Regulation of Nursing Practice

Some individuals may espouse the point of view that no industry is more regulated than the healthcare industry. Statues and regulations give individuals a right to a cause of action or the government the right to demand that healthcare providers and hospitals carry out certain activities (Hudson, 1990). While laws provide the legislative and legal authority, regulations provide further detail for implementation of laws. Lack of knowledge in these areas can lead to violations of state government regulations that ultimately result in disciplinary measures, fines, or litigation.

In this article the author will discuss regulations governing the practice of nursing, assess potential risks in relation to specific practices, and offer strategies to manage these risk. While there are numerous regulations governing the healthcare delivery process, this article will be limited to nursing practice acts and authority of boards of nursing.

The word law is defined as the sum total of manmade rules and regulations by which society is governed in a formal and binding manner (Betts & Waddle, 1992). It encompasses the actions of the legislative branch in enacting statues, executive branch in administering statutes through rules, and the judicial branch in interpreting statutes and rules. There are three major sources that provide laws governing our society: statutory laws, common laws, and administrative laws. Statutory laws are those generated by state legislatures or Congress. Common laws evolve from judicial decisions. Administrative law is developed under the authority of regulatory agencies such as state boards of nursing.

In addition to knowing how law is established, it is also important to understand how laws are violated. Criminal law relates to a violation of the law. In criminal cases, an individual commits a crime and faces trial in the criminal court system. In contrast, civil law deals with disputes over legal rights and duties of individuals in relation to one another. In civil cases, compensation may be awarded to the injured party from the person who caused the harm (Harris, 1991). Finally, administrative law relates to a regulatory agency or board of nursing restricting one's ability to practice.

These laws are not mutually exclusive. Depending on the violation, a nurse may be tried in more than one system. For instance, misappropriating patient funds or controlled substances may lead to a criminal conviction. However, these activities are also violations of the nursing practice act, and as such, may result in disciplinary actions from the board of nursing. Therefore, in addition to receiving criminal punishment, the nurse may also have his/her license to practice revoked or suspended or the nurse may be placed on probation.

The regulation of healthcare providers, professionals and institutions, is a state function. Each state licenses healthcare providers practicing within the state's geographic boundaries. The authority for this activity is provided by the United States Constitution which dictates that healthcare providers be regulated by the states as opposed to the federal government. Therefore, each state has established a regulatory agency, referred to as the board of nursing, to carry out these duties with respect to the nursing profession. Statutory authority is provided to the boards of nursing by state legislatures. These statutes are known as nursing practice acts.

The mission of these regulatory boards is to protect the health, safety, and welfare of the public. This is accomplished through the administration of responsibilities such as establishing criteria for practice, issuing licenses, regulating standards of conduct, investigating complaints against licensees, and promulgating rules that regulate nurses and nursing practice. Implicit in these major responsibilities for upholding public protection are (1) rule making authority, (2) quasi-judicial authority, and (3) administrative authority (Betts & Waddle, 1992).

Risk Management Laws

In recent years, there has been an increase in the establishment of risk management laws, more commonly known as "mandatory reporting laws." The intent of such laws is to provide a mandatory mechanism of reporting substandard nursing practice to the appropriate licensing agency. Mandatory reporting laws require that certain actions of licensed nurses, such as alcohol, drug, and patient abuse or neglect, be reported to the licensing board.

An important aspect of mandatory reporting laws is the definition of a reportable incident. For example, the Kansas law defines reportable incident as an act by a "healthcare provider which: 1) is or may be below the applicable standard of care and has a reasonable probability of causing injury to a patient; or 2) may be grounds for disciplinary action by the appropriate licensing agency" (Jaeger, 1993).

Minnesota regulations require, "any healthcare institution or organization located in this state shall report to the board any action taken by the institution or organization or any of its administrators or committees to revoke, suspend, limit, or condition a nurse's privilege to practice in the institution, or as part of the organization, any denial of privileges, any dismissal from employment, or any other disciplinary action" (Minnesota Board of Nursing, 1994, p. 16).

