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.

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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

Click to view PDF

Last month’s article on Guiding Transfusion Guidelines: Part 1 covered the general concepts of implementing clinical practice guidelines. Appropriate transfusion decisions are a critically important and often overlooked part of the transfusion safety chain from donor to patient¹, so evidence-based transfusion guidelines are a necessary piece of blood utilization infrastructure. Perhaps the biggest problem hospitals face is to actually assign hard and fast numbers for transfusion criteria, often referred to as “transfusion triggers,” for specific blood products. In general, physicians don’t like being told what to do (the issue of autonomy) because of the years of training and experience required to practice medicine. Along those same lines, physicians on committees are also uncomfortable telling other physicians what to do, particularly if they aren’t in the same specialty. This general discomfort about being proscriptive with regard to physician practice is amplified by the standard academic comment that physicians should never use transfusion triggers; they should instead carefully assess the physiologic status of each patient individually. The end result is that many hospitals create transfusion guidelines that are purposely broad, and in the end these guidelines provide little help to the clinician trying to make a reasoned decision at the bedside or to the utilization review nurse trying to assess transfusion appropriateness. 

I don’t mean to offend physicians in academic medicine because they have done a tremendous amount to advance our transfusion knowledge, but the statement to never use transfusion triggers is not based in reality. There are two facts in the real world of transfusion medicine, validated on a daily basis by our consulting group:
2)     All physicians, whether they realize it or not, use transfusion triggers based upon the comfort level obtained during their informal training, so hospitals need to reset comfort levels and encourage physicians to center decisions on more current and evidence-based transfusion criteria. 

1)     Most physicians in the US have never received formal training in medical school or residency on blood component therapy, so their transfusion training lacks standardization and is more aligned with habits, misconceptions and myths; 

In particular, the transfusion trigger for red blood cells has been moving to a more conservative level as a result of the findings of the TRICC trial that we discussed in part 1 of this series. Based upon this prospective randomized trial, as well as the ACP Practice Guidelines², we established the transfusion criteria for stable patients without active cardiac disease as a hemoglobin of 7 gm/dL at St. Vincent Indianapolis back in 2001, and we set a hemoglobin of 8 gm/dL for patients with active cardiac disease. At the time, there were a number of objections that certain patient populations required more liberal transfusions than these criteria because the patients had “special” requirements (pulmonary, cardiac, neurosurgery, plastic surgery, orthopedic surgery, etc), but there was no compelling evidence to support these contentions. What we now know is that while anemia may be harmful in many patients, transfusions are increasingly found to be ineffective and can actually worsen patient outcomes. The paradox seems to be that high risk patients are harmed by anemia yet suffer most from the adverse effects of blood transfusions, suggesting that anemia management is our most effective strategy. At the bottom of this article is a link to download the St. Vincent transfusion guidelines we put in place in 2001. We are currently going through a review and will likely do some minor revisions, but they have served us well for the past 10 years. I am also including some other excellent references^3-6 that can help develop transfusion guidelines at your institution. 

The bottom line with transfusion guidelines is that you can’t please everyone, you have to use the best information available, you have to draw a line somewhere, and most importantly these are guidelines not standards. A physician can still make a clinically appropriate and justifiable transfusion decision outside the guidelines; they simply need to document their rationale (deviate but document). I suggest that at the bottom of each group of transfusion indications there should be a final line that states “other indication – please list”. This allows the physician to transfuse “off label” as long as there is documentation to support the transfusion decision. It is then the job of the blood utilization committee to track these “off label” transfusions and over time decide whether they fall into one of three categories: 

1)     Infrequent random use: no action required
2)     Systematic use by an individual physician: requires targeted education
3)     Systematic use by many physicians for a common indication: suggests the need to review and possibly add a new approved indication. 

St. Vincent Indianapolis Hospital Transfusion Guidelines 

Selected References

1. Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion 2003;43:1190-9.
2. Welch HG. Prudent strategies for elective red blood cell transfusion. Ann Intern Med 1992;116:393-402.
3. America’s Blood Centers. The transfusion trigger updated:  current indications for red cell therapy. ABC Bulletin 2003;6(2).
4. American Society of Anesthesiologists. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiol 2006;105:198-208.
5. Rao SV. Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. JAMA 2004;292:1555-62.
6. Napolitano LM. Clinical practice guideline: red blood cell transfusion in adult trauma and critical care. Crit Care Med 2009;37:3124–3157.

Along the lines of better blood use, a recurring question I get from hospital administrators is what is the biggest “bang for the buck” to improve blood utilization within their hospitals? I think in many cases they are expecting me to offer some magic bullet drug, procedure, or reporting system, but the answer ultimately comes down to behavioral change.  In my experience, the single most effective mechanism to improve blood utilization is the successful implementation of evidence based transfusion guidelines.  As such, I want to discuss briefly my lessons learned in this area.

