Can Medicine Be Made Mistake-Proof ?

It has been more than eight years since the Institute of Medicine (IOM) released its groundbreaking report, "To Err Is Human: Building a Safer Health System," which triggered renewed attention to the problem of medical errors.¹ In that time, numerous patient safety initiatives in the public and private sectors have been launched, and the National Patient Safety Goals (NPSGs) from the Joint Commission (JC) have taken on renewed importance.

Medical errors exact a high price in human life and costs to the healthcare system. As many as 98,000 Americans die annually as a result of medical errors. According to the Institute for Healthcare Improvement (IHI), patient safety improvements represent not only a professional and moral imperative, but also a tangible impact on the financial bottom line for healthcare institutions. The IOM has estimated that medical errors resulting in injury cost as much as $29 billion each year, over half of which reflects healthcare costs.² Bates³ studied the impact of medication errors on a healthcare organization and discovered that preventable adverse drug events in two teaching hospitals caused an increase in length of stay of 4.6 days, at a cost of $4,685 each. He also reported that the overall rate of adverse drug events was 6.5 per 100 admissions, of which 28 percent were judged to be preventable almost two of every 100 admissions. Another example of the cost of poor quality is hospital-acquired bloodstream infections that prolong a patients hospitalization by a mean of seven days. Estimates of attributable cost per bloodstream infection range between $3,700 and $29,000.⁴

Healthcare professionals may have a better idea of what constitutes a medical error and the associated costs, but what lags behind is the ability to understand why errors persist and what can be done to prevent them in the future. To review, an accident is considered to be an unplanned, unexpected, and undesired event, usually with an adverse consequence.⁵ An adverse event is considered to be an untoward, undesirable, and usually unanticipated event, such as death of a patient, and employee, or a visitor in a health care organization. Incidents such as patient falls or improper administration of medications are also considered adverse events even if there is no permanent effect on the patient.⁶ An adverse sentinel event is defined by the JC as an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes the loss of limb or function.⁶

Kohn¹ defines an error as a failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim; the accumulation of errors results in accidents. There are several types of errors that are useful in healthcare-related discussions:

An error in judgment is an error related to flawed reasoning⁶

An error of commission is an error which occurs as a result of an action taken. Examples include when a drug is administered at the wrong time, in the wrong dosage, or using the wrong route; surgeries performed on the wrong side of the body; and transfusion errors involving blood cross-matched for another patient⁶

An error of negligence is an error due to inattention or lack of obligatory effort.⁶

An error of omission is an error which occurs as a result of an action not taken, for example, when a nurse omits a dose of a medication that should be administered; errors of omission may or may not lead to adverse outcomes.⁶

Can Healthcare Become Mistake-Proof?

Some believe that willpower and determination are not enough to avoid making errors in the healthcare environment. Grout⁶ observes, "People who make these errors are not unmotivated or negligent. More importantly, they cannot eliminate the errors simply by telling themselves to do better and deciding not to commit them."

If to err is human, is error prevention impossible? The JC has stated that "no matter how knowledgeable or careful people are, errors will occur in some situations and may even be likely to occur."⁶ Healthcare is a double-edged sword, with providers having the power to heal as well as the ability to harm. Some experts suggest that the healthcare industry take a cue from manufacturing, which has been moving toward mistake-proofing processes and/or design features to prevent errors. The Japanese manufacturing community refers to the concept of mistake-proofing as poka-yoke (pronounced "pokayokay") which can be translated as "avoiding inadvertent errors." Automobile manufacturer Toyota was the first to benefit under Shigeo Shingos mistake-proofing initiatives within the car-making process and now the healthcare industry is beginning to incorporate some aspects of the Toyota production system into their efforts to reduce medical errors.⁶ The airline industry is another sector that has been influencing healthcares embrace of safety efforts; Murphy⁷ describes how some major hospitals have hired professional pilots to train their critical-care staff on how to apply aviation safety principles to their work. "They learn standard cockpit procedures like communication protocols, checklists and crew briefings to improve patient care, if not save patients lives. Though healthcare experts disagree on how to incorporate aviation-based safety measures, few argue about the parallels between the two industries or the value of borrowing the best practices."⁷

The manufacturing and airline industries show that even small details of product design can offer inspiration for solutions that enhance safety. Take, for example, the design of filing cabinets; if more than one file drawer is opened at a time, the center of gravity might move forward enough to cause the cabinet to fall on the user. That's why most modern file cabinets are designed to avoid this type of injury, as opening one drawer locks the rest of the drawers. The design facilitates (perhaps even forces) correct behavior, experts say.⁶ Similarly, the engineered active and passive safety devices of a medical syringe can help prevent needlestick injuries to healthcare workers.

It appears however, in the eyes of a few experts, that healthcare has a long way to go toward meeting manufacturings high-water mark; Kohn¹ remarks, "Patients should experience healthcare processes that are more reliable than manufacturing processes. Regrettably, that is not yet the case."

