Karolinska University Hospital's management comment Kjell Asplund investigation: "An exceptional and unacceptable series of events".

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On August 31 2016, Kjell Asplund presented the external investigation concerning the circumstances around which three patients underwent windpipe surgery, led by Paolo Macchiarini between 2011-2013, at Karolinska University Hospital.

On August 31 2016, Kjell Asplund presented the external investigation concerning the circumstances around which three patients underwent windpipe surgery led by Paolo Macchiarini between 2011-2013. The investigation revealed serious irregularities in the management of the three patients and serious flaws in hospital procedures, systems and culture.

- We take the results of the investigation very seriously, said Head of Karolinska University Hospital, Melvin Samsom. What has happened is totally unacceptable; and in many ways exceptional. The study shows a sequence of events enabling Paolo Macchiarini to operate completely outside the hospital's standard rules and procedures, and without any warning from our internal systems. Our primary tasks now are to ensure that this situation never arises again and to regain the trust of our patients that we always put the patient first.

- This is a thorough investigation that provides a comprehensive overview of the entire series of events, said Chief Medical Officer Nina Nelson Follin. We will now focus closely on the recommendations presented by Kjell Asplund and take the necessary steps to strengthen our procedures, adherence to laws and regulations and clarify responsibilities of managers and doctors for patient safety.

In parallel with the investigation, Karolinska has already taken a number of measures:

  • We are working with leadership issues such as an open culture and clarification of responsibilities.
  • We have installed a whistleblower function as a complement to other systems.
  • Strengthened processes for joint recruitment with Karolinska Institute where hospital responsibilities are clarified.
  • Developed an internal routine for the start of clinical trials.
  • Responsibility for adherence to laws and regulations has been clarified and emphasized to managers on all levels.
  • Initiated an investigation of all other operations performed by Paolo Macchiarini between 2010-2013.

The hospital's new business model is based on the patient's journey through the health care system; integrating care, research and education. This further specifies responsibility and cooperation in the organization.

- What has happened affects the reputation of Karolinska University Hospital. We are committed to doing everything we can to restore the trust of our patients. The hospital has 15 000 employees who take care of many patients everyday and do their job in an excellent way, says Melvin Samsom.

More information

A summary on the investigation: The Macchiarini Case - Investigation of the synthetic trachea transplantations at Karolinska University Hospital

Background

In February 2016, the Director of Karolinska University Hospital commissioned an investigation with the directive to answer a number of questions surrounding Macchiarini and the trachea transplants he performed at the hospital. The task also included making improvement recommendations based on the facts that came forth in the investigation.

The task was assigned to Kjell Asplund, Professor Emeritus in Medicine at Umeå University, Chairman of the Swedish Council on Medical Ethics (Smer) and former Director-General of the National Board of Health and Welfare.