Compliance and Quality Connection

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DavidHoffmanBy David Hoffman
From Compliance Today, a publication for HCCA members.

In preparing for a lecture to my Regulating Patient Safety class at the Earle Mack School of  Law at Drexel University, I came across a very interesting article titled “High-Reliability Health Care: Getting There from Here.” [i] High-reliability science is the study of organizations in industries like commercial aviation and nuclear power that operate under hazardous conditions while maintaining safety levels that are far better than those of healthcare. The authors evaluated highly reliable organizations[ii] and found that “an environment of ‘collective mindfulness’ in which all workers look for, and report, small problems or unsafe conditions before they pose a substantial risk to the organization and when they are easy to fix” was effective in achieving high-reliability.[iii]  Doesn’t that sound like what a culture of compliance is all about?  The creation of a corporate culture of compliance that mandates that every employee has the obligation to report possible non-compliant activity has the exact same mission.

The authors further noted that:

“[H]ospitals are currently characterized by low reliability.  This fact implies strongly that hospitals cannot solve these problems [unsafe conditions] by simply and directly adopting high-reliability principles and practices all at once. Imagine what might happen if all the workers in a hospital suddenly acquired a keen sense of collective mindfulness and began to recognize and report all the unsafe conditions and errors they encountered from the moment they arrived at the hospital. The organization would soon be deluged with such reports that its capacity to fix the problems uncovered by the reports would be overwhelmed, and many unsafe conditions would necessarily remain unaddressed.”[iv]

In adapting high-reliability science to hospitals, the authors maintain that three major changes would have to occur in order to move toward high reliability:

  1. The leadership’s commitment to the ultimate goal of zero patient harm;
  2. The incorporation of all the principles and practices of a safety culture throughout the organization; and
  3. The widespread adoption and deployment of the most effective process improvement tools and methods.[v]

Again, these principles are consistent with “effective” compliance principles, including leadership commitment, using compliance principles throughout the organization, and using effective compliance policies and procedures.

But, I was puzzled by the authors’ conclusion that leadership (i.e., board, CEO/management) and physicians, all critical components to an effective compliance program, were deemed as in the “beginning stages of organizational maturity” when the “Board’s [and CEO/management] quality focus is nearly exclusively on regulatory compliance.”[vi]  Interestingly, there was no definition of regulatory compliance offered in the article.

I have maintained for years that regulatory compliance and quality are inextricably linked.  I have counseled every healthcare client that compliance officers must have a seat at the Quality table and vice versa.  Regulatory compliance is not just about billing activities; it must be defined to include the delivery of quality healthcare to patients and residents in order to support the submission of claims for services rendered. Whether the stage of development is deemed to be “beginning” or “approaching” organizational maturity, the role of compliance officers in assisting hospitals in achieving high reliability is without question.  If we view regulatory compliance through a clinical lens, it is apparent that patient safety is paramount. As such, the Compliance department must be an integral part in any healthcare provider’s drive to becoming a high-reliability organization.

[bctt tweet=”@SCCE #Compliance and Quality Connection” via=”no”]

[i] Mark R Chassin and Jerod M. Loeb:  “High-Reliability Health Care:  Getting There from Here.” The Milbank Quarterly 2013; vol. 91, no. 3, pp. 459-490.
[ii] Id. at 459
[iii] Id. at 461
[iv] Id. at 467 citing Weick, K.E., and K.M. Sutcliffe, . 2007. Managing the Unexpected. 2nd ed. San Francisco:  Jossey-Bass
[v]Id. at 468
[vi] Id. at 474 (Table 2)

David Hoffman (dhoffman@DHoffmanAssoc.com) is President of David Hoffman & Associates, PC, a national health care consulting firm in Philadelphia, dedicated to assisting health care providers in complying with regulatory requirements and ensuring patient safety through legal and clinical compliance.

1 COMMENT

  1. A ‘culture of silence’ is toxic and nowhere has its consequences been more evident than in healthcare. Leadership surmounting that mindset can unleash healthcare organizations just as it did in general industry with quality and safety issues. Without disclosure and openness you can’t have a learning organization. ‘Silence’ / ’Openness’ is a key metric of organizational maturity.

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