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Testimony

of the

American Hospital Association

before the

Subcommittee on Labor, Health & Human Services, and Education

of the

Appropriations Committee

of the

United States Senate

on

The Institute of Medicine Report

December 13, 1999

Mr. Chairman, I am Stanton Smullens, M.D., chief medical officer of Jefferson Health System in Philadelphia, PA. I am here today on behalf of the American Hospital Association’s (AHA) nearly 5,000 hospital, health system, network, and other health care provider members. We are pleased to have the opportunity to testify on an issue of critical importance for hospitals and the patients and communities they serve: the Institute of Medicine’s (IOM) report on medical safety, and what hospitals and health systems are doing to improve patient safety.

The Jefferson Health System was formed in 1996 when Thomas Jefferson University, a large academic health center in Philadelphia, formed the Jefferson Health System with three acute care hospitals and one rehabilitation hospital called the Main Line Health System. In 1998, The Albert Einstein Healthcare Network, the Frankford Health Care System, and the Magee Rehabilitation Hospital joined the system. There are now nine acute care hospitals, three rehabilitation hospitals, a home care agency, and long-term care facilities within the system. There are more than 3,000 physicians associated with our system, most of whom are in private practice. The member hospitals remain committed to their local communities. I tell you this to emphasize the diversity of our organization, which includes a large center-city academic health center, suburban hospitals, a large city teaching hospital, and smaller community hospitals. Jefferson Health System is, in many ways, a cross-section of the nearly 5,000 hospital and health system members of the AHA.

I have spent most of my career as an actively practicing vascular surgeon and teacher at Thomas Jefferson University Hospital. In 1996 I assumed a leadership role in an organization that linked the physicians with the University Hospital to deal with managed care issues. I assumed another role in June of this year when I became the first chief medical officer of the Jefferson Health System. I bring a great deal of practical experience to this position, which is to educate, encourage, and promote a quality agenda among the members. This experience shows me that much of what is outlined in the IOM report is accurate. The timing of the report is excellent since it focuses attention at a time when many other activities are under way to address these issues, which many of the members of the IOM panel first brought to national awareness several years ago.

BACKGROUND

For thousands of years, healers have lived by the motto primum non nocere – first, do no harm. The nurses, doctors, and others on the patient care team in hospitals strive every day to deliver the safe, compassionate care that patients deserve. But in today’s complex, high-tech world of medicine, our best intentions can have unwanted and unintended consequences. The IOM report, "To Err is Human: Building a Safer Health System," points out that, as good as our systems are for preventing and reducing medical errors of all kinds, we can and must do better.

THE IOM REPORT AND HOSPITALS

We applaud the members of the IOM Committee on Health Care in America for developing a report that shines a bright yet objective spotlight on the problem of medical errors. The IOM report is important, outlining the significance of the medical error problem in this country.

It acknowledges that medicine is delivered by people who are highly trained and receive continuous education to stay on top of their respective areas of discipline. Hospitals and caregivers already work under strict internal quality control procedures, in addition to federal, state, local and independent oversight. Hospitals have important systems in place – checks and balances to reduce the potential for human error. For example, they have quality teams, physicians and nurses who examine unexpected deaths, treatment errors and accidents, to identify and correct the cause. And most hospitals have teams of experts whose sole focus is to develop and oversee safety policies to prevent accidents before they happen.

In addition, there are many organizations that specialize in the area of reducing and preventing medical errors. The AHA is working with several of these organizations so that we can help hospitals and health systems benefit from their knowledge and expertise. Among them: the National Patient Safety Partnership – a public/private partnership of organizations; the National Coordinating Council for Medication Error Reporting and Prevention; and the American Medical Association National Patient Safety Foundation. We’re doing this because, as the IOM report points out, a vigilant, ongoing, stepped-up effort to improve patient safety is needed.