Donald Berwick, president and chief executive officer of the Institute for Healthcare Improvement (IHI), argues that improving patient safety requires changes in the design of healthcare systems: "...We are human and humans err. Despite outrage, despite grief, despite experience, despite our best efforts, despite our deepest wishes, we are born fallible and will remain so. Being careful helps, but it brings us nowhere near perfection... The remedy is in changing systems of work. The remedy is in design. The goal should be extreme safety. I believe we should be as safe in our hospitals as we are in our homes. But we cannot reach that goal through exhortation, censure, outrage, and shame. We can reach it only by commitment to change, so that normal, human errors can be made irrelevant to outcome, continually found, and skillfully mitigated."⁸

Croteau and Schyve⁶ state that "techniques for designing safe processes are known, waiting only to be adapted to healthcare." Mistake-proofing is one of these techniques and is an important addition to the tools employed to improve patient safety.⁶ Many patient safety initiatives (some of which are enumerated below) are important enablers of the mistake-proofing process. According to Grout, "They create a foundation for, or aid in, mistake-proofing implementation. Others are areas of opportunity in which existing patient safety efforts create resources for identifying likely mistake-proofing projects."⁶

Creating a safety culture: This is a set of attitudes, values, perceptions, norms, and behaviors that can reduce the likelihood of unsafe acts, and which encourage thorough disclosure of, and learning from, adverse events.⁶

Creating a just culture: This refers to a working environment that is conducive to "blame-free" reporting but also one in which accountability is not lost.⁶

Event reporting refers to actions undertaken to obtain information about medical events and near-misses. The reporting reveals the type and severity of events and the frequency with which they occur.⁶

Root cause analysis (RCA) is a set of methodologies for determining at least one cause of an event that can be controlled or altered so that the event will not recur in the same situation. These methodologies reveal the cause-and-effect relationships that exist in a system.⁶

Technology is becoming a valuable aid to patient safety. Bar coding and computerized physician order entry (CPOE) systems are being used to boost mistake-proofing efforts in hospitals.⁶

ICPs and Patient Safety

Infection control practitioners (ICPs), given the very nature of their work, are instrumental in championing patient safety. In fact, in February, the Association for Professionals in Infection Control and Epidemiology (APIC) encouraged its members to provide input on the Joint Commissions proposed 2009 National Patient Safety Goals (NPSG) and to further expand their voice on patient safety issues.

"We believe that ICPs were the original patient safety advocates and experts," says Kathy Warye, chief executive officer of APIC. "Between the Joint Commissions National Patient Safety Goals and the new CMS requirements, I think were seeing infection prevention and control elevated to a new position in the healthcare hierarchy, and thats a good thing for patients. As part of that its critical for ICPs to provide their unique expertise to the development of patient safety initiatives and documents. We have encouraged our members to respond to the Joint Commissions proposed goals because they are the ones making patient safety happen. We hope the Joint Commission will view that feedback favorably and take ICPs suggestions into consideration when finalizing these goals." Warye adds, "I think the Joint Commission wants to see infection prevention elevated on the radar of healthcare CEOs and theres no better way to do that than to put it front and center in the NPSGs. That is a demonstration of their interest in bringing greater emphasis to infection prevention as well as supporting and resourcing ICPs."

The proposed 2009 NPSGs address healthcare-associated infections (HAIs) and reflect the JCs participation in a recent HAI Allied Task Force which will soon release guidelines on several HAI topics. According to the JC, the 2009 NPSG topics that are HAI-related strive to be consistent with these new guidelines but are not identical in their format. The guidelines are scheduled to be published in a special edition to the Society for Healthcare Epidemiology of America (SHEA)s journal, Infection Control and Hospital Epidemiology, this month.

The JC first introduced its National Patient Safety Goals in January 2003 in an expanded effort to improve patient safety in accredited organizations. Each goal includes specific evidence-based requirements that identify opportunities for reducing risk to patients. The JC is focusing on new and revised NPSGs on the topics of patient identification; and HAIs including methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile-associated disease (CDAD), catheter-associated bloodstream infections (CABSI) and surgical site infections (SSI) in acute-care hospitals; medication reconciliation; and patient involvement in their care.

Of particular interest to ICPs is Goal 7, the mandate to reduce the risk of HAIs. Proposed implementation expectations for Goal 7 requirements in 2009 include:

Educate healthcare workers about multidrug-resistant organisms (MDROs) and the necessity for prevention

Measure MRSA, CDAD, CABSI and SSI infection rates, monitor compliance with best practices and evaluate the effectiveness of prevention efforts

Provide MRSA, CDAD, CABSI and SSI infection rate data and prevention outcome measures to key stakeholders

Educate patients and their families about MRSA, CDAD, CABSI and SSI prevention

Conduct a risk assessment for MRSA, CDAD, CABSI and SSI incidence, prevalence, acquisition and transmission

Implement hand hygiene practices

Use contact precautions for patients with MRSA and CDAD to reduce patient-to-patient spread of infection

