Donor reactions and injuries from whole blood donation

In this review of common and uncommon donor reactions and injuries, donation-associated deaths were found to be extremely rare and generally thought to be coincidental; the rate of coincidental deaths was less than what would be expected based on life insurance tables.¹ Vasovagal reactions, hematomas/bruises, and history of irritation or allergic reaction to adhesive tape or skin preparations are observed daily in a busy blood collection center. Syncopal vasovagal reactions sometimes resemble shock, but unlike shock, they reverse themselves and do not cause death. Through good management, a blood donor organization can minimize the incidence of syncope. Accidental arterial venipuncture is very uncommon (1 in 100,000), and donors with arterial punctures do well if pressure is applied for an extended period of time. Rarely, a pseudoaneurysm results, and this requires surgery. AV fistulas and compartment syndromes can also occur, but these are extremely rare; most experienced blood center physicians have never observed a case. Neurologic needle injuries occur approximately once in every 6,300 donations. Although neurologic needle injury complaints are usually received within 10 days of blood donation, 10% of the injured donors may complain weeks to months later. Most donors with needle injuries recover within a month and many within a day or two, but approximately 30% will have a recovery period of greater than 1 month and an occasional case may exceed 6 months. Donors with neurologic needle injuries generally have a full recovery, even when the recovery period may be extended. Thrombophlebitis has a low incidence (1 in 50,000 to 1 in 100,000), and infection at the phlebotomy site is rare. Both are easily treated and have little impact on the donor's health.     

Reducing the risk of transfusion-transmissible viral infection through blood donor selection: the Australian experience 2000 through 2006

BACKGROUND: Selection of voluntary donors who are at low risk of transfusion-transmissible viral infection (TTVI) is central in maintaining the safety of the blood supply. Evaluation of its effectiveness and the dynamics of the process may offer opportunities to further improve transfusion safety. STUDY DESIGN AND METHODS: The impact of donor selection on prevalence of TTVI was analyzed in all allogeneic donations in Australia between July 2000 and June 2006 by interviewing donors found to have a TTVI. The presence and disclosure of infective risks was reassessed. RESULTS: A total of 6.3 million donations were tested; of these, 1,449 (0.02%) were repeat-reactive for a TTVI and were discarded. This comprised 605 (42%) positive for the presence of hepatitis B, 818 (56%) positive for the presence of hepatitis C, 18 (1%) positive for the presence of human immunodeficiency virus, and 20 (1%) positive for the presence of human T-cell lymphotropic virus-I and/or -II (HTLV-I/II). This prevalence was 50 to 350 times lower than in the Australian population. In 1,158 cases (80%), an infective risk was identified; 509 donors (44%) had more than one. The most common identified were country of birth and parental ethnicity (n = 682, 26% of risks), tattoos and/or piercings (n = 448, 18%), and intravenous drug use (n = 302, 12%). In 302 cases (21%) disclosure at predonation screening would have resulted in deferral. Factors influencing nondisclosure included temporal remoteness and perceptions that laboratory testing rendered disclosure unnecessary. CONCLUSION: These findings affirm the effectiveness of current stringent donor selection criteria in reducing the residual risk of TTVI. Ongoing donor education regarding the importance of risk disclosure is required.     

Potential increased risk of virus transmission due to exclusion of older donors because of concern over Creutzfeldt-Jakob disease. The National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study

BACKGROUND: Concern over the theoretical possibility of disease transmission via blood from donors who develop Creutzfeldt-Jakob disease has led to proposals to exclude older individuals from donating plasma for further manufacture into pooled plasma donations. The impact of extending this age-deferral policy to blood donors was examined with respect to the risk for known transmissible viruses. STUDY DESIGN AND METHODS: Demographic characteristics and confirmed prevalence rates (/10(5) first-time donations) and incidence rates (/10(5) person-years for repeat donors) for viral markers were compared for donors < 50 years old (n = 1,259,805 [85%]) and > or = 50 years old (n = 219,856 [15%]) and for donors < 60 years old (n = 1,409,176 [95%]) and > or = 60 years old (n = 70,485 [5%]). Incidence rates were combined with infectious window-period estimates for each virus, to calculate the risk of virus transmission per 10(6) donations. RESULTS: Unadjusted prevalence rates were significantly greater for younger than for older donor groups for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) (p < or = 0.05). Incidence rates (and transmission risk estimates) for HBsAg were significantly higher in the < 50 donor group than in the > or = 50 group (p < or = 0.05), and those for HIV, human T-lymphotropic virus, and HCV were not significantly higher (p > 0.05). Blanket removal of donors over the age of 50 would potentially lead to the following significant increases in the risk of infected units: HIV, 12 percent; HCV, 21 percent; and hepatitis B virus (HBsAg), 22 percent. CONCLUSION: Removal of donors over the age of 60 would not significantly affect the risk of infected units. Deferral of donors > or = 50 years of age from whole-blood donations for unfounded concerns about Creutzfeldt-Jakob disease could have adverse effects on both blood availability and safety.     

