College of American Pathologists
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Tightening the reins on surgical blood procedures

March 2002
Anne Paxton

Point-of-care autologous blood collection and administration are performed in hundreds of thousands of surgical cases annually, despite a lack of formal standards to assure their safety and efficacy. But that is about to change.

Beginning this month, the American Association of Blood Banks will institute voluntary standards for perioperative autologous blood procedures. Under the standards, institutions may, for the first time, seek accreditation for their perioperative autologous blood programs. But more important, they will have guidelines for running a quality program: 10 quality system essentials governing organization, process control, and equipment safety.

"Traditionally, several perioperative autologous blood procedures have been done in the operating room on devices approved by the U.S. Food and Drug Administration," says Paula J. Santrach, MD, director of intraoperative autologous transfusion in the division of transfusion medicine, Mayo Clinic, Rochester, Minn. "But," she adds, "there’s really been no oversight or standardization of these techniques."

The CAP’s transfusion medicine checklist for its Laboratory Accreditation Program contains three questions on perioperative autologous blood recovery and reinfusion programs. The questions are designed to promote defined responsibilities, acceptable procedures, and oversight by the transfusion service medical director.

The new AABB standards go further, however, by setting up an infrastructure to provide for quality products and services, says Dr. Santrach, who chaired the perioperative standards program unit of the AABB Standards Program Committee.

At the point of care

The standards address three processes that occur in the operating room or in a procedure room in the presence of the patient: acute normovolemic hemodilution, cell salvage and recovery, and component production. Blood banks typically are not involved in these procedures; at most institutions they are done by surgeons or anesthesiologists, perfusionists, circulating nurses, or outside contractors.

Acute normovolemic hemodilution, which was defined and developed nearly 25 years ago, involves removing whole blood from a patient shortly before a surgical procedure that is expected to result in significant blood loss and maintaining the circulating blood volume with acellular fluid. Depending on their hemoglobin count, patients can tolerate the blood donation and benefit from the reinfusion of their own whole blood at the end of the procedure, Dr. Santrach says.

Hemodilution entails collection into standard blood bags and is "pretty straightforward," she adds.

The other two perioperative autologous blood techniques may be more involved.

Cell salvage, or autologous blood recovery, tends to be used in high blood-loss procedures like cardiac or vascular surgery, liver transplants, and some types of orthopedic surgery. "You may take the blood out of the wound, collect it into a reservoir, then directly transfuse it back without filtering," Dr. Santrach says. "The more common procedure is to concentrate, wash, and then give it back to the patient. A centrifuge in the OR pumps blood from the reservoir into a bowl, spins it down, washes it with saline, and brings it back to the patient. It’s a lot more involved, and you need training to do it. It’s not necessarily intuitive or easy."

The third technique, perioperative autologous component production, is almost a manufacturing process. "People are actually starting to make components like platelet gel, platelet concentrate, cryoprecipitate, fibrin glue, or autologous growth factor," Dr. Santrach says. "And all of them have varying steps to end up with a final product."

The practice of perioperative autologous blood collection and administration is widespread, but its use differs from one hospital to another. Because of the Mayo Clinic’s size, Dr. Santrach estimates it handles 4,000 such procedures annually. "Smaller hospitals don’t do as many, and a lot of places won’t do it at all," she says. "It varies depending on the type of surgeries they perform and the number."

Room for error

The amount of errors that occur in perioperative autologous blood processes is unknown. It is mainly cell salvage and processing, rather than hemodilution, that are potential problems, says Richard Weiskopf, MD, professor of anesthesia at the University of California at San Francisco. But since the procedures are unregulated, "Nobody even knows how much of a problem exists," he says.

"There have been reports in the literature of various problems, and certainly questions about the safety and under what circumstances use of the devices is efficacious," says Dr. Weiskopf, a member of the AABB’s perioperative autologous blood standards panel and a former member of the FDA Blood Products Advisory Committee. "The AABB," he adds, "was more concerned about safety issues—ensuring that what is transfused is safe. There have been no standards with respect to how you judge what you’re doing and the product that’s being administered."