We agree with the report that we need to avoid "blaming individuals for past errors" and instead "focus on preventing future errors by designing safety into the system." We also agree that, as the report states, "professional societies and groups should become active leaders in encouraging and demanding improvements in patient safety." The AHA is committed to being just that kind of leader, so that America’s health care system does indeed focus not on blame, but on prevention.

The IOM report focuses on the broad issue of medical safety. The AHA, at a White House event with President Clinton, announced an initiative to improve medication safety, because medication errors are one of the most common sources of overall medical errors. We used the opportunity to point out that whatever happens at the national level will only be valuable if it helps the women and men like me and those I work with at the Jefferson Health System – people who are on the front lines of health care – do their jobs even better.

AHA ACTIVITIES

More than a year ago, the AHA board and many of our hospital leaders attended a national forum in Cleveland. The topic: improving patient care. Though we have long been involved in improving the quality of care provided in the nation’s hospitals, we came away from that particular meeting with a strong sense from hospital leaders that, on a national level, we could do more … we needed to address these issues head on.

But the issue of medical error is very broad in scope. We set our sights specifically on improving medication safety – reducing and preventing medication errors that result from things like different drugs being packaged in similar containers, use of confusing abbreviations on labels and prescriptions, illegible doctor handwriting, and more.

Against the backdrop of all this activity came the IOM report, which led overnight to increased awareness of the importance and seriousness of this issue. The release of the report couldn’t have been more timely, coming at the same time as we were preparing to kick off our initiative to take a comprehensive look at hospitals’ ability to prevent medication errors and help them make improvements where needed.

As part of our initiative, we formed a partnership with a highly respected organization in this field, the Institute for Safe Medication Practices (ISMP). This non-profit research and education organization is dedicated to reducing the incidence of medication error throughout the health care system, and will provide leadership and technical expertise for the AHA’s initiative.

ISMP provides independent review of errors reported through the Medication Errors Reporting Program (MERP), which ISMP was instrumental in founding. Through MERP, health care professionals across the nation voluntarily complete pre-addressed mailers or dial a toll-free number (800-23-ERROR) to report actual and potential medication errors with complete confidentiality. As an official MedWatch partner, ISMP shares all information and prevention ideas with the U.S. Food and Drug Administration (FDA) and other professional and policy organizations. Working with practitioners, regulatory agencies, health care institutions, professional organizations, and the pharmaceutical industry, ISMP provides timely and accurate medication safety information and works toward improvements in drug distribution, naming, packaging, labeling, and delivery system design.

The following four objectives are key to our medication safety campaign with ISMP.

Develop a non-punitive process

Most of what has been learned in recent years about how to reduce errors and increase patient safety is based on two principles. First, individuals, by the very nature of being human, are vulnerable to error. Although they are the focus of the error, errors happen because of the systems in which these individuals work. As a result, reducing errors will require us to design and implement more error-resistant systems.

Second, we have to create an environment in which we learn from failure. This requires us to identify an effective mechanism for candid discussion of errors. This cannot be achieved in an environment of punishment or fear of legal prosecution for doctors, nurses and other caregivers who step forward after an unfortunate mistake is made.

Candor is absolutely critical if we are to be truly successful in identifying, learning from and reducing not only medication errors, but all medical errors, and making the health care system safer. We need to create a non-punitive culture at all levels that supports the collection of information about errors, along with candid discussion of errors, their causes, and ways to prevent them from happening again. A safe, non-punitive environment will encourage people to report errors, which is the first step in reduction and prevention.

Share successful practices with every hospital and health system

We sent to every AHA member the attached "Quality Advisory on Improving Medication Safety." The advisory includes background on the issue, a long list of resources our members can turn to for help, and a three-page list of "successful practices" for improving medication safety. Some of these practices can be adopted easily and quickly, such as providing staff with information about ordering, dispensing, administering and monitoring medications, not storing certain concentrated solutions on hospital wards, and helping patients better understand what they are talking, why, and how to use it safely.

