Americans don’t usually spend much time thinking about the nation’s blood supply.
This is mainly because the collection and distribution system is safe and efficient. But there’s a new behind-the-scenes problem, according to some hospital officials, who fear that changing the way platelets are handled will dramatically increase the cost – and in some cases the number of transfusions needed – to treat cancer patients. injured and undergoing surgery.
The concern revolves around the American Red Cross, the country’s largest provider of blood products, which will use extremely expensive technology to reduce the risk of platelet contamination by dangerous bacteria. But the move limits hospitals from choosing less expensive testing options that are also effective. “We are very concerned that blood collection centers have decided what is best for our patients when we are on the front lines,” he said. Dr. Aaron TobianDirector of Transfusion Medicine at Johns Hopkins Hospital.
His concerns are shared by some in Congress, including Rep. Earl “Buddy” Carter (R-GA), who in February joined 12 other Republicans in Congress in signing a letter to the Department of Health and Human Services asking if something could be done to expand the choice of hospitals in line with blood safety guidelines.
“This has particularly affected rural hospitals,” which are on a tight budget, he told KHN.
The Red Cross transition, which is expected to be fully implemented by next year, is linked to an FDA recommendation in late 2020 to use any of the three methods to reduce the risk of platelet bacterial contamination.
Under these guidelines, hospitals can purchase platelets specially treated to reduce pathogens, which is the method the Red Cross and some other smaller vendors are aiming for. Or, blood centers can test samples of each unit of platelets for bacterial contamination at least 36 hours after blood is drawn. Another option is to use a rapid bacterial test shortly before platelet transfusion, which is done in addition to the initial post-collection bacterial screening.
The FDA has not ranked the options. And many hospitals and blood centers already use one or more of them. No test or process is 100% effective.
“Each of these methods has pros and cons,” said Dr. Claudia Cohn, Chief Medical Officer for the non-profit Association for the Advancement of Blood Transfusion and Biotherapy, which represents healthcare providers involved in transfusion medicine. She is also a professor of laboratory medicine and pathology at the University of Minnesota.
FDA offered guidance because platelet transfusions are associated with a higher risk of sepsis and death than any other blood component, with some studies putting the chance of a serious infection at 1 in 10,000. Platelet transfusions are important to prevent or treat bleeding in some patients, such as patients with certain types of cancer, injured in accidents or undergoing surgery that can lead to a lot of blood loss.
The Red Cross, which annually collects about 1 million units of platelets, has chosen a process that reduces the number of pathogens, the most expensive option, adding about $150 more per unit to hospital costs for platelets. This precludes the use of the cheapest alternative, the $25 rapid test made by Verax Biomedical, because the test is not FDA approved for use on these processed platelets. Another testing method adds about $83 per unit.
The Red Cross, which collects and distributes about 40% of the nation’s total blood supply, signed a five-year deal in April with California-based Cerus Corp., which supplies the synthetic compound and ultraviolet illuminator used to process platelets. Approved in 2014, it remains the only such system sold in the US.
Platelets are already one of the most expensive blood products, with an average unit price of $500.
Reducing pathogens could result in a six-figure extra cost to small hospitals’ annual spending and “$1.5 million to $3 million” to what large academic medical centers spend each year on platelets, Tobian said, based on the analysis. research he was a co-author.
Some of this could be passed on to patients – for example, if they pay a percentage of the cost of treatment or higher insurance premiums.
But hospitals may also have to shoulder some of the extra costs.
The financial implications for the Red Cross and other blood providers are unclear. Organizations that supply blood are seeing a decrease in donations and are operating on a small margin, although platelets tend to be one of their most profitable products. The reduction in pathogens allows the Red Cross to charge higher fees for platelets, but it must also buy the processing system from Cerus.
In their latest IRS filingsCovering the fiscal year ending June 30, 2021, the Red Cross said its “biomedical services” generated $1.89 billion in revenue but cost $1.83 billion, a $49 million difference.
Red Cross spokeswoman Janelle Ely said in an email that it was “not a revenue number” but did not provide more details. She wrote that in some years, the Red Cross’s spending exceeded its income, and in others it was the other way around.
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She also did not provide details about the cost of buying the system from Cerus, whose chief medical officer joined the company after holding a similar position with the Red Cross.
Pathogen-reduced platelets, while requiring a higher upfront cost, represent a better value for hospitals because they reduce bacterial risk “and also mitigate other pathogen threats such as parasites, viruses, and even pathogens that we might we don’t know yet.” written by Jessa Merrill, Director of Communications for Biomedical Services, American Red Cross, in a separate email. It is a “ready-to-use product that does not require testing or further manipulation.”
Hospitals say other testing methods described by the FDA also have benefits, including longer platelet shelf life. Platelets tested for bacteria can be used for up to seven days compared to five days for processed platelets.
“We have to be very efficient,” said Kazem Shirazi, a blood transfusion service technician at George Washington Hospital in Washington, D.C., who spends part of his day juggling surgeons’ requests for supplies in operating rooms with the need to have on hand in the ward emergency care.
Shorter lead times for the platelets his hospital buys from the Red Cross means “we end up spending more,” Shirazi said.
Patients will probably not know which method is being used to obtain platelets, although studies show that the more expensive option can sometimes increase the amount needed.
The process is useful for killing pathogens, but it also “creates platelets that don’t do their job either,” Cohn said.
Meta-analysis of 12 studies of cancer patients treated with pathogen-reduced platelets found no increased risk of death or bleeding. However, he showed an increase in “the number of transfusions needed.”
And that’s the problem. Tobian of Johns Hopkins University said doctors like to keep transfusions to a minimum: “The safest transfusion is the one that can be avoided.”
Security was another issue raised by Rep. Carter during the April 27 House meeting. Energy and Trade Committee hearing. He mentioned three cases of platelet-related sepsis since 2019. These platelets were treated with a pathogen reduction method, the FDA said in a statement. December memorandum.
But Red Cross spokesman Merrill dismissed Carter’s example, saying these cases “were not related to failure in pathogen reduction/inactivation, but to a post-production problem.”
Some cases of platelet contamination—both in processed and tested platelets—may involve tiny leaks or other damage to storage containers. proposed an article published last year in Transfusion magazine. Among the authors were two employees of Cerus.
The type of treatment method may depend on the size of the hospital. Small hospitals that do not have trauma centers or large cancer programs use far fewer platelets each year than large academic centers that may need 10,000 or more units per year. “Small centers love pathogen-reduced platelets because they don’t have to fiddle with them and they’re easy and safe to use,” Cohn said.
But academic hospitals, which do a lot of transfusions, are “really disappointed,” she said. “If their blood providers are only willing to offer one kind, they are limited.”
Kaiser Health News is a national health policy news service. This is an editorial independent program of the Henry J. Kaiser Family Foundation and not affiliated with Kaiser Permanente.