29 May 2022

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Quality, Safety, and Risk Management in the Context of Full Disclosure

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Academic level: Master’s

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Pages: 8

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To err is human, so the saying goes, illuminating the fact that medical errors are inherent in the work of healthcare providers. Health systems face significant challenges in handling such errors due to lack of proven frameworks because the potential for negative implications cannot be understated. Nevertheless, it is unethical to sweep incidences leading to errors under the carpet in the pretext that the patient will remain in the dark about the error. Accountability and credibility in the medical profession are defined by disclosure of such errors without regard for repercussions, which may be inevitable depending on how patients and third party insurance agencies react to the revelation. Simply put, it is the right of the patient to know that an error occurred during a specific medical procedure and the magnitude of its effects on their health. However, evidence suggests that medical malpractice is tending towards a crisis in the US as practitioners adopt ‘deny and defend’ strategy. Healthcare systems teach practitioners to remain silent and defer cases of medical errors to legal counsel, a strategy encouraged by financial concerns, and rising premiums associated with such malpractice errors. The Patient Safety Network (2017) posited that such an approach is detrimental to risk management in healthcare settings. Therefore, it is imperative to explore the concept of full disclosure from thee perspectives of different stakeholders to understand its implications on risk management.

The history of disclosure programs in the US is well documented with the first such framework developed by Lexington Veterans Affairs Medical Center, Kentucky. According to a research brief presented by Jennifer (2014), the center started using humanistic approaches in 1987 following two cases that cost it $1.5 million each in judgments. The whole concept behind disclosure programs is in the building of safer health systems that aid in risk management. The need for such programs is imperative and is backed by data that paints a grave picture of the US healthcare system. Each year, 98,000 deaths in the US occur due to medical errors. The annual cost of errors incurred by hospitals and health systems range between $17 million and $29 million. In addition, tort costs continue to increase at a rate of 9.1% annually as patients continue to sue specifically due to perinatal injuries and misleading information from physicians (Jennifer, 2014; Kohn et al. , 1999). Therefore, one can argue that full disclosure can aid in not only ensuring quality service and patient safety, but also in managing, associated risks and reduce the rising costs of resultant lawsuits.

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Consumer Perception of Full Disclosure 

The US healthcare system is under pressures due to increased calls for safety and accountability. According to Kuhn and Youngberg (2002), The Institute of Medicine's report “ To err is human: building a safer health care system ” published in 1999 revealed issues that healthcare systems grapple with, thus highlights the inherent need for traditional risk management model that focuses on department risk assessment, loss management, and risk financing. Healthcare risk management is a critical component of the healthcare system, but the report quashed rising hopes of progress being made in managing risks that contributed to medical errors and patient harm. Patients continue to be harmed due to problems and processes long identified as faulty and may be the cause of the rise in malpractice verdicts and settlements. At the time, Kuhn and Youngberg (2002) posed critical questions whose answers could prove vital in revolutionizing risk management in healthcare settings.

How could it be that we have worked so hard and for so long and have seemingly accomplished so little?

How can it be that the problems identified by risk managers over the years that contributed to patient harm and cost the organizations millions of dollars have not yet been solved?

What is it about the way our organizations are managed that makes change so difficult?

How can these systems problems be fixed so that more patients are not harmed?

Fast forward to the last three to five years, the situation has changed less. Exploration of antecedents to barriers in prompt and honest disclosure of care-related un-intended harm to patients by Wolk, Sine, and Paull (2014) revealed that fear of legal action is the leading factor. Other factors behind the slow adoption of disclosure programs are social and non-jurisprudential explanation challenges. Gallagher et al. (2006) noted significant improvement in the success of disclosure programs with most physicians disclosing medical errors to patients and acknowledging that such disclosure was warranted (see figure 1 below). The findings are consistent with the recent survey results where 20% of over 2,000 physicians admitted withholding the truth from patients when they committed an error. Moreover, a significant proportion failed to discuss financial implications with the patient and provided misleading information through a positively biased picture of prognosis, risk, and benefit in relation to the disease ( Patient Health Network , 2017).