Others are longer-term practices that, with time and money, can create significant changes throughout our members’ organizations. Among these are the development of a voluntary, non-punitive system to monitor and report errors that might occur within hospitals, and the computerization of medication administration systems.

We compiled the list of successful practices with the help and advice of some of the best experts in the field – including the ISMP, the Institute for Healthcare Improvement, the Massachusetts Coalition for the Prevention of Medical Errors, the National Coordinating Council for Medication Error Reporting and Prevention, the National Patient Safety Partnership and many others.

Develop a "medication safety awareness test" for use by hospitals

To follow up on how the successful practices are being implemented, we’ll work with ISMP to develop a "Medication Safety Awareness Test" to help our members assess their progress. This tool will also help the AHA get an idea of what other help its members may need, and help us track and demonstrate hospitals’ success at improving medication safety.

Serve as a clearinghouse of information and resources for hospitals

The AHA will continue making available to its members up-to-date information on improving medication safety. We will gather information from outside sources and work with other national organizations to develop information and data. We are planning a medication safety "summit," gathering other organizations and hospital leaders together to discuss widespread efforts to improve medication safety. And we will be adding to our Web site (www.aha.org) a special area containing all the information, data, best practices, and other resources we compile in our medication safety improvement campaign.

CONCLUSION

Mr. Chairman, the IOM report is very timely. It comes as America’s health care system enters a new century of caring for people. It marks an opportunity for us to rebuild the public’s confidence and trust in the health care system they rely on every day. And it reminds us that, despite setbacks, we still deliver the greatest health care in the world.

But it also notes that "large, complex problems require thoughtful, multifaceted responses." Reducing and preventing medication errors, and improving the overall safety of the health care system, will demand the thoughtful collaboration and participation of everyone involved in the health care field: hospital leaders, pharmacists, drug manufacturers, doctors, nurses, government agencies, other organizations, and consumers. America’s hospitals and health systems are committed to this effort.

AHA Quality

December 6, 1999

A Message to AHA Members:

Primum non nocere. Above all, do no harm. Healers have lived by this motto for thousands of years. The minimum our patients expect from us is safe and compassionate care when they enter a hospital. And they deserve to get it.

But in today’s complex, high-tech world of medicine, our best intentions can have unwanted consequences. And those consequences are contributing to the public’s eroding confidence and trust in the health care system.

While the recently released Institute of Medicine study has drawn a lot of attention to medication errors, we have been working on this issue for some time. Following up on discussions with the AHA Board of Trustees and Regional Policy Boards on improving hospitals’ accountability to their communities, the AHA is developing an initiative to help you improve patient safety by reducing and preventing medication errors. To provide leadership and technical expertise in this effort, we have formed a relationship with the Institute for Safe Medication Practices (ISMP), a not-for-profit research and education organization dedicated to reducing the incidence of medication error throughout the health system.

This is what you can expect from us in the coming months.

First, we will provide you with strategic and practical advice to reduce the potential for and incidence of medication error. To jump start this initiative, we are attaching several successful practice recommendations compiled from respected sources.

Next, together with ISMP, we are developing a "Medication Safety Awareness Test" that will help you assess your progress on implementing recommendations in your hospital, and that will enable us to track and demonstrate your success at improving medication safety.

The recommendations that follow can greatly improve patient safety. The first set can be implemented immediately; they focus on standardization and simplification of processes that will likely reduce the potential for human error. The second set require changes to existing organizational systems; they will likely require a longer-term implementation plan and may rely on computerization of the physician order-entry and pharmacy dispensing processes.

Here are some ways to get started:

• Consider organizing a senior management team to review and discuss the attached recommendations. This team could include the CEO, chief medical officer, chief operating officer, chief nurse executive, director of pharmacy, risk manager, director of information systems, and others. Some organizations also include patients on this team. Assess your organization’s processes as they compare to the recommendations and track your progress on implementing changes.

• Review your policies and procedures for reporting and investigating errors. Create an open, non-punitive culture that evaluates and corrects errors.

