CHAPTER 4. Legal Issues of Infusion Nursing
Mary C. Alexander, MA, RN, CRNI®, CAE, FAAN and Hugh K. Webster, Esq.
Legal Standard of Care, 49
Legal Terminology, 52
Legal Principles, 54
Risk Management Strategies, 57
Summary, 58
Nowhere in professional nursing has the role of the nurse grown as fast, as effectively, and as favorably as in infusion nursing. The development of infusion nursing reflects a general trend in the nursing profession. Nurses today monitor complex physiologic data, operate sophisticated lifesaving equipment, and coordinate the delivery of health care services. More importantly, nurses now have responsibility for exercising discriminatory judgment. No longer do nurses blindly follow physicians’ orders; they collaborate with physicians to ensure that their patients receive the highest quality of care.
The expanding responsibility of infusion nurses has advantages and disadvantages. The nurse’s emerging role offers rewards such as intellectual stimulation and professional satisfaction. However, the heightened status also means increased legal risks for the nurse and the added potential for liability. It is therefore the intent of this chapter to broaden awareness of the legal issues of infusion nursing. Four major topics are discussed: the legal standard of care, legal terminology, legal principles, and risk management strategies.
LEGAL STANDARD OF CARE
Nurses have a duty to provide reasonable, prudent patient care as required by the situation. The care delivered by the nurse must comply with what is expected, given the circumstances in which the care is provided. This is known as the legal standard of care.
The legal standard of care is used to evaluate the quality of nursing conduct and has several important characteristics (Beare and Myers, 1998). First, the standard of care is a reasonable expectation of the nursing care. This means that the care represents the typical performance of a professional nurse who has special knowledge and skill beyond that of an ordinary person. For example, an infusion nurse is expected to be able to perform a successful venipuncture on the first attempt. Second, the standard of care is measurable. The care can be evaluated based on what a similarly prepared nurse would do in the same situation. For example, a nurse who has been educated to insert a peripherally inserted central catheter (PICC) would know the appropriate site preparation procedure to prevent a catheter-related bloodstream infection (CRBSI). Third, the standard of care is valid based on where the care was delivered. There is variability based on the state where the care is delivered, thus influencing the established standard by which the care may be evaluated. An example of such variability is whether a registered nurse is allowed to determine PICC tip placement on a chest radiograph. There are some states that allow this practice, while a few others specifically limit it within the scope of nursing practice. Fourth, the standard of care must be applicable based on the current state of knowledge. Standards evolve with increasing knowledge and experience, so the care must be evaluated within the historical context of when the care was delivered. For example, the 2006 revision of the Infusion Nursing Standards of Practice is applicable only to infusion nursing care delivered since that document was published.
Standards can be voluntary, such as those promulgated by professional groups, or they may be mandated legislatively. Nursing, like most other professions, is regulated by these dual controls, both of which are aimed at providing quality patient care. Professional standards are the forerunners of legal standards. What has become the customary, usual nursing practice, as defined by the profession, later translates into the legal duty the nurse owes to the patient.
To clarify, the difference between standard of care and standard of practice is that the focus with a standard of care is on the recipient of care, the patient, while the focus with a standard of practice is on the provider of care, in this case the nurse. The legal standards of care for infusion nursing are derived from four sources: federal statutes and regulations, state statutes, professional standards, and institutional standards.
FEDERAL STATUTES AND REGULATIONS
Federal statutes are laws that have been enacted by Congress and are published in the United States Code. Regulations interpreting and implementing these laws are promulgated by numerous federal agencies, including the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA), and the U.S. Department of Health and Human Services (USDHHS). Agency regulations are published in the Code of Federal Regulations. The most applicable federal statutes and regulations relative to infusion nursing concern occupational safety and health, infection prevention and control, medical device safety, federally funded insurance programs, and patient self-determination.
Occupational Safety and Health Administration
By law, the Occupational Safety and Health Administration (OSHA) has the authority to both establish and enforce regulations to promote job safety and protect the health of workers. One of OSHA’s regulations is the Hazard Communication Standard, or “right-to-know” law, which requires that employees be informed of the hazardous potential of chemicals encountered in the workplace (Federal Register, 2001). Hence, infusion nurses must be knowledgeable of warning labels on hazardous chemical containers used within the health care organization, and in completing material safety data sheets (MSDSs).
