Incidence and Risk Factors
Although pregnant women are physiologically well prepared to withstand the “usual” blood loss of delivery (typically 500- 1000 mL), as many as 10% to 15% of deliveries result in excessive bleeding. Obstetric hemorrhage is defined as blood loss exceeding 1500 mL or the need for blood transfusion, and it is the leading cause of maternal mortality. Obstetric hemorrhage has many potential causes, including uterine atony, rapid or prolonged labor, previous pregnancies, uterine infection, failure to deliver the placenta, lacerations of the cervix or vagina, uterine inversion and the retention of products of conception. Factors that may increase a woman’s risk include prolonged active labor, placenta previa, pre-eclampsia, episiotomy, ethnicity (southeast Asian or Hispanic), obesity and multiple pregnancies. Uterine atony, the most common cause of obstetric hemorrhage, occurs when the uterine muscles fail to contract normally after the delivery of both the baby and placenta. When the placenta separates from the wall of the uterus, the blood vessels that supplied it during pregnancy are severed, resulting in uncontrolled bleeding in the absence of normal uterine contraction.

Recent findings published in the British Journal of Obstetrics and Gynaecology detailed the incidence and risk factors for severe obstetric hemorrhage.¹ During a five-year period, out of more than 307,000 births considered from national data, researchers identified severe obstetric hemorrhage in 3,501 births, or 1.1% of cases. Women undergoing emergency cesarean delivery had the highest adjusted odds ratio for severe hemorrhage at 3.61 (meaning a 360% increased incidence), followed by those with Von Willebrand’s disease (OR 3.31) and elective cesarean deliveries (OR 2.47). In addition, mothers older than age 40 were more likely to suffer severe hemorrhage than those in the 25-to-29-year age range, with an odds ratio of 1.41. Obstetric hemorrhage was also the topic of a Joint Commission Sentinel Alert published in January 2010.²

Approaches to Treatment
Traditional management of obstetric hemorrhage involves searching for the source of the bleeding and implementing steps to stop it. If bleeding is suspected to originate in the uterus, actions that can be taken include uterine massage, which may stimulate the uterus to contract; uterotonics, such as oxytocin; uterine exploration and curettage; and uterine packing. Laparotomy may be performed if other interventions prove ineffective, with the surgeon undertaking repair of uterine injuries and ligation of the internal iliac artery or branches of the uterine artery. In unresponsive cases, an emergency hysterectomy is performed in an attempt to stop the bleeding.³ All cases of severe obstetric hemorrhage are complicated by rapid rates of blood loss since the uterus at term gets almost 1/5th of the total blood flow of the body, and clotting disorders such as disseminated intravascular coagulation (DIC) are common.

Some hospitals are taking a more aggressive approach to treatment, implementing hospital-specific, standardized protocols and responses to manage obstetric hemorrhage. Members of obstetric hemorrhage teams adhere to a “rehearse to be ready” philosophy, practicing responses to different scenarios in order to be prepared in the event obstetric hemorrhage occurs. Of interest, the Illinois Department of Public Health implemented the Obstetric Hemorrhage Education Project in 2008 to develop and implement protocols to reduce the incidence of maternal morbidity and mortality due to obstetric hemorrhage.

The Merits of a Team Approach
Time is of the essence in order to prevent or minimize harm to the baby and mother, and since the best outcomes are obtained through preparation, St. Vincent Women’s Hospital Indianapolis developed the ‘Heme Team’ as an innovative approach to provide the best care available in ‘Code Red’ situations. In cases of obstetric hemorrhage, a complex series of actions must be performed quickly and correctly by a variety of caregivers, including the obstetrician, anesthesiologist, nurses, surgery personnel, neonatal specialists, laboratory technicians and perfusionists/ autotransfusionists. In order to consistently and correctly perform these series of actions in a coordinated way, the Heme Team was formed to study the situation and develop mechanisms to standardize procedures.

Because of the around-the-clock nature of labor and delivery, preparedness drills are performed at various times to cover all shifts. When a case of obstetric hemorrhage occurs, the obstetrician performs standardized surgical management of the patient while the anesthesiologist performs standard resuscitation procedures. The blood bank provides blood product support and the perfusion team responds to the labor suite to provide both diagnostic and therapeutic support. Perfusionists provide point-of-care diagnostic tests to provide clinicians with near real-time information on the patient’s blood counts and coagulation status. Armed with that information, physicians are able to make smarter decisions about blood component therapy and to gauge and track the rate of bleeding. Perfusionists also provide support via autotransfusion machines, which can recycle the mother’s blood and reduce the need for banked blood products, potentially lowering the risk of transfusion-related complications.⁴ In the case of a smaller hospital with limited blood bank resources, autotransfusion can be life saving in cases of massive hemorrhage.

