Do No Harm: Can Health Care Live Up to It?

R. Nat Natarajan and Amanda Hoffmeister

The Mayberry Chair addresses performance excellence in all areas of manufacturing and services which employ business graduates. The health care sector represents about one seventh of the US GDP, and faces numerous quality and performance problems of great significance to virtually all Americans. Increasingly, business graduates are employed in the health sector, as this sector becomes more and more challenged with cost control, while at the same time raising expected quality levels. Although there are many performance parallels between the health care and other sectors, there are also numerous special issues and terminology, as well. It is important and beneficial to encourage health care specialists to learn from other sectors. It is also very likely that other sectors will learn much from a better understanding of health care. This article addresses key issues in health care appropriate for sharing with the Mayberry community and places them in context with more traditional “quality management.”

Issues concerning safety and quality have recently been under more intense public limelight and scrutiny. Recent publications have increased public awareness of safety or lack thereof in health care systems. They are the Institute of Medicine’s (IOM) study titled To Err is Human: Building a Safer Health System [1] and the follow-up reports that were triggered by it, the IOM’s recently released report, Crossing the Quality Chasm: A New Health System for the 21st Century [2], and Report of the Quality Interagency Coordination (QuIC) Task Force to the President [3].

The key findings of the IOM report concerning medical errors can be summarized as follows. The majority of medical errors today are not produced by negligence, lack of education, or lack of training. Rather, errors occur in our health care systems due to poor systems design and organizational factors, much as in any other industry. Health care workers are placed in systems and settings where errors are bound to happen. That is, the systems are designed to achieve a particular set of goals, but inadvertently produce a certain level of errors.

I. What is Different About Health Care?

There are some characteristics of the health care industry that distinguish it from other industries. Although the managerial processes in the health care industry are similar to those of other industries, the prevalent norms, culture, practices, and the regulatory framework can promote or hinder efforts to improve safety.

  1. Health care systems are very complex in terms of their constituent elements (e.g., patients, physicians and other health care professionals, purchasers of health care, payers, insurers, regulators, accrediting and licensing bodies, health care administrators, and professional groups), the web of relationships between them, and the knowledge, skills, and technologies that are utilized. These groups have their own definitions of errors and quality in health care. The interests of some of these groups are also sometimes in conflict.
  2. It is difficult in health care systems to establish precise linkages between the inputs and the resulting outcomes. Therefore, it is not always possible to study and model the delivery of clinical care as a “process” as it is done in, say, manufacturing. The outcomes in terms of patients’ physiological and psychological states lag—sometimes in years—the treatments they receive. The outcomes are also dependent on the cooperation and the compliance of patients themselves. Hence, it becomes quite difficult to implement the principle that quality Gurus like Dr. Deming emphasize—quality can be improved only by improving the process. Lack of process knowledge could also be one of the factors that lead to litigation being viewed as the only recourse in the case of adverse outcomes. The difficulties are compounded by the fact that advances in clinical knowledge, medications, and technologies in health care are taking place very rapidly.
  3. In health care, there is an information asymmetry between the care provider and the patient. The professional judgment of the caregiver determines the nature of the clinical care that is provided. Thus, the patient often cannot judge the quality or the safety of clinical care that s/he is receiving. In this respect, health care may not be very different from other professional services (e.g., accounting, legal, education) where such asymmetry also exists and professional judgment influences the outcomes. Nevertheless, it underscores the difficulties in developing and monitoring quality and safety standards for clinical practices. This makes the health care market one in which the consumers do not have the requisite information about quality, safety, and utility to make informed choices. Thus consumers cannot adequately exert their power in the marketplace to bring about changes in health care providers.
  4. In many health care institutions, there are dual lines of authority—one involving the medical staff and the other the administrative staff. In most organizations in other industries, the managerial core has control over the technical core. This complicates health care decision-making concerning design and implementation of safety improvement projects.
  5. Health care organizations are concerned about litigation in the context of tracking and reporting medical errors. This inhibits the relevant information from being shared within and between health care organizations. Legal constraints on access to and sharing of information relating to patients also prevent the dissemination of the information, which could be useful in preventing errors.
  6. In other industries like the automotive, large customers routinely exert pressure on their suppliers for continuous improvements in quality and costs. This is just beginning to happen in health care as large group purchasers want the health care organizations to improve their performance, but this has not become standard industry practice so far.
  7. Mechanisms and institutions for research and dissemination of research on safety in health care are still in a developmental stage.
  8. There are powerful subcultures in health care organizations based on occupation and specialization, for example, physicians, nurses, and pharmacists. Their interests and functional orientations are not conducive to a systems approach to the promotion of safety.
  9. Another unique aspect is that the rate of health care errors is far higher than the error rate in other industries. In one study of intensive care units (ICU), the correct action was taken 99.0 percent of the time, translating to 1.7 errors per day in the units studied. One out of five of these errors was serious and/or potentially fatal. If performance levels even substantially better than those found in the ICU (for example, 99.9%, a 10-fold reduction in errors) were applied to the airline and banking industries, it would still equate to two dangerous landings per day at O’Hare International Airport and 32,000 checks deducted from the wrong account per hour. In these industries, such error rates would not be tolerated. According to industry studies, the aviation industry seems to be operating at 5-Sigma level of errors. According to the IOM report, even when using the lower estimate of 44,000, deaths in hospitals due to preventable adverse events exceeded in 1997, the deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (15,516).