In 2001 OSHA revised the 1991 Final Rule of the Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other Sharps Injuries which expands on standard precautions and addresses the risk of occupational exposure to bloodborne pathogens. The standard specifies that all body secretions can be potentially infectious, and that personnel having contact with patients must adhere to strict guidelines. The revision includes examples of engineering controls, and requires exposure control plans, solicitation of employee input, and recordkeeping. Compliance with the guidelines is subject to comprehensive enforcement procedures (Federal Register, 2001).
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is a federal agency under the USDHHS, whose mission is to promote health and quality of life by preventing and controlling disease, injury, and disability by means of surveillance, research, and demonstration projects. Although this agency does not regulate health, the CDC is responsible for providing guidance in the form of recommendations, which are considered voluntary standards. An example related to infusion nursing is the Guidelines for the Prevention of Intravascular Catheter-Related Infections (CDC, 2002; Bennett and Brachman, 2007). Sometimes, the voluntary guidelines issued by the CDC may be adopted by a federal agency and, in effect, become regulations. Such was the case when OSHA adopted the standard precautions developed by the CDC for compliance interpretation.
Food and Drug Administration
Since 1938 the Food and Drug Administration (FDA) has been responsible for regulating products such as food, cosmetics, prescription and over-the-counter medications, and biological agents to ensure that they are safe and effective for their intended purposes. In 1976 this authority was extended to medical devices. With enactment of the Safe Medical Device Act of 1990 (SMDA), device-user facilities, such as hospitals, ambulatory surgical centers, nursing homes, and outpatient treatment facilities, are legally required to report to the FDA and the manufacturer, if known, incidents in which a medical device may have contributed to the serious injury, serious illness, or death of a patient. The term device is broadly defined and may include infusion-related equipment such as venous access devices, solution containers, and electronic infusion devices (FDA, 2002). It is the infusion nurse’s professional responsibility, regardless of the practice setting, to inspect product integrity before use and to report any suggested or potential medical device problems (INS, 2006). To report significant adverse events, product problems, or product use errors, the health care professional is to use the FDA’s MedWatch program. Guidelines for voluntary reporting to the FDA are listed in Box 4-1.
Box 4-1
PRODUCT PROBLEM REPORTING PROGRAM
WHEN TO REPORT
Problems with medical devices should be reported if the event observed involves, or has the potential to cause, a death, serious injury, or life-threatening malfunction. This includes problems such as the following:
• User error is the cause (the design of the device or unclear/incomplete labeling may have contributed to the problem).
• A decision is made to no longer use the device because of a malfunction that has occurred.
• Repeated repairs fail to solve the problem.
• Design or repair changes by the manufacturer have adversely affected the performance, safety, or efficacy of the device.
• The problem was the result of incompatibility between devices of different manufacturers and labeling failed to warn the user of this potential for problems.
• The malfunction results in prolonged hospitalization, readmission, or repeated surgical procedures.
WHAT TO REPORT
A complete description of the problem and information regarding the device needs to be submitted, including the following:
• Product name
• Manufacturer’s name and address
• Identification numbers of the device (lot number, model number, serial number, expiration date)
• Problem noted (including any actual or potential adverse effects)
• Name, title, and practice specialty of the user of the device
HOW TO REPORT
Problems are reported to MedWatch, the Food and Drug Administration (FDA) safety information and adverse event reporting program. Reports can be made by telephone: 1-800-FDA-1088; by facsimile: 1-800-FDA-0178; by mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787; or on-line: www.fda.gov/medwatch/report.htm.
Centers for Medicare & Medicaid Services
The Centers for Medicare & Medicaid Services (CMS), formerly known as the Health Care Financing Administration (HCFA), is a federal agency created in 1977 to administer the Medicare program and the federal portion of the Medicaid program. Because CMS is responsible for ensuring the quality of health care for beneficiaries participating in these federally funded health insurance programs, the agency sets standards for health care providers receiving Medicare/Medicaid reimbursement. Nurses employed by such providers must comply with the applicable standards, which are commonly referred to as CMS regulations.
Patient self-determination
The Patient Self-Determination Act of 1990 requires that all health care providers accepting Medicare and Medicaid payments provide written information regarding advance directives. An advance directive is a document by which an adult patient may legally decide about future medical treatment. The information is provided at the time of admission to the facility, and it recognizes the patient’s rights as a competent adult to decide about the use of do-not-resuscitate orders and the withdrawal of life-sustaining equipment (Monarch, 2002). Although this requirement is federally mandated, each state is responsible for overseeing this program; thus there may be implementation variations from state to state.