Lowering the hemoglobin cutoff for female plateletpheresis donors

BACKGROUND: The standards of the American Association of Blood Banks describe a minimum hemoglobin level of 12.5 g per dL for apheresis donors. Until 1995, the authors' institution accepted occasional platelet donors with a lower minimum hemoglobin (11.5 g/dL), if accompanied by medical director approval. STUDY DESIGN: All donation records from a 6-month period before 1995 were retrospectively reviewed to determine whether this lower hemoglobin cutoff adversely affected either the safety of the platelet donation process or donors' subsequent hemoglobin levels. RESULTS: Of 450 donations, 56 (12%, Group 1) were from donors with hemoglobin concentrations between 11.5 and 12.4 g per dL (2 donations from 1 man; 54 donations from 45 women). The remaining 394 donations (88%, Group 2) came from donors with hemoglobin concentrations > or = 12.5 g per dL (216 donations from 118 men; 178 donations from 119 women). The frequency of donor reactions was acceptable (Group 1, 11%; Group 2, 6%); 2 percent of donations by Group 1 donors and 1 percent by Group 2 donors were terminated because of these reactions. Of 46 donors in Group 1, 30 returned to donate platelets again at a later time; at least once, 23 (77%) had a hemoglobin > or = 12.5 g per dL. Ten donors in Group 1 returned for additional donations within 56 days; no meaningful decrease in hemoglobin levels occurred. A hemoglobin cutoff of 12.5 g per dL during the study period would have excluded 1 percent of platelet donations by men and 23 percent by women. CONCLUSION: The data demonstrate that the lower hemoglobin cutoff of 11.5 g per dL is a safe and relevant threshold for accepting female plateletpheresis donors and would allow more participation by women in blood donor programs.     

The effect of short-term, temporary deferral on future blood donation

BACKGROUND: Most blood donor deferrals are temporary and short-term. The effect of short-term, temporary deferral (STTD) on blood donor return rates and subsequent blood donations is an important issue. STUDY DESIGN AND METHODS: Donors given STTDs during the first 3 months of 1993 were computer-matched with nondeferred donors on the basis of age, sex, and donation date. Computer records were evaluated during the next 4.25 years (4/93-6/97) to determine donor return rates and subsequent blood donations. RESULTS: The most common reasons STTD were low hemoglobin (46%), colds and/or sore throats (19%), and elevated temperature (10%). Nondeferred donors were 29 percent more likely than donors with STTD to return over the next 4.25 years (80% vs. 62%), and nondeferred donors donated 81 percent more whole blood units (13,798 vs. 7,615) over the same period. CONCLUSION: The study showed that STTD have a very negative impact on blood donor return rates and subsequent blood donations. Actions to alleviate these negative effects are indicated.     

Second donation of granulocyte-colony-stimulating factor-mobilized peripheral blood progenitor cells: risk factors associated with a low yield of CD34+ cells

BACKGROUND: There are still limited data on the efficacy and safety of repeated donations of granulocyte-colony-stimulating factor (G-CSF)-mobilized peripheral blood progenitor cells (PBPCs) for allogeneic transplantation. STUDY DESIGN AND METHODS: Sixty-seven healthy donors undergoing two consecutive mobilizations of PBPCs within a median interval of 5 months (range, 0.1-47 months) were investigated. For both first mobilization (FM) and second mobilization (SM), G-CSF (lenograstim) at 7.5 microg per kg per day was administered. RESULTS: The nonhematologic side effects were comparable between both mobilizations. A significantly lower yield of CD34+ cells x 10(6) per kg of donor weight was obtained on Day 5 of SM in female (n = 31; FM, 5.0; SM, 3.23; p = 0.008) but not in male (n = 36; FM, 5.96; SM, 5.36; p = 0.24) donors. Multivariate analysis identified a lower CD34+ blood concentration on Day 5 of FM (p < 0.001) as well as female sex (p = 0.015) as independent risk factors for a lower yield of progenitor cells, whereas donor age and body mass index, interval between donations, and schedule of G-CSF application showed no significant impact. CONCLUSION: The identified risk factors allow the estimation of the efficacy of a SM in an individual donor before G-CSF administration, thus avoiding distress to both the donor and the recipient.     

