By Elissa Fuchs and Al Staropoli, AABB Writers

Providing high-quality patient care does not happen by accident. Rather, it is the result of researching the best ways to manage illness, developing guidelines that correspond with these findings, and then implementing protocols in a consistent, thorough manner. Evidence-based medicine, or the concept of providing health care that is clinically proven to be as safe and effective as possible, provides a framework to manage new information about health and disease.

As with other areas in medicine, the transfusion and cellular therapy communities are trying to provide the best care based on the most updated evidence and suited to patients’ particular needs.

“In our fields, there is a current shift toward outcomes-based research. It is more of a priority to identify patient populations who would benefit from transfusions versus those who wouldn’t, and which patients would benefit from certain types of transfusions,” said Aryeh Shander, MD, chief of anesthesiology at Englewood Hospital and Medical Center in Englewood, N.J. He added that he hopes to see this trend grow in the future.

Mayo Clinic anesthesiology professor Gregory Nuttall, MD, agreed that protocols have to strike a balance between ensuring that all people receive uniformly high-quality care and accounting for individual differences among patients.

“Transfusion guidelines pretty much concur, although there are differences. The Society of Thoracic Surgeons and Society of Cardiovascular Anesthesiologists guidelines are predominantly looking at heart surgery patients, while the American Society of Anesthesiology guidelines are broader, for use in anyone undergoing surgery and anesthesia.”

In the patient care and outcomes arena, there are some medical centers and research projects that are pushing the envelope. One such example is Intermountain Healthcare, a system of hospitals, surgery centers, doctors and clinics based in Utah and southeastern Idaho that has received national press and praise from President Barack Obama for being on the forefront of quality improvement.

Some feathers in Intermountain’s cap include a more than 50 percent drop in ventilator-associated pneumonia — a condition that occurs when patients are intubated and placed on ventilators — from 2004 to 2006. In obstetrics, the facility has decreased the number of elective inductions — when labor is induced for a nonmedical reason — performed on women less than 39 weeks pregnant from nearly 30 to 5 percent while nationwide the number of elective birth inductions has increased. Administering specific protocols for patients with bronchiolitis — an inflammation of the airways that most frequently occurs in infants — yielded faster recoveries and shorter hospital stays. A key element of producing good outcomes at Intermountain has been reducing discrepancies among patients’ treatment, said Brent James, MD, MStat, executive director of Intermountain’s Institute for Health Care Delivery Research, a program that aims to improve quality and reduce cost of health care services.

“Variations from one doctor to another, or one nursing unit to another … [were] endemic — it didn’t matter which specialty or subgroups of health care professionals you looked at,” James said. “We began to address this by asking ourselves the question, ‘Why does this variability exist and how do we know what is really best for patients?’”

To reduce variation and improve upon its services, Intermountain developed courses to instill a shared culture of safety and quality care. The organization also has a 20-day advanced training program in clinical practice improvement focused on quality control geared toward senior leaders, managers and health care professionals. Another course teaches physicians how to recognize when system failures can create errors.

“We decided to make clinical quality a business strategy and started to build core infrastructure within Intermountain for that specific purpose,” Brent said. “The reason we could do it, arguably, is because we had enough graduates of the advanced training program scattered through Intermountain. In a sense, it provided us with the intellectual foundation.”

Intermountain’s use of advanced technology also works to its patients’ advantage, as studies have shown that “wired” health care organizations often produce better outcomes. Since the 1960s, Intermountain has been developing and using computerized health records. Four years ago, it began partnering with GE Healthcare to create the next generation of hospitals’ medical information systems. This year, for the 10th time in 11 years, the organization was named one of the 100 most wired hospitals by Hospitals & Health Networks.

Another cited example of a facility that provides high-quality, evidence-based care is the Mayo Clinic in Rochester, Minn. With a staff of almost 55,000 serving nearly half a million patients every year, the center’s interdisciplinary and team-based approach promotes patient-centric care and creates an environment of accountability.

Like at Intermountain, health care IT is an important piece of improving patient care at Mayo. For several years, it has instituted a bar coding system in operating rooms and intensive care units. “One of the biggest risks in the U.S. is still giving the wrong unit to the wrong person,” Nuttall said, adding that bar code technology helps prevent this. “We are doing this because we want better care. If you can avoid a mistransfusion and the potential complications associated with a transfusion, it’s a good thing.”

