Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards

During the last decade, many Israeli hospitals have joined an accreditation process in order to receive the prestigious quality approval certificate from the Joint Commission International (JCI). This approval confirms that all the medical activities in the hospital are carried out in a safe and coordinated manner and on the basis of the most up-to-date medical guidelines and knowledge available. The accreditation process thoroughly examines different aspects of the hospital’s activities focusing on International Patient Safety Goals (IPSG). IPSG address areas of concern related to patient safety. High-alert drugs constitute one these major areas.

Assaf Harofeh Medical Center is one of Israel’s largest tertiary medical centers, with over 800 acute care beds. It serves a population of over 500,000 in central Israel. The hospital provides all the major services including: emergency, intensive care, general medical, surgical, cardiac, pediatric, neonatal, gynecological and obstetrical medical services. Up to recently, concentrated KCl solutions (14.9 %) were supplied to all hospital wards as part of the routine weekly order. These concentrated solutions were stored in separate cupboards away from other solutions and medications and marked with a special sticker indicating that they are high-alert drugs. The nurses prepared the solution for infusion according to doctors’ orders by inserting the required dose of KCl into the appropriate infusion solution bag (saline, glucose 5 % etc.).

Potassium chloride (KCl) is an electrolyte most commonly used for potassium replacement in various clinical conditions related to hypokalemia (low potassium levels). KCl administration via the intravenous (IV) route should only be used when the oral or enteral route is not possible or will not achieve the required increase in serum potassium within a clinically acceptable time [1‐3]. Since severe hypokalemia (<2.5 mEq/L) may result in muscle necrosis and cardiac arrhythmias, concentrated KCl IV solutions are widely used and administered as diluted solutions to treat this condition. These patients may require rapid infusion of IV KCl. A delay in administering this therapy could compromise patient care and result in cardiac arrest [4]. However, these concentrated solutions can be fatal if given inappropriately. Concentrated KCI has been identified as a highrisk medication by organizations in Australia, Canada and the United Kingdom of Great Britain and Northern Ireland (UK). In the United States of America, 10 patient deaths from misadministration of concentrated KCl solution were reported to the Joint Commission in just the first 2 years of its sentinel event reporting programme: 1996–1997. In Canada, 23 incidents involving KCl misadministration occurred between 1993 and 1996 [5‐9].

According to a new policy, all hospital wards are now being supplied with commercial “ready-to-use” diluted KCl solutions, which are available in three different concentrations [10]. Concentrated KCl solutions are restricted to the pharmacy and to those critical care areas where concentrated solutions are needed for urgent use such as the Intensive Care Unit, the Cardiac Care Unit and other nominated departments. KCl concentrated solutions have been removed from the routine stock in all other wards and clinical departments.

In emergency cases of severe hypokalemia and in other instances such as heart failure requiring administration of bolus doses, these wards receive concentrated KCl solutions from the pharmacy by personal prescription. Since the hospital pharmacy is not staffed on a 24-h basis, a stock of concentrated KCl is also kept in one of the critical care departments so that it is available to the departments during off-pharmacy hours.

The purpose of this switch was to reduce the potential risk of accidental overdose of IV KCl arising from the use of KCl concentrated solutions by prescribing and using (whenever possible) commercially available ready-to-use diluted solutions, save valuable nursing time, and to ensure that patients requiring IV KCl as part of their treatment continue to receive it promptly and safely.

Switching to KCL dilution solutions is a new national trend emerging in parallel at various hospitals. Several considerations brought us to the decision to choose the FMEA methodology out of a variety of risk assessment methodologies. Firstly, the hospital demanded a prompt assimilation (roughly, in 2 months’ time) of the change. Secondly, since we were dealing with a high alert medication, we looked for a methodology that focuses on systematic identification of the potential risks, prioritizing them and preparing a preventative program in parallel to executing the innovative changes in practice. The FMEA methodology supplied a reasonable solution for the outlined requirements. As different medical centers adopted distinct methodologies and due to lack of accumulative experience in the Israeli healthcare system, we chose a process that enabled us to identify risks and proactively address them before causing any potential harm. The goal of our work was to present a process of risk management as a step toward developing safer hospital policy. The aim of this paper is to present the usage of the FMEA methodology as an advanced tool to achieve this policy. It is worthwhile to emphasize that the FMEA methodology enabled us to make an easy and smooth implementation of a change associated with a high alert drug therapy. In a 4-month time period, most of the physicians and nurses underwent an abrupt change in their therapeutic perception by abandoning a long term and very flexible routine use of KCL solutions and began adhering instead to a strict regimen of only 5 ready to use KCL solutions. Moreover, this transition was implemented without causing any harm to even one single patient.

