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Maternity Care and Liability: Most Promising Policy Strategies for Improvement

      Abstract

      Background

      The present liability system is not serving well childbearing women and newborns, maternity care clinicians, or maternity care payers. Examination of evidence about the impact of this system on maternity care led us to identify seven aims for a high-functioning liability system in this clinical context. Herein, we identify policy strategies that are most likely to meet these aims and contribute to needed improvements. A companion paper considers strategies that hold little promise.

      Methods

      We considered whether 25 strategies that have been used or proposed for improvement have met or could meet the seven aims. We used a best available evidence approach and drew on more recent empirical legal studies and health services research about maternity care and liability when available, and considered other studies when unavailable.

      Findings

      Ten strategies seem to have potential to improve liability matters in maternity care across multiple aims. The most promising strategy—implementing rigorous maternity care quality improvement (QI) programs—has led to better quality and outcomes of care, and impressive declines in liability claims, payouts, and premium levels.

      Conclusions

      A number of promising strategies warrant demonstration and evaluation at the level of states, health systems, or other appropriate entities. Rigorous QI programs have a growing track record of contributing to diverse aims of a high-functioning liability system and seem to be a win–win–win prevention strategy for childbearing families, maternity care providers, and payers. Effective strategies are also needed to assist families when women and newborns are injured.

      Introduction and Background

      A new report, Maternity Care and Liability: Pressing Problems, Substantive Solutions (
      • Sakala C.
      • Yang Y.T.
      • Corry M.P.
      Maternity care and liability: Pressing problems, substantive solutions.
      ), and an overview of report highlights in this issue clarify that the current liability system does a poor job of meeting needs of childbearing families, maternity care providers, and maternity care payers, who cover liability-related expenses. Policy interventions are needed to better achieve a high-functioning liability system that:
      • Promotes safe, high-quality maternity care consistent with best evidence, and minimizes avoidable harm;
      • Minimizes maternity professionals' liability-associated fear and disaffection;
      • Avoids incentives for defensive maternity practice;
      • Fosters access to high-value liability insurance policies for all maternity caregivers;
      • Responds appropriately when women and newborns sustain injury;
      • Assists families with responsibility for costly care of infants and women with long-term disabilities in a timely, efficient manner; and
      • Minimizes legal and administrative costs (
        • Sakala C.
        • Yang Y.T.
        • Corry M.P.
        Maternity care and liability: Least promising strategies for improvement.
        ).
      Policy interventions that might address these chronic concerns fall within four broad categories: Tort reform to modify the traditional legal process for handling claims of negligent injury (
      • Mello M.M.
      • Zeiler K.
      Empirical health law scholarship: The state of the field.
      ;
      • Studdert D.M.
      • Mello M.M.
      • Brennan T.A.
      Medical malpractice.
      ), tort alternative reform to use other mechanisms to help make that system more efficient and responsive to injured patients (
      • Studdert D.M.
      • Mello M.M.
      • Brennan T.A.
      Medical malpractice.
      ), liability insurance reform to improve liability insurance policies and access to them (
      • Baker T.
      Medical Malpractice and the insurance underwriting cycle.
      ;
      • Sage W.M.
      Medical malpractice insurance and the emperor’s clothes.
      ), and health care reform that impacts liability matters.

      Methods

      We used a best available evidence approach to help clarify the potential for specific strategies to meet the seven proposed aims of a high-functioning liability system. Finding no systematic reviews or experimental studies, we preferred studies that took into account potential competing predictor variables and confounding factors within empirical legal studies and health services research traditions. We preferred studies specifically about maternity care and liability, and considered more general studies when maternity-specific research was unavailable. We preferred results from the current or previous liability cycle but, when unavailable, consulted earlier studies. We preferred national or multistate studies to state-level studies. We excluded studies from other countries. We searched PubMed and LexisNexis, with widely varying search terms owing to the diverse topics. The search results, health care news sources, journal table of contents notification services, and referees also pointed to relevant studies. In the absence of better quality empirical sources, we consulted theoretical analyses and commentaries and made judgments, indicated as such, about the plausibility of impacting priority aims.
      We deemed strategies that have been shown to impact or may plausibly be expected to impact multiple aims of a high-performing liability system to be priorities for implementation, evaluation, refinement, and—as warranted—spread.

      Results

      We evaluated 25 strategies that might lead to a higher functioning liability system within maternity care. Ten—a mix of tort alternative, liability insurance, and health care reforms—hold promise for substantive, multidimensional improvement and are discussed herein. The first six have potential to prevent harm and ensure that it is rare. The final four show promise for improving response to harm or claims of harm when they occur. Improvement strategies are needed for both prevention and redress.
      Table 1 holds these strategies up to the proposed policy aims. Within the prevention and redress sections in the table and discussion below, the strategies are ordered from greatest to least demonstrated or projected impact across the aims. Fifteen strategies did not hold up well against the proposed aims, in many cases with the benefit of multivariable maternity-specific studies. A companion paper in this issue covers those strategies and studies (
      • Sakala C.
      • Yang Y.T.
      • Corry M.P.
      Maternity care and liability: Least promising strategies for improvement.
      ).
      Table 1Evidence Summary: Effects of Most Promising Reforms on Diverse Aims of Liability System
      InterventionsAims
      ↑ Safe, High- Quality Care↓ Clinician Fear, Distress↓Defensive Practice, Practice Variation↑ Public Interest Liability Insurance↑ Appropriate Response to Injury↑ Help for Infants, Women With Disabilities↓ Legal and Administrative Costs
      Prevention strategies
       Quality improvement+
      Support from assessment includes maternity-related data.
      ++
      Support from assessment includes maternity-related data.
      (+)(+)(−)+
      Support from assessment includes maternity-related data.
       Enterprise liability(+)(+)(+)(+)(+)?(+)
       Leverage of health insurance, accrediting, credentialing, etc.(+)(+)(+)(+)(+)(−)(+)
       Shared decision making(+)(+)(+)(+)(+)(−)(+)
       Aligning legal standard with best evidence(+)(+)(+)(+)(−)(−)(+)
       Liability insurance coverage regulation(+)??(+)(−)(−)(−)
      Redress strategies
       Disclosure, empathy, apology(+)??(+)(+)(+)(+)
       Health courts(+)???(+)(+)(+)
       Administrative compensation systems(−)???+
      Support from assessment includes maternity-related data.
      +
      Support from assessment includes maternity-related data.
      +
      Support from assessment includes maternity-related data.
       High-low agreements(−)(−)(−)(−)(+)(+)(+)
      Abbreviations: +, Stronger evidence suggests strategy has this effect; (+), Plausible that strategy has this effect and/or weaker evidence suggests that it does; −, Stronger evidence suggests strategy does not have this effect or has modest effect at best; (−), Weaker evidence suggests that strategy does not have this effect or has modest effect at best; or impact implausible in absence of evidence; ?, It is difficult to anticipate actual impact.
      Support from assessment includes maternity-related data.

