In recent years, pulmonary transfusion reactions have gained increasing importance as serious adverse transfusion events.
Review of the literature.
Pulmonary transfusion reactions are not extremely rare and, according to hemovigilance data, important causes of transfusion-induced major morbidity and death. They can be classified as primary with predominant pulmonary injury and secondary as part of another transfusion reaction. Primary reactions include transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and transfusion-associated dyspnea (TAD). Secondary pulmonary reactions are often observed in the wake of hemolytic transfusion reactions, hypotensive/anaphylactic reactions, and transfusion-transmitted bacterial infections.
Knowledge and careful management of cases of pulmonary transfusion reactions are essential for correct reporting to blood services and hemovigilance systems. Careful differentiation between TRALI and TACO is important for taking adequate preventive measures.
Acute lung injury; Transfusion reaction; Transfusion risks
The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program.
Material and Methods
The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active he-movigilance-program established.
INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic.
The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections.
Pathogen inactivation; Platelets; Plasma; Amotosalen
The Agence Française de Securite Sanitaire des Produits de Santé (Afssaps; French Health Products Safety Agency) is responsible, through its hemovigilance unit, for the organization and the functioning of the national hemovigilance network. In accordance with the French law, it receives all data on adverse transfusion reactions regardless of their severity. With the aim of evaluating the tolerance of two kinds of labile blood products (LBP), pooled platelet concentrates (PP) and apheresis platelet concentrates (APC), we screened the French national database from January 1, 2000 to December 31, 2006. We observed that the number of transfusion incident reports is more than twice as high with APC (8.61:1,000 LBP) than with PP (4.21:1,000 LBP). The difference between these two ratios is statistically significant as shown by chi-square test (e = 21.00 with α = 5%). The risk to suffer adverse reactions of any type, except for alloimmunization, is higher with APC, and the major type of diagnosis related to APC is allergic reaction (1:200 APC issued) even if those allergic reactions are rarely serious. The new French National Hemovigilance Commission should impel a working group evaluating this topic and above all the impact of additive solutions which have been used since 2005 to put forward preventives measures.
French hemovigilance; Apheresis platelet concentratece; Pooled platelet concentrate; Adverse reaction
Epidemiological data are essential for monitoring trends and outbreaks of infectious diseases in the general population. The reporting system pursuant to the Infection Protection Act in Germany results in a very good quality of timely nationwide data on all reportable diseases including those relevant for the blood supply: HIV, hepatitis C, hepatitis B and syphilis. Notifications of acute hepatitis B and first-time diagnosed hepatitis C infections in the general population showed a declining trend in the past years, but the number of reports of HIV and syphilis infections increased until 2007 especially among men who have sex with men. New preventive strategies should also address changes in sexual behavior. The specific surveillance of blood donors is an important part of the hemovigilance system. The highly effective donor selection process results in a small number of confirmed infections among donors in Germany. The surveillance data enable us to identify specific trends that might challenge blood safety like the increase in HIV infections among repeat donors. Specific evaluations are performed when needed. These additional studies can be used to modify guidelines or recommendations and to (re)evaluate the need for or the effect of further testing.
Blood donation; HBV; HCV; Hemovigilance; HIV; Epidemiology
To optimize blood ordering and accurately assess transfusion practice, in 1987, an "on line" computerized, knowledge-based, blood order critiquing system was integrated into the HELP Hospital Information System (HIS) at LDS Hospital. Evaluations of the computerized ordering system demonstrated its benefits and limitations on transfusion practice. Based on this experience, a second generation blood ordering system using a consultation mode was developed. A pilot test of this blood order consultant system, using historical data in the HELP system's database, was performed. This pilot test demonstrated that the consultation system provided accurate recommendations for red blood cell (RBC) and platelet orders. Comparing the appropriateness of blood orders with the recommendations made by the director of the blood bank, the orders recommended by the computer "consultant" agreed 95.5% of the time. The computer consultation system also recommended fewer RBC units for transfusion. Preliminary results obtained using the consultant approach suggest that we may be able to simplify blood ordering practice and also reduce the number of units of blood products ordered. Based on these findings we are now preparing to compare the "critiquing" and "consultation" approaches using a clinical trial.