II. Quality Management in Health Care

The traditional approach to quality management in health care has relied on licensure, certification and accreditation, and the use of chart review methods. Over the years, a number of organizations have been involved in the development and deployment of these structural quality assurance mechanisms. Most notable ones are Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Commission on Professional and Hospital Activities (CPHA), Regional Medical Programs (RMPs), Experimental Medical Care Review Organizations (EMCROs), Professional Standards Review Organizations (PSROs), and Peer Review Organizations (PROs). In one sense, these organizations form the backbone of the regulatory structure of the health care industry. Thus, the traditional quality management was externally driven. The positive aspect of this system is that it provided safeguards to the public in terms of standards of health care and minimal competence of the health care professionals and ensures at least their minimal participation in quality management activities. Its shortcomings are that it uses negative incentive of punishment in the cases of non-compliance, and the underlying premise seems to be that sanctions are needed to ensure quality. This cannot be expected to promote learning. It is seen as adding to costs, while only modest improvements are being achieved.

In the last 15 years or so, there have been many instances where the health care organizations have used the principles that underlie the industrial quality control model. These are the principles of total quality management (TQM) and continuous quality improvements (CQI) that have been successfully implemented in the manufacturing sector.

However, these concepts and tools did not always find acceptance among health care administrators and providers. Doubts such as: “How do we define and measure quality, which is a more subtle concept in health care?”; “Isn’t quality mainly a matter of the physician making the correct decision?”; “Where is the uniform product in medical care when every patient is different?”; and “How can it work with physicians who do not like to see themselves as team players?” were expressed. Some authors have argued that the nature of health care industry and practices are not conducive to the successful application of TQM.

It is difficult to generalize about effects of TQM in health care from isolated examples. Fortunately, the National Demonstration Project on Quality Improvement in Health Care provides a collection of twenty-one experimental projects whose purpose was to study if the quality management model will work in the health care setting.

Some of the important lessons learned were: quality improvement tools can work in health care, involving doctors is difficult, non-clinical processes draw early attention, and health care organizations may need a broader definition of quality.

Despite these important insights that were gleaned from these projects, as acknowledged by the initiators of the overall study, there were two major gaps that were associated with these projects. First, only a few project teams addressed core clinical processes such as physician decision making, diagnostic strategies, and medical treatments. Most teams worked on business and service support processes such as appointment waiting times, Medicare billing, patient discharge processes, and the hiring and training of nurses. Here the problems were similar to the quality problems in other industries. Another gap was that the projects did not try to change the organizational cultures. Clearly, both these gaps have to be addressed in any effort to reduce or eliminate medical errors.

III. Errors in Health Care

Errors in health care do not lend themselves to commonly agreed-upon definition and classification. This poses a challenge in the design and implementation of measures to prevent them.

An error is defined by QuIC 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.

Medical error is defined through adverse events. Medical error is an adverse event or near miss that is preventable with the current state of medical knowledge. Note that consideration of errors is broadened beyond preventable adverse events that lead to actual patient harm to include “near misses,” sometimes known as “close calls.” A “near miss” is an event or situation that could have resulted in an accident, injury, or illness, but did not, either by chance or through timely intervention. The broader definition of error allows learning from close calls as well as from incidents leading to actual harm [3]. Such learning has proved to be very valuable in other industries, such as aviation, manufacturing, and nuclear energy.