Obstetricians and anesthesiologists must be familiar with the risk factors, causes and treatment of obstetric hemorrhage. Most importantly, training and tools for this infrequent but potentially catastrophic complication must be geared to deal with this scenario at any time of the day or night in order to provide mothers and babies with the best outcomes. As part of the Heme Team, physicians and nurses receive instruction and training in a systematic protocol to treat obstetric hemorrhage. Drills and reviews of cases ground the team in real-world practice and encourage all involved to strive for continued improvement. I strongly recommend that all hospitals providing obstetric services develop a similar approach to the management of obstetric hemorrhage as a patient safety measure and to improve the quality of care.

Submitted by: Timothy Hannon, MD, MBA | Founder & President, Strategic Healthcare Group, LLC

Selected References:

1. Al-Zirqi I, Vangen S, Forsen L, et al. Prevalence and risk factors of severe obstetric haemorrhage. BJOG 2008;115(10):1265-72, 2008.
2. Preventing maternal death. The Joint Commission, Sentinel Event Alert; Issue 44: January 26, 2010.
3. Bodelon C, Bernabe-Ortiz A, Schiff MA, et al. Factors associated with peripartum hysterectomy. Obstetrics & Gynecology 2009;114(1):115-23.
4. Waters JH. Indications and contraindications of cell salvage. Transfusion. 2004;44:40S-44S.

Although the first generation of autotransfusion machines had a number of safety and quality issues, modern autotransfusion machines operated by trained individuals are a safe, efficient and cost effective way to reduce the need for banked allogeneic blood. These machines wash out 90- 95% of supernatant contaminants and debris, and return a high percentage of shed blood with good technique. A distinct advantage of autotransfusion blood is that it is fresh and autologous, a tremendous bonus as we increasingly ponder the risks of allogeneic blood and the “storage lesion.” The general indications for autotransfusion include an anticipated blood loss of 20% or more of the patient’s estimated blood volume; when blood would ordinarily be crossmatched; when more than 10% of patients undergoing the procedure require transfusion; or when the mean transfusion for the procedure exceeds one unit. In my experience, autotransfusion is an overlooked and underutilized strategy in most hospitals across the nation. A prime reason is an underestimation of the relative risks and costs of allogeneic blood products, leading to poor risk-benefit and cost-benefit comparisons between banked blood and autotransfusion. Other reasons include a lack of availability of the technology in some hospitals, and misperceptions about absolute vs. relative contraindications for autotransfusion.

Autotransfusion has been traditionally used in cardiac, vascular and orthopedic surgery, and it’s use has been contraindicated in contaminated intra-abdominal surgery, obstetrics and cancer surgery. Several studies in the last decade have moved these types of surgeries from absolute contraindications to relative contraindications. Studies such as Dr. Brown’s case series have shown autotransfusion to be safe and potentially lifesaving in trauma patients, and Dr. Waters has spent years proving that autotransfusion can also be safe in obstetric hemorrhage.² Obstetric hemorrhage is the leading cause of maternal death during childbirth, so adding autotransfusion as an option in severe hemorrhage is a recommended component of an OB hemorrhage response team. Autotransfusion has also been shown to be safe in some cancer surgeries, such as radical retropubic prostatectomy.³ Although autotransfusion machines are ineffective in washing out all cancer cells, it has been noted that these patients already have circulating cancer cells at the time of operation and that those returned cells may be incapable of metastasizing. Further, using the patient’s own blood can potentially avoid the immunosuppressive effects of allogeneic blood. Not all cancer surgeries are amenable to autotransfusion, and Dr. Waters recommends the use of a leukoreduction filter to further reduce cancer cells from the washed, shed blood.⁴

A final point of discussion is that not all autotransfusion is created equal. Some orthopedic and cardiac surgeons continue to return unwashed wound shed blood to patients postoperatively. It is my opinion as well as the opinion of other experts that the return of unwashed shed blood is not a sound practice.⁵ Blood collected from surgical wounds typically has a low hematocrit and is usually of poor quality from surgical debris and harmful inflammatory mediators. Common complications associated with retransfusion of unwashed shed blood include systemic inflammatory response (SIRS), TRALI, and increased postoperative bleeding as a result of fibrin degradation-induced disseminated intravascular coagulopathy (DIC). Simple filtration systems are insufficient to remove cytokines and fibrin degeneration products, so I feel there is no “safe” amount of this blood that can be returned. If shed blood is of sufficient quantity to be retransfused, it should be washed on a certified autotransfusion device that is operated by qualified personnel. To further complicate the situation, there is concern that the surgical drains themselves may contribute to an increased blood loss in orthopedic surgery. A review of the use of drains in the Journal of Bone and Joint Surgery concluded that the use of drains in primary hip and knee surgery did not decrease complication rates compared to not using drains, but did result in more blood transfusions.⁶ This probably relates to continued “weeping” from cut bone surfaces that is encouraged by drains, as opposed to tamponade with no drain and a pressure dressing. Therefore, there seems to be no role for autotransfusion in unilateral primary hip and knee surgery since the use of drains seems obviated.⁷