Blood safety must be maintained throughout the whole transfusion chain to prevent the transfusion of incorrect blood components. The estimated risk of an incorrect transfusion is in the order of 1 per 10,000 units of blood. Although several kinds of errors contribute to “wrong blood” events, 70% of errors occur in clinical areas with the most common being due to failure of the pre-transfusion bedside checking procedure.
Materials and Methods
Several methods are available to reduce such errors. The I-TRAC Plus system by Immucor consists of an identification bracelet which is a bar-coded wristband and a handheld portable computer that identifies patients and blood bags by a scanner and prints the information through a portable printer. The labels attached on the blood order forms and on the sample tubes are read and recorded in the blood bank’s informatics system (EmoNet INSIEL). Labels showing the bar-code of the assigned number, which includes the ID number of the patient, the ID number of the unit and a code identifying the kind of product and use (allogeneic or autologous), are generated and applied to the blood components. The transfusions are administered after checking the unit and the patient’s wristband using the scanner of a portable PC.
In 5 years a total of 71,400 units of blood components were transfused to 15,430 patients using the I-TRAC Plus system. The system prevented 12 cases of mis-identification of patients (5 in 2003, 0 in 2004, 1 in 2005, 1 in 2006 and 5 in 2007).
In 2003 we introduced the use of a bar-code matching system between a patient’s wristband and the blood bag to avoid mistakes at the bedside. In 5 years the system provided benefits by avoiding errors in the identification of patients, thus preventing “wrong blood” transfusions.
Recipient identification; transfusion safety; mistransfusion
OBJECTIVE: To develop and implement a computerized version of the International Classification of Primary Care. To create a data bank and to conduct a descriptive study of our clinic's clientele. DESIGN: Testing a software program and creating a data bank. SETTING: Family Medicine Unit at Enfant-JÃ©sus Hospital, Quebec City. PARTICIPANTS: All Family Medicine Unit doctors and patients seen between July 1, 1990, and June 30, 1993. MAIN OUTCOME MEASURE: Description of our clientele's health problems using the ICPC. RESULTS: During the study, 48,415 diagnostic codes for 33,033 visits were entered into the bank. For close to 50% of these visits, two or more health problems were coded. There was good correlation between the description of our clientele and descriptions in other studies in the literature. CONCLUSION: This article describes the development of a data bank in a family medicine unit using a software program based on the ICPC. Our 3-year experiment demonstrated that the method works well in family physicians' daily practice. A descriptive study of our clientele is presented, as well as a few examples of the many applications of such a data bank.
A data processing system designed to improve the management and usage of blood and blood products has been developed as a pilot for general application throughout the West Midlands Regional Health Authority. The package provides for the routine clerical, patient record, and stock management aspects of a hospital blood bank laboratory. It can be tailored to the individual requirements of different laboratories and may be implemented in a variety of ways on a family of computer systems of differing power and capacity, thus accommodating widely varying workloads and archiving requirements. Bar code readers are included in the system design, and may be used for data input where standard Codabar labels are affixed to blood products by blood transfusion centres. The system has been installed in one hospital laboratory and preliminary results indicate a high degree of acceptability at all levels. Further refinement of the software to meet minor deficiencies and the requirements of the recent DHSS Health Circular BLD/2/13 are currently being specified.
The Transfusion Advisor is a knowledge-based system designed to facilitate the review of transfusion requests in the hospital blood bank. We have developed and performed an evaluation of a research prototype of the system which draws conclusions about twelve hemostatic disorders and critiques the appropriateness of the use of frozen plasma, cryoprecipitate (cryo), and platelets, which are products most commonly used for the treatment of hemostatic disorders. Our evaluation of the system revealed that there was closer agreement of the expert system with the domain expert than with the clinicians ordering the transfusions, and that the use of the transfusion advisor to screen transfusion requests may result in a substantial decrease in the use of these blood products.
The French Hemovigilance Network has been established in 1994 and records all adverse events associated with the transfusion of a labile blood products (LBP) regardless of their severity. From 1994 to 2006 35,423,172 LBP were issued, 85,812 adverse transfusion reactions notified, and 139 cases of transfusion related acute lung injury (TRALI) observed. The LBP most at risk is fresh frozen plasma (FFP), followed by platelets concentrates (PC) and packed red cells (PRC). However, because the use of FFP is not frequent in France, it only accounts for about 10% of TRALI, whereas PRC and PC are involved in the remaining cases. In no case, pooled FFP treated with solvent-detergent were involved. Patients’ profiles are peculiar with a high disease burden. Therefore, targeting a prevention policy only on FFP would result in a marginal reduction of TRALI in France.
