Information management of medical errors in Greece: The MERIS proposal

International Journal of Information Management 29 (2009) 15–26

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Information management of medical errors in Greece: The MERIS proposal Athanassios Vozikis ∗ University of Piraeus, Department of Economic Science, 80 Karaoli & Dimitriou Street, 18534 Piraeus, Greece

a r t i c l e

i n f o

Keywords: Medical errors Patient safety Information management Information systems

a b s t r a c t There is a substantial amount of public concern about patient safety, as, according to estimates from major studies, hundreds of thousands die in hospitals each year all over the developed world as a result of medical errors that could have been prevented. Unprecedented research commissioned by the EU has found that almost one out of every four families has experienced a serious medical error. Greek citizens concerning about serious medical errors in the hospital environment, were at the top of the list. Greek Ombudsman’s report on medical errors has raised the debate among health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nationwide mandatory reporting with public release of performance data, to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. Any successful safety program will first require a national effort to make significant investments in information systems, along with providing an environment and education that enables to contribute to an active quality improvement process. In this paper we propose the development and implementation of Medical Error Reporting Information System (MERIS), in order to identify, collect, analyse and report medical errors and patient adverse events, as a tool for enhancing patient safety and health care quality. We also describe the necessary organisational structure and the infrastructure environment of the system and the barriers to its successful implementation. © 2008 Elsevier Ltd. All rights reserved.

1. Introduction For years, experts have recognized that medical errors exist and compromise health care quality, but the response to the 30 November, 1999, release of the Institute of Medicine’s (IOM) report, “To Err is Human: Building a Safer Health System”, brought medical errors to the forefront of public attention (IOM, 1999). In March 2001, the second IOM report, “Crossing the Quality Chasm: A New Health System for the 21st Century”, was published (IOM, 2001). The ‘chasm’ report extends the findings of the ‘error’ report to other important dimensions of healthcare quality. The reports concluded that the majority of these errors were the result of systemic problems rather than poor performance by individual providers, and outlined a four-pronged approach to prevent medical mistakes and improve patient safety. Much has been written worldwide about medical errors and improvements in their reporting and handling since then. Recently, the Eurobarometer survey, which was released by the European Commission (EC, 2005) found that almost half of those

∗ Tel.: +30 210 4142280; fax: +30 210 4142301. E-mail address: [email protected]. 0268-4012/$ – see front matter © 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.ijinfomgt.2008.04.012

surveyed said that hospital patients should be worried about being victims of medical errors. In this paper we propose the development and implementation of Medical Error Reporting Information System (MERIS), in order to identify, collect, analyse and report medical errors and patient adverse events, as a tool for enhancing patient safety and health care quality. We also describe the necessary organisational structure and the infrastructure environment of the system and the barriers to its successful implementation. In detailed, in chapters 1 and 2, the definitions, classifications and epidemiology and root causes of adverse events and medical errors are given. In chapters 3 and 4, the measurement process and tools, as well as the underreporting factors of medical errors are presented. In chapters 5, the research agenda for medical errors reporting is presented and the role of Information Technology in adverse events and medical errors reporting is described: In chapter 6, policy issues and the formation of a national strategy for the development of MERIS is analysed. In chapter 7, the characteristics and the content of MERIS are described in detail. Finally in chapter 8, conclusions of MERIS successful implementation are drawn and additional/parallel strategies on patient safety are proposed.

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2. Definitions, context and classifications

Table 1 Types of medical errors.

2.1. Definitions and context

Diagnostic Error or delay in diagnosis Failure to employ indicated tests Use of outmoded tests or therapy Failure to act on results of monitoring or testing Treatment Error in the performance of an operation, procedure, or test error in administering the treatment Error in the dose or method of using a drug Avoidable delay in treatment or in responding to an abnormal test Inappropriate (not indicated) care Preventive Failure to provide prophylactic treatment Inadequate monitoring or follow-up of treatment Other Failure of communication Equipment failure Other system failure

The lack of standardized nomenclature and a universal taxonomy for adverse events and medical errors complicates the development of a response to the issues outlined in this paper. A number of definitions have been applied to medical errors and patient safety. The World Health Organization (WHO) Collaborating Centers for International Drug Monitoring defines an adverse drug event as follows (WHO, 1984): • “Noxious and unintended and occurs at doses used in man for prophylaxis, diagnosis, therapy, or modification of physiologic functions.” In To Err is Human, the IOM adopted the following definitions: • An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. • An adverse event is defined as an injury caused by medical management rather than by the underlying disease or condition of the patient. In an effort to thoroughly consider all of the relevant issues related to medical errors, the QuIC expanded of the IOM definition, as follows (QuIC, 2000): • An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

or psychological injury” by the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]). • Legal definition (e.g., errors resulting from negligence (IOM, 1999)). • Type of setting (e.g., outpatient clinic, intensive care unit), and • Type of individual involved (e.g., physician, nurse, patient). Finally, Leape proposed a classification of medical errors’ types as presented in Table 1 (Leape, 1993). 3. The epidemiology and the root causes of medical errors

