Legal, regulatory, and ethical issues

Chapter 3


Legal, regulatory, and ethical issues



Chapter objectives


After studying this chapter, the learner will be able to:


• Define negligence as it applies to caregivers.


• Discuss informed consent.


• Describe the importance of patient care documentation.


• List several methods of documentation of patient care.


• Identify three potential events that could lead to litigation.


• Describe the role of TJC in the promotion of patient safety.



Key terms and definitions



Advance directive 


Document that indicates wishes concerning health care and usually designates someone to make decisions if the patient is unable to do so for self.


Autonomy 


Self-government or independence.


Causation 


Action directly or indirectly causing an injury.


Consent 


Voluntary, autonomous permission to proceed with an agreed-on course of action.


Damages 


Compensation awarded to make restitution for an injury or a wrong.


Defendant 


Person named as the object of a lawsuit.


Deposition 


Statement given under oath that is a documentation of fact used in a court of law.


Iatrogenic 


Injury or illness caused by professional intervention of a health care provider.


Indicator 


A measured increment of performance, process, system, or outcome.


Liability 


Legally responsible for personal actions.


Malpractice 


Substandard delivery of care that results in harm.


Near miss 


An event or situation that just by chance did not cause patient injury. A very close call.


Negligence 


Careless performance of duty.


Plaintiff 


Person who initiates a lawsuit.


Proximate cause 


An act of commission or omission by one or more persons that caused a consequence to another.


Root cause analysis 


The baseline reason for the occurrence of failure in a process or system.


Sentinel event 


An unexpected occurrence that involves physiologic or psychologic injury or death. This occurrence signals the need for appropriate reporting and documentation, immediate investigation, and response.


Systems approach 


A global attitude of improvement and safety that encompasses involvement of individuals and the organization at all levels. Adverse events are attributed not only to individuals but also failure of the interaction of the individual and the organization.


Tort 


Wrong committed by one person against another; civil action.



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Competent patient care is the best way to avoid a malpractice or negligence claim. Unfortunately, even under the best of circumstances, a patient may be injured and recover monetary damages as compensation. Understanding how a liability action starts and how it proceeds is important in the effort to avoid the many pitfalls that can lead to being named and successfully sued in a lawsuit.


Caregivers should consider that liability is not the only rationale behind competent care. The main focus should be the desired outcome for the patient and the exemplary delivery of care. Performing in a particular manner merely to avoid being sued is not an ethical practice.



Legal issues


Inherent in professional practice is the duty to safeguard the safety and rights of patients. The patient is at risk for harm during any surgical procedure. These factors also may present health care providers with ethical dilemmas that are complicated by legal issues. Respect for the patient’s autonomy and the patient’s right to make informed decisions about his or her own health care should be considered and balanced by the professional obligations of beneficence (the duty to benefit) and nonmaleficence (not to harm).


Any caregiver can be named in a lawsuit. Being named in a suit does not mean that you have been successfully sued and does not always mean you are liable for anything. Attorneys frequently name everyone involved with the patient in the suit as part of the fact-finding process for building the lawsuit. When in doubt about personal competency for a new or unfamiliar procedure or piece of equipment, seek guidance from the clinical educator or immediate supervisor.


Regardless of who is in charge of the team, each team member is responsible for his or her own actions. When performing duties within the scope of practice and according to facility policy and procedure, the risk of being successfully sued in a malpractice or negligence suit is very limited. Honest mistakes can result in patient injury. If a suit is brought to court, a jury can evaluate a reasonable set of circumstances, facts, and testimony to render a verdict in favor of the caregiver. The plaintiff does not always win. If the verdict is found in favor of the plaintiff, the damages awarded may be for compensatory award. Many states have set limits on the amount of money that can be awarded by the court.


The quality of health care is assessed through the outcome of services rendered. If the outcome is unacceptable, patients tend to take grievances to court. The severity of an injury usually determines whether a claim of merit will arise, but other contributing factors include a breakdown of rapport between the patient and the health care team members and unrealistic expectations about the outcome of care.


Causes for litigation lie in patients’ and their families’ belief that physicians and/or health care organizations have not provided appropriate diagnosis, treatment, or results. Although the physician is professionally responsible for patient care, other patient care personnel act as part of the health care team, carrying responsibility for their own actions. Medical and surgical sales personnel and suppliers of equipment and drugs also are indirectly involved in treatment and may be held responsible for product liability.