      Prevention: Quality Improvement—A Health Care Reform

      Patient safety and other quality improvement (QI) efforts are increasingly viewed as essential for achieving liability system aims (
      • Clark S.L.
      • Belfort M.A.
      • Dildy G.A.
      • Meyers J.A.
      Reducing obstetric litigation through alterations in practice patterns.
      ;
      • Clinton H.R.
      • Obama B.
      Making patient safety the centerpiece of medical liability reform.
      ;
      • Hickson G.B.
      • Entman S.S.
      Physicians influence and the malpractice problem.
      ;
      Joint Commission on the Accreditation of Healthcare Organizations
      Health care at the crossroads: Strategies for improving the medical liability system and preventing patient injury.
      ;
      • Pearlman M.D.
      Patient safety in obstetrics and gynecology: An agenda for the future.
      ;
      • Pearlman M.D.
      • Gluck P.A.
      Medical liability and patient safety: Setting the proper course.
      ;
      • Sage W.M.
      Medical liability and patient safety.
      ;
      • Schoenbaum S.C.
      • Bovbjerg R.R.
      Malpractice reform must include steps to prevent medical injury.
      ).
      • Mello M.M.
      • Hemenway D.
      Medical malpractice as an epidemiological problem.
      argued that injury reduction has limited potential to reduce malpractice claims and premium levels because very few who sustain injuries file claims. However, hospitals and health systems that are self-insured, pay malpractice premiums for both facilities and clinicians, have transparent performance reporting, and pay for high-cost newborn injuries have incentives to prevent harm. They have begun to report that rigorous QI programs are leading to improved care and health outcomes, and substantial decreases in claims, payouts, and premiums:
      • Over the first decade of its system-wide maternity care QI program, the nation's largest hospital system reduced its primary cesarean rate, improved maternity outcomes, reduced its obstetric malpractice claim rate by two thirds, and brought its cost of claims below costs for “accidents on hospital grounds” (
        • Clark S.L.
        • Meyers J.A.
        • Frye D.K.
        • Perlin J.A.
        Patient safety in obstetrics—The Hospital Corporation of America experience.
        ;
        • Clark S.L.
        Patient safety in obstetrics: A new theme for the 21st century.
        ;
        • Clark S.L.
        • Belfort M.A.
        • Byrum S.L.
        • Meyers J.A.
        • Perlin J.B.
        Improved outcomes, fewer cesarean deliveries, and reduced litigation: Results of a new paradigm in patient safety.
        ).
      • In its 16 hospitals with maternity units, a health system evaluated its liability history and implemented patient safety programs. Over a 5-year period, birth trauma decreased from 5.0 to 0.2 per 1,000 births, birth-related occurrences that could lead to a claim decreased from 7.2 to 2.5 per 1,000 births, the average cost per claim decreased from $1 million to less than $500,000, and the number of new claims decreased by 48% (
        • Simpson K.R.
        • Kortz C.C.
        • Knox G.E.
        A comprehensive perinatal patient safety program to reduce preventable adverse outcomes and costs of liability claims.
        ).
      • Reviewing liability claims, a health system identified maternity care as having the greatest potential for improving patient safety. After implementing a protocol-driven electronic system that monitors adherence to standards of care and provides real-time alerts, the four participating hospitals improved targeted quality measures by 25% and learned from near misses. Within 3 years, the system recouped costs of investing in and operating the system through reduced self-insurance funding. It experienced large declines in actual compared with expected frequency and severity of claims and a claim-free period of 15 months for the 2007 loss year (
        • Smith L.L.
        • Berry D.
        Partnering with technology to reduce OB losses.
        ).
      • In the seventh year of implementing a comprehensive patient safety program, a tertiary academic referral center achieved a 99.1% decrease in obstetric liability payouts relative to the average of the first 3 years. On average, in the 3 most recent years, the center saved over $25 million annually relative to average payouts in the initial four years. Sentinel events fell to zero in the 2 most recent years, with similarly favorable results for several severe adverse events, and a very favorable outlook for future payouts (
        • Grunebaum A.
        • Chervenak F.
        • Skupski D.
        Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events.
        ).
      • A safety net tertiary care center implemented a multifaceted labor and birth safety program over 5 years. The number of claims that its insurance companies reserved for financing possible legal expenses declined about 20% annually. The center experienced no claims during the four most recent years, with about 2,400 births annually (
        • Iverson R.E.
        • Heffner L.J.
        Obstetric safety improvement and its reflection in reserved claims.
        ).
      • A risk insurance company and risk management foundation affiliated with a major university instituted a premium discount program for maternity providers who complete specific patient safety activities, and found that "early results show a drop in malpractice claims frequency and a downward trend in adverse outcomes" (
        • McCarthy J.L.
        Carrots, not sticks: Using malpractice insurance premium as incentives to promote patient safety.
        ).
      The studies generally juxtapose time trends for both program implementation and health and liability measures, and do not consider competing explanations for results. An analysis that did consider other variables found a relationship between malpractice claims and the Agency for Healthcare Research and Quality's Patient Safety Indicators of in-hospital complications and safety events:
      • In a multivariable analysis, investigators found a strong correlation between changes in Patient Safety Indicator event counts and changes in the volume of claims against obstetrician-gynecologists at the county level in California from 2001 to 2005; Patient Safety Indicator event count changes accounted for about 30% of the variance in malpractice claims (
        • Greenberg M.D.
        • Haviland A.M.
        • Ashwood J.S.
        • Main R.
        Is better patient safety associated with less malpractice activity? Evidence from California.
        ).
      Given the consistent finding of an inverse relationship between rigorous QI and liability, multifaceted QI with strong leadership seems to be a priority strategy for liability reduction. These results provide health systems with the “business case for quality” (
      • Hyman D.A.
      • Silver C.
      The poor state of health care quality in the U.S.: Is malpractice liability part of the problem or part of the solution?.
      ). Obstetrical quality leader Steven Clark encourages colleagues to focus on the 75% of paid claims consistently associated with substandard care, over which they have some control, versus the 25% unassociated with substandard care, over which they have little control (
      • Clark S.L.
      Patient safety and litigation reduction: 2 sides of the same coin.
      ). He and his team concluded, “we are absolutely confident that adoption of our approach on a national level could, within 5 years, both dramatically reduce adverse perinatal outcomes and to a large extent eliminate the current obstetric malpractice crisis” (
      • Clark S.L.
      • Meyers J.A.
      • Frye D.K.
      • Perlin J.A.
      Patient safety in obstetrics—The Hospital Corporation of America experience.
      ). Such an approach prevents harm and improves care for those who might have submitted claims in the face of injury and for the vast majority who do not submit claims.
      A focus on improving intrapartum care has greatest potential to reduce liability because at least 60% of obstetric negligence claims and more than 80% of payments for injury awarded in suits against these specialists involve this period (
      • Cohen W.R.
      • Schifrin B.S.
      Medical negligence lawsuits relating to labor and delivery.
      ).
      Despite the growth of implementation science, numerous strategies and programs for improving maternity care quality and safety, and interest in reducing liability, few studies measure the impact of specific quality and safety initiatives on liability system aims. Data are needed to better understand the impact of the QI strategies and programs identified in Table 2 on liability-related matters.
      Table 2Maternity Care Quality Improvement Strategies With Potential to Reduce Liability
      StrategyRole in Maternity Care
      Using national standardized safety measures, “Safe Practices” and “Serious Reportable Events,” to measure, report, and improve performance
      National Quality Forum
      Safe practices for better healthcare—2010 update: A consensus report.
      ,
      National Quality Forum
      Safety.
      Using national standardized perinatal care quality measures and adverse event reporting systems to measure, report, and improve performance
      • Hibbard J.H.
      • Stockard J.
      • Tusler M.
      Does publicizing hospital performance stimulate quality improvement efforts?.
      ;
      • Levinson D.R.
      Adverse events in hospitals: State reporting systems (OEI-06-07-00471).
      ;
      • Main E.K.
      New perinatal quality measures from the National Quality Forum, the Joint Commission and the Leapfrog Group.
      ;
      National Quality Forum
      Perinatal and reproductive health endorsement maintenance: Technical report.
      Implementing payment reform to align incentives with quality

      Center for Healthcare Quality & Payment Reform. (n.d.). Which healthcare payment system is best? Pittsburgh: CHQPR.

      ;
      • Hyman D.A.
      • Silver C.
      The poor state of health care quality in the U.S.: Is malpractice liability part of the problem or part of the solution?.
      ,
      • Hyman D.A.
      • C. Silver C.
      Medical malpractice litigation and tort reform: It’s the incentives, stupid.
      ;
      • James B.C.
      • Savitz L.A.
      How Intermountain trimmed health care costs through robust quality improvement efforts.
      ;
      • Lantos J.
      Cruel calculus: Why saving premature babies is better business than helping them thrive.
      ;
      • Rosenthal M.B.
      • Li Z.
      • Robertson A.D.
      • Milstein A.
      Impact of financial incentives for prenatal care on birth outcomes and spending.
      Implementing maternity care quality improvement collaboratives or maternity-focused programs within broad-scope collaboratives

      Childbirth Connection. (2012c). Quality improvement toolkits. Available at: http://transform.childbirthconnection.org/resources/toolkits/.

      ;
      • Main E.K.
      • Bingham D.
      Quality improvement in maternity care: Promising approaches from the medical and public health perspectives.
      Implementing focused toolkits to improve practice

      Childbirth Connection. (2012b). Maternal and perinatal care quality collaboratives. Available at: http://transform.childbirthconnection.org/resources/collaboratives/.

