Continuing Education Case Studies O-Level Case Study O2: Communication tools for managing patients with special transfusion needs (fludarabine therapy)
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Case Study O2 was motivated by
A report in the December 2003 issue of Transfusion1
Case #10 from the 2003 SHOT Report.2
Question about managing patients on fludarabine that appeared on transfusion, the mailing list of Canada's Transfusion Safety Officers
This is the second in the "Other cases" series (cases initially published elsewhere). The original cases form only the starting point for the TraQ cases.
This TraQ case study includes educational enhancements designed to emphasize learning points related to managing patients with special transfusion needs.
This case'sformat is different from that of serologic cases (which investigate a specific patient's laboratory and clinical data). Instead, a transfusion-related issue is discussed in general using several different patient cases to illustrate learning points.
Upon completion of this exercise, participants should be able to
Fludarabine, a purine antimetabolite with potent immunosuppressive properties, has previously been associated with the development of transfusion-associated GVHD (TA-GVHD) in patients with hematologic malignancies. Its role as a risk factor for TA-GVHD in patients without underlying leukemia or lymphoma is uncertain.
A 42-year-old female with refractory lupus nephritis received three monthly cycles of fludarabine (30 mg/m2/day on Days 1-3) and cyclophosphamide (500 mg/m2 on Day 1). Three months after the last dose of fludarabine, she received 2 units of packed RBCs and 6 units of pooled random platelets, none of which were irradiated. Two weeks later, fever, rash, aminotransferase elevations, hyperbilirubinemia, and pancytopenia developed.
Marrow biopsy showed severe aplasia and skin biopsy was consistent with GVHD. Allele-level HLA typing on circulating lymphocytes revealed extra HLA alleles not present in her pretreatment sample, but identical to the HLA haplotypes of an unrelated platelet donor. Treatment with antithymocyte globulin, cyclosporine, and prednisone was followed by preparatory conditioning for a PBPC transplant from an HLA-identical sibling, but the patient died of disseminated candidiasis before transplant.
Fludarabine and other purine analogs are increasingly used in the treatment of disorders other than hematologic malignancy, such as autoimmune disease. The occurrence of TA-GVHD after fludarabine therapy in a patient with lupus strongly suggests that this drug is sufficiently immunoablative to be an independent risk factor for TA-GVHD. Irradiation of blood components should be considered in all patients who receive fludarabine therapy.
A 66 year old male patient received fludarabine for chronic lymphatic leukaemia. The ward staff were unaware of the indication for irradiated blood components and so the laboratory was not informed. Over a 5 month period the patient received 13 units of unirradiated red cells.
"We are developing a new process to ensure that the transfusion service is aware of patients who have had bone marrow transplants and patients who are on fludarabine. As we do not perform BMT we are not always aware that patients require irradiated blood products when they arrive here.
We are trying to work something out with pharmacy to notify the transfusion service through Meditech whenever fludarabine is ordered. Hopefully this will help, however, it will not solve our issue around transplant patients.
Any suggestions? How do your transfusion departments deal with this issue?
Serious Hazards of Transfusion (SHOT) reports2 from the UK have identified poor communication as an important cause of adverse events. In the 2003 SHOT Report, 31% of ICBT* cases involved patients (n=107) who received blood components that did not meet special requirements. Mostinvolved errors at the request stage and patients at risk of transfusion-associated graft-versus-host disease (TA-GVHD), for whom there was a failure to provide irradiated components.
The commonest indication for irradiated products (comprising more than half the cases) was treatment with a purine analogue. Increasing use of fludarabine and other purine analogues means that many more patients are susceptible to TA-GVHD.
*ICBT: incorrect blood component transfused
For educational purposes this case will discuss
To test your knowledge and as an advance organizer for the discussion section, read and consider these questions:
Proceed to the Discussion:
Communication deficiencies are a common cause of transfusion errors for patients with special transfusion needs. Increasing use of purine analogues such as fludarabine means that more patients are susceptible to TA-GVHD.
1. Mistake-proofing is commonly used in transfusion services.
2. Mistake-proofing technological devices are increasingly used by transfusion services.
3. What are some of the limitations of technological mistake-proofing devices?
4. Transfusion errors have many causes, including misidentification, training deficiencies, work overload, faulty communication, and more.
5. What are some general long-term strategies used to prevent communication errors in medicine?
6. This case deals with failure to provide irradiated blood for patients with special transfusion needs such as those being treated with fludarabine. Provide 4 concrete examples of how these errors may occur.
7. Describe 7 communication mechanisms that can be used to increase transfusion safety for patients with special needs such as requiring irradiated blood.