Liability


To be liable is to be legally bound and responsible for personal actions that adversely affect another person. Every patient care provider should always carry out duties in accordance with standards and practice guidelines established by federal statutes, state practice acts, professional organizations, and regulatory agencies, as well as those that are common practice throughout the community. Deviation from these standards and practices that cause injury to a patient can result in liability for negligence or malpractice. For this type of civil suit to be successful for the plaintiff, he or she has to prove that negligent care or malpractice caused the injury.


Negligence is the failure to use the care or skills that any caregiver in the same or a similar situation would be expected to use. These acts of omission or commission that cause damage to a patient may give rise to tort action, which is a civil lawsuit.


Malpractice is any professional misconduct, unreasonable lack of skill or judgment, or illegal or immoral conduct. Malpractice and negligence claims usually are settled in a civil court; however, depending on the severity of the injury and the extent of the misconduct, they may be taken to criminal court. From the legal point of view of damages or fault, professional negligence is often synonymous with malpractice in a tort action. Factors contributing to a successful lawsuit on behalf of the plaintiff have been called the “four D’s of malpractice”:



Statutory laws (laws by legislation) and common laws (laws based on court decisions) differ from state to state. Courts differ at times in their interpretation of laws. Any caregiver who is in some manner thought to be responsible for injury to a patient may be sued. The nurse manager or clinical educator responsible for assigning duties to this individual may be included in the suit if delegation and supervision are in question.


Caregivers, such as nurses, technologists, and technicians are considered employees of the health care facility. The facility is almost always named in the suit as being ultimately responsible for hiring, monitoring credentials, evaluating, and disciplining their employees.


The court may rule that a learner or an experienced practitioner is liable for his or her own acts. A learner may be held responsible for independent actions in proportion to the amount and type of instruction received and judged by the standard of other learners in training. An instructor can be named with the learner as partially liable.


Medical care and professional liability have become institutional problems. The primary cause of professional liability claims is iatrogenic medical injury—an injury or other adverse outcome sustained by a patient as a result of treatment. Many incidents in the perioperative environment have been causes for a lawsuit.



Liability prevention for the facility and the team


Complex technologies, acuity of hospitalized patients’ conditions, short-stay procedures, diverse roles of providers, inadequacy of staffing numbers, and other factors present challenges in managing risks of liability. Many surgeons restrict their practices to avoid patients who have complex diseases or who are at high risk of uncertain outcomes. Others practice defensive medicine, ordering tests principally to protect themselves against possible litigation. Because lawyers have become increasingly sophisticated in representing injured patients, all health care providers need to take measures to protect themselves from litigation. A preventive strategy includes the following:



• Become active within the professional organizations associated with setting the standards for practice. Most organizations provide up-to-date education and resources for improvement of practice. Have a voice in shaping the future of the profession.


• Remain current with continuing education. Become certified, and maintain the credential.


• Establish positive rapport with patients. Patients are less likely to sue if they perceive that they were treated with respect, dignity, and sincere concern. Patients have the right to accurate information and good communication.


• Comply with the legal statutes of the state and standards of accrediting agencies, professional associations, and the health care facility policies.


• Adhere to the policies and procedures of the facility. Seek a position on the policy and procedure committee in order to have a say in the formation and revision of facility practices.


• Document assessments, interventions, and evaluations of patient care outcomes. Leave a paper trail that is easy to follow for the reconstruction of the event in question.


• Prevent injuries by adhering to policies and procedures. Shortcuts can be hazardous to the patient and team members.


• If an injury occurs, control further injury or damage by reporting problems and taking corrective action immediately.


• Maintain good communications with other team members.


• In addition to these strategies, the facility as the employer and the caregiver as the employee should take steps to avoid liability. The facility protects the patient, its personnel, and itself by maintaining safe and well-defined policies and procedures based on national standards and recommended practices.



Liability insurance


Formerly it was thought that patients did not sue nurses and other patient care providers because they had no large assets. Unfortunately, this is no longer true. Increased autonomy increases the risk for liability. Perioperative nurses make independent nursing decisions based on their assessments, and they can carry out and/or delegate certain patient care interventions without a physician’s order. No matter how careful the caregiver is, mistakes can happen. An unintentional wrong may cause injury to a patient.


Most facilities carry insurance that covers incidents that result in harm to a patient when policies and procedures are followed; however, they may not cover the employee who fails to follow the established protocol. In some instances the facility’s insurance may not adequately cover all of the expenses associated with a lawsuit, such as a private attorney and lost wages during suspensions and trial.


The caregiver who accidentally caused the injury may be named in the suit as an individual or as a codefendant. Carrying personal liability insurance protects against a possible discrepancy with the facility’s insurance coverage and provides the employee with the opportunity for representation by a personal attorney.


