In my May 2015 article on Risk-Based Thinking (RBT), I discussed the current state of healthcare related to risk and our current performance as a profession.  Since that article, there have been other journal articles that showed improvements in our performance, related to risk, which we all know translates to patient safety.  Today I see that 241 hospitals appeared on the CMS HAC (Hospital Acquired Conditions) list for the third year in a row.

Rather than repeat the performance data detailed in the last article, I’ll spend more time on the benefits of implementing, maintaining and improving an integrated process and risk based management systems as part of your accreditation.

Let’s start with some brief definitions.  Risk is defined as the effect of uncertainty on achieving objectives.  Risk-based thinking is not defined in our DNV-GL accreditation (specifically in ISO 9001:2015), but it was defined in a pre-cursor document to the 2015 version…and I like this definition.  Risk-based thinking is defined as the “process of considering risk qualitatively and possibly quantitatively when planning, implementing and managing a quality management system”. Aviation and nuclear industries use this definition of risk as it relates to operational and organizational processes.  This broadens some of the traditional definitions of risk (finance or legal) in healthcare.

We know that we are still very “siloed” in our hospitals.  We really understand our processes in our own silo, yet we are “under-aware” of the critical interactions our processes have with processes in other silos!  Negative issues manifest mostly when our efforts or our final products do not meet the need of the person or service in the next process.  This is a very real risk.

We need our processes to produce repeatable outcomes, based on process design, not on individual heroics.  Basic process management (understanding the processes and their sequence and interaction, which is a foundational element of your DNV-GL NIAHO accreditation) will enable you to better control and sustain those processes, especially those that require a high degree of consistency. You must include a risk consideration and work to improve consistency in those processes with the greatest risk.

Hospitals should create a risk management framework, a defined organizational structure to manage risks, to help create better outcomes.  By creating a risk framework, integrated with our processes, we can produce a safer environment for our patients.  The need for heroics is diminished, since our processes are no longer “people- dependent”.

While it is not a difficult process, it is the discipline to make these changes that is difficult.  Many of our contemporaries may not be open to change, so that hurdle must be addressed early.

Here’s how a sound, mature process and risk-based system can help you manage some current challenges.

Value-based purchasing:  Moving to a “pay for performance” reimbursement model is the number one item keeping hospital CEOs and CFOs up at night in 2016.  Using the basic foundation that ISO 9001 presents, a closed-loop system for sustainability and improvement, a hospital can better manage contracted staff and ensure more consistent outputs of clinical services.  This also includes the ancillary or support activities, such as purchasing, EVS/EMS, Sterile Processing, etc., that can indirectly affect clinical outcomes.

HIPAA Compliance:  Now that fines are being levied for breaches (thanks to HITECH), maintaining privacy has become a real liability to our bottom line.  Using your design requirements to create and improve processes that factor in the risk of failure, you can best manage your IT, human factors and the interfaces between both.  Using the same closed-loop system described above, you can check the degree of effectiveness routinely before an event might  occur.

ICD-10 implementation:  Implementing ICD-10 was a major undertaking.  There was a lot of confusion and anxiety associated with the change.  Working in an environment that manages processes well, (business as well as clinical) can ease the concerns brought about by changes such as ICD-10 implementation.  You have a defined approach for managing change that will create reasonable assurance that you considered all potential risks and worked to overcome all significant roadblocks.   Additionally, the new requirements for awareness, specifically, the negative effect of non-conformance on the organizational objectives, increases internal communication and can reach across silos to ensure we’re all doing the right thing.

MACRA: The uncertainty that this change is bringing in 2017 can be managed through similar requirements described above in value-based purchasing, etc.  In fact, most significant changes that occur in hospitals can be managed effectively by optimizing the foundational elements of your DNV-GL accreditation.  By nature of the design of the quality management system being integrated into your hospitals business processes and strategic direction, the benefits just need to be identified and realized.

Also, consider implementing an advanced level of internal auditing that works into your accreditation, called Value-added auditing (VAA)™. Value-added auditing provides a more mature and thorough look at all of your processes (clinical, financial, managerial and support) and can provide a prospective view (not just retrospective as internal audits have been historically) of your hospital operations.

We have to move from the silos we have created and understand how our processes affect other processes, directly and indirectly.  Inserting a risk management framework (risk-based thinking) into our process management will begin to optimize your accreditation.

Commercial aviation made this leap to next level process and risk management years ago.  Having worked with NASA during these changes, specifically after the Columbia disaster, I understand how they broke down their silos and worked as a true system.  Though not perfect, they manage their processes and associated risks at the right level to gain that assurance that the mission will be a success.  Our patients deserve the same, clinically and financially.  If we don’t manage our business processes, we can go broke trying to help our patients.  If we don’t manage our clinical processes, we can go broke trying to defend ourselves in court.

Bio:

Ted is a Pharmacist, a Certified Enterprise Risk Manager (CERM)®, and a Senior Advisor with BlueSynergy Associates.  He advises and instructs hospitals in quality, risk and environmental management systems.  Ted led the largest ISO 9001 implementation in healthcare at the Veterans Administration.  He is a Senior Member of ASQ and a certified Lead Auditor in quality management systems by Exemplar Global.  He can be reached by email at tschmidt@bluesynergyassociates.com.