In order to minimize professional risk, it is important that nurses understand the concept of a prevailing standard of care. The nursing standard of care is what the reasonably prudent nurse, under similar circumstances, would have done. It is a peer standard of care that reflects not excellence but a minimum standard of "do no harm." The nursing standard of care is determined by statute such as nursing practice acts, professional organizations such as the American Nurses Association, and employing institutions through policies and procedures. Although many standards of care are well defined and long standing, new standards are regularly being formulated to address changes in the practice of nursing.

The American Nurses Association defines unlicensed assistive personnel as individuals who are trained to function in an assistive role to the licensed registered nurse in the provision of patient/client care activities as delegated by the nurse. The increasing use of assistive personnel in the healthcare delivery system poses several risks for nurses. Nurses should be aware of issues regarding scope of practice, delegation, and supervision of assistive personnel. While this discussion is limited to unlicensed assistive personnel, concepts of delegation are also applicable to licensed practical nurses and certified nurse aides.

Generally, assistive personnel perform patient care/support tasks that are non-threatening and noninvasive. However, as the costs of healthcare services rise, facilities are attempting to contain costs. One popular means of decreasing expenditures is to reduce labor costs. Registered nurses comprise the largest portion of facility labor cost. In order to quickly reduce expenses, facilities are reorganizing their workforce and decreasing registered nurse staffing. A reduction in the number of registered nurses is accompanied by an increase in the use of unlicensed assistive personnel.

Unlicensed assistive personnel are minimally educated healthcare workers who receive on-the-job training. There are no state or federally-mandated education programs for these workers. Further, there are not standard methods for testing competency or for regulating these individuals. Data indicate that quality and safety of patient care decreases as the use of assistive personnel increases.

Unlike nurses, whose profession is regulated by state nursing practice acts, unlicensed personnel are legally allowed to perform only activities which fall outside of nursing activities as delineated in nurse practice acts (Kreplick, 1995). Nursing practice incorporates knowledge, judgment, and skill. Professional nursing skills include assessment, diagnosis, interventions, and evaluation. These are skills far beyond the scope of unlicensed assistive personnel. Risk for both hospitals and nurses increases when the lists of tasks performed by unlicensed assistive personnel involves judgment and skill as in sterile dressing changes and catheterization. If the unlicensed individual is providing nursing care and/or representing his/her care as nursing care without proper authority, regulatory interventions should be implemented to stop the unauthorized practice of nursing.

In addition to assistive personnel practicing nursing without a license, inappropriate delegation poses both professional and legal risk for nurses. The concept of delegation incorporates legal and managerial principles. Delegation is the transfer of authority by one person to another. Because delegation or the transfer of authority is never absolute, the one in authority may not delegate all their authority, responsibility, or accountability. The professional nurse is accountable legally, based upon licensure laws, to use the nursing process in making the decision to delegate in a manner that does not jeopardize patient safety.

In other words, when delegating, it is the registered nurse who uses professional judgment to determine the appropriate activities to delegate. Any nursing intervention that requires independent, specialized nursing knowledge, skills or judgment cannot be delegated (Kreplick, 1995). Since boards of nursing are charged with protecting the health, safety, and welfare of the public, disciplinary actions may be taken against the license of the registered nurse who fails to delegate or supervise unlicensed personnel as outlined in the statutes and regulations.

Thus, nurses must consider their professional responsibility and liability when overseeing the activities of unlicensed personnel. State nursing practice acts provide the legal definition circumscribing the scope of nursing practice. In the case of delegation, nurses risk action from the board of nursing in the following four instances: 1) delegation to an individual lacking sufficient education or experience to perform the nursing function; 2) delegation of tasks and responsibilities contrary to the state nurse practice acts; 3) delegation that poses substantial risk or harm to a patient; and 4) inadequate supervision of unlicensed personnel to whom nursing tasks have been delegated (Kreplick, 1995).

In addition to being professionally responsible for improper delegation and supervision of unlicensed personnel, nurses may also be held liable for any incorrect actions which may result. Professional nurses who negligently delegate or supervise unlicensed personnel may be subject to civil liability if a patient is injured, providing the patient can show the following: 1) the professional nurse had a duty; 2) he/she breached that duty by failing to act as a reasonably prudent nurse would have; 3) the professional nurse's conduct caused harm complained of, and 4) the nurse's conduct was the proximate cause of the harm (Kreplick, 1995).

