Safe Patient Care

July 1, 2000

Safe Patient Care

Safe Patient Care

By Pat Tydell, RN, MSN, MPH

Historically, the healthcare industry has not viewed itself as a high-risk industry andhas not used the same type of rigorous, systematic review of each adverse event oruntoward outcome as has been done in high-risk industries like aviation and nuclear power.For example, there is no oversight entity for the healthcare industry like the NationalTransportation Safety Board (NTSB) that deconstructs and analyzes each airline accident toisolate the critical causative factors and to develop approaches to minimize futureoccurrences through technical design changes, system or process changes, or improvedtraining. Similarly, unlike the nuclear power industry, healthcare has not widely useddetailed process engineering that carefully analyzes alternative scenarios toprospectively establish the safest, most risk-free method to handle potentially hazardoussituations. The aviation and nuclear power industries have controlled the risk of adverseevents by focusing meticulous attention on the design of their operating systems to makeit difficult for personnel to make mistakes and easy to correct mistakes before theyresult in an untoward outcome. The result, contrary to public perception, is that thesehigh-risk industries have reduced their risk of an adverse event 1,000 to 10,000 timeslower than what occurs in healthcare. One of the major challenges facing healthcare todayis to become a highly reliable industry such as in aviation and nuclear power generation.

The need for reducing risk in the healthcare field has come into clearer focus for thepublic beginning with the catastrophes of 1995. That frightening and disorienting yearproduced a rash of tragic patient accidents. It began with the news that Betsy Lehman, 39,a health columnist for The Boston Globe, had died not of breast cancer but of a fourfoldmiscalculation in the amount of the chemotherapeutic drug she was receiving at Dana-FarberCancer Institute. It happened because the total dose to be given over four days insteadwas given on each of the four days, an error that was not corrected by doctors, nurses, orpharmacists. A similar incident occurred at the University of Chicago Hospitals where a40-year old man receiving chemotherapy for prostate cancer was given a lethal dose of thisdrug. At about the same time of the Dana-Farber incident, a vascular surgeon at a hospital(Tampa, Fla), was accused of amputating the wrong leg. Then came reports of surgery on thewrong side of the brain at Sloan-Kettering Cancer Center in New York.

The year ended badly. Seven-year-old Ben Kolb entered Martin Memorial Hospital (Stuart,Fla) for an elective ear procedure and died during the procedure as a result of receivingthe wrong drug during the surgery--at a lethal dose. A bright, beautifultwenty-one-year-old with asthma and allergies had been receiving allergy shots for a year.She was wheezy and congested, so her doctor put her on an antibiotic, steroids, andseveral other medications. On December 27, 1995, she went to her appointment and was givenher allergy shot. Her reaction came within minutes of the shot. Her heart stopped. She wasput on life support and was removed from it. She died on December 31, 1995.

The errors continued into 1996. A two-month-old baby boy was given 0.9 milligrams ofDigoxin, a heart drug, when he should have been 0.09 milligrams. The baby died in spite ofall resuscitative efforts. In October 1996, a medication error at a Denver hospitalresulted in the tragic death of a newborn and the indictment of three nurses on charges ofcriminal negligent homicide.

These adverse, tragic events did not go unnoticed by practitioners within thehealthcare industry this time. Although the field for studying errors of human factorsbegan in the 1940s, the healthcare industry, especially medicine, routinely dismissedthese types of studies as unsound and alarmist. After the events of 1995, the work ofthese psychologists and engineers came together with the work of a small group ofphysicians, who had also studied error in medicine, began to organize and to instruct thefield on how to reduce medical errors. This partnership was formalized into The NationalPatient Safety Foundation (NPSF) headquartered at the American Medical Association inChicago. This partnership produced two groundbreaking conferences in 1995 and 1998 and anavalanche of articles, studies, and experiments in the field of error reduction. Theinterest in the healthcare field on how to study and to reduce errors has introducedmedical personnel to the tools of psychology and systems engineering. The Joint Commissionhas also responded by developing new standards and requirements for their accreditedfacilities on how to identify errors, report them, and conduct reviews. The process usedfor studying adverse events in an organization will be discussed.

What Can a Healthcare Organization Do to Reduce Errors or to Find the Cause When anError Occurs?

When a healthcare organization is faced with an error or needs to uncover the cause ofa near miss or problem, one of the most helpful and useful processes is to conduct a rootcause analysis. A root cause analysis is a process for identifying the most basic orcasual factor or factors that underlie variation in performance, including the occurrenceof adverse events.1 This type of analysis has the following characteristics:

  • Focuses primarily on systems and processes, not individual performance.

