May 11, 2006


In This Issue . . .

Improving Patient Safety through Risk Management
Part I: Laying the Foundation By Learning the Tools
Julie L McDowell

For clinical laboratories, patient safety efforts include rooting out any weak areas in the total testing process that might lead to errors and failures. One method of identifying, evaluating, and monitoring these areas is through a risk management process, which was the focus of a recent workshop sponsored by the Clinical Laboratory and Standards Institute (CLSI), “Risk Management Tools for Improved Patient Safety”. This issue of Strategies is Part I of a two-part series on risk management. This article examines the different elements of risk management, and its potential to help clinical laboratorians improve their operations while reducing the risk of error.

Like the Lean and Six Sigma quality improvement programs, the risk management process has its roots in the manufacturing industry, particularly in standards published by the International Organization for Standardization (ISO, For IVD manufacturers, ISO 14971, “Medical devices: Application of risk management to medical devices,” outlines a systematic process that extends throughout the life of a product, and aims to reduce risk of harm as low as is technically and economically feasible, according to CLSI workshop speaker Donald M. Powers, PhD, President of the Powers Consulting Group, which provides advisory services related to quality systems. But now laboratorians are also finding risk management to be a valuable method for improving patient safety.

“For laboratories, risk management translates into ‘error reduction to enhance patient safety', and focuses on potential failures in the testing process that can lead to incorrect or delayed test results,” Powers explained, adding that quality improvement programs such as Six Sigma and Lean can be integrated into the risk management process to enhance safety efforts. ISO is also working on a specific standard for the clinical laboratory community—ISO 22367, “Medical laboratories—Reduction of error through risk management and continual improvement,” which is scheduled to be published this fall.

Nearly all clinical labs are currently employing some form of risk reduction, either as part of a QC, patient safety, or preventative action program. Despite its potential impact on increasing patient safety in the clinical laboratory, the risk management system is just making inroads, said Michael A. Noble, MD, FRCPC, Professor and Chair, Program Office for Laboratory Quality Management, University of British Columbia (Vancouver). “It is not a system for which there are a lot of comfortable fits in the laboratory yet, but there are some areas that do make a lot of sense,” he explained. “For example, laboratories are now going through the processes of looking at how they receive samples from the patient wards and how they are implementing new equipment, new staff, and procedures. That's similar to implementing or creating a new product in industry.”

Managing Risk

There are four primary stages of the risk management process, according to Powers: risk analysis, evaluation, control, and monitoring. The initial stage is when the hazards and their causes are identified, as well as event sequences that can turn hazards into harm. Hazards in the laboratory refer to incorrect or delayed test results, and harm is the resulting injury to patients. This risk analysis involves systematic estimation of the severity of possible harm caused by the physician's reliance on laboratory results and the probability that the harm would occur. The severity of each hazard is estimated on a scale ranging from negligible to catastrophic.

Two tools used to estimate risk are failure mode and effects analysis (FMEA) and fault tree analysis (FTA). FMEA evaluates parts of the system that might fail and can result in problems, such as potential problemsassociated with identifying patients and drawing blood.
Box 1 (click on thumbnail to see larger image.)

 The quantitative element of FMEA includes estimating the probability of failure and ranking the relative risk. An important element of FMEA is understanding the process by mapping the sequence of events, according to workshop presenter Tina A. Krenc, Manager for Core Research & Development, Abbott Laboratories Diagnostic Division ( Abbott Park , Ill.). Process mapping uses symbols and a flow chart to visually depict how people, methods, machines, and materials interact throughout an entire process in the lab (see Box 1). “When starting the FMEA process, it is essential that the analyst understand the process, such as by using a process map, and the requirements or function of each step,” advised Krenc. “A FMEA helps to analyze failures to meet requirement or functions.” Similar to FMEA, the FTA is also a visual depiction, but it's more event-oriented (see Box 2 and 3). It's employed when a failure is being investigated, such as an incorrect specimen tested, and when laboratorians want to evaluate the interactions between systems and humans to determine all the potential causes. “When performing an FTA, it's important to understand the top failure that can occur, and then brainstorm all the reasons why that failure or event could happen,” Krenc explained.

Box 2 (click on thumbnail to see larger image.)

Box 3 (click on thumbnail to see larger image.)

Evaluating, Controlling, and Monitoring Risk

After the initial risk analysis phase, the second phase focuses on evaluation. This is when the estimated risks are compared with a predetermined acceptability threshold. Unacceptable risks—those that pose a high probability of serious harm—are identified so laboratorians can focus on reducing them to an acceptable level, according to Powers. The third phase, risk control, is when efforts are made to reduce the level of each risk to an acceptable level. “The ISO standard established a hierarchy of risk control measures, requiring first that attempts be made to design the products and processes to avoid failures, then to implement protective measures, such as ways to detect failures before incorrect results are reported, and lastly, by providing information to enable the users to avoid risks, such as warnings and contraindications,” he added.

Finally, risk monitoring is the ongoing collection and evaluation of feedback and other information used to identify new hazards or increased risks. “This monitoring validates the original risk estimates, which are updated periodically based on real world experience,” explained Powers.

Getting Started

To implement a sustainable risk management process, Powers recommends that labs start slowly, with one test procedure at a time. For example, select one analyte based on medical importance—and perhaps difficulty—and establish a risk management plan before starting risk analysis. “Risk management in industry is beginning to be viewed as a specialized discipline, so a lab serious about implementing risk management needs to identify someone to become the lab's expert resource,” said Powers. “Training in the risk management process and its tools are essential, so whoever is identified as the labs' risk management expert should expect to attend a training program—there are many available that will provide the basics. This person should reach out to IVD manufacturers for guidance and assistance, since they are already familiar with risk management principles and most would be willing to help their customers get started.”

In addition to investing in these resources, commitment from lab management is also important, points out Powers. There will be changes and demands for investment, as risk assessments uncover opportunities for improvement and corrective action. “There isn't yet a cookbook recipe for applying the risk management process to clinical laboratories, so a laboratory director must be willing to break new ground,” he explained. “There are enough precedents in industry to indicate it can work in the laboratory, given the right leadership and vision. Eventually we can expect ISO standards and CLSI guidance documents written specifically for clinical laboratories, but first the pioneers have to prepare the way.”

For more information:

  • In addition to ISO 14971, (, there are excellent resources available through the American Society for Quality (, which publishes inexpensive booklets on risk management.
  • Presentations from the CLSI workshop are expected to be posted on the organization's Website,, in the near future.

Next issue :

Improving Patient Safety through Risk Management

Part II: One Lab's Story about Implementing the Process

Julie McDowell is the Editor of Strategies. She can be reached by email.

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