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Biomedical subjects

J V Linden

Publications and source records attributed to J V Linden.

At least 19 recordsLinked to original sources

New York State guidelines for cord blood banking. Department of Health.

In response to the profound interest in the transplantation of umbilical cord blood, the New York State (NYS) Department of Health embarked on a regulatory strategy designed to provide guidance to the practitioner while allowing for the flexibility required by the inherent developmental nature of the technology. The result was the development of the Guidelines for Collection, Processing, and Storage of Cord Blood Stem Cells, adherence to which is optional. It is anticipated that through the use of such guidelines as a supplement to the existing hematopoietic progenitor cell (HPC) regulations for tissue banks, practitioners may provide to potential patients the safest and most efficacious cord blood products currently available, and information gained through the use of these products will be of optimal value toward the goal of continuous improvement in the delivery of this new technology.

Blood Banks

Fatal air embolism due to perioperative blood recovery.

This study was initiated to investigate the incidence of acute mortality from air embolism associated with perioperative blood recovery and the causative factors and common characteristics of such fatalities. All facilities providing transfusion services in New York State are required to report severe adverse reactions to, and the total number of, transfusion and blood recovery procedures performed. Relevant data for the period from January 1990 to June 1995 were tabulated. During this time, 127,586 perioperative blood recovery procedures were performed, and 8,955,619 conventional blood components were transfused. The frequency of fatal air embolism after readministration of recovered blood was approximately 1:30,000-1:38,000; none followed conventional transfusion. Characteristics common to the fatalities (including an additional case reported before the study interval) were examined; all involved reinfusion of recovered blood under pressure. In the population studied, the incidence of fatal air embolism after the perioperative readministration of recovered blood was significantly higher than that after conventional transfusion. A model of such a system demonstrated that as much as 200 mL of air could enter the circulation in as little as 4 s, rendering visual detection and intervention extremely difficult. Education and guidelines to reduce the risk and mortality associated with this procedure are recommended.

Adult

Data on apheresis, blood collection, and transfusion-related activities: statistical analyses of the American Association of Blood Banks institutional membership questionnaires.

BACKGROUND: The American Association of Blood Banks annually surveys institutional members on activities pertinent to blood collections, apheresis, and transfusions. STUDY DESIGN AND METHODS: Retrospective descriptive statistics and comparative statistical analyses including trend tests were performed on selected topics from the 1989, 1990, and 1991 Institutional Questionnaires. The data were compiled by institution type, namely, regional and community blood donor collection centers and hospital-based facilities. Evaluated topics included the apheresis and therapeutic procedures performed, transfusion-associated AIDS and hepatitis, and the blood components (red cells, platelets, fresh-frozen plasma, and cryoprecipitate) that were collected, transfused, or outdated or discarded. RESULTS: Significant findings (p<0.05) included upward trends over time in the numbers of donor plateletpheresis units collected and transfused and in the numbers of random-donor platelet concentrates collected by hospitals. There was an upward trend over time in the outdating or discarding of all blood component types that was reported by hospitals. Data from blood centers showed the outdating or discarding of significant numbers of apheresis platelets, fresh-frozen plasma, and cryoprecipitate. No significant trends were identified in the reported cases of transfusion-associated hepatitis or AIDS. CONCLUSION: Ongoing data analysis of the institutional questionnaires provides information on trends in blood collection and transfusion-related activities.

Blood Banks

Blood donor-, apheresis-, and transfusion-related activities: results of the 1991 American Association of Blood Banks Institutional Membership Questionnaire.

Approximately 2154 regional blood centers and hospital-based blood banks and transfusion services responded to the 1991 American Association of Blood Banks Institutional Membership Questionnaire that elicited data from 1990. Information from 2144 institutions was considered valid. Questionnaire topics were donor blood collections, hemapheresis, perioperative cell salvage, component usage, and transfusion-associated diseases. Institutional members reported collecting 9.3 million units, of which 90.9 percent were for allogeneic use in the community, 6.0 percent were for autologous use, and 3.1 percent were directed donations. The percentage of directed-donor units that were crossed over for allogeneic use (51%) was greater than the percentage of units transfused to the designated patient (49%). Only 12.5 percent of institutions reported obtaining specific consent for transfusion. Of the 15.4 million transfused blood components, 8.5 million were red cells, 4.1 million were platelets, 1.8 million were fresh-frozen plasma, and 0.9 million were cryoprecipitate. There were 1263 reported cases of transfusion-associated hepatitis. Approximately 44 percent of the patients who were tested proved positive for hepatitis B surface antigen, and 80 percent of the patients who were tested proved positive for antibody to hepatitis C. The questionnaire's aggregate results can be used to assess current patterns of blood donation and transfusion activities.