2.2. Classifications

3.1. The epidemiology of medical errors

Most people believe that medical errors usually involve drugs, such as a patient getting the wrong prescription or dosage, or mishandled surgeries, such as amputation of the wrong limb. However, there are many types of medical errors. The following seven categories summarize types of medical errors that can occur (Lazarou, Pomeranz & Corey, 1998):

It is clear that, although the United States provides some of the best health care in the world, the numbers of errors in health care are at unacceptably high levels. The Institute of Medicine’s report (IOM, 1999) estimates that more than half of the adverse medical events occurring each year are due to preventable medical errors, causing the death of tens of thousands. The consequences of medical mistakes are often more severe than the consequences of mistakes in other industries – leading to death or disability rather than inconvenience on the part of consumers – underscoring the need for aggressive action in this area. As shown in the following Table 2, the estimated total number of iatrogenic deaths – that is, deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures – in the US annually is $783,936 (Null Gary et al., 2007). It is evident that the American medical system is itself the leading cause of death and injury in the US. By comparison, approximately 699,697 Americans died of heart in 2001, while 553,251 died of cancer (USNCHS, 2003). European medical errors statistics are difficult to acquire. Unlike in the US, there is no official authority collecting data relative to medical errors occurrences. Nevertheless, existing figures indicate an increase in reported medical malpractice incidents in recent years. A United Kingdom estimate of clinical risks by University College London suggests that nowadays 3–4% of patients in the developed world are harmed during a hospital stay. For 70% of them the resulting adverse effect is short-lived, 16% endure permanent disabilities, while 14% subsequently die.1 The Kellog Foundation found that Britain’s medical malpractice death rate is comparable to that of

• Medication Errors, such as a patient receiving the wrong drug. • Surgical Error, such as amputating the wrong limb. • Diagnostic error, such as misdiagnosis leading to an incorrect choice of therapy, failure to use an indicated diagnostic test, misinterpretation of test results, and failure to act on abnormal results. • Equipment failure, such as defibrillators with dead batteries or intravenous pumps whose valves are easily dislodged or bumped, causing increased doses of medication over too short a period. • Infections, such as nosocomial and post-surgical wound infections. • Blood transfusion-related injuries, such as a patient receiving an incorrect blood type. • Misinterpretation of other medical orders, such as failing to give a patient a salt-free meal, as ordered by a physician. There are many possible ways to categorize medical errors, but no universally accepted taxonomy. Classifications have included: • Type of health care service provided (e.g., classification of medication errors by the National Coordinating Council for Medication Error Reporting and Prevention). • Severity of the resulting injury (e.g., sentinel events, defined as “any unexpected occurrence involving death or serious physical

1

Sunday Times, 19.12.1999.

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Table 2 Estimated annual mortality and economic cost of medical intervention. Condition

Deaths

Cost

Author (Lazarou et al., 1998) (IOM, 1999) Xakellis, Frantz, Lewis (1995), Barczak et al. (1997) Weinstein (1998), MMW (2000) Burger, Kayser-Jones, Bell (2000) Starfield (2000a) HCUP (2003) Tunis and Gelband (1994)

Adverse drug reactions Medical error Bedsores Infection Malnutrition Outpatients Unnecessary procedures Surgery-related

106,000 98,000 115,000 88,000 108,800 199,000 37,136 32,000

$12 billion $2 billion $55 billion $5 billion – $77 billion $122 billion $9 billion

Total

783,936

$282 billion

the United States. Medical error is the third most frequent cause of death in the United Kingdom after cancer and heart disease, killing up to 40,000 people a year.2 The number of medical errors deaths therefore is four times greater than the number of deaths due to all other types of accidents. In Germany,3 1999 estimates put the number of medical errors incidents at 400,000 per year. In Ireland, one in every 100 patients is estimated to experience some form of medical error.4 In Greece, there are not any official medical errors statistics. Nevertheless, calculations indicate that about 20–30 patients die every day and other 200 are harmed because of preventable medical errors. Rates in the later adverse event studies from UK, Denmark and New Zealand are remarkably similar, all being around 10%; US rates are much lower, with Australia seemingly much higher. The lower rates in the US might reflect better quality care, but could also reflect the narrower focus on negligent injury rather than the broader quality improvement focus of most other studies (Thomas et al., 2000a). Do the figures really reflect the underlying standard of healthcare in these countries? Although differences in adverse event rates between countries attract a great deal of media attention, much debate and occasional recrimination, the whole issue needs to be set in a broader context. Other attempts to compare health systems have produced a completely different picture. For example, the 2000 World Health Organization report on the health systems of 191 countries, ranked using an aggregate measure based on several dimensions (such as population health, health inequalities, responsiveness to need and financial fairness), provoked an intense debate on the validity of measuring and comparing healthcare systems. The US, despite its huge expenditure, was ranked 37th—bottom of the industrialized countries and below Greece, Portugal and Ireland.

• The FDA reports that many patient deaths and injuries are associated with the use of FDA-regulated medical products within a complex and time-pressured health care system. Reducing the incidence of medical errors can save thousands of lives and billions of dollars. • Donald M. Berwick, president of the Institute for Health Care Improvement has identified the leading cause of medical mistakes as the increasing complexity of health care. His general recommendations were for more simplification and greater standardization, such as the use of bar codes to ensure that the right patient receives the right dose of the right medication.

