Tightening the reins on surgical blood procedures
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,"
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."
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.