Chapter 7. Examples of Mistake-Proofing in Health Care
Mistake-Proofing the Design of Health Care Processes -
Chapter 7: Examples of Mistake-Proofing in Health Care
This chapter contains 30 examples of mistake-proofing in health care. They range from simple, inexpensive (even hand-made) devices to sophisticated, expensive electronic equipment that can be used anywhere. The creator of one example is a noted expert in graphic displays of quantitative information. Another example has been shown in New York's Museum of Modern Art. All are possible solutions to daunting problems and exemplars of design approaches to solving the problem of human beings making mistakes.a
Example 7.1—The Broselow® Tape for Pediatric Trauma
Broselow® Pediatric Emergency Tape is used to reduce errors and increase the speed of treating pediatric trauma patients. The tape is laid out next to the child (Figure 7.1). The tape measure is color-coded according to height. The child is measured along the tape, and the appropriate treatment color is determined. The caregiver then knows that appropriately sized medical devices and appropriate doses of medications are contained in packets of the same color and can begin treatment immediately.
Dosages of commonly used medications are printed on the Broselow® Tape. Fewer calculations are required, resulting in fewer errors and less time elapsed before treatment actually begins. Supplies are stored in a movable cart or in a satchel (Figure 7.2), with each item also color-coded according to the Broselow® Tape.
Example 7.2—Finding the Chart in a Patient's Home
In-House Home Health, Inc. reports that, in the home, the patient's home chart becomes lost among the patient's belongings or newspapers and is not available for documentation or continuity of care. Environmental conditions of the patient's home are beyond the control of the agency staff.
The mistake-proofing device in this case is a sturdy bag with the agency's contact information printed on the bag.
The bag is hung on the bedroom doorknob with the patient's home chart inside (Figure 7.3). Any supplies, equipment, or documentation are placed inside the bag, ensuring that all agency staff will be able to locate the patient's chart when entering the home. The bag also makes it less likely for the chart to get mixed in with newspapers or other clutter that might be in the home.1
Example 7.3—Labeling of Bottled Breast Milk
A hospital risk manager reported that:
The father of a neonatal intensive care unit (NICU) baby suggested that the previously collected and stored container of breast milk should have some type of seal that would, when broken, indicate tampering. The staff agreed and instituted a system whereby the mother could place a seal on the container after collecting the milk. The seal consists of a paper band placed across the top of the container (Figure 7.4).
The mother is instructed to place the baby's last name on the band on top of the container. A second label designed for breast milk containers, indicating the baby's last name and date/time of collection, is placed around the container covering the ends of the label, which has been placed over the top of the container.
With these labels in place, the container cannot be opened without breaking the seal. The parents and staff are instructed not to use any container that has a broken seal.
Example 7.4—Ensuring that Time-Outs Occur
The chief medical officer in Figure 7.5 volunteered to appear on a flyer that is bundled in every sterile surgical kit. Before a surgery, the scrub nurse puts the flyer over the tools to be used in the surgery, blocking the surgeon's access to the tools until the flyer is removed. When the flyer is removed, it reminds the surgical team to perform the required time-out. Although this technique cannot be considered an example of strong mistake-proofing, it is a starting point and is likely to be more effective than the sign usually placed above a door as in Figure 7.6.
During a time-out, prior to the procedure, the team agrees that they are in possession of the correct information and are about to perform the correct procedure on the correct patient. The sign in Figure 7.6 must be seen to be useful; placing it over the surgical kit would most likely be more effective than hanging it on a nearby wall.
Example 7.5—Look-Alike and Sound-Alike Medications
In the absence of planning a change to a robotic pharmacy, a simple job aid can help avoid dispensing the incorrect medication. In Figure 7.7, staff members know that each red bin in the pharmacy contains a look-alike or sound-alike medication. The bins shown contain Celebrex® and Celexa®.
