Interview with Christian Schärer, Head of Inspection Management and Blood Surveillance and Julia Engels, Vigilance Assessor Haemovigilance “Errors can occur in every link in the transfusion chain”

What tasks are carried out by Haemovigilance at Swissmedic?

Christian Schärer: Haemovigilance monitors the entire transfusion chain, from the blood donor via a large number of interfaces to the person who receives the infusion, i.e. the patient. Responsibilities are clearly regulated. The transfusion services are the manufacturers of the products and as such responsible for drawing blood and manufacturing and supplying the products. They require a licence from Swissmedic and are inspected regularly. Haemovigilance at Swissmedic monitors quality assurance and transfusion reactions, i.e. adverse reactions ranging from fever and allergies to life-threatening shock.
Julia Engels: All the actors in the transfusion chain have an obligation to report signals, incidents and new risks to Swissmedic. The manufacturers and hospitals must designate a haemovigilance officer for this purpose, usually a doctor. Swissmedic evaluates these reports, identifies critical points and safety gaps – and initiates preventive actions and improvements.

What are the particular challenges in this field?

Christian Schärer: Handling biological substances from the human body, blood being a prime example, storage and the necessary laboratory testing of the blood products, distribution logistics and use of the products in patients in hospitals are all aspects that make major demands on the entire process chain. In addition, the transfusion process at the hospital is complex, involving many professionals, from nurses and doctors to quality officers.
Julia Engels: Blood products in Switzerland are very safe – yet there is always a residual risk of incidents. This is because we are dealing with a very special product: blood and labile blood products are “living medicines” donated by people. Every step in the process, from donor selection to aftercare of the patient, must be monitored and traceable down to the last detail. If, for example, a blood product is suspected of having transmitted an infection, a look-back process can be used to track the product for up to 30 years after the transfusion took place.

“Swissmedic can intervene in various ways, from monitoring reporting processes to targeted inspections.”

How many reports does Haemovigilance receive every year?

Julia Engels: Swissmedic receives around 4,500 reports from all parts of the transfusion chain every year. Some reports concern side effects experienced by donors, such as loss of consciousness after a donation or the discovery of an infectious disease in donated blood. Others concern problems such as infections or allergic reactions in the recipient of the transfusion. It is also important to report transfusion errors such as product mix-ups and near misses – errors following which nobody was harmed – so that critical steps can be eliminated and processes improved.

Is there a trend in the number of reports?

Christian Schärer: The number has been growing constantly since the haemovigilance reporting requirement was introduced in 2002, which shows that acceptance of the reporting system is good and that it is being used. Swissmedic intervenes specifically at institutions whose figures are indicative of under-reporting. During inspections, the processes to achieve compliance with the reporting requirement are also always reviewed.

What role does enforcement play in haemovigilance?

Christian Schärer: As the competent authority, Swissmedic plays a fundamental role in maintaining a functioning national blood transfusion service. As an independent authority we have various ways of enforcing the current regulations in the interest of patient safety. At the same time we follow scientific developments and modify quality standards accordingly.
Swissmedic can intervene at various levels, from monitoring reporting processes to targeted inspections. Administrative proceedings or even criminal investigations may result from recurrent deficiencies or failure to comply with the reporting requirement. Basically, though, our task is not to apportion blame but to use reports to find out the cause of the error – so that it can be avoided in future. In enforcement, this combination of a “no blame” culture in the haemovigilance reporting system and the role of inspector is not a contradiction in terms.
Julia Engels: The focus is on patient safety. The main concern of Haemovigilance is therefore to identify relevant potential for improvement in processes and to correct them.

Can you give us some specific examples of enforcement measures?

Julia Engels: Haemovigilance can play a fundamental role in modifying manufacturing conditions. For example, in the past the fact that bacteria can multiply in blood platelet concentrates and then be transmitted during a transfusion was a major problem. The problem was identified as a result of haemovigilance reports. In Switzerland the manufacture of platelet concentrates was therefore modified and something known as pathogen inactivation was introduced. This is a process in which any infectious pathogens – such as bacteria – are killed during manufacture. After this modification had been made, there was a distinct decline in haemovigilance reports of bacterial transmission.