Figure 1: Trends in error disclosure by physicians (Gallagher et al. , 2006).

Consumers’ perspective about disclosure is founded on society’s expectation of physicians to be honest all the time. Patients have the right to know about actual or potential conflicts of interest, financial, or otherwise, and the practitioner should voluntarily provide such information. Under the circumstances, consumers perceive anything less than full disclosure and truth-telling as wrong. Gallagher et al. (2006) established that components of disclosure that matter most to the patient include:

Disclosure of all harmful errors

An explanation as to why the error occurred

How the error's effects will be minimized

Steps the physician (and organization) will take to prevent recurrences

One can argue that components that matter most to patients reflect their orientation towards full disclosure serving to mitigate future risks of similar or other errors. The perspective is consistent with the consensus among different stakeholders that full disclosure has a positive role in risk management within healthcare settings. Evans (2016) and Moffatt-Bruce et al. (2016) argued that full disclosure serves as a dispute resolution framework because full disclosure followed by early offer and an apology have economic and ethical benefits. The argument is consistent with observed increase in transparency and attendant communication whose advantages are irrefutable.

Traditionally, healthcare facilities viewed patients harmed through error or negligence as a threat, prompting the adoption of deny and defend strategy. However, theoretical and experiential evidence is growing illustrating that full disclosure, an apology, and fair compensation programs have the potential to protect all parties at lower cost. Based on this evidence, one can argue that calls for integration of disclosure, patient safety, and risk management activities are highly justifiable. The combination creates room for physician led guidance in determining the need for disclosure and provides mentor assistance with the actual process of disclosure. Consequently, it provides proactive error prevention through quick facilitation of information use in making relevant changes. The approach also provides room for accessing collaborative law and thus the possibility to resolve the issues without resorting to litigation.

Health Agency Perspective of Full Disclosure 

The consensus among stakeholders is that physicians are burdened by the calls to increase quality of disclosure, a process that would entail addressing their discomfort and fear of lawsuits ( Patient Safety Network, 2017). Such fears are founded on the fact that disclosure of an error may be admissible as evidence in a malpractice lawsuit. A 2008 survey established that on eight states in the US explicitly prohibited use of ‘admission of fault’ as evidence in a trial, but empirical evidence indicates that patients are less likely to file a lawsuit if physicians fully disclose errors and apologize. The survey shed light into why the desire to preserve professional standing drove medical malpractices into the underground, but also calls for a rethink of the approach because measures for lessening the blows exist. However, reluctance can be observed mostly owing to health facilities resolve to protect their reputation because of the damaging effects and liability they associate with revealing mistakes to patients. In light of this understanding, health agencies, which are mandated with policy development should develop and implement frameworks for full disclosure in a bid to ensure quality, safety, and accountability.

The need for health agencies to be proactive in employing disclosure as a risk management framework is informed by findings in the Institute of Medicine's report “ To err is human: building a safer health care system ” showing that 25.1 incidences of malpractice occur in every 100 hospital admissions, which translates to 25% of patients suffering from preventable harm. The report further shows that 2.9% of the cases result to permanent injury including brain damage, 8% in life-threatening illnesses, and 2.4% in deaths. According to Evans (2016), Paul Levy, former CEO of Boston’s Beth Israel Deaconess Medical Center, contextualized the situation by observing, “ I don't think that crashing a 727 jet every day and killing everybody aboard is a good standard of care in U.S. hospitals. If that happened in aviation, they would shut the airlines down.” The figures justify the assertions that a paradigm shift is needed in frameworks of risk management in healthcare settings, and full disclosure of errors and malpractice represents the bedrock of such reforms.

Disclosure of medical errors to patients is heralded as an improbable risk management strategy. National Quality Forum safe-practice guidelines encourage integration of disclosure, risk management, and patient safety in healthcare systems. The drive is motivated by ethical and practical arguments in favor of disclosure.

