Recombinant human erythropoietin (rHuEPO) was approved for use in the treatment of anemia in ESRD in 1989.  Over the course of almost a quarter of a century, there have been several revisions in product recommendations, labels and reimbursement for ESAs.  Most of these changes were a result of studies showing an increased risk for thromboembolic phenomena in patients exposed to ESAs.  Specifically, in 2010, an article in the New England Journal of Medicine brought attention to the issue of possible adverse cardiovascular events and the use of ESAs in patients with ESRD¹.  The CHOIR, CREATE, and TREAT studies all, in various ways, pointed to adverse events associated with ESA use in this patient population. ^2-4 Thus, the subsequent “snowball” effect of the FDA revision of clinical indications coupled with the Medicare bundling of reimbursement proved to effectively limit use of these agents. ^5,6 In particular, the current reimbursement bundle from Medicare began phasing in in January 2011.  Along with these issues, there is also a requirement for outpatients with ESRD to maintain a target Hgb greater than 10g/dL. or an additional 1-2% decrease in reimbursement occurs (personal communication).  Given the current reimbursement constraints for ESA use, many nephrologists are choosing to transfuse to maintain this Hgb, viewing the cost associated with transfusion to be less in the long-term than what they might lose with ESAs.

So, if indeed we are beginning to see an increase in transfusion in patients with ESRD, this may be a reflection of the regulatory and reimbursement changes as noted.  Unfortunately, the medical community, as well as the FDA and Medicare, have likely not taken into account the true “costs” associated with chronic transfusion therapy.  These costs are NOT limited to merely the direct acquisition cost but include the indirect dollars accumulated in donation, testing, processing, issuing and administering RBCs.  The cost of adverse events associated with transfusion must also be considered, especially in this somewhat precarious patient population.  These include, but are not limited to: transfusion-related immune modulation, transfusion-related iron overload, transfusion-related circulatory overload, transfusion-related acute lung injury, potential for hemolytic transfusion reactions and possible transfusion-transmitted diseases. Overall dollars attributed to transfusion may actually be close to $1200/unit and outpatient reimbursement for transfusion represents only a fraction of this. ^7,8

I certainly understand the physicians’ hands seem often to be tied. However, the “costs” in terms of dollars or poor clinical outcomes associated with transfusion should clearly be considered in the decision-making process for this group of chronically-ill anemic patients.  Another significant population to be considered in the same light is the Hematology/Oncology patients with chemotherapy or radiation therapy-induced anemia.  If reimbursement has not affected this group, it likely will in the foreseeable future.

This appears to me to be another example of the cavalier attitude that surrounds transfusion therapy and unfortunately our government agencies are feeding the frenzy!

REFERENCES

1.  Unger EF. Erythropoiesis-stimulating agents-time for a reevaluation. N Engl J Med, 2020;362:189.
2. Szczech LA et al. A secondary analysis of the CHOIR trial shows that comorbid conditions differentially affect outcomes during anemia treatment. Kidny Int, 2010;77:239
3. Druecke TB et al. Normalization of hemoglobin levels in patients with chronic kidney disease and anemia. N Engl J Med, 2006; 355:2071
4. Pfeffer MA et al. A trial of darbapoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med, 2009; 361:2019
5. Speigel DM et al. Changes in hemoglobin level distribution in US dialysis patients from June 2006 to November 2008. Am J Kidney Dis, 2010; 55:113
6. Weiner DE, Watnick SG The 2009 proposed rule for prospective ESRD payment: Historical perspectives and public policies- bundle up! Am J Kidney Dis, 2010; 55:217
7. Shander A et al. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion, 2010; 50:753
8. CMS Publishes 2012 Hospital Outpatient Prospective Payment System Rule,  http://www.aabb.org/programs/reimbursementinitiatives/Pages/12hoppsrule.aspx

Hospitals often use pre-printed transfusion order forms drafted by the Blood Utilization Committee. As a mechanism to encourage compliance and to support auditing, the Blood Bank will not release blood products without the completed order form (except for emergencies). The order form is usually completed by a nurse taking a verbal order or transcribing a written order onto the form. Sometimes the physician does not provide an indication for a transfusion. The reality is that most of the time the nurse uses her best judgment (e.g. recent labs) to complete the form, however only care providers licensed to order blood products may diagnose the clinical indication for a transfusion.

