CHAPTER 40 1. Identify how an attorney may use the nursing process for litigation. 2. Define standards of care and guidelines for establishing the standard of care. 3. Define malpractice and the conditions that constitute malpractice. 4. Define concepts of liability and negligence. 5. Discuss the importance of documentation in the patient’s record and guidelines for charting. 6. Discuss the nurse’s role in informed consent. 7. Identify scope-of-practice issues in providing patient care functions. 8. Identify the risks and benefits of possessing professional liability insurance. In the past, the specialty of obstetrics was considered the “high-risk” area for malpractice suits and loss of licensure. Today litigation is not uncommon in our own area of specialization. Neonates are seen as a “special” population that is afforded extra protection (Verklan, 2012). Thus neonatal nurses must be cognizant of the minimum standards of professional conduct that they, as health care providers, must adhere to. The purpose of this chapter is to familiarize the nurse with the concepts and ramifications of legal concerns as they pertain to the realm of neonatal intensive care nursing. Topics that will be discussed include standards of care, liability, documentation, informed consent, scope of practice, and professional liability insurance. 1. Assessment: gathers data related to the neonate’s physiologic and psychosocial status. a. Vital sign records, flow sheets, and nursing progress records. b. Body and organ-system findings (e.g., cardiopulmonary findings). c. Laboratory and diagnostic reports. d. Medical progress notes. e. Intake and output. f. Progress notes from other disciplines (e.g., respiratory, social work, pharmacy). g. Information from the family. 2. Diagnosis: correctly identifies the neonate’s condition using the data obtained from the assessment step, from documents on the nursing care plan, and in the progress notes. 3. Planning: develops a plan of care that incorporates all aspects of the neonate’s condition. a. Uses a multidisciplinary approach. b. Documents interventions and anticipated outcomes for the targeted diagnosis on the nursing care plan. c. Incorporates research-based findings into practice. 4. Implementation: carries out the plan of care. b. Documents all pertinent information on the neonate’s medical record. 5. Evaluation: evaluates the neonate’s response to the plan of care as outlined by the multidisciplinary team, noting any revisions or changes to the plan. a. Implementation process is not complete without evaluating the effectiveness of the intervention. b. Communicates patient response to treatment to members of the multidisciplinary team. c. Documents pertinent findings in the patient’s medical record. d. Revises plan of care based on the patient’s response and anticipated outcomes. B. The attorney, as well as all interested parties involved in the legal process, will use the steps of the nursing process to: 1. Interpret the medical record. 2. Identify possible deviations from the standard of care. 3. Speak the same language as the nurse. 4. Generate questions that will be used to depose a nurse defendant. 5. Use the reports of expert witnesses who will outline how the nurse did or did not follow the nursing process. The standard of care outlines the minimum criteria by which proficiency is defined in the clinical area. When the standard is not specifically referred to in the state nurse practice act, it becomes a guideline for practice rather than law. In the legal system, the standard of care is established by defining what a reasonable and prudent nurse would have done in the same or similar circumstances. The issue of excellence in practice or quality of care given does not pertain to the argument—what is being sought is reasonableness and prudence. A reasonable and prudent nurse is a nurse with like education, background, and experience who would behave in a corresponding manner, given a parallel set of events. The plaintiff attorney has the burden to prove that the standard(s) do exist and that the defendant nurse failed to meet the standard(s). In addition, it is expected that the standard of care given to neonates everywhere is the same. “A neonatal nurse is a professional nurse who provides skilled nursing care for low-risk, high-risk and critically ill neonates, high-risk neonates, and their families. The neonatal nurse has specialized knowledge and develops and maintains clinical competence through standardized practice and continuing education” (Association of Women’s Health, Obstetric and Neonatal Nurses [AWHONN] and National Association of Neonatal Nurses [NANN], 1997, p. 8). “Although neonatal nurses may provide basic neonatal care, they may also focus on an area of expertise, as for example, intensive or critical neonatal care, transport, lactation, grief, extracorporeal membrane oxygenation or developmental care” (American Nurses Association [ANA], 2013; AWHONN and NANN, 