• Review information about incidents that occur within your institution and use it to find opportunities for improvement. Consider personally investigating an adverse event yourself, including talking directly with those involved.

• Help your organization’s physicians, nurses, and other patient care staff be prepared to respond to patients’ questions about adverse medical events and about the general quality of care in your organization.

• Make sure your staff is aware of the tremendous amount of information available from organizations like the ISMP, the Institute for Healthcare Improvement, the Food and Drug Administration, the U.S. Pharmacopeia, the Massachusetts Hospital Association, the National Coordinating Council on Medication Error Reporting and Prevention, the National Patient Safety Partnership, the National Patient Safety Foundation, the American Society for Health-System Pharmacists, and the American Society for Healthcare Risk Management.

• Lead the way with executive behavior: Declare the goal of safety to be a specific priority of you and your board. Be certain to keep your board and organized medical staff up to date on all the actions you’re taking.

Look for more from us in the near future. We'll provide strategic and practical advice on reducing errors, and we’ll be your clearinghouse for information and resources. The AHA is committed to helping you create a safer, more effective, and more efficient health care system.

 Dick Davidson

President

AHA Quality Advisory

December 6, 1999

 Improving Medication Safety

 Most of what has been learned in recent years about how to reduce medication errors and increase patient safety is based on two principles. First, individuals, by the very nature of being human, are vulnerable to error. Although individuals are the focus of the error, errors happen because of the systems in which those individuals work. As a result, reducing error will require us to design and implement more error-resistant systems. Second, we have to create an environment in which we can learn from failure – a safe, non-punitive environment that supports open discussion of errors, their causes, and ways to prevent them.

These principles have a common denominator – they require the leadership and commitment of senior executives, medical, nursing, and clinical staff to create change within our organizations.

Medication systems in hospitals are complex and multi-layered, involving many steps and many individuals. This complexity increases the probability of failure. While many errors are caught before they can cause harm, it can be tragic whenever a patient’s safety is compromised. Error can occur at any stage – prescribing, ordering, dispensing, administering, or monitoring the effects of a medication. According to the Institute for Safe Medication Practices, some common sources of medication error in health systems include:

Unavailable Patient Information: Critical patient information (diagnoses, lab values, allergies, drug contradictions, etc.) is often unavailable to pharmacy, nursing, and medical staff prior to dispensing or administering drugs.

Unavailable Drug Information: Pharmacists often are not readily available on patient care units and written resources may not be up-to-date, which can lead to dose miscalculations or ignorance of drug interactions. Because errors occur most often during the prescribing and administration stages, accessible drug information must be readily available and close at hand for all staff who prescribe and administer drugs.

Miscommunication of Drug Orders: Failed communication is at the heart of many errors. This includes poor handwriting, confusion of drugs with similar names, careless use of zeroes and decimal points, confusion of metric and apothecary systems, use of inappropriate abbreviations, ambiguous or incomplete orders, and, sometimes, conflicts between practitioners.

Problems with Labeling, Packaging and Drug Nomenclature: Most drugs are dispensed through unit dose systems that parse medications into smaller-sized doses. These systems, however, do not always provide for thorough preparation, packaging, and labeling of medications, with screening and checking by both nursing and pharmacy personnel, and they may not be available throughout every unit in the hospital (e.g., ERs and ICUs). Drug administration procedures often do not ensure that medications remain labeled until they reach the patient’s bedside, a frequent source of error.

Drug Standardization, Storage, and Stocking: Stocking multiple concentrations of the same drug, or storing drugs in look-alike containers or in ways that obscure drug labels, may contribute to error. Lack of safety procedures for use of automated dispensing technology or inadequate check systems may also contribute to errors.

Drug Device Acquisition, Use and Monitoring: Lack of standardization in drug delivery devices, improper default settings, unsafe equipment (e.g., free-flow infusion pumps), and the lack of independent check systems for verifying dose and rate settings can all contribute to device-related errors.