Example 7.6—"Tall Man" Labels
"Tall man" labels also can be used used to distinguish look-alike or sound-alike medications. This technique employs capital letters in unusual places in a word to create larger visual differences between words that are otherwise visually similar. The Food and Drug Administration (FDA) began requesting tall man labeling in 2001.1,2
The effect is more pronounced when the beginning and ending syllables of the drug name are the same.
|Normal Text||Tall Man Text|
Note: Example courtesy of an anonymous participant at a HealthInsight Learning Seminar. Used with permission.
Example 7.7—High-Risk Medicine Cues
A number of deaths were reported to have been caused by the accidental administration of concentrated solutions. The National Patient Safety Agency (NPSA) of the United Kingdom has been working with manufacturers to ensure the availability of a broader range of diluted products and to help introduce distinctive packaging so that solutions, such as potassium chloride, are easily identified and distinguished from other intravenous products (Figure 7.8).
The following "cues" were devised for potassium chloride:
- The official name (U.S. Pharmacopeia) was changed to "Potassium Chloride for Injection Concentrate." The word "concentrate" in the new name indicates the need to dilute the product prior to use.
- A requirement that labels contain a boxed warning that reads: "Concentrate: Must be Diluted Before Use."
- A unique requirement that the cap used in the packaging of this drug be black in color and that it contain an imprint in a contrasting color with the words: "Must be Diluted."3 Go to Chapter 8, Example 8.27.
Example 7.8—The Bloodloc™
The Bloodloc™ (Figure 7.9) is a plastic, one-time use padlock that restricts access to a unit of blood. It is opened by a three-letter code that can only be found on the patient's wristband (Figure 7.10). Use of the Bloodloc™ has been documented in several studies.4-6, Cost is a common concern. AuBuchon7 reported that the cost of the Bloodloc™ is "between $3 and $4 dollars per unit." His calculation of the cost effectiveness, from the societal perspective (excluding liability costs), was approximately $200,000 per quality-adjusted life year (QALY). Actual values can vary because "Traditional quality-adjusted life year (QALY) cost analysis is complex and assigns arbitrary dollar values to catastrophic outcomes such as death."7 Nevertheless, in terms of proportional cost, AuBuchon's comments are not unreasonable.
AuBuchon7 stated that at a cost-effectiveness of $200,000 per QALY, the Bloodloc™ is not as cost effective as many medical and surgical interventions, where $50,000 per QALY is generally considered the upper limit. It is much more cost effective, however, than many interventions in transfusion medicine aimed at assuring safe transfusions. The cost-effectiveness of using nucleic acid testing (NAT, used to screen whole blood donors for the HIV and hepatitis C viruses), and testing for the p24 protein found in HIV (the p24 test identifies actual HIV viral particles in blood 1 week or more after infection) is more than $1 million each. The cost effectiveness of solvent detergent (SD) plasma is $3 million per QALY.8 The SD process pools up to 500,000 units of thawed fresh frozen blood plasma and treats it with solvent and detergent to remove viruses such as HIV and hepatitis.
Additionally, factoring in liability payments to a patient's family members make the Bloodloc™ and similar expensive interventions much more desirable from the hospitals' standpoint.
Regarding the Bloodloc™, AuBuchon stated:
"It's a barrier. It prevents the transfusionist from getting to a unit of blood that they are not supposed to get to."
Because the Bloodloc™ may slow the process of administering units of blood in emergent situations, the locks are often opened after the patient arrives in the operating room but before the actual need for transfusion occurs. Since the plastic bag can be cut open, circumventing the Bloodloc™, some hospitals began the practice of putting the Bloodloc™ directly on the tubing that extends out of the unit of blood.
Example 7.9—Child Scale
Using a flat scale, it was easy for children to roll off the scale and injure themselves. The scale in Figure 7.11 is equipped with a seat that provides more security for the child while being weighed. The contributor of this example notes that it "would be more secure if it had a seat belt."
Example 7.10—A Safer Blood Pressure Cuff
In the past, blood pressure cuffs containing mercury posed a risk to patients when they were broken. New blood pressure cuffs containing no mercury (Figure 7.12) are safer.
