Criteria of transplantation medicine: the great liver failure.

The scandal surrounding the allocation of donor livers should be addressed. But the audit report is sloppy, contradictory and arbitrary.

Dialysis patients have a special position in the complicated points system for organ allocation. Picture: dpa

Cameramen jockeyed for position, journalists lined up down the aisle, OB vans waited down the street. Rarely has a press conference in the rooms of the German Medical Association in Berlin attracted so much public interest as the one on September 4, 2013, which was to be about the livers and the scandal once again, for the last time.

Faith in justice in transplant medicine had been lost the year before. There had been allegations of manipulation at several university hospitals. Doctors were accused of deliberately disregarding the guidelines of the German Medical Association on the allocation of donor organs in order to favor their own patients in the allocation process. To this end, they made false statements to the organ procurement agency Eurotransplant, for example regarding their patients’ alcohol consumption, their need for dialysis or the size of their liver cancer tumors.

These are parameters that influence the chances of finding a donor liver. And this in an area of medicine where the scarcity of resources makes it a matter of life or death. But now, the medical president promised, things are looking up: "Transplant medicine," said Frank Ulrich Montgomery, "is safer today than it has ever been."

But it is precisely this that now, six months later, there are doubts among physicians and lawyers. They are directed against the inspectors of the "Examination and Monitoring Commissions", or PuK for short, the very inspectors that Montgomery’s German Medical Association, together with the National Association of Health Insurance Funds and the German Hospital Association, had sent out in the months before. The PuK auditors, including doctors, lawyers and representatives of state ministries, were to examine all 24 German liver transplant centers for irregularities in the allocation of organs in 20. But how objective, how reliable, how credible is the auditors’ verdict?

A counter opinion

First things first. On September 4, the inspectors presented their final report in Berlin. The results confirmed what had been suspected anyway, and perhaps that is why no one initially questioned what was being presented: Of 24 centers, 20 had violated the guidelines of the German Medical Association, and of these, again four centers, according to the audit report, "systematically" and "seriously." Namely, these were the university hospitals of Gottingen, Leipzig, Munich – Rechts der Isar and Munster.

From then on, they were regarded as the villains of their guild. In Regensburg, systematic violations had also been discovered previously, but long before the 2010/2011 investigation period. "Audit and monitoring commissions," praised the physician president, "are swiftly working control bodies that meet the requirements of the complex field in terms of expertise, content and law."

Really? Norbert Roeder, Medical Director of Munster University Hospital (UKM) and head of one of the four clinics that have fallen into disrepute, is the first to publicly voice criticism of the commission: "We emphatically reject the statement that ‘systematic violations of guidelines’ occurred at UKM," Roeder told the taz newspaper. The expression suggests "a methodical and planned approach in the knowledge and with the intention of deliberately violating relevant regulations." Such a conclusion could not be drawn, however, "also on the basis of the facts presented in the report." Of the 25 cases objected to in Munster, Roeder wants to recognize 9 as violations of the guideline; however, these were due to documentation and communication problems, not systematic or intentional.

The guidelines for maintaining the waiting list and for organ allocation are formulated by the Standing Commission on Organ Transplantation (StaKO) of the German Medical Association. Its 18 members are each appointed for four years by the Board of the German Medical Association. Parliament and the government have little say in the closed expert committee; according to the statute, a single member is appointed at the suggestion of the Conference of Health Ministers of the Lander; all others come from interest-driven organizations, such as the German Transplantation Society, the German Foundation for Organ Transplantation, the Eurotransplant Foundation, the health insurance funds or patient groups. As a consequence of the organ scandal, the legislature insists that in future the guidelines must at least be approved by the Federal Ministry of Health before they come into force. This was not the case before.

Roeder bases his criticism – also – on a legal opinion by Thomas Gutmann, a law professor from Munster, commissioned by the clinic. In 45 pages, Gutmann meticulously analyzes all of the review board’s assessments of Munster, characterizing most of them as "absurd," some he calls "fictitious." "The rationale of the audit report suffers from serious deficiencies," he writes. "The relevant guidelines are misinterpreted in a way that is hardly understandable." Gutmann has been one of the high-profile legal experts on transplant medicine for 20 years; a favorable opinion is considered impossible in expert circles.

According to Gutmann, the commissions used "non-guideline material" to substantiate the central accusations, which had no normative quality whatsoever. And: "The commissions disregarded essential evidence on the state of the art of medical science and also systematically and sustainably closed their minds to almost all facts that would have proven that the main accusations are unfounded.

Double standards?

The suspicion is considerable: Did the Commission apply double standards in its assessment of Munster University Hospital – and possibly in the assessment of other centers as well? Did it exceed its mandate – to verify compliance with the guideline? Did it use documents other than the guideline itself as a standard for evaluation, or did it interpret things into the guideline that are not even there? Did all of this lead to individual centers possibly being unjustly outed as "systematic" falsifiers and losing their reputation, while other hospitals got off lightly? And, and this is perhaps the central question, one of the positive consequences of the organ scandal could be to answer it: Are the guidelines for organ allocation still up to date? Do they reflect the current state of science – and can they reflect the reality of transplantation in this country?

