User login
FDA clears new blood typing, screening instrument
The Food and Drug Administration has granted marketing clearance for the immunohematology instrument NEO Iris.
NEO Iris is a fully automated blood bank instrument designed for the mid- to high-volume laboratory, according to Immucor, the company marketing the device. Immucor says NEO Iris provides the highest type and screen throughput on the market – up to 60 types and screens per hour.
NEO Iris performs ABO/Rh D typing, weak D testing, donor confirmation, cytomegalovirus screening, immunoglobulin G direct antiglobulin test and crossmatch, and antibody identification and screening.
The workflow management tool on Neo Iris has STAT priority and allows operators to run tests in any order at any time, according to Immucor.
The company says NEO Iris can hold up to 224 samples, and “modules can pipette, incubate, centrifuge, and read simultaneously.” NEO Iris integrates with Immucor’s data management software, ImmuLINK, to aggregate test results and produce reports with complete testing history.
The Food and Drug Administration has granted marketing clearance for the immunohematology instrument NEO Iris.
NEO Iris is a fully automated blood bank instrument designed for the mid- to high-volume laboratory, according to Immucor, the company marketing the device. Immucor says NEO Iris provides the highest type and screen throughput on the market – up to 60 types and screens per hour.
NEO Iris performs ABO/Rh D typing, weak D testing, donor confirmation, cytomegalovirus screening, immunoglobulin G direct antiglobulin test and crossmatch, and antibody identification and screening.
The workflow management tool on Neo Iris has STAT priority and allows operators to run tests in any order at any time, according to Immucor.
The company says NEO Iris can hold up to 224 samples, and “modules can pipette, incubate, centrifuge, and read simultaneously.” NEO Iris integrates with Immucor’s data management software, ImmuLINK, to aggregate test results and produce reports with complete testing history.
The Food and Drug Administration has granted marketing clearance for the immunohematology instrument NEO Iris.
NEO Iris is a fully automated blood bank instrument designed for the mid- to high-volume laboratory, according to Immucor, the company marketing the device. Immucor says NEO Iris provides the highest type and screen throughput on the market – up to 60 types and screens per hour.
NEO Iris performs ABO/Rh D typing, weak D testing, donor confirmation, cytomegalovirus screening, immunoglobulin G direct antiglobulin test and crossmatch, and antibody identification and screening.
The workflow management tool on Neo Iris has STAT priority and allows operators to run tests in any order at any time, according to Immucor.
The company says NEO Iris can hold up to 224 samples, and “modules can pipette, incubate, centrifuge, and read simultaneously.” NEO Iris integrates with Immucor’s data management software, ImmuLINK, to aggregate test results and produce reports with complete testing history.
PBM saves blood, costs in HSCT unit
BOSTON – Implementing a patient blood management (PBM) program for patients undergoing hematopoietic stem cell transplantation (HSCT) resulted in significant reductions in blood product use with an attendant reduction in costs, but without negative effects on patient-centered outcomes, investigators reported.
Since the PBM program began, the number of transfusions and the units transfused declined without affecting mortality, ICU admission rates, or other transfusion-related complications. The program saved the hospital more than $600,000 over 1 year, reported Nilesh Jambhekar, MD, an anesthesiology resident at the Mayo Clinic in Rochester, Minn.
“In general, PBM implementation is probably helpful in reducing both platelet and [packed red blood cell] utilization, but it’s not an easy thing to do. It requires institutional buy-in and key players to make it happen,” he said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
“Ongoing PBM-related activities [such as] surveillance, education, and clinical decision feedback are critical to maintaining success that we’ve had,” he added.
The investigators looked at blood-product use both before and after the Mayo Clinic started a PBM program that included emphasis on AABB best practice guidelines and electronic clinical decision support for transfusion orders.
They analyzed the frequency and proportion of red blood cell (RBC) and platelet transfusions, total transfusion quantities, transfusions that occurred outside of the clinical guidelines, and the activity-based costs of transfusions.
Dr. Jambhekar acknowledged that the study relied on rigid hemoglobin and platelet thresholds when considering transfusions conducted outside of the guidelines, which they defined as RBCs administered for hemoglobin values greater than 7 g/dL and platelet transfusions for platelets counts greater than 10 x 109/L. He noted, however, that they conducted sensitivity analyses to account for exceptions, such as patients with coronary disease or neutropenic fever.
The patient-centered outcomes they evaluated included mortality, hospital and ICU admission rates, transfusion reactions, cerebrovascular and coronary ischemic events, and infections.
The study included data on 360 adults who underwent HSCT in 2013, before the PBM program was implemented, and 368 transplanted in 2015, after implementation. In each cohort, patients were followed out to 90 days after transplant.
The investigators found that the total number of units transfused dropped from 1,660 units of platelets and 1,158 U of RBCs before implementation, to 1,417 U and 826 U, respectively, after PBM implementation.
Significantly, in addition to an overall reduction in units transfused, the investigators saw substantial changes in the proportions of inappropriate (outside guidelines) transfusions of red blood cells between the two time periods, with 94.2% of RBC transfusions occurring outside the guidelines in 2013, compared with 35.4% in 2015 (P less than .0001). Similarly, the proportion of inappropriate platelet transfusions declined from 73.4% to 48.7% over the same time period (P less than .0001).
Also of note was the fact that all-cause mortality at 3 months was significantly lower after the PBM program was introduced. The 3-month mortality rate for the 2013 cohort was 30.7%, compared with 20.2% for the 2015 cohort (P = .001). Neither hospital or ICU admission with 30 days or hospital or ICU lengths of stay differed significantly between the groups.