Submitted by: Timothy Hannon, MD, MBA | Founder & President, Strategic Healthcare Group, LLC

One of the most serious risks of blood transfusion is an ABO incompatible transfusion or mistransfusion. In 1999 The Joint Commission (TJC) identified mistransfusion as a sentinel event and suggested strategies for reducing transfusion risks. Unfortunately, in 2008 TJC reported 18 transfusion related sentinel events, the highest number reported for any year since TJC began reporting in 1995. Utilizing hospital event reporting systems (ERS) to document mislabeled blood samples and transfusion related adverse events will help prevent mistransfusion sentinel events.

Despite TJC mandates that blood samples be labeled in the presence of the patient, a recent study found that patient misidentification was associated with 88% of pre-analytic laboratory events, largely due to mislabeling during the process of specimen collection. Current laboratory practices of rejecting erroneously labeled specimens without documenting the occurrence provides no opportunity for process improvement. Until such time that technology eliminates opportunities for errors related to sample mislabeling, the ERS should be used to analyze hese events and reduce recurrence.

Just as other types of undesired events in hospitals are subjected to analysis and trending, when an incorrectly labeled sample arrives in the lab there is potential for patient harm and the incident should be subjected to an investigation with appropriate process improvement, staff re-education, and/or retraining. Samples for type and cross match or type and screen that reach the lab with an incorrect label must be subjected to root cause analysis as a potential sentinel event. When the lab representative simply asks the phlebotomist to redraw a mislabeled sample there is no opportunity to learn from the error and correct the system that allowed the error to occur.

The incidence of transfusion errors from patient misidentification is 1: 16,000 – 19,000. The two person verification procedure for transfusions is prone to “become lackadaisical, in essence a rubber stamp, thereby providing false reassurance rather than truly increased safety.” Real time, random surveys of patient identification and transfusion verification procedures should be conducted in all clinical areas that provide transfusions and reported through process improvement systems to help ensure truly independent double checks that promote transfusion safety.

Finally, the procedures used by clinicians for reporting a transfusion reaction or adverse event must incorporate risk management notification. Subjecting that all transfusion related adverse events (including near misses) to appropriate risk review, investigation, and root cause analysis is an essential element for improving transfusion safety.

Healthcare risk management programs have the tools necessary to support transfusion safety initiatives; however event reporting systems and random clinical practices surveys are seldom utilized to improve sample labeling accuracy and patient identification and transfusion verification procedures. Incorporating established event reporting systems and patient safety initiatives into transfusion oversight is essential for preventing mistransfusion.

Submitted by: Susann Stephenson, RN, JD | Consultant, Risk Management, Strategic Healthcare Group, LLC

This month as we celebrated Nurse’s Week I hope you were all able to reflect on the many contributions that the profession of nursing has made in healthcare. More nursing programs than ever before are embracing evidence-based care models, developing multidisciplinary care teams and establishing professional accountability. Significant progress with hospital initiatives focusing on the prevention of falls, pressure ulcers and hospital-acquired infections are nurse-driven and a testament to the success of coordination and teamwork in the healthcare setting. However, our work is far from finished. Hospital blood management and transfusion safety are two areas that have received minimal attention over the years. It is estimated that millions of blood products are ordered without evidence of clinical need each year in the US, resulting in unnecessary exposures to a scarce, expensive and hazardous resource. It is also estimated that 1 in 12,000-16,000 transfusions (over 2000 annually) are administered to the wrong patient, a startling number that has remained unchanged for 30 years. The nursing profession must accept a vital role in improving hospital transfusion practices if we are going to make our patients safer. The growing national focus on appropriate blood utilization and transfusion safety demonstrates the importance of blood management from a quality, safety and stewardship standpoint. Although blood management programs typically focus on physician blood utilization practices, nursing owns several crucial roles in transfusion safety. These four major roles are described below.

• Educator: educating nurses on safe transfusion practices and the management of transfusion reactions; encouraging the use of evidence-based guidelines by physicians; patient education about the risks, benefits and alternatives to transfusion
• Advocate: advocating safe and appropriate transfusion practices for our patients (right patient, product, dose, time, indication), as well as the effective use of transfusion alternatives
• Technician: managing the technological and complex aspects of safe blood administration
• Assessor: vigilant patient assessment during and after transfusion to identify adverse events early and minimize patient harm.

