Assessing Medical Error in Health Care

November-December 2002


Mr. Kadzielski is head of West Coast Health Law Practice, Fulbright & Jaworski, LLP, Los Angeles; Ms. Martin is director of Performance Improvement, VHA West Coast, Pleasanton, CA.

A year ago we wrote about the complex process involved in identifying, categorizing, and assessing medical error in health care in the United States ("Assessing Medical Error in Health Care," Health Progress, November-December 2001, pp. 14-17). That article discussed the 1999 Institute of Medicine (IOM) report on medical error, "To Err Is Human," and the erosion of public trust in U.S. health care.

The IOM report has inspired many proposed solutions to the medical error problem. Some of these solutions present difficult challenges for health care providers whose resources have already been stretched by other problems, including nursing shortages and bioterrorism fears. Even so, Catholic health care providers, with their commitment to moral and ethical values, should be in the forefront in the development of a new culture of patient safety.

Toward a Culture of Safety
How can we — using our knowledge of both medical error and the obstacles to solving it — prevent medical error in an efficient and effective way? Success, we believe, will come from combining efforts and focusing on creating a culture of safety. Of course, making a cultural change in an organization is very difficult and takes time. However, it can be done — with the genuine commitment of the organization's leaders.

Creating a culture of safety requires that safety and reduction of medical error truly become a top priority of the entire organization — a priority demonstrated in action, not just in words. Catholic organizations can capitalize on the fact that they see health care as an essential good and a service to people in need. Providing a safe environment for all patients is integral to health care that serves the common good. The leaders of Catholic organizations will, by focusing on these important values in their communication and interaction with their staffs, facilitate a more rapid adoption of, and commitment to, a culture of safety.

One huge barrier to developing a safety-oriented culture is the tendency of health care professionals, administrators, and physicians to blame and punish those who commit errors. A blaming, punitive atmosphere impedes the reporting of medical errors and "near misses" and encourages staff to cover up latent errors that might otherwise have been uncovered.

Developing a blame-free environment usually requires leaders to change their perspective and, above all, apply the new concept consistently. A single firing or disciplining of a health care worker found to be at the "sharp end" of an error can undermine many months of policy development and communications with staff. Actions speak louder than words. Punitive action taken as the result of a frontline staff member's reporting of an error will undermine the staff's faith in the leaders' ability to follow their own new policies. Some leaders fear that a blame-free system will exempt clinicians from accountability. But this will not happen if leaders refine accountability into the following premise and then share it with the staff: Everyone has a duty to prevent error whenever possible and a duty to report all errors and near misses. Everyone has a duty to remedy resultant injuries and a duty to disclose such injuries to the injured parties.

The Veterans Administration (VA) provides a good example of the false starts that can occur when an organization moves toward a nonpunitive environment. In 1997, almost a year after the VA had launched its Patient Safety Improvement Initiative — which was designed to facilitate learning, not accountability — the agency formed a new, external panel of Patient Safety System Design to recommend alternative methods of enhancing reporting as a means of improving patient safety.1 This was necessary because although the Patient Safety Improvement Initiative had provided more information on what was happening in the system, it still fell far short of its goal. Departing from the typical "name and blame" approach in medicine is much easier to state in policy than to implement and cause to be embraced by all hospital staff.2

When Catholic health institutions incorporate the faith-based value of respect for the dignity of all persons, including staff members, into leadership strategies and interactions with all staff, a blame-free environment becomes both more evident and more credible as the foundation of a true culture of safety.

While hospitals are making efforts to increase the voluntary reporting of errors and near misses and promoting an educational analysis for system improvements, other organizations are, with federal support, implementing mandatory reporting systems. An example is New York State's Patient Occurrence and Tracking System (NYPORTS). Implemented statewide in 1998, this Web-based mandatory system makes it easier for hospitals to report adverse incidents, as required by state law. In December 2001, New York Governor George E. Pataki announced that NYPORTS had been awarded a $5.4 million federal grant. With this money, the state plans to improve the completeness of reporting so that the data, once analyzed, can be used to identify risk reduction strategies and reduce medical errors. Toward that end, New York will sponsor three demonstration projects that will help hospital systems study specific types of preventable errors.3

