ISBT Code 128 implementation at a regional blood center.

BACKGROUND: Application specifications for ISBT 128 bar code symbology and the International Council for Commonality in Blood Bank Automation (ICCBBA) were created in 1994. By June 2000, the FDA considered ISBT 128 a standard for uniform labeling of blood and blood components. Our blood center initiated a change process for ISBT 128 implementation and "went live" in 2003. STUDY DESIGN AND METHODS: The intention to adopt ISBT 128 symbology with hospitals was actively communicated in October 2001. A Codabar-ISBT label cross-reference book was developed, FDA approval for the fullface label format in April 2002 was requested, and FDA approval was received in March 2003. In December 2002, donor identification labels and number sets were ordered, and an integration test plan was subsequently developed with departmental process flowcharts for each of the nine affected departments. Each step was tested, the labeling changes were approved in May 2003, training was completed in June 2003, and ISBT bar code symbology was implemented on July 1, 2003. A written survey was sent to hospital transfusion services in April 2004. RESULTS: Implementation went smoothly except for an unanticipated high rate of "no-reads" on some analyzers in the testing lab. The hospitals spent an average of 18 hours preparing for changes, 14 hours on validation, 4 hours on documentation and procedure development, and 8 hours on training. CONCLUSION: ISBT bar code symbology was successfully implemented. Hospital transfusion services made some adjustments and, overall, readily accepted the new bar code symbology.

A feasibility evaluation of an automated blood component collection system platelets and red cells.

BACKGROUND: The purpose of these studies was to evaluate the functional properties of blood components collected with an automated collection system. STUDY DESIGN AND METHODS: Single-donor platelets (n = 44) and packed red cell (RBC) units (n = 10) were collected. In vitro and in vivo assays were used to assess the function of single-donor platelet components stored for 5 days and of packed RBC units after storage for 42 days at 4 degrees C. RESULTS: Adverse events observed in the 44 study subjects were minor. The mean 24-hour recovery value for the packed RBC units stored for 42 days was 83.6 +/- 5.4 percent, with a mean percentage of hemolysis on Day 42 at 0.46 +/- 0.19 percent. The 25 patients receiving platelet components achieved a mean corrected count increment of 15.1 +/- 10.4 x 10(3). All platelet concentrates had less than 1 x 10(6) total white cells. CONCLUSION: Both in vitro and in vivo testing for the packed RBCs collected and stored for 42 days met the standards for both hemolysis and percentage of 51Cr 24-hour RBC recovery. The in vitro results and transfusion data on white cell-reduced platelet components transfused to thrombocytopenic patients were comparable to those on available platelet components.

Hemovigilance in the United States of America.

Although hemovigilance is not a word used commonly in the United States, the concept of monitoring morbidity associated with blood transfusion is accepted widely. Currently, quality management focuses on error avoidance rather than error detection in both the "manufacturing" and "clinical" aspects of blood banking. "Manufacturing" is regulated predominantly by current Good Manufacturing Practices while clinical transfusion medicine follows clinical practice guidelines. There are multiple overlapping mechanisms for quality assurance and error reporting among governmental, professional, and non-profit regulatory agencies. The strategies of each stress the on-going need for a systems approaches to preventing errors.

Cost analysis of intraoperative blood salvage during orthotopic liver transplantation.

Approximately 6,000 to 7,000 orthotopic liver transplantation (OLT) procedures are performed annually, which require the administration of large volumes of blood products. Thus liver transplantation can significantly strain local and regional blood resources at a time when transfusion practices are changing dramatically, in large part because of anxiety caused by the human immunodeficiency virus. Intraoperative autologous transfusion has been proposed as a means of both reducing transfusion demands and lessening the hazards of allogeneic transfusion. However, the cost effectiveness of intraoperative blood salvage has not been unequivocally determined. We retrospectively examined the cost of intraoperative autologous transfusion during OLT for a 2-year period at the University of Cincinnati Hospital. A direct comparison was made between the charge for autologous transfusion and the calculated cost of allogeneic transfusion. Seventy OLT procedures were performed during the years 1993-1994. The average charge for autologous transfusion was $1,048.73 per case. Cell-salvage volumes for all cases were added, and the calculated conservation of allogeneic packed red blood cells totaled 359.6 units, worth $30,026.60 or $428.95 per case. The break-even point is approximately 12.6 units, and most patient do not receive this volume of salvaged blood. In fact, cell salvage reached cost equivalence in only three cases (4.8%). Moreover, the cost deficit of autologous transfusion during this 2-year period averaged $586.56 per case.