A pre-printed or electronically formatted transfusion order form that has been approved by the medical staff is a valuable patient care tool: it encourages providers to comply with transfusion guidelines and communicates necessary clinical information from the ordering provider to the Blood Bank staff and to the transfusing nurse.

If a physician writes a transfusion order without an indication or does not document the indication on the hospital’s transfusion order form, the nurse must clarify the order with the prescriber. Regardless whether the nurse ‘knows’ the transfusion indication for her patient, failing to clarify the order would likely be practicing beyond the scope of a nursing license.

Nurses receiving verbal orders are taught to write the order in the patient’s chart then read it back for confirmation. The nurse receiving a verbal order for transfusion should document the order directly onto the transfusion order form; if the physician fails to state the indication, the nurse should ask the physician before reading back the complete order.

Physician noncompliance with approved medical staff procedures is a peer review matter. Effective leadership, for example through the hospital’s Blood Utilization Committee, can address any issues or concerns with communication and safe prescriber behavior.

References

1. AABB 5.19.2 (Transfusions shall be prescribed and administered under medical direction.)
2. AABB 5.11.1 (Transfusion service shall accept only complete, accurate, and legible requests.)
3. CAP TRM. 40850
4. Roback. Evidence based plasma guidelines. Transfusion 2010; 50:1227-1239.
5. Napolitano. Clinical Practice Guideline: RBC transfusion in adult trauma and critical care. Crit Care Med 2009; 37(12):3124–3157.

Slichter, Evidence based platelet transfusion guidelines. Hematology 2007; 172-178.

10. Hovav, et al. Transfusion. 1999;39:277-281

Transfusion has been a mainstay of patient care for years.  It is identified as the #1 procedure performed in hospitals.¹  The development and ultimate use of specific blood components has provided ways to tailor transfusion therapy to the patient’s clinical needs.  Processing and storage of blood components, although allowing for more targeted and diverse therapy, also may have its attendant downside.  Transfusion, of course, is certainly life-saving in many instances, however recent attention and scientific literature have highlighted the increased risk-to-benefit ratio associated with transfusion.  The so-called “storage lesion” may play a part in some transfusion-associated adverse events.

There are well-documented changes that occur in vitro with stored blood, RBCs in particular.  These include decreasing concentration of 2,3-DPG, release of free hemoglobin, formation of microparticles, and nitric oxide interactions, all of which may be pro-inflammatory or pro-thrombotic, thus affecting oxygen delivery to the tissues. ^2-5 These changes may progress over the lifetime of the RBC unit; shelf-life currently being 42 days, refrigerated.

These current studies have encouraged many clinicians to cast doubt on the ability of “older” RBCs to provide adequate oxygen delivery for anemic patients.  The difficult questions remain and indeed are not limited to the following:

1)      Is there clear clinical evidence that “older” RBCs do not provide adequate tissue oxygenation in vivo?

2)      What is the definition of “old” blood?  Is this >7days, >14days, >21 days or somewhere in between?

3)      Is there some recovery of older RBCs once transfused into the patients’ intravascular milieu?

4)      Are only certain patient populations with specific comorbid conditions at risk?

5)      If indeed the storage lesion is clearly identified and defined, how will this affect acquisition of whole blood donations throughout our communities, i.e. what are the implications for stewardship and inventory management that would be necessary to maintain our blood supply?

6)      How does one currently deal with the ethical issue of providing “younger” units to certain subsets of patients and not others?

Several prospective randomized controlled trials are currently proposed and enrolling patients to study these exact questions^{. 6-8} These are single-center as well as multicenter studies, involve adult and pediatric populations, and interestingly have varied definitions of the “age” of RBCs.   Until the time that these studies report their findings, it is unlikely that a paradigm shift to “younger and fresher”  blood is necessary or even possible.

At this particular point, I would agree with Dr. Dzik in his 2008 Transfusion Medicine article:

“Given the fragile balance of blood supply and demand on which modern medicine depends, the decision to reduce the period of allowable storage is an important one that deserves data generated from carefully designed prospective RCTs.  Let us do the studies and find out the truth.” ⁹