TRALI; Hemovigilance; Blood transfusion; Sickle cell disease; Public health
Hemorrhage is the major cause of cardiac arrest developing in the operating room. Many human factors including surgical procedures, transfusion practices, blood supply, and anesthetic management are involved in the process that leads to hemorrhage developing into a critical situation. It is desirable for hospital transfusion committees to prepare hospital regulations on 'actions to be taken to manage critical hemorrhage', and practice the implementation of these regulations by simulated drills. If intraoperative hemorrhage seems to be critical, a state of emergency should immediately be declared to the operating room staff, the blood transfusion service staff, and blood bank staff in order to organize a systematic approach to the ongoing problem and keep all responsible staff working outside the operating room informed of events developing in the operating room. To rapidly deal with critical hemorrhage, not only cooperation between anesthesiologists and surgeons but also linkage of operating rooms with blood transfusion services and a blood bank are important. When time is short, cross-matching tests are omitted, and ABO-identical red blood cells are used. When supplies of ABO-identical red blood cells are not available, ABO-compatible, non-identical red blood cells are used. Because a systematic, not individual, approach is required to prevent and manage critical hemorrhage, whether a hospital can establish a procedure to deal with it or not depends on the overall capability of critical and crisis management of the hospital.
Crisis management; Hemorrhage; Risk management; Transfusion
The National Practitioner Data Bank became operational September 1, 1990, as a flagging system to identify health care practitioners who may have been involved in incidents of medical incompetence. Query volumes have grown substantially over the Data Bank's first 4 years of operation. The greatest increase has come in the number of voluntary queries. By the end of 1994, the Data Bank had processed more than 4.5 million requests for information on practitioners, more than 1.5 million of which were received in 1994 alone. The proportion of queries for which the Data Bank contains information on the practitioner in question has grown as the Data Bank has come to contain more reports. During 1994, 7.9 percent of queries were matched. The Data Bank contained more than 97,500 reports at the end of 1994. More than 82 percent of the reports concerned malpractice payments. Licensure reports made up the bulk of the rest. Physicians predominate in reports, accounting for slightly more than 76 percent of the total. The remainder are related to dentists (16 percent) and all other types of practitioners (8 percent). Since reporting of adverse actions is mandatory only for physicians and dentists, the proportion of reports attributable to these types of practitioners is higher than it would be if adverse action reporting requirements were uniform for all practitioners. State malpractice payment rates and adverse action rates vary widely, but a State's rate in any given year is highly correlated with its rate in any other year. State malpractice rates are not strongly correlated with adverse action rates, neither are the rates for physicians strongly correlated with those for dentists. There is a weak tendency for States with smaller physician populations to have higher levels of licensure and privileging actions.
The World Health Organization (WHO) recommends the creation of national blood transfusion services. Burkina Faso has a CNTS (Centre national de transfusion sanguine - National Blood Transfusion Center) but it currently covers only 53% of the national blood supply versus 47% produced by independent hospital blood banks.
To evaluate blood collection, testing, preparation and prescription practices in the regions of Burkina Faso that are not covered by the CNTS, we conducted a cross-sectional survey.
Data were collected by trained professionals from May to June 2009, at 42 autonomous blood centers not covered by the CNTS.
Blood collection was supervised in all sites by laboratory technicians without specific training. There was no marketing of community blood donation nor mobile collection. Donation was restricted to replacement (family) donors in 21.4% of sites. Pre-donation screening of donors was performed in 63.4% of sites, but some did not use written questionnaires. Testing for HIV, hepatitis B virus and syphilis was universal, although some sites did not screen for hepatitis C virus. In 83.3% of the sites blood typing was performed without reverse ABO typing. In 97.6% of the sites, nurses acted alone or in conjunction with a physician to order blood transfusions.
Shortcomings in non-CNTS blood centers argue for the development of a truly national CNTS. Such a national center should coordinate and supervise all blood transfusion activities, and is the essential first step for improving and institutionalizing blood transfusion safety and efficacy in a developing country.