Nurses are the single largest group of healthcare professionals in the country, making them a powerful force to help improve patient care. As patient advocates and knowledgeable caregivers, educated and enthusiastic nurses must play a significant role in promoting evidence-based practices and optimizing the safety of the transfusion process.

Submitted by: Joseph Thomas, BSN, RN | Vice President, Clinical Systems, Strategic Healthcare Group, LLC

In the current environment of healthcare reform, the pressure for cost savings and cost effective healthcare has never been greater. As I define it, blood management is about quality, safety and stewardship, with a goal to ensure the careful and responsible management of the community blood supply as well as the safe and efficient use of healthcare resources involved in blood management. Blood management promotes the optimal use of blood products. Implementing evidence-based guidelines successfully is the most cost effective way to reduce unnecessary blood expenditures. A previous newsletter article emphasized effective blood utilization committees as the heart of blood management programs, making sure patients get no more or no less blood than they need. A quote by Dr. Donald Berwick from the Institute of Healthcare Improvement that sums up this balanced approach is: “Patient’s should get all the care they need and none they don’t; safely, efficiently and at low cost.”

Blood costs are increasingly on the minds of hospital administrators and have recently been in the news1,2. As hospitals try to reduce costs, they first focus on non-labor associated costs savings (e.g., supplies) because lowering operating costs is more popular than laying off healthcare workers. As chief executives lean on their departments to find supply chain savings, laboratory directors quickly discover that their #1 cost item is blood products. In spite of the fact that the price of blood products has tripled since 2001 and that blood use is increasing in most hospitals, lab directors and hospital administrators previously looked at these blood expenditures as the ‘cost of doing business’. In other words, their perception was that these costs were unavoidable, assuming that blood was being used appropriately within their hospitals. The literature and our experience has shown that most U.S. hospitals over-transfuse by at least 20- 30% because of a failure to adapt more conservative, evidence-based guidelines and because of a lack of proactive management of patients at risk for transfusions. As such, better blood management becomes an essential strategy for reducing lab costs while improving quality and patient safety. The word is finally getting out that blood management saves blood, saves dollars and saves lives.

The cost of blood products is a topic that I am very familiar with because I wrote a book chapter on transfusion economics as part of my MBA3. One of the most interesting discoveries for me was the tremendous cost of transfusion costs – icebergstoring, testing, dispensing and administering blood products within the hospital. Blood is a very resource intensive product, consuming large amounts of med tech and nursing labor, as well as significant amounts of supplies and allocated overhead. One activity based accounting study concluded that the cost to purchase blood represents only 19% of transfusion-related costs, and that the total cost to transfuse a unit of blood (in 2009 dollars) was from $850- $9404. A study published in this month’s journal Transfusion used an even more detailed accounting method in a review of surgical blood transfusions. This study also concluded that blood purchase costs represent only 21%- 28% of transfusion-related costs, and that the cost to transfuse a single unit of blood was from $726- $11835. While these costs are considerable, an additional accounting for the cost of transfusion-related adverse events can more than double the final cost to $2100- $3200 per unit6. A variety of controlled studies have demonstrated a direct relationship between the amount of blood products that a patient receives and serious complication rates. These complications are largely due to the immunosuppressive effects of donor blood and include stepwise increases in infection rates, ventilator support times, ICU and hospital length of stay, short term and long term mortality and cancer recurrence rates7. It should be evident from the previous discussion that the total cost of transfusing patients is substantially more than just the cost to buy it. The cost of purchasing blood products is merely the tip of the iceberg of total blood costs, when accounting for transfusion-related labor, supplies, overhead and potential adverse effects.

I hope you can join me for an upcoming Blood Management UniversityTM webinar, “Blood Management Economics” on April 22nd at 1 PM EDT. In addition to exploring the costs of producing and transfusing blood products, we’ll discuss the merits of developing a business case for blood management. A blood management business case is essential for gaining support to start a program, and it also provides ongoing financial metrics for program sustainability and growth.

Submitted by: Timothy Hannon, MD, MBA | Founder & President, Strategic Healthcare Group, LLC

Selected References:

• 1 Tracy D. Blood is big business: why does it cost so much? Orlando Sentinel, April 5, 2010.
• 2 Annual costs total $1.6 to $6 million per hospital surveyed warranting improved conservation & cost containment strategies. PR Newswire, April 5, 2010.
• 3 Hannon TJ, Paulson-Gjerde, K. Contemporary economics of transfusions. In: Perioperative Transfusion Medicine (2nd ed), 2005, Spiess BD, editor. Williams & Wilkins: Baltimore.
• 4 Cremieux PY, Barrett B, Anderson K et al. Cost of outpatient blood transfusion in cancer patients. J Clin Oncol 2000;18:2755-61.
• 5 Shander A, Hoffmann A, Ozawa S, et al. Activity-based costs of blood transfusion in surgical patients at four hospitals. Transfusion 2010;50:753-65.
• 6 Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy, 2007;27(10):1394-1411.
• 7 Blumberg N, Kirkley SA, Heal JM. A cost analysis of autologous and allogeneic transfusions in hip replacement surgery. Am J Surg 1996;171:324-30.

