Reenginyeria de processos per a la millora de la seguretat clínica en el servei de medicina intensiva

En els darrers anys la Seguretat del Pacient (SP) s’ha convertit en una de les pedres angulars de la Qualitat Assistencial. La Medicina inclou processos assistencials (PA) cada vegada mes complexos, que juntament amb la tecnologia i la interaccio humana, augmenten el risc de produir Esdeveniments Adversos (EA). El Servei de Medicina Intensiva (SMI) es una de les arees de l’hospital on la possibilitat que es produeixin EA es mes elevada. La Qualitat Assistencial compta amb recursos per la gestio del risc dels PA, que contribueixen a la seguretat del pacient. L’ Analisi Modal de Fallades i Efectes (AMFE) es una eina prospectiva i sistematica, que permet identificar, analitzar, avaluar i prevenir els EA que es podrien donar en els PA, definint 3 coeficients de puntuacio: gravetat, la probabilitat que es produeixi una fallada i probabilitat de detectar-la. El producte dels 3 coeficients dona l’index de prioritat de riscos (IPR), que permet establir la prioritat de les accions de millora. Un altre recurs es Six Sigma, eina que permet el calcul de la probabilitat d’aparicio de defectes d’un proces, anomenats defectes per milio d’oportunitats (DPMO), permetent quantificar en els processos redissenyats, la disminucio de la probabilitat de presentar defectes. L’objectiu general proposat va ser demostrar que l’AMFE, dintre d’un proces de reenginyeria de processos, era una eina util pel redisseny de processos assistencials de risc del SMI. Per aixo es van seleccionar quatre PA de risc amb Tecnica de Grup Nominal. Aquests van ser: control estricte de la glucemia en pacients postoperats de cirurgia cardiaca, posicio del capcal en pacients en ventilacio mecanica invasiva, sedacio i analgesia en el pacient critic en ventilacio mecanica invasiva i notificacio i registre d’esdeveniments adversos en el SMI. Els tres primers eren PA de suport i el 4rt era un PA estrategic. Els objectius especifics per cada proces redissenyat despres de l’AMFE van ser: demostrar la disminucio del risc d’hipoglucemia en postoperats de cirurgia cardiaca; demostrar la millora del compliment de l’indicador posicio semiincorporada; millora en el proces redissenyat de sedacio i analgesia dels indicadors monitoritzacio de la sedacio i sedacio adequada, i en darrer lloc, dissenyar un proces nou, que fos la base del proces de Seguretat Clinica del SMI, dissenyant i validant un sistema de notificacio i registre d’EA. Els resultats despres de la implementacio del proces redissenyat a partir de l’AMFE van assolir els objectius previstos. El proces control de la glucemia va aconseguir reduir del 45% al 25% les determinacions en risc d’hipoglucemia i un augment dels pacients en rang, passant del 36% al 56%, amb un augment del nivell sigma del proces d’ 1,6 al 2,1. El proces posicio del capcal va passar d’un compliment de l’indicador del 20% al 90%, augmentant el seu nivell sigma de 0,6 a 2,8. El proces redissenyat de sedacio i analgesia, va aconseguir un nivell de compliment de l’IQ monitoritzacio de la sedacio del 100%; aixo va permetre quantificar l’IQ de sedacio adequada que va ser del 87,5%. Finalment, l’aplicacio de les accions de millora de l’AMFE van permetre dissenyar un sistema de notificacio i registre d’esdeveniments adversos, validat en el seu primer any de funcionament, facilitant la monitoritzacio i l’analisi dels EA. A la vista dels resultats, podem afirmar que l’AMFE es una eina valida en l’analisi del risc i redisseny dels Processos Assistencials, demostrat amb la millora de la mesura dels IQ i amb la disminucio de la variabilitat dels PA estudiats. La reenginyeria de PA en el SMI, amb l’AMFE per l’analisi del risc, permet redissenyar nous PA mes segurs, millorant la Seguretat Clinica en el SMI. In the last years the Patient Safety (PS) has become one of the cornerstones of the Healthcare Quality. Medicine includes Healthcare Processes —they are increasingly more complex— that combined with technology and human interaction increase the risk of causing Adverse Events (AE). The Intensive Care Unit (ICU) is one of the hospital areas where the possibility of causing AE is higher. The Healthcare Quality has resources intended for the risk management of healthcare processes that contribute to the patient safety. The Failure Mode and Effects Analysis (FMEA) is a prospective and systematic tool that enable the identification, analysis, evaluation and prevention of the AE that can take place during the healthcare process. This tool uses three coefficients: severity, the probability of the failure occurring and the probability of detecting it. The product of this three coefficients results in the Risk Priority Number (RPN) that allows setting the priority of the corrective actions. There is another resource called Six Sigma, it is a tool that enables the calculation of the probability of a process defect to be occurred — called defect per million opportunities (DPMO)— allowing to quantify the probability of presenting defects in redesigned processes. The overall objective proposed was to prove that FMEA, within a reengineering process, was a useful tool for redesigning the risky healthcare processes of the ICU. For this reason, four risky healthcare processes with a Nominal Group Technique were selected: strict monitoring of glycemia levels in cardiac surgery patients during the postoperative period; the headboard position in patients with invasive respiratory support; sedation and analgesia in critical patients with invasive respiratory support; and the notification and the record of adverse events in the ICU. The first three processes were a supportive healthcare process and the last one a strategic healthcare process. The specifics aims for every redesigned process after the FMEA were: proving the hypoglycemia risk reduction in patient, that had a cardiac surgery, during the postoperative period; proving the improvement of the fulfillment of the semirecumbent position indicator; proving the improvement in the sedation and analgesia redesigned process of the monitoring indicators of sedation and the suitable sedation; and finally, designing a new process that were the basis of the Clinical Safety of the ICU, designing and validating a notification and recording system of AE. After the implementation of the redesign process from the FMEA, the results had achieved the intended objectives. The glycemia control process achieve to reduce from 45% to 25% the values under hypoglycemia risk and to raise the patients in the range, going from de 36% to the 56% with a raise of the sigma level of a process from 1.6 to 2.1. The headboard position process changes from 20% to 90%, increasing its sigma level from 0.6 to 2.8. The redesigned process of sedation and analgesia achieved a 100% compliance level of the quality indicator of sedation; this fact allowed quantifying the quality indicator of the suitable sedation —it was 87.5%. Finally, the application of the corrective actions of the FMEA enabled to design an adverse event notification and recording system — that was validated in the first year of operation— facilitating the monitoring and the analysis of AE. According to the results, it is possible to affirm that the FMEA is a useful tool for analyzing the risk and for redesigning the Healthcare Processes. It was proved through the improvement of the measurement of the quality indicators and the decrease of the variability of the healthcare processes that were studied. The reengineering of the healthcare process in the ICU — using the FMEA for the risk analysis— enables to redesign new safer healthcare processes, improving the clinical safety in the ICU.