Changes in the healthcare delivery model have implications throughout the system. The healthcare delivery system will continue to use unlicensed assistive personnel to augment staff mix. States continue to evaluate the effectiveness of statutes and regulations governing delegation and supervision. Therefore, it is important that nurses are knowledgeable of the state's rules and regulations pertaining to delegation and supervision. In addition, nurses must understand the components of the delegation process and successfully incorporate delegation into their practice.

Changes in the organization, financing, and delivery of services are having a substantial effect on the practice of healthcare professionals and on systems that establish competence to practice. Public advocacy groups, employers, and state and federal regulatory agencies have made regulatory reform related to professional accountability a national priority. Managed-care organizations, employers, and the government - - concerned with their own accountability -- recognize that competence affects both cost and quality of care.

Regulatory agencies such as state boards of nursing have the authority to issue and deny licenses and to remove those individuals deemed unsafe to practice. The usual qualifications for licensure are educational preparation and passing a licensure examination. The public recognizes licensure as a sign that the individual is safe to practice -that is the individual is competent. Black's Law Dictionary defines competent as being "duly qualified; answering all requirements; having sufficient ability or authority; and possessing the requisite natural or legal requirements."

Today, regulatory boards and employers are faced with the dilemma of determining competency after initial licensure. However, maintaining competency to practice has traditionally been the professional responsibility of the nurse.

Determination of continuing competency for renewal of licenses became the focus in the 1960s. Peer review, self evaluation, and continuing education are mechanisms currently in use to determine continuing competency. Many states require continuing education for renewal of licenses for registered nurses. Although the goal of mandatory continuing education is to ensure competence, it has not been adopted as a viable regulatory mechanism. Costs associated with mandatory continuing education are substantial, and its effectiveness is difficult to document.

However, new healthcare delivery and data collection systems have made the margin for poor performance narrower than ever. The importance of performance measures in maintaining and improving quality is well understood by nurses and most healthcare organizations (Willoughby, Budreau, & Livingston, 1997). A critical component of providing quality nursing care is the competence of the nursing staff. There is movement toward data collection to clearly document quality outcomes. Competency monitors are intended to document and monitor the ability of staff to perform safely and effectively in a given setting.

For years, the health professions have resisted reassessment as a condition of relicensure or recertification and have defended a system that examines professionals only once in their lifetime. Yet as early as 1981, the National Organization for Competency Assurance stated:

"Healthcare technology is advancing too fast for a certificate of competency earned at the beginning of one's career to constitute proof of competency many years later. Demonstrations of continuing competence are as reasonable and necessary as are required demonstrations of entry-level competence. However, the lack of any standardized procedure for assuring that licensees have kept abreast of technology or research developments and can still provide quality services to the public has led to demands for regulatory agencies to monitor the continued competence of healthcare providers" (Willoughby, Budreau & Livingston, 1997, p. 44).

The National Council of State Boards of Nursing defines the elements of competence as specific knowledge base, awareness of practice standards, psychornotor skills, decision-making skills, communication skills, experience and attitude. Tools that can be used to quantify performance and characterize skills include continuing education credits; written documentation, such as copies of quality assurance logs; observation; peer review; quality assurance findings; a lab practicum in which the employee perfonns tests for evaluation; and verbal or written tests. A criterion used to measure employee job performance usually falls into one or more of three skills categories: critical thinking, interpersonal relations, and technical skills (Willoughby, Budreau, & Livingston, 1997).

Boards of nursing are obligated to take appropriate disciplinary measures against a practitioner who fails to meet the standard of practice or who practices in an unsafe manner. Although policy and regulations in this area are in flux, it is the individual nurse's responsibility to maintain competency through self assessment and self limitation.

In the healthcare setting, practicing while under the influence of drugs or alcohol is a violation of the nursing practice act and endangers both the patient and nurse. Further, drug use may give rise to litigation if an impaired healthcare provider injures a patient while providing care. Because tort liability can arise for an employer out of injury to a patient resulting from an act of negligence by a drug impaired employee, the healthcare employer has a special interest in intervening quickly and efficiently when drug use or impairment is suspected on the job.

