Malpractice Prevention, Patient Safety, and Quality of Care: A Critical Linkage

proactive risk management

There is growing evidence of a negative effect of the current American preoccupation with malpractice on efforts to reduce error, enhance safety, and improve other domains of quality. The use by some insurers of systems assessment and risk analysis programs, linked to rewards for performance—which, taken together, we term —offers an opportunity to enhance our focus on systems and to bring patient safety and malpractice risk reduction into close congruence with other quality improvement efforts. Given the increasing burden of malpractice, as well as the emerging concerns about patient safety, managed care organizations and their providers need to work together with malpractice insurers and quality improvement experts to refocus their efforts on creating systems improvement; driving measurement, analysis, and feedback; and developing incentives for performance that will align quality and risk management efforts and drive breakthroughs in quality, including patient safety.

(Am J Manag Care. 2004;10:281-284)

Crossing the QualityChasm: A New Health System for the 21st Century

Two recent Institute of Medicine reports haveincreased our knowledge of the key issues relatedto patient safety and of the factors that lead toless than optimal quality of care in our healthcare system.^1,2 The latter of these reports, ,classified patient safety as 1 of 6 desirable attributes ofour healthcare system (the other domains of qualitywere efficiency, patient-centeredness, timeliness, efficiency,and equity). Current efforts to include patientsafety in quality improvement efforts have been overshadowedby the specter of malpractice litigation andhampered by a conceptual difference in approaches toquality related to patient safety vs other desirable attributessuch as effectiveness or patient-centeredness.

Improvement and accountability in domains otherthan safety have been driven by the forces of professionalismand regulation and by a combination of theseforces that underlies certification and accreditation programs.^3,4 In the past 2 decades, market-based interventions,including reporting and rewarding performance,have been introduced with varied degrees of success.^3,5By contrast, before publication of the Institute ofMedicine reports, patient safety was assumed by thepublic to be mitigated through the threat of malpractice,the efforts of providers to avoid malpractice, and theremoval of “bad†physicians. Recent efforts by theInstitute for Healthcare Improvement, the NationalPatient Safety Foundation, The Leapfrog Group, andothers have begun to bring quality improvementapproaches, professionalism, and marketplace mechanismsinto play in an effort to drive improvements inpatient safety.^6-10 However, little attention has been paidto how to integrate these efforts to enhance patient safetywith other efforts in quality improvement or with thepersistent issue of avoiding malpractice litigation.

MALPRACTICE AND PATIENT SAFETY

To Err Is Human: Building a Safer HealthSystem

In contrast to the public's view, there is little evidencethat malpractice, specifically litigation related to malpractice,acts as an impetus to improve patient safety or todeter unsafe practices or that it even compensates victimsin a fair and equitable manner.^11-15 Moreover, malpracticelitigation is based on the need to prove negligence andto place blame on an individual (or entity) and is antitheticalto the systems and quality improvement focusof patient safety suggested by the Institute of Medicinereport .¹ Given our recurrent malpractice insurance crisis,it is likely that, without some shift in emphasis, moretime, resources, and concern will be placed on efforts toavoid malpractice litigation in the future.^16,17

proactive risk management

Despite this overshadowing presence of litigation, afew malpractice insurers are increasing their emphasison a set of programs that use a proactive, empiric, systems-focused approach to determining the causes oferrors and their relationship to patient harm and subsequentlitigation. These insurers use this information tocreate tools to assess and improve systems as a means toreduce the likelihood of future errors, patient harm, andlitigation.^18-22 We have termed this set of activities and believe this emphasismirrors in many ways the shift of clinical medicine duringthe past 4 decades from an almost exclusive focus oncaring for acute events, such as heart attacks, to a complementary emphasis on the proactive identification andmanagement of risk factors (hypertension, diabetes mellitus,and hypercholesterolemia) as means of preventingheart attacks.