8. Patients in developed countries have easy access to health information and increasingly communicate with health providers about their treatment.
9. Heathcare is increasingly interdisciplinary. Which health professions are involved in the transfusion needs of patients taking purine analogues such asfludarabine?
10. How do regulatory standards address the need for effective communication mechanisms for patients with special transfusion needs such as irradiated blood?
1. Leitman SF, Tisdale JF, Bolan CD, Popovsky MA, Klippel JH, Balow JE, et al. Transfusion-associated GVHD after fludarabine therapy in a patient with systemic lupus erythematosus. Transfusion 2003 Dec;43(12):1667-71.
2. Serious Hazards of Transfusion. Annual report 2003.Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004 May 25;170(11):1678-86.
Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. Br Med J 2000;320: 759.
Bates DW. Using information technology to reduce rates of medication errors in hospitals. Br Med J 2000;320:788-91.
Callum JL, Kaplan HS, Merkley LL, Pinkerton PH, Rabin Fastman B, Romans RA, et al. Reporting of near-miss events for transfusion medicine: improving transfusion safety. Transfusion 2001;41:1204?11.
Chassin MR, Becher, EC. The wrong patient. Ann Intern Med 4 June 2002 Jun2;136(11):826-33.
Coffrey J. Preparing for accreditation: What's the process? QMP-LS News 2002 Jul 9; 37:1-4.
Coffey RP. Technology cannot replace healthcare workers (letter). Br Med J 2000;321:505.
Dzik WH, Corwin H, Goodnough LT, Higgins M, Kaplan H, Murphy M, et al .Patient safety and blood transfusion: new solutions. Transfus Med Rev 2003 Jul;17(3):169-80.
Turner CL, Casbard AC, Murphy MF. Barcode technology: its role in increasing the safety of blood transfusion. Transfusion. 2003 Sep;43(9):1200-9.
Wenz B, Burns ER. Improvement in transfusion safety using a new blood unit and patient identification system as part of safe transfusion practice. Transfusion 1991 Jun;31(5):401-3.
Woolf SH, Kuzel AJ, Dovey SM, Phillips RL Jr. A string of mistakes: the importance of cascade analysis in describing, counting, and preventing medical errors. Ann Fam Med 2004 Jul-Aug;2(4):317-26.
How can the transfusion service laboratory increase transfusion safety for patients requiring irradiated blood components?
The transfusion service laboratory should take a leadership role by initiating multiple communication mechanisms, such as:
List four health professions that play a role in safe transfusion for patients taking fludarabine.
The health professions are
What role, if any, can patients play in increasing transfusion safety?
Patients need to take an active role in the transfusion process. For example, they should be
What are some long-term strategies for preventing communication errors that cause transfusion and other medical errors?
Long-term strategies include
1. Which of the following have studies shown is most often the underlying cause of failure to request irradiated components for patients at risk of GVHD?
Miscommunication is the most common cause.
Prescribing incorrect (un-irradiated) blood components may be caused by a myriad of deficiencies, including:
Strategies for correcting communication deficiencies are presented below.
The 2003 SHOT Report 1 includes many cases offailure to provide irradiated components for patients treated with a purine analogue. Patients at risk for TA-GVHD include all patients receiving fludarabine and perhaps all patients receiving nucleoside analog therapy. Problems related to fludarabine is an on-going problem as the 2000-2001 SHOT Report 2 included 33 cases of failure to request the appropriate component with the most common error being failure to request irradiated components for patients at risk, including16 cases where the patients were on
Robust systems are needed to ensure that patients at risk of TA-GVHD receive irradiated cellular components. The pharmaceutical industry and hospital pharmacists have important roles to play.
There must be effective communication when patient care is shared between hospitals, to ensure that relevant information is available to all concerned.
There is a need for education regarding guidelines and policies on special transfusion requirements.
Patients should, wherever possible, be educated and empowered regarding their special requirements and staff should take note of information from patients.
Transfusion laboratory IT systems should provide effective ?flagging? of special requirements and alert staff to select appropriate components.
SHOT recommendations provide a framework for the type of communication tools needed to prevent these errors and are directed to
Prevention of TA-GVHD in patients receiving purine analogues is the responsibility of prescribers, but can and must be supported by the pharmaceutical industry and pharmacists and by suppliers of laboratory IT systems. All patients should receive an information card and leaflet and haematologists must ensure that there is an effective system of flagging special transfusion requirements in the laboratory. Referrals for shared care must include timely communication of all relevant information.
