Latest news with #healthcare reform
South China Morning Post
a day ago
- Health
- South China Morning Post
US begins organ-transplant reform as ‘signs of life' found before some retrievals
The US Department of Health and Human Services (HHS) has launched a reform of the organ-transplant system and threatened to close a major procurement body after a probe found premature attempts to start organ retrieval while patients showed signs of life. The investigation conducted by the Health Resources and Services Administration (HRSA), a division of HHS, examined 351 cases where organ donation was authorised but not completed. It found 73 patients had shown neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time organ procurement was initiated, the HHS said in a statement on Monday. The probe also found evidence of poor neurologic assessments, questionable consent practices, and misclassification of causes of death in several cases, the agency said.
CNN
a day ago
- Health
- CNN
HHS says it will begin reforms of organ donation system after federal investigation finds ‘horrifying' problems
The US Department of Health and Human Services said Monday that it's undertaking an initiative to reform the country's organ donation system, after a federal investigation found that one organization in the Kentucky region began the process to take organs from people who may not have been dead. A House subcommittee is holding a hearing Tuesday on organ donation safety lapses and how procurement and transplant organizations intend to improve the system, to regain the trust of donors and their families. That trust is essential because the US organ donation system relies on people to volunteer to donate, often when they get a driver's license. As of 2022, about 170 million people in the US have signed up to donate their organs when they die, but there is always more demand for organs than what is available. Last year, there were more than 48,000 transplants in the US, but more than 103,000 people were on waiting lists. About 13 people in the United States die every day waiting for a transplant, according to the federal Health Resources and Services Administration. HHS says the reform initiative was launched after an investigation by the Health Resources and Services Administration found problems with dozens of cases involving incomplete donations – when an organization started the process to take someone's organs but, for some reason, the donation never happened. According to a report on the federal investigation, as well as a memo prepared ahead of the House subcommittee hearing, the cases were managed by Kentucky Organ Donor Affiliates, a procurement organization that handles donations in Kentucky and parts of Ohio and West Virginia, which has merged with another group and is now called Network for Hope. Of the 351 cases in the investigation, more than 100 had 'concerning features, including 73 patients with neurological signs incompatible with organ donation,' HHS said in a news release Monday. At least 28 cases involved patients who may not have been deceased at the time the organ procurement process began, raising 'serious ethical and legal questions.' 'Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,' HHS Secretary Robert F. Kennedy Jr. said in the release. 'The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor's life is treated with the sanctity it deserves.' Network for Hope has not responded to CNN's request for comment, but it says on its website that it is 'fully committed to transparency' and is in full compliance with all requirements of the Centers for Medicare & Medicaid Services, which regulates organ donation organizations. 'Our goal has always been and will remain to meet the highest ethical and medical standards in donation and transplantation.' The investigation found patterns such as failures to follow professional best practices, to respect family wishes, to collaborate with a patient's primary medical team, and to recognize neurological function, suggesting 'organizational dysfunction and poor quality and safety assurance culture' in the Kentucky-area organization, according to a report from the Health Resources and Services Administration. The investigation also found that the Kentucky-area organization and the Organ Procurement and Transplantation Network, which oversees the local groups, failed to 'adequately recognize and respond to poor patient care and quality practices,' the report says. The organ procurement organization in Kentucky is one of 55 in the US, and since the federal review, the Health Resources and Services Administration said, it has received reports of 'similar patterns' of high-risk procurement practices at other organizations. The agency is mandating system-level changes to safeguard potential organ donors across the US and said the Kentucky-area organization needed to conduct a 'full root cause analysis of its failures to follow internal protocols.' It also said the organization must adopt a formal procedure to halt a donation process if there are safety concerns. Network for Hope says on its website: 'We are equally committed to addressing the recent guidance from the HRSA and we are already evaluating whether any updates to our current practices are needed.' The federal investigation was launched after one case in Kentucky came to light during a congressional hearing in September. In 2021, 33-year-old TJ Hoover was hospitalized after a drug overdose. He woke