Failure mode and effect analysis applied to the procedure for intrathecal chemotherapy

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.
• 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	1	8	1	8	Establishing a care pathway	Neurology
  Wrong medication	Toxicity	No care pathway	Nurse/doctor	10	1	8	80	Establishing a care pathway	Neurology
  	Toxicity	Administration route not verified	Nurse/doctor	10	2	8	160	Use of minibags	Pharmacy
  	Toxicity	Similar drug package	Nurse	10	5	6	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	2	7	140	Electronic prescription	Quality control
  Inappropriate technique	Puncture-related complications	Not verifying patient's state (laboratory analyses, anticoagulants)	Nurse/doctor	8	2	10	160	Implementing checklist prior to administration	Neurology, nursing staff
  	Puncture-related complications	Doctor's lack of experience	Nurse/doctor	8	2	10	160	Establishing a care pathway	Neurology
  Patient identification	Toxicity/reduced effectiveness	Not verifying patient data	Nurse/doctor/patient	10	1	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	8	2	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.