Acquired Immunodeficiency Syndrome

Mandating vitamin K prophylaxis for newborns in New York State.

New York State's infant deaths and hospitalizations attributed to hemorrhagic disease of the newborn and other neonatal hemorrhagic conditions were reviewed. In 65% of 34 deaths reviewed, vitamin K was not documented as given or was given only after the onset of hemorrhage. Vitamin K was not included in standing orders in any of 22 hospitals contacted. As a result of this review, vitamin K prophylaxis was made a mandatory newborn care procedure in the State Public Health Code.

Cerebral Hemorrhage

A report of 104 transfusion errors in New York State.

In New York State, significant incidents involving the collection, processing, or transfusion of blood must be reported. Incident reports received over a 22-month period involving transfusion of blood to other than the intended recipient or release of blood of an incorrect group were analyzed. Among 1,784,600 transfusions of red cell components; there were 92 cases of erroneous transfusion that met study criteria (1/19,000). There were 54 ABO-incompatible transfusions (1/33,000); three of these (1/600,000) were fatal. Correction for underreporting of ABO-compatible errors resulted in an estimate of 1 per 12,000 as the true risk of transfusion error. National application of New York State data results in an estimate of 800 to 900 projected red cell-associated errors in the United States annually. The majority of reported errors occurred outside of the blood bank (43% resulted solely from failure to identify the patient and/or unit prior to transfusion and 11% resulted from phlebotomist error), while the blood bank was responsible for 25 percent of errors and contributed, with another hospital service, to 17 percent. The risk of transfusion of ABO-incompatible blood remains significant, and additional precautions to minimize the likelihood of such events should be considered.

ABO Blood-Group System

Blood donation and transfusion practices: the 1990 American Association of Blood Banks Institutional Membership Questionnaire.

Responses to the 1990 American Association of Blood Banks (AABB) Institutional Membership Questionnaire were submitted by 2126 regional blood centers, hospital-based blood banks, and transfusion facilities. Data from 2117 of these facilities were considered to be valid. The questionnaire included information on blood donor demographics, number of units collected, and collection procedures; services performed; usage of blood components; and transfusion-transmitted diseases reported during 1989. Institutional members collected 7.4 million whole blood units, of which 90.8 percent were donated for allogeneic use, 6.0 percent were donated for autologous use, and 3.2 percent were donated for directed use. Approximately 630,546 allogeneic and directed-use blood donors were deferred, most often for low hemoglobin or hematocrit values. Approximately 225,205 full allogeneic and directed-donor units were discarded, primarily for elevated alanine aminotransferase levels or the presence of hepatitis B core antibody. The 14.3 million transfused components included 56.7 percent red cell-containing components, 27.4 percent platelets, 11 percent fresh-frozen plasma, and 4.8 percent cryoprecipitate. Institutional members reported 1397 cases of transfusion-associated hepatitis. In this group, 921 patients were tested for hepatitis B surface antigen after the transfusion; 339 (36.8%) were found to be hepatitis B surface antigen positive. The AABB Institutional Questionnaire results provide recent data on blood donor and transfusion-related activities that are vital to the evaluation of current transfusion medicine practices.

Acquired Immunodeficiency Syndrome

The regulation of hematopoietic stem cell collection and storage: the New York State approach.

In December 1988, the New York State (NYS) regulatory code on bone marrow banking went into effect. The goals of the regulations were to codify a high standard of practice, to prohibit charlatanism in the practice or promotion of stem cell banking, and to promote legitimate research. The NYS approach modeled the stem cell regulatory language after that already established for blood banks and clinical laboratories. Also, the stem cell standards are an element of standards applicable to all tissue banks, developed as a result of a comprehensive transplant law enacted in NYS in 1990. The code itself, published as an addendum to this article, mandates that a qualified (by training and experience) medical director and medical advisory committee be appointed, and gives broad and complete responsibility for the services provided to that medical director. Explicit written policies and procedures regarding administrative, technical, safety, and quality issues are necessary, but regulatory micromanagement of the laboratory was avoided by limiting detailed procedural requirements. We believe that these regulations have contributed to the quality and safety of stem cell-related therapies in NYS.

Biological Specimen Banks

An estimate of blood donor eligibility in the general population.

