BACKGROUND
LEARN (Leveraging Existing Assessments of Risk Now) For Pediatric Patient Safety
Existing Risk Assessments for Review
Evaluating the Quality of an FMEA
Preparing the Risk Assessment Sheet
Customizing General Risk Results

Existing Risk Assessments for Review
Easily available sources of studies
Publically available risk studies
Peer-reviewed literature
Collecting Existing Risk Assessments from other sites

Easily available sources of studies
Unlike Root Cause Analyses (RCAs), Failure Modes Effects Analyses (FMEAs) are prospective risk assessments and as such do not describe events that have occurred, therefore these studies can be shared without risk.  Several FMEAs are presented on publicly available websites and have been published in peer-reviewed literature.

Many institutions already conduct risk assessments as part of their quality and safety procedures.
Risk Assessments your organization has completed may include:
*  Across processes within a single institution
*  Across the institutions in a multi-institutional system
*  A Consortium focused on a specific process

Publically available risk studies
The Institute for Healthcare Improvement provides an online tool to create an FMEA report.⁶ The website offers those who use this tool the option of making their report available on the site. This has resulted in a resource for FMEAs from sites across the country covering a variety of topics. You can look through a list of topics and chose FMEAs that fit this description or look at the list of specific organizations’ FMEA reports.

Peer-reviewed literature
Several FMEAs have been published in peer reviewed literature and are available for review and use in combination with other existing risk assessment studies.

Collecting Existing Risk Assessments from other sites
There can still be a reticence by some to share these results across institutions.  But through inter-institutional agreements and strong collegial connection and shared focus, risk studies can and will be shared.  In particular, institutions may have concerns around privacy, even when all identifiers are removed from the risk assessment. There can be significant delays in obtaining risk assessments from outside sites. Sites may have to be actively engaged before sharing these risk assessments and an IRB may be necessary.

Evaluating the Quality of an FMEA Study  [back to top]

Conducting risk assessments is new the field of medicine.  As such, collected risk assessment study results may be presented I an idiosyncratic format and may not contain all of the desired elements.  Due to the wide variation in the quality of FMEAs and other risk assessments, the LEARN Team developed the Risk Assessment Quality Evaluation Tool. This tool can be used to direct a study to ensure that all elements are addressed as well as to   evaluate the origin and comprehensiveness of existing risk assessment results.

The LEARN project used a combination of all three methods to collect a range of FMEAs.  Six FMEAs were conducted by the Northwestern University Institute for Healthcare Studies as a part of the Risk Assessment of Pediatric Emergency Transfers project. Additionally, by working with colleagues at the National Association of Children’s Hospitals and Affiliated Institutions and Battelle Northwest National Laboratories, several FMEAs from outside institutions were collected and evaluated.  Finally, the analysis included FMEAs from the Institute for Healthcare Studies website.

For more information on conducting an FMEA, see visit the Risk Assessment of Pediatric Emergency Transfers Toolkit website or the Department of Veterans Affairs National Center for Patient Safety (http://www.va.gov/ncps/safetytopics.html).

Preparing the Risk Assessment Sheet  [back to top]
Enter the data from the risk assessments into the Risk Assessment Review Sheet.  The Risk Assessment Review Sheet is an Excel spreadsheet with the following columns for data to be entered from the existing risk assessment:

Process Steps
Risk Assessment Sources (FM #)
Failure Modes
Failure Mode Causes
Risks Contributors
Frequency, Consequences and Safeguards
Child Specific Risk Factors
Event Type
performance Shaping Factors
Reconciliation
Risk Binning


Process Steps
The Risk Assessments obtained from various sources may use different titles, for example the Institute for Healthcare Improvement simply uses the term “steps.”⁶ Regardless of the name, this section of the Risk Assessment Review Sheet should be completed using the exact language of the Risk Assessment listing each of the steps in the process.

Risk Assessment Source (FM#)

Failure Modes
The Risk Assessments should describe at least one failure mode for each process step. Use the exact language of the Risk Assessment to fill in the Risk Assessment Review Sheet.

Failure Mode Causes
The Risk Assessment lists the reasons the Failure Mode occurs as the Failure Mode Cause. There may be more that one Failure Mode Cause.  If so, create a row for each Failure Mode Cause.  The Risk Assessment Sheet should list the associated Process Step and Failure Mode in the row with each Failure Mode Cause listed in the original Risk Assessment, thus, including all of the relevant information regarding the Failure Mode Cause on each row.

Risks Contributors
The Risk Assessment should list the Risk Contributors for each Failure Mode. There may be more that one Risk Contributor for a Failure Mode.  If so, create a row for each Risk Contributor.  The Risk Assessment Sheet should list the associated Process Step and Failure Mode in the row with each Risk Contributor listed in the original Risk Assessment thus, including all of the relevant information regarding the Failure Mode Cause on each row. .

Frequency, Consequences and Safeguards
Tables 1, 2 & 3 below show the VA Healthcare Failure Mode Effects Analysis (HFMEA) Hazard categories and score ranges used to evaluate the Failure Modes. The Risk Assessment Review Sheet provides columns for the score and a narrative for each of these three elements. However, this language may vary across Risk Assessments. For example, the Institute for Healthcare Studies uses the terms likelihood of occurrence (frequency), severity (consequences) and likelihood of detection (safeguards). Each of these sections is generally given both a score and a narrative description in the Risk Assessment Sheet.