      Implementing medication safety systems, including focus on common “high-alert” medications (synthetic oxytocin, narcotics/opioids, epidural or intrathecal medications)
      • Clark S.L.
      • Simpson K.R.
      • Knox G.E.
      • Garite T.J.
      Oxytocin: New perspectives on an old drug.
      ;
      Institute for Safe Medication Practices (ISMP)
      ISMP's list of high-alert medications.
      ;
      • Keohane C.A.
      • Bates D.W.
      Medication safety.
      Reducing unwarranted overuse of interventions that are associated with sentinel events and serious maternal and newborn morbidity, including cesarean section and labor induction
      • Elkamil A.I.
      • Andersen G.L.
      • Salvesen K.Å.
      • Skranes J.
      • Irgens L.M.
      • Vik T.
      Induction of labor and cerebral palsy: A population-based study in Norway.
      ;
      • Gilbert W.M.
      • Jacoby B.N.
      • Xing G.
      • Danielsen B.
      • Smith L.H.
      Adverse obstetric events are associated with significant risk of cerebral palsy.
      ;
      • Kramer M.S.
      • Rouleau J.
      • Baskett T.F.
      • Joseph K.S.
      Maternal Health Study Group of the Canadian Perinatal Surveillance System
      Amniotic-fluid embolism and medical induction of labour: A retrospective, population-based cohort study.
      ;
      • Marshall N.E.
      • Fu R.
      • Guise J.-M.
      Impact of multiple cesarean deliveries on maternal morbidity: A systematic review.
      ;
      • Martinez-Biarge M.
      • Madero R.
      • González A.
      • Quero J.
      • Garcia-Alix A.
      Perinatal morbidity and risk of hypoxic-ischaemic encephalopathy associated with intrapartum sentinel events.
      ;
      • Mercer B.M.
      • Gilbert S.
      • Landon M.B.
      • Spong C.Y.
      • Leveno K.J.
      • Rouse D.J.
      • et al.
      National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
      Labor outcomes with increasing number of prior vaginal births after cesarean delivery.
      ;
      • Murray D.M.
      • O’Riordan M.N.
      • Horgan R.
      • Boylan G.
      • Higgins J.R.
      • Ryan C.A.
      Fetal heart rate patterns in neonatal hypoxic-ischemic encephalopathy: Relationship with early cerebral activity and neurodevelopmental outcome.
      ;
      • Silver R.M.
      Delivery after previous cesarean: Long-term maternal outcomes. 2011.
      ;
      • Silver R.M.
      • Landon M.B.
      • Rouse D.J.
      • Leveno K.J.
      • Spong C.Y.
      • Thom E.A.
      • et al.
      National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
      Maternal morbidity associated with multiple repeat cesarean deliveries.
      ;
      • Vardo J.H.
      • Thornburg L.L.
      • Glantz J.C.
      Maternal and neonatal morbidity among nulliparous women undergoing elective induction of labor.
      Implementing shared decision making using high-quality, up-to-date decision aids
      • Dugas M.
      • Shorten A.
      • Dubé E.
      • Wassef M.
      • Bujold M.
      • Chaillet N.
      Decision aid tools to support women’s decision making in pregnancy and birth: A systematic review and meta-analysis.
      ;
      • Frosch D.L.
      • Moulton B.W.
      • Wexler R.M.
      • Holmes-Rovner M.
      • Volk R.J.
      • Levin C.A.
      Shared decision making in the United States: Policy and implementation activity on multiple fronts.
      ;
      • Say R.
      • Robson S.
      • Thomson R.
      Helping pregnant women make better decisions: A systematic review of the benefits of patient decision aids in obstetrics.
      ; Stacey et al., 2012
      Developing systems for effective patient-centered informed consent processes, consistent with the predominant “patient” standard of informed consent and childbearing women's desire for information prior to consent
      American College of Obstetricians and Gynecologists
      Professional liability and risk management: An essential guide for obstetrician-gynecologists.
      ;
      • Declercq E.R.
      • Sakala C.
      • Corry M.P.
      • Applebaum S.
      Listening to Mothers II: Report of the second national U.S. survey of women's childbearing experiences.
      ;
      • Matiasek J.
      • Wynia M.
      Reconceptualizing the informed consent process at eight innovative hospitals.
      ;
      National Quality Forum
      Implementing a national voluntary consensus standard for informed consent: A user’s guide for healthcare professionals.
      ;
      • Studdert D.M.
      • Mello M.M.
      • Levy M.K.
      • Gruen R.L.
      • Dunn E.J.
      • Orav E.
      • Brennan T.A.
      Geographic variation in Informed Consent Law: Two standards for disclosure of treatment risks.
      Harnessing potential of electronic health records to foster access to full and accurate documentation and data collection and to support appropriate care
      • Bernstein P.S.
      • Farinelli C.
      • Merkatz I.R.
      Using an electronic medical record to improve communication within a prenatal care network.
      ;
      • Cusack C.M.
      Electronic health records and electronic prescribing: Promise and pitfalls.
      ;
      • Eden K.B.
      • Messina R.
      • Li H.
      • Osterweil P.
      • Henderson C.R.
      • Guise J.-M.
      Examining the value of electronic health records on labor and delivery.
      ;
      • George J.
      • Bernstein P.S.
      Using electronic medical records to reduce errors and risks in a prenatal network.
      ;
      • Haberman S.
      • Feldman J.
      • Merhi Z.O.
      • Markenson G.
      • Cohen W.
      • Minkoff H.
      Effect of clinical-decision support on documentation compliance in an electronic medical record.
      ;
      • Nielsen P.E.
      • Thomson B.A.
      • Jackson R.B.
      • Kosman K.
      • Kiley K.C.
      Standard obstetric record charting system: Evaluation of a new electronic medical record.
      ;
      • Quinn M.A.
      • Kats A.M.
      • Kleinman K.
      • Bates D.W.
      • Simon S.R.
      The relationship between electronic health records and malpractice claims.
      Building effective teams, improving interpersonal relationships and communication and strengthening collaborative practice
      • Hickson G.B.
      • Entman S.S.
      Physician practice behavior and litigation risk: Evidence and opportunity.
      ;
      • Lyndon A.
      • Sexton J.B.
      • Simpson K.R.
      • Rosenstein A.
      • Lee K.A.
      • Wachter R.M.
      Predictors of likelihood of speaking up about safety concerns in labour and delivery.
      ;
      • Lyndon A.
      • Zlatnik M.G.
      • Wachter R.M.
      Effective physician-nurse communication: A patient safety essential for labor and delivery.
      ;
      • Mann S.
      • Pratt S.D.
      Team approach to care in labor and delivery.
      ;
      • Merién A.E.
      • van de Ven J.
      • Mol B.W.
      • Houterman S.
      • Oei S.G.
      Multidisciplinary team training in a simulation setting for acute obstetric emergencies: A systematic review.
      ;
      • Nielsen P.
      • Mann S.
      Team function in obstetrics to reduce errors and improve outcomes.
      ;
      • Pratt S.D.
      • Mann S.
      • Salisbury M.
      • Greenberg P.
      • Marcus R.
      • Stabile B.
      • et al.
      John M. Eisenberg Patient Safety and Quality Awards: Impact of CRM-based training on obstetric outcomes and clinicians’ patient safety attitudes.
      ;
      • Williams A.L.
      • Lasky R.E.
      • Dannemiller J.L.
      • Andrei A.M.
      • Thomas E.J.
      Teamwork behaviours and errors during neonatal resuscitation.
      Implementing high-reliability practice that aligns care with best evidence and reduces practice variation, including use of clinical decision support, protocols, explicit evidence-based guidelines, checklists, etc.
      • Clark S.L.
      • Meyers J.A.
      • Frye D.K.
      • Perlin J.A.
      Patient safety in obstetrics—The Hospital Corporation of America experience.
      ;
      • Clark S.L.
      • Belfort M.A.
      • Byrum S.L.
      • Meyers J.A.
      • Perlin J.B.
      Improved outcomes, fewer cesarean deliveries, and reduced litigation: Results of a new paradigm in patient safety.
      ;
      • Clark S.L.
      • Belfort M.
      • Saade G.
      • Hankins G.
      • Miller D.
      • Frye D.
      • et al.
      Implementation of a conservative checklist-based protocol for oxytocin administration: Maternal and newborn outcomes.
      ;
      • Fausett M.B.
      • Propst A.
      • Van Doren K.
      • Clark B.T.
      How to develop an effective obstetric checklist.
      ;
      • Grobman W.A.
      • Miller D.
      • Burke C.
      • Hornbogen A.
      • Tam K.
      • Costello R.
      Outcomes associated with introduction of a shoulder dystocia protocol.
      ;
      • Hasley S.K.
      Decision support and patient safety: The time has come.
      ;
      • Knox G.E.
      • Simpson K.R.
      Perinatal high reliability.
      ;
      • Pettker C.M.
      Standardization of intrapartum management and impact on adverse outcomes.
      Implementing quality of care peer review systems (e.g., American College of Obstetricians and Gynecologists Voluntary Review of Quality of Care)
      • Lichtmacher A.
      Quality assessment tools: ACOG Voluntary Review of Quality of Care program, peer review reporting system.
      ;
      • Stumpf P.G.
      Voluntary Review of Quality of Care peer review for patient safety.
      Using laborists (maternity care hospitalists) for labor and birth care, which may foster retention of core knowledge and skills, high intrapartum competence, on-site provider presence throughout labor, appropriate use of interventions to control onset of or hasten labor, better maternal experience, better health professional satisfaction
      • Devoe L.D.
      The future of intrapartum care: Navigating the perfect storm—An obstetrician’s odyssey.
      ;

      Gussman, D. (n.d.) Hospitalists review essay. Available at: oblaborist.org/studies.php.

      .;
      • Srinivas S.K.
      • Lorch S.A.
      The laborist model of obstetric care: We need more evidence.
      In education programs, renewed focus on teaching fundamentals of intrapartum care and common standardized terminology
      • Cohen W.R.
      • Schifrin B.S.
      Medical negligence lawsuits relating to labor and delivery.
      ;
      • Devoe L.D.
      The future of intrapartum care: Navigating the perfect storm—An obstetrician’s odyssey.
      Taking safety and emergency preparedness courses, including Advanced Life Support in Obstetrics, Managing Obstetrical Risk Efficiently, Managing Obstetric Emergencies and Trauma, and PRactical Obstetric MultiProfessional Training
      • Beasley J.W.
      • Dresang L.T.
      • Winslow D.B.
      The Advanced Life Support in Obstetrics (ALSO) program: Fourteen years of progress.
      ;

      Childbirth Connection. (2012a). Maternal and newborn care quality and safety courses. Available at: http://transform.childbirthconnection.org/resources/safetycourses/.