FMEA methodology was used to assess the riskiness of each element of the process.

Medication errors are a huge challenge for many players in the hospital area: clinicians, pharmacists and medical administrators. Historically, KCl solutions were self-prepared and custom-made, mainly due to the high cost involved with the switch. In this article, we describe the FMEA methodology as a smart tool to implement a new policy. The advantages of FMEA as a risk management methodology enable policy makers to identify hazards as a step towards developing safer hospital strategy.

Switching to KCL diluted commercial preparations is a new national trend. As different medical centers embraced their own best practice distinct methodologies, our rationale was to avoid the halo effect when imitating others. Derived from the urge to avoid bias, our strategy was to adopt an analytical methodology for intra- institutional implementation relying on comprehensive considerations of a group of experts within our organization.

FMEA as an analytical methodology enables in depth inspection to reveal the roots of hazards and take steps towards an acceptable strategy to balance patient safety, effective pharmaceutical activity and economic management. Ranking the different dimensions, the frequency of occurrence, the severity of effects and the probability of detection, clarified the possible loci of intervention paving the way toward desirable directives and cementing organizational policy. The cascade of methodology- process-outcome is presented in Fig. 2. FMEA was used to assess the consequences of implementing a process of substituting concentrated KCl solution with ready-to-use KCl solutions. Out of 13 selected possible failure modes with the highest RPN, six critical major risks were identified. However, only three intervention strategies were required to successfully overcome these obstacles. Using FMEA methodology enabled us to lay out the potential failure modes and focus on the most risky ones. Applying method insights resulted in a remarkable organizational attitude and practice shift towards a top safety level. Our work, similarly to other studies using FMEA methodology [15, 16], showed that FMEA prioritizes the potential harms and minimizes riskiness of complex processes.

The purpose of the 1-day survey was to examine the implementation of the new policy. The results showed adherence to the recommended guidelines and predefined standards in 96.4 % of the cases, supporting a good implementation process, and were compatible with the scoring as was expressed on the FMEA scales. The single inappropriate infusion stated in the results section was associated with a prescribed (out of habit) KCL solution in a concentration the physician used to prescribe before the reform. As a matter of fact, this concentration did not exist amongst the 5 available solutions (though a very similar one did exist). The nurse carried out the written order, though in this specific event, there was no indication to use a concentrated KCL solution at all.

One limitation in our study was that we measured the adherence rates only once, approximately 4 months after the policy implementation starting point. It would be appropriate to examine the adherence to the guidelines again in a 1 year.

Currently, there is a trend towards switching to commercially diluted KCl solutions as a wise step to minimize the rate of potential medication errors. Before the commencement of the program, several adverse events were reported in our institution. The implementation process has been assessed for a 2-year period, and though the survey was done once, up to date, no incident of adverse event has been reported. This demonstrates clearly the adherence of the medical staff to a presumably, well designed protocol.

Using FMEA methodology enables in-depth inspection to reveal the roots of hazards and take steps towards an acceptable strategy to improve patient safety, effective pharmaceutical activity and economic management. It is an effective proactive risk assessment tool to assist multidisciplinary groups in understanding a process, identifying errors that may occur and reducing potential risks. We have presented a utilization of this method for implementing a change in the routine use of IV KCl. A safe and smooth implementation may encourage us to use FMEA as a universal and generic instrument in future projects at our institution demanding risk minimization.

FMEA, Failure mode and effect analysis; FSP, Frequency of occurrence (F), Severity of effects (S), Probability of detection (P); IPSG, International patient safety goals; IV KCl, Intravenous potassium chloride; IV, Intravenous; JCI, Joint Commission International; KCL, Potassium chloride; RPN, Risk priority number