Submitted by: Joseph Thomas, BSN, RN | Vice President, Clinical Systems, Strategic Healthcare Group, LLC

Preoperative preparation and planning are essential for the safe and optimal management of surgical patients. This principal applies to the management of preoperative anemia in elective surgical patients with anticipated major blood loss. As the use of autologous predonation continues to fall out of favor due to its ineffectiveness as a blood conservation measure, there is growing interest in proactively addressing anemia in high risk surgical patients. Of all the risk factors for transfusion in surgical procedures, low red cell mass is consistently at the top of the list; more importantly, it is one of the few risk factors that is modifiable. Anemia and transfusion in surgical patients have been associated with a higher incidence of complications, including infection, longer length of stay, and increased perioperative mortality. Early identification of anemia in surgical patients has recently gained national attention as it falls under one of the Joint Commission’s Blood Management Performance Measures, currently being beta tested in 75 hospitals. As such, early recognition of anemia in surgical patients may soon become a requirement rather than a recommendation for hospitals.

In order to successfully establish a preoperative anemia management program, a multidisciplinary, multimodal approach is required. The following are recommended steps to establish such programs:

1. Develop a multidisciplinary team to lead the initiative (representatives from surgery and anesthesia, administration, nursing, preadmission testing, orthopedic case manager/coordinator, physician liaison, pharmacy and finance)
2. Identify a physician champion that will help to develop and utilize the protocol
3. Review the literature and develop a preoperative anemia protocol/order set for the use of epoetin alfa and iron supplementation in elective surgical patients
4. Develop a strategy for early identification of anemic high risk surgical patients at least one month prior to elective major blood loss surgery
5. Establish a location where the preoperative patients can be evaluated and treated under the protocol/ order set
6. Determine where and how the protocol/ order set will be first be rolled out
7. Prospectively capture outcomes data and financial data (reimbursement) for patients on the protocol to support its continued use.

While the steps described above are fairly straightforward, there are also cultural challenges to address, including ownership and accountability for the protocol. Education about the risks of anemia and transfusion, along with the benefits of better preoperative patient preparation are necessary prerequisites to implementing such protocols. This education should target surgeons as well as their office staff, and patient care guides describing blood management options should also be provided.

Early identification and management of patients at risk of complications is an increasing focus of regulatory agencies and hospital systems, and a number of third party insurers are pushing for financial alignment through non-payment of “never events.” Preoperative anemia management programs present a tremendous opportunity to reduce a modifiable risk for our patients, and I challenge you to join the growing number of hospitals establishing such programs.

Selected References:
• Dunne JR, Malone D, Tracy JK, et al. Perioperative anemia: an independent risk factor for infection, mortality, and resource utilization in surgery. J Surg Res 2002, 102:237:244.
• Faris PM, Ritter MA, Abels RI. The effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation. The American Erythropoietin Study Group. J Bone Joint Surg Am 1996, 78:62-72.
• Goodnough LT, et al. Detection, Evaluation and Management of Anemia in the Elective Surgical Patient. Anesth Analg 2005;101:1858-61

February is always a good month to talk about blood utilization oversight because it is the anniversary of the Transfusion Requirements in Critical Care (TRICC) trial, published in the New England Journal of Medicine on February 11th, 1999.1 In this study, 838 anemic critically ill patients were prospectively randomized into one of two treatment strategies: transfuse at a hemoglobin level of 10 gm/dL, a very traditional approach to these challenging patients, or transfuse at a hemoglobin level of 7 gm/dL, which was a very radical departure from common practice in 1999. The results of this study were shocking and changed the practice of transfusion medicine because the patients who were transfused at the more liberal “trigger” of 10 gm/dL had substantially worse outcomes than those transfused at the more conservative trigger of 7 gm/dL, particularly cardiopulmonary outcomes such as pulmonary edema, ARDS and myocardial infarction. Further, hospital mortality rates were also higher in those patients transfused more liberally. The conclusion of the authors back in February of 1999 was that “a restrictive strategy of red cell transfusions is at least as effective as and possibly superior to a liberal strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction or unstable angina.” Of great interest, even the exception to the rule noted by the authors, those patients with acute coronary syndromes (ACS) have now been shown to also have higher mortality rates when transfused liberally.2,3,4 The results of the TRICC trial coined the phrase “less is more for transfusions,” a concept whose evidence has grown even stronger over the past decade. An editorial comment that I regularly make from the podium is that although the TRICC trial is ranked as the #1 landmark study that has changed transfusion practice worldwide,5 how many physicians who regularly order blood products within our hospitals are familiar with this now 11 year old study?