A frequently reported problem in this category was a failure to notify the transfusion laboratory of the need for CMV negative and/or irradiated components. This is a commonly recurring theme both in "near miss" events and in full incidents and often indicates a need for improved communication between hospitals where patients are receiving shared care. The majority of errors in this category were made by junior doctors, usually senior house officers, highlighting the need for education and training for medical staff requesting and prescribing blood components.
Good communication is required in all cases but particularly when patient care is shared between different hospitals. Hospitals must have clear protocols to ensure accurate information relating to this risk is communicated in a timely manner. Provision of the BCSH/NBS patient card and leaflet are also recommended.
The following are examples of communication policies and procedures designed to provide safe transfusion for patients on fludarabine therapy.
If you would like to add a communication tool used at your facility, please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Source: Canada's Transfusion Safety Officer (TSO) mailing list "transfusion" (edited to preserve confidentiality):
We are trying to develop a new process to ensure that the transfusion service is aware of patients who have had bone marrow transplants and patients who are on fludarabine. As we do not perform BMT we are not always aware that patients require irradiated blood products when they arrive here.
We are trying to work something out with pharmacy to notify the transfusion service through Meditech whenever fludarabine is ordered. Hopefully this will help, however, it will not solve our issue around transplant patients.
Any suggestions? How do your transfusion departments deal with this issue?
We needed to address this very issue recently, particularly about whether a patient was on or had recently been on Fludarabine. Unfortunately I couldn't get any specific guarantees regarding notification from Pharmacy. However, I have discussed the issue with our cancer physicians and reminded them of the need to specify irradiated components for such patients and this has worked well since then.
We are also a Meditech facility, so I would be interested in any flags, warnings, or pop-up boxes that you can figure out that will make this process easier. In addition, I also add information to the Blood Bank History comment if I come across such patients when reading through physician notes in Meditech.
Our bone marrow and stem cell transplant patients who receive autologous transplants return to us one day post-transplant.
This seems to work very well for us. Patients who have allogeneic transplants recover at the hospital where the procedure is performed so the notification process for them is not always as efficient. The staff of the oncology clinic are usually very good about providing verbal notification and the same process is followed for flagging patients in Meditech.
Our pharmacy department notifies us when a patient is started on fludarabine therapy. We then add a special instruction into our LIS to say patient needs irradiated blood and is on purine analogues
The BMT patients are made known to the transfusion service (TS) via a form that is faxed from the Transplant Coordinator.
For fludarabine and cladribine, renal transplants we ask the
This process was supported with inservices to all the nursing staff in the various areas, periodic repeats - some doctors are good at it, others less so. Since we use the same form for CMV-negative, we tend to be vigilant about reviewing requisitions for "new leukemia" in case they forget to send form at diagnosis and try to follow-up with education.
We find this is more and more an issue when our patients move from place to place for their care. At any given time, most of our patients are not local. For us, the first time we usually hear of a patient is when they show up a few hours prior to their procedure. If the patient requires anti-CMV negative or irradiated components, there is not enough time to get if from our blood supplier in a city 355 km (221 miles) away. We try to keep special components on hand but it is constantly a guessing game.
One thing we have suggested is to issue cards, similar to antibody cards, to patients who require any type of special handling such as requests for premedication, irradiation, etc.
Source: UK National Blood System Hospitals website
Information for patients needing irradiated blood (NBS brochure)
The need for effective communication mechanisms for patients with special transfusion needs is required by various transfusion safety standards, such as CSTM Standards for Hospital Transfusion Services, v. 1(reproduced with permission):
CSTM (H4.1.1): There shall be an established policy defining when irradiated cellular blood products are required for the prevention of transfusion-associated
graft versus host disease. (referenced to CSA Z902-04 #11.7.1)
CSTM (H4.1.4):There shall be an established process to ensure that recipients of irradiated products continue to receive irradiated products as long as clinically indicated. (referenced to CSA Z902-04 #11.7.3)
AABB Standards (# 5.16) also requires that there be a mechanism to ensure that patients with special transfusion requirements receive only blood and components that meet those requirements for as long as clinically indicated.
1. Which of the following have studies shown is most often the underlying cause of failure to request irradiated components for patients at risk of GVHD?
2. What are some long-term strategies for preventing communication errors that cause transfusion and other medical errors?
3. What role, if any, can patients play in increasing transfusion safety?
4. List four health professions that play a role in safe transfusion for patients taking fludarabine.
5. How can the transfusion service laboratory increase transfusion safety for patients requiring irradiated blood components?
Proceed to Summary
1.Serious Hazards of Transfusion. Annual report 2003.
