In 28 cases, the US Government determined, donors may still have been alive when organ retrieval began

Robert F. Kennedy jnr, US Secretary of Health and Human Services, has announced reforms to the nation’s organ transplant system. Photo / Marvin Joseph, the Washington Post

United States Health and Human Services Secretary Robert F. Kennedy jnr announced reforms to the nation’s organ transplant system today, citing recent findings that the process of removing organs has on some occasions begun even when donors showed signs of life.

The federally chartered non-profit groups known as organ procurement organisations (OPOs) that co-ordinate the donation process will face decertification if they fail to follow protocols that regulate when an organ can be extracted from a dead patient, according to a release from HHS.

The announcement, which comes ahead of a House hearing tomorrow on safety breaches in the organ donation system, stems from an HHS investigation into reports that workers for OPOs pressured doctors to start procuring kidneys, livers, and other organs from patients even as they showed signs of life.

It follows a report by the New York Times about such patients, including one who was presumed to be dead but whose heart was discovered to be beating after a surgeon made an incision in her chest for procurement surgery.

“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Kennedy said in a statement.

In a March report, HHS looked at 351 cases in which organ donation was authorised but not completed.

It found 103 cases with “concerning features, including 73 patients with neurological signs incompatible with organ donation”, according to Kennedy’s statement. At least 28 patients may not have been deceased when organ procurement was initiated, the statement said.

HHS also said it found evidence of “poor neurological assessments, lack of co-ordination with medical teams, questionable consent practices and misclassification of causes of death”.

Kennedy said OPOs will need to adopt a formal process allowing any staff member to halt a donation process if patient safety concerns arise.

They also will need to review any failures to follow protocols - including a requirement to wait five minutes after a patient is dead before making an incision - and develop clear policies around who is and isn’t eligible for organ donation.

The nation’s supply of organs - which falls far short of demand - has been boosted in recent years by the practice of removing organs from patients who have experienced “circulatory death”.

Such patients may still show brain activity but doctors have determined they are near death and won’t recover. With family consent, life support can be withdrawn and doctors then wait for the heart to stop beating.

Most organ donations are still from brain-dead patients, but OPOs in some cases have pressured doctors to move quickly in procuring organs in the short time frame required.

HHS launched its investigation after a House committee hearing in September, where the former employee of an OPO revealed that she, a surgeon and other workers refused to procure organs from a patient who was being prepared for surgery but was shaking his head and crying.

The procurement organisation, Network for Hope, is responsible for co-ordinating organ donation in Kentucky and parts of Ohio and West Virginia. Its officials were not immediately available for comment.