Example 7.11—Sign Your Site
On July 1, 2004, the Joint Commission (JCAHO) made "sign your site" (Figure 7.13 and 7.14)—the practice of marking the correct site on which a procedure is scheduled to take place—mandatory. Prior to this policy, data suggested that one in four orthopedic surgeons would perform a wrong-site surgery during a 35-year career.b
b. More information on JCAHO's patient safety practices is available at: http://www.jcipatientsafety.org/22782/
A template similar to the one in Figure 7.16 was used in a blood center to ensure that incoming forms were completed. Additional information could be added to the template to indicate valid ranges for numeric entries, further adding to the effectiveness of the job aid.11
The template in Figure 7.16, pre-developed to highlight key words and terms, is made using ingredients found at any office supply store: colored plastic pocket dividers and a knife.
Instructions to make the template are simple:
- Insert the form.
- Mark the areas to highlight.
- Remove the form and insert a sheet of cardboard or card stock.
- Cut out the marked portions.
Time to completion: 2 minutes.
Example 7.13—High Risk Medications
The red boxes in Figure 7.17 designate the medication, Retavase®, as a high-risk medication. Administered to cardiac patients who have just had a myocardial infarction, the medication dissolves clots that have blocked arteries. The boxes also contain all items needed for administration of the medication.
JCAHO defines high-risk and high-alert medications as medications involved in a high percentage of medication errors or sentinel events and medications that carry a high risk for abuse, error, or other adverse outcomes. Examples include medications with a low therapeutic index, controlled substances, medications not approved or recently approved by FDA, psychotherapeutic medications, and look-alike and sound-alike medications. JCAHO requires organizations to identify high-risk and high-alert medications used within the organization.c
Example 7.14—Emergency Defibrillator
The emergency defibrillator in Figure 7.18 is one of many installed in airports, airplanes, and other public places throughout the United States. It has been designed so that anyone can operate it. The device gives its operator verbal instructions during the process. It also employs sensors to deliver a shock, but only when one is necessary.
Example 7.15—The 5 Gauss Line
The European Magnetic Resonance Forum (EMRF) Web site10 states that:
The national regulatory boards decided to limit the threshold for access to MRI areas to 5 Gauss [a measure of the strength of magnetic attraction]. It seems advisable to mark this area by signs or lines on the floor.
Using a line on the floor as a sensory alert (Figure 7.19), a mistake-proofing device in the magnetic resonance imaging (MRI) suite is a start, but its effectiveness is dependent on the constant attention of technicians and patients. Adult patients are required to try to remember relevant events in their medical history, such as the metal plates and screws they received after a skateboarding accident as a 13-year-old. Expecting patients to remember these details is an unreliable safety mechanism. Patients are often unsure of even more recent events. Processes have been redesigned out of concern that patients will forget recent information (go to Chapter 5, Example Set 5.20).
The EMRF Web site also states:
To prevent such accidents, the installation of a metal detector through which everybody has to pass before entering the MRI suite has been recommended, but is rather cumbersome.
Every person working or entering the magnet room or adjacent rooms with a magnetic field has to be instructed about the dangers. This should include the intensive-care staff, and maintenance, service and cleaning personnel, as well as the crew at the local fire station.
It is not clear that a metal detector in its current configuration is the best and final answer to MRI safety. However, it is also not clear that installing a metal detector is a less "cumbersome" solution than the marginal increase in training needed for a large and diverse group of workers that spans organizational boundaries.
Example 7.16—More Color-Coding
The white form on the left in Figure 7.20 is used for a heparind infusion order. The pale blue form on the right is used for a heparin cardiology dosing protocol order. Standard and cardiology protocols differ, so the forms are in different colors. For heparin administration, the mistake-proofing is a subtle sensory alert. The distinction between the white and the pale blue forms could be missed if they are presented to users in close proximity. This is very weak mistake-proofing. Yet, it is better than the confusion generated by two white forms.
Example 7.17—Leave Me Alone, I Have to Concentrate
The line around the medication dispensing station in Figure 7.21 provides a visual cue that co-workers should not interrupt the process of retrieving medications. The organization that implemented this sensory alert expects nurses who are in the zone to be allowed to attend to the details of selecting the correct medication and self-checking their work without distractions by others.
