The Quality-Cost Connection

Worst practices used in conducting FMEA projects

Part 2 of a two-part series
By Patrice Spath, RHIT
Brown-Spath & Associates
Forest Grove, OR

As often occurs when new Joint Commission on Accreditation of Healthcare Organizations standards are introduced, hospitals are rushing to complete failure mode and effect analysis (FMEA) projects to comply with patient safety requirements.

Organizations caught up in the whirlwind of standards compliance are tempted to execute the FMEA project work without proper training. It’s important to note that there are many different FMEA models, and no one particular technique is most suitable. However, some FMEA difficulties are common to all organizations.

This is the second of a two-part series on how FMEA projects can prove more valuable to the facility when "worst practices" are avoided. Worst practices numbers 1-8 were described in last month’s Quality-Co$t Connection column.

This month, the remaining four worst practices are covered, along with suggestions on how to avoid these practices.

Worst Practice #9: Fail to critique the effectiveness of proposed actions.

To make a health care process safer, actions should result in a reduction of the criticality score for each high-priority failure mode. Lowering the probability of occurrence, decreasing the severity of the effect, and/or improving the detectability score will reduce the criticality score. If an action plan is not expected to reduce the criticality score of the failure mode, then another action should be developed.

For instance, to reduce the possibility that a physician would order an inappropriate medication or dosage, one FMEA project team recommended there be a consistent spot on all nursing units for medication reference materials for physicians. That was the only recommendation for reducing the likelihood of this failure mode. What are the chances that this action will reduce the probability, severity, or detectability of an inappropriate medication order?

FMEA project teams should subjectively analyze the predicted effect of proposed actions before implementing the changes. This involves recalculating the failure mode criticality scores based on what the team imagines will occur after the proposed action is implemented.

For example, the team is asked, "After creating a consistent spot for medication reference materials, what is the probability that a physician will order the wrong medication dosage?"

If the action is expected to make a difference, then the probability of the failure should go down. This recalculation exercise should be done for each of the high-priority failures for which actions have been proposed.

During pilot testing of actions, data about the occurrence and detection of failures can be gathered. After a period of time, the data are used to objectively recalculate the failure mode criticality scores. As part of the evaluation of the effectiveness of actions, the team’s predicted post-action failure mode criticality scores can be compared to what actually happened.

Worst Practice #10: Don’t adopt a systems view.

For the most part, the actions taken to reduce the likelihood of failures are directed at changing people or processes. New double-checks are added, record forms are revised, individuals are retrained, procedures revised, etc. Unfortunately, during the action planning step of the FMEA, the latent system failures that set up people to make mistakes often are ignored.

If the organization’s underlying system for managing processes is not addressed, the future safety of patients remains in jeopardy. For example, hospitals have implemented surgery-site marking and pre-incision site and patient verifications to reduce wrong-site surgery. However, if the system of care in the operating room expects the surgical nurses to regularly function with heavy mental workloads, this latent failure can contribute to a future accident. Numerous organizational factors directly affect the safety of patient care, as well as the work conditions and actions of individuals at all levels.

Those latent failures generally revolve around issues related to resource management, organizational climate, and the characteristics or conditions of work that have been established by management. Those factors must be carefully considered during the development of actions intended to reduce the likelihood of failures.

Worst Practice #11: Overlook human factors.

Preventing failures in the delivery of health care services requires changes in the macro and micro aspects of the systems in which people work. Changes in procedures, rules, workflow, automation, the introduction of new technology and equipment, and other system changes help make people effective. However, the needs of the people working in the system also must be considered when developing action plans. In this regard, FMEA projects often fail by:

  • creating additional work for fewer people;
  • removing people from roles in which they were comfortable;
  • placing people in unfamiliar new roles as if they were interchangeable parts;
  • not involving or consulting with the people affected by decisions. Instead, assumptions about what is good for them are made.

When introducing workflow changes, automation, new roles, and other interventions designed to make a process safer, the FMEA team members should always ask, "What needs of the people involved are affected, how will their energy and interests in the job change, and what skills will the proposed changes affect positively and negatively?" Interventions to reduce failures and improve patient safety work best when they address both the needs of the system and the individuals who inhabit them.

Optimal solutions occur when system- and individual-level needs are addressed. The question to answer is: What is in the best interest of the system, the people who work in it, and the individuals we serve? That question involves three groups of players. It would be a mistake to implement risk reduction strategies that leave one of the stakeholders out.

Worst Practice #12: Don’t broadly apply lessons learned.

The risk-reduction strategies implemented during an FMEA project often have application beyond the scope of the FMEA investigation. Yet the lessons learned in one project seldom are applied to other, similar processes.

For example, to reduce the risk of wrong-site surgeries, the surgery department in one hospital created a rejection process to be used when physicians fax orders for patients who will be coming in for surgery. If the orders are incomplete or unclear, the orders are faxed back to the physician with a rejection form indicating the deficiencies that need to be corrected before the patient’s arrival. If this action works well for the surgery department, why not use the same process in patient registration for all pre-admitted patients?

To ensure everyone learns about the good ideas that come out of FMEA projects, the lessons learned need to be shared throughout the organization. Lessons learned are the knowledge or understanding gained by the improvement experience. The experience may be positive, such as reduced errors, or negative, such as solutions that didn’t work as intended.

Many hospitals use staff meetings, newsletters, training conferences, or program reviews to communicate lessons.

Listed below are some other examples of what could be done to improve knowledge sharing.

  • Designate an individual to serve as the "lessons learned" coordinator to lead and manage efforts to share lessons learned in all improvement projects, including FMEA projects.
  • Develop ways to broaden and implement mentoring and storytelling as additional mechanisms for lesson sharing.
  • Identify incentives to encourage more collection and sharing of lessons among employees and improvement project teams, such as links to performance evaluations and awards.
  • Solicit user input on the value of the organization’s current lesson-sharing efforts to determine how knowledge can be better disseminated.
  • Initiate information technology pilot projects to evaluate the usefulness of electronic information sharing.
  • Track and report on the effectiveness of the lessons-learning efforts using objective performance measures.

A common barrier to sharing lessons learned from any process improvement project is the perception that people will be punished if a recommended action does not achieve its intended goal. Overcoming this barrier requires strong support from the organization’s leaders. Perceived intolerance of mistakes by management will cripple any knowledge-sharing efforts.

FMEA is a new tool in a health care organization’s process improvement toolkit. If used sensibly, this tool can effectively reduce the risk of unintended patient harm. By converting worst practices into best practices, the value of individual FMEA projects will be greatly enhanced.