STATE STATUTES
A jurisdiction is a legally established geographic area, such as a state. Variations exist among state statutes because each state government may enact laws specific for that geographic area. A state cannot enact a law that conflicts with federal laws, but it may pass additional regulations (Monarch, 2002). The primary types of state statutes that affect the delivery of infusion nursing care are the Nurse Practice Acts, requirements for nurse licensure, joint policy statements, and licensing of health care facilities.
Nurse Practice Acts
The practice of nursing is regulated by a legislatively enacted Nurse Practice Act (NPA). Although each NPA is unique, most contain similar provisions such as a scope of practice, definitions, description of the composition of the boards of nursing (BON), and requirements for initial licensure and licensure renewal. NPAs, along with administrative rules, and the Administrative Procedures Act (APA) determine what nurses regulated by the BON can and cannot do within the jurisdiction (Monarch, 2002).
NPAs may be general or specific in their guidance for a particular procedure or action. Those states that publish only general standards in the NPA announce specific criteria for nursing behavior in bulletins or newsletters. Some states may have specific position statements allowing or limiting the inclusion of activities within the state’s scope of practice. In other states, a decision tree may be used to assist in determining whether an act is within the scope of practice. Each nurse is responsible for familiarizing himself or herself with the NPA of the state in which the nurse practices (Monarch, 2002 and Markovich, 2008).
Requirements for nurse licensure
Each NPA specifies that the nurse must be licensed to practice nursing within the state. The minimum requirements for licensure are established by the state board of nursing (BON). The state BON is also empowered to suspend or revoke the license of any nurse for violation of the specified norms of conduct for that state.
The mutual recognition model of nurse licensure allows a nurse to have one license (in his or her state of residency) and to practice in other states (both physically and electronically), subject to each state’s practice law and regulation. Under mutual recognition, a nurse may practice across state lines unless otherwise restricted. To achieve mutual recognition, each state must enact legislation or regulation authorizing the nurse licensure compact (NLC). The nurse must legally reside in an NLC state to be eligible to have a multistate license (National Council of State Boards of Nursing [NCSBN], 2008).
Joint policy statements
When questions regarding the professional responsibility of nurses to perform specific therapeutic procedures cannot be answered by existing state statutes, a joint policy statement may be issued. Sponsors of joint policy statements include the state’s nursing association, medical society, and hospital association (Weinstein, 2007).
Licensing of health care facilities
Each state has a department of health that sets standards for the licensing of health care facilities. Although these standards are generally directed toward the physical facilities, qualifications of employees, and maintenance of records, they are interrelated with nursing practice. For example, the state health department may mandate how and where medications are to be stored, and the nurse’s conduct must not violate these standards.
PROFESSIONAL STANDARDS
Professional standards are not merely the minimum criteria enacted by the legislature, but represent an attempt by a peer group to establish a level of competency that is expected by the profession and has been recognized as such by courts (Koeniguer v. Eckrich, 1988).
In health care, professional standards may apply to the entire industry or may pertain only to a specific profession or specialty. The American Nurses Association (ANA) has developed generic standards that address nursing practice, while The Joint Commission has accreditation standards that health care organizations use to measure their delivery of patient care. In contrast, the Infusion Nurses Society (INS) has developed the Infusion Nursing Standards of Practice that specifically address infusion nursing practice. In addition, standards, guidelines, criteria, and recommendations from other professional organizations—such as the AABB (formerly known as the American Association of Blood Banks), the American Society of Health-System Pharmacists (ASHP), the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N), the Association for Professionals in Infection Control and Epidemiology (APIC), and the Oncology Nursing Society (ONS)—also influence the professional standards for infusion nursing.
American Nurses Association
The ANA has published Nursing: Scope and Standards of Practice that describe a competent level of nursing care as demonstrated by the critical thinking model known as the nursing process. The nursing process includes the components of assessment, diagnosis, outcomes identification, planning, implementation, and evaluation (ANA, 2004). As such, they are considered the foundation for nursing practice.
The Joint Commission
The Joint Commission (TJC), formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), is a private, nongovernmental accrediting body that defines optimal, achievable standards for health care organizations such as hospitals, home care services, nursing homes, and ambulatory care centers. The intent of the standards is to improve the quality of health care provided to the public by stimulating health care organizations to meet or exceed the standards through accreditation.
Infusion Nurses Society
INS introduced the first standards for the specialty practice of infusion nursing in 1980. The standards are reviewed routinely, and subsequent revisions reflect changes in clinical practice and technological advances based on evidence-based practice and research. The Infusion Nursing Standards of Practice are specific to the specialty practice of infusion nursing and are applicable in all practice settings in which infusion care is delivered (INS, 2006).
