The Quality Connection: Put patient safety process changes to the test

By Patrice Spath, RHIT
Brown-Spath & Associates
Forest Grove, OR

Health care organizations are beginning to redesign processes to improve patient safety. Process redesign recommendations may originate from a root -use analysis or from a proactive assessment of a high-risk process. It is important to ensure that changes in patient care processes achieve the desired goal — a safer health care environment for patients. Before fundamental changes are made to a process, it is important to test the proposal. Even the most well-intentioned process changes could increase the likelihood of mistakes. Before finalizing patient safety improvement recommendations, people must understand how a change in one process might transform the entire system of care.

The Joint Commission is emphasizing the importance of analyzing and/or pilot testing a new or redesigned process. Expect surveyors to ask how you evaluated the safety of new processes prior to final implementation. Even if the process suffers from a major problem that must be solved quickly, do not neglect the testing phase. Quick fixes in one area can completely disrupt patient care activities in another.

When designing a safer patient care process, first decide on which changes to try. There may be several ideas to choose from. Everyone should understand that process improvement is a learning activity. No one should be blamed for making the wrong suggestions. After all, even if a change doesn’t work out as expected, it will suggest ways to make things better. When selecting the process redesign suggestions to try first, consider the following questions:

  • Can the change be tested on a small scale?
  • Will the effect be evident reasonably soon?
  • Will the effect be easy to measure?
  • Does the process change require new measurements or will existing measurements be sufficient to evaluate results?
  • Is the change simple to do or will it take a long time to implement?
  • Can the pilot test be done without disturbing other patient care processes?

Systematically test proposed changes

There are several ways of testing process changes. A pilot test may not be the first step. Construct a flowchart of the redesigned process then conduct a failure mode, effects and criticality analysis (FMECA). At each step in the process, determine what could go wrong, how significant this failure would be, and whether a mistake at one step in the process could be caught before it reaches the patient. Don’t overlook the transition points in the process steps. For example, what could go wrong in the communication of information from one caregiver to the next? The results of this FMECA analysis is used to further refine what is intended to be a safer patient care process prior to formal pilot testing.

Another technique for evaluating the safety of a process prior to implementation is stress testing. Much like the stress tests done to evaluate a person’s cardiac health, the subject (the process) is subjected to extreme stress (theoretical disturbances). The process redesign team hypothesizes "worse case" scenarios. For example, the process for surgical site identification prior to incision might work just fine for 99.99% of cases. But what if you have an extraordinary situation such as an emergency night surgery? X-rays are not available in the operating room; the patient is nonresponsive; after the patient is draped, the surgeon unknowingly applies a tourniquet to the patient’s uninjured leg in preparation for surgery; and the operating room is short staffed. How will you prevent a wrong-site surgery in this situation? Stress testing a process can help identify where additional safeguards or revisions are needed.

FMECA and stress testing are theoretical techniques for evaluating the safety of a new process. Before making changes in the process, a pilot test can be conducted. This is a preliminary test or study of the new process to try out procedures and make any needed changes or adjustments. For example, the people involved in caring for patients undergoing surgery try out new methods for identifying the correct surgical site. To minimize disruption of patient care, it may be best to pilot test the new process in only one unit or for one population of patients. Training is always important when pilot testing a process change. A training assessment should be done, especially if the change requires new skills or competencies. Coordination will be needed to ensure the right people receive the right training at the right time to maximize the positive effects of the redesigned process.

It is also helpful to consider the risks associated with implementing change. There may be potential downsides or adverse affects associated with some changes. For example, from a staff member’s perspective, changes that result in additional work may be interpreted as a burden. Plans to address these concerns and mitigate their effects should be developed. Staff reluctance to accept process changes may undermine the results of the pilot project.

Before conducting the pilot test, check to be sure all the proper approvals have been obtained. This may add time to the testing process, but it is an important component of the project. There should be a clear plan of what needs to happen and when. Issues that have the potential to unexpectedly halt the progression of the pilot project should be clearly identified on the timeline.

Pilot testing of new or redesigned processes is done for a specific purpose — to improve patient safety. But how will you determine whether or not the pilot test is a success? To achieve meaningful change, it is important to know what problems the new process was expected to fix. For example, the goals for a project involving better preoperative identification of surgery sites might include:

  • The correct operative site is always marked preoperatively.
  • Patient records are always available in the operating room.
  • Patient X-rays are always available in the operating room.

The goals of the process redesign influence your data requirements. You’ll need to design methods for gathering information during the pilot project to determine the success of the process changes. Other data you may wish to collect include staff satisfaction with the new process, unanticipated outcomes, and key issues that may affect the pilot test results (e.g. staffing levels, patient satisfaction, etc.). Systematic measurements should be maintained for each stage of the pilot project. Do not rely on people’s memories or intuition.

Measure success

It should first be determined if the established goals were achieved. If the goals were not achieved or were modified, then the reason(s) should be documented. Many times there are unanticipated consequences to changing a process. Whatever the outcome, it is important to document it so benefits can be attributed and/or new issues that arise can be addressed. It is important to identify the key factors that lead to success or failure of the new process. It can sometimes be difficult to document and openly share those things that did not work. However, this is important so that future process changes can be more effective in safeguarding patients from mistakes. You may need to do several pilot projects before determining the best process for improving patient safety.

When selecting the best process redesign solution there is one general principle to keep in mind. In the long run, a change that reduces variation in the process without making the process unsafe for patients is more desirable than a change that increases variation in the way people do things. This is because reduced variation makes mistakes less likely.

Share lessons learned

The knowledge gained during all phases of the process testing should be shared with others who may benefit from the lessons learned. There may be a number of closely related patient care units or people performing similar functions that can clearly benefit from the information. For example, the process of surgery site identification in the inpatient environment has implications in many other provider settings. It is important to remember that the information gained from your process testing, whether positive or negative, is valuable. Sharing lessons learned will help others improve patient safety in their environment while avoiding pitfalls.