失效模式与效应分析在临床输血管理中的应用效果

[目的]完善临床输血护理流程,加强临床输血安全管理。[方法]成立输血安全护理管理团队,应用失效模式与效应分析（FMEA）方法,列出输血护理流程的各个步骤,以及各步骤可能发生的失效模式,并计算失效模式的危机值（RPN）,查找目前输血护理流程中存在的危险因素,针对影响安全输血的高危因素,制定改进措施并应用于临床输血过程中。比较实施FMEA 前后 RPN 值及病人安全输血效果。[结果]实施 FMEA 后取血、输血时间不合格率明显下降,护士输血查对实践考核合格率较实施前提高,影响安全输血高危因素的 RPN 值明显下降。[结论]FMEA 模式应用于临床输血护理管理中有利于提高护士评估风险意识与能力,前瞻性地发现流程中潜在的危险因素,提高病人输血护理安全。     

Blood transfusion costs by diagnosis-related groups in 60 university hospitals in 1995

BACKGROUND: Transfusion services are frequently challenged to initiate efforts to reduce blood transfusion costs. One approach is to analyze blood transfusion costs for individual medical and surgical Diagnosis-Related Groups (DRGs). Rank ordering of DRGs by transfusion costs and interinstitutional comparisons of these costs may lead to the selection of DRGs for further analysis of the process of blood transfusion. STUDY DESIGN AND METHODS: Common DRGs (n = 486) that were related to discharges in 1995 were analyzed from 60 university hospital members of the University HealthSystems Consortium (UHC). Cost data were tabulated by using cost-to-charge ratios reflecting all aspects of blood transfusion-related costs of participating institutions. RESULTS: Of these 486 DRGs, 471 had identifiable mean blood costs, and 34 had median blood costs, mostly for surgical conditions. Transfusion costs represented a small proportion (< or = 1%) of total hospitalization costs for most DRGS: Nonetheless, millions of dollars were spent on blood transfusion, and for the most expensive DRGs, the costs ranged from 5.0 to 8.6 percent of total hospitalization costs. Transfusion costs are more variable for the DRGs with the lowest transfusion costs than for those with the highest transfusion costs. CONCLUSION: Members of the UHC may utilize such analyses to identify surgical or medical diagnoses with transfusion costs at variance with the group norm. These DRGs could then be targeted for further evaluation of components contributing to high costs, for possible alterations in physician or clinical laboratory practices. Considering those conditions with the highest cumulative transfusion costs (e.g., BMT, liver transplant, acute leukemia, and cardiothoracic procedures), changes in transfusion practices that affect these particular patient categories may have a significant impact on global blood transfusion costs.     

Expensive blood safety initiatives may offer less benefit than we think

BACKGROUND: Various blood safety initiatives have ensured a historically low risk of infection transmission through blood transfusion. Although further prevention of infection transmission is possible through, for example, nucleic acid testing and future introduction of pathogen inactivation, such initiatives are very costly in relation to the benefit they offer. Although estimation of the cost-effectiveness requires detailed information about the survival of transfusion recipients, previous cost-effectiveness analyses have relied on incorrect survival assumptions.
STUDY DESIGN AND METHODS: Based on empirical data of more than 1 million Scandinavian transfusion recipients followed for up to 20 years, we present two new survival functions. In a fictitious example we assessed the impact of survival assumptions on the estimated costs per quality-adjusted life-year (QALY) gained, by using the survival functions of three previous cost-effectiveness analyses along with the two new survival functions.
CONCLUSIONS: We conclude that despite considerable costs, previous cost-effectiveness studies may have underestimated the costs per QALY gained by as much as 44%.     

Reducing risks in blood transfusion: process and outcome

The last decade has seen substantial improvements in the provision of safe 'infection-free' blood for patients in many countries. This has resulted from the combined effects of better donor education, selection, testing and exclusion processes. The residual risk of infection with HBsAg attributable to laboratory error is less than 0.1/100 000 (1/750 000). The risk for HIV remains to be quantified but may approach this figure. With such low risks it will be difficult to provide statistical evidence that further improvements in the process of selection, testing or exclusion will have an impact on reducing risk from either agent. Over the same time, less progress has been made reducing risk to the recipient attributable to problems in the clinical supply process, i.e. getting the right blood, to the right person, at the right place, at the right time. Uniform definitions of terminology defining blood donation characteristics, together with the sharing of performance data are essential if we are to make national and international comparison of the risks that patients face when they receive a transfusion. Equally, the use of agreed definitions, and the sharing of data on the clinical outcomes of transfusion can provide the key to better prescribing based on evidence of actual risks and benefits.     