Actual Experience with the New JCAHO Safety Standards
On June 28, 2001, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced that new standards regarding patient safety and the reduction of medical errors would be implemented July 1 of that year.4 JCAHO added these standards to its "Leadership," "Improving Organizational Performance," and "Management of Information" areas. It also emphasized patient safety more strongly in its "Patient Rights," "Education of Patients and Families," "Continuity of Care," and "Management of Human Resources" areas. The new standards, responsibility for which falls on an organization's leaders, encourages the development of a culture of safety. In all, 31 new and revised standards have been added to seven functional chapters. The standards state that hospital leaders are to create an environment that:

  • Encourages error identification and remedial steps to reduce the likelihood of future, recurring errors
  • Minimizes individual blame or retribution to those involved in or who have reported an error
  • Establishes an actual or virtual organization-wide patient safety program that uses both internal and external knowledge and experience to prevent the occurrence of errors

In early 2002, JCAHO encouraged patients, by promoting a series of questions for them to ask health care providers, to take an active role in the prevention of medical error. The program is entitled "Speak Up." A brochure for it urges patients to do several things, including:

  • Educate themselves on diagnoses, medical tests, and treatment plans
  • Speak up if they have questions or concerns
  • Ask a trusted family member or friend to be their advocate
  • Participate in all decisions about their treatment5

Again, this promotion of a patient-provider partnership to reduce medical errors will not seem threatening to Catholic health care institutions because they suffuse all aspects of their operations with faith-based values. This partnership can and should be used to reinforce the values of respect for all persons and the belief that health care is a service and an essential good.

Although JCAHO in early 2002 declared a moratorium on scoring hospitals negatively on patient safety standards in situations where interviewees were unaware of Sentinel Event Alerts — its newsletter of patient safety advisories — the commission has directed accreditation surveyors to ask questions about incorrect site surgery. Our own experience this year has been that the physician surveyor is asking the following questions:

  • Has your hospital had a sentinel event or a near miss with an incorrect site surgery?
  • If yes, then please show your analysis of the root cause of the event or near miss.
  • If no, then please show a proactive analysis of this very high-risk and problem-prone process.

Through these questions, JCAHO underscores the fact that, despite its issuance of two Sentinel Event Alerts on incorrect site surgery, the number of reports of this error has increased. (This occurred during the period when hospitals were working to establish a blame-free environment, which resulted in more reports than before of actual events and near misses.) The episode also demonstrates JCAHO's continued sensitivity to patient safety issues, especially to the more obvious ones that tend to make newspaper headlines.

JCAHO has further codified its focus on patient safety with the announcement of six new patient safety goals that will go into effect January 1, 2003. These goals are disseminated in the commission's Sentinel Event Alerts; each goal includes one or two evidenced-based or expert recommendations.6 In the future, JCAHO has said it may continue some goals and replace others but will issue no more than six goals in each year.

The commission expects all hospitals to either incorporate these goals (or an acceptable alternative) or offer surveyors a credible explanation as to why a goal does not apply. Failure to adopt the goals will result in "type I" recommendations.*

* To maintain accreditation, health care organizations must resolve type I recommendations within a specific amount of time.

Disclosure of Information to Patients and Others
One of the most controversial new standards challenges the way hospitals currently address errors resulting in patient injury. The new requirement under "Patient Rights (RI.1.2.2)" says: "Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." The "intent" of this standard states, "The responsible licensed independent practitioner or his or her designee clearly explains the outcomes of any treatments or procedures to the patient and, when appropriate, the family, whenever those outcomes differ significantly from the anticipated outcomes." 7

In the past, health care organizations that feared liability and resultant legal actions have sometimes chosen not to inform the patient or family members of medical errors. The new standard forces organizational leaders to begin working toward a culture of safety and full disclosure of medical error to those affected by it.

ýhe difficulties with the disclosure process have been emphasized by both lawyers and health care professionals. As we noted in our previous article, Americans live in a culture of blame and punishment, where victims of medical errors expect significant financial compensation after findings of ultimate fault are made. This naturally tends to make providers reluctant to disclose information relating to medical errors. Yet an important distinction can and should be made between disclosure of errors to patients and families — which has been shown to have a positive effect on litigation avoidance — and disclosure of errors to governmental agencies, or to the public at large — where it may well be used in the blame/punishment cycle against those providers or others. Care must be taken to ensure that the patient comes first in this process and that disclosures made to patients — and made for his or her benefit — are the top priority.

