Ensuring quality and patient safety: CQI business as usual’ isn’t enough
Traditional approach weak on cultural change, anticipation of errors
Ever since the 1999 publication of To Err Is Human by the Institute of Medicine, health care quality managers and oversight agencies have placed an increased focus on patient safety. However, observers say, addressing patient safety improvement with a traditional continuous quality improvement (CQI) approach may not be the way to go. Some say the fault lies within CQI itself, while others blame inadequate implementation, but most agree that "business as usual" is not the way to improve patient safety.
"CQI mechanisms to control risks have not been entirely successful because CQI does not allow for human error," says Patrice L. Spath, RHIT, of Brown-Spath Associates in Forest Grove, OR. "CQI expects people to be infallible."
"It’s a weakness in the way it’s implemented," counters Richard Croteau, MD, executive director for strategic initiatives with the Oakbrook Terrace, IL-based Joint Commission on Accreditation of Healthcare Organizations. "There’s nothing in CQI that says we shouldn’t consider human error when evaluating process. A series of interrelated steps lead to outcome, and people do influence outcome. The two are interwoven by design; this provides the opportunity for improvement," he says.
"If we look at quality as it has been implemented in the past, we won’t be successful in reducing patient errors," says Monica C. Berry, BSN, JD, CPHRM, president of the American Society for Healthcare Risk Management in Chicago. "The whole notion of quality in the past has become the idea of doing it, so it became an end rather than a means. In the whole process of just doing it,’ what has happened over time is that we have gotten lost in that process and fallen down in the implementation."
Spath asserts that, in the health care setting, there are two distinct aspects of CQI, each of which has its shortcomings. One affects the culture of the organization, while the other relates to CQI project work. On the cultural side, organizational commitment is lacking, she says. "What has happened is that a lot of administration leaders saw CQI as synonymous with Joint Commission requirements and pushed it down to people lower in the organization," Spath explains. "They gave it to the quality manager, or perhaps to the risk managers, and expected individual managers in each department to improve their processes. Quality managers knew what to do; they had the ownership, but they didn’t have the power to effect organizational change like senior leaders do. Nor did they have the same power to make others accountable."
When it comes to actual process improvement, a lack of training, combined with an inherently flawed approach, create a formula for failure, Spath says. "Most of our managers are people who moved up into management from on-line positions and did not get the training they needed in how to improve processes," she adds. "Second, the solutions were not necessarily the best fixes in terms of improving patient safety; a lot of the focus was on improving the efficiency of process."
Any number of CQI projects have been undertaken to improve outpatient testing, reduce waiting times, improve patient flow in the organization, get test reports out more quickly, or improve customer service, Spath notes. "What we didn’t do is look at the mistakes that could be made in that superefficient model that can result in patients not getting the right test, for example," she says. "Let’s say an old lady comes into radiology for an IVP. She’s checked in, and she sits down. Another lady is scheduled for abdominal X-rays, and sits down without checking in. The radiology tech calls the name of the first lady, who doesn’t hear him, and the second lady stands up. The tech puts her in the dressing room, and does an IVP on the wrong person. So, one patient did not do what we expected her to, and the radiology tech did not check the patient’s ID. We didn’t ask What if?’ questions during the process, because CQI just doesn’t include that focus on human error."
So, Spath concludes, CQI has given us more efficient processes, but not necessarily error-resistant processes.
Effective or not, CQI and patient safety improvement are stuck with each other, Berry says. "Quality and risk management are joined at the hip. Neither one will be successful without a commitment to approach problems in a collaborative way." The problem in the past has been as much methodology as implementation, she adds. "Part of the reason we are struggling is that there are so few people trained to do CQI properly," Berry says. "We continue in a cycle that never really allows us to determine whether we’ve been able to make change to the degree we thought we would."
"I believe CQI and safety improvement to be interrelated," Croteau adds. "Both require an organizational commitment to an ongoing process. CQI should not be practiced as discreet projects or by specifically appointed individuals; that is contrary to the intent of CQI."
And what of Spath’s assertion that CQI overlooks the potential for human weakness? "That may be, but that’s an adoption of a cultural attitude in health care rather than something that’s inherent in CQI," Croteau responds. "We’ve had problems in health care accepting that people make mistakes. That is not the case in other fields; other people practice CQI in an environment that assumes people do make mistakes." In other words, he says, health care professionals need to put back into CQI that which they have taken out. "I’m not inclined to dis’ CQI," he says. "Perhaps we’ve not taught it effectively in health care, and more specifically, we have not dealt with the cultural issue, which we now must address in patient safety issues."
