Risk management in a health care setting is a particular challenge. Risk managers are primarily tasked with identifying areas and practices that could harm patients, associates, and visitors; creating protocols to minimize those risks; and developing a process of documentation and reporting for when a serious safety event occurs.

Besides the obvious "holy grail" of risk management - the complete health and safety of the patients we serve - there are two compelling reasons to implement a robust risk management protocol:

First, as a provision of the 2010 Affordable Care Act (ACA), hospitals must now document preventable adverse events that patients suffer during a hospital stay, and are penalized by lower Medicare reimbursements if such events do occur – correlating lesser-quality risk management with lower reimbursements.

Second, as a result of easily-accessible information about hospitals regarding mortality and morbidity, patient experience, rates of nosocomial infections, etc., a hospital’s reputation is only as good as its risk management demonstrates.

Given the above factors, how does a health care organization implement or strengthen its risk management program, while avoiding practices that are perceived by associates as punitive?

While risk management has been used in industrial applications for many years, it has only recently been used in the clinical lab. There are standard tools used in industry to effectively manage risk that are easily adaptable to use in the clinical lab.²

First, it is of utmost importance for a laboratory to map its processes and identify areas of potential failure. With respect to instrumentation, a failure modes and effects analysis (FMEA) can be employed to determine the likelihood and effects of instrument failures, and determining a course of action to address the failures.²

Second, instruments and systems can both benefit from the "Failure Reporting And Corrective Action System (FRACAS)". This approach can identify and suggest corrective actions for processes carried out in the clinical lab.²

Since labs have already been implementing a number of activities which can be fairly categorized as risk management, these and other tools can be integrated into an institutions Individualized Quality Control Plan (IQCP).²

A hospital or health care institution can use the above-mentioned techniques in the context of crafting their own IQCP. The CLSI guideline EP23-A, titled "Laboratory quality control based on risk management", explains how four general principles of risk management used in manufacturing can be used with equal effectiveness in health care.

First, the institution collects performance and application information about all processes performed in the lab, whether machine- or human-based. Conditions unique to one’s own institution are also addressed at this step. All of these factors can affect the degree of risk and likelihood of error.

Second, a risk assessment based on the above conditions is performed, and measures are determined as to how best to mitigate risk and error.

Third, the quality control plan is created as a summary of identified hazards and their corresponding corrective / mitigating actions, including applicable documentation and communications (vis a vis FRACAS).

Last, the IQCP is monitored for effectiveness; weaknesses and gaps in the program are addressed, and the plan is modified accordingly (see "Continuous Process Improvement (CPI)").

Risk management in health care, as in industry, has a number of beneficial effects besides optimal patient care. Paraphrasing from industry, some of the benefits of a robust risk management program as part of an IQCP include:

• Seeing "hidden" risks. By analyzing our processes, our working environment, etc., we can glean insights as to what areas of our overall operation can introduce risk to our patients, associates, and visitors.

• Fosters trust in the institution. A hospital with robust risk-management policies and procedures engenders the trust of regulatory agencies as well as the general public.

• Creates transparency of process in the event of legal action against the institution. The best defense against a claim of negligence is to be able to demonstrate that strong risk mitigation measures are in place and practiced.³

Are you ready to strengthen your risk management practices? Let Ektelligen® assist you in examining the effectiveness of your risk management practices. We can help you integrate a well-structured risk management component to your already-existing QC program, or assist you in building an Individual Quality Control Plan (IQCP) from the bottom up. Contact an Ektelligen® representative today and rest secure in your lab’s risk management practices.