Transfusing safely: a 2006 guide for nurses

Transfusion is a 'vein-to-vein' process. The blood supply in Australia is extremely safe in terms of viral risk, although a 'zero risk' blood transfusion is never possible. Safe transfusion practice continues to rely on highly-trained and experienced staff undertaking procedures correctly, in robust hospital systems within a safety and quality framework that includes an adverse event reporting system. Such a reporting system should work to enhance any hospital system where weaknesses or deficiencies are found. Further information on national guidelines and other aspects of transfusion in Australia can be found at: www.anzsbt.org.au/publications and www.transfusion.com.au. A transfusion administration checklist for nurses can be downloaded from: http://www.transfusion.com.au/Resourc eLibrary/resource_safety_2 .asp     

The cost-effectiveness of autologous transfusion revisited: implications of an increased risk of bacterialinfection with allogeneic transfusion

BACKGROUND: Previous analyses have found autologous transfusion to be very expensive but have not considered avoidance of postoperative bacterial infections as one of its benefits. STUDY DESIGN AND METHODS: A cost-utility analysis using a Markov cohort simulation model compared autologous blood transfusion to allogeneic transfusion in a hypothetical cohort of patients undergoing elective total hip replacement with respect to discounted quality-adjusted life years (QALYs) and health-care system costs. RESULTS: Assuming a base case rate of serious infection of 3.7 percent, a relative risk of infection of 1.85, and additional costs of $12,980 per infection, autologous transfusion has a cost-effectiveness of $2,470 per QALY. If the relative risk of bacterial infection following allogeneic transfusion exceeds 1.1, the cost-effectiveness of autologous transfusion is less than $50,000 per QALY and if the relative risk exceeds 2.4, autologous transfusion is dominant, resulting in both lower costs and greater QALYs. If there were no increased risk of transfusion, the cost-effectiveness of autologous transfusion would be $3,400,000 per QALY. CONCLUSIONS: If there is only a modest increase in the risk of bacterial infection following allogeneic transfusion, autologous transfusion would result in improved outcomes at a cost of less than $50,000 per QALY. Autologous transfusion would be dominant above a relative risk of infection that is within the range of values observed in randomized controlled trials. However, if there is no increased risk of bacterial infection, autologous transfusion would be a very expensive strategy. Until more definitive data are available on the magnitude and costs of this risk, we advise against prematurely closing the debate about the cost-effectiveness of autologous transfusion.     

The red cell transfusion trigger: has a sin of commission now become a sin of omission?

The benefits of a Hct range of 30 to 35 percent include improved oxygen delivery and enhanced hemostasis, which help minimize complications in patients at high risk for ischemia and perioperative nonsurgical bleeding. In these settings, the conservative transfusion practice of using a lower Hct range should be replaced with a more aggressive approach. The known risks of blood transfusion would appear to be sufficiently low and the benefits sufficiently high to justify maintaining a Hct of at least 30 percent. An even higher Hct, of 35 percent, may be desirable in patients who have overt cardiopulmonary disease or who are at high risk for myocardial ischemia. Many retrospective studies have been conducted to persuade us that a conservative transfusion trigger is a safe and prudent practice, but retrospective studies are not what we need. What we need is a series of well-designed, prospective, randomized trials to evaluate the impact of a more aggressive transfusion policy on perioperative mortality, morbidity, and nonsurgical bleeding in patients with known cardiopulmonary disease or who are at high risk for myocardial and cerebrovascular ischemia.     

系统追踪在安全输血护理管理中的应用

目的探讨系统追踪在安全输血护理管理中的应用方法与效果。方法成立系统追踪小组,制订追踪标准,确定追踪路径及内容,运用追踪方法对输血患者进行安全输血追踪检查。根据追踪结果,确定高风险项目,制订改进措施并严格落实。结果护理人员输血相关知识考核成绩提高(P0.01);安全输血合格率、血标本采集合格率、输血前评估率、护理记录合格率、血袋返回率均提高(P0.01或P0.05)。结论系统追踪方法在安全输血护理管理中是行之有效的。     