Although many states have proposed medical error legislation in the past year, and a significant number have adopted measures intended to prevent medical errors, only a few have directly addressed the central issue of mandatory disclosure of errors to governmental agencies — primarily because of the perceived "chilling effect" such reports might have. The most creative approach has been that taken by Minnesota, which, in August 2001, established a confidential website where health facilities could report errors on an anonymous basis and then access the aggregate data in order to assist each other improve performance and quality. Health care providers may wish to follow the Minnesota program to determine whether such anonymous reporting helps improve quality and patient safety.*

* The innovative Minnesota law, S.F. 560, is part of reforms enacted in 2001 to create a Web-based, anonymous error-reporting system. Although other states have attempted to enact reporting laws to deal with errors, much of the debate involved has centered on whether the reporting should be mandatory or voluntary. Some states, such as Colorado, with its Colorado Revised Statutes 25-1-25 (2000), make reports public. Others — for example, Connecticut, in 2000 AB 6941 — make such reporting subject to regulations that have yet to be drafted. Still others — such as New York's CLS Public Health, section 2998 — establish "patient safety" centers with directions for the development of a "voluntary and collaborative" reporting system. Other states are likely to produce measures such as these in 2003.

In any event, a provider should take care in cases where disclosure to government agencies is involved, whether the disclosure is voluntary or mandatory. The provider should consult legal counsel with expertise in such matters because the disclosure could provoke a legal chain reaction that lasts for years and exposes the well-meaning caregiver to pain and suffering from a regulatory, if not criminal, standpoint.

Leadership Analyses of High-Risk Process
Another new standard that significantly affects hospitals is in JCAHO's "Leadership" chapter. Standard LD.5.2 states that leaders must ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented. The key to this new standard is the requirement for prospective ongoing analysis of a high-risk process. This is not a root cause analysis of an event or near miss, but rather an analysis designed to find the potential failure points before there is an event reported. Since July 1, 2001, JCAHO surveyors have taken discussion and problem-solving time from the survey agendas to share steps of the JCAHO recommended method of analysis for this new standard. This technique is borrowed from the engineering world, where it is known as "Failure Mode, Effect, and Criticality Analysis" (FMECA). In JCAHO's accreditation manual, the intent statement for this standard outlines the need for selecting at least one high-risk process for proactive risk assessment, identifying failure modes, and, for each failure mode, identifying its "criticality" — the likelihood that it will affect a patient.

FMECA is a systematic way of prospectively examining a design for possible ways in which failure can occur. It assumes that no matter how knowledgeable or careful people are, failures can happen because of weaknesses in the process. This method attempts to identify these weak points and their criticality before the process fails. Performing FMECA involves three steps:

  • Listing the failure modes for the proposed or actual situation or design
  • Describing the effect of each failure mode on the other components or systems
  • For each failure mode, rating the likelihood of occurrence, accessibility, and detectability, and determining the risk priority

Surgical site verification is an example of a high-risk process that — because it may have severe repercussions for the patient, hospital, and physician — can be prospectively examined to meet this standard. Performing surgery on the wrong limb, organ, or side of the body can obviously have extreme consequences. Although many people consider such surgical error highly unlikely, its incidence has in fact been increasing despite sentinel event warnings issued by JCAHO.

Although many health care leaders are uncomfortable with the increased public scrutiny their organizations have received because of medical error, this scrutiny will be positive if it results in actions to reduce the frequency and severity of such error. Creating a culture of safety will, because it makes the frontline staff feel safe when reporting them, show leaders the frequency and extent of errors and near misses.

Catholic health care professionals, physicians, and administrators remain in today's complex patient-care environment because their beliefs and principles motivate them to provide optimal care for all patients. The challenge for such leaders will be to recapture the public's trust and confidence and demonstrate that Catholic health care organizations are committed to providing high-quality care in a culture of safety with an absolute minimum of medical errors.