In another example utilizing visual cues to reduce interruptions,12 a nurse wore a vest prominently labeled "do not disturb." Interruption rates fell approximately 64 percent.
Example 7.18—What is Normal?
The square in Figure 7.22 measures 1 inch on each side. The figure provides patient data for more than a period of 1 year. It uses the hash marks to indicate the normal range. This figure appears on the first row, third from the left, in Figure 7.23. A large amount of information can be conveyed in a very small amount of space. Comments on the patient's condition and treatment are in the right column of Figure 7.23.
Example 7.19—Automatically Terminated
In 1993, Leveson and Turner14 wrote about their analysis of accidents that occurred in 1976 with the Therac-25 (a computerized radiation therapy machine):
Between June 1985 and January 1987, six known accidents involved massive overdoses by the Therac-25, with resultant deaths and serious injuries. They have been described as the worst series of radiation accidents in the 35-year history of medical accelerators.
Patients died from overexposure to radiation as a result of poor software design and ineffective controls. This failure may have acted as a catalyst for radiology equipment manufacturers to design new equipment. New designs were introduced.15 The machine in Figure 7.24 detects the amount of radiation that has penetrated a patient and automatically terminates exposure when a predetermined level has been reached. The treatment is optimized by factoring in the variables of patient size and density.
Example 7.20—Blood Sample Traceability
The cassette in Figure 7.25, the complete blood count (CBC) analyzer, and a printout match the cassette number and the patient number.
Example 7.21—Leave that Stopper in Place
The blood analyzer in Figure 7.26 accepts tubes without requiring technicians to remove the rubber stopper so that employees are not contaminated with blood. It is also labeled with patient information that matches the printout in Example 7.20.
Example 7.22—Oral Syringes: Two for One
The oral syringes in Figures 7.27 and 7.28 are designed so that they will not fit onto any IV tubing. Oral medication cannot be accidentally administered intravenously. The orange color of the oral syringes in Figure 7.27 provides an additional visual sensory alert, indicating that the syringe is not to be fitted to an IV.
Example 7.23—Newborn Resuscitation
Two photos of a neonatal resuscitation device are shown in Figures 7.29 and 7.30. The device has two important mistake-proofing features:
- A pressure relief valve that prevents excessive gas pressure delivery to the lung.
- A pressure gauge to measure the actual pressure delivered by squeezing the deflatable portion of the bag.
This device protect infants' airways from errors in providing augmented ventilation during resuscitative efforts.
Example 7.24—X-Ray-Detectable Sponges
X-ray detectable sponges (Figure 7.31) contain a radio-opaque (impenetrable by x-rays) substance, such as a small embedded flexible strip, or barium sulfate. These sponges are an improvement, but not a perfect solution.16 X-rays can easily detect the presence of sponges when they are large and "left out in the open" in muscle or fat tissue. When they are small and left near bone, however, they become much more difficult to find in the image. Also go to Chapter 8, Example 8.10.
Example 7.25—Anti-Reflux Valves
A reflux is a backward or return flow. Anti-reflux valves are designed to prevent fluids that have been expelled from returning to the body and leading to varied complications. Anti-reflux valves ensure that there is no return flow after fluids have been expelled, thereby avoiding the "mistake" of a return flow (Figure 7.32).