Dr. Jambhekar noted that in a multivariable analysis accounting for baseline differences between the groups as a possible explanation for the higher mortality in the 2013 cohort, mortality for patients treated before the PBM program remained significantly higher, with an odds ratio of 1.85 (P = .0008).
There were also no significant differences in either MIs, cerebrovascular events, sepsis, and febrile or allergic transfusion reactions.
He noted that in addition to the rigid thresholds used, the study was retrospective in design – and therefore could not fully account for potential confounders – and that it is unclear whether the results could be generalized for adoption by other institutions.
The study was internally funded. Dr. Jambhekar reported having no financial disclosures.
SOURCE: Jambhekar N et al. AABB 2018, Abstract PBM3-ST4-22.
BOSTON – Implementing a patient blood management (PBM) program for patients undergoing hematopoietic stem cell transplantation (HSCT) resulted in significant reductions in blood product use with an attendant reduction in costs, but without negative effects on patient-centered outcomes, investigators reported.
Since the PBM program began, the number of transfusions and the units transfused declined without affecting mortality, ICU admission rates, or other transfusion-related complications. The program saved the hospital more than $600,000 over 1 year, reported Nilesh Jambhekar, MD, an anesthesiology resident at the Mayo Clinic in Rochester, Minn.
“In general, PBM implementation is probably helpful in reducing both platelet and [packed red blood cell] utilization, but it’s not an easy thing to do. It requires institutional buy-in and key players to make it happen,” he said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
“Ongoing PBM-related activities [such as] surveillance, education, and clinical decision feedback are critical to maintaining success that we’ve had,” he added.
The investigators looked at blood-product use both before and after the Mayo Clinic started a PBM program that included emphasis on AABB best practice guidelines and electronic clinical decision support for transfusion orders.
They analyzed the frequency and proportion of red blood cell (RBC) and platelet transfusions, total transfusion quantities, transfusions that occurred outside of the clinical guidelines, and the activity-based costs of transfusions.
Dr. Jambhekar acknowledged that the study relied on rigid hemoglobin and platelet thresholds when considering transfusions conducted outside of the guidelines, which they defined as RBCs administered for hemoglobin values greater than 7 g/dL and platelet transfusions for platelets counts greater than 10 x 109/L. He noted, however, that they conducted sensitivity analyses to account for exceptions, such as patients with coronary disease or neutropenic fever.
The patient-centered outcomes they evaluated included mortality, hospital and ICU admission rates, transfusion reactions, cerebrovascular and coronary ischemic events, and infections.
The study included data on 360 adults who underwent HSCT in 2013, before the PBM program was implemented, and 368 transplanted in 2015, after implementation. In each cohort, patients were followed out to 90 days after transplant.
The investigators found that the total number of units transfused dropped from 1,660 units of platelets and 1,158 U of RBCs before implementation, to 1,417 U and 826 U, respectively, after PBM implementation.
Significantly, in addition to an overall reduction in units transfused, the investigators saw substantial changes in the proportions of inappropriate (outside guidelines) transfusions of red blood cells between the two time periods, with 94.2% of RBC transfusions occurring outside the guidelines in 2013, compared with 35.4% in 2015 (P less than .0001). Similarly, the proportion of inappropriate platelet transfusions declined from 73.4% to 48.7% over the same time period (P less than .0001).
Also of note was the fact that all-cause mortality at 3 months was significantly lower after the PBM program was introduced. The 3-month mortality rate for the 2013 cohort was 30.7%, compared with 20.2% for the 2015 cohort (P = .001). Neither hospital or ICU admission with 30 days or hospital or ICU lengths of stay differed significantly between the groups.
Dr. Jambhekar noted that in a multivariable analysis accounting for baseline differences between the groups as a possible explanation for the higher mortality in the 2013 cohort, mortality for patients treated before the PBM program remained significantly higher, with an odds ratio of 1.85 (P = .0008).
There were also no significant differences in either MIs, cerebrovascular events, sepsis, and febrile or allergic transfusion reactions.
He noted that in addition to the rigid thresholds used, the study was retrospective in design – and therefore could not fully account for potential confounders – and that it is unclear whether the results could be generalized for adoption by other institutions.
The study was internally funded. Dr. Jambhekar reported having no financial disclosures.
SOURCE: Jambhekar N et al. AABB 2018, Abstract PBM3-ST4-22.
BOSTON – Implementing a patient blood management (PBM) program for patients undergoing hematopoietic stem cell transplantation (HSCT) resulted in significant reductions in blood product use with an attendant reduction in costs, but without negative effects on patient-centered outcomes, investigators reported.
Since the PBM program began, the number of transfusions and the units transfused declined without affecting mortality, ICU admission rates, or other transfusion-related complications. The program saved the hospital more than $600,000 over 1 year, reported Nilesh Jambhekar, MD, an anesthesiology resident at the Mayo Clinic in Rochester, Minn.
“In general, PBM implementation is probably helpful in reducing both platelet and [packed red blood cell] utilization, but it’s not an easy thing to do. It requires institutional buy-in and key players to make it happen,” he said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
“Ongoing PBM-related activities [such as] surveillance, education, and clinical decision feedback are critical to maintaining success that we’ve had,” he added.
The investigators looked at blood-product use both before and after the Mayo Clinic started a PBM program that included emphasis on AABB best practice guidelines and electronic clinical decision support for transfusion orders.
