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The recent expansion of healthcare ethics to evidence based research practice aims to address patient safety issues surrounding medical treatment an intervention. The “nature, behaviour and consequences of patient safety incidents and their surrounding circumstances” are a longstanding concern, and one which has the potential to cost healthcare institutions exceptional levels of expenditure in medical malpractice damages.
The World Health Organization (WHO) policy outlined in Ethical Issues in Patient Safety: Interpreting Existing Guidance covers the framework to ethical practice in medicine (WHO, 2013). Research inquires directed at resolving ethical challenges in contemporary policy and procedure (i.e. informed consent), inform WHO’s mandate for a globally recognized, universal agreement on ethical principles in healthcare best practices.
A key issue to emerge from evidence based research relates to the ethical principle of ‘beneficence’ in respect to identification of physician errors identified in studies of recorded clinical practice (WHO, 2013). The most critical rule element within medical malpractice law, physician intent is an important indicator of risk to patients. WHO asks the critical question: what implication does the principle of ‘respect for persons’ have on legal analysis of patients’ and professionals’ behaviour?
WHO ethics committee review of medical malpractice errors in deviation from rule adherence in practice illustrates the recommended approach to investigation of gaps in patient care and patient safety in healthcare institutions. The emergence of a patient safety movement coinciding with this trend in international and national healthcare policy reform reveals that implementation of universal risk management protocols in hospital organizations and clinical settings to manage medical malpractice complaints is only a partial solution to liability.
Negligence by hospital institutions and medical malpractice is one of the leading causes of fatality in the United States. Imposition of U.S. tort laws enacted to protect patients from harmful wrongdoing as result of professional negligence, provide rule framework to healthcare institution policy. Medical malpractice incidences are a legal liability, often resulting in deep pockets litigation. For this reason, the rise of patient safety as a priority topic within healthcare policy has had important impact on professional interpretation of a tortious duty to a reasonable standard of care.
In Showalter (2008) The Law of Healthcare Administration in depth analysis is given the landscape of medical malpractice law in the United States. Tort laws on negligence and liability (i.e. Battery) are examined as the framework to institutional and national policies and rules to conduct. Showalter explores the complications to the rule of professional negligence, and looks at how healthcare workers, by act or omission, face ethical and legal dilemmas in the practice setting.
Relevant to the discussion is the role of ‘expert witnesses’ within evidentiary proceedings in court. Medical expertise by licensed physicians serving as ‘witnesses’ provide knowledge about the principles, best practices and standards applied on the job. Professional duty to care, including informed consent, is the axis from which all deviations from accepted standards of practice in the medical community are judged.
Informed consent for treatment may only be permissible where all parties involved in the agreement have the mens rea, or mental capacity to participate in a bi-lateral agreement through mutual assent. A contract law matter from the outset, the case of June and the declined feeding tube is risky due to potential violation of patient consent.
Violation of doctor-patient agreements and subsequent intervention where a patient has attempted to rescind contractual consent is the major complaint to medical malpractice suits. Strict adherence to the informed consent law will mitigate physician obligation to such complaint, and especially where it has been determined that: 1) the intervention is an ‘emergency’ as the patient will surely die if not treated immediately; and 2) the patient, while admitted in the clinical setting, has been observed as incapacitated (Showalter, 2008). Cause-in-fact of physician responsibility for medical errors may be decided in court for this reason.
The Patient Safety Movement
The patient safety awareness education campaign to follow the Institute of Medicine's (IOM) landmark report, To Err Is Human has prompted healthcare policymakers and institutional stakeholders to revaluate patient safety programs. Otherwise known as the Patient Safety Movement, IOM’s leadership has led to new benchmark reporting of routine performance by hospital and other clinical care staff (Hatlie, 2004). Aligned with the National Patient Safety Foundation (NPSF), the IOF supports healthcare consumers in their advocacy for better safety conditions.
Consumer equity in patient safety reform agendas now place emphasis on patients as partners in the movement for a risk-free healthcare sector. Authentic patient-centered goals in advocacy for patient decision in policy and safety programs are part of the series of actionable objectives driving the movement (Hatlie, 2004). The non-profit group, Consumers Advancing Patient Safety (CAPS) offers six (6) goals to ensure patient-centered safety proceeds as a priority in U.S. healthcare policies and institutions and to inform global progress in patient safety (Hatlie, 2004):
Goal #1: Establish a national Patient Safety Authority;
Goal #2: Create local Patient Safety Advisory Boards in every community;
Goal #3: Institute a non-punitive national patient safety learning/reporting system;
Goal #4: Establish a national education effort on patient safety for providers and consumers;
Goal #5: Develop a national patient safety awareness campaign that emphasizes partnership, trust, and open communication;
Goal #6: Provide just compensation for patients who are harmed and alternatives to litigation for obtaining it.
