Patient safety and clinical human factors

Definitions

Patient Safety: The absence of preventable harm to a patient during the healthcare process and reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum. Simply, it is about maximising the things that go right and minimising the things that go wrong for patients.

Human Factors: The scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design and optimise human well-being and overall system performance. The terms ‘Human Factors’ and ‘Ergonomics’ arose from slightly differing backgrounds but are used synonymously.

Clinical Human Factors: Application of Human Factors science to solve challenges on a wide range of topics related to healthcare, including hospital environments, medical and drug delivery devices, healthcare IT, patient safety, healthcare systems, health policy and provider well-being.

Nontechnical Skills: A subset of Human Factors, these are the cognitive, social and personal resource skills that complement technical performance.

Human Error: This is defined as an act of commission (doing something wrong) or omission (failing to do the right thing) that leads to an undesirable outcome or significant potential for such an outcome. Mistakes and slips are differentiated in the Human Factors literature; mistakes are errors in choosing an objective or specifying a method of achieving it (e.g., bad planning), whereas slips are errors in carrying out an intended method for reaching an objective (e.g., the plan was good, but actions were wrong).

Adverse Event: An injury caused by medical management (rather than the underlying disease) that prolonged hospitalisation, produced a disability at the time of discharge or both. These are also called ‘iatrogenic events’, because the complications are attributed to medical management rather than progression of disease.

Near Miss: An event that could have had adverse consequences but did not. In a near miss, an error occurred, but the patient did not experience clinical harm, either through early detection or sheer luck.

Duty of Candour: A legal duty for both individual healthcare staff (professional) and organisations (organisational) to be open and honest with patients and their families when something goes wrong that causes significant harm. An apology, appropriate remedy, support and explanation of its effects should be offered.

Manual review of medical records

This ‘gold standard’ research method in patient safety involves retrospective record review. Initial review looks for signs of possible harm from medical care that may trigger more detailed review for the presence of adverse events. This method relies on triggers – signs of possible safety problems such as unexpected death, unexpected intensive care admission, readmission, patient complaint or specific events (e.g., Clostridium difficile infection). However, if an adverse event is not regarded as a trigger or goes unrecorded, it will not be captured.

Prospective surveillance

Recently, there has been increasing use of surveillance to identify patient safety incidents in near-real time and help manage risk proactively and rapidly. This resource-heavy, multimodal approach using observers, staff interviews, chart review and incident reporting is more successful in detecting harm as it is not solely reliant on what is recorded in the case records.

Analysis of routinely collected hospital data

Routinely collected coded health administrative data from all admissions can be used to perform standardised analysis to identify rare adverse events and associations with patient, clinician and system-level factors. However, because such data are not collected prospectively or by clinical experts, accuracy is not always good. There are also several less frequently employed methods of measuring adverse events, such as patient-reported methods (interviews, surveys) and malpractice claims. Fatal accident inquiries also provide detail on a small number of particularly concerning cases.

Voluntary reporting

This widely used method can be performed in multiple ways including incident reporting systems, mortality and morbidity meetings and patient complaints. It tends to underestimate adverse events because reporting disincentives exist based on organisational safety culture and include extra work, trust, fear of reprisals, rigid hierarchical structures, lack of effectiveness of many reporting systems and habituation of healthcare staff to particular practices. A positive response reinforces to employees that they are safe to speak out, which in turn promotes regular critical upward feedback. A culture needs to exist where any healthcare worker is encouraged to openly question the actions of another in a nonconfrontational way as a learning opportunity for all.

Whistleblowing

Whistleblowing is defined as disclosure by organisation members of illegal, immoral or illegitimate practices, under the control of their employers, to persons or organisations that may be able to effect action. Simply, a whistleblower is a person who raises concern about wrongdoing. Staff often avoid formal whistleblowing routes such as reporting to external regulators and instead raise concerns locally. However, several recent high-profile national public inquiries into healthcare failings in the UK have noted that employees of failing organisations attempted to raise concerns locally only for these to be ignored.