2019

CAREER CORNER

Has Information About Quality Become a Liability?

by Diane Kulisek

While having lunch with a good friend not long ago, I gained unique insight into a very real concern for those of us in the quality profession and the organizations we work with.

Venting, I said, “Why is it that other types of business managers—meaning those not categorized as quality practitioners—seem so reluctant to hear about quality or regulatory compliance issues? I just don’t understand why a rational, successful, business person would want to ignore a problem that costs his or her organization so much money and disappoints so many customers when left unresolved.”

My friend chuckled at my naiveté, despite knowing I had more than 30 years of experience as a quality practitioner. I did NOT see the humor in the situation.

Sensing my discomfort, she went on to say, “This is one of those times it’s good to have a friend in another profession.” My friend is, among other things, a personal injury attorney.

She went on to explain that simply by acknowledging that a problem exists, today’s executives and their organizations can become vulnerable to liability lawsuits. She also pointed out that any executive who accepts risk management as a way of doing business is confirming there is a risk that needs to be addressed.

Legal Obligation to Act

In fact, the moment any business manager becomes aware of a quality problem, he or she has a legal obligation to take action to protect others from it; otherwise, the organization can be charged with negligence, fraud, endangerment or other un-pleasant potential allegations.

Bottom line: It is not in the best interest of any company decision maker to know about a problem. In fact, one could almost say the more effective top managers are at avoiding information about quality or regulatory compliance issues, the more successful they might be at mitigating potential liability for themselves and their organizations.

The extent to which people are ready to sue one another in today’s society has certainly had other negative impacts on my quality of life, but this was the first time my career choice had been identified as a large contributor to the problem. Suddenly, I realized the fundamental essence of the quality profession—providing information about quality—had become more a liability than a benefit!

Quality of Life

With regard to quality of life, healthcare errors are among the leading causes of death for Americans, according to a fact sheet from the U.S. Agency for Health Care Quality and Research.1 As many as 98,000 people die in hospitals each year as a result of medical errors.

This figure is “higher than motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516),” the fact sheet goes on to point out. About 7,000 people per year are estimated to die from medication errors alone—about 16% more deaths than those attributable to work related injuries.”2

Why aren’t greater strides being made to improve quality in healthcare? One word: liability. Admitting to healthcare quality issues means potentially admitting to malpractice.

Few physicians or small clinics can afford the huge cost of protection from litigation related to malpractice lawsuits. It certainly would seem to be in their best interest not to acknowledge any error had been made by them or their organizations. We’re not talking about lying here. We’re not even talking about withholding information. We’re talking about not even accepting a problem as a problem.

Industrialist Henry Kaiser is quoted as having said, “Problems are opportunities in work clothes”3 It seems to have become generally accepted that the politically correct way to describe a problem to anybody outside an organization and even outside of a person’s department is not as a problem but, instead, as an opportunity.

Even employee performance re-views have stopped using phrases such as “poor performance” or “unacceptable behavior” and have begun describing such problems as “opportunities for improvement.”

Recommendations

One of the primary roles of the quality professional has been accountability for providing accurate and actionable information about quality in a timely and effective manner. How can this be done if simply having information about quality problems can now be viewed as a source of undesirable potential liability for business decision makers?

My recommendations are as follows:

  1. Understand the liabilities associated with certain types of information, and initiate actions to mitigate the potential for such liabilities before problems are reported to your organization’s decision makers. Top managers might be more willing to listen if they can trust you have already taken whatever action you could to protect their interests and those of the company. A fringe benefit could be that they will provide you greater access to the resources and authority necessary to pursue those initiatives and ensure they are both fully implemented and demonstrably effective.
  2. Know what your legal obligation for external reporting is. Make sure you report the problems you must report to avoid placing you or your organization in violation of the prevailing laws. On the other hand, also understand not all problems are required to be reported to any external entity immediately or, in some cases, ever. Know the difference.
  3. Implement timely and effective corrective and preventive actions that will clearly demonstrate due diligence for problem resolution and effective risk mitigation before reporting the problem or interacting with customers or authorities if you can legally take the time to do so. If the corrective actions can only be pursued after a problem is reported, expedite post-report problem resolution efforts to the absolute greatest extent possible. In the event a criminal charge or lawsuit is filed, the well-documented speed and effectiveness of your organization’s response to correct the problem and prevent recurrence might be the best evidence you will have to refute potentially serious allegations.
  4. Prioritize your problem resolution efforts, putting the most critical issues at the top of your to-do list. Start with those that impact safety. Under no circumstance would it be appropriate to allow a condition to persist that endangers public or personnel safety. In fact, safety is the only consideration of most laws and regulations involving quality problems.

Beyond that, however, address only as many issues as your organization can reasonably resolve with available resources. Then, move down the list of issues in order of criticality, matching the availability and depth of information and resolution efforts to available resources.

No Guarantees

Today’s liability laws and risks are so complex not even an attorney can ensure these approaches will prevent liability from negatively impacting those who know of a quality problem.

However, approaching quality issue resolution in the four ways noted in this article can demonstrate you and your organization’s reasonability to regulators while focusing limited resources in the most effective possible manner to best address public safety, regulatory compliance, business sustainability and customer satisfaction—pretty much in that order.

Not all quality information is likely to result in liability, but not all responses to quality problems are created equal. One of the newly emerging roles of quality practitioners can be to champion, manage and reduce the potential for their organization’s liability.

Those who strive to limit potential liability should find that they have plenty of opportunity to make value added contributions to their organizations and that quality information will be viewed more often as the asset it is intended to be.


REFERENCES

  1. Agency for Healthcare Research and Quality, Medical Errors: The Scope of the Problem, fact sheet, Publication No. AHRQ 00-P037, www.ahrq.gov/qual/errback.htm.
  2. Ibid
  3. Ginger E. Blume, “Mistake Phobia is Common,” www.drgingerblume.com/scripts_mistake_phobia.htm.

DIANE G. KULISEK of Simi Valley, CA, is president of CAPAtrak LLC, and an independent quality management consultant, writer and motivational speaker. Kulisek holds a master’s degree in engineering management from California State University, Northridge. She is a member of ASQ and active with the ASQ Food, Drug and Cosmetic Division, ASQ Region Seven (the Southwest), ASQ San Fernando Valley Section 706, as well as in promotion of ASQ’s economic case for quality.


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