A prospective, randomized study of the use of platelet concentrates irradiated with ultraviolet-B light in patients with hematologic malignancy.

BACKGROUND: Irradiation of platelet concentrates (PCs) with ultraviolet-B (UVB) light inactivates the contaminating white cells and might be an alternative to filtration for the prevention of alloimmunization to HLA antigens and subsequent refractoriness to further platelet transfusions in multiply transfused patients with bone marrow failure. STUDY DESIGN AND METHODS: Patients with hematologic malignancy, mainly acute myeloid leukemia, were prospectively assigned in a random manner to receive either UVB-irradiated or control, nonirradiated PCs. All patients were given red cells that were white cell reduced by filtration. Transfusion efficacy and alloimmunization were assessed by means of corrected count increments, requirement for red cells and PCs, and measurement of lymphocyte-reactive antibodies. RESULTS: UVB-irradiated PCs had a clinical efficacy similar to controls as judged by corrected count increments at 1 to 6 and 12 to 24 hours and by the median requirement for red cell and platelet transfusions. Alloimmunization determined by measurements of lymphocyte-reactive antibodies using both conventional and antiglobulin-augmented lymphocytotoxicity techniques was not abolished in recipients of UVB-irradiated PCs (4/30, 13%) but was less than that in controls (5/20, 25%; p = NS). The mean number of platelet transfusion episodes prior to the occurrence of alloimmunization was greater in the control group (27 vs. 10; p = 0.017). CONCLUSION: In this trial, UVB irradiation did not diminish the clinical efficacy of platelet transfusions. There was a small but nonsignificant reduction alloimmunization, but no difference in refractoriness of the two groups was observed. Larger prospective randomized studies are required to confirm these findings and to compare UVB irradiation with white cell reduction.

Fibrin sealant: summary of a conference on characteristics and clinical uses.

The 2-day conference clearly outlined the formulations of products that are being developed or are commercially available in Europe. The major difference between products in the United States and those in Europe is that US manufacturers are preparing fibrin sealant that does not contain aprotinin, epsilon amino caproic acid, or any other type of antifibrinolytic agent, whereas antifibrinolytic agents are included in all such preparations used in Europe. The conference provided no clear consensus that such agents are essential to the efficacy of the product. Although many investigators believe in the clinical benefit of fibrin sealant, most of the studies to demonstrate efficacy have not been performed in a well-controlled fashion. However, fibrin sealant, if found in a controlled trial to have clinical efficacy, could be approved by the FDA for a narrow indication. Opportunities remain for greater exploration of different forms of the product, not only as a hemostatic agent, but as an adjunct to wound healing and as a matrix for delivery of drugs and proteins with other biologic activities.

Transfusion strategies: opportunities for improvement.

Opportunities for improving transfusion practice that involve patient care, technological advancements, and technology changes in the clinical arena are discussed. Patient care should be enhanced by optimizing transfusion therapy and the source of donors of platelet concentrates, i.e., single donor platelets (obtained by plateletapheresis from a single donor) or to random donor platelets (containing a pool of six to eight platelet concentrates separated from whole blood donations). The availability of "third-generation" leukocyte-reduction filters provides the technology for significantly and consistently providing leukocyte-reduced blood components. The potential benefits of using these filters is presented. Platelet crossmatching represents a technology change involving clinical practice. Suggestions for incorporating this test into platelet transfusion algorithms are included.