Mayo also has developed systems to reduce the chance that blood products are transfused unnecessarily. Patients may face other adverse events aside from mistransfusions, so reducing the amount of transfused blood may be in the patient’s best interest. The organization created an algorithm for transfusing the appropriate amount of blood products for certain patients in the operating room or intensive care unit. When the product is ordered through the computer order entry system, the algorithm automatically determines the appropriate number of units to be transfused based on various patient characteristics.

“In essence, it asks the provider ‘Do you really need this blood?’” Nuttall said. “The interesting thing is that after instituting the system, the number of red cell units transfused dropped off.

“We targeted heart surgery because in most institutions it is one of the big users of blood products,” he said. “Mayo, along with other institutions, has done prospective randomized trials looking at the use of transfusion algorithms in the operating room to guide transfusion therapy with point-of-care testing.”

Reducing blood transfusions also can save institutions financially, which some stakeholders claim is not always true with patient care innovations. A 2007 Mayo Clinic study has shown significant savings by using the algorithm. Research published in the American Journal of Hematology found that electronic order entries significantly decreased the number of red blood cell units transfused in a group of anemia patients, which lowered the price tag from $616,442 to $556,226.

The Research Angle

Blood management continues to be studied in the research arena. A trial spearheaded by the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, which began in 2004, is testing transfusion guidelines for patients undergoing surgery for hip fracture with a history of cardiovascular disease.

The Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair, or FOCUS, aims to determine whether a higher blood transfusion threshold actually improves functional recovery while reducing morbidity and mortality. Although transfusions frequently occur after hip surgery, there is limited data supporting this practice.

In the FOCUS trial, 2,016 patients were divided into two groups: one that received transfusions to keep the hemoglobin level at or above 10 g/dL, and one that was only transfused if the hemoglobin level fell below 8 g/dL or for symptoms of anemia.

“Red cell transfusion today is largely a combination of training, personal opinion and point of view. The magic 10g/dL figure has been widely used by clinicians in the past, but there has been a push to challenge this number because many people recognize there isn’t evidence to support it,” said Jeffrey Carson, MD, chief of general internal medicine at Robert Wood Johnson Medical School and the study’s principal investigator. “There is also the view that you should not treat a number but rather evaluate patients, assess their symptoms and consider this in the context of their blood count before making transfusion decisions.”

The study, funded by the National Heart, Lung and Blood Institute, is being conducted at 47 medical centers in the U.S. and Canada. Some initial data were presented at the AABB Annual Meeting in October and are accessible online at www.aabb.org/annualmeetingnews.

“There are various levels of evidence, with the highest coming from two or more randomized clinical trials, that show similar results. If we have consistent, high-quality evidence, then it is reasonable for organizations to strongly encourage physicians to follow the evidence and not use blood in a way that is not beneficial,” Carson said.

Another patient care research project focuses on transfusion-related acute lung injury, a complication that is the leading cause of transfusion-related death in the U.S. In recent years, AABB has suggested that blood facilities make efforts to transfuse blood products from low-risk donors, namely males and females who have never been pregnant, and Standards for Blood Banks and Transfusion Services requires that facilities track adverse events related to transfusion, including TRALI. U.S. facilities may be seeing some fruits of their labor: The Food and Drug Administration reported that from 2007 to 2008, TRALI fatalities decreased from 34 to 16.

“This is the first clear U.S. data that interventions may be working,” said Darrell Triulzi, MD, director of the division of transfusion medicine at the University of Pittsburgh. He said that at his facility today, more than 90 percent of plasma units come from low-risk donors, and he knows of other centers that have employed similar measures. To gain a larger perspective, AABB conducted a survey in which 136 facilities described what measures they were undertaking to reduce the incidence of TRALI. Some preliminary findings were presented at the AABB Annual Meeting last month and are available at www.aabb.org/annualmeetingnews.

Biovigilance is another way that the blood community will be able to learn more about TRALI incidence. “Biovigilance is absolutely critical,” Triulzi said. “It will capture sublethal cases of TRALI. Tracking deaths [as is FDA mandated] is a start, but we are missing 90 percent of the picture.”

Triulzi emphasized that the blood community has learned a great deal from the U.K.’s Serious Hazards of Transfusion program, but a U.S. version “will be the largest, and it will allow us to detect smaller differences among interventions.”

This article was published in the current issue of AABB News.