3.2. The root causes of medical errors

• • • •

According to a variety of sources, the root cause of medical errors is due to the complexity of today healthcare systems. • The IOM emphasized that most medical errors are systems related and not attributable to individual negligence or misconduct. The key to reducing medical errors is to focus on improving the systems of delivering care and not to blame individuals. Health care professionals are simply human and, like everyone else, they make mistakes.

2 3 4

Sunday Times, 19.12.1999. Gelber Dienst, 10.09.1999, www.schwarzpharma.de. Irish Times, 17.02.2001.

Additionally there are some specific factors that can increase the prevalence of medical errors: • Incomplete patient information (not knowing about patients’ allergies, other medicines they are taking, previous diagnoses, and lab results, for example); • Unavailable drug information (such as lack of up-to-date warnings); • Miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations; • Lack of appropriate labelling as a drug is prepared and repackaged into smaller units; and • Environmental factors, such as lighting, heat, noise, and interruptions that can distract health professionals from their medical tasks. Researchers for The Journal of the American Medical Association5 have identified several issues that have contributed the incidence of medical errors including: Complexity of the health care system. Reluctance of doctors to admit errors. Lack of leadership. Insurance reimbursement system that rewards errors since hospitals can still bill for additional services when patients are injured but often will not pay for practices that reduce those errors.

This orientation of thought – that systems, not individuals, produce errors – has profound implications for caregivers and reporters. Medical leaders believe that focusing on systems is the best way to prevent errors. Assigning blame helps keep them hidden. A systems approach emboldens the health care policy officers

5

Medical errors still claiming lives, USA Today, Wednesday 18 May, 2005.

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to come forward with information needed to understand how mistakes occur. Many doctors and nurses would like nothing better than for the media to stop skewering them individually and report on errors in the safer, neutral language of system failures. Indeed, if there is one overarching critique of quality stories from the medical profession, it is that the reporters look for victims and villains and blame caregivers too much. For journalists, however, reporting on system failures can be difficult, as such stories tend to be dry and antiseptic. But some journalists say the medical professionals may have a point. These reporters believe that the deepest stories include not only personal practices but also some sense of how these errors result from system failure. Reporters cannot let individuals off the hook, but the media should remember that no one acts alone. An error can usually be traced back to the system that sustains and directs the “perpetrator.” 4. Identifying and measuring medical errors and adverse events 4.1. Framework for identifying medical errors The overall goal of improved safety in health care is to reduce patient injury or harm, which underscores the importance of distinguishing between errors and harm. Although detection and analysis of errors is important in understanding failure-prone aspects of health care delivery systems and designing strategies to prevent and mitigate these failures, there is special value in quantifying actual harm. Medical errors are failures in processes of care and, while they have the potential to be harmful, numerous reports have shown they are often not linked to the injury of the patient. Because events of harm are clear clinical outcomes, they are particularly likely to engage both clinicians and administrators in a thorough review of the system factors that led to the adverse event, with a clear focus on improving patient outcomes. By concentrating on the events actually experienced by patients, a hospital can begin to foster a culture of safety that shifts from individual blame for errors to comprehensive system redesign that reduces patient suffering. To address the clear need to quantify adverse patient outcome, this paper focuses on the identification of harm or injury to the patient, as shown in Plate 1 (HCUPnet, 2003).

4.2. Methods for studying and measuring medical errors There are a number of methods of studying errors and adverse events, each of which has evolved over time and been adapted to different contexts. Each of the methods has particular strengths and advantages, and also weaknesses and limitations. Table 3 illustrates a general framework to help select error and adverse event measurement methods (Thomas, Laura, & Petersen, 2003): Although these methods can provide important and actionable information about systems, they also have weaknesses. They are incapable of providing error or adverse event rates because they are imprecise, primarily because of the various factors that influence whether an error or adverse event leads to a claim, incident report, or autopsy. In the error reporting systems method, errors witnessed or committed by health care providers may be reported via structured data collection systems. Analysis of error reports may provide rich details about latent errors that lead to active errors and adverse events. But error reporting systems alone cannot reliably measure incidence and prevalence rates of errors and adverse events because numerous factors may affect whether errors and adverse events are reported. Providers may not report errors because they are too busy, afraid of lawsuits, or worried about their reputation. High reporting rates may indicate an organizational culture committed to identifying and reducing errors and adverse events rather than a truly high rate. Despite these limitations, error reporting systems can identify errors and adverse events not found by other means, such as chart reviews, and can thereby be used in efforts to improve patient safety. 5. Underreporting of iatrogenic events 5.1. Only a fraction of medical errors are reported As few as 5% and no more than 20% of iatrogenic acts are ever reported (Bates, Cullen & Laird, et al., 1995; Barczak, Barnett, & Childs Bosley, 1997; Leape, 1994; Starfield, 2000a,b; Thomas et al., 2000b). Leape (1994) said he was well aware that medical errors were not being reported. A study conducted in two obstetrical units in the UK found that only about one-quarter of adverse incidents were ever reported, to protect staff, preserve reputations, or for fear of reprisals, including lawsuits (Bates et al., 1995). An analysis by

Plate 1. Framework for identifying medical errors.

