Role of Partnerships: Second Annual Meeting of Child Health Services R
Errors in Children's Health Care
Errors in Children's Health Care
Shirley Girouard, R.N., Ph.D.
Michael Goldberg, M.D.
Rainu Kaushal, M.D., M.P.H.
Paul Kurtin, M.D., FACP
Christopher Lomax, Pharm.D.
The recent Institute of Medicine (IOM) report, and the President's response, have brought major national attention to errors in health care. This session provided a conceptual framework for thinking about errors in pediatric care, addressed what is known about errors in children's healthcare, noted gaps between knowledge and practice, and drew implications for how partnerships can enhance the research and practice agendas in pediatric errors.
Recent Developments in Highlighting the Issue of Errors
Setting the context for panel speakers, Shirley Girouard, R.N., Ph.D. made several points about the issue of errors in children's healthcare. Patient safety has become a significant public issue with the release of the IOM report on medical errors in 1999. The report has since stimulated action by State and Federal policymakers, accrediting organizations, provider groups, and others interested in health care issues. For example, the Quality Interagency Coordinating Task Force (QuIC), led by HHS Secretary Donna Shalala and Department of Labor Secretary Alexis Herman, recently released a report to the President on the Federal response to the IOM report, and aims to shape the direction that should be taken in children's health care.
Although child health services researchers (in particular, providers and organizers of care) have always been concerned about child health care quality issues, Dr. Girouard noted that there is much room for research and quality improvement and related activities in the area of children's health care. There is also a significant knowledge deficit in the field. The IOM report, for example, only references children's care once. Therefore, the recommendations contained in the report have implications for research in the traditional sense as well as in the evaluation sense and for policy analysis/research. One of the IOM recommendations calls upon Congress to create a Center for Patient Safety within AHRQ in order to develop a better understanding and knowledge of errors in healthcare. Similarly, each of the other recommendations implies that further research must occur before anything substantial can be achieved.
Michael Goldberg, M.D. noted that the IOM report places a strong emphasis on:
- Nationwide mandatory reporting systems for hospitals and care delivery settings.
- Development of voluntary and confidential reporting systems for physicians and other health care providers.
However, these two goals work against each other. While one side encourages error notification and the free flow of information for analysis and learning, the other side wants outcomes reporting for investigation into errors, and for establishing accountability.
Dr. Goldberg emphasized that physicians must be involved in any system, and there must be a clear and unambiguous direct benefit to them to encourage their participation in outcomes reporting. The issue goes much further that non-punitive reporting; there must be a clear argument for why the practicing physician will benefit.
The component of a typical outcomes reporting system are: a system for data acquisition, a system for data transmission, and a data repository. Many organizations have developed outcomes reporting systems for research, accountability, and data analysis. For example, the American Academy of Orthopedic Surgeons (AAOS) developed the MODEM system. Yet Dr. Goldberg noted that this system, as well as all others, have failed.
Dr. Goldberg posed the question of whether the process of developing a reporting system was begun with the wrong assumptions:
- That physicians would willingly share data.
- That data collection would easily be incorporated into patient care encounters.
- That physicians would want and value this feedback.
Making these assumptions, Dr. Goldberg pointed out, is wrong. In his words, "the issue is not technology, but psychology." In reality, physicians do not like to collect data due to extra burdens such as time and office costs. The bottom line is to illustrate to them:
- The added value of data collection.
- Why data collection is necessary.
- What questions the data will answer.
Dr. Goldberg highlighted the fundamental difference between data and information. Physicians are already involved in collecting reams of data without garnering any useful information. The only way to encourage physicians to collect useful data is to link it to credentialing, certification, or reimbursement. Once again, a direct benefit must be illustrated.
When the AAOS reporting system (MODEM) failed, the Academy turned its attention to a "real problem," in Dr. Goldberg's words, and developed a Task Force on Wrong-Site Surgery. Wrong-site surgery poses a devastating problem not only to the patient but to the surgeon as well. Analyses have shown that this type of error results from:
- Poor preoperative planning.
- Lack of institutional control.
- Failure of the surgeon to exercise care.
- Simple mistakes in communication between the patient and surgeon.
Wrong-site surgery occurs most frequently in common procedures in the lower extremities and spine (orthopedics) and in breast biopsies (general surgery). Mistakes are easily made in organs that have similar physiology in the absence of external disease.
The probability of occurrence of wrong-site surgery, while not remarkably high, is nonetheless alarming because of its preventability. Data collected from the Physicians' Insurance Association of America over a 10-year period points to 25 complaints of wrong-site surgery against orthopedic surgeons and 105 complaints against general surgeons. All but one of the wrong-site surgeries was performed in a hospital setting, suggesting systematic problems. Although this number is low considering the total number of orthopedic and general surgeons in this country, this type of error is unacceptable because it is totally preventable.
Among the methods of preventing this type of error are:
- Discussing the surgery with the patient and operating staff.