They analyzed the frequency and proportion of red blood cell (RBC) and platelet transfusions, total transfusion quantities, transfusions that occurred outside of the clinical guidelines, and the activity-based costs of transfusions.
Dr. Jambhekar acknowledged that the study relied on rigid hemoglobin and platelet thresholds when considering transfusions conducted outside of the guidelines, which they defined as RBCs administered for hemoglobin values greater than 7 g/dL and platelet transfusions for platelets counts greater than 10 x 109/L. He noted, however, that they conducted sensitivity analyses to account for exceptions, such as patients with coronary disease or neutropenic fever.
The patient-centered outcomes they evaluated included mortality, hospital and ICU admission rates, transfusion reactions, cerebrovascular and coronary ischemic events, and infections.
The study included data on 360 adults who underwent HSCT in 2013, before the PBM program was implemented, and 368 transplanted in 2015, after implementation. In each cohort, patients were followed out to 90 days after transplant.
The investigators found that the total number of units transfused dropped from 1,660 units of platelets and 1,158 U of RBCs before implementation, to 1,417 U and 826 U, respectively, after PBM implementation.
Significantly, in addition to an overall reduction in units transfused, the investigators saw substantial changes in the proportions of inappropriate (outside guidelines) transfusions of red blood cells between the two time periods, with 94.2% of RBC transfusions occurring outside the guidelines in 2013, compared with 35.4% in 2015 (P less than .0001). Similarly, the proportion of inappropriate platelet transfusions declined from 73.4% to 48.7% over the same time period (P less than .0001).
Also of note was the fact that all-cause mortality at 3 months was significantly lower after the PBM program was introduced. The 3-month mortality rate for the 2013 cohort was 30.7%, compared with 20.2% for the 2015 cohort (P = .001). Neither hospital or ICU admission with 30 days or hospital or ICU lengths of stay differed significantly between the groups.
Dr. Jambhekar noted that in a multivariable analysis accounting for baseline differences between the groups as a possible explanation for the higher mortality in the 2013 cohort, mortality for patients treated before the PBM program remained significantly higher, with an odds ratio of 1.85 (P = .0008).
There were also no significant differences in either MIs, cerebrovascular events, sepsis, and febrile or allergic transfusion reactions.
He noted that in addition to the rigid thresholds used, the study was retrospective in design – and therefore could not fully account for potential confounders – and that it is unclear whether the results could be generalized for adoption by other institutions.
The study was internally funded. Dr. Jambhekar reported having no financial disclosures.
SOURCE: Jambhekar N et al. AABB 2018, Abstract PBM3-ST4-22.
REPORTING FROM AABB 2018
Key clinical point:
Major finding: The program saved more than $600,000 in transfusion-related costs.
Study details: Retrospective study that compared clinical outcomes for 728 patients before and after implementation of a PBM program.
Disclosures: The study was internally funded. Dr. Jambhekar reported having no financial disclosures.
Source: Jambhekar N et al. AABB 2018, Abstract PBM3-ST4-22.
Portable hematology analyzer gets FDA nod
The Food and Drug Administration has granted .
HemoScreen requires a single drop of blood and uses disposable cartridges that provide automatic sample preparation.
HemoScreen can analyze 20 standard complete blood count parameters and produces results within 5 minutes.
Study results suggested that HemoScreen provides results comparable to those of another hematology analyzer, Sysmex XE-2100 (J Clin Pathol. 2016 Aug;69[8]:720-5).
“The HemoScreen delivers lab accurate results,” Avishay Bransky, PhD, CEO of PixCell, said in a statement.
HemoScreen “would be especially useful” in physicians’ offices, emergency rooms, intensive care units, oncology clinics, and remote locations, he added.
HemoScreen makes use of a technology called viscoelastic focusing, which employs microfluidics and machine vision algorithms to analyze cells.
The Food and Drug Administration has granted .
HemoScreen requires a single drop of blood and uses disposable cartridges that provide automatic sample preparation.
HemoScreen can analyze 20 standard complete blood count parameters and produces results within 5 minutes.
Study results suggested that HemoScreen provides results comparable to those of another hematology analyzer, Sysmex XE-2100 (J Clin Pathol. 2016 Aug;69[8]:720-5).
“The HemoScreen delivers lab accurate results,” Avishay Bransky, PhD, CEO of PixCell, said in a statement.
HemoScreen “would be especially useful” in physicians’ offices, emergency rooms, intensive care units, oncology clinics, and remote locations, he added.
HemoScreen makes use of a technology called viscoelastic focusing, which employs microfluidics and machine vision algorithms to analyze cells.
The Food and Drug Administration has granted .
HemoScreen requires a single drop of blood and uses disposable cartridges that provide automatic sample preparation.
HemoScreen can analyze 20 standard complete blood count parameters and produces results within 5 minutes.
Study results suggested that HemoScreen provides results comparable to those of another hematology analyzer, Sysmex XE-2100 (J Clin Pathol. 2016 Aug;69[8]:720-5).
“The HemoScreen delivers lab accurate results,” Avishay Bransky, PhD, CEO of PixCell, said in a statement.
HemoScreen “would be especially useful” in physicians’ offices, emergency rooms, intensive care units, oncology clinics, and remote locations, he added.
HemoScreen makes use of a technology called viscoelastic focusing, which employs microfluidics and machine vision algorithms to analyze cells.
Antigen profiling may help prevent transfusion complications
BETHESDA, MD. – according to one researcher.
“We strongly feel that you should get an extended red cell type on the first encounter” for patients facing long-term transfusion support, Connie Westhoff, PhD, of the New York Blood Center, said at Sickle Cell in Focus, a conference held by the National Institutes of Health. “This can be a one-time test. It doesn’t have to be repeated.”
