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Written Statement


National Summit on Medical Errors and Patient Safety Research

Panel 3: Particular Systems Issues

Testimony of Patricia W. Underwood, American Nurses Association

The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements

The American Nurses Association (ANA) appreciates the opportunity to address the nursing profession's perspective on areas for priority consideration in developing a research agenda related to public safety and medical errors. This issue is one of great importance to the nursing profession. As front line health care workers, nurses have substantial contributions to make in the effort to reduce health care errors. ANA is the only full-service professional organization representing the nation's registered nurses through its 53 state and territorial nurses associations. Members of ANA constituent associations include staff nurses, advanced practice nurses, academics, researchers, and nurse administrators. The scope of ANA's membership, reaching into all varieties of nursing experience in every type of practice setting, gives ANA the capacity to address issues of error and public safety in a comprehensive way.

We will also address particular staffing issues that impact quality of care and incidence of medical errors by a broader range of hospital personnel. While the nursing profession cannot appropriately speak to the specific concerns of other disciplines and auxiliary personnel, as the primary coordinators of care in institutions, nursing has insights that should valuable in all facets of the discussion of staffing and medical error.

The recent Institute of Medicine (IOM) study, To Err Is Human: Building a Safer Health System (IOM, December 1999), quantified what nurses and other health professionals have been concerned about for quite some time: changes in the health care system have compromised the safety and quality of care and have contributed to the unacceptable and alarming incidence of medical errors. The IOM study identified many factors that contribute to medical errors and compromise public safety. However, the report failed to consider a significant structural component of health care delivery: the number and mix of health care staff delivering direct patient care. Over the past ten years, many expert and seasoned registered nurses (RNs) at all levels in health care institutions, have left or been forced to leave the delivery of direct patient care, especially within the acute care system. In many instances they have been replaced by unlicensed assistive personnel. It is the experience of many remaining RNs that their ability to influence the design of care delivery systems and to advocate effectively for patient safety has been diminished as institutions have increasingly focused on cost containment as a priority.

An important consideration in the discussion of medical errors, particularly in institutional settings, is to keep in mind that patients are in health care facilities for expert nursing care. Patients who have been treated or have undergone a medical procedure and then do not need expert nursing care are sent home. Therefore, any consideration of medical errors that does not look at a full range of nurse staffing issues is missing a crucial element that lies at the center of safe patient care. The fact that the IOM report had essentially nothing to say about this issue and the paucity of research in this area are both indicative of the relative neglect of staffing research. The American Nurses Association has pushed hard for a number of years to remedy this neglect.

ANA is very much encouraged by a 1998 study by researchers for the Agency for Health Care Policy and Research (AHCPR), now the Agency for Health Research and Quality, examining the relationship between nurse staffing and selected adverse events. The study, "Nurse staffing levels and adverse events following surgery in U. S. hospitals" (Kovner and Gergen, 1998), showed that patients who have surgery done in hospitals that have fewer registered nurses per patient than other hospitals run a higher risk of developing avoidable complications following their operations. The study found hospitals that provided one more hour of nursing care per patient day than the average nursing care hours per patient day had almost ten percent fewer patients with urinary tract infections and 8 percent fewer patients with pneumonia. An additional one hour per day of nursing care is about a seventeen percent increase in nurse staffing levels.

Researchers Christine Kovner, Ph.D., R.N., and Peter Gergen, M.D., M.P.H., in analyzing data from 506 hospitals in ten states, found that the fewer full-time equivalent registered nurses per inpatient day a hospital has, the greater the incidence of urinary tract infection, pneumonia, thrombosis (formation of blood clots), pulmonary congestion, and other lung-related problems following major surgery. These are complications that nurses often can prevent by getting patients out of bed and walking after surgery, by monitoring them closely, and by other hands-on nursing practices.

According to Kovner, in a report by AHCPR, the finding of a strong inverse relationship between registered nurse staffing and adverse patient events should be considered when developing strategies to reduce costs. About 1.2 million registered nurses work in hospitals, where they make up nearly a quarter of hospital staff and constitute hospitals' single largest labor cost.

Among the study's other findings are that large hospitals have significantly lower urinary tract infection rates than smaller ones; large and medium-sized hospitals have higher rates of lung-related disorders than smaller facilities; and both public and not-for-profit hospitals have significantly lower urinary tract infection rates than do for-profit hospitals. This study reinforces previous studies, limited both in numbers and in scope and design, showing a significant correlation between registered nurse staff and the quality of care in health care institutions.