Use of bi-level biotinylation for concurrent measurement of in vivo recovery and survival in two rabbit platelet populations.

BACKGROUND: The objectives of this research were 1) to determine whether two populations of platelets may be labeled with different levels of biotin and followed concurrently in vivo by flow cytometry and 2) to determine whether the level of biotinylation affects the in vivo platelet recovery and survival. STUDY DESIGN AND METHODS: Two platelet aliquots were biotinylated under conditions that resulted in either a lower or a higher number of biotin molecules per platelet. After transfusion, the two populations were distinguished and quantitated by flow cytometry. RESULTS: In five animals, recoveries were 69.8 +/- 27.0 percent for low-biotin platelets and 72.6 +/- 26.7 percent for high-biotin platelets. For each animal, the recoveries agreed closely. Life span, determined by the multiple-hit method, was 2.68 +/- 0.63 days for low-biotin platelets and 2.58 +/- 0.69 days for high-biotin platelets. These values for recovery and life span are consistent with those measured in rabbits by using radioisotope labels. CONCLUSION: Platelet biotinylation offers a nonisotopic method for direct comparison of alternative harvest and storage conditions. It also offers the potential for simultaneous evaluation of the in vivo characteristics of platelets from at least two donors.

Hepatitis C is a poor prognostic indicator in black kidney transplant recipients.

BACKGROUND: The significance of hepatitis C in kidney transplant recipients is unclear. The prevalence of antibodies to hepatitis C among candidates for transplantation is up to 50% in some centers. METHODS: We screened 640 frozen serum samples obtained pretransplantation from all kidney recipients at the Medical College of Wisconsin between January 1979 and March 1990 for antibody to hepatitis C using the second generation immunoassay. Charts were reviewed from all hepatitis C antibody-positive (anti-HCV+) patients and 256 randomly chosen hepatitis C antibody negative (anti-HCV-) controls. Actuarial patient and graft survival in these two groups were determined. RESULTS: The prevalence of anti-HCV was 8.3%. Blacks and i.v. drug users were disproportionately represented in the anti-HCV+ group. Of the anti-HCV+ patients, 18.9% developed chronic hepatitis independent of race. Black anti-HCV+ patients had a 5-year graft survival of 28 +/- 11% compared to 67 +/- 7% in black anti-HCV- patients (P = 0.003). Black anti-HCV-, white anti-HCV-, and white anti-HCV+ patients all had similar graft survival. Anti-HCV was not a poor prognostic indicator for overall patient survival or the development of aplastic anemia and malignancies including hepatocellular carcinoma. CONCLUSIONS: Anti-HCV is a significant risk factor for reduced kidney graft survival in blacks apart from i.v. drug abuse. Black anti-HCV- patients had graft survival similar to white transplant recipients, indicating that anti-HCV may be one marker for the poorer graft survival in blacks that has been observed in most transplant programs. Anti-HCV in kidney transplant recipients increases the risk for the development of chronic hepatitis post-transplant.

Blood transfusion and postoperative infection in orthopedic patients.

Adverse effects of the transfusion of homologous blood on tumor recurrence and resistance to bacterial infection have been reported previously, but the findings are inconclusive. A retrospective review of patients undergoing orthopedic surgery was conducted, and the rate of the postoperative infectious complications was compared among those receiving homologous blood, autologous blood, both types, or no transfusion support. An overall postoperative infection rate of 6.1 percent was observed: 6.9 percent among persons receiving homologous blood, 5.0 percent among those receiving autologous blood, 11.9 percent among those receiving both homologous and autologous blood, and 4.9 percent among those not receiving transfusions (p = 0.37). Among patients receiving homologous blood, a subset of 15 patients received homologous whole blood and had an infection rate of 20 percent. Significant predictors of postoperative infection included increasing age, spinal surgery, high admission hematocrit, and greater time in surgery. Of factors relating to transfusion, only the use of homologous whole blood was a significant predictor of postoperative infection, which suggests a detrimental effect of homologous plasma. It can be concluded that, in this group of patients undergoing relatively nontraumatic surgery, several variables that are not related to transfusion, as well as the use of homologous whole blood, were significant predictors of postoperative infection.