Before you get the impression that I’m throwing physicians under the bus, let me explain that they are not entirely quote to blame. It turns out that most physicians who order blood products, including anesthesiologists like myself, have never received formal training in blood component therapy. Most medical schools do not have a curriculum in transfusion medicine, and most residencies don’t cover the subject at all. Absent standardized training, what medical students and residents get is on-the-job training, which is only as good as the person doing the training and of course varies greatly from institution to institution. For that reason, transfusion practice is essentially inherited from the institution where a physician trained and is therefore shrouded in habits, misconceptions and myths. To put this issue into greater perspective, blood transfusions are the second most common procedure in U.S. healthcare, second only to live births, with 30 million units of blood products a year being ordered mostly by physicians not formally trained to do so, and administered mostly by nurses who lack training in transfusion administration and transfusion safety. As if this gap in basic training isn’t serious enough, physicians are often slow to integrate new information into their practices, particularly for issues which they may view as peripheral, e.g. blood transfusions. The Institute of Medicine has stated that it takes physicians an average of 12- 14 years to incorporate advances in evidence-based medicine into their clinical practices, and in the case of more conservative transfusions, the IOM seems to be correct.

With that preamble about the current state of transfusion education and transfusion practice in the U.S., it should be self evident that hospitals need strong and effective blood utilization committees to develop, promote and monitor evidence-based guidelines for blood component therapy. My counsel to clinical and administrative leaders is that they should assume that doctors and nurses arriving from the finest medical schools, residencies, and nursing schools have no idea how to properly order and administer blood products; if it turns out they know what they are doing, it can be a pleasant surprise. The assumption that physicians and nurses lack competency for a therapy that is hazardous in the best of circumstances is the safest bet for our patients, and completely changes our view of the importance of blood utilization committees that are effective.

I hope that you’ll be able to join me for our upcoming Blood Management UniversityTM Live Learning webinar, “Building Effective Blood Utilization Committees” on March 15th at 1 PM EST. Topics for discussion will include the regulatory requirements for blood utilization oversight as well as the Joint Commission’s push for Blood Management Performance Measures, which are mainly centered around measures of the effectiveness of this oversight. More importantly we’ll explore the practical aspects of building effective blood utilization committees, which I believe to be the heart of blood management programs. In addition to discussing important resources for the development of blood utilization committees,6 I’ll detail the three characteristics that I attribute to committees that actually make a difference: multidisciplinary, representative and activist. A multidisciplinary approach is required since blood and blood related resources cross so many hospital departments, including nursing, lab, perfusion, quality, risk management, pharmacy, IT and finance. Representative implies that the committee looks like the departments that actually use blood, meaning there is strong representation of both physicians and nurses from the “bloody” specialties such as cardiac surgery, anesthesia, critical care, orthopedics, oncology and hospitalists. I believe that it is also best practice to have a physician who actually transfuses blood to chair this committee, adding both insight and credibility to the proceedings. The final attribute is that this be an activist committee, on a mission to improve blood utilization and transfusion safety 24/7/365. This is as opposed to a committee that punches the clock once a quarter to meet the minimum regulatory requirements. What we need now, more than ever, are blood utilization committees with the energy and passion to ensure the quality and safety of transfusion therapy while promoting stewardship of the blood supply.

Submitted by: Timothy Hannon, MD, MBA | Founder & President, Strategic Healthcare Group, LLC

Selected References:
• 1 Hébert PC, Wells G, Blajchman MA, et al. A multicenter, randomized, controlled trial of transfusion requirements in critical care. NEJM 1999;340(6):409-68.
• 2 Rao SV, Jollis JG, Harrington RA, et al. Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. JAMA 2004;292(13):1555-62.
• 3 Aronson D, Dann EJ, Bonstein L, et al. Impact of red blood cell transfusion on clinical outcomes in patients with acute myocardial infarction. Am J Cardiol 2008; 102: 115-19.
• 4 Shishebohr MH, Madhwal S, Rajagopal V, et al. Impact of blood transfusions on short-term and long-term mortality in patients with ST-elevation myocardial infarction. J Am Coll Cardiol Intv 2009;2(1):46-53.
• 5 Blajchman MA. Landmark studies that have changed the practice of transfusion medicine. Transfusion 2005;45:1523-30.
• 6 Hannon TJ. Transfusion guidelines: development and impact on blood management. In: Saxena S, Shulman IA. eds. The transfusion committee: putting patient safety first. Bethesda,MD: American Association of Blood Banks Press, 2006:115-29.

