Risk Management Analysis

  • Jolene E. Cormier, BSN, RN, EMT-P, CHRN, CHT
  • Volume 09 - Issue 3

Risk Management is defined by ISO 14971 as “the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating and controlling risk” (Schmidt). The purpose of risk management is to identify risks, take steps to mitigate them, and evaluate whether the actions had the intended outcome. ISO 14971 (Schmidt) lists three steps to the risk management process:

  1. Risk analysis – identifying hazards associated with a device, a procedure, or activity.
  2. Risk evaluation – assess the probability of the hazard occurring and the severity or impact of the consequence. Probability and severity can be scored using a lowmedium-high determination. A sample matrix can be found in the NFPA 99 Handbook (2015, p.74).
  3. Risk control – methods for mitigating the risk which can include redesigning a system or process, staff training or protective measures

Redesigning a process or system (inherent safety) is considered the most effective for controlling risk, while a focus on training is considered the least. Some risks can be eliminated (adding an item to the No Go list prevents risks associated with that item); however, often risks cannot be completely eliminated. As stated by Schmidt, “safety means the freedom from unacceptable risk.”

There are two risk analysis methods, retrospective and prospective, based on whether the process is being completed proactively or reactively. If an incident has already occurred a retrospective risk analysis is used to evaluate the cause or causes of the error and try to prevent reoccurrence. A prospective risk analysis attempts to identify possible risks and tries to reduce or eliminate them before an occurrence. In a perfect world all risk analysis would be proactive: In reality both techniques are subject to biases that can affect quality or accuracy. Bias constitutes a “pre-conceived preference or inclination that has the potential to affect the impartiality of evaluations or decisions” and can result in risks being overlooked or prematurely dismissed (Peacos). Different forms of bias that can affect risk management include: 1) team assembly (individuals with a similar mindset or not including someone who is not affected by the outcome); 2) not considering risks from supporting systems; 3) resistance to change. A hospital system’s internal resources (risk management, environment of care, safety, and infection control) can qualify as team members not affected by the outcome and of a different mindset. Risk analysis expert Paul Baybutt recommends having a devil’s advocate on the assessment team to combat the effects of cognitive biases, someone willing to challenge your views to help determine their validity.

Prospective risk management techniques are often used when evaluating or modifying equipment for the hyperbaric environment; however, this process can be applied throughout the hyperbaric department. It is important to have a systematic method for completing any risk assessment so none of the items or steps that may be required are missed or forgotten. These items/steps may include: identifying the hazard, the probability and severity matrix used, infection control, fire risk, consulting external or internal resources, relevant information/literature review, training and documentation of the process.

Before I lose anyone, the key word is may; not all of these items will be necessary, depending on what is being considered or assessed, and the time commitment depends on the project and the key players (or resources) that need to be involved. An expertise in risk analysis is not necessary; literature reviews, consulting resources, and assembling a diverse team can help ensure everything addressed. Documentation may not need to be extensive but having a record trail is important, as it can serve as a template for future assessments and provide justification for the end result.

To illustrate how quickly and easily some risk assessments can be completed and documented, following are two examples of completed prospective risk analyses that resulted in a change in practice and/or policy.

PROSPECTIVE RISK ANALYSIS FOR ALCOHOL FOAM IN THE HYPERBARIC ROOM
Problem: Alcohol foam was automatically installed outside and inside the hyperbaric chamber room due to hospital policy. There were case reports of fires due to ignition of alcohol gel/foam, with increased fire risk in a hyperbaric environment. However, alcohol foams reduce the spread of health-care associated infections.
Probability: Low. Few cases have been reported, and alcohol evaporates quickly. Ignition sources are kept out of the monoplace chamber, and patient grounding is checked before each treatment.
Severity: 1. Fire in the monoplace chamber – high due to mortality rate; all previous incidences have proven fatal. 2. Spread of hospital-acquired infections – low due to the presence of an effective alternate. A sink with soap is located in the hyperbaric room.
Internal Resources: Infection control manager and environment of care (EOC) safety officer. An email was sent to the internal resources identified with copies of the case report found. Responses were sent by the end of the day, and engineering removed the alcohol foam. The change was discussed among the hyperbaric team.
 
PROSPECTIVE RISK ANALYSIS FOR DEFIBRILLATION IMMEDIATELY OUTSIDE A MONOPLACE CHAMBER
Problem: The risk of fire due to arcing during defibrillation immediately outside a monoplace environment. The patient and associated linens are oxygen-enriched after they are removed from a monoplace chamber, which is pressurized with 100% oxygen
Probability: Low. Fires have been reported during defibrillation in an oxygen-enriched atmosphere (OEA) when oxygen is flowing directly across the patient’s chest, and when paddles are used for defibrillation. Our facility has an AED, which uses pads. Also, cold oxygen is heavier than air and will fall to the floor within 30 seconds. Patient covering and scrub top/gown will need to be removed, resulting further in oxygen dissipation from around patient.
Severity: 1. Fire – high. Fire can result in patient death and staff death or injury. 2. Patient death due to cardiac arrest and delayed defibrillation – high. Immediate early defibrillation and chest compressions are shown to improve survival for patients in cardiac arrest.
Clinic Conclusion: As long as adhesive pads are used, not paddles, it is unnecessary to move the stretcher away from the chamber for defibrillation. The risk of death due to delayed defibrillation is greater than the risk of fire due to arcing in these circumstances. As long as pads are used with AED it is unnecessary to delay defibrillation in patients who have had an apparent cardiac arrest inside the monoplace chamber once they are removed from the chamber.
Internal Resources: Clinic medical director, policy committee to review changes. After being approved by the hyperbaric team and medical director, the new policy was presented to the policy committee, education provided to staff and safety drills updated to reflect the change in procedure.
REFERENCES
ECRI Institute. Fires from defibrillation during oxygen administration. Health Devices. July 1994; 23(7): 307-308.
ECRI Institute. Defibrillation in oxygen-enriched environments. Health Devices. Mar-Apr 1987; 16(3-4): 113.
Garcia JR. Management of the critically ill patient in a hyperbaric setting: nursing considerations and preventions. In LarsonLohr V. Editor, Hyperbaric Nursing and Wound Care. 2010; 83-108. Flagstaff, AZ: Best Publishing Company.
Sunde K, et al. Part 6: Defibrillation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation 2010; 81:e71–e85. DOI: 10.1016/j. resuscitation.2010.08.025
Theodorou AA, Gutierrez JA, Berg RA. Fire attributable to a defibrillation attempt in a neonate. Pediatrics. 2003; 112(3). Whelan HT, Kindwall EP. Hyperbaric Medicine Practice. 4th edition. 2017. North Palm Beach, FL: Best Publishing Company.

Special thanks to devil’s advocate Jane Ahlstrom, CHT.

References

Baybutt P. Cognitive biases in process hazard analysis. J Loss Prev Proc Ind. 2016; 43: 372-377.

Peacos P. Bias: The hidden danger to your risk assessment. 2016. Am Pharm Rev. Retrieved from: https://www.americanpharmaceuticalreview.com/Featured-Articles/184365-Bias-The-Hidden-Danger-to-Your-Risk-Assessment/

Schmidt B. (201). Prospective risk management. Patient Safety and Quality Healthcare. 2010. Retrieved from: https://www.psqh.com/analysis/prospective-risk-management/

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About the Author

Jolene-E-Cormier
JOLENE E. CORMIER, BSN, RN, EMT-P, CHRN, CHT is senior director at large with the BNA and a volunteer on the UHMS safety committee. The views expressed in this article are her own and not the formal opinion of either of these organizations. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..
 

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