Surgical safety checklists: patient safety to check off

Interview with Daniela Renner, research associate at the Agency for Quality in Medicine (AQuMed)

You find out after surgery that the left knee was treated instead of the right one. Although such mistakes rarely happen, they can have serious consequences – both for the patient and the image of the physician and the hospital.


Photo: Yound woman with short, brown hair - Daniela Renner

Daniela Renner; ©ÄZQ

The Agency for Quality in Medicine (AQuMed) in Germany now published nine surgical safety checklists that are meant to help avoid mix-ups with patients and interventions in the operating room. Daniela Renner, research associate at the AQuMed, explains how these checklists originated and how they contribute to improving patient safety in hospitals.

How often does a patient mix-up, an error in intervention or site happen in operating rooms?

Daniela Renner
: There are currently no reliable numbers for this in Germany. There is especially no data on near mix-ups. After all, it doesn’t need to be the wrong leg that’s being amputated; it’s already bad enough that a patient is being wrongly anesthetized for instance, but this was realized in time before a skin incision was made and things turned out in the end. We only have an analysis by the Ecclesia insurance company, which was being conducted in 247 German hospitals over the course of 10 years. During this time, there were 104 reported patient or surgical intervention mix-ups.

In international studies relating to Western healthcare systems, the rate of such mix-ups is quantified at 1in 3,000 or rather 1 in 30,000 surgeries. The difference in frequency depends on the discipline.

What are the main reasons for such mix-ups?

: The treatment including the surgery is a highly complex process that involves many individual steps with many involved parties over a long period of time. It starts with the patient’s admission and goes all the way to a surgical incision – in between, it involves an extreme amount of staff from different occupational groups and hierarchy levels. This offers a large potential for communication problems, sketchy responsibilities and jurisdiction as well as not clearly defined planning processes.

In 2006, the World Health Organization (WHO) has initiated the High 5s Project. Within the scope of this project, several surgery safety checklists were tested in several countries between 2010 and 2013. How was this project conducted in Germany?

: The goal of the High 5s Project is the implementation and evaluation of standardized recommended actions to improve patient safety in hospitals. With the aid of the German Ministry of Health (German: Bundesministerium für Gesundheit), we were able to obtain 16 hospitals to implement the recommended actions in Germany. The main tool of this recommended action is the surgical safety checklist that was first translated and individually adapted to the hospitals.

In Germany, the national coordination centers for this project are the Agency for Quality in Medicine (AQuMed) and the Action Alliance for Patient Safety (German: Aktionsbündnis Patientensicherheit, APS). The AQuMed is in charge of obtaining hospitals and implementing the recommended actions. The Institute for Patient Safety at the University of Bonn (German: Institut für Patientensicherheit der Universität Bonn, IfPS) is responsible for the evaluations on behalf of the APS.
Photo: Nurse checks a list in the OR

In the surgical safety checklists, many process steps are covered, which correspond to the different needs of the departments and facilities; © Wen Hui Wang

At the end of the three-year project phase, the AQuMed now published nine surgical safety checklists. How did the different versions originate?

: The nine checklists include points on prevention of surgical mix-ups that are requested by the High 5s Project. They were combined with new contents that resulted from the needs of the different disciplines and hospitals.

What process steps are covered in the surgical safety checklists?

: The internationally developed standardized recommended actions state that mix-ups during surgical inventions can be avoided with three complementary process steps. Those are the preoperative verification process, labeling of the surgery site and the team time-out immediately before the start of the surgery. All of these process steps are documented on the High 5s checklist. The checklist therefore also serves process documentation. However, this doesn’t mean that only those three points should be included in there. With our nine checklist versions, other process steps, which correspond to the different needs of the departments and facilities, are also being checked.

Who completes the checklist and are hospitals obligated to use them?

: The checklist essentially accompanies the patient. It starts with the patient’s admission into the surgical ward and ends with the team time-out right before the surgical intervention. During each station, the respective responsible party needs to "check off" his or her part on the checklist and sign for it. The checklist subsequently becomes a part of the patient’s health record.

Surgical safety checklists are already standard in many hospitals. However, they are currently not mandatory. That being said the current coalition agreement states that surgical safety checklists are meant to be introduced as a safety standard. Yet it is still not foreseeable whether an obligatory use is actually going to be enforced.

The AQuMed is currently in the process of analyzing the data that was collected during the project phase. Can you already give us early results?

: We have collected data from over 150,000 checklists. In addition, hospital representatives were also frequently asked about their experiences with the implementation: where did they have problems with the implementation, how were they able to overcome obstacles, what were supporting factors, what recommendations do they have for others etc. We are currently still in the evaluation phase. We already released various posters and presentations on this subject. We are currently preparing an implementation handbook. We want to sum up our experiences and provide practical tips to those, who want to introduce a checklist. The handbook will be released at the beginning of next year.
Foto: Michalina Chrzanowska; Copyright: B. Frommann

© B. Frommann

The interview was conducted by Michalina Chrzanowska and translated by Elena O'Meara.