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Table 3 Advantages and disadvantages of methods used to study adverse events and medical errors. Study method

Advantages

Disadvantages

Morbidity and mortality conferences and autopsy

Can suggest contributory factors Familiar to healthcare providers

Hindsight bias Reporting bias Focused on diagnostic errors Infrequently used

Case analysis/root cause analysis

Can suggest contributory factors structured systems approach

Hindsight bias Tends to focus on severe events Insufficiently standardized in practice

Claims analysis

Provides multiple perspectives [patients, providers, lawyers]

Hindsight bias Reporting bias Non-standardized source of data

Error reporting systems

Provide multiple perspectives over time Can be a part of routine operations

Reporting bias Hindsight bias

Administrative data analysis

Uses readily available data Inexpensive

Might rely on incomplete and inaccurate data The data are divorced from clinical context

Record review/chart review

Uses readily available data Commonly used

Judgements about adverse events not reliable Medical records are incomplete Hindsight bias

Review of electronic medical record

Inexpensive after initial investment Monitors in real time Integrates multiple data sources

Susceptible to programming and/or data entry errors Expensive to implement

Observation of patient care

Potentially accurate and precise Provides data otherwise unavailable Detects more active errors than other methods

Time consuming and expensive Difficult to train reliable observers Potential concerns about confidentiality Possible to be overwhelmed with information

Potentially accurate and precise for adverse events

Time consuming and expensive

Includes recent data from interviews

Active clinical surveillance

Wald and Shojania (2001) found that only 1.5% of all adverse events result in an incident report, and only 6% of adverse drug events are identified properly. The authors learned that the American College of Surgeons estimates that surgical incident reports routinely capture only 5–30% of adverse events. In one study, only 20% of surgical complications resulted in discussion at morbidity and mortality rounds (Vincent, Stanhope, & Crowley-Murphy, 1999). From these studies, it appears that all the statistics gathered on medical errors may substantially underestimate the number of adverse drug and medical therapy incidents. They also suggest that our statistics concerning mortality resulting from medical errors may be in fact be conservative figures. Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA. The reasons range from not knowing such a reporting system exists to fear of being sued. Yet the public depends on this tremendously flawed system of voluntary reporting by doctors to know whether a drug or a medical intervention is harmful. If hospitals admitted to the actual number of errors for which they are responsible, which is about 20 times what is reported, they would come under intense scrutiny (Vincent et al., 1999). Jerry Phillips, associate director of the FDA’s Office of Post-Marketing Drug Risk Assessment, confirms this number. “In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur” (Bates, 1998). Dr. Jay Cohen, who has extensively researched adverse drug reactions, notes that because only 5% of adverse drug reactions are reported, there are in fact 5 million medication reactions each year (Dickinson, 2000). 5.2. Factors influencing reporting behaviour The patient safety purpose of identifying adverse events is to prevent their recurrence. If errors that are identified cannot be prevented by systematic procedures or protocols, then reporting them

may not be necessary to an error prevention system. Other reasons for reporting them, such as identifying practitioners who are not capable of practicing within acceptable bounds of competence may, however, be important. There are many plausible reasons for underreporting medical errors. Massachusetts Health Policy Forum Issue Brief drew upon several sources and suggested the following factors (Barach & Kelly, 2000) (Table 4.1). The following factors were suggested by the Institute of Medicine in its report To Err Is Human (Table 4.2). The British Department of Health, in its own study of medical error similar to that of the Institute of Medicine, An Organization Table 4.1 Factors influencing reporting behavior. Legal Fear of reprisals Lack of trust Bad publicity Organizational culture Profession-dependent individuals Bureaucratic organizations Code of silence Fear of colleagues in trouble Skepticism Extra work Lack of effectiveness of present reporting systems Regulatory Exposure to malpractice liability Increased premiums Investigation and potential censure License suspension and subsequent loss or income Attitude that regulations are unnecessary or irrelevant Financial Loss of reputation, job Extra work, waste of resources Potential loss of revenues, contracts Not cost-effective

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Table 4.2 Factors influencing reporting behavior.

Table 5 The research agenda on medical errors reporting systems.

Concern for keeping the identities of organizations and providers confidential Concern that reported information may not be used so that time spent reporting is considered worthwhile Lack of training and education in recognizing relevant events Lack of clear standards, definitions and tool for reporting Lack of payment for reporting

Time period

Short term

Table 4.3 Factors influencing reporting behavior. Lack of awareness of the need to report, what to report, and why Lack of understanding of how to report Staff feel they are too busy to make a report Too much paperwork involved in reporting The patient recovers from the adverse event and the urgency goes out of the situation Fear of ‘point-scoring’ by colleagues, retribution by line management, disciplinary action or litigation An assumption that someone else will make the report No evidence of timely feedback and/or corrective action being taken resulting from making a report

