commonly delayed when it is most needed by the patient or family. Feedback to the health care providers is often absent or markedly delayed. Any education performed uses closed claims data, which takes a long time to become available and has much of the information sealed by gag clauses. Information must be available on a real-time basis to improve patient safety and prevent medical errors. The vast majority of patient errors are from system breakdowns and the only way to devise systems to prevent these errors is total transparency of all information.9

Liability insurance Common sources of professional liability insurance are policies purchased from commercial carriers, physicianowned companies, self-insured trusts, or risk retention groups. Most insurance carriers base rates on geographic location with consideration of the frequency and severity of paid claims associated with the specialty in the region. The experience record of the individual physician is rarely considered in establishing the premium.15 The level set may be different for a physician with a similar practice in another county or state. The justification for this rate structure is based on retrospective data of physicians in that geographic area. It is my recommendation that professional liability insurance premiums be based on the record of the individual physician in a manner similar to that of automobile or homeowners policies.

Solutions The proposed solution of tort reform to solve the present professional liability crisis is unlikely to occur at either the federal or state level. Tort reform does not address preventable medical errors (often misconstrued as negligence) or patient safety. Three areas that must be dealt with directly to solve the medical error and patient safety issues are risk management, professional liability insurance, and the tort system.

Risk management The name of risk management should be changed to ‘‘patient safety and risk prevention.’’ Risk managers

Weinstein prevent full disclosure of important information to the patient, family, or health care team. The risk managers are employed by either the institution or insurance company and are not working for the patient or the providers. The patient should be the prime focus of the risk prevention team and the office must act in a proactive manner. A separate office of litigation management should be established to deal with legal issues involved when a lawsuit has been filed. During recruitment of the physician, an interview should be performed by someone trained in assessing communication skills. Patient satisfaction has been directly linked to physician communications skills.16 Communication failures are associated with an increase in medical errors.17 Patients who are dissatisfied with their medical care and have filed lawsuits cite communication issues approximately 70% of time.18 Some physicians are poor communicators and many have never been taught communication skills. Teaching these skills should become a function of the risk prevention office as this method of patient interaction does prevent future legal problems.18 The total work record and litigation history (regardless of outcome) of the physician should be reviewed. Any past patient complaints must be addressed to determine how these complaints were resolved and what corrective actions or education the physician took to prevent recurrences. Physicians with a history of patient complaints are more likely to become involved in a lawsuit.19 A Veterans Health Administration report documented an underreporting of adverse events within the hospital but if a patient incident report had been generated, the tort claim was more likely to end in payment and the payment was likely to be higher.20 Hospital practitioners are the best observers of the quality of the health care system. The Institute of Medicine Roundtable on Quality of Care stated the threats to quality are overuse, underuse, and misuse of treatments.21 Physicians must be willing to report any of these perceived threats or potential system errors noted. Every report must be carefully evaluated, action initiated to resolve the issue, and expeditious follow-up given to the reporting physician. The hospital staff frequently knows which systems or physicians are putting patients at unnecessary risk. The hospital staff (physicians, nurses, and/or technicians) working as a team are the KEY to improving patient safety and preventing medical errors. The total medical enterprise must protect the patient from avoidable medical injury and improve patient safety. Preventable medical errors must be identified early, acknowledged completely to the patient/family, and proper compensation provided for loss. The cloak of privileged communication and peer review should be removed if the public is to regain trust in the health care system. This is clearly evidenced by the book entitled

1163 Wall of Silence in which patients and families detail their outrage over the current lack of disclosure of medical mistakes.22 Florida is taking an early lead in opening peer review by its recent amendment to its state constitution that peer review meeting notes all be made public.23 A new movement exists to support the importance and positive impact of early full disclosure of any adverse outcome to the patient with issuance of an ‘‘I’m Sorry’’ letter.24 The actual practice of full disclosure is uncommon in health care, but, it is the ‘‘only approach to medical error.’’25 Full disclosure has not been demonstrated to increase the risk of legal action to either to the physician or institution.6 An excellent example of full disclosure and its benefits is the 3 R’s (Recognize, Respond, Resolve) program of the Colorado Physicians Insurance Company (COPIC). During the initial 18 months of the pilot program, 592 adverse patient outcomes were reported by physicians. In 360 cases, discussion by a trained team resolved the issue, whereas in 232 cases, some financial compensation (maximum $30,000) was offered at a level less than the cost of a legal defense. No lawsuits were filed, even though patients were not asked to waive their rights to initiate one. Physicians in the 3R’s program must agree to prompt reporting of adverse events, full disclosure of all patient injuries, participation in education programs on effective physician patient communication, and make changes to prevent future medical errors. By this process, physicians accrue points used to obtain preferred premium rate status. Resolution of the event with financial compensation is not reported to the state or National Practitioner Data Bank. The program has been so successful that COPIC requires participation for all their policy holders.

