The American Nurses Association (ANA) appreciates the opportunity to discuss our concerns about patient 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 2.6 million registered nurses, including staff nurses, nurse practitioners, clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists through its 53 state and territorial nurses associations.

"To Err is Human: Building a Safer Health System" (IOM, December 1999) describes a fragmented health care system that is prone to errors and detrimental to safe patient care. This problem is not new to registered nurses and the American Nurses Association (ANA). ANA has long recognized this problem and has worked to address issues related to nursing care that enhance patient safety and outcomes for many years. We are encouraged, however, by the release of this report in an effort to spur public dialogue and reach consensus on solutions to these pressing issues.

The human cost of medical errors is high. Based on the findings of one major study, medical errors kill some 44,000 people in U.S. hospitals each year. Another study puts the number much higher, at 98,000. Even using the lower estimate, more people die from medical mistakes each year than from highway accidents, breast cancer, or AIDS. Moreover, while errors may be more easily detected in hospitals, they affect every health care setting: day-surgery and outpatient clinics, retail pharmacies, nursing homes, as well as home care. Deaths from medication errors take place both in and out of hospital settings - more than 7,000 annually - exceeding those from workplace injuries.

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 or the patient's illnesses.

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 no longer 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 ("Colorado Case Blurs Line", 1997). Although criminal prosecution for medication errors is not a common practice, the fact that such cases exist point to the adherence to promoting 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.

Specific recommendations of the IOM report follow with ANA's response to each recommendation:

4.1 IOM recommends that Congress should create a Center for Patient Safety within the Agency for Health Care Research and Quality. The Center should: 1) set the national goals for patient safety, track progress in meeting those goals, and issue an annual report to the President and Congress on patient safety; and 2) develop knowledge and understanding of errors in health care by developing a research agenda, funding Centers for Excellence, evaluation methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety.

ANA supports the creation of a Center for Patient Safety as an oversight body to advance standards, policies and actions related to reducing health care error. Such a center would provide a focal point for safety and quality activities by focusing on safety issues applicable to the full range of providers and health delivery systems. This entity must include adequate representation by nurses and other health professionals who are the front-line individuals in patient care.

This Center must support research to determine what factors lead to errors. Specifically, the Center must be charged with collecting data on organizational practices and other factors that may be associated with the occurrence of errors. In our current knowledge, no one can state with any certainty what practices could or are more likely to lead to errors. Some practices are more obvious than others. For example, bad handwriting or open stock of certain powerful drugs have been observed to be the cause for errors in health care delivery. Other causal factors that may contribute to health care errors may not be as apparent. For example, the IOM report lacks important information on the relationship between system errors and appropriate nurse staffing. In fact, ANA has voiced criticism of the report due to its inadequate attention to the staffing component of this issue.

Inadequate or inappropriate staffing may mean too few registered nurses, lack of appropriate training or orientation for an RN 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 are necessary elements in the provision of quality care. At a minimum, the Center for Patient Safety should collect data related to: average ratio of patients to registered nurses and licensed practical nurses, and unlicensed personnel, measures which differentiate between severity of patient illness, mortality and morbidity rates, readmission rates, incidence of post-discharge professional care, and length of stay, in order to examine the relationship of these variables to occurrence of health care errors.

Another issue that the Center for Patient Safety should examine the relationship between the errors rates and continuous hours worked by health care professionals. Just as there is concern about the number of hours worked by medical residents, ANA has become increasingly concerned by hospitals increased reliance on the use of overtime, particularly mandatory overtime, by its registered nurse staff. In today's health care workplace, 16 hour shifts are becoming increasingly commonplace and 24 hour shifts are not unheard of. Too many hospitals have come to rely on the use of overtime for a substitute for adequate supply of staff.

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 study's recommendation that health care organizations should implement proven medication safety procedures. However, an area of inadequate staffing that needs to be addressed in this recommendation, is the inappropriate use of unlicensed assistive personnel, UAP. The role of the UAP is important. The UAP assists the registered nurse, not provide nursing duties that are within an RN's scope of practice. More health care facilities, especially state facilities are increasingly relying on UAP's to administer medications.

Currently, a number of states have legalized medication administration by unlicensed personnel in state institutions and subacute. 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 UAP's to administer medications, New York, Maine, Illinois and others have similar laws. ANA recommends that the Center of Patient Safety review the inappropriate use of UAP's administering medications in each state. Another area where 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. Due to the low number of school nurses working in the school systems, many students receive their medication from school administrators.

