Resources Module 6: Understanding and Managing Clinical Risk

Patient Story

It was a busy Sunday in the pharmacy at Rainbow Babies & Children’s Hospital in Cleveland. The hospital’s computer system had been down for about ten hours before; Eric Crop, started his shift. He had been in busy situations many times before. In fact, he had 14 years of experience and had been president of the Northern Ohio Academy of Pharmacy.

But on this day, he made the mistake of not thoroughly checking a saline-solution base that a technician (who only had a high school diploma and no formal training) had prepared for a child’s chemotherapy treatment. She mixed it more than 20 times stronger than ordered, and he didn’t catch it. When a nurse administered it, the high concentration of the sodium chloride flowing through the child’s veins made her brain swell and put her in a coma. Three days later, she died. Her name was Emily, and she was two years old.

Eric was eventually convicted of involuntary manslaughter, for which he received six months of jail time, six months of house arrest, three years of probation, a $5,000 fine, and 400 hours of community service. He also lost his license to practice.

Ohio has since adopted Emily’s Law, which requires that all pharmacy techs undergo training and pass a competency exam. (Kita, 2012)

The above story highlights the importance of credentialing and registration, as fitness to practice is an important component of patient safety and clinical risk management.

Understanding and Managing Clinical Risk

Clinical risk management deals mostly with improving the quality and safety of health-care by identifying the circumstances and situations that put patients at risk and then acting to prevent or control those risks. The following process is used to manage clinical risks:
a) identify the risk;
b) assess the frequency and severity of the risk;
c) reduce or eliminate the risk;
d) assess the costs saved by reducing the risk or the costs of not managing the risk.

Gathering information about clinical risk includes: incident monitoring, near misses, sentinel events and complaints.

WHO defines an incident as an event or circumstance that could have or did lead to unintended and/or unnecessary harm to a person and/or a complaint, loss or damage.The main benefit of incident monitoring lies in the collection of information useful for the prevention of similar incidents in the future.The key to an effective reporting system is for staff to routinely report incidents and near misses.

A near miss is an incident that did not cause harm. Some people call near misses “near hits”,
because the actions may have caused an adverse event, but corrective action was taken just in
time or the patient had no adverse reaction to the incorrect treatment.

An adverse event that is usually unexpected and involving a patient’s death or serious
physical or psychological injury to a patient.Many health-care facilities have mandated the reporting of sentinel events because of the significant risks associated with their repetition.

A complaint is defined as an expression of dissatisfaction by a patient, family member or
carer with the care provided. It helps to identify areas that can be improved.Communication problems are common causes of complaints, as are problems with treatment and diagnosis.

Coronial investigations are carried out by specifically appointed people, called coroners in many countries, are responsible for investigating deaths in situations where the cause of death is uncertain or thought to be due to unethical or illegal activity. Coroners often have broader powers than a court of law and, after reporting the facts, will make recommendations for addressing any system-wide problems.

Health-care organizations are required to check that health-care providers have the
appropriate qualifications and are competent to practise which is an important component of patient safety. Credentialing, Accreditation and Registration (licensure) are the processes employed.

Every healthcare professional is personally accountable for managing risk arising from sleep deprivation, fatigue, stress, mental health problems, work environment, failure of instruction and supervision and communication issues.

Paying attention to the following help to manage risks:

• Know how to report known risks or hazards in the workplace
• Keep accurate and complete health-care records
• Know when and how to ask for help from a supervisor or senior health-care professional
• Participate in meetings that discuss risk management and patient safety
• Respond appropriately to patients and families after an adverse event
• Respond appropriately to complaints

Essential reading for this topic is WHO handout, Understanding and managing risk (WHO,2012)

Optional reading for this topic is

Toolkit - Pocket Guide for Clinical Risk Management by the Department of Health, Western Australia


Kita J (2012) Doctors confess their fatal mistakes. Readers Digest. Yahoo! life[Online][Accessed on 28 April 2021][Available at

World Health Organization (WHO) (2012). Understanding and managing clinical risk [Online][Accessed on 28 April 2021][Available at

Last modified: Tuesday, June 8, 2021, 6:50 AM