with a Memory, recommended a mandatory reporting scheme for adverse health events and specified near misses and changing the organizational culture to encourage reporting in the National Health Service (NHS). In its follow-up report of plans to implement a new patient safety system in the NHS, Building a Safer NHS for Patients, the British Department of Health noted the following barriers in the NHS that need to be overcome in order to encourage reporting adverse events and near misses (Table 4.3). 6. The research agenda on medical errors reporting systems—the landscape of medical errors reporting systems worldwide 6.1. The research agenda on medical errors reporting systems Although the success of healthcare informatics models is well documented and their applicability to patient safety is clear, they have not been widely adopted. A National effort to further knowledge about the application and effectiveness of these technologies to patient safety improvement and to promote the appropriate adoption of these tools would build on a strong foundation of prior work and put health care technologies to use in improving the quality of care for Greek people. In Greek National Health System most health care providers currently work with handwritten patient notes, which are often difficult to read, not readily available, incomplete, and prone to alteration, destruction, and loss. Electronic medical records and interactive decision-support tools would have the potential to allow health care providers timely knowledge of a patient’s health history and improve clinical care. Information technology has tremendous potential to reduce errors in health care by providing information when it is needed, providing clinical feedback, and alerting providers to potential problems. But, as well known, information technology also has the potential to cause errors. Therefore, attention to human factors and other aspects of system design is vital. Additional research is needed to explore the effectiveness of information systems and other technical aspects of medical products. The research agenda, especially for medical errors reporting systems, should focus on short, medium and long-term aspects, as shown in Table 5.

Medium term

Long term

Issues on research agenda What makes a reporting system successful? What useful data sources exist? What can we learn from existing systems? What data should be collected and how? Can we develop a common definition of a “reporting system” or what data is most useful for which purposes? For example, should reports primarily focus on errors, injuries, “incidents,” risk factors, or safety practices? Who should submit those reports? Should it be providers, hospitals or organizations, patients, manufacturing companies, and/or administrative bodies? How should the data be collected? Should it be by compiling routinely collected surveillance data on indicators of possible errors, performing a medical record review, or conducting surveys? How should be classify the types of errors (commission, omission, severity)? How can privacy/confidentiality be assured? What legislation facilitates/hinders reporting? What infrastructure is needed to support data collection, analysis and use? How does one collect information on omissions of care? How can data be clustered to facilitate analysis? How do we measure success of the reporting systems? In providing information to potential users, how can confidentiality and the need to inform be balanced? How can we best develop infrastructure to support data collection, analysis, and use? How do we measure overall success of the reporting systems? How can more complete data be collected?

Adopted from: Research Agenda: Medical Errors and Patient Safety. National Summit on Medical Errors and Patient Safety Research. October, 2000. http://www.quic.gov/ summit/resagenda.htm.

6.2. Medical errors reporting systems—the landscape worldwide The Netherlands is the latest country to announce the development of a national medical error reporting system. Australia has had one since 1989, Denmark has one, the UK introduced theirs in 2001, Canada announced their plans in 2003 and the USA has a proliferation of error reporting systems, including several that have been going for a number of years and that have a well developed body of knowledge steering their use and development—for example, the Medical Event Reporting System for Transfusion Medicine (MERS-TM) and the US Pharmacopeia’s MEDMARX Reporting System. Developed western countries do therefore seem to have “bought into” the message that medical error reporting systems are a very “good thing”—although there is little evidence that pragmatic cautions have been well considered in setting them up (Tunis & Gelband, 1994). 7. Medical errors’ information management: policy issues and towards a national strategy 7.1. Medical errors’ information management—policy issues Patient safety is extraordinarily important to the public, but the policy issues around adverse event detection and medical errors are nettlesome. In Greek health care system today, most adverse events are detected using spontaneous reporting, which identifies only a small number of adverse events. This is probably the major reason that problems with patient safety have been overlooked until recently. However, information technology can be used in a variety of ways to detect adverse events continuously and relatively inexpensively.

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Unfortunately, given the current structures of health care in the U.S., there are strong incentives for Healthcare Organizations to turn a blind eye to medical errors and adverse events. In particular, serious, preventable adverse events typically should be reported to the Ministry of Health. Unfortunately such events often lead to long lasting internal investigations from the hospital’s manager or end up in the press or in the courts, with adverse consequences for a doctor, a hospital or for the Health Care System. Thus, adverse events have negative connotations to many, and our current system offers few incentives to healthcare organizations to look for them aggressively (Bates et al., 2003).

in how our society views and treats medical errors. We would like to stress that medical error reduction is fundamentally an information problem. The solution to reducing the number of medical errors resides in developing mechanisms for collecting and managing existing information. If we are going to make significant strides in enhancing patient safety, we must think in terms of the information we need to obtain, create, and disseminate. With this in mind, we suggest there are five critical, information-based tasks whose completion is essential to an effective error-reduction strategy. In theory, a single organization could perform all of these tasks, but in fact, multiple public and private sector organizations will have roles to play (CHSOI, 2003):

7.2. Medical errors’ information management—towards a national strategy

1. The first task is the creation of a blame-free, protected environment that encourages the systematic surfacing and reporting of serious adverse events and medical errors. Today, the blameand-punishment orientation of our society drives errors underground. Indeed, we believe that most medical errors never reach the leadership level of the organizations in which they occur. For the typical caregiver involved in a medical error that leads to a serious adverse event, the incentives to report are all negative—potential job loss, humiliation, shunning. It is a small wonder that we know so little about this terrible problem. If we are to get a handle on the epidemiology of medical errors, we must create a protected, blame-free environment that

Our proposed strategy will focus on the tasks that we believe must be carried to reduce errors nationwide. Dramatically reducing the number and seriousness of errors will take a concerted effort – particularly including a willingness to share information – by all who participate in and oversee the delivery of health care. The goal for the country should be to find ways to increase knowledge about why errors occur and to manage that information in a manner that will enhance patient safety. On the surface this sounds simple, but success will in fact require a cultural shift Table 6.1 Serious reportable events in healthcare.