A professional liability policy can be individualized to meet the practice of the insured. The policy costs are tax deductible and the protection of personal assets and wages may well be worth the price of the coverage. Professional associations recommend individual professional liability insurance and frequently offer discounts to members.



Borrowed servant rule


In the past the surgeon was considered the captain of the ship in the perioperative environment and was liable for the negligent acts of servants. In the early 1940s and 1950s, courts held that this doctrine, based on the master–borrowed servant relationship, was applicable by the mere presence of the surgeon. Once having entered the OR, the surgeon was considered to have complete control over other team members. But courts now recognize that the surgeon does not have complete control over the acts of the perioperative patient care team at all times.


Each member of the team has significant performance autonomy. The surgeon usually is not held responsible when a perioperative caregiver fails to carry out a routine procedure as expected. Courts have decided that certain procedures do not need to be personally performed by the surgeon, such as counts or mixing medications on the sterile field. According to the borrowed servant rule, the surgeon is liable for acts of team members only when he or she has the right to control and supervise the way in which a perioperative caregiver performs the specific task. A good example of this is counting sponges, sharps, and instruments. The facility, not the surgeon, establishes the mechanism by which the employee team accounts for items used during a procedure. The surgeon does share some liability if he or she prohibits or prevents the team from accomplishing this task. If this is the case, the circulating nurse should clearly document the surgeon’s refusal to permit counting in the medical record and report to the immediate supervisor.



Independent contractor


The employer may be held responsible for employees under the master-servant rule. However, the current trend is to hold an individual responsible for his or her own acts under the principle of the independent contractor. For example, a private scrub person, biomedical technologist, or first assistant may contract with several surgeons to provide services on a fee-for-service basis. These individuals are not directly employed by the facility but are usually credentialed and given permission to work with the surgeon by the medical staff department. Some questions may arise concerning the level of responsibility of the facility for credentialing someone who is accused of substandard practice. The facility will be named in the suit initially but may be dropped at a later date.


In 2006, the Joint Commission (TJC) determined that the facility that permits independent contractors such as private first assistants, interns, residents, or other privately engaged personnel is responsible for specific standards associated with accountability. These standards are as follows:




Doctrine of the reasonable man


A patient has the right to expect that all patient care personnel will use knowledge, skill, and judgment in performing duties that meet standards exercised by other reasonably prudent professionals involved in similar circumstances.


Whenever a mishap occurs in patient care, the cause of the event is compared with local and national standards of care. Experts are consulted by attorneys and the mishap is studied. The results should show whether the same event performed by someone else of the same or similar education and role would have had the same result under the same or similar circumstances. This is how the courts determine the reasonableness of a caregiver’s actions. An example of this might be how drugs are administered. The average nurse in average circumstances would check and recheck to be sure the right patient gets the right drug. A careless nurse might omit checking the patient’s ID and administer the wrong drug. This would be considered unreasonable and would be a source of liability.



Doctrine of res ipsa loquitur


Translated from Latin, res ipsa loquitur means “the thing speaks for itself.” Under this doctrine, the courts allow the patient’s injury to stand as inference of negligence. The defendant has to prove that he or she did not act negligently. Before this doctrine can be applied, three conditions must exist:



This doctrine applies to injuries sustained by the patient while in the perioperative environment, such as a retained foreign object (e.g., sponge, towel, needle, other instrument), a fall, or a burn. The defendant must prove that a breach did not occur and that he or she was not negligent.



Doctrine of respondeat superior


An employer may be liable for an employee’s negligent conduct under the respondeat superior master-servant employment relationship. This implies that the master will answer for the acts of a servant. If a patient is injured as a result of an employee’s negligent act within the scope of that employment, the employer is responsible to the injured patient. The patient may name both the facility and the employee in a civil suit, but the employee may be dropped from the suit if he or she was following facility policy and procedure and acting within the appropriate scope of practice.


A facility may have outdated practices or unsafe procedures. One example might be the labelling of drugs on the sterile field. Instead of requiring the name and dose of the drug to be written on the sterile container and the syringe, the facility may permit the scrub person to place the cap of the syringe into the medicine cup containing local anaesthetic to signify the contents of both the syringe and cup. This is a practice that was in effect in some facilities up to a few years ago. It is clearly an unsafe practice to require a scrub person to manage drugs on the sterile field in this manner. The facility would be found liable for this action if it required the employee to perform at this unacceptable level.