In other words…soldier on and stay tuned…

References

1. The 2009 National Blood Collection and Utilization Survey Report. http://www.aabb.org/programs/biovigilance/nbcus/Documents/09-nbcus-report.pdf
2. Roback J  Vascular effects of the red blood cell storage lesion.  Hematology: Transfusion Medicine: Adverse Complications of Stored Blood,  Amer Soc Hematol, 2011.
3. Yazdanbakhsh K et al.  Immunoregulatory effects of stored red blood cells.   Hematology: Transfusion Medicine: Adverse complications of Stored Blood,  Amer Soc Hematol, 2011.
4. Hovav T et al.  alteration of red cell aggregability and shape during blood storage.  Transf, 1999;  39: 277.
5. Mini-Symposium on RBC Storage. Transf, 2011;  51: 844-900.
6. Paxton A  RBC storage duration: Is older riskier?  CAP Today, 2011;  25:10.
7. Pavenski K et al.  Red blood cell storage lesions and related transfusion issues: A Canadian Blood Services research and development symposium.  Transf Med Rev, 2012; 26: 68.
8. Van de Watering L (for the BEST Collaborative)  Pitfalls in current published observational literature on the effects of red blood cell storage.  Transf, 2011; 51: 1847.
9. Dzik W  Fresh blood for everyone? Balancing availability and quality of stored RBCs.  Transf Med, 2008; 18: 260.
10. Hovav, et al. Transfusion. 1999;39:277-281

Pre-disposing conditions such as: uterine atony, placenta  previa, placenta accreta, uterine abruption,  retained placental elements, prolonged labor, lacerations occurring with delivery and underlying congenital coagulation disorders, can place patients at risk for associated postpartum hemorrhage.  Hemorrhage is frequently acute in onset,  severe, and may be associated with coagulopathy. Postpartum hemorrhage still  remains a significant cause of morbidity and mortality even in developed
countries.  Thus, the need for detailed and effective protocols is essential.

The California Quality Care Collaborative Task Force, in 2010, reported on their effort to provide comprehensive discussion, guidelines, references and tools for rapid diagnosis and intervention for obstetric hemorrhage.¹   This group advocated team-based continuing education and drills to maintain competency and heightened awareness of obstetric hemorrhage. This idea of protocol-driven drills was recommended previously by The
Joint Commission.²

Goodnough et al. review their institutional processes in the “How Do I..” section of the December, 2011 issue of Transfusion. ³ Their policies and procedures have been based on accumulating evidence and analysis of the needs of this particular patient population.^4-6 Coagulopathy associated with obstetric hemorrhage likely has different inherent initiating
events than those associated with trauma. Ongoing research and evidence-based guidelines will hopefully bridge the gaps in our current knowledge allowing better, more rapid recognition, monitoring, and treatment for these patients.

The single most important feature of obstetric hemorrhage that sets it apart from other clinical scenarios is that it is not just one life that is to be considered, but the lives of two individuals: mother and baby.  Collaborative management of postpartum hemorrhage thus demands coordinated, practiced efforts to consider the risk: benefit ratio and interventions that affect a mother and child.

References:

1. Lyndon A. Improving health care response to obstetric hemorrhage. California Maternal Quality Care Collaborative.
2. The Joint Commission. Healthcare at the Crossroads: Strategies
   for Improving the Medical Liability System and Preventing Patient Injury
   2005 May27.
3. Goodnough T. How we treat: transfusion medicine support of obstetric services.
   Transfusion 2011 Dec; 51(12):2540-48.
4. Butwick AJ. Retrospective analysis of transfusion outcomes in pregnant patients at a tertiary obstetric center.  Int J Obstet Anesth  2009 Oct; 18(4):302-8.
5. Burtelow M. How we treat: management of life-threatening primary postpartum
   hemorrhage with a standard massive transfusion protocol. Transfusion 2007 Sep; 47(9):1564-72.
6. James AH. Blood component therapy in postpartum hemorrhage. Transfusion 2009 Nov; 49(11): 2430-33.

In 1999, TJC reported² that the causes of transfusion sentinel events most commonly fell into six general categories: care planning, information-related (patient identification and labeling), staff training and sufficiency, communication, patient assessment, and product storage outside blood bank.

In the 2011 report, leadership is identified as the most frequent cause of mistransfusions, with leadership being defined to include standardization (e.g. guidelines, (aka planning)), culture, resource allocation and policies. Other common root causes continue to be information management, staff training and sufficiency, communication, patient assessment and physical environment.