1997; AWHONN, 2009). Ewing v. Aubert (1988) set out that a maternal–child nurse is held to the standard of care of a nurse practicing in the maternal–child specialty. Neonatal nurses, a subspecialty within maternal–child nursing, must be cognizant of what the professional practice standards are for that subspecialty: A nurse who practices her profession in a particular specialty owes to her patients the duty of possessing the degree of knowledge or skill ordinarily possessed by members of her profession actively practicing in such a specialty under similar circumstances. It is the nurse’s duty to exercise the degree of skill ordinarily employed, under similar circumstances, by members of the nursing profession in good standing who practice their profession in the same specialty and to use reasonable care and diligence, along with his/her best judgment, in the application of his/her skill to the case (King v. Department of Health & Hospitals, 1999). The quality of the nursing care provided is judged according to national standards, making obsolete the “locality rule.” The locality rule permitted nurses to be judged according to the standard of care evidenced by nurses working in the same geographic area, reflecting the community’s accepted practices. Recognition of national standards by professional neonatal nursing organizations and accreditation agencies is reflected in clinical policy and procedure manuals. In addition, accredited schools of nursing across the nation have similar curricula and textbooks, and nurses attend similar continuing education conferences. Thus it is expected that the professional nurse will be and remain competent and continually updated on the standards of care and practice (ANA, 2013; AWHONN, 2009). Five basic types of evidence are used to establish the legal standard of care: (1) state and federal regulations; (2) institutional policies, procedures, and protocols; (3) testimony from expert witnesses; (4) standards of professional organizations; and (5) current professional literature. These agencies establish the standards of care and scope of practice. The national standards tend to be written in broad language to permit flexibility without compromising standards to accommodate differences within each state. The standard of practice is also defined by the state nurse practice act as mandated by each state’s legislature. Here the scope of practice is delineated for each level of nursing (e.g., licensed vocational nurse, registered nurse, APN). For example, a registered nurse may not delegate the act of assessment and the formulation of a nursing diagnosis to any assistive personnel who are unqualified to perform this task (ANA, 2012). In addition, standards of nursing practice are also regulated by the state board of nursing, the department of health, The Joint Commission (TJC), and the Health Care Financing Administration, in addition to other regulatory agencies (Iyer, 2011). The hospital’s policies, procedures, and protocols also outline the standard of care. The policy establishes the purposes for performing a procedure, whereas the procedure is the guideline for how that procedure should be carried out. These guidelines must reflect the national and state standards of care, should be reviewed at least annually, and should be revised to reflect current acceptable nursing practice (TJC, 2013). In addition, these guidelines must also be (1) prepared by a qualified committee of professionals who practice in the specialty, (2) consistent with current research and practice literature, (3) archived for the length of liability, and (4) accessible to staff (Rottkamp, 2011). The policy and procedures manual should be approved by both the unit and the hospital’s nursing and medical administrations. Being unaware of the policy and procedures for the standard clinical practice at your institution is not an acceptable excuse for not being held accountable for your practice. The policy and procedures manual is often one of the first documents requested by both the plaintiff and defense attorneys because it is the best source for specific standards by which to evaluate a specific nurse’s care. Because the statutes of limitations endure for 18 to 21 years and standard care practices change dramatically across the years, keeping the policy and procedures manual will also help to determine what the standard of care was at the time the neonate was hospitalized. A nurse expert is typically required to articulate what the standard of care is or was in the situation in which the nurse has deviated from the usual and customary standard of care. A nursing expert opinion requires that the person expressing that opinion possess special skill, knowledge, and experience in the neonatal area and knowledge of the standards applicable at the time of the occurrence (Zerres et al., 2011). The judge and jury have little knowledge related to neonatal physiology, pathophysiology, and the relevant neonatal