Medical errors have also been classified according to legal definition, e.g., errors resulting from negligence and type of individual involved (e.g., physician, nurse, patient). It must be noted that there is no universal agreement on the above classification. Errors occur not only in hospitals but in other health care settings, such as physicians’ offices, nursing homes, pharmacies, urgent care centers, and care delivered in the home. Unfortunately, very little data exist on the extent of the problem outside of hospitals.

It is also important to distinguish between active and latent errors. Active errors occur at the level of the frontline operator, and their effects are felt almost immediately. This is sometimes called the “sharp end.” Latent errors tend to be removed from the direct control of the operator and include things such as poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations. These are called the “blunt end.” Any attempt to prevent errors must address the latent errors, which implies focusing on the entire system and not just the elements of it.

The implication of these definitions and classifications is that a single approach to error reduction and prevention is not fruitful. Different types of errors call for different approaches.

IV. Error Prevention in Other Industries

Error prevention strategies in other industries have been part of an overall strategy for process improvement. The important features of these strategies can be summarized as follows:

  1. They have emphasized the control of the variation in the process.
  2. Processes were simplified; standards were developed, documented, and adhered to.
  3. Inexpensive but effective solutions (e.g., mistake proofing or poka-yoke) were used to design errors out.
  4. Automation, information, and simulation technologies were used to reduce and prevent defects.
  5. Trained and empowered employees implemented error prevention methods. They often worked in a multi-disciplinary team structure.
  6. Organizations have benchmarked their processes to identify and close performance gaps in critical processes.
  7. Process improvement strategies focused on multiple dimensions of process performance e.g., cost and cycle time.

V. Prospects for Error Reduction in Health Care

QuIC shares the belief of many experts that errors can be reduced and safety enhanced in health care by applying lessons from successful efforts in other American industries to improve quality. Today, there is no shortage of knowledge or the mechanisms to disseminate that knowledge. The Baldrige framework has been extended to the health care sector. There are many other state and local quality award programs that provide avenues for sharing best practices. Within health care itself, organizations like the National Coalition for Healthcare and Institute for Healthcare Improvement disseminate the best practices.

The second and final report of the IOM Crossing the Quality Chasm: A New Health System for the 21st Century goes beyond safety and identifies other areas where the need for improvement is urgent. Safety is viewed as one of the performance dimensions of health care performance. Effectiveness, patient-centeredness, timeliness, efficiency, and equity are the other dimensions. One of the ten recommended principles to guide design is that safety should be system property [2].

Several federal agencies have already taken the lead in creating meaningful patient safety systems within their health care delivery organizations. Veterans’ Affairs has an exemplary patient safety program, and the Department of Defense is developing one that is modeled after that of VA. The National Institutes of Health’s Clinical Center has a long standing “Occurrence Reporting System” to report unanticipated patient care events [3].

Large purchasers of health care are also driving the changes in many health care organizations. For instance, General Motors (GM), which has 1.25 million people in its health plans, is the largest private purchaser of health care in the U.S. It is working with partners in the health care industry to teach them principles of lean organization such as standardized work; plant, machine, and office layout; workplace organization and visual controls; lead time reduction; error proofing; employee process control; planned maintenance; and reduction of variation.

These forums and mechanisms are indeed necessary, but they are not sufficient to ensure the actual transfer of these best practices. For instance, it has been noted that the National Safety Partnership publicized a list of 16 proven and accepted best practices in medication safety. Many of them have been known for years but most are not used in a majority of hospitals. The case of health care industry in Japan also reinforces this point. Despite having a manufacturing industry known for its world class quality management system, the Japanese health care sector lags far behind U.S. in terms of efficiency, overall management, and the application TQM and CQI ideas.

All this leads one to conclude that there has to be a “felt need” for industry-wide, effective prevention of errors in health care in the U.S. At the level of individual health care organization, this “felt need” will be generated by a mix of factors. They are: (1) External compulsions by the consumers, purchasers, payers, accreditors and regulators. (2) Economic incentives from the marketplace that affect the bottom-line. (3) The leadership role and the role models of the federal agencies. (4) The organizational leadership that is willing and able to overcome the internal obstacles.

The on-line versions of Institute of Medicine reports 1)To Err is Human: Building a Safer Health System, 2) Crossing the Quality Chasm: A New Health System for the 21st Century can be found at the website of National Academy Press www.nap.edu. 3) Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Report of the Quality Interagency Coordination Task Force (QuIC) to the President February 2000 is available at http://www.quic.gov/report/

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