Spath offers a number of suggestions for supplementing CQI to make patient safety improvement initiatives more effective. "There are techniques like reduced reliance on memory, simplifying the process — not something we have traditionally looked at," she says. (For Spath’s recommendations for reducing the likelihood of errors, see table.)
| Reduce Errors with CQI Add-Ons | |
| Here are some recommendations for improving a process to reduce the likelihood of errors. | |
| 1. | Simplify the process/reduce hand-off approach. |
| 2. | Reduce reliance on memory. |
| 3. | Standardize. |
| 4. | Improve information access. |
| 5. | Design for errors (e.g., expect errors will happen and build safeguards into the process to catch them). |
| 6. | Adjust work schedules. |
| 7. | Adjust the environment. |
| 8. | Decrease reliance on vigilance. |
| 9. | Choose the right people for the job. |
| Source: Patrice Spath, Spath-Brown Associates, Forest Grove, OR. | |
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"The Joint Commission wants us to evaluate the culture of the organization as it relates to patient safety — to measure the commitment throughout the organization and then to take appropriate action. This is not something we did as part of TQM [total quality management]."
From the Joint Commission’s viewpoint, "We are very upfront now, talking about the fact that people make errors," Croteau says. "[However], I don’t like the word error’; engineers always use the word failure,’ which is not taken so personally." According to Croteau, Spath’s description of cultural weaknesses in traditional CQI is right on the mark. "This is what we’ve done as CQI/TQM has evolved over the years. Now we have an interest in demanding attention to the specific issue of patient safety. We want to learn from our errors in implementing CQI to make it more effective in improving safety. We recognize that we created CQI as a job to be delegated to a person, and that it has not worked that well. We must charge the leaders of the organization to make a personal commitment and integrate this into the culture of the organization," he says.
Leaders must establish quality and safety standards and hold their people to them, Spath says. "The quality managers’ role should be that of facilitator; they should serve as an in-house consultant. They will gather up the data to see if standards are being met, to look at aggregate information to identify opportunities for improvement. They should generate ownership to provide a support function but not to make it happen. By taking on all the responsibility for quality, everybody else in the organization relinquishes it. We can’t take on the responsibility for patient safety." Rather, she advises, upper managers should build constant patient safety improvement into a list of performance expectations for all employees.
At the project level, Croteau says, "You must ask yourself, what are your goals for process improvement? If your goal is to improve waiting times, you will focus on efficiency issues. You also may want to include mistakes. Don’t throw out your CQI tools; just add tools to your toolbox that help you look at human processes."
When it comes to those tools, should quality managers consider some "new" approaches, such as failure mode and effects analysis (FMEA), or as the Joint Commission calls it, failure mode effects and criticality analysis (FMECA)? "You need a process to reduce error," Croteau asserts, "But FMECA won’t help you on the organizational level. In order to use a failure mode analysis approach, you have to define a process or a system, what it is in terms of its components and the way they interrelate. That’s the key; anything you can define in that manner can be used. It isn’t just about identifying human error — it’s about any kind of failure."
You could do an FMECA to improve timeliness, but developed with a focus on safety, he offers. "It’s not limited in that sense, but when you start to make improvements, you have to be careful that aspect of quality does not degrade performance in another dimension. For example, when you improve safety, you typically degrade timeliness." (For more on failure mode analysis, see QI/TQM, February 2002, cover story.)
Speaking of timeliness, Berry would like to see the whole CQI process streamlined. "We’ve gotten caught up in the length of the process; it takes forever to get from phase one to that phase where you monitor the implementation," she explains. "That length of time is something we don’t have when it comes to changing patient safety initiatives," Berry says. How can the project time be cut down? "We need to look at things and develop a much more rapid cycle," she advises. "I believe that was probably part of the Joint Commission requiring root-cause analysis to be completed within 45 days."
In the final analysis, any CQI project must affect patient outcomes and satisfaction, Spath explains. "What this is really getting at is, are we really making the patient any healthier? That’s the real linchpin between quality and risk," she says. "Leaders can no longer ignore their responsibility."
For more information, contact:
• Patrice L. Spath, RHIT, Brown-Spath Associates, P.O. Box 721, Forest Grove, OR 97116. Telephone: (503) 357-9185. E-mail: [email protected].
• Richard Croteau, MD, Executive Director for Strategic Initiatives, Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook, IL 60181. Telephone: (401) 295-7147. E-mail: [email protected].
• Monica C. Berry, BSN, JD, CPHRM, President, American Society for Healthcare Risk Management. Telephone: (815) 971-2188. E-mail: [email protected].
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