nursing care. They therefore need assistance in understanding just what a reasonable and prudent nurse would have done in the given circumstances (e.g., did the nurse meet the accepted standard of care?). Both liability and damages have to be proved in nursing malpractice cases. Thus two types of experts are usually necessary: a nurse to address the nursing standard of care and a physician to determine causation, that is, to link the breach of standard to the injuries suffered by the neonate. Professional nursing philosophies dictate that nurses be the only witnesses permitted to testify as experts outlining what the nursing standard of care is in a nursing malpractice suit. However, it is the quality of the expert’s experience and education that determines the competency and credibility of the testimony (Zerres et al., 2011). Professional associations represent the interests of nurses. The ANA has developed standards with measurable criteria that define professional nursing practice (2010) as well as neonatal nursing (2013). Specialty organizations such as the NANN, AWHONN, American Association of Critical-Care Nurses (AACN), and National Association of Pediatric Nurse Associates and Practitioners (NAPNAP) have adapted these standards to define the standards of care and professional practice guidelines applicable to the care of neonates. For example, AWHONN publishes Standards for Professional Nursing Practice in the Care of Women and Newborns (2009). Current texts and journal articles, although technically hearsay, aid in establishing the legal standard of care. A number of journals specific to the care of neonates focus on clinical, management, and research articles. Clinical articles are useful in helping to determine the applicable standard of care at the time of the malpractice suit, whereas nursing textbooks provide information related to the standard of care associated with nursing techniques and care (Iyer, 2011). Research articles are beginning to assume more importance in the legal arena because of the desire to document evidence-based practice. Evidence-based practice is defined as the incorporation of the current best evidence in clinical decision making. Increased use of websites such as Medline and CINAHL for research/clinical information have led to an increase in the critique of published literature by nurses. Hospitals holding Magnet status must demonstrate that nurses participate in research utilization or they will lose their designation. Despite this, the integration of research findings into clinical practice is slow, taking as long as 10 to 15 years. However, keeping theory and clinical practice on par with the literature and remaining current with regard to continuing education will assist the nurse in ensuring that his or her professional standards are synonymous with those of his or her peers. Standards of care are often confused with practice guidelines. Standards of care are the basis for proving that the nurse had a duty to the patient and that there was a breach of that duty. Clinical practice guidelines, with reference to the standards of care, are meant to assist the health care provider in the delivery of care in specific clinical circumstances. For example, Guidelines for Perinatal Care outlines recommendations regarding nurse providers, nursing ratios, staffing guidelines, and outreach education for inpatient perinatal care facilities providing basic, specialty, and subspecialty care (American Academy of Pediatrics and American College of Obstetricians and Gynecologists, 2012). Critical pathways are another example of a practice guideline that is modified to reflect the neonate’s clinical progress. Therefore, the difference between a standard of care and a practice guideline is that the standard always must be adhered to, whereas the guideline suggests a voluntary approach to achieve a desirable patient outcome (Iyer, 2011; NANN, 2010a). The ethical standards of nursing practice may also be the issue in a malpractice suit: The Mississippi Board of Nursing charged Terry Lynn Hanson, a registered nurse, with abuse of neonatal patients. It was noted that her clinical practices included holding a baby around its neck with only one hand, carrying babies by holding them under their axillae, carrying naked babies around the NICU and washing them in the unit’s sinks, and that she endangered the babies by rapidly flipping the levers on the incubators when attempting to stimulate them. The Board, finding her guilty on all charges, revoked her license. Nurse Hanson appealed to the Supreme Court of Mississippi, who held that her behavior constituted a reckless disregard of the health and safety of the neonates. The Court also ruled that she was negligent by holding babies under the axillae, permitting their bodies to dangle, removing them naked from incubators to bathe and weigh them in different areas of the NICU compromised thermoregulation and exposed them to risks of infection, and