Transfusion therapy has come full cycle in Iraq and Afghanistan as fresh whole blood (FWB) use has again found a place in the resuscitation of military casualties. The use of equal ratios of packed red blood cells, plasma and platelets (so called 1:1:1 therapy) to effectively reconstitute whole blood is gaining ground in civilian trauma centers to attempt to replicate the approach of military trauma teams. While this is an exciting and potential live saving therapy, have we considered the “collateral damage” of these trauma resuscitation protocols and does the current evidence support this approach?

The first point to be made is that blood is not a benign substance and has a number of adverse effects that can mitigate or even eliminate clinical benefits. While the most common causes of death for trauma patients within the first 48 hours is either exanguination or massive head injury, after 48 hours the leading causes of death are sepsis, multisystem organ failure and ARDS, all linked causally to blood transfusions in a dose-dependent manner. The great paradox of trauma resuscitation protocols is that the physicians who use them are typically boarded in critical care medicine, a specialty that helped define modern blood component therapy and coined the phrase “less is more” to describe the clinical benefits of conservative transfusion triggers. Even in trauma patients, transfusions should always be used in a cautious and thoughtful manner, giving no more or no less blood than the patient needs based upon the best available evidence.

While much has been made of the experience in Iraq demonstrating the efficacy of “high ratio” FFP:RBC protocols (approaching 1:1), can we extrapolate this data to civilian trauma patients? Beyond the fact that combat injuries are not easily replicated in civilian trauma centers (thankfully) since these patients often have multiple penetrating wounds and massive orthopedic blast injuries, there also has been intermingling of fresh whole blood along with the use of recombinant factor VIIa in military casualties. Further, the most cited military study by Borgman1 retrospectively reviewed combat injuries from 2003- 2005 in Iraq, during which time there were a number of logistic changes to the military trauma system as well as alterations in the medical management of trauma patients. Beyond the military data, there are precautions in interpreting the growing number of papers citing the civilian trauma experience. All civilian studies to date are either retrospective studies or prospective cohorts using retrospective “controls”, again raising the issue of changes in patient care beyond these resuscitation protocols over time. There is also a significant issue in that trauma patients are a tremendously heterogenous group (as opposed to say hip replacement patients) making comparisons across patient groups challenging at best. This particular issue has likely contributed to the undoing of blood substitute studies in trauma thus far. Other issues include a subjective and after-the-fact segmenting of trauma patients into “buckets” of ratio groupings introducing the possibility of bias, particularly since there at times seems to be an overt push to validate reconstituted whole blood (1:1:1 therapy). Most concerning is an issue that has often been overlooked in the discussion section of these papers, the thorny issue of “survivor bias”. The concern here is that only patients who survive long enough to receive treatment get the additional plasma therapy, which then effectively labels nonsurvivable injuries in the lower plasma ratio groups as treatment failures. Best described in a recent paper by Snyder et al, “Therefore, it could be concluded that the nonsurvivors in our study population did not die because they got a lower FFP:PRBC ratio; they got a lower ratio because they died.”3

The final issue to discuss is recently published data from civilian trauma centers that is somewhat at odds with the military data. A review of FFP:RBC ratios and outcomes at two trauma centers (LA County/USC and Grady Memorial) showed no further survival benefit in patients given ratios of FFP:RBC beyond 1:3, suggesting that plasma use in higher ratio protocols might be excessive and wasteful.4,5 The most concerning data comes out of Denver Health where an analysis of their data demonstrated a “U” shaped curve, with a decline in mortality as FFP:RBC ratios increased to 1:3, but as the ratio climbed further to 1:1 mortality rates also increased.6 As the authors discussed, once the therapeutic effect of the plasma has peaked, the adverse effects such as transfusion related lung injury (TRALI) and transfusion associated circulatory overload (TACO) may predominate. Once again we come to appreciate the fact that blood has a very narrow therapeutic window, so the optimal ratio of FFP:RBC in these trauma protocols is much more than an academic question.

I hope that you can join me for a webinar on January 25th at 1 PM EST entitled “Trauma Blood Management: Damage Control Resuscitation and Massive Transfusion Protocols”. In addition to discussing the literature on trauma resuscitation protocols in much greater detail, we’ll review damage control resuscitation including pre-hospital care, adjuncts to trauma resuscitation such as recombinant factor VIIa, and the physiology of Acute Coagulopathy of Trauma Shock (ACoTS). We’ll also discuss strategies to minimize the collateral damage of trauma resuscitation, such as using best-practice massive transfusion protocols, designating a limited number of gatekeepers who can initiate the protocol, incorporating active check points for the continuation of the protocol, and using point-of-care/ near patient testing to convert the approach from empiric to goal-directed therapy at the earliest possible time.