The clinician's approach to the management of risk

Although risk has always been accepted as an integral part of any medical or surgical therapy, it is only in recent years that quantitation of this risk in transfusion medicine is being assessed in a detailed and practical manner. Balancing of the risk/benefit equation in relation to blood component therapy has only become a day-to-day issue in clinical medicine since the recognition that HIV could be transmitted by blood transfusion. Blood transfusion has never been as safe a procedure as most patients and clinicians have thought, with numerous potential complications and new ones being recognized. As medical teaching in blood component therapy has not had a high profile in most undergraduate and postgraduate medical curricula, there has been an inappropriately low level of awareness for the indications for the risks and benefits of blood component therapy. Since the appearance of transfusion-transmitted HIV, clinicians and patients alike have rapidly become aware of the potential risks associated with transfusion medicine. This paper addresses the issues of how the clinician can minimize the risks of blood component therapy and to effectively present the risks and benefits to clinical users and potential recipients of blood component therapy. Paradoxically, in developed countries, transfusion therapy is probably safer than it has ever been in the past, but the perception of the community is the opposite. Why is this so?, and what can be done to improve that patient's perception and associated fear? The ultimate answer rests with improving assessment of risks versus benefits, effective education and communication with the patient (and relatives) in order to achieve meaningful informed consent.     

How do we … integrate pathogen reduced platelets into our hospital blood bank inventory?

For more than 50 years there has been an ongoing effort to combat transfusion‐transmitted infections and provide patients with the safest possible blood. This initiative has driven much of the research within the transfusion community. Initial methods included screening donors for travel histories to banned areas and for high‐risk behaviors, but pathogen‐specific assays performed at the collection and manufacturing sites also have become key factors in assuring blood safety. Many of these have focused on donor and laboratory‐based screening for transfusion‐transmitted diseases, as evidenced by the hepatitis and human immunodeficiency virus screening in the 1970s, 1980s, and 1990s. More recently, this effort has expanded to develop donor screening assays to identify other blood‐borne pathogens, such as Zika and West Nile viruses and Babesia. Bacterial contamination of units of platelets (PLTs), however, remains a significant concern. In recent years, the Food and Drug Administration has approved rapid tests to identify bacterially contaminated PLT units in the blood bank before transfusion. Other supplemental methods have been developed, however, that aim to inactivate blood‐borne pathogen(s) present in the blood product, rather than to rely on our ability to identify and interdict contaminated and infected components. Pathogen reduction technology, as this is referred to, provides a proactive way to further reduce the risk posed by transfusion‐transmitted infections.     

Emerging infectious disease agents and their potential threat to transfusion safety

BACKGROUND: Emerging infections have been identified as a continuing threat to human health. Many such infections are known to be transmissible by blood transfusion, while others have properties indicating this potential. There has been no comprehensive review of such infectious agents and their threat to transfusion recipient safety to date.
STUDY DESIGN AND METHODS: The members of AABB's Transfusion Transmitted Diseases Committee reviewed a large number of information sources in order to identify infectious agents with actual or potential risk of transfusion transmission now or in the future in the US or Canada; with few exceptions, these agents do not have available interventions to reduce the risk of such transmission. Using a group discussion and writing process, key characteristics of each agent were identified, researched, recorded and documented in standardized format. A group process was used to prioritize each agent on the basis of scientific/epidemiologic data and a subjective assessment of public perception and/or concern expressed by regulatory agencies.
RESULTS: Sixty-eight infectious agents were identified and are described in detail in a single Supplement to TRANSFUSION . Key information will also be provided in web-based form and updated as necessary. The highest priorities were assigned to Babesia species, Dengue virus, and vCJD.
CONCLUSION: The information is expected to support the needs of clinicians and transfusion medicine experts in the recognition and management of emerging infections among blood donors and blood recipients.     

Patient safety and blood transfusion: new solutions

Current risk from transfusion is largely because of noninfectious hazards and defects in the overall process of delivering safe transfusion therapy. Safe transfusion therapy depends on a complex process that requires integration and coordination among multiple hospital services including laboratory medicine, nursing, anesthesia, surgery, clerical support, and transportation. The multidisciplinary hospital transfusion committee has been traditionally charged with oversight of transfusion safety. However, in recent years, this committee may have been neglected in many institutions. Resurgence in hospital oversight of patient safety and transfusion efficacy is an important strategy for change. A new position, the transfusion safety officer (TSO), has been developed in some nations to specifically identify, resolve, and monitor organizational weakness leading to unsafe transfusion practice. New technology is becoming increasingly available to improve the performance of sample labeling and the bedside clerical check. Several technology solutions are in various stages of development and include wireless handheld portable digital assistants, advanced bar coding, radiofrequency identification, and imbedded chip technology. Technology-based solutions for transfusion safety will depend on the larger issue of the technology for patient identification. Devices for transfusion safety hold exciting promise but need to undergo clinical trials to show effectiveness and ease of use. Technology solutions will likely require integration with delivery of pharmaceuticals to be financially acceptable to hospitals.     