that overstimulation increased the risk of intraventricular hemorrhage (Tammelleo, 1998, p. 1). The term malpractice means negligence on the part of the nurse, in that she or he has violated the standards of ordinary nursing practiced by nurses of similar background in the same specialty of nursing. Malpractice is professional misconduct that may be intentional or unintentional. If the individual is acting in a personal capacity, then the individual would be subject to negligence, as malpractice is limited to the omission, lack, or misuse of a professional skill. By undertaking professional services to the patient, a nurse represents that she/he possesses, as a duty, the degree of learning and skill ordinarily possessed by nurses of good standing practicing in the same community under similar circumstances. It is the nurse’s further duty to use the care ordinarily exercised in like cases by reputable members of the profession practicing in the same or a similar locality and under similar circumstances. The nurse is to use reasonable diligence and best judgment in the exercise of her or his skills and learning in an effort to accomplish the purpose of employment. A defendant nurse must violate one of these duties before being found to have committed malpractice (Fulginiti et al., 2007, p. 1375). It must be emphasized that the nurse need possess only the knowledge and skill possessed by the average reasonable, prudent nurse and must exercise reasonable care, skill, and judgment in carrying out her or his professional work. The nurse need not be perfect or able to predict every single difficulty or uncertainty regarding the patient. However, the nurse must act in a careful or prudent fashion in the delivery of professional care while exercising reasonable care, skill, and judgment. Occasionally an unexpected situation arises so quickly that one’s actions on hindsight may not be considered to have been the perfect course of action. A mistake in judgment is not considered malpractice: A mistake in judgment on the part of the nurse is not evidence of negligence. If a nurse possesses reasonable and ordinary skill and uses care ordinarily used in like or similar situations by nurses of reasonable and average skill, practicing in the community at the time in question, she/he is not guilty of negligence even though her/his judgment may be subsequently proven incorrect. (Fulginiti et al., 2007, p. 1375) Today nurses are recognized as professionals who are responsible and accountable for the care they give to their patients. If the nurse is liable to the patient because of negligent conduct, that nurse can be held legally responsible for the harm caused to that patient (Verklan, 2012). Harm must result from the act, because without damage, no legal wrong has been committed. Baby R was born after a difficult labor including the presence of meconium and episodes of hypoxia. Routine orders for the admission were given despite the presence of risk factors for hypoglycemia. Over the next three hours of life, the baby’s glucose values decreased from 104 mg/dL to 28 mg/dL. The nurse fed the baby, but did not notify the physician. The neonate continued to experience hypoglycemia throughout the night. The glucose level increased to normal parameters after a feeding in the morning. The physician examined the baby shortly after the feeding, noting that she was at risk for hypoglycemia. No further orders were given such as the need to begin intravenous glucose. A neonatologist was not consulted. Later that day profound hypoglycemia was evidenced by seizure activity. Nursing did not notify the physician of the seizure activity until later in the evening when the seizures became worse. The physician returned to the nursery and examined Baby R. Once the seizures were observed, the baby was transferred to another hospital. The hospital settled for $1.75 million prior to trial (Laska, 2005). The plaintiff, the party bringing the suit, must prove the following four elements in a malpractice case: 1. The nurse had a duty to her or his patient. 2. There was a breach of that duty. 3. Harm or damages did occur to the patient. 4. Breach of that duty resulted in harm (proximal cause). An infant, born in a depressed state, had Apgar scores of 3 and 8 at 1 and 5 minutes, respectively. Although his condition was improving, he continued to have raspy breathing that required suctioning. It was alleged that the defendants failed to provide adequate special care and observation, causing the baby to suffocate on its own secretions. The neonate was discovered in a cyanotic state two hours after birth. Resuscitative techniques restored the heartbeat in eighteen minutes. He was transferred to another hospital, declared to be brain-dead, and was removed from life support four days later. The plaintiff claimed that resuscitation was both delayed and improperly performed. The defendants argued that the baby appeared normal, that the cause of the respiratory