      ;
      ;
      • Grady K.
      • Howell C.
      • Cox C.
      Managing obstetric emergencies and trauma: The MOET course manual.
      ;
      • Milne J.K.
      • Lalonde A.B.
      Patient safety in women's health-care: Professional colleges can make a difference. The Society of Obstetricians and Gynaecologists of Canada MORE(OB) program.
      Using simulation to build skills, knowledge, and teamwork and to prepare for emergencies
      • Fisher N.
      • Eisen L.A.
      • Bayya J.V.
      • Dulu A.
      • Bernstein P.S.
      • Merkatz I.R.
      • et al.
      Improved performance of maternal-fetal medicine staff after maternal cardiac arrest simulation-based training.
      ;
      • Gardner R.
      • Raemer D.B.
      Simulation in obstetrics and gynecology.
      ;
      • Gardner R.
      • Walzer T.B.
      • Simon R.
      • Raemer D.B.
      Obstetric simulation as a risk control strategy: Course design and evaluation.
      ;
      • Merién A.E.
      • van de Ven J.
      • Mol B.W.
      • Houterman S.
      • Oei S.G.
      Multidisciplinary team training in a simulation setting for acute obstetric emergencies: A systematic review.
      Creating a plan for respectful management of serious adverse events, integrating into organization's culture of quality and safety, and implementing it as needed
      • Conway J.
      • Federico F.
      • Stewart K.
      • Campbell M.J.
      Respectful management of serious clinical adverse events.
      Conducting analysis of adverse events and associated circumstances, and incorporating lessons into care systems
      • Boothman R.C.
      • Blackwell A.C.
      Integrating risk management activities into a patient safety program.
      ;
      • Mulligan M.A.
      • Nechodom P.
      Errors and Analysis of Errors.
      ;
      • Schifrin B.S.
      • Ater S.
      Fetal Hypoxic and Ischemic Injuries.
      ;
      • Smetzer J.
      • Baker C.
      • Byrne F.D.
      • Cohen M.R.
      Shaping systems for better behavioral choices: Lessons learned from a fatal medication error.
      Carrying out analyses of closed and open claims and circumstances associated with them, and incorporating lessons into care delivery systems
      • Angelini D.J.
      • Greenwald L.
      Closed claims analysis of 65 medical malpractice cases involving nurse-midwives.
      ;
      • Clark S.L.
      • Belfort M.A.
      • Byrum S.L.
      • Meyers J.A.
      • Perlin J.B.
      Improved outcomes, fewer cesarean deliveries, and reduced litigation: Results of a new paradigm in patient safety.
      ;
      • Crawforth K.
      The AANA Foundation Closed Malpractice Claims Study: Obstetric anesthesia.
      ;
      • Hickson G.B.
      • Clayton E.W.
      • Githens P.B.
      • Sloan F.A.
      Factors that prompted families to file medical malpractice claims following perinatal injuries.
      ;
      • Jevitt C.
      • Schuiling K.D.
      • Summers L.
      The National Practitioner Data Bank: Information for and about midwifery.
      ;
      • Kravitz R.L.
      • Rolph J.E.
      • McGuigan K.
      Malpractice claims data as a quality improvement tool: 1. Epidemiology of error in four specialties.
      ;
      • Richards B.
      • Thomasson G.
      Closed liability claims analysis and the medical record.
      ;
      • Ward C.
      Analysis of 500 obstetric and gynecologic malpractice claims: Causes and prevention.
      ;
      • White A.A.
      • Pichert J.W.
      • Bledsoe S.H.
      • Irwin C.
      • Entman S.S.
      Cause and effect analysis of closed claims in obstetrics and gynecology.
      When patients are harmed during care processes, implementing national “Care of the Caregiver” standard, through just treatment, respect, understanding and compassion, supportive care, and transparency
      • Denham C.R.
      The missing safe practice.
      ;
      National Quality Forum
      Safe practices for better healthcare—2010 update: A consensus report.
      Developing and implementing standards and measures for clinician behavior, and carrying out system-level programs to identify problem clinicians and address shortcomings
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion No. 366: Disruptive behavior.
      ;
      • Chervenak F.A.
      • McCullough L.B.
      The diagnosis and management of progressive dysfunction of health care organizations.
      ;
      • Leape L.L.
      • Fromson J.A.
      Problem doctors: Is there a system-level solution?.
      ;
      • Rosenstein A.H.
      Managing disruptive behavior in the health care setting: Focus on obstetrics services.
      ;
      • Simpson K.R.
      Disruptive clinician behavior.
      Improving the accuracy, completeness, and timeliness of data in the National Practitioner Data Bank and the Healthcare Integrity and Protection Data Bank, and using them to identify unsafe caregivers

      Sibelius, K., & Wakefield, M. K. (2010, February 12). Letter to governors. Available at: http://www.propublica.org/images/uploads/series/NPDB-HIPDB-Dear-Governor.pdf

      ;
      • Weber T.
      • Ornstein C.
      Dangerous caregivers not on list: A federal database fully available to hospitals on March 1 missing disciplinary records from states.
      Comparing the effectiveness of change strategies and implementing the most effective approaches
      • Clark S.L.
      • Frye D.R.
      • Meyers J.A.
      • Belfort M.A.
      • Dildy G.A.
      • Kofford S.
      • et al.
      Reduction in elective delivery at <39 weeks of gestation: Comparative effectiveness of 3 approaches to change and the impact on neonatal intensive care admission and stillbirth.
      These innovations involve a sea change in the conventional culture of safety and error, from deflecting to taking responsibility, conflict to cooperation, limiting access to information to transparency, avoidance and delays to timely resolution of adverse events, failure to learn and apply to seizing opportunities for improvement, and focus on individuals to focus on systems.

      Prevention: Enterprise Liability—A Tort Alternative Reform

      Many respected health law scholars support a model known as “enterprise liability,” which concentrates malpractice liability and responsibility for high-quality health care in hospitals, health plans, and other enterprises while reducing or eliminating clinician liability (
      • Bovbjerg R.R.
      • Berenson R.
      Enterprise liability in the twenty-first century.
      ). However, enterprise liability is not easily applied if health professionals are not affiliated with one and only one entity, no state currently offers a legal climate suitable for this model, and it has not been piloted. However, self-insured health systems and integrated delivery systems can embrace many of its elements (
      • Mello M.M.
      • Kachalia A.
      Evaluation of options for medical malpractice system reform: A report to the Medicare Payment Advisory Commission (MedPAC).
      ). Enterprise liability addresses core aims of the liability system, because it
      • Is consistent with the finding that about two-thirds of injuries owing to error involve individual and system factors, whereas about one third can be attributed solely to individuals (
        • Mello M.M.
        • Studdert D.M.
        • Moran P.
        • Dauer E.A.
        Policy experimentation with administrative compensation for medical injury: Issues under state constitutional law.
        );
      • Incents self-insured entities with premiums reflecting past claims experience to foster patient safety, versus limited experience rating with individual liability (
        • Abraham K.S.
        • Weiler P.C.
        Enterprise medical liability and the choice of the responsible enterprise.
        ;
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        );
      • Gives liability responsibility to entities that have the benefit of system leaders, centralized planning, and resources for QI programs, which are more difficult for solo and group clinicians (
        • Mello M.M.
        • Studdert D.M.
        Deconstructing negligence: The role of individual and system factors in causing medical injuries.
        ;
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        ;
        • Sage W.M.
        The forgotten third: Liability insurance and the medical malpractice crisis.
        );
      • Fosters health system coordination (
        • Sage W.M.
        Medical malpractice insurance and the emperor’s clothes.
        );
      • Reduces clinician discomfort, defensiveness, pressure to conceal errors, and stigma, fostering greater cooperation and potential to support injured parties and learn from errors (
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        ;
        • Sage W.M.
        • Hastings K.E.
        • Berenson R.A.
        Enterprise liability for medical malpractice and health care quality improvement.
        );
      • Reduces health professional discontent by removing penalties such as threat to reputation, embarrassment, and—regardless of merit—reporting settlements to National Practitioner Data Bank and disclosing claims on applications for admitting privileges, board certification, and liability insurance (
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        );
      • Enables more equitable distribution of liability costs across specialties, sparing obstetrician-gynecologists and other high-risk specialists from disproportionate cost (
        • Abraham K.S.
        • Weiler P.C.
        Enterprise medical liability and the choice of the responsible enterprise.
        ;
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        ;
        • Sage W.M.
        The forgotten third: Liability insurance and the medical malpractice crisis.
        );
      • Shields health professionals from periodic liability insurance premium spikes (
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        );
      • Provides large risk pools to ensure that resources are available for large judgments (
        • Abraham K.S.
        • Weiler P.C.
        Enterprise medical liability and the choice of the responsible enterprise.
        );
      • Has potential to build in other strategies such as arbitration and no-fault payment (
        • Sage W.M.
        The forgotten third: Liability insurance and the medical malpractice crisis.
        ), schedules for fair and predictable non-economic damages compensation (
        • Abraham K.S.
        • Weiler P.C.
        Enterprise medical liability and the choice of the responsible enterprise.
        ), and disclosure and offer;
      • Reduces multi-defendant litigation costs by consolidating liability in a single corporate defendant (
        • Abraham K.S.
        • Weiler P.C.
        Enterprise medical liability and the choice of the responsible enterprise.
        ;
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        ); and
      • Has fostered safety in other industries (e.g., aviation and automobile;
        • Peters Jr., P.G.
        Resuscitating hospital enterprise liability.
        ) and is used to compensate workplace injury (
        • Mello M.M.
        • Studdert D.M.
        Deconstructing negligence: The role of individual and system factors in causing medical injuries.
        ).
      A recent review of likely effects of this model found that a well-designed enterprise liability system could reduce overhead costs of litigation and liability insurance costs, reduce defensive behaviors, and improve health care quality. Investigators were unable to anticipate effects on the frequency and cost of claims and on physician supply (
      • Mello M.M.
      • Kachalia A.
      Evaluation of options for medical malpractice system reform: A report to the Medicare Payment Advisory Commission (MedPAC).
      ).