Thus, the importance of developing and implementing clear policies and procedures concerning drug use, diversion, and impairment in the workplace cannot be overemphasized. Some hospitals and employers take a punitive approach with impaired nurses. However, the punitive approach is now giving way to a rehabilitative approach. The American Nurses Association and many boards of nursing focus on rehabilitating nurses whose practice may have been impaired by psychological dysfunction or substance abuse so that they may return to work.

Nurses suspected of being impaired or diverting drugs should be reported to the board of nursing. Almost every state nursing practice act includes statutory or regulatory language related to this behavior. Generally, impairment while on duty, habitual addiction to drugs or alcohol which affects the nurse in his/her professional duties, and/or diversion of drugs from the facility can result in disciplinary action against the registered nurse. Disciplinary action may include placing a nurse on probation or revoking or suspending a license to practice. However, many states have incorporated assistance programs which sleek to rehabilitate the nurse and allow continued employment. In such instances the nurse may practice on a restricted license while the state agency closely monitors his or her performance.

After a recovering nurse's re-entry to work, monitoring for continued abstinence is essential for both the employer and the recovering nurse in order to protect the patient and to provide documentation that the nurse continues to be "clean and sober" (Brent, 1991). Generally, the boards of nursing will define who will be responsible for monitoring the nurse. Regular reports detailing urine screen results, notification of employment changes, support group meetings, and performance evaluations are reviewed by the agency.

Chemical dependence in the workplace must be met with a sound plan of action, by both regulatory agencies and employers, in order to protect patient safety and reduce liability.

Almost 140,000 advanced practice nurses are creating a new role in the healthcare delivery system. The term advanced practice registered nurse (APRN) is an umbrella term given to registered nurses who have met advanced educational and clinical practice requirements. These nurses may also be identified as nurse practitioners, certified nurse midwives, clinical nurse specialists, and certified registered nurse anesthetists (American Nurses Association, 1995). These expanded roles have led to new statutes and regulations regarding advanced practice nursing as well as increased legal exposure. Therefore, it is imperative that APRNs understand the legal responsibilities that exist within their scope of practice.

The first area of difficulty encountered by APRNs is one of standardization. Regulatory requirements for being recognized as an APRN vary from state to state. Some states require master's level preparation and specialty certification, while others do not. In addition, each state defines advanced level nurses differently. Some states may not recognize all four categories of APRNs. For example, the Michigan Nursing Practice Act certifies clinical nurse specialists as nurse practitioners while Nevada recognizes only nurse practitioners, nurse midwives, and nurse psychotherapists as APRNs. Finally, some states, such as Illinois, Minnesota, and Tennessee, do not have title protection for advanced practice nurses. For example, in Minnesota, authority for nurse practitioners to practice is covered under a broad nursing practice act. In contrast, Nebraska enacted a separate act for APRNs.

A second important area of clarification involves legal distinctions in the definition of nursing practice as opposed to medical practice. Practice laws carefully define the scope of advanced nursing practice. Two states (Alaska and New Mexico) and the District of Columbia allow APRNs to practice independent of physician supervision. Thirty-four states have enacted statutes that authorize the nurse practitioner to provide care without physician supervision when controlled substances are not being prescribed. The remaining states require advanced practitioners to enter into collaborative or supervisory relationships with physicians. While the APRN remains legally responsible for his/her own actions, he/she must understand the parameters of these agreements before entering into any relationship with another healthcare provider (Henry, 1996).

Further, the practice of APRNs is regulated differently from state to state. Those states that allow APRNs to practice independently regulate advanced practice solely under the board of nursing. States that require some type of physician supervision or collaboration may regulate advanced practice through a joint committee of the boards of nursing and medicine. These boards promulgate rules to define the scope of practice for APRNs including prescriptive authority and dispensing of medications.

A third area of confusion for advanced practice nurses is reimbursement of services. Direct reimbursement for advanced practice nurses has been recognized under Medicaid and Medicare, Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), and the Federal Employee Health Benefits Program (FEHB). However, Medicaid is a joint state/federal program. This means that in order for APRNs to receive Medicaid reimbursement, specific state legislation must be enacted. The same holds true for third party reimbursement. Reimbursement language is generally not included in nursing practice acts but instead in insurance related vehicles. As a result, changes in state insurance laws have been enacted in many states to achieve direct payment for nursing services from private insurance companies. The most common mechanisms through which APRNs have acquired access to direct payment are mandated benefits laws and nondiscrimination provisions. Again, it is important to note that statutory recognition of APRNs is a necessary component for reimbursement.

