Author: jdesilva@qmii.com

Is there a potential downside to medical audits wherein the audits are focused on finding and fixing problems? A recent discussion with a medical professional piqued my interest in the value of Medical Audits given that QMII, a subject matter expert in auditing, has ventured into the medical auditing field. This led to a conversation with a few additional healthcare professionals to understand a little more about medical audits, their findings and how organizations address them. My additional reading outlined a lack of effective systemic corrective action. In this article, I discuss some aspects of the medical audit process and what organizations can do to improve the process of audits and of implement corrective action.  

There are various types of medical audits including clinical audits, billing/coding audits, financial audits, operational audits and compliance audits. While there are regulations, protocols and standards against which these audits are conducted, in many cases, industry-best practices are also used as audit criteria. This brings subjectivity into the audit as ‘best practices’ knowledge may vary from auditor to auditor based on their experience. Auditing to an auditor’s experience has a major drawback not just in the medical industry but in all industries. It takes the auditors away from requirements which then results in biased inputs to the leadership that may be inaccurate.  This also leaves the auditee (the organization being audited) on the receiving end of findings for which there are no certain requirements. That is, they may make changes to their system based on the finding of one auditor only to find that another auditor objects to the very actions they implemented based on the previous auditor. 

Medical Audits and Recommendations 

In medical audits, it is common practice for auditors to provide recommendations to address findings. These recommendations are based on experience and industry-best practices. In ISO audits this is not allowed. In most industries, including the healthcare industry, there is no obligation to act upon any of the recommendations of an auditor. However, if auditors are perceived to be in a position of authority, then there is an underlying implication that the audit recommendation must be implemented. This is for fear of the nonconformity occurring again only for someone to say, “the auditor told you what to do and no action was taken”. This then also implies, audits do not delve deeply enough to identify systemic weaknesses within the processes or the workflow. 

In speaking with the medical professionals within my professional circle of friends, it was surprising to hear that in many cases the personnel being asked to address the audit findings are unaware of any root cause analysis methodologies nor have they been given any formal training in the subject. Further, they are not clear about what a CAPA is but do know that they need to provide some action to close out the finding. In such cases, is it then fair to expect effective corrective action? Perhaps, the lack of effective corrective actions perpetuated the need for auditor recommendations! 

Without proper training, it is but natural for personnel responding to audit findings to default to the recommendations of the auditor and implement those actions prescribed by the auditor as the corrective action in and of itself. Sadly, in such cases the root cause of the issue goes unaddressed. Sometimes such cases may lie in inadequate resources, technology or even lack of guidance/policy from leaders. While the aim of the audits is to identify where the process may require additional controls, all for providing better healthcare for the patient, the outcome may only be a band-aid. 

What can be done to change this? 

While change may not come overnight, there are a few key steps that can be taken to improve the audit process overall right up until corrective action and meet the end goal of providing better healthcare.  

Auditor training – Auditors must be trained to remain objective through the audit process, to focus on the requirements (criteria) of their audit, to focus on factual evidence and objectively assess it (yes, no experience!). Further they must understand the implications of providing recommendations and thus not provide any recommendations. The auditors are but to focus on assessing the effectiveness of the corrective action plan submitted and verifying the effectiveness of actions taken.  

Root Cause Analysis Training – Healthcare organizations must invest in providing their personnel with training in the different root cause analysis methodologies and how to apply it to identify the root cause(s) of a problem.  

Reinforcing that Recommendations need not be accepted/addressed – Organizations must be professional to build the courage to stand up to auditors and not accept recommendations. Auditors do not know all facets of the process from the short sample of the organization they witness. If their “advice” in the recommendations is wrong/ineffective, who then pays the price? 

Auditor Selection – ISO 19011 provides guidance on the behaviors and skills that an auditor should exhibit, and these are applicable to an auditor selected to conduct any type of audit. Auditors must be evaluated periodically to ensure they are remaining objective through an audit and working to identify the effectiveness of controls and adequacy of resources in assessing if the overall objectives have been met. To learn more about how QMII can support your organization’s audit process, click here. 

–Julius DeSilva, Senior Vice-President