Although definitions have been refined, some terminology has changed, and leadership is now being recognized as an independent cause of sentinel events at the bedside, the healthcare community still has lessons to learn when it comes to improving blood transfusion safety. The causes of the 2011 transfusion-related adverse events appear to be very much the same as the root causes identified in the Sentinel Event Alert that TJC published in 1999.²

A comprehensive, evidence-based blood management program addresses each of the root causes of transfusion related sentinel events: Physicians who order blood products must receive formal training in blood management and implement standardized transfusion guidelines based upon current scientific evidence.^3,4,5  Similarly, nurses need continuous formal training in transfusion safety and blood administration competency.⁶ Finally, effective blood utilization oversight is required to assure appropriate care planning for patients at risk of significant blood loss, the safest possible resource allocation, and transfusion guidelines based upon best practice. Until hospitals embrace a meaningful blood management program, patients will continue to be at risk for unnecessary blood product administration and transfusion-related sentinel events. The lesson, as always, is to apply current evidence to improve the quality of care and patient safety.

References

1. http://www.jointcommission.org/sentinel_event.aspx
2. Sentinel Event Alert No. 10, Blood Transfusion Errors: Preventing Future Occurrences, The Joint Commission, Aug. 30, 1999.
3. Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion 2003; 43:1190-9.
4. Stover EP, Siegel LC, Parks R et al. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology 1998;88:327-33.
5. Corwin HL, Gettinger A, Pearl RG et al. The CRIT Study: Anemia and blood transfusion in the critically ill–current clinical practice in the United States. Crit Care Med 2004;32:39-52.
6. Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy 2007;27:1394-411.

© Strategic Healthcare Group LLC

Last’s week’s Journal of the American Medical Association included a clinical crossroads case study on autologous predonation (1). The scenario was a relatively healthy, non-anemic woman (“Mrs. C”) who was scheduled for elective knee replacement surgery and was asking for advice on blood avoidance options.  Her specific concerns were voiced as: “Personally, I do not want anyone else’s blood. I believe I should give my own blood for safety reasons. I read the paper a lot and watch the news, and you hear so much about infectious diseases. That’s my concern; I have never had an infectious disease in my life and at this age, I don’t think I want to get one.”(1)  From her standpoint, she logically inquired about options such as predonating her own blood prior to surgery or using a directed donor.

I am sure that this is still a common question from patients, and I view it as a great opportunity to provide patient education and an informed consent discussion for transfusion.  Mrs. C is right to be concerned about the risks of transfusion, but she is right for the wrong reason.  While the general public is concerned about the risk of transmittable disease such as HIV and hepatitis, these risks have been reduced to less than 1:1,000,000 through the use of donor deferrals and donor testing.  While the blood industry remains vigilant for the next emerging threat such as Chagas Disease and Babesiosis, the clear and present danger is the non-infectious serious hazards of transfusions, which occur with a frequency that is 10x- 100x times more frequent than viral transmission.  The most significant of these adverse events are mistransfusion due to clerical errors, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion related immunomodulation (TRIM) (2, 3).  There is also growing concern about the adverse effects of blood related to its storage (4).  Patients and providers are often unaware of these non-infectious hazards, and that lack of awareness can lead to inappropriate risk-benefit treatment decisions and improper informed consent.

The second issue is Mrs. C’s concern to reduce her need for a blood transfusion. Mrs. C should be reassured that she is at low risk for transfusion given her ample hemoglobin and expected blood loss.  Pierson published an algorithm for orthopedic blood conservation based upon the expected blood loss from a procedure and the preoperative hemoglobin (5).  For a unilateral primary knee replacement, the expected blood loss would be 4.8 gm/dL, which includes an extra 1 gm/dL safety factor.  Given her starting hemoglobin of 15.1 and expected nadir hemoglobin of 10.3 gm/dL, it is highly unlikely she would need a transfusion, at least if evidence-based transfusion guidelines were used.

If Mrs. C was undergoing a revision or bilateral joint replacement, or if she was significantly anemic preoperatively, I would then counsel her on the best available options for blood management.  While predonation was a great option in the early 1990’s, the risk-benefit ratio has evolved to the point that predonation now offers little safety benefits over allogeneic blood.  The risk of transmissible disease has dropped significantly, blood storage issues are universal and non-infectious risks such clerical errors and TACO can occur just as readily with autologous blood as with allogeneic.  In fact, the anemia of predonation moves patients closer to a transfusion trigger and some physicians use more liberal transfusion triggers for predonated blood in spite of recommendations against this practice (6, 7). Coupled with the fact that patients are typically not given sufficient time to restore red blood cell mass after donating, predonation is no longer a recommended blood conservation approach in orthopedic surgery (8).