Disclosure is regarded as the right thing to do because patients and their family have the right to know what happened to facilitate risk management and efforts to correct effects of the mistakes

Disclosure is the ethical thing to do, a notion shared by the American College of Physicians and the American Medical Association, agencies that advocate for ethics requiring physicians to disclose medical errors to patients

Disclosure is the smart thing to do from legal perspective and fears are alleviated by research showing that it does not raise the prospects of litigation (Mastroianni et al. , 2010). Secrecy in malpractice causes anger among patients, and angry patients are more likely to sue.

Disclosure improves patient care and safety as it opens avenues for open discussions about the mistake, how to rectify it, and how to avoid similar future incidences instead of focusing on cover-ups

Disclosure promotes trust and helps providers because meaningful forgiveness from patients and their family inspires physicians to improve service delivery by reflecting on past mistakes.

Health agencies face significant challenges in addressing the concept of disclosure due to lack of modalities that have been proven to work. Loren et al. (2010) suggest adoption of a collaborative approach with risk managers during disclosure of errors because risk managers have a more favorable attitude about disclosing errors to patients compared to physicians. However, they are less suited to providing full apology, which physicians can do better. Such is the inconsistency in policies for addressing disclosure of medical errors. Despite initiative for disclosure existing worldwide, health agencies call for uniform policy that centers on addressing disclosure in a non-punitive manner (Kalra, Kalra, & Baniak, 2013). There is a consensus among health agencies that the relationship between the patient and the physician during disclosure is shrouded in uncertainty, hence the need for update and improvement of existing disclosure frameworks to facilitate a culture of accountability towards risk management. For instance, the Communication and Optimal Resolution (CANDOR) toolkit developed by the Agency for Healthcare Research and Quality for helping organizations implement communication and response programs. Healthcare organizations have been challenged to create a conducive environment to disclosure through integration of risk management and patient safety activities, and provision of training and support for practitioners (Moffatt-Bruce, Ferdinand, & Fann, 2016).

Third-Party Payer’s Perception of Full Disclosure 

Disclosure or non-disclosure of medical errors has serious implications for third party payers of the costs of resulting effects. According to Mello et al. (2007), the need for hospitals to improve their safety and risk management frameworks is incentivized by the high costs of adverse effects from medical errors. An analysis of cost sharing of from adverse effects revealed that hospitals only bore 22% of the cost implying that third party payers catered for the remaining 78%. The externalization of costs of costs of adverse effects has elicited calls for legal reforms and market interventions to address the situation (Mello et al. , 2007). The findings corroborate earlier observations by Freeman et al. (1999) that many physicians sanction the use of deception to secure approval of medically indicated care from third party payers. The practice was attributed to the traditional ethic of patient advocacy that limited physicians and patient engagement. However, one can argue that some physicians to cover the costs of adverse effects from medical errors and malpractice can use such deception unethically.

The interest of third party payers in disclosure of medical errors is paralleled by long-term interest of legal scholars in the role of tort liability system in providing economic incentives towards patient safety and risk management. One of the issues advocated for that physicians and other health practitioners should worry about involves ensuring that one is covered by adequate malpractice insurance. Third party payers may harbor concerns that they are deceived to cover for errors committed by physicians. While such concerns are justified, Everett et al. (2013) established that most physicians lie for altruistic reasons rather than egoistic or self-preserving purposes that may or may not cause harm to patients, insurance companies, or physicians themselves.

The implication of such an approach is that it reflects the need for quality, safety, and risk management frameworks in relation to disclosure of medical errors. Only then can physicians feel comfortable to reveal cases of malpractice because they are covered for under insurance and practical processes for addressing the adverse effects from the error. The evidence cited herein on physician deception of third party payers can be taken as an indication of the role of insurance firms in in providing incentives to healthcare facilities and physicians towards quality and safety healthcare. Expression of willingness to insure and pay for costs of adverse effects and associated procedures and processes can incentivize disclosure of medical errors because it reduces the likelihood of lawsuit if the patient understands the cost of correcting the error would be catered for.  