1. Surgical events

2. Product or device events

3. Patient protection events

4. Care management events

5. Environmental events

6. Criminal events

A. Surgery performed on the wrong body part B. Surgery performed on the wrong patient C. Wrong surgical procedure performed on a patient D. Unintended retention of a foreign object in a patient after surgery or other procedure E. Intraoperative or immediately postoperative death in an ASA Class I patient A. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility B. Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended C. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility A. Infant discharged to the wrong person B. Patient death or serious disability associated with patient elopement (disappearance) C. Patient suicide, or attempted suicide, resulting in serious disability while being cared for in a healthcare facility A. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration) B. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products C. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility D. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility E. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates F. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility G. Patient death or serious disability due to spinal manipulative therapy H. Artificial insemination with the wrong donor sperm or wrong egg A. Patient death or serious disability associated with an electric shock while being cared for in a healthcare facility B. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances C. Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility D. Patient death or serious disability associated with a fall while being cared for in a healthcare facility E. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider B. Abduction of a patient of any age C. Sexual assault on a patient within or on the grounds of a healthcare facility D. Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare facility

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Table 6.2 Comparison of proposition for mandatory and voluntary systems.

Mandatory system Voluntary system

What is the purpose of system?

Who administers the system?

What data are collected?

Are data on individual incidents disclosed?

Accountability Quality improvement

State Private

Serious adverse events Near misses

Yes No

will lead to a more accurate understanding of their scope and nature. 2. The second task is the production of credible “root cause” analyses of serious adverse events and medical errors. When a serious error occurs, it is essential that there be an intensive, no-holds-barred vetting of all of the potential causes underlying the event. We call these responses “root cause” analyses—a term borrowed from the engineering world’s orientation to a systems approach both to solving problems and to producing desired outcomes. 3. The third task is implementation of concrete, planned actions to reduce the likelihood of similar errors in the future. The principal derivative of a root cause analysis is an action plan that focuses on improving the organization systems which related to the serious adverse occurrence. It is essential that implementation of this action plan be monitored and confirmed by an independent oversight body. The response to an error does not terminate simply with the report itself or even an analysis of what went wrong. 4. The fourth key task is the establishment of patient safety standards which health care organizations must meet. The patient safety standards for health care organizations must be made clear in order to make the identification and management of medical errors a high priority for organization leadership. The new stan-

dards require that the leadership of a health care organization establish processes for identifying and managing sentinel events and put these into practice. The standards also require that the organization monitor the performance of particular processes that involve risks or may result in sentinel events, and intensely analyze undesirable patterns or trends in performance. Compliance with these new patient safety standards is evaluated through our periodic onsite inspection process. 5. The fifth task is to dissemination of experiential information learned from errors to all organizations at risk for serious adverse events. To have a positive national effect on patient safety, information gleaned from errors must be aggregated, analyzed and disseminated to the health care community at large. This can be done at different levels in the health care system. 8. MERIS: analysis of medical errors reporting informartion system 8.1. MERIS modules Traditional efforts to detect adverse events have focused on voluntary only reporting and tracking of errors. However, public health

Plate 2. MERIS architecture.

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researchers have established that only 10–20% of errors are ever reported and, of those, 90–95% cause no harm to patients. A national strategy need a more effective way to identify events that do cause harm to patients in order to quantify the degree and severity of harm, and to select and test changes to reduce harm. So, MERIS supports two Web-based modules of reporting systems: the voluntary reporting module, for errors that result in very minimal or no harm, and the mandatory reporting module, for errors that result in death or serious permanent injury. This approach is modelled after highly successful reporting efforts in

the aviation industry, where incidents or “near misses” are reported to a non-regulatory entity, while accidents that result in death or serious injury or substantial damage to aircraft are reported to investigative and regulatory entities. The proposed nationwide system of medical errors reporting includes both mandatory and voluntary components: • Mandatory Reporting System. The development of a nationwide mandatory reporting system will aim in the collection of standardized information by public and private healthcare

Report Title

Please describe the incidence in details

Incidence data

Does thw incidence caused any harm?

Place of incidence

Date/Time of incidence

Please select

Please select

Please fill in (yyyy/mm/dd)

Pleaese check all that fit

Medical Error Classification Other factors (please fill in)

Factors contributed to the Medical Error

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Pleaese check all that fit

Other factors (please fill in)

Plate 3. Reporting form.