According to Roeder, the head of the clinic, he himself has experienced how the examiners in Munster have "differently assessed identical patients" with, for example, cancerous tumors in the liver. Sometimes, for one and the same patient, a certain tumor size was first evaluated as conforming to the guidelines for listing for transplantation, then suddenly as an exclusion criterion. This is surprising, since the regulations of the guideline are clear; they are supposed to show at which stage of cancer a transplantation is reasonable, i.e. promising: According to the guideline, patients are considered transplantable if they either have a single tumor between 2 and 5 centimeters in size. Or they have up to three tumors, each smaller than 3 centimeters.

The sense and nonsense of these rigid values is debatable. However, they are part of the guideline – and only their compliance should be checked by the commission. However, the auditors also identified violations of the rules when patients with up to three tumors, each smaller than 1 centimeter, were scheduled for transplantation. The underlying assumption – controversial among physicians – is that nodules of such size cannot be clearly identified as tumors with the imaging methods currently available. Consequently, the necessity of transplantation is doubtful.

The guideline itself, however, as stated, does not specify a lower limit on tumor size. The commission based its decision to nevertheless identify guideline violations on, among other things, "internationally accepted guidelines on HCC" (hepatocellular carcinoma, editor’s note). These guidelines date from 2012 and are purely recommendatory in nature. They have nothing to do with the national directives, which have a law-like function. Already at this point, the argumentation that this is a violation of the guidelines is flawed.

In order to detect and sanction any violations, the German Medical Association, the National Association of Statutory Health Insurance Funds and the German Hospital Association formed a monitoring commission and an audit commission at the German Medical Association in 2001. The Monitoring Commission is active in the event of anomalies in organ donation, while the Audit Commission in the event of irregularities in organ allocation. The committees are not democratically legitimized. In the last term of office, all members of the Supervisory Commission were also members of the Audit Commission. Also striking are the numerous dual memberships between the StaKO – which sets the guidelines – and the audit commission – which monitors compliance. Commission meetings are not public, and deliberations are confidential. If the commissions find violations of the Transplantation Act or the guidelines, they cannot punish them themselves. Rather, they must report them to the relevant state authorities or public prosecutors.

The criteria are not clearly defined

The commissions left questions about this unanswered, as did another 21 questions from the taz about the audit report. Instead, their chairmen, Anne-Gret Rinder and Hans Lippert, informed taz in a letter dated February 27, 2014: "With regard to your list of questions, we would like to refer you to the 2012/2013 commission report and the enclosed individual reports, which provide a conclusive answer to your questions. […] In view of this, a further explanation of the report with the attached individual reports is not required."

The University Hospital of Munster sees things differently. Because also the comparability of the evaluations of the centers among themselves does not stand scientifically objectifiable criteria, criticizes the medical director Roeder. "In comparable circumstances", for example in patients who received one of the – similarly functioning – combined liver and kidney dialyses called Prometheus, Mars or albumin dialysis to support therapy, the commission had come to "different results", for example in Kiel, Munster and Rechts der Isar in Munich.

In fact, in its audit report on the liver center in Kiel, the commission recognizes a "violation of guidelines" because the physicians reported the Prometheus combined dialysis procedure they used to Eurotransplant as dialysis. In Munster, meanwhile, the commission considers the classification of the Mars procedure as dialysis to be a "systematic violation of the guidelines. At the Rechts der Isar in Munich, on the other hand, where a patient was treated with albumin dialysis, the commission concludes: "In this case, however, the dialysis report cannot be considered a guideline violation because of ambiguous regulations in the guidelines themselves."

Commission turns a deaf ear

The Commission is unable to clarify these contradictions. Instead, it recommends that people read its report more carefully: "For example, the testing scheme of the liver tests is presented in each of the individual reports." In fact, the audit report states that "each transplant center was audited according to a scheme defined by the audit commission and the monitoring commission, based on uniform criteria."

However, the report leaves the definition of these "uniform criteria" open. It provides no information about which facts had to be fulfilled for the Commission to classify an incident as a "conspicuousness," an "unintentional error," a "violation of guidelines," a "systematic violation of guidelines," a "serious violation of guidelines," a "deliberate disregard," a "systematic disregard," a "systematic or deliberate misrepresentation," or "manipulation. This circumstance, criticizes also the expert Gutmann, makes it impossible for non-commission members to understand why which center was evaluated and how.

Much has gone wrong in the allocation of organs. Image: imago/Jochen Tack

But that is exactly what is needed. For many centers, it was the assessment of the dialyses that determined whether or not the violations found were systematic.

Which type of dialysis?

The background: Dialysis patients were originally targeted by the auditors because they have a special position in the complicated points system for organ allocation. The reason for this is that patients who are so severely ill that their kidneys are damaged in addition to their liver are quickly moved up the waiting list, which considerably increases their chances of receiving a transplant.