- Making the patient's charts available in the operating room.
- Initialing the operative organ in permanent marker (an AAOS-developed strategy).
In all cases, prevention depends on truthful information-sharing and accurate records. Dr. Goldberg noted that it would be difficult to make these recommendations in the face of mandatory reporting systems where clearly, the cycle of "blame and retrain" is in action.
In summary, Dr. Goldberg posed the question of whether, for issues such as wrong-site surgery, efforts should go into reporting systems or into finding solutions and disseminating answers. This is a critical research question. Implications for clinical research are to understand physician behaviors and to articulate the direct benefits in order to avoid the "schizophrenia" occurring between mandatory/voluntary reporting and honest sharing of information.
Error Rates and Error Prevention
Rainu Kaushal, M.D., M.P.H. examined the public's perception of the recent media coverage of medical errors (e.g., IOM report). She cited a Lou Harris survey that showed 42 percent of Americans reported that they or a family member or friend had experienced a medical mistake within the past 5 years; that percentage translates to roughly 100 million Americans. Half of those surveyed felt the major problem was "bad" doctors, and three-quarters felt that doing away with bad doctors was the most important change for improving the problem.
A 1984 Harvard study that first highlighted adverse drug events found that after reviewing the charts of all hospitalized patients in New York State, 3.7 percent of hospitalized adult patients suffered an adverse event due to medical mismanagement (19.4 percent of these were complications of medications, which was the most common cause of adverse events).
Dr. Kaushal reviewed some of the definitions as they are used in the Harvard study:
- Medication errors are errors in drug ordering, transcribing, preparing, dispensing, administering or monitoring. (She noted that not all medication errors have the potential to harm patients, and most have few potential complications.)
- Potential adverse drug events (potential ADEs) are medication errors that have the potential for injury. The two types of potential ADEs are preventable and non-preventable. (Dr. Kaushal noted that two-thirds of potential ADEs are non-preventable.)
- Serious medication errors are potential ADEs and preventable ADEs.
- Rule violations are faulty orders with little potential harm or extra work due to correct interpretation by nursing and pharmacy without additional clarification.
One of the first studies to look at medication errors and ADEs in 1995 found that in reviewing 10,070 inpatient adult orders, 530 medication errors occurred (seven percent were potential ADEs and one percent of the errors resulted in an ADE). This ADE Prevention Study concluded that ADEs occur at a rate of 6.5 per 100 admissions, and one-third of ADEs are associated with medication errors and thus preventable. Inpatient ADEs in adults are medically significant and costly. Typically, the length of hospital stay is increased by about two days, the cost per ADE is $2400, and mortality is three times higher. These estimates exclude costs of injuries to patients, of malpractice claims, or of admissions due to ADEs.
A Harvard study funded by the Risk Management Foundation aimed to determine the rates of medication errors, potential ADEs, and ADEs in two academic pediatric institutions, to compare pediatric rates with adult rates, and to determine prevention strategies for potential ADEs and ADEs. The study concluded that among 10,778 orders reviewed, 616 medication errors occurred (a rate of 5.7 percent) and 120 of those were serious medication errors (1.1 percent). In comparing pediatric and adult rates of medication error, the highest rate of serious errors occurred in the neonatal intensive care unit, followed by the pediatric intensive care unit. (Using similar methods, a Harvard study conducted in 1992 found that potential ADEs were three times more likely to occur in pediatric patients.)
The types of errors that occurred were with:
- No/wrong date.
- Missing/wrong weight.
- Illegible order.
- Known allergy.
- Wrong drug/patient.
Errors were most likely to occur at the stage of physician ordering, followed by the stage of transcribing, nurse administering, pharmacy dispensing, and patient monitoring. The study also analyzed prevention strategies for serious medication errors, and found that 45 percent of errors were prevented by using computerized order entry. Other effective strategies included drug-dose check, drug-route check, guided dose algorithm, drug-allergies check, and computerized MAR.
Dr. Kaushal offered some reasons for the higher rate of pediatric errors: weight-based dosing allows for tenfold mistakes to be made, and pediatric patients have less tolerance for medication errors than adults. While pediatric and adult medication errors occur at similar rates, pediatric medication errors have more potential for adverse effects than adult medication errors. Most of the detected errors were dosing errors, and computer order entry has the largest potential for prevention, followed by drug-dose checks.
Dr. Kaushal offered two different approaches for the alleviation of the medication errors problem: changing the process of the medication system, and/or changing the organization of the institution and its personnel.
Process changes would involve:
- Decreased reliance on vigilance and memory (e.g., computer order entry, checklists).
- Standardization (e.g., unit dosing, standard equipment).
- Using constraints and forcing functions.
- Using protocols and checklists wisely.
- Improving access to information (e.g., Internet access).
- Reducing hand-offs.
- Elimination of look-alike and sound-alike medications.
- Careful automation.