The vital importance of registered nurses at the bedside is a critical piece in preventing medication errors. The registered nurse at the patient's bedside is the patient's safety net. ANA agrees with the IOM study's recommendation that health care organizations should implement proven medication safety procedures. However, an area of inadequate staffing that needs to be addressed is the inappropriate use of unlicensed assistive personnel (UAP). The role of the UAP is important. The UAP is to provide assistance to the registered nurse, not substituting for the RN by delivering care that is within an RN's scope of practice. While some procedural components of nursing care can be performed by unlicensed persons, the assessment and critical judgment components that are essential to quality of care are lost. More health care facilities, especially state facilities, are increasingly relying on UAPs to administer medications. Thus, medication administration occurs without the application of critical judgment.

The organization of health care within a hospital depends on interdisciplinary teams of professionals and auxiliary workers, all of whom have defined areas of expertise and responsibility. Provision of safe care demands that there be adequate numbers of each of these health care team members and that their deployment be appropriate to their training and expertise. One of the reasons that proposals to require specific ratios of specific types of practitioner are problematic is that they do not ensure that a full complement staff are available. For instance, if a certain number of registered nurses is required for a particular patient census and acuity, it is counterproductive to then permit a reduction in numbers of respiratory therapists or unlicensed assistants as a cost saving measure.

Currently a number of states have legalized medication administration by unlicensed personnel in state institutions and subacute care facilities. For example, the Commonwealth of Massachusetts General Law Chapter 94C,7g authorizes unlicensed personnel to administer medication to patients within the Departments of Mental Retardation and Mental Health. The oversight of a registered nurses is not mandated by the state. The Massachusetts Nurses Association has been battling with the Massachusetts state legislature for many years regarding this issue. Financial cost appears to be the reason the Commonwealth does not raise the standard of care for their most vulnerable patients. Massachusetts is not the only state that relies on UAPs to administer medications; New York, Maine, Illinois, and others have similar laws. ANA recommends review of the inappropriate use of UAPs administering medications in each state. Another area in which the administration of medication by unlicensed individuals is increasing is in schools. In 1996, there were approximately 45,000 school nurses, mostly part-time, for 87,125 school buildings and millions of school children. Because of the low number of school nurses working in the school systems, many students received their medication from school administrators. This trend is particularly worrisome because many children with disabilities, who are being accommodated in the public school systems, may have complex medication and therapeutic needs. It is unsafe for these children and unfair to the administrative personnel and teachers who are being required to perform nursing duties to permit these practices to continue.

For a number of years, ANA has advocated for enactment of legislation to require health care institutions to make public specified information on staffing levels, mix and patient outcomes. At a minimum, institutions would have to make public, in comparable formats:

  • the number of registered nurses providing direct care;
  • numbers of unlicensed personnel utilized to provide direct patient care;
  • average number of patients per registered nurse providing direct patient care;
  • patient mortality rate;
  • incidence of adverse patient care incidents;
  • methods used for determining and adjusting staffing levels and patient care needs.

The reason for this legislative proposal goes to the heart of the problem: transparency in health care quality and safety is more important than commercial proprietary considerations of health care institutions. If researchers do not have access to the data—and data that is in usable form—then every claim by the nursing profession of the effects of understaffing or inappropriate staffing on patient safety can be dismissed as unsupported. But to go further, if there is no funding for the research, we are left in the same untenable position and patients continue to pay the price with their health and safety on the line. For the nursing profession, the indictment of "anecdotal claims," as opposed to scientific evidence, is extraordinarily frustrating. The profession is committed to evidence-based decisionmaking and care. The proprietary control of the data and the level of funding necessary for research of this nature are typically not available to nurse researchers. These barriers are longstanding and must be overcome if public health and safety interests are to be served.

That concern about necessary research brings us to ANA's proposals for addressing a systemic medical error problem. ANA believes that staffing (the number and mix of hospital and other institutional staff) is the most significant aspect of the health care delivery infrastructure and requires specific focus by the research community. The following areas are proposed for consideration:

I. Research is needed to evaluate the occurrence of medical errors in relationship to the following variables:

  • Average ratio of patients to registered nurses, to licensed practical nurses, and to unlicensed personnel;
  • Differential illness severity;
  • Mortality and morbidity rates;
  • Incidence of post-discharge professional care;
  • Length of stay.

