Americans generally do not spend much time thinking about the country’s blood supply.
This is mainly because the collection and distribution system is safe and efficient. But according to some hospital officials, there is a new challenge behind the scenes, who fear that changes in the way blood platelets are handled will increase costs – and in some cases, the number of transfusions needed to treat cancer patients, through trauma, and surgery. Those.
The concern revolves around the American Red Cross, the country’s single-largest blood products supplier, which will use an expensive technology to reduce the risk of exclusively dangerous bacterial spotted platelets. However, the move limits the hospital’s choice of less expensive testing options, which is also effective. “We are very concerned that the blood collection centers have decided what will be best for our patients when we are in the front row.” Dr. Aaron Tobian, director of the Department of Transfusion Medicine at Johns Hopkins Hospital.
His concerns have been echoed by some in Congress, including Rip. Earl “Buddy” Carter (R-Ga.), Who joined 12 other congressional Republicans in February, asked if anything could be done to sign a letter to the Department of Health and Human Services to increase hospital choice to comply with blood safety guidelines. .
“This has particularly affected rural hospitals, which have tight budgets,” he told KHN.
The Red Cross switch, which is expected to be fully implemented by next year, stems from the FDA’s recommendation to use one of three methods to reduce the risk of bacterial contamination of blood platelets by the end of 2020.
Under these recommendations, hospitals may purchase specially processed platelets to reduce pathogens, a procedure that is being pursued by the Red Cross and some other, smaller suppliers. Or blood centers may test a sample of each unit of platelets for bacterial contamination, at least 36 hours after blood collection. Another option is to use a quick test for bacteria shortly before platelet transfer, which occurs in addition to initial screening for bacteria after collection.
The FDA did not rank the options. And many hospitals and blood centers have already recruited one or more of them. No test or process is 100% effective.
“Each of these methods has pluses and minuses,” said Dr. Claudia Cohen, chief medical officer of the nonprofit Association for the Advancement of Blood and Biotherapy, which represents healthcare providers involved in transfusion medicine. He is also Professor of Laboratory Medicine and Pathology at the University of Minnesota.
Because the FDA provides guidelines because platelet transfusion is associated with a higher risk of sepsis and death than other blood components, some studies have estimated the risk of serious infection in 1 in 10,000 people. Platelet transfusion is important for the prevention or treatment of hemorrhage in some patients, such as those with certain types of cancer, those who have had a trauma accident, or are undergoing surgery, which can lead to significant blood loss.
The Red Cross, which collects about 1 million units of platelets annually, chooses processing methods that reduce pathogens, the most expensive option, adding about $ 150 more per unit to hospital costs for platelets. This excludes the use of the lowest-cost option, a $ 25 rapid test made by Verax Biomedical, as that test is not approved by the FDA for use on those processed platelets. Other testing methods add about $ 83 per unit.
The Red Cross, which collects and distributes about 40% of the country’s total blood supply, signed a five-year agreement in April with California-based Ceres Corporation, which provides synthetic compounds and ultraviolet light used to process platelets. Approved in 2014, it remains the only such system to be sold in the United States
Platelets are already one of the most expensive blood products with an average price of $ 500 per unit.
The pathogen reduction could translate into an additional six-figure annual cost to small hospitals, and the “$ 1.5 million to $ 3 million” that large academic medical centers spend on platelets each year, Tobian said, based on a research paper he co-authored.
Some of this may be paid to patients – if they pay a percentage of their treatment costs, for example, or at a higher insurance premium.
But the hospitals may have to bear some extra cost.
The financial impact on the Red Cross and other blood suppliers is unclear. Blood donors are cutting back on grants and operating at thin margins, although platelets are one of their most lucrative products. Pathogen reduction allows the Red Cross to charge more for platelets, but it must buy processing systems from the best.
In its most recent IRS filing, covering the fiscal year ending June 30, 2021, the Red Cross stated that its “biomedical services” brought in $ 1.89 billion in revenue, but cost $ 1.83 billion, a difference of $ 49 million.
Red Cross spokesman General Eli said in an email that it was “not a revenue figure” but would not provide further details. In some years, Red Cross spending has surpassed revenue, he wrote, and in others, the opposite is true.
He did not elaborate on the cost of purchasing the system from Serus, whose chief medical officer joined the company after holding the same position at the Red Cross.
Pathogen-depleted platelets, where a higher advance cost is required, are a good value for the hospital because they reduce the risk of bacteria “mitigating other pathogen threats such as parasites, viruses and even pathogens we do not yet know,” wrote Jessa Merrill, American Red. Communications Director of Cross Biomedical Services, in a separate email. It is a “ready-to-use product that does not require any testing or further manipulation.”
Hospitals say other testing methods described by the FDA have advantages, including longer durations for platelets. Platelets tested for bacteria can be used for up to seven days, compared to the five-day life of processed platelets.
Kazem Shirazi, a technical specialist in transfusion services at George Washington Hospital in Washington, D.C., said: Hand supply in emergency room.
Shirazi said reducing the time limit for buying platelets from his hospital’s Red Cross meant “we waste more.”
Patients may not know which method is used to obtain platelets, although research suggests that the more expensive option may sometimes increase the amount of product needed.
This process is useful for killing pathogens, but also “creates a platelet that doesn’t do its job,” Cohen said.
A meta-analysis of 12 studies of cancer patients receiving pathogen-reduced platelets found no risk of death or bleeding. However, it does show an increase in the “number of transfers required”.
And that’s a problem. Tobian of Johns Hopkins said that physicians want to keep the number of transfusions to a minimum: “The safest transfusion is the one that can be avoided.”
Another concern raised by Rep. Carter during the April 27 hearing of the House Energy and Commerce Committee was security. He mentioned three cases of platelet-associated sepsis since 2019. Those platelets were processed in a pathogen-reducing manner, the FDA said in a December memorandum.
But Red Cross spokeswoman Meryl Carter rejected the example, saying the incidents were “not due to a failure of pathogen reduction / deactivation, but to a post-production problem.”
Some platelet contamination – both processed and tested platelets – may involve minor leaks or other damage to storage containers, according to a study published last year in the journal Transfusion. The two Cerus employees were among the writers.
The approach to the processing method may depend on the size of the hospital. Smaller hospitals, which do not have trauma centers or larger cancer programs, use far fewer platelets per year than large academic centers, which may require 10,000 or more units annually. “Smaller centers prefer pathogen-reducing platelets because they don’t have to bother with it and it’s easier and safer to use,” Cohen said.
But academic hospitals, which do a lot of transfusions, are “really frustrated,” he said. “If their blood suppliers are willing to make only one kind of offer, they are interrupted.”
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