One process change solution that has been tested in a 1998 Brigham study is using physician order entry with integrated checks. This system decreased the rate of serious medication errors by 55 percent, and decreased the rate of all medication errors by 81 percent. Dr. Kaushal noted, however, that such a system was costly (i.e., $2 million).
Organizational changes would include:
- Optimizing work environments (e.g., reasonable work loads).
- Creating a safe environment (e.g., for reporting).
- Teamwork (e.g., multi-disciplinary, non-authoritarian management).
- Leadership commitment.
One organization change solution that has been tested is including a pharmacist on rounds in the intensive care unit. One study showed that 99 percent of the pharmacist's recommendations were accepted, and there was a 66 percent decrease in preventable ADEs at the ordering stage.
In conclusion, Dr. Kaushal emphasized that medication errors and adverse drug events are important and widely publicized. They are common, costly, and clinically significant in both hospitalized adults and children, but serious medication errors are more common in children. Using a systems-based approach, interventions can be designed to decrease these errors.
Child Health Accountability Initiative
Paul Kurtin, M.D. described the Child Health Accountability Initiative (CHAI), a collaboration among 14 of 45 free-standing children's hospitals across the country. Founded in 1997, the mission of CHAI is to enhance the quality of child health services by establishing, via a collaborative multi-site network, evidence-based and consensus-derived outcomes measures. This year CHAI is focusing on patient safety (and reducing medical errors in particular). One of its goals is designing, evaluating, and implementing national quality measures and health outcomes for children, utilizing hospitals that care for children as learning laboratories.
CHAI also undertakes collaborative projects and research to promote clinical practices that lead to improved health outcomes for children. The benefits of a collaboration like CHAI are its improvement of health outcomes for children, its expanded consumer information base, its enhanced advocacy of public policy for children, and its increase in provider performance and efficiency.
The CHAI collaborative has become a national resource for child health improvement and a successful model worth spreading within and between institutions. The collaborative is currently partnering with organizations in order to find best ways of diffusing information about effective programs and innovations. CHAI is working with the Institute for Healthcare Improvement to develop leadership skills and processes for effective spread of innovative ideas, and with the University of Southern California Schools of Business and Communication, as well as the IBM Institute for Knowledge Management, to examine effective modes of dissemination.
A project called Partnering for Patient Safety, which kicked off on June 21, 2000, has the mission of:
- Developing standardized nomenclature, definitions, tracking methodologies, and rate calculations.
- Comparing rates of medication errors and adverse drug events in each aspect of the medication process (i.e., prescribing, transcribing, dispensing, monitoring).
- Identifying best practices for each aspect of the medication usage process.
- Implementing best practices at all sites.
- Documenting changes in error rates as well as the impact of error rates on financial and clinical outcomes.
- Sharing lessons learned with the world.
CHAI will do all this through partnerships with the Institute for Healthcare Improvement; Premier, Inc.; and external experts. Dr. Kurtin noted that such a collaboration allows the sharing of the limited expertise in the medical errors field.
Improving Chemotherapy Systems
Christopher Lomax, Pharm.D. presented the Chemotherapy Systems Performance Improvement Project at the Children's Center for Cancer and Diseases (Children's Hospital, Los Angeles). The project includes a focus on strategies for reducing medication errors:
- Chemotherapy order sets.
- Road maps.
The goal was to provide all patients with quality care via a cohesive multi-disciplinary team that supports processes to promote safety, communication, efficiency, collaboration, and seamless delivery of care. Dr. Lomax focused his presentation on chemotherapy order sets and road maps.
Dr. Lomax observed that there was a need to improve the translation of a treatment plan into a standard order set. The process needed to begin with the conception of a treatment plan and end with the administration of medication. Order sets were generated by adhering to a team-approved standardized format, and a process was established for multi-disciplinary review of new order sets. The order set template includes:
- Pre-chemotherapy criteria.
- Pre-chemotherapy hydration.
- Supportive care.
- Monitoring/laboratory work.
- Discharge criteria.
Order sets are to be maintained in a retrievable and secure computer source, and the system is to be incorporated into long-term physician order-entry goals.
The goal of the road map/documentation effort was to improve the communication and documentation of a patient's treatment plan, beginning with the initiation of therapy and ending with the completion of that phase of therapy.
Each patient was to be provided with a definable treatment plan to be included in their permanent record, and given a current and accurate road map indicating medications given in conjunction with their treatment plan. The road map tool also documents dosage adjustments that are required during therapy.
The documentation strategy was to consistently and accurately document medication administration. Multi-disciplinary team interventions were to be timely and accurately documented in an easily retrievable format regardless of location (inpatient or outpatient). This documentation tool (road map) will be in a standard and predictable format, providing practitioners with a clear understanding of:
- The treatment plan source.
- Therapy administered.
- Pertinent observations, toxicities, and therapy modifications.
Current as of June 2000
Errors in Children's Health Care. Role of Partnerships: Second Annual Meeting of Child Health Services Researchers. June 27, 2000. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/chsr2err.htm