This study sought to assess and mitigate the risk associated with AKI management among hospitalized patients using FMEA. The analysis pinpointed three critical failure modes, all linked to medication. These modes directly involve pharmacists and clinicians, and could be effectively addressed through the implementation of a CDSS.
Although numerous studies had demonstrated the risk of acute kidney disease, traditional studies had primarily focused on AKI occurring but treatment (21, 22). In this study, FMEA was adopted to identify the risk of AKI management across disease stages and medical conditions. One advantage of FMEA is that all roles involved in the process can be included to complete the risk assessment, ensuring the feasibility and effectiveness of the interventions. For example, in this study, besides healthcare professionals, patients were also included. Another advantage was its ability to quantify each failure mode.
Failure modes with top three highest RPN score were related to recognition of nephrotoxic drugs and drug dosage adjustment. These three failure modes were under the failure process of medication, and have been confirmed to significantly affect the progression of AKI in previous studies (23, 24). Since medication could be managed by both healthcare providers and clinical pharmacists, the engagement of clinical practice from pharmacists were limited in China due to several reasons, first, the clinical pharmacist was trained under desired specialty without general internal medicine; secondly, the renal impairment dosage adjustment is not mandatory present in package insert, therefore, when related information was not present in the package insert, providers would assume there was not necessary to adjust; last, clinical pharmacist were extremely understaffed, therefore, only a few wards would be covered with clinical pharmacist. In extreme understaffed clinical situations, such as in developing countries, pharmacists may be excluded from multidisciplinary teams. During the interview, it’s also found that some participants, such as clinicians and nurses, were not fully aware of the responsibilities of clinical pharmacists. Another study by Dong et al(25). revealed challenges in health resources in China, including inadequate training and continuing education for pharmacists, as well as variations in the qualifications of clinical pharmacists across different healthcare facilities.
The failure mode with the fourth highest RPN was patient recorded the wrong urine volume. The possible cause might be related with low health literacy. Patient might not understand the medical purpose behind, or know how to use the tools for urine measuring. Therefore, for the intervention we suggested that poster of instruction should be hanged in the patients’ bathroom to remind them. Double check urine volume with another healthcare professionals was not recommended across the department to avoid added extra burden for nurses, therefore, only the wards with high occurrence of AKI would strength the force of urine volume recording.
For the failure process of supportive care, besides lack of personnel as a common issue for most of healthcare facilities, there was another possible cause mentioned frequently during the interview, which was the devices not occupied at high efficiency. Therefore, Dialysis multidisciplinary team with specialties should be assembly in the teaching hospital, with nephrologist, nurses, nutritionist, clinical pharmacist and devices rather than counseling each of them to the bedside.
To manage the failure modes with high RPNs, CDSS would be applied as a risk reduction tools to assist the healthcare providers for daily clinical decision making. Nowadays, CDSS showed a flourishing rate of developing and application in clinical practice, as it can effectively compensate for the shortage of personnel and achieve more accurate and timely support. (26). Yet, not all of them demonstrated a true benefit in real-world practice(27), healthcare professors were experiencing enormous inefficient pop-ups built in computerized provider order entry (CPOE), to avoid this CDSS becoming one of burdens instead of a helpful hint, the methodologist of FMEA was adopted to evaluate the necessity of this CDSS(28). This CDSS has been evaluated by the doctors, nurses and pharmacists who are the daily users of the system, instead of programmers and researchers with limited clinical experiences. There was a significant reduction in the RPN between current status and after CDSS launch for all the failure modes including the top 3 mentioned above. It meant that the CDSS fulfilled the purpose of reducing the risk during diagnosis and treatment AKI.
The advantages of this study were as follows, the potential risks of misdiagnosis and inappropriate medical work up of AKI were identified by a multidisciplinary team in 4 centers by Delphi method; direct interviews also provided us with the most up-to-date information and enabled us to integrate this knowledge into CDSS development to make it a feasible program. This study, initiated by clinical pharmacists, demonstrates their importance to other health professionals. Experts from various clinical departments participated, as AKI affected any medical department. Thus, future research could develop a standard protocol for monitoring, diagnosing and treating AKI, based on the failure modes and interventions identified in this study. FMEA has its own limitations, for instance, the subjectivity of the experts. Also, the current criteria for diagnosis of AKI are based on increasing serum creatinine and volume of urine, however, patients who lack baseline value of serum creatinine would be handled with hypothetic value by the clinicians(29). Our next study would use real-world data to analyze the patients’ outcome before and after the launch of CDSS.