Doctrine of corporate negligence


Under the corporate negligence doctrine, the facility may be liable not for the negligence of employees but for its own negligence in failing to ensure that an acceptable level of care is provided. The facility has a duty to provide services and is responsible for the following:



Corporate negligence includes the use of personnel who are inadequately trained for the position they hold. The Alabama Supreme Court found HealthTrust, Inc. liable for permitting a surgical technologist to perform in the role of first assistant at Crestwood Hospital in 1997 (Cantrell v. Crestwood). The surgical technologist was holding a retractor during an open hip procedure on a pediatric patient and permanently injured the sciatic nerve. Her leg is disfigured, and she has undergone multiple failed surgeries to restore function. The surgeon was not found liable for the acts of the facility’s employee.



Extension doctrine


If the surgeon goes beyond the limits to which the patient consented, liability for assault and battery may be charged. This doctrine implies that the patient’s explicit consent for a surgical procedure serves as an implicit consent for any or all procedures deemed necessary to cope with unpredictable situations that jeopardize the patient’s health. By medical necessity and sound judgment, the surgeon may perform a different or an additional surgical procedure when unexpected conditions are encountered during the course of an authorized surgical procedure (e.g., finding an abscess near the target organ or finding a tumor extended into adjacent structures).


The surgeon may extend the surgical procedure to correct or remove any abnormal or pathologic condition under the extension doctrine. The court will determine whether the patient consented to a specific procedure or generally to surgical treatment of a health problem. The surgeon may not routinely remove the appendix or gallbladder during a tubal ligation.




Invasion of privacy


The patient’s right to privacy exists by statutory or common law. The patient’s chart, medical record, videotapes, x-rays, and photographs are considered confidential information for use by physicians and other health care personnel directly concerned with that patient’s care. The patient should give written consent for videotaping or photographing his or her surgical procedure for medical education or research. The patient has the right to refuse photographic consent.


The patient has the right to expect that all communications and records pertaining to individualized care will be treated as confidential and will not be misused. This includes the right to privacy during interview, examination, and treatment. The surgery schedule bearing the names of the patients should not be posted in a location where the public or other patients can read it.


Some patients, such as celebrities, may request to be admitted with an alias. Care is taken when identifying these patients so that they will not be confused with other patients and receive the wrong procedure. Community hospitals may be admitting people from the surrounding neighborhood. The caregiver may be in a position to learn private information about a neighbor. Maintaining the confidentiality of patient information is imperative. Every health care worker has a moral obligation to hold in confidence any personal or family affairs learned from patients. Many facilities have implemented confidentiality agreements with all health care personnel on the premises. Schools for surgical personnel require students to sign confidentiality agreements before going to a clinical site. An example of a college confidentiality agreement can be found at http://evolve.elsevier.com/BerryKohn.



Health insurance portability and accountability act (HIPAA)


HIPAA was published in the Federal Register in 2003 and the final rule took effect in April 2005. This act provides for confidentiality of health data involved in research or transmitted and stored by electronic or any other means. The release or disclosure of this protected health information (referred to as PHI) requires patient authorization. HIPAA covers far more than PHI—it covers fingerprints, voice prints, and photographic images.a


When a victim of crime or a perpetrator is in a healthcare facility, both have the right to privacy. Caregivers may not speak to news media or any other person concerning either individual. If a crime is discovered by a caregiver the information must be reported to an appropriate supervisor. At no time is a caregiver to make a promise of secrecy to a suspected perpetrator.



Abandonment


Abandonment consists of leaving the patient for any reason when the patient’s condition is contingent on the presence of the caregiver. If the caregiver leaves the room knowing there is a potential need for care during his or her absence, even under the order of a physician, the caregiver is liable for his or her own actions.


In Czubinsky v. Doctor’s Hospital, the surgeon ordered the circulating nurse to leave the room to help him start another procedure. During the circulating nurse’s absence, the patient had a cardiac arrest. The only team members on hand were the anesthesia provider and the surgical technologist. At the trial, the circulating nurse admitted to knowing that it was wrong to leave the patient because of his condition but left because of the surgeon’s insistence. The expert witness testified that the circulating nurse should not have been ordered away from the patient to work in another room. The court decided that if adequate help for resuscitation had been available in the OR during the patient’s crisis, he would not have suffered permanent brain damage, which occurred because of this breach of duty. According to the court, the circulating nurse had a duty to remain with the patient.