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organizations about medical errors and adverse events that result in death or serious harm. Adverse events and medical errors reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery systems. We recommend that this system should be implemented nationwide, linked to systems of accountability, and made available to the public. We believe that if the Ministry of Health chooses to implement the mandatory reporting system, a dedicated Department should serve as the responsible entity. According to latest research (NQF, 2007), only serious events must be reported. The proposed classification is presented in Table 6.1. The mandatory reporting system adapts the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Errors. Therefore, it counts only adverse events that cause harm to the patient (as defined above), whether or not the result of an error. Accordingly, excludes the following categories in the NCC MERP Index because these categories describe medication errors that do not cause harm. Category A: Circumstances or events that have the capacity to cause error. Category B: An error that did not reach the patient. Category C: An error that reached the patient but did not cause harm. Category D: An error that reached the patient and required monitoring or intervention to confirm that it resulted in no harm to the patient. The mandatory reporting system includes categories E–I of the NCC MERP Index because these categories describe errors that do cause harm. Category E: Temporary harm to the patient and required intervention. Category F: Temporary harm to the patient and required initial or prolonged hospitalisation. Category G: Permanent patient harm. Category H: Intervention required to sustain life. Category I: Patient death. • Voluntary Reporting System. Voluntary error reporting is at the heart of any safety improvement strategy. The vast majority of errors results in no harm, or has only very minimal temporary effects. These types of errors represent very important opportunities to identify systems’ weaknesses and institute improvements before serious harm occurs. To facilitate the development of voluntary reporting systems, we recommend that the Ministry of Health must implement peer review protections to the information included in voluntary sys-

tems, and that extra financing and technical support be provided, so as to an applied research centre to be created. In many countries, some excellent voluntary reporting programs already exist. The different characteristics of Mandatory and Voluntary modules, are shown in Table 6.2. 8.2. The infrastructure environment of MERIS system The MERIS technical architecture, as shown in Plate 2, is basically Web-based, also supported by a local area network, in a way so as to share information locally and via web. MERIS resources and information management is analyzed in the seven following paragraphs. • Unit 1—Data base Basic component of MERIS is the development of a relational Database with dual aiming: ◦ Integration of different information needs. ◦ Supporting specialized information needs. Database will be stored to a powerful server. For the development of the data base a RDBMS system will be used, as Microsoft SQL Server, Oracle Database Server, Sybase Adaptive Server, etc. • Unit 2—Application Data base abilities will be exploited by designing a friendly Graphical User Interface—GUI. A structured online reporting form developed. The top section of the scroll-down form is shown in Plate 3. This simple interface provides several predefined fields for: (1) the degree of patient harm that resulted from the error, (2) the location of the error or near miss, (3) the time of occurrence of the error, (4) the categories in which the error would fit, (5) the factors that contributed to the event, and (6) the factors that mitigated the effects of the event. In addition, a text box was provided for feedback and suggestions on how to improve the error reporting system. Responses to fields 1–6 in the list above were to be chosen from either a drop-down list or a check box. • Unit 3—Data Warehouse MERIS database, records and manages a wide rage of continuously renewing operational data. So the need of historical data so as data backup make necessary the development of a Data Warehouse. Data Warehouses are capable of analytical data selection from relational databases, and furthermore data “cleaning” and integrating. The process of data storing methodology and information transformation consists from six layers:

Plate 4. Information process to data warehouse.

A. Vozikis / International Journal of Information Management 29 (2009) 15–26

•

•

• •

• 1st layer—Data Sources. • 2nd layer—Population responsible for the selection, and transformation of operational data. • 3rd layer—Operational Data Warehouse, containing crossfunctional information. • 4th layer—Pipes, responsible for the transformation of operational data to information. • 5th layer—Business Information Warehouse (BIW), the core of DW. • 6th layer—Meta data repository. A graphical presentation of information management is shown in Plate 4. Unit 4—System Administration The System Administrator will provide Write/Read access rights and will be responsible for the global management of MERIS system. Unit 5—Web Server The Web Server will function as the “gate” of MERIS to Internet. There will be stored the web-pages and the applications for the external users. The web-pages will be dynamic (ASP, XML), so as the data collection process to be fast and reliable. Unit 6—Firewall Protection against external threats. Unit 7—Safety Interaction with “MERIS” system All MERIS users’ reports data, will be filed in and transmitted using the SSL-128 bit security protocol.

9. Conclusions—proposals It is clear that a systematic effort to understand and reduce medical errors will be the cornerstone of health care providers’ professional responsibility in coming years. The development and implementation of MERIS, in order to identify, collect, analyse and report medical errors and patient adverse events, as a tool for enhancing patient safety and health care quality, will contribute to the efforts to minimize medical errors. For improving the safety of the health care system, additional actions (parallel to MERIS development and implementation) can and should be taken to reduce errors. Below is provided some of the current activities, as well as recommendations for additional activities to reduce errors through increased awareness of medical errors: • • • • • •

Building Public Awareness of Medical Errors Building Purchasers’ Awareness of the Problem Working With Providers to Improve Patient Safety Using Decision-Support Systems and Information Technologies Using Standardized Procedures, Data Integration Checklists, and the Results of Human Factors Research

Of course, the key task for the future effectiveness of any medical errors’ reduction strategy will be to identify quality-assurance practices that could respond effectively to system data. We must not forget, that even countries with a long history of error reporting, have not yet implemented comprehensive programs to correct problems once they are identified. Also, information about new medical technologies should be included in programs to reduce the incidence of medical errors. Although the medical literature has focused primarily on medication- and procedure-related errors, there is little information on the potential benefits and hazards associated with the use of new medical technologies.