      Prevention: Leverage of Health Insurance, Accreditation, and Credentialing—A Health Insurance and Health Care Reform

      Rather than operating independently, health insurance can and should be linked to liability (
      • Sage W.M.
      Medical malpractice insurance and the emperor’s clothes.
      ), and potential or actual medical errors should be handled within rather than separate from the health care system. Private and public payers enter into agreements on behalf of beneficiaries and indirectly finance malpractice costs through clinician and facility reimbursement; they thus have a justifiable interest in liability matters. Payers could favorably impact liability issues by acting proactively as purchasers.
      • Sage W.M.
      Medical malpractice insurance and the emperor’s clothes.
      argued that,Policymakers should link financial relief for the malpractice crisis to selected improvements in safety and accountability within the health care system, such as voluntary error reporting and analysis, better communication with patients and families, and pay-for-performance mechanisms. The most straightforward way to accomplish this is through health insurance, particularly the Medicare and Medicaid programs. (483–484)
      Similarly,
      • Sage W.M.
      The forgotten third: Liability insurance and the medical malpractice crisis.
      has identified ways to better integrate liability coverage into the professional, commercial, and regulatory framework of health care financing and delivery. Insurers, credentialing and accrediting bodies, and others with oversight responsibility or other types of leverage have great, unrealized potential to assume responsibility for the delivery of safe, effective care. They can foster use of QI strategies and tort alternative approaches such as disclosure and apology. The Wyoming Healthcare Commission identified a comprehensive package of strategies that the state can pursue to address medical error and medical injury compensation (
      • Roberts D.
      • Glode J.
      • Cadez F.
      • in consultation with Mello, M. M
      Report on Medical Errors and Medical Injury Compensation.
      ). Such leverage could effectively address multiple liability system aims and hasten a culture of safety.

      Prevention: Shared Decision Making—A Health Care Reform

      Shared decision making (SDM) is a process for providing balanced information about care options to a person who has a specific condition, presenting potential benefits and harms of the options, weighing the person's values and preferences, and reaching and implementing a personalized decision. High-quality decision aids are essential tools for SDM (

      Ottawa Hospital Research Institute. (2011). Patient decision aids. Available at: http://decisionaid.ohri.ca.

      ). This approach has an impressive track record in health care generally (
      • Stacey D.
      • Bennett C.L.
      • Barry M.J.
      • Col N.F.
      • Eden K.B.
      • Holmes-Rovner M.
      • et al.
      Decision aids for people facing health treatment or screening decisions.
      ), an evolving track record in maternity care (
      • Dugas M.
      • Shorten A.
      • Dubé E.
      • Wassef M.
      • Bujold M.
      • Chaillet N.
      Decision aid tools to support women’s decision making in pregnancy and birth: A systematic review and meta-analysis.
      ;
      • Say R.
      • Robson S.
      • Thomson R.
      Helping pregnant women make better decisions: A systematic review of the benefits of patient decision aids in obstetrics.
      ), and an increasing role in health care policy in the United States (
      • Frosch D.L.
      • Moulton B.W.
      • Wexler R.M.
      • Holmes-Rovner M.
      • Volk R.J.
      • Levin C.A.
      Shared decision making in the United States: Policy and implementation activity on multiple fronts.
      ).
      Decision-making processes and standards are crucial for liability involving decisions to undertake certain care pathways and forgo others. Current standards of informed consent and their implementation often do not serve patients well and pose liability hazards to clinicians (
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ).
      Legal scholars and health services researchers argue that SDM is superior to informed consent from quality and liability perspectives, and should be strengthened and widely implemented (
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ;
      • O’Connor A.M.
      • Wennberg J.E.
      • Legare F.
      • Llewellyn-Thomas H.A.
      • Moulton B.W.
      • Sepucha K.R.
      • et al.
      Toward the “tipping point”: Decision aids and informed patient choice.
      ). This approach can reduce the risk of liability by fostering high-quality clinician–patient communication, because poor communication and breakdown of these relationships lead to lawsuits (
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ), including among childbearing families (
      • Sloan F.A.
      • Githens P.B.
      • Clayton E.W.
      • Hickson G.B.
      • Gentile D.A.
      • Partlett D.F.
      Suing for medical malpractice.
      ).
      • Monico E.P.
      • Calise A.
      • Calabro J.
      Torts to contract? Moving from informed consent to shared decision-making.
      ) identified benefits of SDM, including improved patient autonomy and understanding, reduced use of unwanted medical procedures, improved communication and trust between patients and clinicians, and clear delineation of mutual responsibilities. They argue that better patient understanding and acceptance of possible outcomes, and more realistic expectations, reduce exposure to liability.
      SDM can reduce liability by moving the clinician and patient from a hybrid tort to a contractual relationship (
      • Green J.A.
      Minimizing malpractice risks by role clarification: The confusing transition from tort to contract.
      ;
      • Monico E.P.
      • Calise A.
      • Calabro J.
      Torts to contract? Moving from informed consent to shared decision-making.
      ). Green argued that courts have encouraged viewing informed consent standards within contractual or consensual relationships, but malpractice system stakeholders that are inclined toward adversarial relationships have retarded this and have shaped clinician approaches to consent form and documentation practices. Consequently, stakeholders are confused and uncertain about whether informed consent is a protection for clinicians, a right of patients, or a way to facilitate good communication and care; and relationships and communication have been hampered. Clinicians can reduce risk of liability by entering into agreements with patients that clarify roles and responsibilities and involve patients in decision making (
      • Green J.A.
      Minimizing malpractice risks by role clarification: The confusing transition from tort to contract.
      ).
      In an instructive study, prospective mock jurors found that a clinician followed the standard of care when care decisions emerged from the use of quality decision aids. The study suggested that a decision aid provides greater protection against a determination of malpractice than the clinician's word or a medical record note about provision of information. Presenting a decision aid to mock jurors educated them about the complexity of the situation, documented content that had been presented to the “patient,” and demonstrated that the “physician” had taken great care to support the patient's knowledge and decision making. Use of the tool seemed to prevent the situation when jurors might feel that a test or procedure should have been undertaken as a precaution, despite evidence or patient preferences to the contrary (
      • Barry M.J.
      • Wescott P.H.G.
      • Reifler E.J.
      • Chang Y.
      • Moulton B.W.
      Reactions of potential jurors to a hypothetical malpractice suit alleging failure to perform a prostate-specific antigen test.
      ). Use of decision aids may thus alleviate pressure for defensive assurance practices that fully informed patients decline (
      • Moulton B.
      • King J.S.
      Aligning ethics with medical decision-making: The quest for informed patient choice.
      ).
      The 9 months of pregnancy provide an opportunity to use SDM for many maternity care decisions. The Informed Medical Decisions Foundation and Childbirth Connection are collaborating to develop, assess, and make available maternity care decision aids for childbearing women (
      • Romano A.
      The first national maternity care shared decision making initiative.
      ).