Some centers – Leipzig, for example – had declared many of their patients to be dialysis patients to the organ allocation agency Eurotransplant, even though they had never received blood washing. Munster also had a handful of such cases. However, the auditors and the center itself attributed these cases more to medical sloppiness and inaccuracies in documentation. So far, so understandable.

In addition, however, the physicians in Munster had performed so-called Mars dialyses on some patients. And it is precisely these therapies – which actually took place – and their declaration as dialyses that are now their undoing: paradoxically, they are the reason why the violations in Munster were judged to be "systematic". Why?

"Medicine is not an exact science"

Mars dialyses – unlike classic kidney blood washes – are combined, innovative blood cleansing procedures that rid both the liver and the kidney of toxins. The review board, however, objected to them on three grounds. First, kidney dialysis should not have been used at all in the patients in question. To put it simply, the patients’ laboratory values were not so bad that they needed dialysis. The Commission came to this conclusion on the basis of medical records reviewed after the fact – in the opinion of Munster Hospital, disregarding the state of medical knowledge in this field.

Secondly, according to the Commission, the Mars dialyses should never have been reported to Eurotransplant as dialyses. Only "kidney replacement procedures" may be reported as dialyses. The Mars dialyses, however, were, thirdly, not kidney replacement procedures. The head of the Transplantation Medicine Office at the German Medical Association, Claus-Dieter Middel, specified to the site: "The guidelines for waiting list management and organ procurement for liver transplantation exclude Mars therapy as […] kidney dialysis therapy, unless kidney failure is present."

However, legal expert Thomas Gutmann also considers this argumentation to be "absurd". Firstly, the organ allocation agency Eurotransplant had for years accepted the report of the Mars patients from Munster as "dialysis patients" without any objections – even though Eurotransplant would have had a legal obligation to consult with the clinic in the event of any non-plausibility of the data.

On the other hand, the guidelines on liver transplantation do not contain any information on when dialysis is or is not indicated for patients with liver disease. For good reason: "Medicine is not an exact science; every patient is different. In general, it is difficult to state with certainty that one therapy option among several possible ones was completely ruled out," explains Andreas Kribben, member of the board of the German Society of Nephrology.

The commission still has no answers

According to Rostock University Professor Steffen Mitzner, head of the Department of Renal Medicine, the following is especially true for people with liver disease: "There are no controlled studies of liver patients on the question of the most suitable renal replacement procedure."

Moreover, the guideline on organ placement does not distinguish between conventional dialysis and albumin dialysis, the Mars or Prometheus procedures. At no point does it specify which type of dialysis may or may not be considered a renal replacement procedure. And it makes no mention of the fact that only "kidney replacement procedures" may be reported to Eurotransplant as dialysis. Instead, the guideline contains a single, thin sentence on the highly complex topic of dialysis. It reads that "in dialysis patients" the creatinine value, which is a blood value indicating kidney dysfunction, is automatically "set at 4 mg/dl." Such an elevated value, simply put, is supposed to reflect the patient’s urgency. That’s all it says.

Why, nevertheless, has the argument that these are systematic violations been maintained unchanged since September 2013? And if there are so many ambiguities in Munster alone, shouldn’t the audit results at the other centers also be verified? The audit commission still has no answers to this question.

Claus-Dieter Middel, head of the Transplantation Medicine Office at the German Medical Association, says: "A closed meeting of the Standing Commission on Organ Transplantation was held in Berlin on November , 2013, to scientifically review the results of the audits of the liver transplantation programs. Within this framework, there was, among other things, a technical exchange with representatives of Munster University Hospital. The Standing Commission on Organ Transplantation confirmed the opinion of the Review Commission and the Monitoring Commission." This is not surprising: the overlap in personnel between the Standing Commission on Organ Transplantation, which issues the guidelines, and the Review Commission, which monitors compliance with them, is considerable.

Inquisitorial appearance

Medical Director Norbert Roeder says, "It was certainly a difficult task for the commission to achieve results under time pressure from the public and politicians. Nevertheless, we would have welcomed a documented technical discussion with all parties involved, especially in those cases where the different interpretations are due to what we consider to be ambiguous guidelines." But it does not look like that will happen in the future either. The inspectors commissioned by the German Medical Association, the health insurance funds and the hospital association have long been on the road elsewhere: they are currently checking transplant clinics for irregularities in hearts and kidneys.

A doctor who witnessed one of the numerous visits subsequently expressed his indignation to the site: "The Inquisition was nothing compared to that. Several hours in the ‘hot seat’. The guidelines are a joke. Hardly compatible with life in the current situation. Once again, the competencies of the examination board were exceeded, and we had to justify ourselves before a former judge and a lawyer for the medical indication for this or that medical measure. That was quite an experience, especially since the ladies were completely blank medically."

The results are expected later this year. They, too, are to be made known to the public – as an audit report.

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