key: cord-0794702-5y38h44c authors: La Russa, Raffaele; Fazio, Valentina; Ferrara, Michela; Di Fazio, Nicola; Viola, Rocco Valerio; Piras, Gianluca; Ciano, Giuseppe; Micheletta, Fausta; Frati, Paola title: Proactive Risk Assessment Through Failure Mode and Effect Analysis (FMEA) for Haemodialysis Facilities: A Pilot Project date: 2022-03-24 journal: Front Public Health DOI: 10.3389/fpubh.2022.823680 sha: 0f0969e9a484f8e55f25769244c433f587430c41 doc_id: 794702 cord_uid: 5y38h44c Haemodialysis (HD) is one of the methods for renal replacement therapy in the management of advanced chronic kidney disease through an osmosis process that allows purification of blood in the dialysis machine. The complexity of the dialytic procedure often requires the presence of a multi-specialist, multi-disciplinary team. The dialysis process is an important target for clinical risk management. Failure Mode and Effect Analysis (FMEA) is a proactive technique, considered a purposeful and dynamic tool for clinical risk management. FMEA is noted in five phases that allow a preliminary assessment of a definite process through identification and classification of risk priorities. This study represents the first of a two-phase project where FMEA is applied to HD in the setting of San Feliciano Hospital. The dialysis center performs ~12,000 dialysis sessions per year. The dialysis process is divided into different stages. A total of 31 failure modes were identified in the whole dialysis stages; more than 2/3 of the failure modes were related to the only connecting of the patient to the dialysis machine. The first phase of the study clearly remarked that the most critical step of the dialytic process is represented by the connection between the patient and the machine, as expected. Indeed, in order to have the dialysis set up, an arteriovenous fistula must be surgically created prior to the procedure and it is one of the most important issues in the HD process because of the necessity of a constant revision of it. FMEA application to HD is a useful tool, easy to be implemented and it is likely to nimbly reveal the practical and potential solutions to the critical steps of the procedure. Haemodialysis (HD) is one of the methods for renal replacement therapy in the management of advanced chronic kidney disease (1) . To purify the blood, HD uses a dialysis machine and a special filter, called a dialyzer. The operating mechanism of the dialysis machine involves the entry of the patient's blood and its purification through an osmosis process. The filter consists of two compartments separated by a membrane, one in which the blood flows and the other one in which the dialysis solution (i.e., dialysate) flows. The dialysate is a special dialysis fluid similar to plasma which flows counter-currently to the blood, so to maximize the concentration gradient of solutes, thus removing urea, creatinine, and other waste products unusually high in the blood; the dialysate, moreover, being constantly replaced, ensures the correct concentration of several solutes in the blood. The membrane, instead, is semipermeable and its very small pores allow the passage of water and solutes, but not that of proteins and blood cells. Moreover, some solutes like Bicarbonate and Calcium, whose concentration in dialysis solution is high, enter the blood section (2) . The main reason why the purifying efficiency of the dialysis machine does not reach that of the healthy kidney is thatapart from the continuous, organic working of healthy kidneys in human bodies-the hemodialytic procedure can take up to 3-6 h and is usually performed three times a week, hence the social, healthcare-associated and economic costs of the procedure itself (3). The dialytic session involves several stages: (i) setting up, which consists of controlling the sanitary conditions of the interested hospital wards, testing and dressing the necessary materials, such as the monitor and the equipment of the dialysis machine; (ii) actual dialysis procedure, formed by patient's evaluation, connection to the extracorporeal circuit, blood circulation circuit activation and its maintenance; (iii) disconnecting the patient from the extracorporeal circuit. It clearly appears that dialysis is a highly complex procedure both from a technological and a clinical point of view. Moreover, dialysis patients are frail because of their healthcare condition and because of the not uncommon, several comorbidities that affect them. The complexity of the dialytic procedure often requires the presence of a multi-specialist, multi-disciplinary team (4) (5) (6) . Therefore, the interaction of these factors makes the dialysis process an important target in clinical risk management (7, 8) . Failure Mode and Effect Analysis (FMEA) is a proactive technique, widely used in Human Reliability Analysis (HRA) studies (9) (10) (11) (12) (13) . HRA's purpose is to examine the activity, process or organizational structure to identify weaknesses and vulnerabilities so that they can be defined and solved. Since its practical use and effective implications, the technique is wellapplicable to healthcare practices (14) . For instance (15) , FMEA has been applied to practical issues such as dosing the right amount of exposition in total body irradiation; it has been used (16) in the diagnostic process, particularly in oncology, where it resulted optimal in the therapeutic decision-making process (17) and, more recently, it showed its potential advantages in surgery (18) . In sum, FMEA can be considered a purposeful and dynamic tool for clinical risk management: it is defined as a predictive technique for the identification and classification of risk priorities, which allows a preliminary risks assessment of a process through a qualitative and quantitative analysis aimed at outlining the intervention priorities. The methodological phases of the FMEA are the following: (i) identification of the target of the analysis; (ii) identification and description of the activities correlated to the target; (iii) identification of failure mode(s); (iv) determination of the risk priority number (RPN) and its analysis; (v) identification of measures and actions to be implemented as preventive, improvement, and/or corrective acts in order to solve the issue represented by the identified target. The RPN is the result of the combination of three different assessments as evaluated by a multidisciplinary group; it gathers and accounts for any failure mode or pattern for its severity (S), occurrence (O) and detection (D) ratings. The RPN must be calculated for each recognized cause of failure (19) . In this way, FMEA does not neglect any potential mistake in the execution of the targeted procedure, thus allowing insertion tests and controls, to develop protocols, to prepare countermeasures (20) . Consequently, this study represents the first of a two-phase project where FMEA is applied to HD in a hospital setting. This pilot project is preliminary to the second actualization since in this stage HD was subjected to a descriptive decomposition in order to isolate the several steps which form the dialysis procedure itself with the aim of secluding the most critical stages and approaching them by resolute and/or prophylactic measures. The second phase of the study will evaluate whether the executed implementations have an impact onto the various steps formerly isolated, and the potential magnitude of them. As far as the FMEA is concerned, a multidisciplinary working group has been set up consisting of eight professionals: nephrologists; nurses; the hospital's clinical risk manager; and experts in risk management from the Sapienza University of Rome. The working group implemented the FMEA and identified five main stages of the dialysis procedure: (i) dialysis machine preparation (ii) connecting the patient to the monitor (iii) dialysis surveillance (iv) disconnecting the patient from the monitor (v) central venous catheter management. Each of the aforementioned stages was further subdivided into single, practical activities; failure modes and consequent, potential repercussions were isolated as well. The fifth stage was inserted as supernumerary since the relevance of it only when present. RPN was determined for each failure mode based on a predetermined score, one for each of the three variables included in the calculation (S, O, and D). The categories, the frequencies set up as probability cut-offs, and their related scores are shown in Table 1 . The contingent presence of any control and/or barrier measure was studied where applicable. According to the results of the RPN score, five categories were set up for the classification of the intervention priorities, and labeled as follows: RPN≥40: "very high";40