The AABB published an excellent “how to” book on transfusion committees back in 2006, and I wrote the chapter on implementing transfusion guidelines.³ One area I reviewed was the science of implementing clinical practice guidelines. This literature supports several conditions that should be met in the process of guideline implementation:

1. The guidelines should be based on scientific evidence, and their application must be meaningful in clinical practice (they must be worth the effort).
2. Key local physicians who are responsible for adapting them to local circumstances should formulate the guidelines and affected users should have the opportunity to critique them.  This condition emphasizes the need for transparency but does not seek to gain 100% consensus, and also recognizes the importance of local opinion leaders (all politics are local).
3. The guidelines should have readily discernible benchmarks or targets for good practice, emphasizing that data and metrics are key.
4. Active educational efforts should accompany dissemination of the guidelines to all affected healthcare providers, and manual or computerized reminder systems should prompt use of the guidelines at points of intervention.  Providing guidance at the time of the clinical decision is not only important for behavioral modification; it is also a patient safety issue for blood transfusions.
5. Implementation of the guidelines must include either direct feedback on performance to individual physicians or general feedback on system performance.  A multitude of studies have been done on the relative merits of prospective, concurrent and retrospective transfusion audits, with predictable results.
6. Accountability for adherence to the guidelines must come from peer pressure, administrative sanction, and/or financial incentives or disincentives.  This condition of course refers to the proverbial carrot or stick, and the situation is rapidly changing with the advent of Accountable Care Organizations (ACOs).

As I list these six criteria, it should stand to reason that a combination of approaches is more effective than single modalities.  To round off the topic, guideline implementation techniques shown to be ineffective are those that rely on passive dissemination (such as stuffing mailboxes) or a voluntary change in practice that lacks an accountability component.

Now that we’ve covered the general concept of guideline implementation, next month we’ll cross over to the favorite question of every blood management medical director I’ve ever worked with: discussing “the number.”

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. Blajchman MA. Landmark studies that have changed the practice of transfusion medicine. Transfusion 2005;45:1523-30.
3. 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.

The laboratory survey evaluates patient care processes using the tracer methodology. The Laboratory Tracer is a unique way for The Joint Commission laboratory accreditation program to look at test results in the context of the surrounding systems not only within the laboratory, but also in other departments including patient records. The survey’s systemic approach strives to assess the performance of interconnected events and departments, and the impact of performance on patient care. Transfusion services and blood administration are an excellent example of how laboratory processes and adverse clinical events can be evaluated to determine if process issues exist within the organization and drive collaborative process improvement efforts. Joint Commission standards require laboratory oversight for blood administration training and policies, stating that other policies cannot conflict with the laboratory’s role.

A suspected RBC transfusion reaction is the subject of The Laboratory Tracer published in Tracer Methodology 101 from The Joint Commission. The surveyor conducting the tracer began by reviewing the medical record to assess the transfusion documentation and to identify the involved care providers. The surveyor questioned nurses about the transfusion process, patient assessment and transfusion reaction recognition and response. In the laboratory the surveyor reviewed quality control procedures for each instrument used for that patient: the patient had a BMP and CBC in addition to the transfusion. The surveyor also spoke with the technicians who performed the tests and investigated the adverse event. As recommended by The Joint Commission, mock tracers are an excellent way for multidisciplinary teams to review processes to identify gaps or potential missteps.

The Joint Commission has updated and revised its laboratory standards for 2011 including an expansion of the transfusion service standards. Learn more about The Joint Commission’s approach to blood transfusion at our next Live Learning Webinar, January 20, 2011, when Jennifer Rhamy, Executive Director of the Laboratory Accreditation Program at The Joint Commission presents Blood Administration from The Joint Commission Perspective.

© Strategic Healthcare Group LLC

Some time ago my delightful 80+ year-old grandmother was diagnosed with a GI bleed that led to hospitalization and multiple transfusions. As I am the only nurse in the family, she made a point to tell me that she needed blood because her “hemoglobins were low.” I quickly determined that she had no idea what hemoglobin was but she was confident her transfusion therapy was necessary because her trusted family physician had told her that her “hemoglobins were low.” During her admission, she signed without reading a general treatment consent that included a paragraph about blood transfusion. My grandmother was not told that there are risks associated with allogeneic transfusion nor was any alternative therapy offered. However, she believed that she was receiving appropriate medical care and she had no apparent adverse events with her hospitalization. Was my grandmother given adequate information to make an informed choice about her medical care? Did her physician and hospital meet minimum legal and regulatory requirements regarding transfusion informed consent? 

Transfusion informed consent is a necessary element of the physician-patient relationship because transfusion is an invasive procedure (a tissue transplant) with definable significant risks.¹ Further, AABB and College of American Pathologists (CAP) state that the patient’s medical record shall include documentation of transfusion consent.² Meeting this ethical and regulatory obligation need not be complicated but a meaningful discussion between physician and patient comparable to that of any other invasive procedure seldom occurs prior to transfusion.  