Example of a Systems-Oriented, Risk ManagementApproach to Malpractice

The set of programs used by COPIC InsuranceCompany, Denver, Colo, is offered as an illustration ofthe firms that use proactive risk analysis and systemsassessment to reduce malpractice occurrences. COPIC(originally an acronym for Colorado Physicians InsuranceCompany) is a physician-sponsored malpracticeinsurer that insures about 75% of the eligible physicianspracticing in Colorado.²³ Although the COPIC program isamong the most highly developed, we would note thatthere are other insurers, such as Medical Mutual, HuntValley, Md,²⁴ and the malpractice subsidiary (CRICO) ofPartners Healthcare, Boston, Mass,²⁵ that place a majoremphasis on proactive risk management. Key elements ofthe COPIC program are described.

Focus on Incident Reporting and Using Data toFoster Prevention

. Physicians and organizationsinsured by COPIC are encouraged to report, via telephone,any incident that they believe might result in amalpractice claim. Although nearly all malpracticeinsurers invite reporting of incidents, COPIC providesencouragement through active outreach and repeatedreminders to providers to report even minor adverseevents. When an incident is reported, it is coded intothe COPIC database. Risk managers and claim adjustersreview the report in the context of information providedby the database of prior incidents. The physician ororganization and insurance company work together tounderstand and address the likely cause and course ofevents resulting from the incident.

The incident database is structured through the useof a coding system developed by COPIC that categorizesreported incidents using multiple characteristics,including the setting, providers involved, and type ofoccurrence. COPIC then uses the data to analyze andunderstand “near misses†and which incidents are mostlikely to lead to malpractice claims and payouts. Thesedata are also used to help structure the systems analysisand feedback, as noted in the next subsection.

Practice Systems Assessment and Feedback

To Err IsHuman: Building a Safer Health System

. Amajor point of the Institute of Medicine report ,¹ and of muchof the literature on safety in general, is that errors andadverse events are more often due to system designflaws than to individual culpability.²⁶ As noted by Leapeet al,¹⁰ systems produce the results they are designed toproduce, including errors that arise. Several ways ofanalyzing systems problems related to patient safetyconcerns have been proposed, including root-causeanalysis and applying the concepts of continuous qualityimprovement.^27-29 A subsidiary of COPIC (PracticeQuality LLC) employs nurses with specialized trainingin the assessment of risks to patient safety that may bepresent in practice settings. The nurses use a standardsurvey protocol to evaluate office systems and practicesin each insured physician's office and hospital at leastonce every 2 years. The overall protocol and assessmentinstrument were developed using information fromincidents, claims filed, and a payout database developedby COPIC. Table 1 provides a synopsis of the areasassessed. Results of the practice risk assessment areshared with the office practice leadership at the end ofthe survey, along with a variety of suggestions andoptions for improving areas identified as being at risk. Inaddition, the program links the providers to “tool kits”and other educational programs that are designed tohelp in correcting problems identified by the audit, aswell as providing clinicians with examples of best practicesthat can enhance safety and other domains ofquality. This focus on systems assessment and improvementprovides an important linkage between patientsafety and other domains of quality, which we will subsequentlyexplore in more detail.

Collaboration and Rewarding Results.

The thirdmajor component of the COPIC proactive risk managementprogram involves the use of an incentive systemthat rewards physicians for adopting safe and effectivepractices. COPIC has created a system by which practicesare awarded points based on their adherence toCOPIC guidelines to improve performance, rangingfrom attendance at educational seminars to online educationalopportunities to implementing changes suggestedby COPIC's practice evaluations. Malpracticepremium rates are tied to baseline levels of performanceon the survey, adherence to suggested correctiveactions, and participation in risk reduction programs. Inaddition, if COPIC's total payouts for claims are lowerthan expected, the savings are shared retroactivelywith insured physicians and organizations in the formof premium credits. Therefore, individual and collectiveperformances are rewarded.

Those individuals and practices that are identified asconsistently poor performers are given repeat surveys,with opportunities for remediation. If the problemappears to lie with an individual practitioner ratherthan the practice systems, referrals are made to programs(separate from COPIC) that provide in-depthassessment of clinical performance, individually tailoredskills training, and, if needed, counseling servicesfor physicians who are identified as having personalhealth issues, chemical dependency, or other problemsthat adversely affect their clinical performance. If all ofthese attempts fail, a last resort is the nonrenewal ofCOPIC insurance. Although this is rarely used, it carriesgreat weight in Colorado, because the state requiresproof of insurance for physician licensure.