up in the operating room to find people shaving his chest, bathing his body in surgical solution and talking about harvesting his organs. Earlier that day, a doctor had declared him brain-dead, according to his medical records, even though he seemed to be reacting to stimuli, making eye contact and shaking his head. Former staffers of the organ procurement organization who were involved in Hoover's case raised concerns that he wasn't brain-dead and should not have been on the operating table. The concerns were ignored, according to the federal investigation. Staff told CNN that the procedure to take Hoover's organs stopped after a surgeon saw his reaction to stimuli. The Kentucky procurement organization told CNN last fall that it had reviewed the case and 'remains confident that accepted practices and approved protocols were followed.' Hoover now lives with his sister in Richmond, Kentucky, and is undergoing extensive physical therapy and treatment, much of which is shared on TikTok in an effort to inspire others. Congress has been investigating the nation's organ donation system for years. Tuesday's hearing is intended to determine what lessons could be learned from the investigation, what changes are necessary to make the system better and what challenges lie ahead. One issue involves organs procured from patients who aren't brain-dead. Although most donations in the US come from people who are brain-dead, there are other circumstances in which a patient may become an organ donor. It's called donation after circulatory death, or DCD, and it has become much more common in recent years, although some experts question the ethics of the practice. A donation after brain death is defined by the Organ Procurement and Transplantation Network as 'the organ recovery process that may occur following death by irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses.' DCD, by comparison, is when 'you've got somebody with essentially devastating illness or injury, and their family's decided to withdraw life support,' Dr. Robert Cannon, an associate professor of surgery and surgical director of the liver transplant program at the University of Alabama at Birmingham, told CNN last year after Hoover's case came to light. Cannon was not involved in Hoover's case but was familiar with it because he testified about lapses in the organ procurement system at the House Energy and Commerce Oversight and Investigations Subcommittee hearing where the case came to light in September. 'Certainly, we have potential DCD donors with lots of reflexes,' Cannon said. 'But as long as the family knows this is what's happening with their loved one, this process is considered ethical and standard.'
CNN
a day ago
- Health
- CNN
HHS says it will begin reforms of organ donation system after federal investigation finds ‘horrifying' problems
Federal agenciesFacebookTweetLink Follow The US Department of Health and Human Services said Monday that it's undertaking an initiative to reform the country's organ donation system, after a federal investigation found that one organization in the Kentucky region began the process to take organs from people who may not have been dead. A House subcommittee is holding a hearing Tuesday on organ donation safety lapses and how procurement and transplant organizations intend to improve the system, to regain the trust of donors and their families. That trust is essential because the US organ donation system relies on people to volunteer to donate, often when they get a driver's license. As of 2022, about 170 million people in the US have signed up to donate their organs when they die, but there is always more demand for organs than what is available. Last year, there were more than 48,000 transplants in the US, but more than 103,000 people were on waiting lists. About 13 people in the United States die every day waiting for a transplant, according to the federal Health Resources and Services Administration. HHS says the reform initiative was launched after an investigation by the Health Resources and Services Administration found problems with dozens of cases involving incomplete donations – when an organization started the process to take someone's organs but, for some reason, the donation never happened. According to a report on the federal investigation, as well as a memo prepared ahead of the House subcommittee hearing, the cases were managed by Kentucky Organ Donor Affiliates, a procurement organization that handles donations in Kentucky and parts of Ohio and West Virginia, which has merged with another group and is now called Network for Hope. Of the 351 cases in the investigation, more than 100 had 'concerning features, including 73 patients with neurological signs incompatible with organ donation,' HHS said in a news release Monday. At least 28 cases involved patients who may not have been deceased at the time the organ procurement process began, raising 'serious ethical and legal questions.' 'Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,' HHS Secretary Robert F. Kennedy Jr. said in the release. 'The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor's life is treated with the sanctity it deserves.' Network for Hope has not responded to CNN's request for comment, but it says on its website that it is 'fully committed to transparency' and is in full compliance with all requirements of the Centers for Medicare & Medicaid Services, which regulates organ donation organizations. 