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1 Health Care Failure Mode and Effect Analysis (HFMEA) of Continuous Renal Replacement Therapies (CRRT): a tool to improve the patients safety on the everyday health treatment D. Esteban Molano Álvarez, Dr. Jose Ángel Sánchez-Izquierdo Riera, Dr. Juan Carlos Montejo, Dª Amelia Guirao Moya, Dª Estrella García Delgado, Dr. Pedro Ruiz López, Dª Teresa Núñez

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3 Introduction The treatment of ARF by CRRT is a common practice in Spanish ICUs. In our ICU the 11,7% of patients. Other clinical conditions such a septic shock, MODS or refractary cardiogenic shock. Extracorporeal Circuit Biocompatibility Circuit Clotting Vascular Access Complications Metabolic Complications Bleeding Heat Loss HUMAN ERROR

4 Introduction 1. No monitoring of magnesium and P levels. 2. Coagulation of the circuit without the possibility of blood return. 3. Duration of the filters less than 24 hours. 4. Improper medical regimen in the treatment order. Molano et al. Risk detection for the safety of the patient when using Continuous Extracorporeal Depuration Techniques. Enf Intensiva 2011;22(1):39-45

5 Introduction Health Care Failure Mode and Effect Analysis (HFMEA) of the CRRT in ICU of the Doce de Octubre Hospital. Tool to identify and evaluate potential failures of processes, their causes and possible effects. Process HFMEA vs Design HFMEA and Media HFMEA. AIM: To identify safety problems in continuous renal replacement therapy (CRRT) in order to implement actions to reduce their effects.

6 Material and Methods HFMEA PROCESS PHASES Definition of the object of analysis. CRRT implementation process in the intensive care unit of Doce de Octubre Hospital. HFMEA Team Dr. Pedro Ruiz López. Head of Quatity Unit of Doce de Octubre Hospital.. Dr. Juan Carlos Montejo González. Chiel of Intensive Care Unit Medicine of Doce de Octubre Hospital. Dr. Jose Ángel Sanchez-Izquierdo Riera. Medical Assistant of Intensive Care Unit Medicine of Doce de Octubre Hospital. D. Esteban Molano Álvarez. Supervisor of ICU Polyvalent of Doce de Octubre Hospital. Dª Estrella García Delgado. Nursing of the ICU Doce de Octubre Hospital. Dª Amelia Guirao Moya. Nursing of the ICU Doce de Octubre Hospital. Dª Teresa Núñez Jiménez. Nurse. Specialist in CEDT of BAXTER Company.

7 Material and Methods Inadequate indication Inadequate therapy indication Transcript inadequate treatment order Delayed start Wrong patient Aseptic failure Improper priming Incorrect assembly lines Failed catheter flow Connecting to the wrong patient Early withdrawal Late Withdrawal Incorrect removal procedure Incorrect catheter removal Indication and FASES treatment regimen Venous Canalization Installation and Connection Maintenance Treatment Withdrawal Graphic Description of the Process Improper catheter Inadequate venous access Canalization Problems Inadequate treatment Equipment failure Coagulation circuits Inadequate monitoring of the patient Lack of asepsis Accidental disconnection Incorrect catheter maintenance

8 Material and Methods Determination of potential failures, causes and effects Risk Analysis Score analysis and allocation acording to predefined criteria frecuency (F), gravity (G) and detectability (D). The Risk Priority Number (RPN) is obtained from the product of F, G y D. The values are used to prioritize the implementation of improvement measures. Improvement Actions and Measures Actions of improvement in those having the highest score. The final phase is to assess the effect of such improvement actions. New HFMEA to detect changes in priorities.

9 Material and Methods

10 Material and Methods PUNCTUATION Frequency Common 9-10 Occasional 7-8 Infrequent 5-6 Remote 1-4 Gravity Catastrophic 9-10 Major 5-8 Moderate 3-4 Minor 1-2 Detection Low 9-10 Occasional 7-8 Moderate 5-6 High 1-4

11 Results MAJOR POTENTIAL FAILURES DETECTED Lack of asepsis in the maintenance of therapies Inadequate treatment indication. Improper connection to the patient. Inadequate treatment. Actual dosage lower than scheduled. Incorrect treatment withdrawal. ALL OF THEM ASSOCIATED TO THE LACK OF TRAINING AND PROTOCOLS. Early coagulation of the circuits related to BLOOD CIRCUIT DESIGN AND FAILURE OF THE CATHETER.

12 Results Development of a protocol for CRRT. Training. PROPOSED IMPROVEMENT ACTIONS Enhance awareness of asespis. Introduction of assembly check list, including aseptic handling. Improve equipment and consumables in order to prevent circuit clotting.

13 Results IMPROVEMENT MEASURE DATE START - END PROPOSED IMPROVEMENT ACTIONS Training RESPONSIBLE PARTICIPANTS * Supervisor and Coordinator of hemofiltration. ACCIONES A REALIZAR: EVIDENCE SCHEDULE 1 Preparation of teaching material (theoretical and practical agenda, presentation slides and video, protocol) Material preparado Septiembre 2010 Planning and Acreditation Documento Junio 2010 Conduct training. Effectiveness evaluation (satisfaction questionnaire, pretest-posttest and practical exam) 1 Jefe de Sº 2 Supervisor 3 Coordinador hemofiltración 6 Unidad de Calidad 3,4,5 7 Suministros 2,3 2,3, 4,5 Listado de asistencia y realización cuestionarios Listado de asistencia y realización cuestionarios 4 DUEs Responsables 5 Especialista del producto Inicio en Octubre 2010 Inicio en Octubre 2010

14 Results MONITORING INDICATORS CRRT TRAINING Attendance level: Attending the meeting Unit Staff Pre-and post-training knowledge assessment. CRRT PROTOCOL DEVELOPMENT Compliance with protocol guidelines. Detection of errors in each patient. Adverse events.

15 Results Completion of check list. MONITORING INDICATORS ENHANCE AWARENESS OF ASEPSIS Decreased bacteraemia rates for hemofiltration catheters. Direct observation of hand washing and the use of clean gloves when handling the circuit. PREVENTION OF EARLY COAGULATION OF THE CIRCUIT (BEFORE 24 HS) Evaluate the application of the recommended improvements. Measure the percentage of clotted circuits before 24 hours.

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17 Conclusions The HFMEA is a useful tool to prioritize potential problems for any process. It facilitates an ordered distribution of possible improvement actions. We won t be able to determine the true effectiveness of this tool until the development of phase 3, in which the indicators will be valued.

18 Conclusiones Se precisa monitorización protocolizada del Mg y P P = ATP Hipofosfatemia (60% de pacientes en estudio RENAL ) Debe corregirse el defecto en la cumplimentación de la pauta terapéutica en las órdenes de tratamiento, con una normalización de la misma Se precisa optimizar la técnica para prolongar su duración y evitar pérdidas hemáticas. Detección de riesgos en TCDE