      Prevention: Align Legal Standards with Best Evidence—A Tort Alternative Reform

      Clinicians are held to a legal standard of care in negligence cases that can deviate from the best current evidence about safe and effective practice. Thus, the current liability system does not reliably hold providers accountable for best practice, despite the system aim of deterring harm. An important improvement strategy is to align legal standards with evidence-based practice (
      • Hines N.
      Why technology provides compelling reasons to apply a Daubert analysis to the legal standard of care in medical malpractice cases.
      ;
      • Massie A.M.
      In defense of the professional standard of care: A response to Carter Williams on "evidence-based medicine.".
      ;
      • Peters Jr., P.G.
      The quiet demise of deference to custom: Malpractice law at the millennium.
      ;
      • Williams C.L.
      Evidence-based medicine in the law beyond clinical practice guidelines: What effect will EBM have on the standard of care?.
      ).
      Clinicians in about 21 state court systems are held to the traditional community or statewide legal standard of care (locality rule): Their practice should be in line with the customary practice of other clinicians in the area (
      • Lewis M.H.
      • Gohagan J.K.
      • Merenstein D.J.
      The locality rule and the physician’s dilemma: Local medical practices vs the national standard of care.
      ). The reasonable person standard in other states holds that practice should reflect care that a reasonable clinician would take in a particular situation.
      This focus on actual practice has practical limitations (
      • Hines N.
      Why technology provides compelling reasons to apply a Daubert analysis to the legal standard of care in medical malpractice cases.
      ;
      • Meadow W.
      Operationalizing the standard of medical care: Uses and limitations of epidemiology to guide expert testimony in medical negligence allegations.
      ) and raises serious quality concerns. Unwarranted practice variation is widespread across geographic areas, facilities, and clinicians in maternity care (
      • Baicker K.
      • Buckles K.S.
      • Chandra A.
      Geographic variation in the appropriate use of cesarean delivery.
      ;
      • Clark S.L.
      • Belfort M.A.
      • Hankins G.D.V.
      • Meyers J.A.
      • Houser F.M.
      Variation in the rates of operative delivery in the United States.
      ) and in health and medicine generally (
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ). Pervasive gaps between evidence and practice reflect both overuse of unwarranted practices and underuse of beneficial practices in maternity care (
      • Sakala C.
      • Corry M.P.
      Evidence-based maternity care: What it is and what it can achieve.
      ) and across medicine (
      Institute of Medicine, Committee on Quality of Health Care in America
      Crossing the quality chasm: A new health system for the 21st century.
      ). Behavior-based standards can thus provide perverse incentives to not improve: It is legally safe to use a practice that has been shown to be effective in rigorous research only when use by enough clinicians has rendered it the standard of care (
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ).
      Incentives that are thus misaligned with quality (
      • Hines N.
      Why technology provides compelling reasons to apply a Daubert analysis to the legal standard of care in medical malpractice cases.
      ;
      • King J.S.
      • Moulton B.
      Rethinking informed consent: The case for shared medical decision-making.
      ) are especially alarming within maternity care, which had a head start, beginning in the 1970s, in developing systematic reviews summarizing the weight of the best evidence about effects of specific forms of pregnancy and childbirth care (
      ). Consequently, thousands of systematic reviews—the optimal methodology for knowing what works in health care (
      Institute of Medicine, Committee on Standards for Systematic Reviews of Comparative Effectiveness Research
      Finding what works in health care: Standards for systematic reviews.
      )—are available to help guide maternity care decisions and to point the way for legal standards.
      An alternative to realigning the standard of care with best evidence would be to expand a “respectable minority” or “two schools of thought” doctrine that provides legal protection to those who wish to deviate appropriately from custom or reasonable person standards (
      • Peters Jr., P.G.
      The quiet demise of deference to custom: Malpractice law at the millennium.
      ).
      Although some propose using clinical practice guidelines to identify standards of care (e.g.,
      • Newman D.
      • Chu V.S.
      • Webel B.
      Medical malpractice: Background and examination of the issues before Congress.
      ), the guidelines do not reliably reflect the most valid scientific evidence. Current challenges include persisting moderate to low quality of many clinical practice guidelines (
      • Alonso-Coello P.
      • Irfan A.
      • Solà I.
      • Gich I.
      • Delgado-Noguera M.
      • Rigau D.
      • et al.
      The quality of clinical practice guidelines over the last two decades: A systematic review of guideline appraisal studies.
      ), considerable variation in processes used to develop guidelines in the United States (
      Institute of Medicine, Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
      Clinical practice guidelines we can trust.
      ), the extent to which national maternity care guideline recommendations reflect expert opinion or weak scientific evidence (
      • Chauhan S.P.
      • Berghella V.
      • Sanderson M.
      • Magann E.F.
      • Morrison J.C.
      American College of Obstetricians and Gynecologists Practice Bulletins: An overview.
      ;
      • Wrigh J.D.
      • Pawar N.
      • Gonzalez J.S.R.
      • Lewin S.N.
      • Burke W.M.
      • Simpson L.L.
      • et al.
      Scientific evidence underlying the American College of Obstetricians and Gynecologists' Practice Bulletins.
      ) and are phrased in intentionally ambiguous ways (
      • Clark S.L.
      • Belfort M.A.
      • Byrum S.L.
      • Meyers J.A.
      • Perlin J.B.
      Improved outcomes, fewer cesarean deliveries, and reduced litigation: Results of a new paradigm in patient safety.
      ), and the challenge of developing and updating guidelines for all relevant clinical topics (
      • Bovbjerg R.R.
      • Berenson R.A.
      The value of clinical practice guidelines as malpractice “safe harbors.”.
      ).
      Courts in many states are governed by the Frye (1923 case) test for related decisions about admission of evidence (e.g., about causation of injury). Frye, which governs many of the most populous states (
      • Cheng E.K.
      • Yoon A.H.
      Does Frye or Daubert matter? A study of scientific admissibility standard.
      ), adopts existing standards within the field under scrutiny, regardless of the rigor used to establish them. The Frye test “is vague, is easily manipulated, obscures the relevant inquiry, imposes a protracted waiting period on the use of sound new evidence and techniques, and lacks any definition of when a scientific proposition has become generally accepted” (
      • Saks M.J.
      • Faigman D.L.
      Expert evidence after Daubert.
      ).
      The competing Daubert standard from the Daubert trilogy of cases (1993, 1997, 1999) has replaced Frye in over half of states. This requires judges to ensure that testimony and other medical evidence are scientifically trustworthy. The Daubert case itself supported admitting a meta-analysis about pregnancy care. The intent of the Supreme Court's Daubert “gatekeeping revolution” was to “incorporate scientific sensibilities into the legal culture,” regardless of its acceptance in the community of practice (
      • Saks M.J.
      • Faigman D.L.
      Expert evidence after Daubert.
      ). However, Daubert implementation has been problematic owing to limitations in the scientific literacy of judges (
      • Saks M.J.
      • Faigman D.L.
      Expert evidence after Daubert.
      ), who often feel unprepared to apply scientific standards (
      • Gatowski S.I.
      • Dobbin S.A.
      • Richardson J.T.
      • Ginsburg G.P.
      • Merlino M.L.
      • Dahir V.
      Asking the gatekeepers: A national survey of judges on judging expert evidence in a post-Daubert world.
      ).
      It is a priority to extend Daubert to all jurisdictions and to find effective ways to assist judges in carrying out this standard. Judges might benefit from scientific training as a criterion for appointment, access to assistance of scientific experts, pretrial hearings, and access to compendia of systematic reviews. It is important to understand whether judges can reliably have and apply the specialized skills that Daubert requires, and whether the health court model (below) would better implement this standard.
      It is urgent, as well, to develop a legal standard of care that is parallel to the Daubert standard for admission of evidence. This crucial alignment with quality would encourage clinicians to stay abreast of evolving research, help to close evidence–practice gaps, and provide incentives to improve maternity care quality, safety, and outcomes.

      Prevention: Liability Insurance Coverage Regulation—A Liability Insurance Reform

      Many liability insurance policies offered to maternity professionals constrain practice, for example, by excluding coverage of vaginal birth after cesarean and imposing a surcharge for a family physician to obtain maternity coverage or for an obstetrician-gynecologist to work in collaborative practice with midwives (
      • Benedetti T.J.
      • Baldwin L.-M.
      • Skillman S.M.
      • Andrilla C.H.A.
      • Bowditch E.
      • Carr K.C.
      • et al.
      Professional liability issues and practice patterns of obstetric providers in Washington State.
      ). We did not find good data about the extent of insurer-imposed practice restrictions impacting maternity care practice.
      These restrictions interfere with professional autonomy (
      • Hale R.W.
      Medical professional liability revisited.
      ) and limit practice that is supported by systematic reviews of best evidence (e.g.,
      • Guise J.-M.
      • Eden K.
      • Emeis C.
      • Denman M.A.
      • Marshall N.
      • Fu R.
      • et al.
      Vaginal birth after cesarean: New insights.
      ;
      • Hatem M.
      • Sandall J.
      • Devane D.
      • Soltani S.
      • Gates S.
      Midwife-led versus other models of care for childbearing women.
      ;
      • Johantgen M.
      • Fountain L.
      • Zangaro G.
      • Newhouse R.
      • Stanik-Hutt J.
      • White K.
      Comparison of labor and delivery care provided by certified nurse-midwives and physicians: A systematic review, 1990 to 2008.
      ). They foster confusion about the safety and efficacy of the practices in question, limit access to valuable care options in communities, and increase expenses.
      In exercising their oversight of the insurance industry, states do not seem to have addressed interference with professional practice that is not in the public interest (
      • Sage W.M.
      The forgotten third: Liability insurance and the medical malpractice crisis.
      ). Greater involvement of states could help to better align the liability system with best scientific evidence, improve the quality of care, and send clear signals to clinicians about high-quality practice. Possible approaches include eliminating such surcharges, making coverage of unwarranted exclusions a condition of doing business in the state, or requiring data to support exclusions or surcharges.

      Redress: Disclosure, Empathy, Apology—A Tort Alternative Reform

      Many who believe that they or a family member have been injured wish to understand what happened, have their grievance acknowledged, and protect others from a similar experience. Often, an open and honest expression of empathy, an apology when a care provider and/or system was at fault, a pledge that the involved parties will learn from the experience, and timely support for resulting expenses and responsibilities constitute an appreciated and sufficient response from involved clinicians and institutions (
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ). Empathy, apology, and redress are consistent with medicine's focus on caring and healing (
      • Todres J.
      Toward healing and restoration for all: Reframing medical malpractice reform.
      ).
      Potential defendants using conventional medicolegal risk management strategies avoid communication and refrain from acknowledging responsibility. However, patients and the public strongly desire disclosure of errors (
      • Mazor K.M.
      • Simon S.R.
      • Gurwitz J.H.
      Communicating with patients about medical errors: A review of the literature.
      ), which is supported by many professional groups, including the
      Joint Commission on the Accreditation of Healthcare Organizations
      Comprehensive accreditation manual for hospitals: CAMH.
      ,

      American Medical Association. (1994). Code of medical ethics: Opinion 8.12—Patient information. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion812.shtml.

      ,
      American College of Obstetricians and Gynecologists
      ACOG Committee Opinion No. 380: Disclosure and discussion of adverse events.
      , and

      American Academy of Family Physicians. (2006). Disclosing unanticipated clinical outcomes: A resource guide for family physicians (position paper). Available at: http://www.aafp.org/online/en/home/policy/policies/c/clinicaloutcomes.html.