Obviously, these relationships are complex, and they both illustrate and intensify the complexities of the changing modern health care system. When determining the appropriate staff mix for hours of care, one size (or formula) does not fit all. In fact, staffing is most appropriate and meaningful when it is based on a measure of unit intensity which takes into consideration the aggregate population of patients and the associated roles and responsibilities of staff. Such a unit of measure must be operationalized taking into consideration all of the patients for whom care is being provided. It must not be based on a simple quantification of the needs of "average" patients but must also include the "outliers." Inadequate or inappropriate staffing may mean too few registered nurses, lack of appropriate training or orientation for a registered nurse assigned to the unit, or inappropriate use of unlicensed personnel. Adequate numbers of staff are necessary to reach a safe level of patient care services. Ongoing evaluation and bench marking related to staffing and patient acuity are necessary elements in the provision of quality care.

It is not a simple matter to tease out the significance of these variables. But if it is not done, there will continue to be a serious deficiency in the information necessary to make staffing decisions that are efficient and, more importantly, that will ensure maximum patient safety. In this era of shortened hospital stays and of outpatient surgery, assigning only one or two registered nurses to an intensive care unit with twelve patients sends off alarm signals for any reasonably informed lay person. Yet registered nurses know, and sometimes complain at the risk of their jobs, that this circumstance is not unusual. Are mistakes more likely then? A "stands-to-reason" argument will not do. It is essential to have valid and reliable data collection and analysis, because nurses' anecdotal experiences are repeatedly dismissed or downplayed by administrators and policymakers.

II. Examine the relationship between error rates and continuous hours worked by health care professionals and other health care workers

The American Nurses Association has identified the problem of excessive overtime required of registered nurses as a public health crisis. The fatigue experienced by other hospital employees, such as pharmacists, dieticians, respiratory therapists, and others is, in the same way a contributing factor to the incidence of medical errors.

The medical profession is at long last beginning to address the danger to patients of interns and residents working for hours and days without proper rest. In contrast, nurses and other hospital personnel are increasingly being required to work excessive overtime. In today's health care workplace, sixteen hour shifts for nurses are becoming increasingly commonplace and it is not unheard of to have twenty-four hour shifts. Too many hospitals have come to rely on the use of overtime as a substitute for an adequate supply of staff. Even the benign sounding reference to use of overtime in "emergencies" too often masks an inappropriate manipulation of staff rather than responsible provision for the usual changes in patient census or acuity or other routine institutional staffing needs. It is important to note that the issue of overtime is not focused on true emergencies - natural disasters in which members of the nursing profession, as well as other emergency workers, have always given help to the very limits of their capacity to do so.

Consider here the issue of power: relative to the nursing profession, the medical profession is in a stronger position to influence practice conditions, at least in part because they are reimbursed for services independently. Nurses and other employees of the institutions traditionally do not hold the power to dominate, much less control, resource decisions, because they are regarded as a labor cost center rather than revenue producers. In this environment, staffing decisions are disproportionately affected by the bottom-line mentality that controls the health care industry.

III. Evaluate the relationship between work environment (quality of work life) and patient safety by assessing the trends in work-related staff illness and injury rates; turnover/vacancy rates; overtime rates; use of supplemental staffing; levels of staff satisfaction; flexibility of human resource policies and benefits packages; and compliance with applicable federal state and local regulations.

Health care delivery inherently involves a certain level of stress which can be physically and emotionally exhausting. Those conditions can be exacerbated by the work environment. Again, it is not only possible, but probable, that these conditions and stresses may contribute to medical errors and threaten patient safety. ANA recommends that studies be undertaken which examine the effects of the workplace environment on the effects on patient safety. A rigorous analysis, unbiased by exigencies of either the institutions or the workforce, is needed for patient-centered consideration apart from the usual claims and counterclaims that typically are part of discussions in labor negotiations. For instance, depending on the setting, nurses and other health care workers may be at risk for infectious diseases from needlesticks or other sharps injuries, back injuries from moving patients with inadequate assistance, or violence involving patients or their family members. These are problems that cause nurses and other health care workers to leave bedside nursing or other hospital work involving direct patient care, either by choice or because of disability. More subtle environmental workplace stresses that are imposed by an employer need to be considered, as well. Rigid personnel policies or unfair scrutiny of personal behavior contribute to the type of environment that may exacerbate adverse outcomes.