INSTITUTIONAL STANDARDS
In addition to governmental and professional standards, each institution or agency specifies its own practice through policies, procedures, protocols, and guidelines. Policies are general statements as to when a particular procedure, method, or action is to be used. In contrast, procedures are step-by-step outlines of how actions or methods are to be performed. A protocol is a formal plan for a course of medical treatment, patient care activity, or research project. Guidelines describe a process of patient care management that has the potential for improving the quality of clinical and patient decision-making (ANA, 2004). As systemically developed statements based on available scientific evidence and expert opinion, practice guidelines address the specific care of specific patient populations or phenomena, whereas standards provide a broad framework of practice. Standards should remain stable over time, as they reflect the philosophical values of the profession (ANA, 2004).
LEGAL TERMINOLOGY
In an age that greatly emphasizes the legal rights of people, nurses have a responsibility to understand the basic precepts of law. Our society is founded on a system of legal principles and processes by which people can resolve problems and disputes without resorting to physical force. The term law has been broadly defined as those standards of human conduct that are established and enforced by the authority of an organized society through its government. To comprehend this legal system and apply the principles to the practice of infusion nursing, the nurse must be cognizant of the terminology commonly used to discuss legal matters.
CATEGORIES OF LAW
There are numerous types of laws and various methods by which they are categorized. Often, laws are categorized in relation to the four sources from which they originate and may be identified as follows: (1) constitutional law, originating from the federal and state constitutions; (2) statutory law, enacted by the legislative branch of government; (3) administrative law, issued by administrative agencies that have been established by the legislature or appointed by the executive branch; and (4) common law, which results from interpretation of the laws by the judicial system. Some texts also classify laws as public and private law. Constitutional, statutory, and administrative laws are considered public law because they deal with public welfare. In contrast, private law is concerned with the rights, duties, and legal relations involving private individuals. Contractual law and laws regarding negligence and malpractice are components of private law (Holmes, 2004).
Laws may also be categorized as to their intent. Such a classification emphasizes how the law affects nurses, and which laws are applicable to practice. Therefore the categories of law relative to infusion nursing include administrative, criminal, contractual, and civil law.
Administrative law
Statutes are laws that are enacted by the legislature and are known as statutory law. When the legislature enacts statutes to regulate business or confer benefits on its citizens, it may be difficult to foresee variations necessary for proper execution of the law. To provide for this eventuality, the legislature may establish an administrative agency empowered to make rules and regulations that have the force of laws. Examples of federal administrative agencies include the FDA, OSHA, and CMS. Regulations from these agencies affect the practice of infusion nursing. FDA regulations emphasize product safety, rules issued by OSHA focus on protection of the health care worker, and CMS guidelines affect providers participating in the Medicare/Medicaid programs.
States may also have administrative agencies that are created by the legislature. The primary example is the state board of nursing, also referred to as the board of nurse examiners, nurse licensing board, or nursing board. These boards set requirements for and grant approval to nursing schools, conduct licensing examinations, and issue and renew licenses for nurses. In addition, they are empowered to revoke or annul a nurse’s license if there is evidence of incompetence, fraud, or deceit in securing the license; unprofessional conduct; practicing while impaired; criminal acts; or gross negligence.
Criminal law
Laws relating to an offense against the general public that results in a harmful effect against society as a whole are classified as criminal law. The primary emphasis of criminal law is defining behaviors that are prohibited or controlled by society. Criminal offenses are prosecuted by a governmental authority and punishment may result in fines and/or imprisonment. Performing infusion nursing procedures in a manner that violates the Nurse Practice Act or the Medical Practice Act is an example of a criminal offense.
Contractual law
A contract is an agreement between two or more persons that creates, changes, or eliminates a legal right or obligation. Most nurses do not have employment contracts, but rather enter into general, flexible arrangements with their employers. However, even if the employing agency has no written contract, there is still a binding legal commitment based on a mutual understanding. The nurse has a duty to perform the nursing assignment in accordance with the standards of professional nursing practice; the employer’s duty is to provide a safe workplace and properly trained and qualified workers.
As infusion nurses become entrepreneurs, there is an increasing need for nurses to understand how to negotiate written contracts for their services. Consideration must also be given as to how the contract may be terminated. If the nurse fails to perform the obligations required by the contract, a breach of contract may be committed and the nurse may be required to pay damages. The term damages usually refers to a sum of money awarded to a person or organization whose rights have been violated by another.
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