Effectively clean and disinfect patient-care equipment and the patient-care environment based on standards identified by the organization

Implement a MRSA surveillance program to identify and track patients with clinical or active surveillance culture/testing specimen positive results for MRSA

Implement a laboratory-based alert system that identifies new patients with MRSA

Implement an alert system that identifies readmitted or transferred MRSA-positive patients

Implement best practices for prevention of CABSIs (including using a catheter checklist and a standardized protocol for central venous catheter insertion, performing hand hygiene prior to catheter insertion or manipulation, and using a standardized supply cart or kit that is all inclusive for the insertion of central lines)

Reinforce the education of healthcare personnel about CABSI prevention and the care of central venous lines

Implement policies and practices aimed at reducing the risk of SSI that meet regulatory and accreditation requirements and are aligned with evidence-based standards (including administering antimicrobial agents for prophylaxis, discontinuing the prophylactic antimicrobial agent within 24 hours after surgery, using clippers or depilatories for hair removal prior to surgery, and maintaining optimal control of blood glucose levels)

"I think what the Joint Commission will hear from our members is concern that the goals and requirements are very prescriptive," Warye says. "On the other hand, so much of it is consistent with evidence-based best practices that many institutions have been undertaking for quite some time. I think there is a balance between wanting organizations to pursue evidence-based practices and not being overly prescriptive understanding that every institution is different and we dont want to take away the flexibility to address any HAI that may be an issue for that facility."

Regardless of what ICPs have to say about the 2009 NPSGs, they are well suited to patient safety work, according to Warye. "ICPs bring a complete skill set to patient safety efforts," she says. "If you look at what they do, from risk assessment to performance improvement, they operate in that spectrum of competencies required of anyone working in patient safety. They have the specific skills that can advance patient safety, but what they need is acknowledgement of that skill set. Many healthcare administrators do not know what their ICP does or brings to the table, to appreciate how they can advance infection prevention initiatives and improve patient safety overall. The Joint Commission is creating an opportunity for ICPs to communicate at a new level and I encourage them to take every opportunity to emphasize the unique knowledge, skills and competencies they use advance patient safety."

One such valuable skill is conducting RCAs for sentinel events, defined by the JC as "an unexpected occurrence involving death or serious physical or psychological injury," and is the antithesis to patient safety. Sentinel events can include unexpected deaths, unanticipated major loss of function, infant abduction or infant discharge to the wrong family, rape, surgery on the wrong patient or body part, and patient suicide. In a white paper⁹ developed for APIC, authors Janet Frain, Denise Murphy, Georgia Dash and Marie Kassai advocate for the integration of sentinel event reporting into an ICPs program. Frain et al. say that these and other events may be prime events for the conduction of an RCA as investigative and problem-resolution tool. An RCA must be completed within 45 days of the occurrence of the sentinel event, and it should identify contributing factors, identify the root cause of the event, and put effective control measures in place to reduce the risk of recurrence.

Because of their constant surveillance for outbreaks, ICPs would be the most likely individuals in the hospital to identify unexpected deaths or unanticipated major loss of function due to infection as a potential sentinel event. Frain et al. recommend that ICPs collaborate with an infectious disease physician, facility administrator and other healthcare leaders to perform an RCA. Frain et al. write, "The ICP is an extremely valuable member of the patient care team. Your experience with outbreak management and ability to identify infectious events, evaluate likely sources for infection, recognize standards that help prevent transmission or development of an infection, and analyze medical literature make you an excellent resource to the team."

References

1. Kohn LT, Corrigan JM, Donaldson MS, eds. Institute of Medicine. To err is human: building a safer health system. Washington, D.C.: National Academies Press. 2000.

2. Botwinick L, Bisognano M, Haraden C. Leadership Guide to Patient Safety. IHI Innovation Series white paper. Cambridge, Mass.: Institute for Healthcare Improvement. 2006.

3. Bates D, Spell N, Cullen D, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA.1997;227(4):307-311.

4. Soufir L, Timsit JF, Mahe C, Carlet J, Regnier B, Chevret S. Attributable morbidity and mortality of catheter-related septicemia in critically ill patients: A matched, risk-adjusted, cohort study. Infect Cont Hospital Epidem. 1999;20(6):396-401.

5. Zipperer LA, Cushman S, eds. Lessons in Patient Safety. Chicago: National Patient Safety Foundation. 2001.

6. Grout J. Mistake-proofing the design of healthcare processes. AHRQ Publication No. 07-0020. Rockville, Md.: Agency for Healthcare Research and Quality; May 2007.

7. Murphy K. What Pilots Can Teach Hospitals About Patient Safety. The New York Times. October 31, 2006.

8. Berwick DM. Not again! BMJ. 2001;22:247-8.

9. Frain J, Murphy D, Dash G and Kassai M. Integrating sentinel event analysis into your infection control practice. White paper from the Association for Professionals in Infection Control and Epidemiology (APIC). January 2004.