To estimate the number of adults medically eligible to donate blood, the percent of the general population over the age of 16 deferrable by 13 current American Red Cross donor guidelines was calculated using the best available United States data. Categories examined included age, weight, hematocrit, pregnancy, blood pressure, heart disease, diabetes requiring insulin, male homosexual activity since 1977, intravenous drug use, sexual partner of high-risk group member, recent transfusion, history of cancer, and other (medical, surgical, travel history). Sex-specific total eligibility rates were estimated by serial multiplication of individual eligibility rates (1.0 minus deferral rates) to account for the proportionate overlap of independent categories, with corrections for expected associations between categories. The resultant eligibility rates for women (57%) and men (70%) indicate fewer eligible donors than commonly stated. Surrogate testing (ALT, anti-HBc) for non-A, non-B hepatitis would further reduce the percent of eligible donors to 55 and 67%, respectively. Based on the actual numbers of women and men in the population, these calculations indicate that an equal number of women and men are medically eligible to donate.

Adolescent

Screening prospective blood donors for AIDS risk factors: will sufficient donors be found?

Using data from various sources--we estimate that 14 to 19 per cent of American males 17-75 have personal histories that place them at high risk of transmitting the HIV infection while an additional 2 per cent of adult females may be similarly affected. Because roughly one fourth of either group may already be unsuited to give blood, we estimate that 10-14 per cent of adult males, and 1 per cent of females would be specifically deferred from giving blood because of personal histories of high-risk behavior. Local adjustments in the assumptions underlying these estimates are needed to apply them to given communities.

Acquired Immunodeficiency Syndrome

The effect of plateletpheresis on the Fenwal CS-3000 on donor platelet counts.

To evaluate the risk of significant plateletpheresis-induced thrombocytopenia in normal volunteer donors undergoing plateletpheresis less frequently than every 56 days and to help understand factors influencing platelet yield in these donors, pre- and postapheresis platelet counts (X 10(3)/microliter) and platelet yields were analyzed from 916 plateletpheresis procedures (Fenwal CS-3000) on 607 donors (405 men, 202 women). The mean preapheresis platelet count was 265 +/- 59 (SD) (range 155-650) (men 256 +/- 55 [170-444]; women 284 +/- 65 [155-650]; P less than .001, t-test). After an average platelet yield of 4.08 X 10(11), the mean postplatelet count was 185 +/- 46 (range 72-420) (men 184 +/- 42 [80-345]; women 194 +/- 52 [72-500]; P less than 0.1). The percent decrease in platelet count (mean 29.4 +/- 13, range -28.1-65.5) had positive correlations with platelet yield (P less than .01, r = 0.10), predonation platelet count (P less than .001, r = 0.29), and age (P less than .01, r = .10) and a negative correlation with weight (P less than .001, r = 0.18) Both the percent decrease and platelet yield were significantly higher in women than in men (P less than .001, t-test), and platelet yield was best predicted by preapheresis platelet count in both sexes (r = 0.65). The effects of plateletpheresis on donor platelet count thus vary widely among donors. Although a decrease of greater than 50% was not a rare event (5.9% of all procedures), in only three instances (0.3%) was the actual postapheresis platelet count below 100 (72, 94, 95). Thus, plateletpheresis in normal donors appears unlikely to produce clinically significant thrombocytopenia immediately after apheresis.

Adult

Increased nickel concentrations in body fluids of patients with chronic alcoholism during disulfiram therapy.

Nickel concentrations were measured by electrothermal atomic absorption spectrophotometry in body fluids of 61 patients with chronic alcoholism during disulfiram treatment (tetraethylthiuram disulfide, 250 mg/day, po). Nickel concentrations in serum, whole blood, and urine were significantly increased at 12 hours after the initial dose of disulfiram. In serum and whole blood, the Ni concentrations reached a plateau after two weeks of treatment; in urine, the Ni concentrations increased progressively during the initial four months of treatment. During the interval from four months to three years of disulfiram treatment, the median concentrations of nickel in serum, whole blood, and urine were elevated 17-, 15-, and 39-fold, respectively, compared to pretreatment values. The effects of disulfiram on nickel metabolism evidently involve chelation of dietary nickel by diethyldithiocarbamate (DDC), a disulfiram metabolite, and gastrointestinal absorption of the Ni-DDC complex. Since animal studies have demonstrated cerebral uptake of the lipophilic Ni-DDC complex, nickel may possibly accumulate in brain cells of disulfiram-treated patients; physicians should therefore be cautious in administering disulfiram to persons with nickel-containing orthopedic prostheses or occupational exposures to nickel.

Adult