      . Despite this broad support, a survey of hospital risk managers found great reluctance to disclose error (
      • Lamb R.M.
      • Studdert D.M.
      • Bohmer R.M.J.
      • Berwick D.M.
      • Brennan T.A.
      Hospital disclosure practices: Results of a national survey.
      ). Guidelines from the American Health Lawyers Association (
      • Belmont E.
      Considerations in the disclosure of serious clinical adverse events.
      ) and procedures and training for disclosure processes (
      • Conway J.
      • Federico F.
      • Stewart K.
      • Campbell M.J.
      Respectful management of serious clinical adverse events.
      ;
      • Liebman C.B.
      • Hyman C.S.
      A mediation skills model to manage disclosure of errors and averse events to patients.
      ;
      • Weiss P.M.
      • Miranda F.
      Transparency, apology and disclosure of adverse outcomes.
      ) are available to foster needed change.
      Most jurisdictions have enacted some form of sympathy/apology immunity laws that may legally protect certain actions, persons, and content. A model law has been developed. Some state laws mandate disclosure (
      • Mastroianni A.C.
      • Mello M.M.
      • Sommer S.
      • Hardy M.
      • Gallagher T.H.
      The flaws in state “apology” and “disclosure” laws dilute their intended impact on malpractice suits.
      ;
      • Pelt J.L.
      • Faldmo L.P.
      Physician error and disclosure.
      ;
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ). Most laws have deficiencies that may work at cross-purposes with their aims (
      • Mastroianni A.C.
      • Mello M.M.
      • Sommer S.
      • Hardy M.
      • Gallagher T.H.
      The flaws in state “apology” and “disclosure” laws dilute their intended impact on malpractice suits.
      ). Implications of apology laws for clinician disclosure and the quality of care are unclear (
      • McDonnell W.M.
      • Guenther E.
      Narrative review: Do state laws make it easier to say “I’m sorry?”.
      ). Sorry Works! Coalition leaders argue that the laws can be helpful, are unnecessary for implementing disclosure programs, and should rarely be used in the legal defense of a physician or hospital (
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ).
      The Sorry Works! Coalition encourages rapid root cause analysis of adverse outcomes or events. If negligence is deemed to have been involved, they recommend admission of fault, apology, and offer of fair compensation. If careful assessment suggests that negligence was not involved, they recommend expression of sympathy without admission of fault or offer of compensation, and vigorous defense in the face of litigation (
      • Wojcieszak D.
      • Banja J.
      • Houk C.
      The Sorry Works! Coalition: Making the case for full disclosure.
      ;
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ). Sorry Works! leaders argue that many calls to trial lawyers can be prevented by good customer service that communicates promptly, defuses anger, preserves relationships, and avoids appearance of cover-up or deception, which are vulnerabilities if litigation proceeds (
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ).
      • Studdert D.M.
      • Mello M.M.
      • Gawande A.A.
      • Brennan T.A.
      • Wang Y.C.
      Disclosure of medical injury to patients: An improbable risk management strategy.
      suggested that disclosure and apology strategies have limited potential to reduce claims. However, a study of Florida families of infants with birth injuries who made malpractice claims found that anger, communication problems, and perceived deception and lack of honesty were common, and motivation for filing claims included wanting to find out what happened, seeking revenge, wanting to ensure that others avoided similar harm, and needing to air grievances (
      • Hickson G.B.
      • Clayton E.W.
      • Githens P.B.
      • Sloan F.A.
      Factors that prompted families to file medical malpractice claims following perinatal injuries.
      ;
      • Sloan F.A.
      • Githens P.B.
      • Clayton E.W.
      • Hickson G.B.
      • Gentile D.A.
      • Partlett D.F.
      Suing for medical malpractice.
      ).
      A 15-year disclosure program within a Veterans Affairs Medical Center was associated with substantial improvement in liability payouts, in contrast with trends for other system facilities (
      • Kraman S.S.
      • Hamm G.
      Risk management: Extreme honesty may be the best policy.
      ;
      • Kraman S.S.
      • Cranfill S.
      • Gamm G.
      • Woodard T.
      John M. Eisenberg Patient Safety Awards; Advocacy: The Lexington Veterans Affairs Medical Center.
      ). Initial reports of implementation of Sorry Works! principles at a growing number of sites are favorable (
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ). The COPIC Insurance Company has achieved similar results from its 3 Rs Program: Recognize (unanticipated events), respond (promptly), and resolve (any related matters), a no-fault variant (
      • Boothman R.C.
      • Blackwell A.C.
      • Campbell D.A.
      • Commiskey E.
      • Anderson S.
      A better approach to medical malpractice claims? The University of Michigan experience.
      ;
      • Quinn R.E.
      • Eichler M.C.
      The 3 Rs program: The Colorado experience.
      ).
      From 1995 to 2007, after implementation of a disclosure and offer program at the University of Michigan, the average monthly rate of new claims fell from 7.02 to 4.52 per 100,000 patient encounters and monthly rate of lawsuits fell from 2.13 to 0.75 per 100,000 patient encounters. Median time from claim reporting to resolution fell from 1.36 to 0.95 years. Average monthly cost rates significantly decreased for total liability, patient compensation, and non–compensation-related legal costs. Incident reporting rose sharply during the study period. The contribution of the program cannot be determined as malpractice claims declined in Michigan near the end of the study period (
      • Kachalia A.
      • Kaufman S.R.
      • Boothman R.
      • Anderson S.
      • Welch K.
      • Saint S.
      • et al.
      Liability claims and costs before and after implementation of a medical error disclosure program.
      ). In surveys, both medical faculty and the plaintiff's bar had favorable views of the program (
      • Boothman R.C.
      • Blackwell A.C.
      • Campbell D.A.
      • Commiskey E.
      • Anderson S.
      A better approach to medical malpractice claims? The University of Michigan experience.
      ). It is credited with accomplishing what 40 years of tort reform had not: Respectful working relationships between the health system and the trial bar (
      • Wojcieszak D.
      • Saxton J.W.
      • Finkelstein M.M.
      Sorry Works!: Disclosure, apology, and relationships prevent medical malpractice claims.
      ).
      We found no reports of the impact of apology and disclosure principles applied to maternity care, which may face distinctive challenges, including the high premium placed on healthy newborns and parents' use of the tort system to secure costs of caring for injured children. Evaluation of a maternity care disclosure project is under way (
      • Kachalia A.
      • Mello M.M.
      New directions in medical liability reform.
      ).
      These principles involve a notable culture change in health care microsystems, and go far toward addressing several persistent liability concerns without statutory change or major reorganization in the legal or health care systems.
      A recent review of the limited record and potential of disclosure and offer programs in medicine generally found that they have potential to reduce claims frequency, payouts, overhead costs, and liability insurance premiums; and to improve the culture of safety. Investigators could not anticipate the impact on defensive assurance behaviors and physician supply (
      • Mello M.M.
      • Kachalia A.
      Evaluation of options for medical malpractice system reform: A report to the Medicare Payment Advisory Commission (MedPAC).
      ).

      Redress: Health Courts—A Tort Alternative Reform

      Many are concerned that juries lack the specialized knowledge to decide whether medical errors have occurred or what appropriate levels of compensation would be. Similarly, judges who infrequently hear medical liability cases are at a disadvantage. Establishing health courts to handle medical liability disputes might address most aims in our proposed framework. Judges in these courts could have special training and would grow in expertise and have comparative experience across medical liability cases. Neutral independent experts could assist them, with limited scope for trial lawyers (
      • Barringer P.J.
      • Studdert D.M.
      • Kachalia A.B.
      • Mello M.M.
      Administrative compensation of medical injuries: A hardy perennial blooms again.
      ;
      • Common Good
      Windows of opportunity: State-based ideas for improving medical injury compensation and enhancing patient safety.
      ;
      • Mello M.M.
      • Studdert D.M.
      • Kachalia A.B.
      • Brennan T.A.
      “Health courts” and accountability for patient safety.
      ). Health courts could facilitate legal system use of abundant systematic reviews and foster evidence-based maternity care practice.
      Although some express concerns that health courts would violate constitutional civil rights to a jury trial, others argue that a constitutional health court system is possible, noting substitution of administrative for judicial remedies in such contexts as workers' compensation, securities law, and environmental law (
      • Elliott E.D.
      • Narayan S.A.
      • Nasmith M.S.
      Administrative "health courts" for medical injury claims: The federal constitutional issues.
      ). An analysis of cases involving constitutional challenges to malpractice reforms concluded that carefully designed health court pilots could withstand such challenges in many states (
      • Mello M.M.
      • Studdert D.M.
      • Moran P.
      • Dauer E.A.
      Policy experimentation with administrative compensation for medical injury: Issues under state constitutional law.
      ).
      Health court advantages include the potential to compensate a broader group of patients by shifting from a standard of negligent injury to one of “avoidability” (injury that would not occur with the best practitioners) and to foster equity by using a standardized schedule for non-economic losses. Proponents argue that health courts would involve less uncertainty, apprehension, malaise, and stigma among clinicians and align well with health care QI (
      • Common Good
      An urgent call for special health courts.
      ).
      With respect to challenges, this model has not been implemented to date in the United States, although state-level systems are being explored (
      • Common Good
      Windows of opportunity: State-based ideas for improving medical injury compensation and enhancing patient safety.
      ;
      • Roberts D.
      • Glode J.
      • Cadez F.
      • in consultation with Mello, M. M
      Report on Medical Errors and Medical Injury Compensation.
      ). It may have little impact on the large proportion of cases that are not tried in court. It faces the political barrier of opposition by attorney groups and would require creation of a parallel court system.
      A recent review of work to pilot and evaluate health courts in the United States found that effects would depend on the specific system put in place. Relative to the tort system, well-designed health courts may reduce legal expenses, reduce provider liability insurance costs, and slightly increase physician supply. This model may not impact claims frequency, the success rate of claims, or the size of awards. Investigators could not predict impact on overhead costs, defensive behavior, and the quality of care (
      • Mello M.M.
      • Kachalia A.
      Evaluation of options for medical malpractice system reform: A report to the Medicare Payment Advisory Commission (MedPAC).
      ).