Current blood management recommendations for orthopedic surgery include preoperative anemia management protocols, intraoperative use of meticulous hemostasis, regional anesthesia, topical hemostatics, minimization of surgical drains, and the use of autotransfusion in selected cases (8).  The use of antifibrinolytics such as tranexamic acid also seems promising (9).  Coupled with conservative transfusion practice driven by evidence based guidelines, transfusion in joint replacement can be avoided in the vast majority of cases.  The overall strategy has become maintenance of the patient’s own red cell mass, or as Woody Allen quipped, “the best place for blood is in our veins.”

Perhaps the most important modifiable risk factor for transfusion is what hospital door Mrs. C walks through on the morning of surgery.  Transfusion practice is notoriously variable in the U.S., and can vary tremendously from hospital to hospital and among surgeons within the same hospital (10).  Asking her surgeon about available blood management options and his or her transfusion rate should be questions at the top of her list.

References

1. Uhl, L. A 68-year-old woman contemplating autologous blood donation before elective surgery. JAMA 2011;306(17):1902-1910.
2. Boucher BA, Hannon TJ.  Blood management: a primer for clinicians.  Pharmacotherapy, 2007;27(10):1394-1411.
3. Despotis G, Eby C, Lublin DM.  A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion 2008;48:2S-30S.
4. Spinella PC, Doctor A, Blumberg N, Holcomb JB. Does the storage duration of blood products affect outcomes in critically ill patients? Transfusion 2011;51(8):1644–50.
5. Pierson J, Hannon TJ, Earles DR.  A blood conservation algorithm to reduce blood transfusions after total hip and knee arthroplasty.  JBJS 2004;86A(7):1512-18.
6. Shander A. Surgery without blood. Crit Care Med 2003;31:S708–14.
7. Gould SA, Forbes JM. Controversies in transfusion medicine: indications for autologous and allogeneic transfusion should be the same: pro. Transfusion 1995;35:446–49.
8. Hannon TJ, Pierson J.  Blood management.  In:  American Academy of Orthopaedic Surgeons Comprehensive Orthopaedic Review, Lieberman JR, editor. AAOS 2009; Rosemont, IL.
9. Alvarez JC, Santiveri FX, Ramos I, et al. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion 2008;48(3):519–25.
10. Bennett-Guerrero E, Zhao Y, O’Brien SM. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA 2010;304(14):1568-75.

Two studies (one recent and one not-so-recent) shed light on what I think is a fascinating and under-recognized consequence of iron deficiency. The morbidity associated with iron deficiency is not due just to anemia. In fact, the symptoms associated with iron deficiency may have less to do with the anemia itself and much more to do with iron deficiency and its impact on iron dependent cellular metabolism.

The FAIR-HF trial published in the New England Journal (4) randomized 459 patients with chronic heart failure and iron deficiency to receive either placebo or intravenous iron (ferric carboxymaltose).  Fifty percent of the treatment group reported being much or moderately improved on the self-reported Patient Global Assessment tool with improvement in NYHA functional class, six-minute walk test, and other outcome measures. Importantly, the iron deficient patients treated with intravenous iron showed improved functional status regardless of whether their starting hemoglobin was greater than or less than 12 g/dl when enrolled in the study. Could iron deficiency itself, rather than anemia be the more important contributor to the signs and symptoms of anemia?

An animal studied published in 1976 by the University of Washington School of Medicine offers insight into this question (5). In this study rats were made anemic, iron deficient, or both, and their running ability measured using a small animal treadmill. As expected, the rats that were severely anemic with hemoglobin less than 6 g/dl had severely impaired running ability regardless of iron status. However, there was an impressive difference between iron replete and iron deficient rats when the hemoglobin was increased to a level consistent with moderate anemia (10 g/dl). Again, iron deficient animals showed a very limited ability to run. However, there was rapid reversibility of this dysfunction (3-4 days) when iron deficiency was corrected even when the hemoglobin was maintained at only 10g/dl. This correlated with normalization of oxidative phosphorylation in mitochondria prepared from the skeletal muscle of the study animals.

The lesson:  transfusion is almost never the treatment of choice in iron deficiency anemia. These two studies teach us that the treatment for iron deficiency is iron! Iron replacement can be done quickly, easily and safely with intravenous iron in patients with symptomatic iron deficiency (with or without anemia) with rapid clinical and symptomatic improvement of the iron deficient patient.