  1. J. P. Bagian, et al., "Developing and Deploying a Patient Safety Program in a Large Health Care Delivery System," Journal on Quality Improvement, vol. 27, no. 10, 2001, p. 524.
  2. "ISMP survey on perceptions of a non-punitive culture produces some surprising results," ISMP Medication Safety Alert, September 19, 2001, which can be found at www.ismp.org. The Institute for Safe Medication Practices (ISMP) has developed a tool that helps hospitals assess staff attitudes as they struggle to come to terms with individual accountability in a nonpunitive culture. (The survey questions are available in the June 27, 2001, ISMP Medication Safety Alert.) ISMP noted that more than half of the 1,200 survey respondents at the executive and staff levels (excluding those who were pharmacists) believed that, to protect patient safety, employees who make fatal or repeated mistakes should incur disciplinary action or termination. Nurses were the most likely to feel this way. Such opinions reflect hindsight bias and undermine efforts to create a nonpunitive culture because they encourage staff to conceal and fail to report their mistakes and near misses, especially if they believe their peers share a punitive attitude toward error. Using an ISMP-like anonymous assessment of staff beliefs (including those of administration personnel, pharmacists, technicians, nurses, and quality improvement and risk management specialists) would give organizational leaders a true picture of staff perceptions with which they could craft new policies and procedures. If leaders have a clear picture of their organization's current environment, they will improve their chances of moving from a punitive culture to a nonpunitive one.
  3. "Governor announces $5.4 million to improve patient safety," press release of December 19, 2001.
  4. "Hospitals Face New JCAHO Patient Safety Standards on July 1," JCAHO press release of June, 28, 2001.
  5. "Speak Up: National Campaign Urges Patients to Join Safety Efforts," JCAHO
  6. JCAHO sentinal event alert.
  7. JCAHO, "2001 Hospital Accreditation Standards, Standards and Intents," 2001.

Action Steps for Creating a Culture of Safety

Make it known that safety is a top priority — through action. bevote resources to safety, manage preventively and proactively, and pay attention to priorities.

Stop talking about eliminating errors. Human error is unavoidable; error cannot be eliminated. The focus should instead be on learning from errors.

Deal with the authority gradient and fear. Stop punishing people for making mistakes, resist blaming frontline staff for system problems, reward safety decisions regardless of cost, and implement effective command and control functions without micromanaging.

Develop and enhance data collection systems. Realize that only a small percentage of organizational problems are known. Develop nonpunitive systems, make reporting easy and reward it, and develop feedback systems.

Decrease reliance on memory. The probability of omission without reminders is 1 percent, but when reminders are embedded in the process, the probability is reduced to 0.3%. This can be done through standardization, automation, checklists, written protocols, built-in reminders, natural mapping of design of processes, equipment, and forms.

Decrease reliance on vigilance. The probability of an inspector recognizing an error is only 10%. Employ constraints, natural mappings, and computerized functions.

Simplify tasks and reduce or eliminate handoffs. The probability of error rises with increases in the number of people involved and steps taken to accomplish a task.

Redesign work processes. Create strategic redundancies, eliminate needless repetition, and identify gaps in processes.

Provide for reversibility and automatic correction where possible.

Plan for recovery when prevention is not possible.

Reduce the need for calculation. Simple arithmetic mistakes can be the cause of error. Use preprinted charts, automation, double-blind checks, and calculators.

Provide adequate training. Use simulation to train, have error drills, and practice failures as well as successful scenarios.

Incorporate ergonomic/human factor design principles in processes. Consider lighting, noise level, unnatural workflow, clutter, and distractions.

Manage fatigue. Implement reasonable work schedules, limit work hours, provide breaks, provide adequate staffing, and recognize and make adjustments for the overstressed employee.

Pay special attention to devices. Include potential users in product evaluation, pilot new devices, provide training before introduction, time the introduction appropriately, and eliminate "rigging" of a device.

JCAHO Patients Safety Goals

(Effective January 1, 2003)

Accuracy of patient information

  • Use at least two means to identify patients when taking blood samples or administering medications or blood products.
  • Conduct a final verification process, or a "time out" during a surgical or invasive procedure to confirm the correct patient, procedure, and site.

Effectiveness of communication among caregivers

  • Verify verbal or telephone orders by reading back the complete order.
  • Standardize abbreviations, acronyms, and symbols used in the organization.

Safety of using high-alert medications

  • Remove concentrated electrolytes from patient care units.
  • Standardize and limit the number of drug concentrations.

Wrong-site, wrong-patient, and wrong-procedure surgery

  • Create a preoperative verification process.
  • Mark the surgical site and involve the patient in the marking process.

Safety of infusion pumps

  • Ensure free-flow protection on all general-use and patient-controlled analgesia intravenous infusion pumps.

Effectiveness of clinical alarm systems

  • Ensure regular preventive maintenance and testing of alarm systems.
  • Ensure that staff activate alarms with appropriate settings and that they are sufficiently audible from distances and with competing noise in the area.


Copyright © 2002 by the Catholic Health Association of the United States
For reprint permission, contact Betty Crosby or call (314) 253-3477.

Assessing Medical Error in Health Care

Copyright © 2002 by the Catholic Health Association of the United States

For reprint permission, contact Betty Crosby or call (314) 253-3490.