If an event necessitates leaving a patient, it is important to transfer care to another caregiver of equal status and function. In uncontrollable circumstances, the perioperative manager should be consulted immediately. The patient must not be left unattended. No one, not even a physician, may release a caregiver from a responsibility to a patient. A child or disoriented patient left alone or unguarded in a holding area, for example, may sustain injury by an electric shock from a nearby outlet or by some other hazard within reach. The circulating nurse may be considered negligent by reason of abandonment for failure to monitor a patient in the OR. The circulating nurse should be in attendance during induction of and emergence from anesthesia and throughout the surgical procedure to assist as needed.



TJC and sentinel events


Professional accountability requires professionals to monitor performance as it applies to patient outcomes. The identification of an undesired outcome may be the result of direct or indirect actions of the caregiver. Such an outcome is referred to as a sentinel event—an unexpected event that involves a risk for or the occurrence of death or serious physical or psychologic injury. Serious injury specifically includes loss of limb or function. The term sentinel was selected to represent the concept because the seriousness of the event requires immediate investigation and response. These events have a significant effect on patient outcomes; they should be evaluated for root cause, and a plan to prevent its occurrence should be prepared.



Root cause analysis


TJC developed and approved a list of sentinel events that should be voluntarily reported and other events that need not be reported (Box 3-1). The TJC publication Conducting a Root Cause Analysis in Response to a Sentinel Event has been made available to institutions as a guideline for investigating the causes of sentinel events. The objective is to improve the system that has permitted the error to occur. Guidelines include a fill-in-the-blank questionnaire to help track the cause of the event.



BOX 3-1   Reportable and Nonreportable Sentinel Events Identified by TJC


Reportable




• Any event that results in the loss of life or limb (e.g., death, paralysis, coma) associated with a medication error


• Suicide of a patient within 72 hours of being in an around-the-clock care setting


• Elopement or unauthorized departure of an individual from an around-the-clock care facility that results in suicide or homicide or permanent loss of function


• Abduction from a care facility


• Rape


• Discharge of an infant to the wrong family


• Hemolytic transfusion reaction involving the administration of blood or blood products having major blood group incompatibilities


• Surgery on the wrong patient or the wrong body part


• Intrapartum maternal death related to the birth process


• A perinatal death unrelated to a congenital condition in an infant weighing more than 2500 g


• Assault, homicide, or other crime resulting in patient death or a major permanent loss of function


• A fall that results in death or major permanent loss of function as a direct result of the injuries sustained


• Hemolytic transfusion reaction involving incompatible blood


• A retained foreign object from surgery



Adapted from The Joint Commission: Accreditation committee approves examples of voluntary reportable sentinel events, 4:1998.


The guidelines suggested by TJC allow each facility flexibility in determining the root causes for events specific to the environment. Using flowcharts, the facility can identify one or more of these root causes. Each facility is encouraged but not required to report sentinel events to TJC. Other sources, such as the patient, a family member, or the media, may generate the report. If TJC becomes aware of an event, the facility is required to perform a root cause analysis and action plan or other approved protocol within 45 days of the event. A TJC glossary of sentinel event terminology can be viewed at www.TheJointCommission.org.



Institutional reporting of sentinel events


The Patient Safety and Quality Improvement Act of 2005b encourages a culture of safety in the health care system. TJC indicates that mistakes are minimized by designing systems that anticipate and possibly prevent human error.c Each procedure has inherent safety risks that are not always apparent. These tend to surface when systems thinking is not foremost in the procedure development process.


The 2005 act references data that show the incidence of reporting to be more accurate when done on a voluntary basis rather than when reporting is mandatory. Health care facilities have requested protection for reporting information because in order to rework the system the faults need to be known. This is the main way of studying problems and finding solutions for improved performance. Many states have adopted the National Quality Forum’s (NQF) list of 28 adverse events as the foundation for mandatory adverse event reporting.d In 2004, Minnesota was the first state to adopt the adverse events list as mandatory to report. In the first year of mandatory reporting, surgical adverse events were the highest reported of all the categories by early 2006. Other states have followed by implementing reporting systems and including additional categories of adverse events that are mandatory to report. For additional information about the NQF adverse event list, go to www.qualityforum.org.



National patient safety goals (NPSGS)


Universal Protocol is incorporated into the sixteen National Patient Safety Goals implemented in July, 2010 by the Joint Commissione (Fig. 3-1). The following Joint Commission accreditation statements incorporate NPSGs’ language to prevent wrong patient, wrong site, and wrong surgery events as part of Universal Protocol:


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FIG. 3-1 The Joint Commission poster for the Universal Protocol. (From The Joint Commission: Speak up initiatives, available at www.jointcommission.org/speakup.aspx.)

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Apr 6, 2017 | Posted by in GENERAL SURGERY | Comments Off on Legal, regulatory, and ethical issues

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