She also stressed the importance of ensuring that this information travels with patients, who may be seen at various hospitals. “One of the challenges here is making this part of the patient’s electronic medical record.”
Alloimmunization has been a major concern for chronically transfused patients, so there’s a real advantage to knowing a patient’s extended red cell antigen profile before the patient develops alloantibodies following transfusion, Dr. Westhoff said. Hemolytic transfusion reactions can sometimes destroy patients’ own RBCs in addition to the transfused RBCs. Having the patient’s profile to identify the potential cause of the incompatibility and guide transfusion support in an emergency can be lifesaving.
The implementation of genotyping by DNA-based methods has brought down the cost of this screening, making it no longer a barrier in care.
Dr. Westhoff cited a study she and her colleagues published on a study typing patients who have sickle cell disease (Transfusion. 2015 Jun;55[6 Pt 2]:1388-93). In that paper, they found that DNA-based RBC typing provided improved accuracy and expanded information on RBC antigens, compared with hemagglutination methods. This led to its implementation as the primary method for extended RBC typing for patients with sickle cell disease at the Children’s Hospital of Philadelphia.
About 65%-70% of antibodies drop to levels that are not detectable by routine assays, further demonstrating the need for DNA-based methods. The drugs used to dampen the immune response in many of these patients may also hinder or impact detection of antibodies that remain at levels that continue to cause in vivo hemolysis, Dr. Westhoff said in an interview.
For patients with sickle cell disease in many Western countries, antigen matching for CEK, at a minimum, is routine. The United States is now moving in this direction.
“Modern transfusion practice is moving to knowing what antigens the patient is at risk to become immunized against. ... What antigens does the patient lack and what antibodies could the patient make,” Dr. Westhoff said in an interview. “It’s a major advantage in your transfusion service to expedite work-ups and patient care by having that extended antigen profile.”
Dr. Westhoff reported no relevant financial disclosures.
BETHESDA, MD. – according to one researcher.
“We strongly feel that you should get an extended red cell type on the first encounter” for patients facing long-term transfusion support, Connie Westhoff, PhD, of the New York Blood Center, said at Sickle Cell in Focus, a conference held by the National Institutes of Health. “This can be a one-time test. It doesn’t have to be repeated.”
She also stressed the importance of ensuring that this information travels with patients, who may be seen at various hospitals. “One of the challenges here is making this part of the patient’s electronic medical record.”
Alloimmunization has been a major concern for chronically transfused patients, so there’s a real advantage to knowing a patient’s extended red cell antigen profile before the patient develops alloantibodies following transfusion, Dr. Westhoff said. Hemolytic transfusion reactions can sometimes destroy patients’ own RBCs in addition to the transfused RBCs. Having the patient’s profile to identify the potential cause of the incompatibility and guide transfusion support in an emergency can be lifesaving.
The implementation of genotyping by DNA-based methods has brought down the cost of this screening, making it no longer a barrier in care.
Dr. Westhoff cited a study she and her colleagues published on a study typing patients who have sickle cell disease (Transfusion. 2015 Jun;55[6 Pt 2]:1388-93). In that paper, they found that DNA-based RBC typing provided improved accuracy and expanded information on RBC antigens, compared with hemagglutination methods. This led to its implementation as the primary method for extended RBC typing for patients with sickle cell disease at the Children’s Hospital of Philadelphia.
About 65%-70% of antibodies drop to levels that are not detectable by routine assays, further demonstrating the need for DNA-based methods. The drugs used to dampen the immune response in many of these patients may also hinder or impact detection of antibodies that remain at levels that continue to cause in vivo hemolysis, Dr. Westhoff said in an interview.
For patients with sickle cell disease in many Western countries, antigen matching for CEK, at a minimum, is routine. The United States is now moving in this direction.
“Modern transfusion practice is moving to knowing what antigens the patient is at risk to become immunized against. ... What antigens does the patient lack and what antibodies could the patient make,” Dr. Westhoff said in an interview. “It’s a major advantage in your transfusion service to expedite work-ups and patient care by having that extended antigen profile.”
Dr. Westhoff reported no relevant financial disclosures.
BETHESDA, MD. – according to one researcher.
“We strongly feel that you should get an extended red cell type on the first encounter” for patients facing long-term transfusion support, Connie Westhoff, PhD, of the New York Blood Center, said at Sickle Cell in Focus, a conference held by the National Institutes of Health. “This can be a one-time test. It doesn’t have to be repeated.”
She also stressed the importance of ensuring that this information travels with patients, who may be seen at various hospitals. “One of the challenges here is making this part of the patient’s electronic medical record.”
Alloimmunization has been a major concern for chronically transfused patients, so there’s a real advantage to knowing a patient’s extended red cell antigen profile before the patient develops alloantibodies following transfusion, Dr. Westhoff said. Hemolytic transfusion reactions can sometimes destroy patients’ own RBCs in addition to the transfused RBCs. Having the patient’s profile to identify the potential cause of the incompatibility and guide transfusion support in an emergency can be lifesaving.
The implementation of genotyping by DNA-based methods has brought down the cost of this screening, making it no longer a barrier in care.
Dr. Westhoff cited a study she and her colleagues published on a study typing patients who have sickle cell disease (Transfusion. 2015 Jun;55[6 Pt 2]:1388-93). In that paper, they found that DNA-based RBC typing provided improved accuracy and expanded information on RBC antigens, compared with hemagglutination methods. This led to its implementation as the primary method for extended RBC typing for patients with sickle cell disease at the Children’s Hospital of Philadelphia.
