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Munich hospital closes liver transplantation list after audit uncovers errors

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7417 (Published 02 November 2012) Cite this as: BMJ 2012;345:e7417
  1. Ned Stafford
  1. 1Hamburg

The medical school hospital at the Technical University of Munich has stopped accepting new liver transplant patients while it investigates suspected manipulation of patient data.

The alleged data manipulation at the hospital, whose official name is Münchner Klinikum Rechts der Isar, was apparently done to make patients seem sicker than they were and therefore to move them ahead of other patients on waiting lists for scarce donor livers.

The Munich case comes after this summer’s allegations of data manipulation at university hospitals in Göttingen and Regensburg, which sparked concerns that Germans would lose trust in the organ donation system and be less likely to sign donor cards.1

Criminal prosecutors are investigating those two cases, as well as the Munich hospital.

Günter Kirste, medical director of the German Organ Transplantation Foundation (DSO) in Frankfurt, told the BMJ that the allegations of data manipulation at the three transplant centres, described in the German press as the “organ scandals,” has caused major uncertainty among the general public. “We are experiencing this in many consultations with relatives of potential organ donors,” he said. “Furthermore, this is being confirmed by declining organ donor statistics.”

The allegations of patient data manipulation at the Technical University hospital in Munich first arose in late September during audits at all of Germany’s 47 organ transplant centers. The audits were ordered by the German Medical Association and the German Ministry of Health in response to the cases in Göttingen and Regensburg.

Technical University hospital officials reviewed all 163 liver transplantations performed between 2007 and July 2012, finding cause for deeper investigation in nine cases. In at least one of those cases, clear evidence of purposeful data manipulation was found and prosecutors were informed.

Neither hospital officials nor Bavarian science ministry officials responsible for overseeing the medical school have released details of the suspected manipulation. But the German press has reported that the alleged manipulation included making it falsely appear that a patient was already on dialysis and therefore urgently in need of a new liver. In another case, it was reported that an alcoholic patient received a new liver although the patient had not been abstinent for the required six months and died a few days later.

More cases of confirmed data manipulation have been discovered since early October and on 26 October the Technical University hospital announced that it would stop accepting new liver patients. The current waiting list will remain valid with transplantations performed when donated livers are available.

Neither the hospital nor the Bavarian Science Ministry would provide details of the alleged manipulation or how many doctors might be involved. But the German press has reported that urine was mixed with blood samples of two liver patients to lower their test results to move them higher up waiting lists.

Tanja Schmidhofer, a hospital spokeswoman, told the BMJ that a task force had been named to conduct an “intensive investigation” of all liver transplantations during previous years. “As soon as the [investigation] results are available, we will publish them,” she said.

Some organ transplantation experts have suggested that the number of centres in Germany performing organ transplants should be reduced to reduce competition for patients and to simplify oversight. The state of Bavaria has seven organ transplant centres, including three in Munich and the one that is being investigated in Regensburg.

In late September the German Medical Association announced strict new guidelines for organ transplant hospitals, including on-site inspections by outside experts at least once every three years.

Kirste said that to win back the trust of potential donors all suspected manipulation cases in Germany must be thoroughly investigated and appropriate action taken in cases that are confirmed.

Foundation officials are “aghast” at the alleged data manipulation, he said, adding: “Such cases are inexcusable and must never be repeated.”

Notes

Cite this as: BMJ 2012;345:e7417

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