RTCrawford’s Weblog

As time permits, I am posting final exam papers written by selected students of mine (with their consent, of course). In each case, they have addressed the question of whether the tools and techniques of continuous quality improvement work in healthcare settings. This seemingly simple question is abundantly difficult. My students, however, are brilliant, and I am frequently rewarded with “mind candy” such as that provided by Sherika Hill, who posits that the continuous improvement of Shewhart’s and Deming’s PDCA cycle is not necessitated by perfection’s impossibility but, instead, by the changing forces and influences of the informing environment.

Sherika Hill

HPAA 761

Final Exam

There is no doubt in my mind that Continuous Quality Improvement (CQI) works effectively in healthcare settings. What is debatable, however, is whether or not the principles as taught in this course are essential to the success of an organization. I argue that CQI is not only necessary for an organization’s success but also its very survival given the forever changing landscape of healthcare.

Although the benefits of CQI may be counted and expressed differently for each healthcare organization in terms of profitability, employee satisfaction, reduced costs, improved patient survival, and better continuity of care, the outcomes are tangible and reproducible. As such, I can agree without hesitation that the principles work. It is possible to effect change in an organization- regardless of the scale, by using data and organizational learning to create a culture that has both the ability and desire to change. The numerous CQI success stories that exist are not invalidated just because there is limited empirical data to attest to the full impact of the initiatives within and across healthcare organizations.

It is widely accepted that “That which is measured, improves“. However, the data is useless if organizations do not know how to interpret it and respond appropriately. CQI provides an organization with this quantitative and qualitative knowledge, going beyond simply measuring performance and monitoring progress. It is a management science based on identifying, controlling, and monitoring variation that is observed in operational practices. In a healthcare setting, these operations can be administrative or clinical, departmental or system-wide, big or small. Regardless of the impetus for change, the goal in every initiative is to optimally reduce or eliminate factors that introduce variation in the end-product. By doing so, management can consistently achieve an outcome that meets the expectations of the end-recipient. [1]

The word “continuous” in CQI denotes the constant need to modify operational practices according to the current internal and external environment.[2] The steps are simple: initiate a framework for change, implement changes, and improve upon results derived by changes. Given its repetitive nature, CQI is not only cyclical but also helical as it spirals outward to encompass additional operational practices that are dependent upon another. The image[3] below depicts such a domino effect, a helical-continuum . This example is based on the need to improve patient recruitment for clinical research studies. As the original cynosure is addressed, new CQI initiatives, influenced by internal and external objectives, may be spurred based on the same theme.

The “quality” sought in CQI is the perceived satisfaction of the end-recipient. Depending on the initiative, the target audience could be patients, providers, caregivers, payors, accreditation boards, policy makers, researchers, etc. Preferences can be ascertained and validated by using multiple sources such as surveys, interviews, focus groups, and anonymous feedback mechanisms. The desired outcome may be quantitative or qualitative or both.

Understanding the end-recipient’s preference is key to improving the right processes to achieve expectations. It should not be taken for granted that a process improvement will benefit all parties involved. One man’s treasure can be another man’s trash. For instance, in the clinical study example above, the metric for improving patient recruitment for a Principal Investigator may be to simply increase the number of enrolled participants by a certain percentage each month. To achieve this goal, considerable thought and refinement may be given to optimizing the recruitment aspects of the study. Having more patients sooner, however, may exceed the throughput of other operations: electronic data capture, shipping, lab processing, analysis, and dissemination of results; creating backlogs and longer lags on project timelines. This same goal- improve patient recruitment- from the perspective of a scientist may have nothing to do with speed but rather balance of participants. Accordingly, if the patient selection process was optimized so that there was an equitable number of a male to females or number of patients to healthy volunteers, the interim analyses could have greater significance. BioInformaticians, however, would whince at the thought of analyzing incomplete data sets. Their idea of improved patient recruitment most likely would be to reduce the number of data errors by optimizing the data entry processes. [4]

“Improvement”, the last word in CQI, relies upon the ability to generate predictable results from a project, program, process, policy, or philosophy. For a project with a specific beginning and end, standardizing outcomes may seem straightforward. However, ensuring a consistent deliverable from a program- portfolio of multiple projects- may be more complicated. Processes, which are cyclical programs, may be even more challenging to improve as inputs and outputs become less distinguishable. The final end-product of policies and philosophies, which underpin and shape organizational culture, may be the most difficult of all to influence given their amorphous yet ubiquitous nature.[5]

Luckily, various CQI tools exist to identify factors that may cause random and inherent variation: flow charts, cause-and-effect diagrams, histograms, Pareto charts, run charts, control charts, and statistical analyses. By eliminating or reducing the variant factors, a standardized end-product can be expected. To create an internal environment that desires change, the CQI principles are necessary to change the organization’s culture.

1) Empower front line employees to assist in identifying problems and to take ownership of implementing solutions.

2) Develop multidisciplinary quality teams that use data to drive decisions.

3) Ensure management provides the necessary commitment, infrastructure, and resources to effectively bring about and sustain needed change.

To survive and be competitive, organizations must be as dynamic internally as their external environment.[6] The landscape of the healthcare industry is constantly changing. There are new competitors, new markets, new technologies and therapies, new information such as the human genome, new rules and regulations, new payors, etc.[7] Consequently, the way that healthcare is delivered must also change. Static organizations will quickly become antiquated. Having the ability and most importantly desire to identify problems, implement solutions, and improve upon the results becomes essential for survival. In this regard, CQI cannot be viewed as a-nice-to-have luxury element reserved for superlative organizations. It is a basic commodity that must be a part of the infrastructure and culture of every healthcare organization.