Hazy responsibility

How had perioperative autologous blood programs eluded standardization? Statutory limits on the role of the FDA have been a key factor.

"The FDA has important regulatory authority over blood and blood banking, and also regulatory authority over devices," says Dr. Weiskopf. "What they don’t do, once a device is approved, is oversee how that device is used." In much the same way, he adds, the agency doesn’t tell a physician how to administer a drug once it has been approved.

Dr. Santrach compares the approach to perioperative autologous blood programs to attitudes sometimes held toward clinical laboratory testing. "The biggest struggle is that there is not a lot of understanding of what can go wrong and the impact it will have on the patient," she says. "It’s just like with tests; they get done, there’s a result, and the users don’t necessarily have a feeling for the potential pitfalls that could lead to an incorrect result."

A network of Veterans Affairs laboratories recognizes these potential hazards. When the CAP added questions about perioperative autologous blood collection to its transfusion medicine checklist, the South Central VA Health Network, which consists of 10 laboratories, asked its internal quality assurance committee to assess how perioperative autologous blood programs are managed. "We found a multiplicity of arrangements, but none were under the oversight of the transfusion committee or blood bank director," says Elizabeth Cary, MD, chief of clinical pathology at the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Miss., and chair of the laboratory network’s quality assurance committee.

The committee is developing a perioperative blood collection and administration program recommendation policy delineating requirements of the program, such as competency assessment and education of all involved personnel, including contractors. The policy outlines the scope of responsibility for all staff, mandates development of quality assurance monitors, and defines how the transfusion committee can provide consultation. At the G.V. (Sonny) Montgomery VAMedical Center, among the monitors reported monthly to the transfusion committee is the number of perioperative cases performed in that time frame and percent compliance with the quality monitors established for the institution.

Learning the language of quality

Dr. Santrach hopes the AABB standards will be well received. "The biggest change for a lot of people who do this is definitely the essentials-based quality that AABB has. For a lot of folks, it’s a foreign language—just as transfusion centers and donor services were five to 10 years ago." The "language of quality" is the hardest thing for people to understand, "but I’ve gotten pretty positive feedback from people who do this a lot," she says.

Adds Dr. Weiskopf, "It’s completely voluntary, just as other AABB certification is voluntary." And the standards program units are modular, he says. "If an institution wants to be certified for this, they go through the process, but the blood bank can be AABB-certified without this."

Meeting the standards should not be costly, Dr. Santrach predicts. While Mayo Clinic has most of the standards in place, many institutions do not, but in Dr. Santrach’s judgment, some institutions are missing nothing more than the documentation. A lot of people are conducting quality assurance, "but either there isn’t a written procedure or there’s no documentation of what happened. They may just have to think in a different way and put the structure and documentation together to show they have it," she says.

Dr. Santrach has told non-blood bankers that the new standards represent an opportunity for surgery and blood banks to work together and share knowledge. "It’s not that the blood bank has to run the program or be involved in the direction of it. It’s that there’s an opportunity for the two groups to increase their understanding of what each other does," she says.

Perioperative autologous blood programs still need to be improved, contends Dr. Weiskopf. "People are not aware of what it takes to produce a quality, safe product, and there’s been no standard with respect to how those products should be tested," he says. "We don’t think this is the final answer, but we didn’t want to take a giant leap all at once. We wanted to establish something that people could live with and that worked. This is a first step in that direction."

Anne Paxton is a writer in Seattle.

"Standards for Perioperative Autologous Blood Collection and Administration" (stock No. 0131000L01) is available for $85 for non-AABB members and $65 for AABB members. Contact the American Association of Blood Banks, 8101 Glenbrook Rd., Bethesda, MD 20814-2749, or call 301-907-6977. The CAP’s transfusion medicine checklist can be found at TRM_MCD_2005-2006.html.