About critical incident reporting systems, CIRS, and their use in medicine, you can read here:
1. Why Did That Happen?
A patient, who is thought to be in general anaesthesia during an operation, lies fully awake and cannot move. Hence, she cannot signal to anyone what she is experiencing. At the same time, she is hearing everything that is being said at the operating table.
In this case, two medications, the narcotic and the analgesic, which are both administered continuously using an intravenous access, have been mixed up. Subsequently, the dosage of the narcotic is much too low.
Why did this mistake with its cruel consequences for the patient happen? What are the root causes and what other circumstances played a role? If the medical team involved wants to prevent the error in the future, it has to answer these questions. We will come back to this case in subchapter 4.
In addition, the team should take the following steps:
- talk to the patient and apologise sincerely; this is absolutely crucial irrespective of possible legal consequences and any compensation for personal suffering
- explore who made the error, but also who else and what circumstances contributed to it
- the culprits should take responsibility and be penalised justly taking all aspects into account
- work out how to prevent this particular mistake during future operations
- think about what CRM principles were left out and how to apply them in the future
- let everyone know in the form of a learning opportunity after the case has been carefully anonymised
- the entire process should be handled professionally
It is not important that everyone learns who has made the error, but that as many professionals as possible learn from it as much as they can in order to improve patient safety.
Here, also critical incident reporting systems, CIRS, come into play. In the subchapters below, we will explore what they are, who can report to them and how the reports are processed. We will also elucidate, what the London Protocol in its second edition is and how it is used during the evaluation of the cases. Last but not least, what are the main findings of a CIRS study review and what are the limitations and the benefits when using CIRS?
2. CIRS Are Run by Hospitals and Larger Organisations
There are different kinds of CIRS. We will look at some examples before we take a brief look at how a CIRS typically works.
2.1. Types of CIRS
- CIRS used within a hospital
- "cirs bayern", in English "cirs Bavaria", which is run jointly by organisations providing prehospital emgerency care, including the Bavarian mountain rescue service
- national CIRS, such as the one provided by the NHS
- the CIRS maintained by care homes, etc.
2.2. How Most CIRS Work
Usually, any health care professional can report an incident which has threatened the safety of at least one patient, or an event in which the patient has actually been harmed. Forms are provided for the case reports and can be filled in anonymously. Staff is not obliged to use the CIRS and does not always deem it necessary to register a case.
A team of clinicians with expertise in patient safety and risk management evaluates the reports as we will explore in detail below. Ideally, recommendations are given which help to prevent the events in the future. The CIRS cases are published anonymously so that they can be accessed by the staff of the respective hospital or even publicly, such as the ones in the "cirs.bayern".
3. The London Protocol in Its Second Edition
The London Protocol guides investigators of clinical incidents and adverse outcomes through their in-depth analysis, which, along with all circumstances, also includes the entire system in which the event has happened (1).
Below, we will first address what is new in the second edition of the London Protocol and why these changes are well thought out, before turning our attention to crucial concepts and the types of factors which contribute to an incident. Lastly, we will briefly touch on the steps taken in the investigation.
3.1. The Main Changes in the Second Edition
Not Only One Single Root Cause
Whenever someone makes a mistake, there is usually not one single root cause, which is behind the mistake we notice on the surface. Rather, there is an often complex chain of events along with contributing factors of various kinds which result in the error. The error, in turn, causes the incident.
What is Most Likely to Trigger Another Incident?
Whilst it is still important to find out what caused the error, the authors state that it is even more important to analyse what factor had the largest effect on what happened. In addition, they emphasise that it is crucial to determine, what factors are most likely to trigger another incident or adverse outcome.
The Goal Is to Create a Safer Healthcare System
In order to achieve a safer healthcare system, the investigators aim at finding the gaps and the inadequacies in the system itself, which also underlie the error. Only when these gaps are identified and closed, the overall safety can be improved. This is the very reason, the authors called their second edition "System Analysis". It is a more proactive view and encompasses all people in the system, from management to those who work directly at the bedside.
Achieving a Safer Healthcare System Is Linked to Just Culture
The entire investigation process can only be carried out effectively in a company culture which embraces fairness and considers justice more important than mere disciplinary actions. Even though the system analysis is important, it is still necessary that culprits take responsibilty and that personal mistakes and omissions are sanctioned justly. This is also the very idea of Just Culture.
3.2. Concepts and Types of Contributing Factors
In the analysis, the human errors and omissions of those at the sharp end will be examined first. In healthcare, the professionals at the sharp end are those who work with the patient directly. From there, the personal failures are placed into the context of the system, which brings us to the contributing factors.
The authors of the London Protocol present the following types of contributing factors in their second editon:
- patient factors
- task and technology factors
- individual (staff) factors
- team factors
- work environmental factors
- organisational and management factors
- institutional context factors
Care Delivery Problems, CDP
The authors have chosen this term for unsafe acts, because they sometimes are not one single act, such as using the wrong syringe, but may extend over time. For instance, it may take some time, before staff notices that a wrong medication has been prescribed and administered for some days already.
3.3. How to Carry out the Investigation of an Incident
In any investigation, it is helpful to take these steps:
- identification of the problem and the decision to investigate
- selection of the experts who will be part of the team in this investigation
- compilation of all relevant data
- reconstruction of the timeline (in what order have the events occurred?)