Linking Patient Safety andEffectiveness of Care at theConceptual and Practice Level

Focus on Risk Factors and Fostering Prevention

.The use of proactive risk management (incident analysisand prevention, systems assessment and feedback, andrewarding performance) is similar in many respects tothe focus in managed care related to enhancing quality inthe domain of effectiveness of care. Most managed careorganizations structure their clinical quality improvementefforts in effectiveness of care around measurementand interventions related to primary and secondary riskprevention. Some examples of this focus include programsrelated to primary immunizations in childhoodand adolescence, screening for cancer in adults, the useof BETA-blockers and controlling cholesterol in patients identifiedas being at high risk for cardiovascular events, andscreening and control of glycosylated hemoglobin inpatients with diabetes mellitus. There is a congruence ofthis approach with that of malpractice insurers likeCOPIC with their focus on measurement and analysis ofincidents to guide preventive efforts in safety.

Practice Systems Assessment and Feedback

. Interms of assessment of systems as a quality measurebeyond the domain of safety, investigators have developedand demonstrated the use of a model that identifies,using existing empiric evidence, systems that arelinked to higher quality processes and outcomes ofcare in prevention and chronic illness.^30-33 The model,variously referred to as the “chronic care†or “plannedcare†model, has been translated into several instruments,including one developed by the NationalCommittee for Quality Assurance that measures thepresence, content, and use of office systems in physicianpractices (available from L.G.P.). Although theseinstruments are in the developmental stages, the basicdomains and some of the subelements of the overallmodel are shown in Table 2 (more information isavailable from L.G.P.). Note the high degree of overlapin content with the office system assessment used byCOPIC (Table 1) to assess the presence or absence ofsystems critical to patient safety. This overlap suggeststhe possibility that a single assessment toolmight provide information to practices related tomultiple desirable attributes, including patient safetyand effectiveness.

Rewarding Performance

An additional factor present in the COPIC model isthe provision of incentives that reward the implementationof systems that are linked to improved safety.Purchasers and health plans, in some cases encouragedby a grant program “Rewarding Performance,†fundedby the Robert Wood Johnson Foundation, have introducedfinancial and other incentives based on clinicalperformance, including effectiveness and patient-centeredness.If these efforts at rewarding performancecould be coordinated with those of malpractice insurerslike COPIC in reducing premiums for malpractice insurancefor improvements in safety, the combined marketlevers might be sufficient to drive substantial improvementin multiple domains of quality.

Integrating Risk Management and Quality

The final common pathway of most quality improvementactivities is the direct participation of cliniciansand practices in systems and behavioral changes thatbring about improvement. However, safety risk managementprograms in most hospitals and group practicesare often a defensive response to malpracticeconcerns and are located and staffed by the hospital orphysician group legal office. These programs are oftennot effective in gaining the involvement of clinical leaderswith the knowledge, experience, and influence necessaryto foster the needed improvement in clinicalpractice systems and provider behaviors. Combiningefforts in risk management with those in qualityenhancement may create a critical mass of focus andpersonnel that could drive systems and behavioralchange. The literature supporting integration of patientsafety with other quality assessment and improvementefforts spans more than 2 decades but provides little evidenceof progress.^34-41

Policy Implications and Future Directions

Despite the barriers to wider dissemination of proactiverisk management–increasing our efforts in systemsimprovement, integrating patient safety with otherdomains of quality, and rewarding performance–webelieve that these efforts, taken together, are close tocreating a synergy that could positively affect healthcarequality and safety. Although none of the activitieswe note are easy to implement, there are examples ofcutting-edge organizations that have successfully implementedmost or all of these practices. We believe it istime to develop policies and interventions that wouldencourage widespread use of these practices. The alternativeof following the traditional path of paying claimsor relying on isolated, disjointed risk management programsis likely to be increasingly costly and dysfunctionalto all parties.

Acknowledgements

We thank Jean Johnson, PhD, and a group of senior staff ofCOPIC for their review of and suggestions concerning an earlierversion of the manuscript.

From the National Committee for Quality Assurance, Washington, DC.

Address correspondence to: L. Gregory Pawlson, MD, MPH, National Committee for Quality Assurance, 2000 L Street NW, Suite 500, Washington, DC 20036. E-mail: pawlson@ncqa.org.

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