FMEA and healthcare

There are several examples of risk assessment tools and process analysis methods available in industry that may be relevant to healthcare. Following methods are recommended within healthcare (Marx & Slonim, 2003), (DeRosier, Stalhandske, Bagian, & Nudell, 2002). Each of the tools has its own advantages and disadvantages. In the following four well known methods as used in the healthcare briefly are explained:

 Failure Mode and Effects Analysis (FMEA) methodology – a prospec-tive process analysis technique with a bottom-up approach. The FMEA begins by asking the question ‘‘what happens if …?” Through this question the model seeks to identify all the potential effects which may result in a failure based on the dispensing process.

 Probabilistic Risk Assessment (PRA) - it “considers multiple combina-tions of failures and allows identification of critical failure paths”, (Marx

& Slonim, 2003), one of PRA’s major advantage. “PRA uses a ‘‘top down’’ approach that identifies the undesirable outcome to be mod-elled first, and then investigates and models all combinations of pro-cess failures that may lead up to this event”, (Marx & Slonim, 2003).

 Root Cause Analysis (RCA) - a multidisciplinary method used to retro-spectively identify aberrant processes that contribute to an adverse pa-tient event; RCA is a retrospective process analysis technique

 Fault Tree Analysis (FTA) - a complementary deductive method for the analysis of failure modes and their respective causes with a top-down approach. FTA is suitable for modelling the interdependencies of dif-ferent failure modes, this interaction may lead to a result of considera-ble size and possibly consideraconsidera-ble severity. In contrast with the FMEA technique it is not possible to consider interactions and the dynamics of the occurrence of failure modes in a system. (EN 60812 - FMEA, 2006).

FMEA in healthcare

The purpose of FMEA as described in section 3.4.2. is still valid for healthcare industry. “The healthcare industry has recently begun using FMEA as a process improvement tool”, (Reiling & Knutzen, 2003). The Joint Commission on Ac-creditation of Healthcare Organizations (JCAHO) requires every hospital to use FMEA as one means to improve its processes. In addition, the American Hospi-tal Association, National Patient Safety Foundation and Veterans Administration support its use, too (Reiling & Knutzen, 2003). On the other hand, limitations and shortcomings recur in healthcare industry as well, but from a different point of view, so for example the observation of human factors plays a major role.

Drawbacks of the traditional FMEA used in healthcare

When taking a look into healthcare area, despite the strengths of FMEA as a process analysis technique, there are reasons to believe that these methods will fall short in being able to produce meaningful results in terms of patient safety interventions for the healthcare industry (Marx & Slonim, 2003):

 FMEA is generally used on a local level without the benefit of multi-institutional experiences to help guide the model (Kohn, Corrigan, &

Donaldson, 2000), (Leape, Bates, & et al., 1995), (JCAHO, 2000), (Roos, Black, & Roos, 1995)

 Individual healthcare institutions often limit their focus to their own safety problems and inadequacies. As a result, the institutions are concerned about allowing their data to become transparent to the pub-lic or other professionals because they may be exposing themselves to litigation or further public scrutiny. (Kohn, Corrigan, & Donaldson, 2000), (IOM, 2001)

 Even FMEA or RCA are performed flawlessly, these qualitative tools are not designed to assist in identifying risk point combinations in complex systems that are more likely to lead to errors (Linerooth-Bayer

& Wahlstroem, 1991), (EN 60812 - FMEA, 2006)

To overcome those above drawbacks an adapted tool, known as Socio-Technical Probabilistic Risk Assessment (ST-PRA), provides an alternative for proactively identifying, prioritizing, and mitigating patient safety risk. “The uniqueness of ST-PRA is its ability to model combinations of equipment failures, human error, at risk behavioural norms, and recovery opportunities through the use of fault trees. While ST-PRA is a complex, high end risk modelling tool, it provides an opportunity to visualize system risk in a manner that is not possible through FMEA”, (Marx & Slonim, 2003). This is what distinguishes ST-PRA from FMEA: FMEA starts with a process to be analysed whereas ST-PRA starts with an undesirable outcome.