About 65%-70% of antibodies drop to levels that are not detectable by routine assays, further demonstrating the need for DNA-based methods. The drugs used to dampen the immune response in many of these patients may also hinder or impact detection of antibodies that remain at levels that continue to cause in vivo hemolysis, Dr. Westhoff said in an interview.
For patients with sickle cell disease in many Western countries, antigen matching for CEK, at a minimum, is routine. The United States is now moving in this direction.
“Modern transfusion practice is moving to knowing what antigens the patient is at risk to become immunized against. ... What antigens does the patient lack and what antibodies could the patient make,” Dr. Westhoff said in an interview. “It’s a major advantage in your transfusion service to expedite work-ups and patient care by having that extended antigen profile.”
Dr. Westhoff reported no relevant financial disclosures.
REPORTING FROM SICKLE CELL IN FOCUS
Rapid bacterial testing of platelets saves money, reduces waste
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
REPORTING FROM AABB18
Key clinical point:
Major finding: Annualized cost savings with rapid bacterial testing were nearly $89,000; platelet wastage decreased from 24% to 10%.
Study details: A retrospective analysis of costs and product wastage before and after implementation of rapid bacterial testing.
Disclosures: The study was internally funded. The authors reported having no conflicts of interest.
Source: Booth AL et al. AABB18, Abstract INV4.
OMS721 gains orphan designation for HSCT-associated thrombotic microangiopathy
The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.
Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.
Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.
Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.
These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).
The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.
The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.
Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.
Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.
Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.
These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).
The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.
The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.
Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.
Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.
Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.
These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).
The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.
Protocol violations, missed transfusions among blood delivery errors
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
REPORTING FROM AABB 2018
Key clinical point:
Major finding: In all, 31% of pediatric errors were due to protocol violation, and 43% of adult errors were due to an ordered transfusion not being performed.
Study details: Descriptive study of data from 32 U.S. hospitals that reported transfusion safety events.
Disclosures: The study was supported by the AABB Center for Patient Safety and University of Vermont. The authors reported no conflicts of interest.
Source: Vossoughi S et al. AABB 2018, Abstract QT4.
Have apheresis units, will travel
BOSTON – If donors can’t get to the apheresis center, bring the apheresis center to the donors.
Responding to the request of a patient with cancer, David Anthony, Amber Lazareff, RN, and their colleagues at the University of California at Los Angeles Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives. They found that, with careful planning and coordination, they could augment their supply of vital blood products and introduce potential new donors to the idea of apheresis donations at the hospital.
“There was a needs drive for an oncology patient at UCLA. She wanted to bring in donors and had her whole community behind her, and we thought well, she’s an oncology patient and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it,” Mr. Anthony said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.
To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.
Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring that there were suitable electrical outlets, space, and support for apheresis machines.
“Over about 2 weeks we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it. The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate,” Mr. Anthony said.
Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable HLA test results.
Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets. Of the four apheresis donors, three were first-time platelet donors.
The first drive collected seven platelet products, including three double products and one single product.
The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier, and bolstered the blood bank’s inventory on a normally low collection day, the authors reported.
“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Mr. Anthony said.
He acknowledged that it is more challenging to recruit, educate, and ideally retain donors in the field than in the brick-and-mortar hospital setting.
“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas at our centers, we have regular donors who come in every 2 weeks, it’s easy for them to make an appointment, and they know where we are,” he said.
The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.
The pilot program was internally funded. The authors reported having no relevant conflicts of interest.
SOURCE: Anthony D et al., AABB 2018, Poster BBC 135.
BOSTON – If donors can’t get to the apheresis center, bring the apheresis center to the donors.
Responding to the request of a patient with cancer, David Anthony, Amber Lazareff, RN, and their colleagues at the University of California at Los Angeles Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives. They found that, with careful planning and coordination, they could augment their supply of vital blood products and introduce potential new donors to the idea of apheresis donations at the hospital.
“There was a needs drive for an oncology patient at UCLA. She wanted to bring in donors and had her whole community behind her, and we thought well, she’s an oncology patient and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it,” Mr. Anthony said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.
To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.
Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring that there were suitable electrical outlets, space, and support for apheresis machines.
“Over about 2 weeks we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it. The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate,” Mr. Anthony said.
Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable HLA test results.
Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets. Of the four apheresis donors, three were first-time platelet donors.
The first drive collected seven platelet products, including three double products and one single product.
The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier, and bolstered the blood bank’s inventory on a normally low collection day, the authors reported.
“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Mr. Anthony said.
He acknowledged that it is more challenging to recruit, educate, and ideally retain donors in the field than in the brick-and-mortar hospital setting.
“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas at our centers, we have regular donors who come in every 2 weeks, it’s easy for them to make an appointment, and they know where we are,” he said.
The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.
The pilot program was internally funded. The authors reported having no relevant conflicts of interest.
SOURCE: Anthony D et al., AABB 2018, Poster BBC 135.
BOSTON – If donors can’t get to the apheresis center, bring the apheresis center to the donors.
Responding to the request of a patient with cancer, David Anthony, Amber Lazareff, RN, and their colleagues at the University of California at Los Angeles Blood and Platelet Center explored adding mobile apheresis units to their existing community blood drives. They found that, with careful planning and coordination, they could augment their supply of vital blood products and introduce potential new donors to the idea of apheresis donations at the hospital.