2. Serious Hazards of Transfusion.Annual report 2000 - 2001.
The 2003 SHOT Report1 reported that almost one-third of cases in which the wrong blood was transfused involved patients who received blood components that did not meet special requirements. Most involved patients at risk of transfusion-associated GVHD for whom there was a failure to provide irradiated components.
This section considers communication policies in general and then discusses specific communication tools for patients receiving fludarabine.
Since poor communication is reported as a major contributor to serious transfusion errors, it follows that good communication policies and procedures are essential to safe blood transfusion. This is especially true for patients with special transfusion needs for whom receiving the wrong blood may be fatal, as was the case for the patient presented in Transfusion-associated GVHD after fludarabine therapy in a patient with systemic lupus erythematosus2 (one of the cases that motivated this case study).
This case was the "first report of TA-GVHD after use of a nonmyeloablative agent in an adult patient without hematologic malignancy (other than patients receiving HLA-haplotype homozygous blood components)."As such, the cause was not failure to communicate the special transfusion need of the patient for irradiated blood. The adverse event happened because of not recognizing that the patient was a candidate for irradiated blood products, given that this was first report of TA-GVHD in such a patient.
Fortunately, the patients in the SHOT Report1 who received un-irradiated blood did not suffer GVHD. However, most of these errors were caused by communication failures.
Although no data exist to document how widespread communication failures are, they are probably endemic in large academic medical centers3. The SHOT 2003 Report:1 recommends that:
Mechanisms must be put in place for appropriate and timely communication of information regarding special transfusion requirements
Poor communication is an important cause of adverse events. In the longer term, IT offers robust solutions, but interim arrangements are required and must be locally implemented and audited.
The SHOT 2003 Report1 outlines 107 cases in which patients with special needs were transfused with the wrong blood. Of these, 81 involved patients at risk of GVHD for whom there was a failure to provide irradiated components. The following are examples from SHOT 2003 Report (highlighted italics not in original):
A 66 year old male patient received fludarabine for chronic lymphatic leukaemia. The ward staff were unaware of the indication for irradiated blood components and so the laboratory was not informed. Over a 5 month period the patient received 13 units of unirradiated red cells.
A 14 year old male was admitted for an open lung biopsy following which he bled and required transfusion. He had previously received a stem cell transplant in another hospital in the same Trust, but there was no facility to link the two transfusion laboratory computer systems and the requester was not aware of the previous history. Non-irradiated red cells were given.
An elderly male patient was admitted to hospital A with an ischaemic foot. He informed the ward staff that he required regular transfusion with ?special blood? at hospital B. The ward confirmed with the transfusion laboratory at hospital B that he had an anti-ANWJ but this information was not passed on to the laboratory at hospital A who were undertaking pretransfusion testing. The antibody screen was negative and 3 units of red cells were issued electronically and transfused. The patient had a rise in temperature and a raised bilirubin, and died 8 days later from bronchopneumonia.
Communication errors affect all aspects of patient care, not just transfusion, and are a significant source of hospital errors in Canada.4 Baker et al. note that "the complexity of care in teaching hospitals means that patients may receive care from several different providers, which may increase the risk of AEs [adverse events] related to miscommunication and coordination of care."
A 2004 study in Annals of Family Medicine suggests that most medical errors in family medicine begin with errors in communication.5 Examples of informational miscommunication that led to diagnosis and treatment errors included
Remedies to tackle communication errors that cause medical errors in general include complex, long-term strategies such as:
* See, for example, this interdisciplinary course from the University of Alberta: INT D410
1. Serious Hazards of Transfusion. Annual report 2003.
2. Leitman SF, Tisdale JF, Bolan CD, Popovsky MA, Klippel JH, Balow JE, et al. Transfusion-associated GVHD after fludarabine therapy in a patient with systemic lupus erythematosus. Transfusion 2003 Dec;43(12):1667-71.
3. Chassin MR, Becher, EC. The wrong patient. Ann Intern Med 4 June 2002 Jun2;136(11):826-33.
4. Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004 May 25;170(11):1678-86.
5. Woolf SH, Kuzel AJ, Dovey SM, Phillips RL Jr. A string of mistakes: the importance of cascade analysis in describing, counting, and preventing medical errors. Ann Fam Med 2004 Jul-Aug;2(4):317-26.
4. What are some of the limitations of technological mistake-proofing devices?
Limitations include
Which type of error are patient barcodes and radio frequency identification designed to prevent?
Patient barcodes and RFID are designed to prevent identification errors.
2. Which group of mistake-proofing examples used in transfusion processes are designed to prevent communication errors?
Of the examples shown, using standard terminology is an example of mistake-proofing used in transfusion processes.