Blood transfusion; Blood donors; HIV; HBV; HCV–Africa; Burkina Faso
ESPRE, a knowledge-based system designed to facilitate good platelet transfusion practices, is under development at the University of Minnesota Hospital and Clinic. This microcomputer based decision support system aids Blood Bank personnel in evaluating requests for platelet transfusions. Because of a direct link with the laboratory computers, most patient data need not be entered manually, but rather can be accessed directly. ESPRE uses a combination of frames and rules during its inference procedure and generates an explanation of its line of reasoning. In a preliminary comparison of the system with blood bank personnel in evaluating transfusion requests, four discrepant cases were found among fifty-eight cases evaluated.
The American Blood Commission has designed a recommended uniform blood labeling system. A central feature of the new label is the bar-code, which allows the label to be read by automated equipment as well as by the human eye. In addition, the label is characterized by new levels of simplicity and uniformity in design over the multitude of labels previously in use in the country's blood banks and hospitals.
The Food and Drug Administration, the federal agency with a regulatory mandate in the area of blood labeling, has announced that it will issue regulations requiring the use of this uniform label, as a means of furthering public safety in transfusion.
Supported by a grant from the Agency for Healthcare Research and Quality, a
University of Iowa Hospitals and Clinics interdisciplinary research
team created an online data-capture-response tool utilizing wireless
mobile devices and bar code technology to track and improve blood products
administration process. The tool captures 1) sample collection, 2) sample
arrival in the blood bank, 3) blood product dispense from blood
bank, and 4) administration. At each step, the scanned patient wristband
ID bar code is automatically compared to scanned identification
barcode on requisition, sample, and/or product, and the system presents
either a confirmation or an error message to the user. Following an
eight-month, 5 unit, staged pilot, a ‘big bang,’ hospital-wide
implementation occurred on February 7, 2005. Pilot period and
preliminary house-wide data indicate improved error capture with the
new barcode process over the old manual process.
Altered signaling in B-cells is a predominant feature of systemic lupus erythematosus (SLE). The genes BANK1 and BLK were recently described as associated with SLE. BANK1 codes for a B-cell-specific cytoplasmic protein involved in B-cell receptor signaling and BLK codes for an Src tyrosine kinase with important roles in B-cell development. To characterize the role of BANK1 and BLK in SLE, we performed a genetic interaction analysis hypothesizing that genetic interactions could reveal functional pathways relevant to disease pathogenesis.
We Used the method GPAT16 to analyze the gene-gene interactions of BANK1 and BLK. Confocal microscopy was used to investigate co-localization, and immunoprecipitation was used to verify the physical interaction of BANK1 and BLK.
Epistatic interactions between BANK1 and BLK polymorphisms associated with SLE were observed in a discovery set of 279 patients and 515 controls from Northern Europe. A meta-analysis with 4399 European individuals confirmed the genetic interactions between BANK1 and BLK.
As BANK1 was identified as a binding partner of the Src tyrosine kinase LYN, we tested the possibility that BANK1 and BLK could also show a protein-protein interaction. We demonstrated co-immunoprecipitation and co-localization of BLK and BANK1. In a Daudi cell line and primary naïve B-cells the endogenous binding was enhanced upon B-cell receptor stimulation using anti-IgM antibodies.
Here, we show a genetic interaction between BANK1 and BLK, and demonstrate that these molecules interact physically. Our results have important consequences for the understanding of SLE and other autoimmune diseases and identify a potential new signaling pathway.
systemic lupus erythematosus; genetics; polymorphism; B-cells; autoantibodies
An aim of the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) initiative is to develop item banks and computerized adaptive tests (CAT) that are applicable across a wide variety of chronic disorders. The PROMIS Pediatric Cooperative Group has concentrated on the development of pediatric self-report item banks for ages 8-17 years. The objective of the present study is to describe the Item Response Theory (IRT) analysis of the NIH PROMIS pediatric pain item bank and the measurement properties of the new unidimensional PROMIS Pediatric Pain Interference Scale. Test forms containing pediatric pain items were completed by a total of 3,048 respondents. IRT analyses regarding scale dimensionality, item local dependence, and differential item functioning were conducted. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. The recommended 8-item unidimensional short form for the PROMIS Pediatric Pain Interference Scale contains the item set which provides the maximum test information at the mean (50) on the T-score metric. A simulated CAT was computed that provides the most information at five possible score locations (30, 40, 50, 60, and 70 on the T-score metric).