Who should donate blood? Policy decisions on donor deferral criteria should protect recipients and be fair to donors

An important element in the development of voluntary blood donation schemes throughout the world has been the attention given to minimising the risk to recipients of donated blood, primarily the risk of transfusion transmitted infections. In response to the appearance of human immunodeficiency virus (HIV) in the 1980s a range of national policies emerged that excluded populations at high risk of contracting HIV from donating blood, with a particular focus on men who have sex with men (MSM), the primary reason being the protection of recipients of donated blood. Recently some countries, including the UK, have revised their policies, informed by advances in screening tests, epidemiological evidence of transmission rates and an increasing concern about unfair discrimination of specific groups in society. Policy makers face a difficult task of balancing safety of recipients; an adequate blood supply for those who require transfusion; and societal/legal obligations to treat everyone fairly. Given that no transfusion is risk free, the question is what degree of risk is acceptable in order to meet the needs of recipients and society. Decisions about acceptance of risk are complex and policy makers who set acceptable risk levels must provide ethically justifiable reasons for their decisions. We suggest it is possible to provide a set of reasons that stakeholders could agree are relevant based on careful evaluation of the evidence of all relevant risks and explicit acknowledgement of other morally relevant values. We describe using such a process in the Safety of Blood Tissue and Organs (SaBTO) review of donor deferral criteria related to sexual behaviour.     

Controversies in transfusion medicine. Alanine aminotransferase screening of blood donors: pro

In my opinion, independent, carefully conducted scientific studies indicate that an accurate, rapid, relatively sensitive, and inexpensive laboratory test substantially reduces the major long-term risk of blood transfusion in the United States; donor ALT has emerged as one of the most effective laboratory determinants for reducing the incidence of NANB PTH. Despite its nonspecificity and limited predictive value, ALT screening may prevent up to 30 percent of cases, one-half of which would progress to chronic liver disease and then possibly to cirrhosis and hepatocellular carcinoma. Blood donors appear to understand and accept the testing rationale as a reasonable precaution. Admittedly, ALT screening is not a perfect solution. It has not been validated by prospective studies and probably never will be. Determination of the proper cutoff value remains controversial. However, the risk of PTH progresses with increasing ALT levels, so that the real issue is not whether to test, but how best to configure the test to exclude the fewest false-positive donors while detecting the most true-positive donors. It is undesirable and expensive to discard safe units of blood, but the primary responsibility of blood collectors is to ensure an adequate supply of safe components. Some still consider the ALT assay technically too demanding for routine use. However, technical concerns regarding performance and interpretation are not insurmountable, and both quality control and proficiency testing are being addressed at the national level. The assay is capable of great precision, and a system employing a national standard and single cutoff has already been described and tested with excellent results. Circumstances have changed since donor screening with ALT was widely implemented in 1986. More thorough screening and testing have eliminated many high-risk donors. Public expectations have changed as well. While it is neither reasonable nor responsible to promise the public blood transfusions without risk, neither is it prudent to propose any major change in management of the blood supply without compelling evidence that such a change will not impair transfusion safety. It is hard to defend discontinuing the ALT screen at this time, especially when the costs of retaining it are minimal and the benefits clearly greater than those of screening for HTLV-I and for Treponema pallidum (in the United States) or HIV-2 (in West Germany). A first-generation assay specific for antibody to hepatitis C will probably be available within a year.(ABSTRACT TRUNCATED AT 400 WORDS)     

Proposed revised nomenclature for transfusion‐related acute lung injury

A decade ago, definitions of “transfusion?related acute lung injury (TRALI)” and “possible TRALI” were standardized for research and clinical diagnosis. Since then, evidence has confirmed that TRALI is often due to transfusion of white blood cell antibodies to at‐risk patients, and the term “TRALI, antibody mediated” is appropriate for such cases. Other TRALI cases are non–antibody mediated. Because specific, nonantibody transfusion factors have not yet been confirmed to cause TRALI in humans, the general term “TRALI, non–antibody mediated” is appropriate for such cases. In contrast, evidence is against possible TRALI being due to transfusion with the more likely cause of the acute respiratory distress syndrome (ARDS) being the alternative ARDS risk factor present in these patients. We propose to drop the misleading term “possible TRALI” and to rename this category of cases as “transfused ARDS.” These nomenclature updates will more accurately categorize ARDS cases that develop after transfusion.     