Environmental Stress: Environmental factors like lighting, heat, noise, and excessive interruptions, can affect individual performance. The process of transcribing orders is particularly vulnerable to distractions in the environment, as staff transcribing orders are exposed to noise, interruptions, non-stop unit activity, and too-long or double shifts.

Limited Staff Education: Many practitioners are not as aware as they should be of situations within their own organizations that have been reported as error-prone, or of similar information published in professional literature.

Limited Patient Education: Medication use is a multi-step, multidisciplinary process that begins and ends with the patient. Patient education about medications – what they are taking, why they are taking it, and how they should take it – is essential to successful medication administration. Patients can be partners in the prevention of error while hospitalized and need to be educated to safely self-administer medications when they go home.

Quality Improvement Processes and Risk Management: Health facilities need systems for identifying, reporting, analyzing, and correcting errors and identifying trends, and measurement systems for tracking the effect of system changes. Also, organizations need to take into consideration information from outside sources about errors that have occurred elsewhere. But above all, health organizations need to cultivate a non-punitive approach to error that will encourage frank identification and analysis of errors when they occur.

 These potential sources of error can be controlled if we design safer systems. With this in mind, the AHA has attached to this advisory a list of successful practices for improving medication safety and for improving overall patient safety within our hospitals and health systems. We encourage your team to review this list of recommendations, plan for implementation, and begin to track your progress.

Our Sources

The recommendations were culled from several reliable sources that are leaders in the effort to reduce and prevent medication errors, and we are grateful for their pioneering efforts. This list includes those organizations, as well as other resources for your organization’s efforts.

• American Society of Health-System Pharmacists (www.ashp.org)
• American Society for Healthcare Risk Management (www.ashrm.org)
• Institute for Healthcare Improvement (www.ihi.org)
• Institute of Medicine (www.national-academies.org)
• Institute for Safe Medication Practices (www.ismp.org)
• Joint Commission on Accreditation of Healthcare Organizations (www.jcaho.org)
• Massachusetts Hospital Association (www.mhalink.org)
• Massachusetts Coalition for the Prevention of Medical Errors (www.mhalink.org/mcpme)
• National Coordinating Council on Medication Error Reporting and Prevention (www.nccmerp.org)
• National Patient Safety Foundation (www.npsf.org)
• U.S. Pharmacopeia (www.usp.org)

1. Cohen, Michael R., Ed. Medication Errors. Washington, D.C. American Pharmaceutical Association. 1999. (Contains a special chapter on high-alert medications and dangerous abbreviations; rich with insight and practical advice on reducing the risk of error.)
2. Corrigan, Janet, et al. To Err is Human: Building a Safer Health System. Washington, D.C. National Academies Press. 1999. (Comprehensive overview of medical error, containing many practical suggestions and recommendations from several trusted sources.)
3. Leape, Lucian, et al. Reducing Adverse Drug Events. Boston, MA: Institute for Healthcare Improvement. 1998. (Concepts to reduce adverse events and a model for improvement.)

1. Your Role in Safe Medication Use: A Guide for Patients and Families is available from the Massachusetts Hospital Association at www.mhalink.org
2. Partners in Quality: Taking an Active Role in Your Health Care is available from the Hospital & Healthsystem Association of Pennsylvania at www.hap2000.org

3. How to Take Your Medications Safely is available from the ISMP at www.ismp.org

4. Just Ask! is available from the U.S. Pharmacopeia at www.usp.org

Information on Safe Medication Practices

From the Institute for Safe Medication Practices

• ISMP Medication Safety Alert!

• Urgent Error Advisories

From the U.S. Pharmacopeia

• Dangerous Abbreviations
• Practitioner Reporting Alerts
• Drug Quality Alerts
• Look-alike Sound-alike Name Lists

From the Joint Commission on Accreditation of Healthcare Organizations

• Sentinel Event Alerts

Easily implemented changes (process redesign)

• Maintain and systematically use unit-dose distribution systems (either manufacturer-prepared or repackaged by the pharmacy) for all non-emergency medications throughout the hospital. Unit dose systems should include, in addition to packaging, systems for labeling and order screening.