Pain; pediatrics; PROMIS; pain interference; Item Response Theory
The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to develop self-reported item banks for clinical research. The PROMIS pediatrics (aged 8–17) project focuses on the development of item banks across several health domains (physical function, pain, fatigue, emotional distress, social role relationships, and asthma symptoms). The psychometric properties of the anxiety and depressive symptom item banks are described.
Participants (n = 1,529) were recruited in public school settings, hospital-based outpatient and subspecialty pediatrics clinics. The anxiety (k = 18) and depressive symptoms (k = 21) items were split between two test administration forms. Hierarchical confirmatory factor-analytic models (CFA) were conducted to evaluate scale dimensionality and local dependence. IRT analyses were then used to finalize item banks and short forms.
CFA results confirmed that anxiety and depressive symptoms are separate constructs and indicative of negative affect. Items with local dependence and DIF were removed resulting in 15 anxiety and 14 depressive symptoms items. The psychometric differences between short forms and simulated computer adaptive tests are presented.
PROMIS pediatric item banks were developed to provide efficient assessment of health-related quality of life domains. This sample provides initial calibrations of anxiety and depressive symptoms item banks and creates PROMIS pediatric instruments, version 1.0.
PROMIS; Anxiety; Depressive symptoms; HRQOL; PRO; Scale development; Surveys; Pediatrics
Previous studies have shown the usefulness of combining information from different data sources to identify and analyse variations in transfusion practices. Good knowledge of the conditions leading to blood use is a fundamental requirement for the assessment of the appropriateness of blood transfusion.
Materials and methods
In this study we combined blood transfusion data obtained from the Blood Bank information system with patients’ data from the Hospital Discharge Database, based on the ICD9 classification system, from 1,827 surgical procedures performed in seven different orthopaedic divisions in the Ravenna area between January and December 2009. Hip and knee replacement surgery (primary or revision) and operations following femoral fractures (partial hip replacement and reduction with internal fixation) were considered. For a subgroup of patients clinical and transfusion data were also combined with haemoglobin values obtained from the laboratory information system.
Of the 1,827 surgical procedures, 1,038 (56.8%) were followed by transfusion of red cells. The likelihood of receiving a transfusion varied depending on the patient’s sex (49% for males, 60% for females), age, and on the surgical procedure, being higher for interventions following femoral fractures and for revisions of hip replacement: about 70% of patients undergoing these interventions required transfusion. A large variability in transfusion rates was observed between the seven divisions, which was only partially explained by the different types of surgery (post-traumatic or elective) performed by any of them: relevant variations were also observed for the same type of intervention.
Combining information from different data sources could be a time-sparing way to gain useful information about transfusion practices, so contributing to optimising blood usage.
blood transfusion; orthopaedics; surgery; benchmark; ICD9
This paper describes the psychometric properties of the PROMIS Pain Interference (PROMIS-PI) bank. An initial candidate item pool (n=644) was developed and evaluated based on review of existing instruments, interviews with patients, and consultation with pain experts. From this pool, a candidate item bank of 56 items was selected and responses to the items were collected from large community and clinical samples. A total of 14,848 participants responded to all or a subset of candidate items. The responses were calibrated using an item response theory (IRT) model. A final 41-item bank was evaluated with respect to IRT assumptions, model fit, differential item function (DIF), precision, and construct and concurrent validity. Items of the revised bank had good fit to the IRT model (CFI and NNFI/TLI ranged from 0.974 to 0.997), and the data were strongly unidimensional (e.g., ratio of first and second eigenvalue = 35). Nine items exhibited statistically significant DIF. However, adjusting for DIF had little practical impact on score estimates and the items were retained without modifying scoring. Scores provided substantial information across levels of pain; for scores in the T-score range 50-80, the reliability was equivalent to 0.96 to 0.99. Patterns of correlations with other health outcomes supported the construct validity of the item bank. The scores discriminated among persons with different numbers of chronic conditions, disabling conditions, levels of self-reported health, and pain intensity (p< 0.0001). The results indicated that the PROMIS-PI items constitute a psychometrically sound bank. Computerized adaptive testing and short forms are available.
Quality-of-life outcomes; quality-of-life measurement; pain
Recently, the National Institutes of Health Roadmap for Medical Research initiative led a large-scale effort to develop the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS’s main goal was to develop a set of item banks and computerized adaptive tests for the clinical research community. Asthma, as the most common chronic childhood disease, was chosen for a disease-specific pediatric item bank.