'Our goal has always been and will remain to meet the highest ethical and medical standards in donation and transplantation.' The investigation found patterns such as failures to follow professional best practices, to respect family wishes, to collaborate with a patient's primary medical team, and to recognize neurological function, suggesting 'organizational dysfunction and poor quality and safety assurance culture' in the Kentucky-area organization, according to a report from the Health Resources and Services Administration. The investigation also found that the Kentucky-area organization and the Organ Procurement and Transplantation Network, which oversees the local groups, failed to 'adequately recognize and respond to poor patient care and quality practices,' the report says. The organ procurement organization in Kentucky is one of 55 in the US, and since the federal review, the Health Resources and Services Administration said, it has received reports of 'similar patterns' of high-risk procurement practices at other organizations. The agency is mandating system-level changes to safeguard potential organ donors across the US and said the Kentucky-area organization needed to conduct a 'full root cause analysis of its failures to follow internal protocols.' It also said the organization must adopt a formal procedure to halt a donation process if there are safety concerns. Network for Hope says on its website: 'We are equally committed to addressing the recent guidance from the HRSA and we are already evaluating whether any updates to our current practices are needed.' The federal investigation was launched after one case in Kentucky came to light during a congressional hearing in September. In 2021, 33-year-old TJ Hoover was hospitalized after a drug overdose. He woke up in the operating room to find people shaving his chest, bathing his body in surgical solution and talking about harvesting his organs. Earlier that day, a doctor had declared him brain-dead, according to his medical records, even though he seemed to be reacting to stimuli, making eye contact and shaking his head. Former staffers of the organ procurement organization who were involved in Hoover's case raised concerns that he wasn't brain-dead and should not have been on the operating table. The concerns were ignored, according to the federal investigation. Staff told CNN that the procedure to take Hoover's organs stopped after a surgeon saw his reaction to stimuli. The Kentucky procurement organization told CNN last fall that it had reviewed the case and 'remains confident that accepted practices and approved protocols were followed.' Hoover now lives with his sister in Richmond, Kentucky, and is undergoing extensive physical therapy and treatment, much of which is shared on TikTok in an effort to inspire others. Congress has been investigating the nation's organ donation system for years. Tuesday's hearing is intended to determine what lessons could be learned from the investigation, what changes are necessary to make the system better and what challenges lie ahead. One issue involves organs procured from patients who aren't brain-dead. Although most donations in the US come from people who are brain-dead, there are other circumstances in which a patient may become an organ donor. It's called donation after circulatory death, or DCD, and it has become much more common in recent years, although some experts question the ethics of the practice. A donation after brain death is defined by the Organ Procurement and Transplantation Network as 'the organ recovery process that may occur following death by irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses.' DCD, by comparison, is when 'you've got somebody with essentially devastating illness or injury, and their family's decided to withdraw life support,' Dr. Robert Cannon, an associate professor of surgery and surgical director of the liver transplant program at the University of Alabama at Birmingham, told CNN last year after Hoover's case came to light. Cannon was not involved in Hoover's case but was familiar with it because he testified about lapses in the organ procurement system at the House Energy and Commerce Oversight and Investigations Subcommittee hearing where the case came to light in September. 'Certainly, we have potential DCD donors with lots of reflexes,' Cannon said. 'But as long as the family knows this is what's happening with their loved one, this process is considered ethical and standard.'
Washington Post
2 days ago
- Health
- Washington Post
Organ retrieval reforms ordered after some donors showed 'signs of life'
Health and Human Services Secretary Robert F. Kennedy Jr. announced reforms to the nation's organ transplant system Monday, citing recent findings that the process of removing organs has on some occasions begun even when donors showed signs of life. The federally chartered nonprofit groups known as organ procurement organizations (OPOs) that coordinate 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 Tuesday morning 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 Sunday 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 authorized 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 coordination 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 organization, Network for Hope, is responsible for coordinating organ donation in Kentucky and parts of Ohio and West Virginia. Its officials were not immediately available for comment.