5.1/5.2 IOM recommends that a mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. Reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care settings.

ANA supports the IOM's proposal that errors which lead to death or serious injury be the subject of mandatory reporting as an initial step in formalizing this system. In the long term, such mandatory reporting should include additional data beyond the sentinel events. ANA believes it is critical to evolve a comprehensive system of mandatory reporting to ensure that all factors in a system can be studied and assessed. What differentiates a fatal error from a minor error may be luck or chance. From a system's perspective, it is critical to understand the causal factors in any error in order to analyze them and prevent them in the future – whether that error resulted in an easily remedied situation or whether that error resulted in death. ANA agrees that it makes sense to start the operations of any mandatory system at one level of reporting, but the Congress must examine and direct how quickly a more comprehensive approach can be implemented.

Whether reporting is mandatory or voluntary, there must be provisions that protect a nurse's right to speak out about activities and/or practices that threaten the health and safety of patients.

6.1 IOM recommends that Congress should pass legislation to extend peer review protection to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and quality.

ANA understands the rationale for making this recommendation and some form of limited immunity may be appropriate in some instances. We are concerned, however, that any immunity be tailored narrowly enough to ensure that it helps attain the goal of patient safety, but doesn't provide a means for hospitals to hide or escape their accountability in health care errors.

7.1 IOM recommends that performance standards and expectations for health care organizations (regulators/accreditors and public/private purchasers) should focus greater attention on patient safety.

ANA strongly supports the establishment of performance standards and expectations for health care organizations. In particular, ANA supports systems for evaluating the impact of reorganization efforts on patient care, the overall patient care environment and the ability of health care providers to continue to practice in safety.

7.2 IOM recommends that performance standards and expectations for health professionals should focus greater attention on patient safety.

ANA long advocated for continuous education of health care professionals on patient safety issues as well as assuring that registered nurses stay current in their practice as approaches that can help reduce errors and promote patient safety. Toward this end, we have supported and worked on approaches to measuring continuing competence of registered nurses that would meet this goal. We do not see how the IOM proposal for relicensure contributes to measuring the competence of professionals since so many professionals practice within speciality areas and periodic relicensing does not assure measure of continuing competency in one's speciality field. Relicensure is one approach to many approaches to measuring continuing competency that has been discussed. It is premature and unhelpful to identify that as the only approach to be promoted as an overall effort to reduce error.

The American Nurses Credentialing Center (ANCC) recently released an international survey of certified registered nurses in the U.S. and Canada. A statistical significant portion of the survey respondents reported that certification enabled their surveillance and early intervention practices – thereby reducing health care error. The competence of health care providers is an important issue, but ANA would support a variety of approaches to this issue.

7.3 IOM recommends that the Food and Drug Administration should increase attention to the safe use of drugs in both pre- and post-marketing processes.

ANA supports this recommendation. ANA has long supported safer manufacturing and distribution of drugs, medical devices, and equipment. Through participation in the National Patient Safety Partnership Initiative for Preventing Adverse Drug Events earlier this year, nurses spoke for these specific issues and took part in developing and disseminating best practice recommendations and consumer guidelines.

8.1 IOM recommends that health care organizations and the professionals affiliated with them should make continually improved patient safety programs with defined executive responsibility.

ANA strongly supports any effort that makes patient safety a coordinated focused effort of the health care system. The establishment of safety programs must include balanced and appropriate representation of the key players and this means more than token nursing representation. Nurses are pivotal to improving patient outcomes and excellent evaluators of the work environment for deficits and solutions for quality improvements. There must be clear responsibility at the top levels of associations and organizations to make sure that needed practices are articulated and implemented.

8.2 Health care organizations should implement proven medication safety practices.

ANA supports the implementation of medication safety practices that are based on sound science and evaluation of those practices. Such improvements should be public information and reach to the core or root cause, not merely be a band-aid approach. For example, having a pharmacist accompany a nurse at medication administration time is not the answer if in fact there is only one nurse for 15 patients and he/she has 2 admissions and 3 discharges at medication time. There are other factors that must be accounted for such as appropriate staffing in this recommendation.

ANA thanks the Committee for sponsoring these hearings on such a critical issue in the health care delivery system today. ANA believes through a variety of strategies and collaboration that we can address this important issue in today's health care system.

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