“There was a needs drive for an oncology patient at UCLA. She wanted to bring in donors and had her whole community behind her, and we thought well, she’s an oncology patient and she uses platelets, and we had talked about doing platelets out in the field rather than just at fixed sites, and we thought that this would be a good chance to try it,” Mr. Anthony said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Until the mobile unit was established, apheresis platelet collections for the hospital-based donor center were limited to two fixed collection sites, with mobile units used only for collection of whole blood.
To see whether concurrent whole blood and platelet community drives were practical, the center’s blood donor field recruiter requested to schedule a community drive in a region of the county where potential donors had expressed a high level of interest in apheresis platelet donations.
Operations staff visited the site to assess its suitability, including appropriate space for donor registration and history taking, separate areas for whole blood and apheresis donations, and a donor recovery area. The assessment included ensuring that there were suitable electrical outlets, space, and support for apheresis machines.
“Over about 2 weeks we discussed with our medical directors, [infusion technicians], and our mobile people what we would need to do it. The recruiter out in the field was able to go to a high school drive out in that area, recruit donors, and get [platelet] precounts from them so that we could find out who was a good candidate,” Mr. Anthony said.
Once they had platelet counts from potential apheresis donors, 10 donors were prescreened based on their eligibility to donate multiple products, history of donations and red blood cell loss, and, for women who had previously had more than one pregnancy, favorable HLA test results.
Four of the prescreened donors were scheduled to donate platelets, and the time slot also included two backup donors, one of whom ultimately donated platelets. Of the four apheresis donors, three were first-time platelet donors.
The first drive collected seven platelet products, including three double products and one single product.
The donated products resulted in about a $3,000 cost savings by obviating the need for purchasing products from an outside supplier, and bolstered the blood bank’s inventory on a normally low collection day, the authors reported.
“We’ve had two more apheresis drives since then, and we’ll have another one in 3 weeks,” Mr. Anthony said.
He acknowledged that it is more challenging to recruit, educate, and ideally retain donors in the field than in the brick-and-mortar hospital setting.
“We have to make sure that they’re going to show up if we’re going to make the effort to take a machine out there, whereas at our centers, we have regular donors who come in every 2 weeks, it’s easy for them to make an appointment, and they know where we are,” he said.
The center plans to continue concurrent monthly whole blood and platelet collection drives, he added.
The pilot program was internally funded. The authors reported having no relevant conflicts of interest.
SOURCE: Anthony D et al., AABB 2018, Poster BBC 135.
AT AABB 2018
Key clinical point:
Major finding: Field-based collection of platelet products saved costs and augmented the hospital’s supply on a normally low collection day.
Study details: Pilot program testing apheresis platelet donations during community blood drives.
Disclosures: The pilot program was internally funded. The authors reported having no relevant conflicts of interest.
Source: Anthony D et al. AABB 2018, Poster BBC 135.
Need blood STAT? Call for a drone
BOSTON – While Amazon and other retailers are experimenting with drones to deliver toasters and toilet seats to your doorstep, drone-delivered platelets and fresh frozen plasma may be coming soon to a hospital near you, experts said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Using a system of completely autonomous delivery drones launched from a central location, U.S.-based Zipline International delivers blood products to treat postpartum hemorrhage, trauma, malaria, and other life-threatening conditions to patients in rural Rwanda, according to company spokesman Chris Kenney.
“In less than 2 years in Rwanda, we’ve made almost 10,000 deliveries – that’s almost 20,000 units of blood,” he said.
One-third of all deliveries are needed for urgent, life-saving interventions, he said.
The system, which delivers 30% of all blood products used in Rwanda outside the capital Kigali, has resulted in 100% availability of blood products when needed, a 98% reduction in waste (i.e., when unused blood products are discarded because of age), and a 175% increase in the use of platelets and fresh frozen plasma, Mr. Kenney said.
Setting up an airborne delivery network in the largely unregulated and uncrowded Rwandan airspace was a relatively simple process, however, compared with the myriad challenges of establishing a similar system for deliveries to urban medical centers in Boston, Chicago, New York, or Los Angeles, said Paul Eastvold, MD, chief medical officer at Vitalant, a nonprofit network of community blood banks headquartered in Spokane, Wash.
Dr. Eastvold, who is also a private pilot, described the regulatory hurdles that will need to be surmounted before blood-delivery drones are as common a sight as traffic helicopters are currently. He added, however, “I can guarantee you that in the future this is going to be an applicable technology to our industry in one way, shape, or another.”
Fast and cheap
Speed and cost are two of the most compelling arguments for blood banks to use drones. Mr. Kenney described the case of a 24-year-old Rwandan woman who had uncontrolled bleeding from complications following a cesarean section. The clinicians treating her opted to give her an immediate red blood cell transfusion, but she continued to bleed, and the hospital ran out of red blood cells in about 15 minutes.
They placed an order for more blood products – ordering can be done by text message or via WhatsApp, a free, cross-platform messaging and voiceover IP calling service – and over the course of 90 minutes Zipline was able to deliver, using multiple drone launches, 7 units of red blood cells, 4 units of plasma, and 2 units of platelets, all of which were transfused into the patient and allowed her condition to stabilize.
Deliveries that would take a minimum of 3 hours by road can be accomplished in about 15-25 minutes by air, Mr. Kenney said.
The drones – more formally known as “unmanned aerial vehicles” (UAVs) – fly a loop starting at the distribution center, find their target, descend to a height of about 10 meters and drop the package, which has a parachute attached. Packages can be delivered within a drop zone the size of two parking spaces, even in gale-force winds, Mr. Kenney said.