References

1)      JAMA 1997;277:973

2)      Blood. 2004;104(8):2263

3)      Blood Cells Mol Dis. 2011;46(2):159

4)      N Engl J Med 2009;361:2436

5)      Journal Clin Invest. Vol. 58 August 1976.447

* * *

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The July supplement to Transfusion, the Journal of Blood Services Management, contains an excellent and quite provocative article surrounding the knowledge of the Food and Drug Administration (FDA) reportable deviations.  [1]

For those outside the highly regulated world of the blood donor center or hospital transfusion service, the FDA biologic product deviations (BPDs) are likely unfamiliar.  Specific regulations were defined by FDA in Nov., 2000, which included BPDs and “near-miss” events.[2] Blood establishments and transfusion services are thus responsible for reporting events that could potentially affect the safety, purity, or potency of distributed blood components.  The key element here is the word potential for direct patient harm is not a requirement.

This article seeks to identify if blood center and transfusion service personnel comprehend what constitutes reportable BPDs.  Using a survey containing eight well-defined case scenarios, respondents were asked to identify which should be reportable events (essentially by asking “yes” or “no”).  Respondents, totaling 176, represented various levels of training, including transfusion service medical technologists, supervisors, and directors.  Hospital size ranged from <100-bed facilities to those with >500 beds.

The results of this survey study revealed only 10 of 176 (5.7%) of respondents answered all eight cases correctly.  The job experience, title, size or type of establishment was not associated with knowledge base.  I myself, reviewed these cases as a personal “test” and answered only five of eight correctly. ( I have been, until recently, the Transfusion Medicine Director of a very large complex facility for 20 years!  I have since passed this on to the TSO for my prior service to use an  educational tool.)

As mentioned, this study is quite interesting and provocative for it highlights that even in the highly regulated environment of the blood center or transfusion service, the majority of us do not possess a clear or complete comprehension of the requirements for FDA BPDs.

Very often, the emphasis of safe transfusion therapy is placed on physician/nursing ordering or administration practices.  This article serves to broaden our scope, reminding those of us on the blood center or transfusion service side, that we are also primary stakeholders in providing for the safety, purity, and potency of distributed blood products.  The devil is in the details!

Irrespective of our position, training, title or “real estate”, we all must collaborate in our quest to ensure safe and effective transfusion practices.  All of these efforts direct us to provide (as we say at SHG):

The right product

To the right patient

At the right time

For the right reason.

# # #

[2] U.S. Food and Drug Administration. Guidance for industry: biologic product deviation reporting for blood and plasma establishments. Washington, D.C.: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER); 2006 October, Available from: URL:http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance/Blood/ucm073455.htm

© Strategic Healthcare Group LLC

In honor of National Nurses Week Strategic Healthcare Group would like to recognize nursing’s vital role in blood management and transfusion safety.    

There are nearly 3.1 million registered nurses in the United States¹ and approximately 30 million blood components transfused each year. With this huge demand for nursing care of transfusion recipients, it is no surprise that an emerging role in nursing is the Transfusion Safety Officer (TSO).² A TSO serves as liaison within the hospital environment to ensure that blood management and transfusion related activities are conducted in the safest possible manner and meet or exceed existing evidence based standards of practice. Nationwide, there are less than 30 nurses in the role of TSO. These nursing professionals understand that blood administration is the most dangerous procedure nurses perform at the bedside and they are dedicated to improving the quality of blood management and the safety of transfusion administration.  

The theme for this year’s National Nurses Week is “Nurses Trusted to Care.” Nursing is a profession in which we practice both the art and science of patient care; patients trust us to compassionately deliver evidence based nursing with the goal of helping without harming. Until recent years, the healthcare community considered blood to be a benign substance given to patients to help them feel better. “The medical community often uses blood as if it were a medication to treat both acute and chronic anemia; however, a transfusion of blood actually is much more akin to an organ transplant. As with organ transplantation, immune system modulation disruptions by transfusion are well-known.”⁵ Existing and emerging evidence compels nurses to recognize and understand that a blood transfusion is a cellular transplant, which may cause more harm than good.  

Blood products should be administered with the same regard and caution as high risk medications.³ Indeed, many of the established transfusion administration safety standards have been applied to improve the safety of high alert/high risk medication administration: double check: 1) the right patient, 2) the right medication – treatment, 3) the right dose, 4) the right time, and 5) the right indication. Just as nurses must know the five rights of medication administration, nurses who administer blood products must know the clinical indication, appropriate dose, expected benefit and the risks of transfusion therapy for the patient receiving the transfusion.  