  • Uncovers special causes in clinical processes and common causes inherent in the process or system.

  • Repeatedly asks "Why?" questions to probe deeper.

  • Identifies changes that could be made in systems and processes to improve the level of performance and reduce the risk of serious adverse events occurring in the future.

This analysis uncovers special and common cause variation in whatever process or systemis being studied. All processes have variation inherent in them. Variation is defined as achange in the form, position, state, or qualities of a thing.1 For example, theprocess of sterilizing instruments varies from time of day, day of the week, and thetechnician doing the process. To reduce variation, it is necessary to determine its cause.A common cause is a type of variation inherent in every process. It is the consequences ofthe way a process is designed to work. A process that varies only because of common causesis said to be stable. To improve the level of performance of a stable process, the processneeds to be redesigned. For example, one common cause variation in sterilizing instrumentsis the time it takes to clean, sterilize, and return the instruments to be used again. Toimprove this process, i.e. decrease the amount of time it takes to complete this cycle, aredesign of the process would have to be done. This redesign would include standardizationof trays and procedures, assembly line methods, additional instruments or sterilizers, ormore staff. A special cause variation in a process comes from unusual circumstances orevents that are difficult to anticipate. Human error and mechanical malfunction areexamples of special cause variation. In the example above, a special cause variation couldbe a utility outage or sterilizer breakdown. Special causes are somewhat easier toidentify and to eliminate. However, special causes in a process are usually the result ofcommon causes of a system. The department that fails to establish contingency plans forunplanned utility outages or to implement an equipment maintenance program will continueto have special cause variations until they redesign their system of planning andpreventive maintenance. When an organization or a department suspects that errors canoccur or have had them occur, a root cause analysis should be done. This determinationwill identify those special cause and common cause variations so the facility can takeaction.

How Is a Root Cause Analysis Conducted?

A team approach is used to conduct a root cause analysis. This team is composed ofstaff who is closest to the process or system and those who have decision-makingauthority. The team will be made from staff at various levels of organization. Since powerand control are issues with a team of different experience, education, and status levels,it is best to have a person trained in group facilitation to be the facilitator. Alsohelpful is a resource person to provide help using the tools of root cause analysis. Aleader should be identified clearly, and the group should have the support of topmanagement to meet as frequently as necessary. Top management should also empower the teamto do its assessment and make changes or recommendations for changes. Resources, includingtime, to do its work need to be provided. Lastly, ground rules for team functioning andcomposition need to be established at the beginning. Frequently, as the assessmentproceeds, additional members may need to be added or consultants brought in.

The team needs to create a work plan. This plan should include how and when the teamwill communicate to senior leadership. It needs to include target dates. Clearly definethe issue(s) regarding the process or system being studied. What is obvious to somemembers of the team may not be obvious to all.

The best way to start the analysis is to use the technique of brainstorming allpossible or potential contributing causes. Following traditional brainstorming groundrules, there are no bad ideas. All ideas are accepted without judgement. It is best tohave the leaders or facilitators write the ideas down. A flip chart is very useful as itcan be mobile and ideas can be displayed. Focus the team on processes, not people. Foreach idea, ask "why?" and keep asking until the team has exhausted all possiblequestions and causes. This stage of the analysis is the key. It provides the initialsubstance for the analysis. If team members are having difficulty, have them write downtheir ideas on post-it notes and put them in rows on the flip chart or go around the tableasking each member to identify one idea.

Now take these ideas and categorize and organize them. For example, there may beseveral ideas that can be categorized under the theme of "equipment" or"materials" or "employees." The best way to depict these causesgraphically is to construct a cause and effect (fishbone) diagram. This analysis tool canhelp the team see relationships and develop further causes. Begin determining whichprocess(es) or system(s) each cause is a part of and whether it is a special or commoncause in that process or system. Categorizing the causes as special or common is not aninherent characteristic of the cause itself. It describes the relationship of the cause toa specific process or system. A special cause in one process could be a common cause inanother. To assure that the group gets to the root cause, ask "why?" at leastfive times in each category. In the example of the utility outage as a special cause ofsterilizing instruments, the questioning would go something like this:

1. Why did sterilization of instruments stop on March 1? Because there was a utilityoutage.

2. Why was there a utility outage? Because there was a water main break in the city.

3. Why did this water main break in the city affect us? Because we have no back-up planor equipment if the bigger system fails.

4. Why don't we have a back-up5 system? Because we haven't planned for one.

5. Why haven't we planned one? Because this problem hasn't happened before.

This process of digging deeper into causes will help point the way to common causes.Another tool that is especially helpful in showing that a special cause in one area can bea common cause in another is the flowchart.