- identification of the care delivery problems, CDPs
- exploration of the contributing factors
- recommendations and action plan
1) Taylor-Adams S, Vincent C (no date of publication mentioned) Systems Analysis of Clinical Incidents, The London Protocol (second edition), Clinical Safety Research Unit, Imperial College London
4. The Analysis of Cases in the CIRS Database
As at least some CIRS use the London Protocol, we will now examine along its guidance, how the case concering the patient at the beginning of this article could be submitted to a CIRS. We will explore how it might be assessed, and what recommendations might be given.
4.1. How to Submit the Case to the CIRS
The form will provide the following or similar sections:
- describe what happened, anonymise all persons: the patient´s characteristics, the type of operation and planned general anaesthesia, the mix-up of the syringes, including all circumstances
- what measures did the team take: depends on when the team noticed the error; if it realised it during the operation, it should have stopped the administration, swabbed the syringes and given a larger single dose of the narcotic before continuing the constant administration of both medications with the correct dosage
- effects of the event: the team should talk about these with the patient and state them in the form
- potential causes: the contributing factors which the team has identified itself
- what measures the team has already taken to solve the issues
4.2. The CIRS Experts Identify the CDP and the Contributing Factors
The Care Delivery Problem
The CDP in this case was a wrong action: The two medications in their syringes had been mixed up as they were placed in the syringe pumps. As these pumps, which deliver medication continuously with a preselected perfusion rate (millilitres per hour), were started, they pumped the two medications into the patient´s vein at wrong rates: too little of the narcotic and too much of the analgesic.
The Contributing Factors May Have Comprised:
- patient factors: a patient with multiple comorbidities or a complication during the induction of general anaesthesia
- task and technology factors: lack of checklists and SOPs, new or other syringe pump than usual
- individual (staff) factors: fatigue, the end of a long night shift, current status of knowledge and skills
- team factors: lack of supervision of a young doctor, this doctor did not dare to ask for help
- work environmental factors: too high a workload, for example a young doctor might have had to take care of this patient alone, the shift might have been too long
- organisational and management factors: financial constraints might have led to too few staff members in one shift
- institutional context factors: regulatory context: When are young doctors considered trained well enough to handle complicated and complex cases alone?
4.3. Recommendations
The recommendations depend on the CDP and the factors that the experts have identified. Of course, the measures, the team has already implemented, will be taken into account. If recommendations are given, they are usually very concrete. In this case, they might address the support which young doctors can expect when they have to take care of a patient with complex comorbidities or during an extensive operation.
Before applying a medication, or starting a syringe pump, it clearly helps to stop oneself and go through the following items in one´s mind, especially in stressful situations and with several medications to give:
- Is this the right patient (e. g. in a crowded emergency department)?
- Are there any allergies to the medication I am about to administer?
- What medication do I want to give?
- Is it the right syringe with the intended medication in the right concentration?
- How many millilitres am I about to give?
Normally, this process takes a few seconds only. As soon as one has made sure that all questions are answered sufficiently, one can go ahead.
5. Review Findings, Limitations, and Benefits of CIRS
5.1. Findings in a Review of CIRS Studies
In a review of 41 studies on hospital-based CIRS (2), the authors found that most incidents were related medication (28,8%), followed by unspecified adverse clinical events (20,6%) and administrative errors (12,9%). The most common contributing factors were active failure (26,1%), communication systems (12,7%), and patient factors (8,1%). Interestingly, nurses submitted most of the reports (83,7%).
2) Goekcimen K, Schwendimann R, Pfeiffer Y, et al. (2023) Addressing Patient Safety Hazards Using Critical Incident Reporting in Hospitals: A Systematic Review. J Patient Saf. 19(1): e1-e8
5.2. Limitations Include Inconsistent Reporting and Few Recommendations
The review mentioned above also found these limitations of CIRS studies:
- inconsistent reporting due to voluntariness
- the forms may not capture all relevant circumstances
- different CIRS are difficult to compare
- the quality standards vary
- recommendations for improvement are not always given; if they are included, they are not standardised
Due to these factors the CIRS cannot unfold their full potential as feedback loops which help to mend the procedures in healthcare and, ultimately, increase patient safety.
5.3. The Benefits We Gain From Studying CIRS Cases
As we have seen above, the use of CIRS and the subsequent enhancement of patient safety definitely need improvement. However, what do we achieve when we use the CIRS, which are available to us, actively?
As the CIRS are free to use, we should evaluate what cases from our own work we could report. If we do, we should think carefully about what has happened, and what circumstances have played a role. Of course, we can think about the CRM principles which might have helped us to prevent the incident or harmful event. Normally, the reviewers will also assess these ideas and comment on them.
Reading the cases in a CIRS is helpful, as well. When we do that, we should first read the case and take the time to reflect on how we would have acted in the same situation. Are we able to detect a chain of events in the case? Who acted in what way, and what were the contributing factors?
How would we use the London Protocol and what would our recommendations be? If we are serious about our work, we might even want to make notes. When we are finished, we should compare our own analysis and ideas with the ones given by the professional reviewers. Last but not least, what learning points can we use in our work routines?
6. Real Cases Taken From CIRS in the Next Article
In the next blog article, we will look at real cases which have been reported to CIRS and evaluated by their staff. As we go along, we will highlight how the cases have been described, how the London Protocol has been used and what recommendations have been made. What can we deduct from them and apply at our own workplaces?
Author: Eva-Maria Schottdorf
Date: September 29th, 2023
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