The elimination of transfusion errors remains number one on The Joint Commission’s list of National Patient Safety Goals. Further, the College of American Pathology (CAP) has reported that the most common transfusion safety violations among healthcare systems involve transfusion reaction recognition and annual education in the recognition of transfusion reactions.³ “There is no doubt that nurses must be able to recognize and act on early signs of an adverse event, and that it is dangerous to fail to respond to signs and symptoms of an adverse event.”⁴ The transfusing nurse is responsible for diligent patient monitoring and assessment throughout the infusion of blood products because “transfusion related complications are serious risks of blood administration and major contributors to transfusion associated morbidity and mortality.”⁵  

The role of the transfusion nurse includes advocating for patients to receive blood products based upon scientific evidence. It is incumbent upon nurses to carefully consider each and every potential transfusion exposure, cognitively review the medical decision and the order to transfuse, and correlate the need for transfusion with the patient’s lab results and clinical status. Nurses must be knowledgeable about the risks associated with transfusion therapy and diligent about assessing patients for signs and symptoms of a transfusion adverse event. Nurses must employ both art and science to ensure effective blood management and optimal transfusion safety.  

1. American Nurses Association (ANA) 2010 Annual Report.
2. We recognize that some TSO’s are members of professions other than nursing; however this article focuses on nursing’s role in transfusion.
3.  Sazama K. Practice parameter for the recognition, management and prevention of adverse consequences of blood transfusion. College of American Pathologists. Arch Path Lab Med 2000 Jan;124(1)61.
4.  Oldham J. Right patient, right blood, right care: safe transfusion practice. Br J Nurs 2009 Mar; 12-25;18(5):312.
5.  Klien H. Allogeneic transfusion risks in the surgical patient. Am J Surg 1995 Dec; 170(6A Suppl):21S.
6.  Katz E. Blood transfusion: friend or foe. AACN Adv Clin Care. 2009 Apr-Jun; 20(2):155.

Click to enlarge

After receiving my third phone call in two days from my transfusion service personnel with concerns about our inventory, I realized yet again how important the role of stewardship is to our blood supply. Inventory issues seem more glaringly apparent during inclement weather or holiday seasons, however stewardship should be a continuous and daily activity.

Most transfusion medicine texts comment generally on the role of the transfusion medicine physician or director in helping to steer component inventory and availability for surgical and medical needs.¹ But there are more pieces to this process which should include physicians, nurses, laboratory professionals, administration and the blood suppliers as part of a well defined plan.

I was recently reviewing several websites and found numerous excellent examples of stewardship processes ranging from hospitals in smaller communities in the U.S. to plans for the entire Canadian Blood System.² Several of these plans incorporate a color coded alert system with definitions of product quantity and anticipated availability over the next hours to days.

At Jewish Hospital, we have a color coded alert system in conjunction with our blood supplier that is specifically based on our case mix and complexity. If an alert is issued internally it is communicated via email and text messaging for primary areas of the hospital (e.g. cardiovascular service, transplant service, ED, main OR). The alert is placed on our physician website and a message scrolls on our plasma screens throughout the hospital. The message is updated as needed. Internally the medical staff has approved a list for triaging medical and surgical transfusions during times of shortage. This involves cooperation and coordination between attending physicians, nursing and transfusion service so that components are utilized effectively and efficiently.

Keep in mind too, that roughly one-third of this nation’s population is eligible to donate blood, yet less than 10% of the population donates annually.³ Not only should healthcare professionals be faithful stewards of our hospital inventories and make careful medical decisions for the transfusion of blood components, we should accept and spearhead the civic duty to donate blood whenever possible. This is a simple act of pure volunteerism.

The responsibility falls on each of us to steward blood product inventories not only within our own facilities but throughout the communities where we live and work. We must all be cognizant of our patients and our blood supply whether we provide bedside patient care in a clinical setting or bench-side patient care in the laboratory. Quality, safe transfusion practice is “vein-to-vein,” from donor to recipient. The next transfusion might be for YOUR parent, YOUR child, YOUR dear friend … they all deserve YOUR careful consideration.

Selected References      

1. Hillyer et al. Transfusion medicine and hemostasis: clinical and laboratory aspects. Elsevier Inc., 2009.
2. http://hospital.blood.co.uk/library/

http://www.traqprogram.ca/library/ 

3. http://www.americasblood.org