Risk assessment should constitute a nurse's best effort to predict the probability of harm in a given situation. Having predicted the level or risk, the nurse then should take action to minimize the risk. A number of steps can be taken to improve the risk management process in relation to the regulation of nursing practice.

Changes frequently occur to either the statutory or regulatory language that govern nursing practice. In the first four months of 1997, more than 200 pieces of legislation were introduced that affect nurses or nursing practice (National Conference of State Legislatures, 1997). It is important that nurses keep abreast of these changes. Professional nursing organizations such as the American Nurses Association and their 53 state constituents can assist nurses in the legislative and regulatory arena.

Further, the nurses should establish life-long learning skills. The practice of nursing is not a static but rather an active field. It is the professional responsibility of nurses to update their skills and maintain their competency. Both formal and informal educational programs and peer review programs are helpful in evaluating and assessing competency.

In conclusion, following and maintaining standards of care will reduce professional and personal liability. Each nurse must read and keep on hand a copy of the nursing practice act. Becoming familiar with the nursing practice act is the best means for nurses to decrease professional and legal risk. Further, nurses are urged to develop a relationship with their board of nursing. Attend board meetings and invite board of nursing members to participate in educational opportunities sponsored by professional organizations or employers.

American Nurses Association. (1995). Advanced practice nursing: A new age. Nursing Facts. Washington, D.C.: Author.

Betts, V. T., & Waddle, F.I. (1992). Legal aspects of nursing: Professional nursing. Philadelphia: W.B. Saunders Company.

Brent, N. (1991). The impaired nurse. Journal of Health Law, 24(4) 112.

Burbach, V. (1996). Regulatoryframework of a delegation systems model. Nebraska Board of Nursing.

Harris, C.H. (1991). Legal aspects of nursing: Issues and trends in nursing. St. Louis: Mosby.

Henry, P. (1996). Analysis of the nurse practitioner's legal relationships. Nurse Practitioner Forum, 70) 5-6.

Hudson, T. (1990). Risk managers see new regulations as boon and burden. Hospitals, 64(18) 40.

Jaeger, D. (1993). Kansas risk management laws and nursing practice. The Kansas Nurse, 68(4) 8-9.

Kreplick, J. (1995). Unlicensed hospital assistive personnel: Efficiency or liability? Journal of Health and Hospital Law, 28(5) 292.

Minnesota Board of Nursing. (1994). Nurse practice act. Chapter 148, 16.

National Conference of State Legislatures. (1997). Health Policy Tracking Service. Denver, CO: Author

Willoughby, C., Budreau, G., & Livingston, D. (1997). A framework for integrated quality improvement. Journal of Nursing Care Quality,--LI (3) 44.

Updated Selected References: 1999 through June 2001

Note: These references are not part of the independent study module, but are provided to you as suggestions for additional reading.

Cavanaugh, ML. (April 2001). Legally speaking: new regulations focus on medical errors. RN 64(4), 71-2, 74, 84.

Davenport, A. (Winter 2000). Risk assessment and the new world health organization recommendations. Midwifery Today 56, 49-50

Fiesta, J. (April 1999). Law for the nurse manager who's liable in equipment cases? Nursing Management 30(4), 12-3, 15.

Giardino, B. (June 2000). Management of patient grievances based on HCFA and Joint Commission rules. Advisor for Nurse Executives. 15(9), 9-12.

Infante, MC. (July 2000). Legally speaking. Malpractice may not be your biggest legal risk. RN, 63(7), 67, 69, 71.

Ventura, MJ. (February 1999). Legally speaking: what information must be revealed. RN 62(2), 61-62, 64, 75.

Terri Gaffney, MPA, RN, was formally the Director of State Government Relations, American Nurses Association, Washington, D. C. and is the current Director of the American Academy of Nursing, Washington, D.C.