Similar to how evidence-based medicine seeks to provide mass customization[8] of care to highly variable patient populations, CQI too must be modularized so that there is an appropriate type and level of intervention for each healthcare organization. Otherwise the costs may be too prohibitive for an organization to undertake the investment.[9] Alternatively, organizations may opt for process re-engineering because they are too intimidated to change their organizational culture.[10] Accordingly, there needs to be CQI guidelines catered for each type of organization: new organizations, growing organizations, seasoned organizations, established organizations, small organizations, medium-sized organizations, large organizations, non-profit organizations, for-profit organizations, inner-city organizations, etc.[11] Once the type of customized CQI is identified, the approaches have to be personalized to the specific needs of the organization just as clinical pathways must factor in a patient’s co-morbidities to create the best treatment plan.

Although the advent of new information technology (IT) may ease the pains of CQI, organizations should not wait for such systems to begin the continual process of improvement. IT will definitely be an asset for data capture and analysis. However, the qualitative measures such as determining the extent to which the culture has been impacted or assessing how much front line employees have been empowered will continue to be experienced rather than computed.[12]

It is true that healthcare organizations existed, competed, and thrived without using CQI tools and techniques prior to the 1980’s. Now, a little more than 20 years later, it is absolutely essential for their survival to have CQI as part of the day-to-day operations. The adage “if it ain’t broke, don’t fix it” no longer applies as a good business practice. CQI offers a complete qualitative and quantitative approach to constantly achieve expectations even though expectations are changing with time. Organizations must do what they can now in terms of the implementing CQI and expand outward in the helical-continuum as resources allow.

[2] Yes. You get it! The logic behind continuously improving an existing process is not just to reform an imperfect process of its remaining flaws (in a never ceasing effort to achieve perfection); although, that is certainly an expressed goal. Instead, no static environment exists in a competitive economy. Staff turnover, initiatives by the competition, breakdowns in performance discipline, adjustments in related and adjacent processes, changes in systems, etc., promote the need for recurrent monitoring and refinement.

[3] Note: This graph is Sherika’s creation.

[4] Excellent!

[5] I love this paragraph but would like to see more in support of the contention that the cyclicality of processes make the distinction between inputs and outputs less evident.

[6] Is simple parity sufficient? Philosophically, you could argue that internal dynamism must exceed the totality of the external forces (i.e., the competitive marketplace and economy). That competitive marketplace and economy, however, often work at diverse purposes and without coordination. This would suggest that simple competency (at some critical mass) should prevail – explaining the success of the number two’s in oligopolies. Personally, I doubt that such fine distinctions constitute the basis on which viable strategic plans may be crafted and deployed with reliable success – primarily because identifying that mercurial tipping point (critical mass) may be impossible.

[7] I have written about this level of extraordinary change in the past – describing it as “hyper-Darwinian.” If the market place is analogous to an ecosystem and firms enter and exit that ecosystem in cycles progressing from creation to extinction, it may be expected that Darwin’s “survival of the fittest” represents a viable model. Firms that do the right things right and do them consistently enjoy a survival advantage.

In Darwin’s world, that advantage follows from unplanned mutations, and, certainly, some of this takes place in competitive markets. The resurgent popularity of Hush Puppies a few years back serves as an example. The more common expectation, however, is that firms identify unmet needs, anticipate economic steering winds, or exercise vision to identify the needs of the market before the market recognizes that it has a need.

Of course, such changes require two things – prior thought by decision-makers and the time and resources to make necessary changes. In other words, the reaction time is not instantaneous. If, however, the volume of external influences demanding or compelling change exceeds the capacity to anticipate and accommodate, the fittest will still survive but survival will not follow from conscious vision, prior planning, abundant and available resources, or stellar execution.

Instead, as in Darwin’s model, the advantage will follow from serendipitous good fortune – i.e., accidents of luck (“The secret our success? Well, we just happen to be at the right place at the right time.”)

I think that we saw something similar to this during the five years following The Balanced Budget Act of 1997, as the industry scrambled to accommodate the dual forces of managed care and reduced CMS compensation. Today, things are more stable, even though constraints persist.

I cannot help but wonder, however, whether we are likely to see a return to hyper-Darwinianism at some point over the next decade – as the boomer generation enters retirement, Medicare approaches insolvency, and Washington becomes increasingly desperate to identify solutions through competing and inconsistent policies and regulations.

This will make it all the more imperative for market participants to achieve uncommon levels of flexibility and performance competence – levels for which there is no historical precedent for an industry that prides itself on the opposite virtues of stability, constancy of purpose, tradition, and the reasoned reticence of “first, do no harm.”

[8] Wonderful!

[9] How? Does this strike you as more easily urged that achieved (most things are)? Personally, I am concerned that we have converted quality improvement into an industry in itself – complete with cost structure, hierarchy, infrastructure, jargon, journals, deities, and consultants. No longer that which is achieved on the factory floor and accomplishable by Joe Sixpack the Bolt Turner, it strikes many as debilitatingly non-scalable and, worse, inaccessible to the firms that hired him.

[10] Reengineering requires its own change of culture and, indeed, no organization that has been “reengineered” is capable of retaining its culture unmolested – especially, if reengineering is errantly perceived as simply cranking up the computer and printing pink slips with a merge routine (a la Al Dunlap). But, even if used as Hammer and Champy commended, reaggregating processes and compacting the hierarchy are culture-changing in themselves.

[11] Is there an unintended consequence of such added complexity? Can it be avoided?

[12] Alas, poor Likert! I knew him, Horatio — a fellow of infinite jest, of most excellent fancy. He hath bore me on his back a thousand times, and how now abhorred in my imagination it is. My gorge rises at it. [Stolen and altered from Shakespeare's "Hamlet."]