Insurance As professional liability insurance becomes extremely expensive or unavailable, the use of risk retention groups or insurance captives has increased. For an insurance captive to be successful, a long-term approach is needed, an aggressive system of claims management must be in place and educational efforts need to focus on patient safety and complete elimination of preventable medical errors. The beneficial role of excess insurance coverage has not been well evaluated and most state patient compensation funds are coming to a close. Having excess coverage has become a self-fulfilling prophecy for large awards. Rarely has a physician or institution been responsible for paying an award that exceeds their current limits of insurance. As the cost of excess coverage has become prohibitive, most hospitals and providers have eliminated or lowered the limits of the excess coverage.

1164 Insurance actuaries are responsible for setting premiums based on frequency and severity of paid claims linked to specialty and practice location. Comparison rates for commercial providers who are in the business of generating a profit are used for a base. Actuaries are extremely conservative and their approach focuses on protection of the assets of the insurance company or institution. The setting of rates should be based on the individual physician’s experience accounting for claims made, accumulated settlement history, record of any medical staff issues, number of patient complaints, and some analysis of mode of practice. Board certification and maintenance of certification should be considered. The rationale for using all claims history in the process of rate setting is the need to consider the large amount of money spent in defending claims. Consideration must be given to a new paradigm for 21st century insurance coverage called ‘‘enterprise liability.’’ In this model, the enterprise (health care system) becomes responsible for the safety and quality of all health care practiced within the institution. All parties must have a common organizational goal being the elimination of all preventable medical injuries. Institutions are able to develop data bases of risk experience that are more reliable than that done for the individual physician, allowing actuaries to better determine liability exposure. Because the institution has more financial reserves and is involved in many more cases than the individual physician, the motivation for the elimination of preventable medical errors should be paramount. The shift of liability coverage from individual to institution is more likely to stabilize rates, as only the entity becomes responsible. An increasing trend for enterprise liability has been the number of physicians becoming employed by the institution as evidenced by the rapid rise in the Laborist movement, a fulltime hospital employed obstetric provider.26

Assisting the tort system Although the health care system works to eliminate all preventable medical errors, the legal system needs to eliminate false or misleading expert witness testimony for either plaintiff or defense. Medical schools and professional medical organizations in various regions of the country should establish a clearing house for evaluation of medical injuries or adverse outcomes. Any board-certified practitioner in the region with documented expertise as established by preset criteria (eg, peer-reviewed publications) could be listed with the clearing house. The list of physicians with their documented expertise is available for public scrutiny. An attorney, patient, or court could contact the clearing house and request an expert review of the medical care rendered. The organization will identify the physician with documented expertise to review the pertinent

Weinstein materials and render a concise report about the medical care. This report will be available for public review and can be used as determined by the requesting party. The fee charged for the expert physician’s time will be paid according to an established schedule. The same organizations should convene panels of expert physicians to establish clear, concise definitions of standards of care for the majority of common medical issues encountered removing the legal system from the determination of what constitutes standard of care. The solutions offered by both of these approaches will return credibility to expert witness testimony. Both the medical and legal professions need to consider new alternatives to the current litigation process. A new proposed legislation entitled ‘‘Fair and Reliable Medical Justice Act’’ (S. 1337) authorizes the secretary of Health and Human Services (HHS) to fund 10 demonstration project grants to test 3 alternative dispute resolutions processes. They are early disclosure and compensation, special health care courts, and administrative determination of compensation. The Early Offers Pilot Program is an example currently being used by the Indian Health Service under HHS.27 Using this program, HHS reviews a claim within 90 days of it being filed and assesses its value. The patient has the same 90 days to submit an amount for which the claim can be settled. The HHS assessment and the patient’s amount both are submitted independently to a settlement depository. If the patient’s amount is at or below the HHS amount, the case is settled immediately. If the numbers are not close, legal action may ensue with both offers remaining confidential.