Selective in vivo removal of rheumatoid factor by an extracorporeal treatment device in rheumatoid arthritis patients.

A prospective phase II trial was conducted to assess the feasibility, tolerance, and efficacy of a device designed for selective removal of rheumatoid factor from the plasma of rheumatoid arthritis patients. The device contained terpolymer hydrogel-coated plates with chemically attached, aggregated human immunoglobulin G, and it operated as an immunoaffinity column. Sixty-one patients aged 25 to 73 underwent weekly plasmapheresis treatments (the primary therapy phase). During the trial, patients continued current rheumatoid arthritis medications without dose adjustments. All patients received two to six treatments (primary therapy). Responding patients were eligible to continue apheresis treatment every 2 to 6 weeks (maintenance therapy). No serious, untoward side effects were noted in the course of this study; of 640 treatments, only 2 (in different patients) were aborted, one because of complaints of dizziness and angioedema and the other because of chest tightness and shortness of breath. Except for a significant (p less than 0.05) decrease in serum iron, no significant changes in complete blood count, serum electrolytes, renal and hepatic function tests, or serum C3 and C4 were noted. Although the trial was not designed to determine clinical efficacy, patients noted less morning stiffness, longer time to onset of fatigue, and improved global pain assessment (p less than 0.004); significant objective improvements were noted in joint pain, tenderness, swelling, and the number of affected joints (p less than 0.001). One-half of the treated patients had at least a 50 percent improvement in objective measures of antirheumatic activity.(ABSTRACT TRUNCATED AT 250 WORDS)

Transfusion practices in the 1990s.

Transfusion practice in the 1990s is expected to continue the trend established in the 1980s toward assuring appropriate use of transfusion therapy. Autologous blood collection is expected to increase further, and pharmacologic agents that promote hemostasis or cell production will be integrated into ongoing efforts to reduce homologous blood usage. Although the risk of transfusion-transmitted diseases should continue to decrease, procedures to inactivate viruses in cellular blood components will be evaluated and artificial oxygen-carrying components may become available.

Prevalence of human immunodeficiency virus type 1 p24 antigen in U.S. blood donors--an assessment of the efficacy of testing in donor screening. The HIV-Antigen Study Group.

BACKGROUND: We performed a multicenter study in 1989 to determine whether screening whole-blood donors for human immunodeficiency virus type 1 (HIV-1) p24 antigen would improve transfusion safety by identifying carriers of the virus who are seronegative for HIV-1 antibody. METHODS: More than 500,000 donations were tested at 13 U.S. blood centers with test kits from two manufacturers. Units found repeatedly reactive were retested in a central laboratory; if the results were positive, they were confirmed by a neutralization assay. A subgroup of units was also tested for HIV-1 by the polymerase chain reaction. Selected donors confirmed or not confirmed as having p24 antigen were contacted for follow-up interviews to identify risk factors and undergo retesting for HIV-1 markers. RESULTS: Positive tests for p24 antigen were confirmed by neutralization in five donors (0.001 percent of all donations tested), all of whom were also positive for HIV-1 antibody and HIV-1 by polymerase chain reaction. Three of the antigen-positive donors had other markers of infectious disease that would have resulted in the exclusion of their blood; two had risk factors for HIV-1 that should have led to self-exclusion. Of 220 blood units with repeatedly reactive p24 antigen whose presence could not be confirmed by neutralization (0.04 percent of the donations studied), none were positive for HIV-1 antibody, HIV-1 by polymerase chain reaction (120 units tested), or virus culture (76 units tested)--attesting to the specificity of confirmatory neutralization. CONCLUSIONS: The finding that no donation studied was positive for p24 antigen and negative for HIV-1 antibody suggests that screening donors for p24 antigen with tests of the current level of sensitivity would not add substantially to the safety of the U.S. blood supply.