One other aspect according to Marx is, human behaviours and errors are very important contributors to failure of the system in the healthcare setting. This results in adding sociotechnical components to the traditional fault tree.

The real power of Fault Tree Analysis (FTA) and the major advantage of Proba-bilistic Risk Assessments (PRA) over FMEA are in performing probaProba-bilistic anal-yses (Marx & Slonim, 2003).

The Joint Commission on Accreditation of Healthcare Organizations used the best out of all three methods and developed the HFMEA™ (Healthcare FMEA) especially for the healthcare industry.

Development of HFMEA™ by JCAHO⁴⁸

As result of the IOM-Report (U.S. Institute of Medicine⁴⁹, see section 1.1.3 Im-provement of patient safety) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) developed in 2001 additional Patient Safety

48 Joint Commission on Accreditation of Healthcare Organizations: http://www.jointcommission.org or

http://www.jointcommissioninternational.org

49 U.S. Institute of Medicine: www.iom.edu

and Medical/Healthcare Error Reduction Standards especially targeted on pa-tient safety and Risk Management (v. Eiff & Middendorf, 2004).

So since 1 July 2001 the Joint Commission on Accreditation of Healthcare Or-ganizations (JCAHO) has required each accredited hospital to conduct at least one proactive risk assessment annually. Therefore FMEA was recommended as one tool for conducting this task (Marx & Slonim, 2003). The purpose of perform-ing an FMEA for JCAHO was to identify where and when possible system fail-ures could occur and to prevent those problems before they happen (Latino, 2004). Unfortunately this official accreditation does not specify if and how the human factors shall be included (Streimelweger, Wac, & Seiringer, 2015).

The FMEA system has been successfully used in industry for many years. The VA National Center for Patient Safety (NCPS)⁵⁰ reviewed the traditional FMEA.

At least, for evaluating healthcare products or processes, “a traditional FMEA is the recommended proactive risk assessment method“, (DeRosier, Stalhandske, Bagian, & Nudell, 2002).

The VA National Center for Patient Safety (NCPS) developed with assistance from the Tenet Health System (Dallas) an enhanced FMEA, the Healthcare Fail-ure Mode and Effects Analysis (HFMEA)™ to optimally meet the need in healthcare. HFMEA™ is a hybrid prospective analysis model that combines concepts of the FMEA model from industry, the Hazard Analysis and Critical Control Point (HACCP) model from food safety with tools and definitions from the VA’s root cause analysis (RCA, for example, Safety Assessment Code - SAC and triage cards) (DeRosier, Stalhandske, Bagian, & Nudell, 2002). The generic definitions used for severity, occurrence, and detectability needed to be modified by HFMEA™. The used components within HFMEA™ and their origins are shown in Figure 12. It is necessary to understand that HFMEA™ is a 5-step-process. Multidisciplinary teams are used to proactively evaluate a healthcare process. The Fault Tree method is known as a deductive procedure and in con-trary to FMEA it follows a bottom-down approach. “The HFMEA Decision Tree^TM presents the steps to follow when evaluating a particular failure mode or failure mode cause. The decision tree serves as a triaging function, identifying areas where the team needs to mitigate vulnerabilities and areas not needing attention because they are not critical, they are highly detectable, or they already have an effective control measure”, (DeRosier, Stalhandske, Bagian, & Nudell, 2002).

50 The VA National Center for Patient Safety (NCPS): http://www.patientsafety.va.gov

Figure 12: HFMEA™ Components and their origins ( (DeRosier, Stalhandske, Bagian, & Nudell, 2002), table 1, p. 250)

HFMEA™ uses for its safety assessment code (SAC) a 4 x 4 matrix: The severi-ty of an event is classified as minor, moderate, major, or catastrophic, and prob-ability is classified as remote, uncommon, occasional, or frequent. The matrix incorporates the severity definition headings along the top horizontal row and the probability definition headings along the left column. The HFMEA™ itself scores range from 1 to 16 (see Figure 13).

Figure 13: HFMEA™ Hazard Scoring Matrix, ( (DeRosier, Stalhandske, Bagian, &

Nudell, 2002), appendix 3, p. 267)