Search for a special cause's common cause in a system by using flowcharting. Forexample, a special cause may be the technician's inability to make the correct decisionabout which type of disinfectant solution to use. This is the human error type of aspecial cause. However, in a system flowchart, this special cause could be a common causedue to inadequate orientation and training of employees. A technician may make the"wrong" decision because the system does not provide adequate orientation andon-the-job training or proper supervision.

The root cause analysis does not need to be completed before changes are implemented.If the team feels that immediate changes are needed, they need to communicate this need tosenior leadership for action. The organization does not need to have the fifth dirty trayreach the surgical suites to take immediate action. The deeper issues may need to beassigned to other departments of the organization as part of its quality improvementprogram.

Throughout this analysis, do periodic assessments of the team's progress. Interiumreports are useful as are minutes. Remember, you can repeat activities as necessary. Theteam can go back to brainstorming if they get stuck creating a cause and effect diagram.Above all else, be thorough. Although the team may make improvements along the way, itshould not stop its analysis until the root cause is identified. Focusing improvements onlarger systems is a way of correcting common cause variation. This is so frequently the"cause" of special cause variation. These improvements are redesigns of systemsthat involve changes in training, policies, procedures, forms, and equipment. Thesechanges take time and are resource intensive to the organization.

Lastly, and most important, have a measurement strategy in place to determine ifchanges made achieve the desired effect. In the example of a shutdown in sterilizationprocesses, waiting for another water main to break is impractical. However, conducting amock unplanned utility outage to test the new system can provide the organization withvaluable information of the changes made as a result of the root cause analysis. Theutility need not be water. If the organization has truly redesigned their system, any typeof utility could be mock tested.

What Additional Items Need to Be Considered in Doing a Root Cause Analysis?

Three additional issues need to be considered when doing a root cause analysis. Thefirst is individual error. Errors by individuals should be initially considered as aspecial cause variation that leads to the discovery of common causes. Few persons come towork and decide that this is the day they will make a mistake. The technician who selectsthe wrong disinfectant does not stand there with two types of disinfectants in hand andconsciously picks the wrong one. Individual errors are most likely the result of commoncause variation of the system and its processes. Those processes most likely are hiring,competency review, continuing education to update staff, supervision of staff to measuretheir performance, communication and accessibility of the information, and design ofprocesses in the work area. Management is responsible for designing processes to controlcauses that persons cannot control for themselves. In systems, examples of these causesare purchasing practices and procedures, contract negotiation, and work environmentorganization. In individuals, examples of these causes are memory, distraction, fatigue,and attention. Processes designed to minimize such weak cognitive functions as memory andattention will alleviate human errors in many work tasks performed. Secondly, a root causeanalysis needs to be organized and procedured in a logical manner. The Joint Commissionhas a well-publicized framework for conducting a root cause analysis. It is presented hereas one way to organize this task.

Lastly, there are a variety of statistical and non- statistical tools that can help touncover the root causes of a process. These include flowcharts and cause-and-effectdiagrams as non-statistical tools and Pareto charts and scatter diagrams as simplestatistical tools. Though there are other, more complex tools, these will be the mainstaytools of the analysis. Flowcharts are graphic representations of either the actual or theideal path that a process follows from start to finish.2 A cause-and-effectdiagram shows the many casual relationships between various actions or events leading to aspecific outcome.3 A Pareto chart uses a vertical bar graph format to show thecomparison between events according to their relative frequency or magnitude.3 Thisis the familiar 80/20 Rule or Pareto's Rule. It states that 80% of your problems/eventscomes from 20% of your causes. Therefore, it is used to determine the relative importanceof a number of causes in order to choose the one or two that will have the most impact onthe event. Scatter diagrams are graphs designed to show the statistical correlationbetween two variables.3 These diagrams do not necessarily show cause and effectbut a relationship. They are most useful when a team wants to show which changes had aneffect. For example, if a team wanted to show the impact of the redesigned process ofsterilizing instruments, they could depict the relationship between the new process andthe number of rejected instrument trays.

Conclusion

This brief discussion on root cause analysis as a tool for reducing errors is anintroduction into the studies of a great many persons. It is a useful tool to organize andto systematize the study of errors. It can be used for any process, even if an error hasnot occurred in it for the true value in learning about errors and reducing them is tobring about safe patient care.

Pat Tydell, RN, MSN, MPH, is a Risk Manager responsible for coordination andoversight of patient safety improvement at the North Chicago Veterans AdministrationMedical Center (North Chicago, Ill).

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