Submitted by: Timothy Hannon, MD, MBA | Founder & President, Strategic Healthcare Group, LLC

Selected References:

¹ O’Keeffe T, et al. A massive transfusion protocol to decrease blood component use and costs. Arch Surg 2008;143(7):686-91
² Borgman MA, et al. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. JTrauma 2007;63:805-13
³ Snyder CW, et al. The relationship of blood product ratio to mortality: survival benefit or survival bias? JTrauma 2009;66:358-64
⁴ Teixeira PGR,et al. The impact of plasma transfusion in massively transfused trauma patients. JTrauma 2009;66:693-97
⁵ Dente CJ, et al. Improvements in early mortality and coagulopathy are sustained better in patients with blunt trauma after institution of a massive transfusion protocol in a civilian level I trauma center. JTrauma 2009;66:1616-24
⁶ Kashuk JL,et al. Postinjury life threatening coagulopathy: is 1:1 fresh frozen plasma: packed red blood cells the answer? JTrauma2008;65:261-71

Of the 14 million units of packed red blood cells administered to 4.8 million patients in the United States every year, approximately 1 percent is administered to pediatric patients. Although a small number when compared to adult transfusions, this still amounts to hundreds of thousands of blood products administered to our smallest and most delicate patient population. One would imagine that such a widely administered product would be regulated to specific clinical review and oversight; however, red blood cell transfusion has not been subjected to the formal risk/benefit analysis that would be routine for new biological therapeutics. Therefore it begs the question, how safe is blood transfusion therapy in children? What are the alternatives to transfusion therapy? What role does blood volume management play in transfusion exposure?

Millions of blood products are transfused each year in the United States–the majority of which are administered by nurses with little formal training in transfusion therapy. While health care resources and the public have focused on the safety of the blood product itself, the safety of the transfusion process has received minimal attention. Transfusions are one of the most hazardous procedures performed by nurses in which complacency, cavalier attitudes, and lack of competence can result in poor patient outcomes. In spite of this, hospitals often meet only the minimal regulatory requirements for nursing education and oversight related to blood component administration. Typically, computer-based training programs, that require little or no skills proficiency, are utilized to fulfill these regulatory mandates. Due, in part, to this knowledge and proficiency gap, a number of regulatory, safety, and quality gaps in the transfusion process have been uncovered in nursing practice audits. A recent multi-center audit of 1602 transfusion administration records was presented at the 2009 AABB Annual Meeting in New Orleans. The results of the audit were alarming and identified specific gaps related to the informed consent process, dual identification prior to transfusion, patient monitoring, and management of adverse events to transfusion. Although blood management programs typically focus on physician blood management practices, nursing practices must also be optimized to improve transfusion safety. Mechanisms to accomplish this must be multimodal and multidisciplinary. Various best practices that have been observed nationally are highlighted below:

• Broad and diverse nursing representation on the Blood Utilization Committee or Blood Management Committee (this must include front line staff nurses).

• Nursing involvement in developing blood management and transfusion safety task forces. These multidisciplinary teams should be established around safety, quality and economic blood management-related opportunities.

• Nursing staff involvement in audits of transfusion documentation and direct observation of blood administration. This is best performed as a peer review process by objective, knowledgeable nursing colleagues (not direct co-workers) and presented to the nursing staff as a “teaching opportunity” and not a “pass/ fail” audit.

• Establish unit-based nursing blood management champions. This is similar to the model employed for wound care, patient safety and infection control champions.

• Nursing education and training models should utilize a multimodal skills-based approach to underscore the importance of properly following nationally-established best practice blood administration procedures.

As health care continues to evolve and progress in the 21st century, team-based patient management will be an essential component for providing high quality medical care. Communication and teamwork with nursing staff remains essential. With over 3 million licensed nurses in the United States, nurses are the single largest group of healthcare constituents in the country. However, considering the educational gaps that exist relating to blood management, nurses must be given the tools to understand the “why” before the “how”. As patient advocates and students of science, educated and engaged nurses can have a significant role in promoting evidence based practices and optimizing the safety of the transfusion process.

Submitted by: Joseph Thomas, RN, BSN | Vice President, Clinical Systems

References:
• Thomas, J., Hannon, T., Parks, J., Sommers, D., Tuttle, B. “Nursing Performance and Knowledge Gaps in Blood Management and Transfusion Safety.” Presented at The Society for the Advancement of Blood Management (SABM) Annual Meeting. Baltimore, MD. September 2008.
• Brooks JP. Reengineering transfusion and cellular therapy processes hospital wide: ensuring the safe utilization of blood products. Transfusion. 2005; 45(suppl 4);1595-1715.
• Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion. 2003;43(9):1190-9.