Conclusion The current professional liability system is not successful in deterring patient injuries or improving patient safety. Although most physicians and professional organizations believe tort reform is the answer, it is unlikely to occur at the national level and does not solve the problems of preventable medical injury, an unsafe health care system or negligent medical practice. Therefore, consideration should be given to the following: 1. Creation of a patient safety and risk prevention group. 2. Elimination of all preventable medical errors. 3. Full disclosure of medical errors, adverse events, and near misses. 4. Instruction of physicians in communication skills and teamwork. 5. Development of a national electronic medical record. 6. Adopt the 100,000 lives Campaign of the Institute for Healthcare Improvement.

Weinstein 7. Dissolve the cloak of the privileged status of peer review. 8. Establish a claims management team to proactively respond to any injured patient. 9. Identify neutral experts to review adverse medical outcomes. 10. Establish evidenced-based standards of care for common events. 11. Increase use of alternative forms of dispute resolution. Adoption of these recommendations will result in improved patient safety, eliminate preventable medical errors, improve health care systems, and establish an equitable judicial process.

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1165 18. Beckman HB, Markakis KM, Suchman AL, Frankel RM. The doctor-patient relationship and malpractice: lessons from plaintiff depositions. Arch Intern Med 1994;154:1365-70. 19. Hickson GB, Federspiel CF, Pichert JW, Miller CS, Gauld-Jaeger J, Bost P. Patient complaints and malpractice risk. JAMA 2002; 287:2951-7. 20. Schmidek JM, Weeks WB. Relationship between tort claims and patient incident reports in the Veterans Health Administration. Qual Saf Health Care 2005;14:117-22. 21. Chassin MR, Galvin RW. The urgent need to improve health care quality: Institute of Medicine National Roundtable on Health Care Quality. JAMA 1998;280:1000-5. 22. Gibson R, Prasad Singh J. Wall of silence. Washington, DC: Regnery Publishing Co; 2003. 23. Glabman M. The future for peer review: Florida’s constitutional amendment chills quality community. Trustee 2005;58:6-10. 24. Zimmerman R. Doctors’ new tool to fight lawsuits: saying ‘‘I’m sorry.’’ Malpractice insurers find owning up to errors soothes patient anger. ‘The risks are extraordinary’. J Oklahoma State Med Assoc 2004;97:245-7. 25. Lamb R. Open disclosure: the only approach to medical error. Qual Saf Health Care 2004;13:3-5. 26. Weinstein L. The laborist: a new focus of practice for the obstetrician. Am J Obstet Gynecol 2003;188:310-2. 27. Taylor M. Another option. HHS test alternatives to malpractice lawsuits. Mod Healthcare 2005;35:16.

Discussion STANLEY ZINBERG, MD, MS. Dr Weinstein is to be commended for selecting the issue of professional liability for his presentation this morning. No other subject evokes as much interest, concern, or passion among obstetrician/ gynecologists as what is referred to colloquially as the malpractice crisis. The members of the American College of Obstetricians and Gynecologists (ACOG) have identified professional liability as the single most important issue impacting their lives, both in clinical practice and academic activities. The subject generates animated conversation among physicians who individually believe that they know how to solve this daunting and threatening situation. The problem is that there is so little in the way of evidence to support their conclusions; evidence that might stand up to rigorous scientific review. These are the facts. Obstetricians/gynecologists have more claims filed against them than against any other specialty. Three quarters have been sued at least once and most will be sued 3 times or more during their working lifetime. More than one quarter have been sued for care during their residency training. Obstetricians/gynecologists are tied for first with family physicians in the percent of claims paid out (36%). Obstetricians/gynecologists are second, after neurologists and neurosurgeons, in the average payment made ($235,059). The median jury award jumped 43%, from $700,000 in 1999 to $1,000,000 in 2000. The median jury award has doubled since 1995. However, obstetricians/gynecologists win 80% of claims filed against them. More than half of the claims are dropped, dismissed, or settled without