Example 7.26—Wristband Checklist
Robert S. Mecklenburg, chief of the Department of Medicine at Virginia Mason Medical Center in Seattle, WA, is designing a bracelet for heart attack patients that uses symbols to track whether they have received the full, universally accepted treatment regimen. The regimen includes receiving beta-blockers within 1 hour of arrival at the emergency department, monitoring cholesterol levels, and counseling on diet and smoking. Patients are not discharged until each item on the wristband medical record is checked off.17
The wristband medical record is being tested as part of our work bundles (Institute for Healthcare Improvement) on cardiac care. It is an example of "visual control" that alerts all in the area that the patient is on the bundle pathway and allows the patient and family to follow and audit execution of the components of the bundle. The response of patients, providers and support staff has been positive. We've moved through several versions to maximize its utility.18
According to service management theory, this simple mistake-proofing device (Figure 7.33) is very powerful. As a customer mistake-proofing device, it lets the patient and family and other caregivers know the status of the health care process.19
Example 7.27—Time to Restock
In Japanese, a "kanban" is a "sign" or visual signal. In Japanese manufacturing, a kanban is used to indicate when work needs to be done.20 St. Joseph's Hospital employs a large sticker to indicate when cabinets are fully stocked (Figure 7.34). This enables the employees who stock the cabinets to know where their attention is needed. When supplies have been used to treat patients, the sticker is torn and employees know that the cabinet needs to be restocked.
What Schonberger20 called "Japanese manufacturing techniques" also has many other names:
- Toyota Production System.
- Stockless Production.
- Zero Inventories.
- and, most recently, Lean Production.
There is a standardized supply cabinet in each room. The presence of the stickers enables the staff to rapidly bypass unoccupied rooms as they restock the facility.
Example 7.28—Knowledge on the Bottle
The standard medicine bottle reveals some design problems: the bottle must be rotated in order to see the entire label. Recently, Target pharmacies began using a new medicine bottle design.e
Good ideas come from many sources. In this case, Target's medication bottle originated when the grandmother of graphic designer Deborah Adler accidentally took another family member's medication. Mistake-proofing features are all over the bottle:
- The bottle is designed to stand on its lid.
- A colored band surrounds the neck.
- The band is color-coded to personalize family members' medications. Each family member can use a different color (yellow, green, blue, purple, or red).
- The bottle has a rounded, rectangular cross section.
- The sides taper toward the top.
- The panels are flat so that all the text on the label is visible at once.
- The typography is larger and more distinct than usual.
- The name of the drug is clearly shown on the front and on the top.
- A patient information card is tucked in the back.21
Deborah Adler's bottle was featured at the New York Museum of Modern Art exhibit, SAFE: Design Takes On Risk, October 2005-January 2006.
Example 7.29—Weaving Tangled Webs
The intravenous (IV) pole and infusion pump in Figure 7.35 provide graphic evidence of how IV tubes can become very tangled. This problem can be mitigated through the use of Donald Norman's concept of natural mappings. One possible solution is the use of in-line IV hooks that provide a one-to-one correlation between the IV bags and the infusion pump channels controlling their flow (Figure 7.36).
Example 7.30—What's the Status?
The flat screen panel in Figure 7.37 provides information to families without violating Federal privacy laws. The locator number (indicated by "locator #" on the screen) is the pager number assigned to each family while they wait. Chase and Stewart,22 discussed in Chapter 1, would most likely categorize the flat screen display in Figure 7.37 in the following way:
Category: server mistake-proofing device
Setting function: Information enhancement
2. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Medication errors. Name Differentiation Project. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm. Accessed June 2007.
3. Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives Hearing Transcript. Reducing medical errors: A review of innovative strategies to improve patient safety. 107th Congress, Second Session. May 8, 2002. No. 107-12.
7. AuBuchon J. Practical considerations in the implementation of measures to reduce mistransfusion, transcript of workshop on best practices for reducing transfusion errors. Food and Drug Administration and the Agency for Healthcare Research and Quality. Bethesda, MD. February 15, 2002. http://www.fda.gov/cber/minutes/0215bloo.pdf. Accessed Sep 2005.
8. Zoon KC. Blood plasma pool facts and a list about blood plasma pooling, the practice of mixing together the plasma of thousands of anonymous blood plasma donors. Testimony before the Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Reform and Oversight, U.S. House of Representatives. July 31, 1997. http://www.bloodbank.com/plasma-pool.html. Accessed March 2007.
17. Connolly C. Toyota assembly line inspires improvements at hospital. Washington Post Friday, June 3, 2005. p. A01 http://www.washingtonpost.com/wpdyn/content/article/2005/06/02/AR2005060201944_pf.html.