arrest was unknown, and that inborn errors of metabolism caused the death. They also countered that failure to respond to resuscitation does not imply negligence (Du Page County [IL] Circuit Court, Case No. 94 L-318 [Laska, 1997]). In this case the plaintiff proved that the defendant owed a duty to the neonate, in that the baby and his parents should expect the care received to be at least equal to the standard of care. However, the plaintiff was not able to prove that the defendant breached the duty (failure to respond to resuscitation does not imply negligence) or that there was proximal cause (inborn errors of metabolism may have contributed to or caused the injury). Thus, despite the neonate’s death (damages), a malpractice suit cannot be won if all four elements are not present. A. The costs of liability when a neonate is involved are high for three reasons: 1. The costs of health care for a damaged infant with a normal life expectancy are high. 2. The longer statute of limitations for minors may permit charges to be made years later, applicable to other medical malpractice actions. 3. There is sympathy toward the family, who may not be able to afford the needed care for the child, as opposed to the deep pockets of a corporation, who may be seen as uncaring and will not miss the money anyway. B. Although an individual nurse is accountable only for his or her own practice, there are three additional theories of liability that may be pursued against a facility or its management (Lewis and Krulewicz, 2011; Rottkamp, 2011): b. Holds the institution responsible for ensuring that the policies and procedures meet the standard of care, and that employees follow these policies. c. Will not impose liability in most circumstances on a nursing supervisor for negligent acts of the nursing personnel he or she is supervising. This responsibility rests with the person who makes changes in the policies and procedures. d. Obligates the nursing supervisor to ensure that the licensed and unlicensed nursing personnel under his or her supervision are able to provide patient care safely. If the supervisor does not document the personnel’s deficiencies and use the chain of command, she or he can be held liable for any damages that befall a patient. e. Holds that negligent employees are always liable for their own conduct. 2. Corporate negligence holds the institution’s management and board of trustees liable for any breach of their duties: b. An equipment standard must be implemented. (1) The institution must have a management plan documenting competency validation for the proper use of medical equipment by the institution’s employees (TJC, 2013). (2) The institution may also name the equipment manufacturer as a third-party defendant in an attempt to shift the blame (Verklan, 2012). Shortly after birth, Baby Wright’s blood pressure decreased, necessitating a transfer to the Special Care Unit. Dr. Bloom ordered a bolus of normal saline (unconcentrated) to be given over 30 minutes. Nurse Diltz offered to prepare the bolus. The hospital stocked both the unconcentrated and the concentrated normal saline solutions in the same place. Nurse Diltz obtained a vial of the concentrated sodium chloride, that had “CONCENTRATE” and “CAUTION: MUST BE DILUTED FOR I.V. USE” in large red letters. There was also a written warning in red letters that the fluid was a 14.6% solution. Nurse Diltz did not read the physician’s order nor did she note the label on the sodium chloride vial. The fluid bolus was subsequently administered to Baby Wright. After the second bolus, Baby Wright suffered severe brain damage. The Wrights sued Abbott Laboratories, the suppliers of the concentrated sodium chloride solution. Abbot never sent a warning letter to the hospital despite the Food and Drug Administration’s warning to change the labeling and package inserts for the concentrated and unconcentrated normal saline products. The plaintiffs argued that Abbott had a duty to warn the hospital about the dangers of inadvertent administration of the wrong solution and that the failure to warn the hospital was the proximate cause of Baby Wright’s brain injury. The court granted summary judgment for Abbott (not guilty). It also found the hospital and its staff should have been aware of the dangers of stocking the look alike products together, and therefore, Abbott Laboratories did not have a duty to warn the hospital of the risk. The Court also found that had Nurse Diltz simply read the physician’s orders and the label on the vial, the concentrated solution would not have been given (Wright v. Abbott Lab., 2001).
Legal Issues
NURSING PROCESS
STANDARD OF CARE
State and Federal Regulations
Institutional Policies, Procedures, and Protocols
Testimony From Expert Witnesses
Standards of Professional Organizations
Current Professional Literature
Further Issues: Practice Guidelines and Ethical Standards
MALPRACTICE
LIABILITY
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