      Redress: Administrative Compensation Systems—A Tort Alternative Reform

      Administrative compensation systems use administrative bodies rather than the tort system to pay for medical injuries (
      • Studdert D.M.
      • Brennan T.A.
      No-fault compensation for medical injuries: The prospect for error prevention.
      ). They conserve or divert resources from legal expenses to injured patients and resolve disputes quicker than the tort system (
      • Studdert D.M.
      • Brennan T.A.
      No-fault compensation for medical injuries: The prospect for error prevention.
      ). By removing the stigma and penalty of individual blame, they may increase the likelihood that clinicians learn from errors, improve systems of care, and deter injury. They have the potential to systematically identify cases and resolve claims proficiently (
      • Studdert D.M.
      • Brennan T.A.
      Toward a workable model of "no-fault" compensation for medical injury in the United States.
      ).
      Within maternity care, administrative systems have the potential to provide efficient and timely assistance overall and for families of newborns requiring costly ongoing care. Two established administrative birth injury compensation funds operate in the United States, in Virginia and Florida, offering alternatives to the tort system for malpractice cases relating to some classes of newborns (
      • Horwitz J.
      • Brennan T.A.
      No-fault compensation for medical injury: A case study.
      ;
      • Studdert D.M.
      • Fritz L.A.
      • Brennan T.A.
      The jury is still in: Florida's birth-related neurological injury compensation plan after a decade.
      ). They were established to foster more affordable medical malpractice insurance; efficiency in claims resolution and victim injury compensation received less adequate attention in their design (
      • Bovbjerg R.R.
      • Sloan F.A.
      No-fault for medical injury: Theory and evidence.
      ).
      The Virginia and Florida programs have intentionally narrow eligibility criteria to keep costs low (
      • Bovbjerg R.R.
      • Sloan F.A.
      • Rankin P.J.
      Administrative performance of "no-fault" compensation for medical injury.
      ). Participating clinicians continue to pay liability insurance premiums, and most potential claims have remained in the tort system.
      • Sloan F.A.
      • Whetten-Goldstein K.
      • Hickson G.B.
      The influence of obstetric no-fault compensation on obstetricians' practice patterns.
      found that obstetricians were far more satisfied with administrative than tort systems, yet most were unhappy with premiums for the former. Evaluation of the first decade of the programs found that they are feasible and efficient, offer important advantages relative to the tort system even when limited in scope, can be adversely impacted by concurrent filing of tort claims, could be further refined for greater impact, and might attract political opposition if expanded (
      • Bovbjerg R.R.
      • Sloan F.A.
      • Rankin P.J.
      Administrative performance of "no-fault" compensation for medical injury.
      ). Parents of children with birth-related injuries who filed claims with Florida's program indicated satisfaction with their compensation (
      • Whetten-Goldstein K.
      • Kulas E.
      • Sloan F.
      • Hickson G.
      • Entman S.
      Compensation for birth-related injury: No-fault programs compared with tort system.
      ). Some Florida claimants with birth injuries would not have met criteria for compensation in the tort system, whereas many with neurologic birth injuries did not qualify for administrative compensation (
      • Sloan F.A.
      • Whetten-Goldstein K.
      • Hickson G.B.
      The influence of obstetric no-fault compensation on obstetricians' practice patterns.
      ;
      • Stalnaker B.L.
      • Maher J.E.
      • Kleinman G.E.
      • Macksey J.M.
      • Fishman L.A.
      • Bernard J.M.
      Characteristics of successful claims for payment by the Florida Neurologic Injury Compensation Association Fund.
      ).
      Comparison of administrative and tort claims for newborn injuries and death in the early years of the Florida and Virginia programs found that the administrative systems nearly eliminated legal costs for resolving disputes and were more likely to pay for claims. Those with administrative compensation in Florida received payment for their actual expenses, whereas those with tort payments were overcompensated. Analysis limited to children with cerebral palsy found administrative system undercompensation and even greater tort overcompensation (
      • Sloan F.A.
      • Whetten-Goldstein K.
      • Entman S.S.
      • Kulas E.D.
      • Stout E.M.
      The road from medical injury to claims resolution: How no-fault and tort differ.
      ). Studies of the first decade of the Florida and Virginia programs may not apply to present conditions.
      • Siegal G.
      • Mello M.M.
      • Studdert D.M.
      Adjudicating severe birth injury claims in Florida and Virginia: The experience of a landmark experiment in personal injury compensation.
      provide a detailed overview of the eligibility criteria and claims determination processes of the two programs with the benefit of key informant interviews in 2004 and 2005. They express surprise that this model has not been more widely implemented.
      A more comprehensive administrative program could attract political and judicial scrutiny as a threat to interests of lawyers and through concerns about the right to sue (
      • Studdert D.M.
      • Thomas E.J.
      • Zbar B.I.W.
      • Newhouse J.P.
      • Weiler P.C.
      • Bayuk J.
      • et al.
      Can the United States afford a “no-fault” system of compensation for medical injury?.
      ). Shifting to no-fault and channeling money that currently covers legal expenses to injured persons could compensate a much larger proportion of injured patients (
      • Mello M.M.
      • Brennan T.A.
      Deterrence of medical errors: Theory and evidence for malpractice reform.
      ).
      Legal scholars have studied the Florida and Virginia programs to ascertain lessons for administrative compensation schemes (
      • Siegal G.
      • Mello M.M.
      • Studdert D.M.
      Adjudicating severe birth injury claims in Florida and Virginia: The experience of a landmark experiment in personal injury compensation.
      ), have examined established administrative compensation systems in other countries for lessons for the United States (
      • Mello M.M.
      • Kachalia A.
      • Studdert D.M.
      Administrative compensation for medical injuries. Lessons from three foreign systems.
      ; see also
      • Kachalia A.B.
      • Mello M.M.
      • Brennan T.A.
      • Studdert D.M.
      Beyond negligence: Avoidability and medical injury compensation.
      ), and have designed comprehensive administrative compensation systems for far-reaching impact (
      • Roberts D.
      • Glode J.
      • Cadez F.
      • in consultation with Mello, M. M
      Report on Medical Errors and Medical Injury Compensation.
      ).
      A recent review of the potential of administrative systems in medicine found that effects would vary according to program design. Relative to the tort system, administrative systems could greatly reduce the legal expense portion of costs and compensate many more individuals at a given level of expense, reduce provider liability insurance costs, reduce provider defensive behaviors, and improve quality of care. Such a system could generate more claims, process claims with greater ease, expand the standard for compensation to avoidability, and increase the success rate of claims, while the size of awards could fall. Investigators could not predict impact on physician supply (
      • Mello M.M.
      • Kachalia A.
      Evaluation of options for medical malpractice system reform: A report to the Medicare Payment Advisory Commission (MedPAC).
      ).

      Redress: High-Low Agreements—A Tort Alternative Reform

      In a high-low agreement, attorneys agree at some point before a jury award and without disclosing to the jury that the plaintiff will receive neither less than a lower compensation level nor more than a higher level. Jury awards outside of this range revert to the closer end of the range. Such agreements address multiple aims of the liability system by simultaneously providing reassurance that a patient will receive some level of compensation and that a payout will not excessively burden insurers and the health system overall. This approach may be well suited to claims for neurologically impaired infants with large future predicted care expenses. It might encourage attorneys to accept cases that they would otherwise forgo (
      • Crane M.
      One way to avert a sky-high malpractice award.
      ).

      Discussion

      This investigation identified numerous promising strategies for improving liability matters across multiple aims within maternity care. These warrant piloting and evaluation at appropriate state, health system, or other levels. Health care systems, liability insurers, and state agencies can lead voluntary experimentation. Some interventions require legislative or regulatory action, continued reorganization of health care, or the development of new infrastructure.
      The

      Agency for Healthcare Research and Quality. (2010). Medical liability reform and patient safety: Demonstration and planning grants. Rockville, MD: Author. Available at: http://www.ahrq.gov/qual/liability.

      is funding several maternity-related pilots under Medical Liability Reform and Patient Safety Demonstration Projects and Planning grants. These include projects to test the relationship between safety and liability, reliably provide evidence-based intrapartum care and improve the handling of adverse events, implement a program of both negotiation and early disclosure and settlement, consider the impact of improved teamwork on liability, and implement a statewide pregnancy-associated mortality review and develop safety recommendations (see also
      • Langel S.
      Averting medical malpractice lawsuits: Effective medicine—or inadequate cure?.
      ).
      Implementing rigorous QI programs within hospitals and health systems has great potential to improve overall care and lead to plummeting claims, payouts, and liability insurance premiums. This win–win–win preventive approach for patients, providers, and payers should become standard maternity care practice. Leaders can move forward on this leading prevention strategy and on the most promising redress strategy—disclosure, apology, and early offer as appropriate—without the need for new legislation, regulation, or intfrastructure. We have identified five other promising approaches to preventing harm and three other promising approaches to assisting those with injuries. Effective approaches to prevention and redress are both needed. The 10 approaches discussed here offer policy makers a broad range of options for implementation, evaluation, refinement, and—as appropriate—spread.

      Acknowledgments

      The authors are grateful to the Milbank Memorial Fund for financial support to prepare the full report from which this paper is derived and to the many individuals named in that report and the referees of this paper who provided feedback that helped us to strengthen the analysis and reporting.

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