• Stress the need for dose adjustment in children, older persons, and patients with renal or hepatic impairment.

• For example, limit the types of general purpose infusion pumps to one or two.

• Use written guidelines, checklists, dose limits, pre-printed orders, double-checks, special packaging, special labeling, and education.
• Remove concentrated potassium chloride/phosphate from floor stock.

• Limit the number of possible concentrations for a drug, particularly high-alert drugs like morphine and heparin. Such standardization will allow the use of premixed solutions from manufacturers or centralized preparation of IV medications in the pharmacy.
• Review JCAHO Sentinel Events Alert #11, Nov. 19, 1999. Also, review Chapter 5 of Michael Cohen’s 1999 book, "Medication Errors," published by the American Pharmaceutical Association.

• Make updated information on new drugs, infrequently used drugs, and non-formulary drugs easily accessible to clinicians prior to ordering, dispensing, and administering medications (e.g., have pharmacists do rounds with doctors and nurses; distribute newsletters and drug summary sheets; use computer aids; and provide access to formulary systems and other internal resources).

• Review error potential for all new products, including a literature review, before any drug or procedure is approved for use; reassess six months to one year later.

• Provide physicians, nurses, pharmacists, and all other clinicians involved in the medication administration process with orientation and periodic education on ordering, dispensing, administering, and monitoring medications.

• Distribute information about known drug errors from outside organizations like the Institute for Safe Medication Practices (ISMP) and the U.S. Pharmacopeia (USP).

• Patients should be educated in the hospital, at discharge, and in ambulatory settings about their medications, what they are taking, why they are taking it, and how to use it safely.

• Encourage patients to ask questions about their medications.

• Encourage health care providers to work with pharmacists on patient education when patients receive certain classes of medications or are discharged on more than five medications.

• Have a pharmacist available on-call when pharmacy does not operate 24-hours a day.

• Make the pharmacist more visible in patient care areas – consider having pharmacy personnel make daily rounds on units, or enter orders directly into computer terminals on patient care units.

• Avoid certain dangerous abbreviations (see ISMP and USP for examples); identify a list of unacceptable abbreviations that will not be used in your institution.

• Include all elements of the order – dose, strength, units (metric), route, frequency, and rate.

• Use full names (preferably generic).

• Use computerized reminders for look-alike and sound-alike drug names.

• Use metric system only.

• Use preprinted order sheets whenever possible in non-computerized order systems.

• Doses

• Times of administration (for example, antibiotics)

• Packaging and labeling

• Storage (for example, placing medications in the same place in each unit)

• Dosing scales (for example, insulin, potassium)

• Protocols for the use and storage of high-alert drugs

Longer-term changes (systems redesign)

• Review policies for how your organization encourages reporting and analyzing errors throughout the institution.

• Encourage open communication and feedback.

• Ensure no reprisals for reporting of errors. Reports will increase if you make it safe to report.

• Encourage the use of computer-generated or electronic medication administration records.

• Plan for the implementation of computerized prescriber order entry systems.

• Consider the use of machine-readable code (i.e., bar coding) in the medication administration process.

• Use computerized drug profiling in the pharmacy.

• Be a demanding customer of pharmacy system software; encourage vendors to incorporate and assist in implementing an adequate standardized set of checks into computerized hospital pharmacy systems (e.g., screening for duplicate drug therapies, patient allergies, potential drug interactions, drug/lab interactions, dose ranges, etc.).

Institute 24-hour pharmacy service if possible …

… alternatively, use night formularies and careful drug selection and storage procedures. To facilitate medication distribution after hours, develop policies and procedures to ensure access to consultation with a pharmacist if a pharmacist is not available on-site.

 AMERICAN HOSPITAL ASSOCIATION

December 6, 1999

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