Table 1.  Frequency of Failure Mode Categories (Freq score)

Table 2.  Consequence of the Failure Mode Categories (Cons score)

Table 3.  Safeguard Effectiveness Categories  (SG score)

Risk Binning [back to top]
Risk Binning id done as the first step after assembling the Risk Assessment Review Sheet for each of the following assessment methods.

Risk Binning involves using the frequency, consequence and safeguard scores to assess the level of risk of a Fail-point using the following table.  After assessing the level of risk – Low, Medium or High – create a Risk Assessment Review Sheet with only the High and Medium fail-points remaining. This is the risk data on which you can conduct further analyses.

Table 4. Risk Binning Table

Customizing General Risk Assessment Results  [back to top]

The LEARN Risk Assessment Sheet contains several elements that are not a part of the traditional FMEA process. Individuals with expertise in each area should be consulted in order to complete this portion of the FMEA analysis.

Child Specific Risk Factors
Event Types
Performance Shaping Factors

Child Specific Risk Factors
The possible child-specific factors are available as a drop-down menu in the Risk Assessment Review Sheet template.

There is growing evidence that the epidemiology of error and patient safety risk differs in pediatrics from that of adult medical care.^7-9  Specific characteristics of children, -- “child specific risk factors” – have been shown to lead to patient safety risk.³  Most medical care for children is delivered in institutions that primarily treat adults and may have only a small pediatric service.  These institutions are unlikely to conduct proactive risk assessments that focus on children’s medical care and may not have the requisite personnel or expertise to conduct such an analysis.  Research on pediatric patient safety has established “child-specific risk factors” and has demonstrated the contribution of these factors to patient safety risk.  Studies are emerging that demonstrate the need for pediatric customization of safety interventions to prevent increases in morbidity and mortality when safety interventions are implemented.⁴  Through the application of these Child-Specific Risk Factor criteria an additional analysis could be conducted to further specify particular risks specific to children’s healthcare to inform safety improvement of children’s healthcare.

The Child Specific Risk Factors were identified through an extensive review of the formal and informal pediatric literature including but not limited to: published reports; websites of pediatric healthcare organizations; conference proceedings.  These theoretically derived Child specific Risk factors were then validated and were shown through review of patient safety event reports to actively contribute to the occurrence patient safety risk in approximately half the events.¹⁰ For more information, please see the related article Child-Specific Risk Factors and Patient Safety.

The validated Child Specific Risk Factors include:

1. Physical characteristics:
   -  Small size, weight, and morphology.
   -  Varied physical characteristics: significant variation in size, weight, and morphology of children.
2. Physiological development: the developing physiologic systems, varied signs and symptoms, impact of growth.
3. Cognitive-social-emotional development: the developing nature of understanding, communication, and behavioral regulation.
4. Minor/legal status:
   -  Parental responsibility for medical management
   -  Decision- making and consent
   -  Confidentiality
   -  Supervision

Event Type  [back to top]
The possible healthcare event types are available as a drop-down menu in the Risk Assessment Review Sheet template.

The list of event types appropriate to healthcare and was developed by reviewing   patient safety events. These categories are effective for designating medical care processes in both hospital-based and ambulatory medical care.⁷

1. Preventive medicine (immunization and preventive screening).
2. Diagnostics (medical history and physical examination, diagnostic testing, reading, recording, and interpreting results).
3. Treatment.
   -  Medications, blood products, fluid, diet (ordering, transcribing, dispensing, and administration).
   -  Surgical and non-surgical procedures (preparation, performance of the procedure, and post-procedural care).
   -  Appointment scheduling, referral, and follow-up communications.
   -  Other medical treatments (psychiatric, social services, and discharge   planning).
4.  Patient monitoring (monitoring of patient status).
5.  Patient communication (communication, education, consent, and confidentiality for preventive care diagnostics, medications, non-surgical procedures and surgical care, post-surgical care, and other medical treatments).
6. Patient identification.
7. Equipment-related (equipment malfunction, equipment availability, and use of equipment).
8. Administrative (medical-record related and other clinically significant administrative processes).

Performance Shaping Factors The Performance Shaping Factors are available as a drop-down menu in the Risk Assessment Review Sheet template.  [back to top]

The Performance Shaping Factors will follow the framework presented by Charles Vincent’s assessment of “factors that influence clinical practice.”¹⁸ and contribute risk.

These include the following: 

1. Institutional context (economic and regulatory context).
2. Organizational and management factors (financial resources, policy standards and goals, and safety culture priorities).
3. Work environment (staffing levels and skills mix, workload and shift patterns, design, availability, and maintenance of equipment, and administrative and managerial support).
4. Team factors (verbal communication, written communication, supervision and help seeking, and team structure).
5. Individual staff factors (knowledge and skill, motivation, physical and mental health).
6. Task factors (task design and clarity of structure and availability and use of protocols).