Disclosure of medical errors is a sensitive concept that many stakeholders in the healthcare sector seek to avoid. Institutions and practitioners have traditionally sought to cover up occurrences of medical errors for fear of the high costs of liability and self-preserving purposes. However, increased calls for accountability in addition to demands for quality, patient safety, and effective risk management frameworks have shifted the balance, and evidence now suggests that stakeholders in the healthcare sector because of its irrefutable benefits are embracing disclosure. It is important to point out that lawsuits against medical errors are an outcome of trust issues between the patient and the physician. Where trust exists, an apology from the latter can drastically reduce the likelihood of legal action. Health agencies have taken the cue to update and improve frameworks for disclosure, drawing on evidence showing that effective approaches potentially enhance patient safety and risk management. Similarly, third party payers of claims whenever medical error cases are presented as normal procedures, should device ways of positively engaging physicians and patients to create an enabling environment for disclosure.

References

Evans, L. S. (2016). Enterprise Dispute Resolution: Full Disclosure and Early Offer Policies in the Event of an Indisputable Medical Error. Journal of Health Care Finance, 42(4).

Everett, J. P., Walters, C. A., Stottlemyer, D. L., Knight, C. A., Oppenberg, A. A., & Orr, R. D. (2011). To lie or not to lie: resident physician attitudes about the use of deception in clinical practice.  Journal of medical ethics 37 (6), 333-338.

Freeman, V. G., Rathore, S. S., Weinfurt, K. P., Schulman, K. A., & Sulmasy, D. P. (1999). Lying for patients: physician deception of third-party payers.  Archives of Internal Medicine 159 (19), 2263-2270.

Gallagher, T. H., Garbutt, J. M., Waterman, A. D., Flum, D. R., Larson, E. B., Waterman, B. M., ... & Levinson, W. (2006). Choosing your words carefully: how physicians would disclose harmful medical errors to patients.  Archives of Internal Medicine 166 (15), 1585-1593.

Jenifer, C. (2014). The risk management and full disclosure models in the United States. Retrieved March 27, 2018 from: https://prezi.com/aoshvnvfr5di/the-risk-management-and-full-disclosure-models-in-the-united/.

Kalra, J., Kalra, N., & Baniak, N. (2013). Medical error, disclosure and patient safety: A global view of quality care.  Clinical biochemistry 46 (13-14), 1161-1169.

Kohn, L. T., Corrigan, J. M., Donaldson, M. S., & To, E. (1999). To En-Is Human: Building a Safer Health System.  Washington, DC: Institute of Medicine .

Kuhn AM, & Youngberg BJ. (2002).The need for risk management to evolve to assure a culture of safety BMJ Quality & Safety 2002;11:158-162.

Loren, D. J., Garbutt, J., Dunagan, W. C., Bommarito, K. M., Ebers, A. G., Levinson, W., ... & Gallagher, T. H. (2010). Risk managers, physicians, and disclosure of harmful medical errors.  Joint Commission journal on quality and patient safety 36 (3), 101-108.

Mastroianni, A. C., Mello, M. M., Sommer, S., Hardy, M., & Gallagher, T. H. (2010). The flaws in state ‘apology’and ‘disclosure’laws dilute their intended impact on malpractice suits.  Health Affairs 29 (9), 1611-1619.

Mello, M. M., Studdert, D. M., Thomas, E. J., Yoon, C. S., & Brennan, T. A. (2007). Who pays for medical errors? An analysis of adverse event costs, the medical liability system, and incentives for patient safety improvement.  Journal of Empirical Legal Studies 4 (4), 835-860.

Moffatt-Bruce, S. D., Ferdinand, F. D., & Fann, J. I. (2016). Patient safety: disclosure of medical errors and risk mitigation.  The Annals of thoracic surgery 102 (2), 358-362.

Patient Safety Network. (2017). Disclosure of errors. Retrieved March 27, 2018 from: https://psnet.ahrq.gov/primers/primer/2/disclosure-of-errors.

Wolk, S. W., Sine, D. M., & Paull, D. E. (2014). Institutional disclosure: promise and problems. Journal of Healthcare Risk Management, 33(3), 24-32.

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