I believe a major barrier to the physician-patient transfusion consent discussion is the physician’s lack of knowledge about transfusion medicine.³ Most physicians who order blood products have never received formal training in blood component therapy. If the physician does not weigh the risks of transfusion against the benefits when ordering blood products, then that physician will not likely discuss risks and benefits with the patient. It seems highly likely that my grandmother’s physician was treating a lab value given the explanation that her hemoglobin was below normal levels. Until transfusing care providers become knowledgeable about current evidence based transfusion therapy, informed consent discussions will remain inadequate. And a seemingly simple consent process will remain difficult to implement. 

The transfusion consent process should begin at the time the physician determines that a patient’s course of treatment may include transfusion. The physician should order transfusion education for the patient and explain in plain words why a transfusion may be needed, the expected benefits, the common risks and the alternatives available to avoid or reduce transfusion. “Providing information ensures patients have sufficient understanding so they have a real chance of making a choice in their best interests.”⁴ This discussion may take place in the physician’s office when a procedure or course of therapy is planned that includes a known risk for transfusion. Or the discussion might occur at the time the physician orders lab tests to diagnose suspected anemia or thrombocytopenia based upon the patient’s medical history or presenting physical condition.  

Patient education that supports transfusion informed consent is essential for an effective consent process. Educational materials are readily available in many formats. Free brochures are available from sources such as NIH⁵, JAMA⁶, and SABM⁷. The Patient Education Institute offers a video that explains blood types and transfusion in simple terms.⁸ Vendors have developed interactive electronic educational materials that patients can review on the internet.⁹ These commercially prepared materials quickly become outdated and hospitals need to obtain medical staff approval prior to implementing them, however improved education may encourage the patient to reflect on therapy choices and become more engaged in the decision making process. It is essential that patient education materials reinforce and not replace the consent discussion between physician and patient. The physician remains ethically and legally obligated to discuss the risks, benefits and alternatives that are specific to each patient’s medical history and current condition.  

The transfusion consent form should also function as an educational tool rather than a legal document relieving care providers of liability.¹⁰ One ideal scenario would be that the physician uses the transfusion consent form as evidence of the consent discussion. While referring to a document written at the 5^th grade comprehension level,¹¹ the physician explains why the patient may need a transfusion, outlines the steps he will take to prevent or minimize the patient’s exposure to blood products and tells the patient about the common risks of transfusion. The physician also defines the expected impact if the patient chooses not to receive blood. At the conclusion of this discussion, the physician signs the attestation statement on the consent form acknowledging the discussion. At a time prior to receiving a transfusion or prior to undergoing a procedure that may entail transfusion, a nurse confirms that the patient has had an opportunity to review educational materials and has no further questions, then uses the same form signed by the physician to document the patient’s transfusion decision.  

My grandmother’s case is typical in hospitals today. Her physician was ethically and legally obligated to discuss the risks associated with transfusion and offer her appropriate alternatives including the choice of no transfusion. The hospital should have provided a consent form that she could understand and supporting educational materials to reinforce the physician’s consent discussion. At the time of this hospitalization, my grandmother was alert and lived independently; she would have enjoyed participating fully in her own healthcare choices.

Submitted by: Susann Stephenson, RN, JD | Director, Risk Management & Patient Safety, Strategic Healthcare Group LLC

1. Fuchs E, The elements of informed consent: is there too much information or not enough? AABB News 2010 May.
2. AABB 5.19.6. CAP TRM 5.19.1.1.
3. Obrien KL, Transfusion medicine knowledge in post graduate year 1 residents. Transfusion 2010 Aug; 50(8):1632.
4. Agard A, Informed consent: theory vs. practice. Nat Clin Pract Cardiovasc Med 2005; 2(6):270. 
5. nhlbi.nih.gov.
6.  Torpy, et al, JAMA Patient Page: Blood Transfusion. JAMA 2004 Oct; 292(13)1646. Citing, www.nhlbi.nih.gov. www.aabb.org. www.redcross.org.
7.  http://www.sabm.org/public/resources.php. Available in English and Spanish.
8. http://patient-education.com/video.asp?p=search&s=SPV&EXTRA=2&SH=VL&fs=VL&mode=FULL&mvc=gs570102%20&lmsg=yes=FULL&mvc=gs570102 &lmsg=yes. Available in English and Spanish.
9. Tanner L, Informed consent: hospitals try high-tech ways to advise patients. AP Wire 2010 Nov. 30. 
10. Brenner L, Beyond informed consent: educating the patient. Clin Ortho and Rel Res 2009 Feb; 467(2):348-51.  Agard A, Informed consent: theory versus practice. Nat Clin Pract Cardiovasc Med 2005; 2(6):270.
11. CMS, 42 C.F.R. §482.24(c)(2)(v).  Interpretive Guidelines for Informed Consent 42 C.F.R. §482.51(b)(2).