Cost analysis of autologous blood transfusion, using cell salvage, compared with allogeneic blood transfusion

Autologous transfusion is an option infrequently used in the UK, partly because the direct costs are greater than for allogeneic transfusion. An analysis of the cost consequences of substituting autologous for allogeneic blood, by using cell salvage, was undertaken from a hospital perspective. Direct costs were estimated for two different cell salvage devices and sensitivity analysis performed on the key variables.
Allogeneic transfusion may be associated with increased rates of postoperative infection due immunomodulation and immunosuppression. As a result, one of the short-term benefits of autologous transfusion is a possible reduction in length of hospital stay. This was the most important variable affecting the cost of autologous transfusion. Cost equivalence for autologous and allogeneic blood was reached at reductions in hospital stay of between 0.3 and 2 days across a range of variables.
Reductions in length of hospital stay of this magnitude have been reported in several small studies. The results of our cost analysis suggest that autologous transfusion should not be rejected on the grounds of cost and we recommend a large-scale randomized controlled trial of autologous vs. allogeneic transfusion.     

Transfusion trigger in critically ill patients: has the puzzle been completed?

In stable critically ill children, the adoption of a restrictive transfusion strategy based on a predefined hemoglobin threshold of 7 g/dl significantly decreased transfusion requirements without affecting outcome. These results strengthen previous observations made in volume resuscitated adults when a similar blood transfusion strategy was used. It also indirectly corroborates studies reporting the beneficial effects of leukoreduction of red blood cell (RBC) transfusion units on patient outcome. This study indicated that the maintenance of a higher hemoglobin concentration with RBC transfusion in an attempt to increase tissue oxygen delivery is not associated with a clinical benefit. This may be related to the storage process, which could affect the ability of RBCs to transport and deliver oxygen to the tissues. This point, however, remains controversial. It should also be remembered that increasing hemoglobin concentration will not always result in a greater oxygen delivery, as transfusion related increased blood viscosity could be associated with a reduction in blood flow. Further research should compare a symptomatic transfusion strategy to a hemoglobin-based strategy on the outcome of high risk patients.     

Strengthening the service continuum between transfusion providers and suppliers: enhancing the blood services network

As the cost of health care increases, the focus on cost containment grows. The pressure to reduce costs comes at the same time the public focus is on ensuring a zero-risk blood supply. The blood supply has never been safer or more expensive. With the relative vanquishing of transfusion-transmitted diseases, noninfectious risks now exceed infectious risks. This has resulted in a call to refocus blood safety efforts on interconnected processes that link a unit of blood from its volunteer blood donor to the patient.
Additional costs in the blood supply chain will create new pressures on an already taxed system that gets little additional reimbursement with each new safety initiative. Opposing interests have created a tenuous relationship between the blood supplier and the transfusion provider. This adversarial relationship does not benefit the ultimate stakeholder, the patient. It is time to create a service partnership that is built on access, cost, and quality. Initiatives must be undertaken at a local, regional, and national level. Locally, blood suppliers and transfusion providers must reevaluate policies that are focused on individual gain and reinvent policies that will reward improvements in the overall system and expand cooperative services. Regionally, both blood suppliers and transfusion providers need to consolidate services to gain cost and quality benefits without compromising the competitive nature of the industry. Nationally, the creation of a strategic plan will help ensure that a mutually beneficial relationship focused on the patient is created between the blood supplier and transfusion provider at all levels. Development of such a plan would benefit the transfusing and supplying parties by identifying areas of common interest and how each may facilitate the achievement of shared benefits.     

Reducing replacement donors in Sub-Saharan Africa: challenges and affordability

In 1975, the World Health Assembly recommended that blood for transfusion should come from voluntary, non-remunerated donors; yet, in Africa, 75-80% of blood for transfusion still comes from hospital-based replacement donors. Although comprehensive economic data are scarce, evidence indicates that blood from voluntary donors recruited and screened at centralized transfusion centres, costs four to eight times as much as blood from a hospital-based, replacement donor system. Donor recruitment, quality assurance systems and distribution mechanisms in the centralized system are major reasons for the cost difference. There are concerns about the sustainability of centralized voluntary donor systems and their compatibility with the levels of health care that exist in many poor countries yet burdening patients' families with the responsibility of finding replacement blood donors will exacerbate poverty and reduce the safety of the blood supply. There are measures that can be introduced into hospital-based systems to improve safe blood supply in Africa but their effectiveness in different contexts needs to be evaluated.