“The whole process is 100% autonomous. The aircraft knows where it’s going, it knows what conditions [are], it knows what its payload characteristics are and flies to the delivery point and drops its package,” he explained.
As drones return to the distribution center, they are snared from the air with a wire that catches a small tail hook on the fuselage.
Airborne deliveries are also significantly cheaper than ground-based services for local delivery, Dr. Eastvold noted. He cited a study showing that the cost of ground shipping from a local warehouse by carriers such as UPS or FedEx could be $6 or more, drones could be as cheap as 5 cents per mile with delivery within about 30 minutes, he said.
The fly in the ointment
Dr. Eastvold outlined the significant barriers to adoption of drone-based delivery systems in the United States, ranging from differences in state laws about when, where, and how drones can be used and who can operate them, to Federal Aviation Administration airspace restrictions and regulations.
For example, the FAA currently requires “line-of-sight” operation only for most drone operators, meaning that the operator must have visual contact with the drone at all times. The FAA will, however, grant waivers to individual operators for specified flying conditions on a case-by-case basis, if compelling need or extenuating circumstances can be satisfactorily explained.
In addition, federal regulations require commercial drone pilots to be 16 years old or older, be fluent in English, be in a physical and mental condition that would not interfere with safe operation of a drone, pass an aeronautical knowledge exam at an FAA-approved testing center, and undergo a Transportation Safety Administration background security screening.
Despite these challenges, at least one U.S. medical center, Johns Hopkins University, is testing the use of drones for blood delivery. In 2017, they demonstrated that a drone could successfully deliver human blood samples in temperature-controlled conditions across 161 miles of Arizona desert, in a flight lasting 3 hours.
Mr. Kenney said that his company is developing a second distribution center in Rwanda that will expand coverage to the entire country and is also working with the FAA, federal regulators, and the state of North Carolina to develop a drone-based blood delivery system in the United States.
BOSTON – While Amazon and other retailers are experimenting with drones to deliver toasters and toilet seats to your doorstep, drone-delivered platelets and fresh frozen plasma may be coming soon to a hospital near you, experts said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Using a system of completely autonomous delivery drones launched from a central location, U.S.-based Zipline International delivers blood products to treat postpartum hemorrhage, trauma, malaria, and other life-threatening conditions to patients in rural Rwanda, according to company spokesman Chris Kenney.
“In less than 2 years in Rwanda, we’ve made almost 10,000 deliveries – that’s almost 20,000 units of blood,” he said.
One-third of all deliveries are needed for urgent, life-saving interventions, he said.
The system, which delivers 30% of all blood products used in Rwanda outside the capital Kigali, has resulted in 100% availability of blood products when needed, a 98% reduction in waste (i.e., when unused blood products are discarded because of age), and a 175% increase in the use of platelets and fresh frozen plasma, Mr. Kenney said.
Setting up an airborne delivery network in the largely unregulated and uncrowded Rwandan airspace was a relatively simple process, however, compared with the myriad challenges of establishing a similar system for deliveries to urban medical centers in Boston, Chicago, New York, or Los Angeles, said Paul Eastvold, MD, chief medical officer at Vitalant, a nonprofit network of community blood banks headquartered in Spokane, Wash.
Dr. Eastvold, who is also a private pilot, described the regulatory hurdles that will need to be surmounted before blood-delivery drones are as common a sight as traffic helicopters are currently. He added, however, “I can guarantee you that in the future this is going to be an applicable technology to our industry in one way, shape, or another.”
Fast and cheap
Speed and cost are two of the most compelling arguments for blood banks to use drones. Mr. Kenney described the case of a 24-year-old Rwandan woman who had uncontrolled bleeding from complications following a cesarean section. The clinicians treating her opted to give her an immediate red blood cell transfusion, but she continued to bleed, and the hospital ran out of red blood cells in about 15 minutes.
They placed an order for more blood products – ordering can be done by text message or via WhatsApp, a free, cross-platform messaging and voiceover IP calling service – and over the course of 90 minutes Zipline was able to deliver, using multiple drone launches, 7 units of red blood cells, 4 units of plasma, and 2 units of platelets, all of which were transfused into the patient and allowed her condition to stabilize.
Deliveries that would take a minimum of 3 hours by road can be accomplished in about 15-25 minutes by air, Mr. Kenney said.
The drones – more formally known as “unmanned aerial vehicles” (UAVs) – fly a loop starting at the distribution center, find their target, descend to a height of about 10 meters and drop the package, which has a parachute attached. Packages can be delivered within a drop zone the size of two parking spaces, even in gale-force winds, Mr. Kenney said.
“The whole process is 100% autonomous. The aircraft knows where it’s going, it knows what conditions [are], it knows what its payload characteristics are and flies to the delivery point and drops its package,” he explained.
As drones return to the distribution center, they are snared from the air with a wire that catches a small tail hook on the fuselage.
Airborne deliveries are also significantly cheaper than ground-based services for local delivery, Dr. Eastvold noted. He cited a study showing that the cost of ground shipping from a local warehouse by carriers such as UPS or FedEx could be $6 or more, drones could be as cheap as 5 cents per mile with delivery within about 30 minutes, he said.
The fly in the ointment
Dr. Eastvold outlined the significant barriers to adoption of drone-based delivery systems in the United States, ranging from differences in state laws about when, where, and how drones can be used and who can operate them, to Federal Aviation Administration airspace restrictions and regulations.
For example, the FAA currently requires “line-of-sight” operation only for most drone operators, meaning that the operator must have visual contact with the drone at all times. The FAA will, however, grant waivers to individual operators for specified flying conditions on a case-by-case basis, if compelling need or extenuating circumstances can be satisfactorily explained.