IV. Research that compares the efficacy in reducing medical errors of institutions that have enhanced monitoring/reporting systems versus institutions where continuous quality improvement principles have been implemented as part of the organizations culture.

The principles of continuous quality improvement (CQI) direct the institution's focus away from an individual incident focus toward examining systems designed to support consistent outcomes and best practices. The culture of CQI is appropriate to the examination of medical errors because the majority of medical errors do not result from individual recklessness, but from basic flaws in the way the health delivery system is organized. Stocking patient-care units in hospitals, for example, with certain full-strength drugs—even though they are toxic unless diluted—has resulted in deadly mistakes. Illegible writing in medical records has resulted in administration of a drug for which the patient has a known allergy. Our evolving and increasingly complex health care system often lacks adequate coordination and appropriate systems to ensure patient safety. For example, when a patient is treated by several practitioners, they often do not have complete information about the medicines prescribed for each of the patient's diagnoses.

CQI is consistent with a root cause analysis approach that replaces individual blame with examination of system failures. Research of this nature is often overlooked because it calls for complex designs that are often of a qualitative rather than a quantitative nature.

Despite increasing evidence that systems fail, institutions are continuing to assign and emphasize individual blame for errors, misjudgments and patient dissatisfaction. Hospital systems and administrators are assuming that the appropriate way to deal with the complexity of errors made in the delivery of health care is to manage the workers—through oversight and discipline—as opposed to identifying and resolving the true problem in the spirit of partnership. ANA has long advocated for investigation of system changes that may result in egregious errors by individual practitioners, noting that health care systems have downsized, restructured and reorganized to the point where processes, initially put in place to protect the public, are breaking down.

As these systems increasingly are failing to protect patients, the severity of discipline applied to individual providers for mistakes is increasing. For example, in a 1996 Colorado case, medication errors were not treated as the domain of the hospital and the state licensing board, but drew the attention of the media and the court systems. Three registered nurses were charged with criminally negligent homicide when a medication error resulted in the death of a child. Although criminal prosecution for medication errors is not a common practice, the fact that such cases exist point to the adherence to promotion of a culture of individual blame. Health care organizations must approach problem solving strategies through shared accountability and partnership for quality improvement. A shared accountability approach diminishes focus on individual blaming and enhances long-range process improvements.

Beyond the institutional attitudes, it is important to consider ways in which day-to-day nursing practice makes it difficult to strengthen reporting systems. Among nurses, there is typically an aversion to reporting errors made by other nurses, and there are various reasons within the culture of the profession and the work environment that could continue to pose barriers even if a blame-free reporting system is instituted.

For instance, a report of erroneous practice, signed by a nurse, generally entangles that nurse in the problem; there often is even an assumption that, because her name is one the report, it is her problem and that she probably caused it. Implications of this sort will not be dissipated because a new system is in place.

Another, and perhaps more important, aspect of this culture is that nurses, in virtually every practice environment, rely upon each other to share the work load. In a typical unit, a nurse who has a patient in crisis needs to have good relationships with her colleagues who will "cover" her other patients. The personal attributes that are necessary to make this informal system work militate against anything that smacks of holding a colleague's feet to the fire outside of the culture itself. This is a complex issue that will not be solved by fiat but by developing an organizational culture that emphasizes that reported errors are subject to analysis leading to corrective action and preventive measures rather than punitive action against staff.


ANA believes nurses are the quality and safety monitors of health care. Nurses worry about systems that put providers and patients at risk. Today's environment demands that the nursing profession assert its powerful voice in the time-honored role as patient advocate by supporting public policies that protect consumers, enhance accountability for quality, and promote access to a full range of health care services. However, no system can succeed, no matter how brilliant, if there aren't qualified staff to implement it. Until health care administrators and the public focus on reducing system problems that contribute to clinical errors, shared accountability for systems improvement in health care can not be achieved. It is crucial that substantial resources be committed to documenting the link between staffing and patient outcomes in order to make informed, data-driven decisions that will allow safe-quality patient care to be the norm in all patient care settings.


To Err is Human: Building a Safer Health System. Institute of Medicine. Washington: National Academy Press, 2000.

Kovner, C. and Gergen P. Nurse staffing levels and adverse events following surgery in U. S. hospitals. Image: Journal of Nursing Scholarship 1998, 30:315-21.

Current as of September 2000

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