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Additional concerns arise from the legal dilemmas that mandatory reporting systems are likely to generate. When the reporting of errors concerns death or other serious detriment to patients, accountability will become an issue. Not only might malpractice claims rise with increased error reporting, but hospitals and health care professionals may be less likely to report mistakes if they are not protected from litigation arising from the reporting process. A successful medical errors’ information management system should ensure that health care organizations are able to examine medical errors without fear of punishment. References Barach, P., & Kelly, M. (2000). Medical errors and patient safety in Massachusetts: What is the role of the Commonwealth! (Massachusetts Health Policy Forum) p. 6. Barczak, C. A., Barnett, R. I., Childs, E. J., & Bosley, L. M. (1997, July–August). Fourth national pressure ulcer prevalence survey. Advances in Wound Care, 10(4), 18–26. Bates, D. W., Cullen, D. J., Laird, N., et al. (1995, July). Incidence of adverse drug events and potential adverse drug events Implications for prevention. ADE Prevention Study Group. JAMA, 274(1), 29–34. Bates, D. W. (1998, April). Drugs and adverse drug reactions: How worried should we be? JAMA, 279(15), 1216–1217. Bates, D. W., Evans, R. S., Murff, H., Stetson, P. D., Pizziferri, L., & Hripcsak, G. (2003, March–April). Policy and the future of adverse event detection using information technology. Journal of the American Medical Informatics Association, 10(2), 226–228. Burger SG, Kayser-Jones J, Bell JP. (2000, June). Malnutrition and dehydration in nursing homes: key issues in prevention and treatment. National Citizens’ Coalition for Nursing Home Reform. Congressional House Subcommittee Oversight Investigation (2003). Cost and Quality of Health Care: Unnecessary Surgery. Washington, DC: Government Printing Office; 1976. Cited in: McClelland GB, Foundation for Chiropractic Education and Research. Testimony to the Department of Veterans Affairs’ Chiropractic Advisory Committee. Dickinson, J. G. (2000, March). FDA seeks to double effort on confusing drug names. Dickinson’s FDA Review, 7(3), 13–14. European Commission (2005). Special Eurobarometer HCUPnet, 2003, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm. Accessed December 18. HCUPnet, (2003 December). Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Institute of Medicine. (1999). To err is human: Building a safer health system. Washington, DC: National Academy Press. Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press. Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998, April). Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA, 279(15), 1200–1205. Leape, L. L. (1993). Preventing medical injury, QRB quality. Review Bulletin, 19(5), 144–149. Leape, L. L. (1994). Error in medicine. JAMA, 21(272), 1851–1857. MMWR. (2000, February). Fourth Decennial International Conference on Nosocomial and Healthcare-Associated Infections. Morbidity and Mortality Weekly Report, vol. 49, No. 7, p.138. NQF (2007). Serious reportable events in healthcare—2006 Update, Washington DC, ISBN 1-933875-08-9. Null, Gary, Dean, Carolyn, Feldman, Martin, Rasio, Debora, Smith, Dorothy (2007). Death by Medicine, Life Extension Foundation. Quality Interagency Coordination Task Force (QuIC) (2000). Report to the President, February, doing what counts for patient safety: Federal actions to reduce medical errors and their impact [Website]. Accessed September 7, 2003. http://www. quic.gov/report/mederr4.htm#evidence. Starfield, B. (2000, July). Is US health really the best in the world? JAMA, 284(4), 483–485. Starfield, B. (2000, November). Deficiencies in US medical care. JAMA, 284(17), 2184–2185. Thomas, E. J., Studdert, D. M., Runciman, W. B., Webb, R. K., Sexton, E. J., Wilson, R. M., et al. (2000). A comparison of iatrogenic injury studies in Australia and the USA. I: Context, methods, casemix, population, patient and hospital characteristics. International Journal for Quality in Health Care, 12, 371–378. Thomas, E. J., Studdert, D. M., Burstin, H. R., Orav, E. J., Zeena, T., Williams, E. J., et al. (2000). Incidence and types of adverse events and negligent care in Utah and Colorado. Medical Care, 38(3), 261–271. Thomas, E. J., & Petersen, L. A. (2003). Measuring errors and adverse events in health care. Journal of General Internal Medicine, 18(1), 61–67. Tunis, S. R., & Gelband, H. (1994). Health care technology in the United States. Health Policy, 30(1–3), 335–396.

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Xakellis, G. C., Frantz, R., & Lewis, A. (1995, May). Cost of pressure ulcer prevention in long-term care. American Geriatrics Society, 43(5), 496–501. Vozikis Athanassios is a Lecturer at the Department of Economics of the University of Piraeus. He holds a MSc in Health Informatics from Kapodistriako University of Athens and a PhD in Health Economics and Information Systems from the University of Piraeus. He has participated in several research projects related to the analysis–development and implementation of information systems, business reengineering processes in the health care sector, as well as in various other sectors in public and private organizations. His research interests are in the field of health economics, environmental health, E.R.P. systems, health information systems and digital economy. He can be reached at [email protected].