In addition, federal regulations require commercial drone pilots to be 16 years old or older, be fluent in English, be in a physical and mental condition that would not interfere with safe operation of a drone, pass an aeronautical knowledge exam at an FAA-approved testing center, and undergo a Transportation Safety Administration background security screening.
Despite these challenges, at least one U.S. medical center, Johns Hopkins University, is testing the use of drones for blood delivery. In 2017, they demonstrated that a drone could successfully deliver human blood samples in temperature-controlled conditions across 161 miles of Arizona desert, in a flight lasting 3 hours.
Mr. Kenney said that his company is developing a second distribution center in Rwanda that will expand coverage to the entire country and is also working with the FAA, federal regulators, and the state of North Carolina to develop a drone-based blood delivery system in the United States.
BOSTON – While Amazon and other retailers are experimenting with drones to deliver toasters and toilet seats to your doorstep, drone-delivered platelets and fresh frozen plasma may be coming soon to a hospital near you, experts said at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Using a system of completely autonomous delivery drones launched from a central location, U.S.-based Zipline International delivers blood products to treat postpartum hemorrhage, trauma, malaria, and other life-threatening conditions to patients in rural Rwanda, according to company spokesman Chris Kenney.
“In less than 2 years in Rwanda, we’ve made almost 10,000 deliveries – that’s almost 20,000 units of blood,” he said.
One-third of all deliveries are needed for urgent, life-saving interventions, he said.
The system, which delivers 30% of all blood products used in Rwanda outside the capital Kigali, has resulted in 100% availability of blood products when needed, a 98% reduction in waste (i.e., when unused blood products are discarded because of age), and a 175% increase in the use of platelets and fresh frozen plasma, Mr. Kenney said.
Setting up an airborne delivery network in the largely unregulated and uncrowded Rwandan airspace was a relatively simple process, however, compared with the myriad challenges of establishing a similar system for deliveries to urban medical centers in Boston, Chicago, New York, or Los Angeles, said Paul Eastvold, MD, chief medical officer at Vitalant, a nonprofit network of community blood banks headquartered in Spokane, Wash.
Dr. Eastvold, who is also a private pilot, described the regulatory hurdles that will need to be surmounted before blood-delivery drones are as common a sight as traffic helicopters are currently. He added, however, “I can guarantee you that in the future this is going to be an applicable technology to our industry in one way, shape, or another.”
Fast and cheap
Speed and cost are two of the most compelling arguments for blood banks to use drones. Mr. Kenney described the case of a 24-year-old Rwandan woman who had uncontrolled bleeding from complications following a cesarean section. The clinicians treating her opted to give her an immediate red blood cell transfusion, but she continued to bleed, and the hospital ran out of red blood cells in about 15 minutes.
They placed an order for more blood products – ordering can be done by text message or via WhatsApp, a free, cross-platform messaging and voiceover IP calling service – and over the course of 90 minutes Zipline was able to deliver, using multiple drone launches, 7 units of red blood cells, 4 units of plasma, and 2 units of platelets, all of which were transfused into the patient and allowed her condition to stabilize.
Deliveries that would take a minimum of 3 hours by road can be accomplished in about 15-25 minutes by air, Mr. Kenney said.
The drones – more formally known as “unmanned aerial vehicles” (UAVs) – fly a loop starting at the distribution center, find their target, descend to a height of about 10 meters and drop the package, which has a parachute attached. Packages can be delivered within a drop zone the size of two parking spaces, even in gale-force winds, Mr. Kenney said.
“The whole process is 100% autonomous. The aircraft knows where it’s going, it knows what conditions [are], it knows what its payload characteristics are and flies to the delivery point and drops its package,” he explained.
As drones return to the distribution center, they are snared from the air with a wire that catches a small tail hook on the fuselage.
Airborne deliveries are also significantly cheaper than ground-based services for local delivery, Dr. Eastvold noted. He cited a study showing that the cost of ground shipping from a local warehouse by carriers such as UPS or FedEx could be $6 or more, drones could be as cheap as 5 cents per mile with delivery within about 30 minutes, he said.
The fly in the ointment
Dr. Eastvold outlined the significant barriers to adoption of drone-based delivery systems in the United States, ranging from differences in state laws about when, where, and how drones can be used and who can operate them, to Federal Aviation Administration airspace restrictions and regulations.
For example, the FAA currently requires “line-of-sight” operation only for most drone operators, meaning that the operator must have visual contact with the drone at all times. The FAA will, however, grant waivers to individual operators for specified flying conditions on a case-by-case basis, if compelling need or extenuating circumstances can be satisfactorily explained.
In addition, federal regulations require commercial drone pilots to be 16 years old or older, be fluent in English, be in a physical and mental condition that would not interfere with safe operation of a drone, pass an aeronautical knowledge exam at an FAA-approved testing center, and undergo a Transportation Safety Administration background security screening.
Despite these challenges, at least one U.S. medical center, Johns Hopkins University, is testing the use of drones for blood delivery. In 2017, they demonstrated that a drone could successfully deliver human blood samples in temperature-controlled conditions across 161 miles of Arizona desert, in a flight lasting 3 hours.
Mr. Kenney said that his company is developing a second distribution center in Rwanda that will expand coverage to the entire country and is also working with the FAA, federal regulators, and the state of North Carolina to develop a drone-based blood delivery system in the United States.
AT AABB 2018
FDA approves DNA-based blood type test
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.