CAPS national response mirrors WHO’s response in mandate of ethical practices in patient safety, and reflects the general direction in healthcare policy reform.
The Patient Bill of Rights provides seven (7) covenants which guide the doctor-patient relationship: 1) To safe, considerate and respectful care, provided in a manner consistent with patient beliefs; 2) To expect all communications and records pertaining to patient care will be treated as confidential to the extent permitted by law; 3) To know the physician responsible for coordinating patient care; 4) To receive complete information about diagnosis, treatment, and prognosis from the physician, in terms that are easily understood; 5) If it is medically inadvisable to provide such information, it will be given to a legally authorized representative; 6) To receive information necessary for you to give informed consent prior to any procedure or treatment, including a description of the procedure or treatment, any potential risks or benefits, the probable duration of any incapacitation, and any alternatives; and 7) Exceptions will be made in the case of an emergency (NIH, 2010).
Informed consent of patients required under U.S. law in treatment intervention of admitted parties by healthcare practitioners is part of the nation’s tort law framework. Informed consent is a standard policy in all healthcare institutions toward the: 1) protection of patients’ rights; 2) foreseeability of all information and forthcoming treatment of a patient; 3) forewarning according to the negligence rule; up to the point 4) that physician immunities are secured. Informed consent is a physician’s professional duty to a reasonable standard of care.
Agents and other third parties may be involved as principals in the decision; and may affect ‘reasonability’ of incompetent patient parties and their informed consent decisions, yet this has no impact on physician responsibility to patients (American Cancer Society, 2010, Showalter, 2008). The Doctrine of Apparent Agency, a rule element to commercial contract law, may be referred to within court decision in some states and allows separation and regulation in relationships between parties defined as: 1) Agents and Principals (i.e. physician/parents v. ex-husband); 2) Agents and the Third Parties with whom they deal on their Principals' behalf; and 3) Principals and the Third Parties when the Agents purport to deal on their behalf (Showalter, 2008).
The four (4) elements to the common law Negligence rule respective to informed consent and subsequent medical malpractice complaint involve physician responsibility that: 1) There must be a duty of care owed to the patient; 2) The physician must fail to meet the standard of care reasonably to be expected in the circumstances; 3) The patient must suffer harm; and 4) The physician’s shortcoming must be causally related to the harm (Staunton and Chiarella, 2007).
Criticism of the Movement
Stark criticism of the legal inviolability of the terms to patient safety and the parameters of reasonability as part of patient informed consent rules and practice illustrate the gap between awareness of risk; and the terms and conditions to physician’s immunity in spite of arguments over “intent” during intervention. In addition to the negligence rule enforced as part of informed consent practice, physicians are also accountable to ’Erosion of Captain-of-the-Ship and Borrowed-Servant Doctrines;’ where medical authority in healthcare institutions may be personally held responsible in cases where patients no longer show that they are equipped to make ‘reasonable’ decisions on their own behalf (Showalter, 2008). Here, the physician is not necessarily protected by emergency rule immunities, and is subject to potential review if ‘duty to a reasonable standard of care’ is called into question. In such case, medical malpractice litigation, followed by alleviation of guilt is likely.
Ethical Issues in Patient Safety: Interpreting Existing Guidance (2013). World Health Organization. Retrieved from: http://apps.who.int/iris/bitstream/10665/85371/1/9789241505475_eng.pdf
Hatlie, M.J. (2004). Consumers and the Patient Safety Movement: Past and Future, Here and There. Patient Safety & Quality Healthcare Oct/Dec 2004. Retrieved from: http://www.psqh.com/octdec04/consumers.html
How is shared decision-making different from informed consent? (2010) American Cancer Society. Retrieved from: http://www.cancer.org/Treatment/FindingandPayingforTreatment/UnderstandingFinancialandLegalMatters/InformedConsent/informed-consent-shared-decision-making
Patient Bill of Rights (2010). NIH. Retrieved from: http://www.cc.nih.gov/participate/patientinfo/legal/bill_of_rights.shtml
Patient’s Guide to the HIPAA Privacy Rule (2010). The U.S. Department of Health and Human Services (DHHS). Retrieved from: http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/consumer_ffg.pdf
Showalter, J.S. (2008). The Law of Healthcare Administration. Chicago, IL: Health Administration Press.
Staunton, P. and Chiarella, M. (2007). Nursing and the Law, 6th Edition. Chatswood: Elsevier Australia Pty. Ltd.
World Health Organization (WHO) (2004). Patient Safety. Retrieved from: www.who.int/patientsafety/en/