The primary objective of this research is to present the details of the psychometric analyses of the asthma domain items.
Item response theory (IRT) analyses were conducted on a 34–asthma item bank. Test forms containing PROMIS Pediatric Asthma domain items were completed by 622 children ages 8 to 12. Items were subsequently evaluated for local dependence, scale dimensionality, and differential item functioning.
A 17-item pool and an 8-item short form for the new PROMIS Pediatric Asthma Impact Scale (PAIS) were generated using IRT. The recommended 8-item short form contains the item set that provides the maximum test information at the mean (50) on the T-score metric. If more score precision is required, the complete 17-item pool is recommended and may be used in toto or as the basis of a computerized adaptive test (CAT). A shorter test form can also be created and scored on the same scale.
The present study presents the PROMIS Pediatric Asthma Impact Scale (PAIS) developed with IRT, and provides the initial calibration data for the items.
asthma; pediatric; quality-of-life; item response theory
The case is described of a 70-year-old man, recently retired but fit and independent, except for haemophilia from which he had suffered all his life. However, he then had rectal bleeding for which he required treatment in hospital. To counteract the bleeding tendency he was transfused with various blood products but none was successful, and finally after an operation to determine precisely the source of the rectal bleeding, he developed peritonitis and died. Apart from the cost of hospital inpatient treatment and the blood products available from blood banks, £8500 was spent on blood products bought in the USA.
This case is discussed by a professor of haematology, a director of a regional blood transfusion service, a medical defence specialist, a consultant in geriatric medicine, and finally by a member of a university department of moral philosophy.
All the medical commentators agree that a very large sum of money was spent in treating this patient, particularly in buying supplies of commercially produced factor VIII which also carries attendant medical risks. But while this is so, it is also argued that the doctors in charge of the case could have done no other as the fatal outcome could not have been foreseen and a doctor's duty is to treat his patient to the best of his ability, even though in this case the patient was elderly and in the hospital concerned other projects had to be cancelled.
The `battle' of the treatment of the aged versus the young is touched upon by all the contributors but it is left to the moral philosopher to examine it more closely and incidentally to direct attention to the nature of the National Health Service which is neither a paternalistic system nor an insurance scheme (thought to be so by some to be a more palatable notion) but a welfare scheme in which the state forces its citizens to do things for the general good. For the moral philosopher age is irrelevant to the debate. Perhaps the consultant in geriatric medicine should have the last word: if the patient had been in the hands of a single general physician or geriatrician, he says, he would have been seen as a whole person and the arguments surrounding the case with hindsight would never have arisen.
Since the first successful transplantation of umbilical cord blood in 1988, cord blood has become an important source of hematopoietic stem and progenitor cells for the treatment of blood and genetic disorders. Significant progress has been accompanied by challenges for scientists, ethicists, and health policy makers. With the recent recognition of the need for a national system for the collection, banking, distribution, and use of cord blood and the increasing focus on cord blood as an alternative to embryos as a source of tissue for regenerative medicine, cord blood has garnered significant attention. We review the development of cord blood banking and transplantation and then discuss the scientific and ethical issues influencing both established and investigational practices surrounding cord blood collection, banking, and use.
Appropriate selection of donors, use of sensitive screening tests, and the application of a mandatory quality assurance system are essential to maintain the safety of the blood supply. Laws, decrees, norms, and/or regulations covering most of these aspects of blood transfusion exist in 16 of the 17 countries in Latin America that are the subject of this review. In 17 countries, there is an information system that, although still incomplete (there are no official reports on adverse events and incidents), allows us to establish progress made on the status of the blood supply since 1993. Most advances originated in increased screening coverage for infectious diseases and better quality assurance. However, in 2001 to 2002, tainted blood may have caused infections in 12 of the 17 countries; no country reached the number of donors considered adequate, i.e., 5% of the population, to avoid blood shortages, or decreased significantly the number of blood banks, although larger blood banks are more efficient and take advantage of economies of scale. In those years, paid donors still existed in four countries and replacement donors made up >75% of the blood donors in another eight countries. In addition, countries did not report the number of voluntary donors who were repeat donors, i.e., the healthiest category. In spite of progress made, more improvements are needed.