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Inicio Neurología (English Edition) Failure mode and effect analysis applied to the procedure for intrathecal chemot...
Journal Information
Vol. 30. Issue 1.
Pages 62-64 (January - February 2015)
Vol. 30. Issue 1.
Pages 62-64 (January - February 2015)
Letter to the Editor
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Failure mode and effect analysis applied to the procedure for intrathecal chemotherapy
Análisis de modos de fallo y sus efectos aplicado al procedimiento de quimioterapia intratecal
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P. de la Riva
Corresponding author
patricia.delariva@gmail.com

Corresponding author.
, M.T. Martinez Zabaleta, M. Arruti González, M.A. Urtasun Ocariz
Servicio de Neurología, Hospital Donostia, San Sebastián, Guipúzcoa, Spain
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Table 1. Risk analysis table for the administration sub-process in intrathecal chemotherapy.
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Dear Editor:

The purpose of this letter is to present failure mode and effects analysis (FMEA), a tool with clinical safety applications that may be useful for minimising risks associated with healthcare procedures. We also describe our experience with applying FMEA to intrathecal chemotherapy at Hospital Universitario Donostia.

Intrathecal chemotherapy is an invasive procedure associated with numerous adverse events, many of which may be caused by human error.

At Hospital Universitario Donostia, intrathecal chemotherapy has traditionally been prescribed and ordered by haematology or oncology departments, whereas the neurology department is responsible for administering the treatment. Since there have been several severe incidents related to intrathecal chemotherapy, we recently decided to find a way to minimise the risks associated with this procedure.

FMEA was performed according to the following steps:

  • 1.

    Select a high-risk process. The chosen process was intrathecal chemotherapy.

  • 2.

    Assemble a team. We gathered a multidisciplinary work team, including doctors and nurses familiar with intrathecal chemotherapy from the haematology, oncology, pharmacy, neurology, and quality control departments.

  • 3.

    Describe the process. We designed a diagram describing the different steps in the process and how they are interrelated (Fig. 1).

    Figure 1.

    Diagram of intrathecal chemotherapy process.

    (0.04MB).
  • 4.

    Analyse risk. Team members brainstormed to list different possible ways in which each sub-process might fail. Next, cause, effect, and detection method for each failure mode were identified and rated for frequency, severity, and detectability on scales of 1 to 10. Finally, total risk for each failure mode was calculated by multiplying the values of these 3 factors (frequency, severity, and detectability) to give the risk priority number (RPN). As an example, Table 1 shows the model sheet used to collect risk analysis data for the sub-process of administering the drug.

    Table 1.

    Risk analysis table for the administration sub-process in intrathecal chemotherapy.

    Failure mode  Effect  Cause  Detection method  Severity  Frequency  Detectability  Initial RPN  Recommended actions  Responsible department 
    Delay in drug administration  Lack of effectiveness  No care pathway  Nurse/patient  Establishing a care pathway  Neurology 
    Wrong medicationToxicity  No care pathway  Nurse/doctor  10  80  Establishing a care pathway  Neurology 
    Toxicity  Administration route not verified  Nurse/doctor  10  160  Use of minibags  Pharmacy 
    Toxicity  Similar drug package  Nurse  10  300  Container specific to intrathecal drugs labelled ‘for intrathecal use only’  Pharmacy 
    Drug not indicated  Toxicity/lack of effectiveness  Lack of communication/workload problem  Nurse/doctor  10  140  Electronic prescription  Quality control 
    Inappropriate techniquePuncture-related complications  Not verifying patient's state (laboratory analyses, anticoagulants)  Nurse/doctor  10  160  Implementing checklist prior to administration  Neurology, nursing staff 
    Puncture-related complications  Doctor's lack of experience  Nurse/doctor  10  160  Establishing a care pathway  Neurology 
    Patient identification  Toxicity/reduced effectiveness  Not verifying patient data  Nurse/doctor/patient  10  10  100  Implementing checklist prior to administration   
    Not checking patient's lab analyses  Complications  Puncture contraindicated because of analysis results or anticoagulant treatment  Nurse/doctor  10  160  Implementing checklist prior to administration  Neurology, nursing staff 
  • 5.

    Propose improvements and monitor implementation of the redesigned process. A total of 10 improvement actions were defined, with priority given to failure modes with higher RPNs. We also decided which team members would be responsible for implementing each new process (Table 1).

Twenty-eight months after implementing improvements, 141 intrathecal chemotherapy procedures have been performed in a total of 38 patients and no incidents have been detected.

FMEA is a tool enabling systematic and prospective identification and prevention of the risks associated with a process. This technique has been widely used not only in healthcare but also in the aerospace and automotive industries.1

In addition to identifying and preventing failures that already occur or may potentially occur, it enables sharing experiences with different units participating in the same process. It is also recommended by several national and international health organisations.2,3

However, some of the main limitations of FMEA are the absence of studies verifying its validity or utility, its reliance on team members’ previous experiences, the mathematically flawed way in which RPN is calculated, and the fact that costs and healthcare available resources are not taken into consideration.4

In conclusion, FMEA is a useful tool since it provides an organised and systematic method which can help resolve failure modes that involve several professionals taking part in a single process.

In addition to intrathecal chemotherapy, neurology departments currently perform many other invasive procedures whose safety could be increased by using this technique. Examples include immunoglobulin administration, plasmapheresis sessions, and intravenous administration of antibiotics or immunosupressants.

References
[1]
J. DeRosier, E. Stalhandske, J.P. Bagian, T. Nudell.
Using health care failure mode and effect analysis: the VA National Center for Patient Safety's prospective risk analysis system.
Jt Comm J Qual Improv, 28 (2002), pp. 248-267
209
[2]
Institute of Medicine Patient safety.
Achieving a new standard for care.
National Academy Press, (2004),
[3]
Joint Commission on Accreditation of Healthcare Organization National Patient Safety Goals. Goals MM 1.10-MM 5.10. Available from: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/ [accessed 19.09.12]
[4]
N.A. Shebl, B.D. Franklin, N. Barber.
Failure mode and effects analysis outputs: are they valid?.
BMC Health Serv Res, 12 (2012), pp. 150

Please cite this article as: de la Riva P, Martinez Zabaleta MT, Arruti González M, Urtasun Ocariz MA. Análisis de modos de fallo y sus efectos aplicado al procedimiento de quimioterapia intratecal. Neurología. 2015;30:62–64.

This study was presented orally, under the same title, at the 64th Annual Meeting of the Spanish Society of Neurology.

Copyright © 2013. Sociedad Española de Neurología
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