Structuring a safer donor-replacement program

BACKGROUND: Replacement donors are more likely than volunteer donors to have positive or abnormal tests for transfusion-transmissible disease. In an effort to increase the donor pool, workers sought to identify a safer replacement-donor subgroup that may be acceptable for routine donations. STUDY DESIGN AND METHODS: In a retrospective review and cohort study, the replacement-donor effect was separated from the new- donor effect. The relative effect the replacement donor has on the risk of transfusion-transmissible diseases, donor retention, and frequency of returning donations was then quantified by comparison against the effect of repeat volunteer donors. RESULTS: The replacement donor had 3.1 times the risk and 0.72 times the donor retention rate and made 0.81 times as many returning donations as the repeat volunteer donor. The figures for the new-donor effect were similar. The two risks were additive, making a new replacement donor particularly hazardous. If replacement donations only from repeat replacement donors were considered, the donor risk and the number of donations per returning donor were made comparable to those for the general (combined) volunteer donor. CONCLUSION: The negative effect of the replacement donor is similar in magnitude to that of the new volunteer donor. A replacement-donation program targeting repeat replacement donors has an acceptable risk profile and may be a valuable adjunct to the collection of blood from general volunteer donors.     

Impact of a transfusion-related acute lung injury reduction strategy on apheresis platelet collections

Background: Most blood centers in the US have implemented transfusion‐related acute lung injury (TRALI) mitigation strategies for apheresis platelet (AP) donations based on theoretical impact of donor loss. The aim of this study is to determine the actual impact of a TRALI mitigation strategy in a US blood center. Study Design and Methods: Daily collection events and resulting products were retrospectively obtained before and after implementation of a TRALI reduction strategy (HLA antibody testing female AP donors four or more pregnancies) for comparison. The retention rate of reassigned donors was determined by reviewing whole blood (WB) and/or apheresis red blood cell (AR) donations post reassignment. Data were obtained to compare donor frequency and split rate from reassigned (historical data) and new AP donors. Results: Mean daily collections (27.7 vs. 30.0) and total products (12,211 vs. 12,957) were significantly higher after implementation, but the number of products/collection event was lower (1.49 vs. 1.40). Mean collections/donor/year (4.0 vs. 1.8) and split rate (36% vs. 27%) were historically higher for reassigned (n = 45) versus new AP donors (n = 1,090). Seventy‐three of 112 donors (65%) testing positive for HLA antibodies returned for WB or AR donations, 31 of 45 (69%) active AP donors returned. Conclusions: Donor loss may not be adequate to estimate impact on AP inventory, as donation characteristics may differ between new donors and those reassigned. We show successful implementation of a TRALI mitigation strategy by increasing collection goals and AP donor recruitment efforts beyond donor loss. Retaining the majority of reassigned donors is feasible. J. Clin. Apheresis 2012. © 2012 Wiley Periodicals, Inc.     

The effect of whole-blood donor adverse events on blood donor return rates

BACKGROUND: Some blood donation-related adverse events (AEs) can negatively impact the blood donor return rate (BDRR) and decrease donor retention. STUDY DESIGN AND METHODS: One-thousand randomly selected whole-blood donors were interviewed 3 weeks after a 525-mL index whole-blood donation for seven AEs. The number of return visits and duration of follow-up were recorded for each of the 1000 donors. A negative binomial regression analysis was used to determine the contribution of the four most common AEs to the BDRR, and interactions between these AEs were also evaluated. RESULTS: The four most common AEs were bruise alone (15.1%), sore arm "alone" (7.0%), fatigue "alone" (5.1%), and donor reaction "alone" (4.2%), where "alone" is defined to also include donors who had a bruise but no other AE. The estimated BDRR for donations without AEs was 1.32 visits per year. The estimated BDRRs for the four most common AEs were: bruise alone, 1.32 visits per year; sore arm alone, 1.30 visits per year (2% reduction in BDRR); fatigue alone, 1.06 visits per year (20% reduction in BDRR); and donor reaction alone, 0.87 visits per year (34% reduction in BDRR). The BDRR for donor reaction, fatigue, and sore arm together was 0.20 visits per year (85% reduction in BDRR). CONCLUSION: Donor reaction had the most negative impact on the BDRR. There appears to be a synergistic effect between donor reaction, fatigue, and sore arm. Theoretically, amelioration of some AEs has the potential to improve BDRRs.     

Red cell collection by apheresis technology

To determine the feasibility of collecting 2 units (450 mL) of red cells per donation by apheresis technology, apheresis red cell collections were compared to whole-blood donations. Forty blood donors were equally divided between the two study arms on the basis of gender and iron supplementation (650 mg ferrous gluconate/day vs. no supplementation). During the 1-year study period, the apheresis participants donated 450 mL of red cells three times, and the whole- blood donors gave 225 mL of red cells (1 unit of blood) on six occasions. There were no reported side effects during the 102 whole- blood donations, whereas symptoms were noted in 83 percent of the 59 apheresis procedures. The most common symptoms were numbness and tingling, which were relieved by a decrease in the plasma-return rate or by the administration of oral calcium supplements. Seven donors dropped out or were deferred during the study. Two whole-blood donors left with medical problems unrelated to the study, one apheresis donor and one whole-blood donor dropped out of the study because of excessive fatigue, and three non-iron-supplemented whole-blood donors had unacceptably low hematocrit levels. By the end of the study, 70 percent of the apheresis donors considered the procedure acceptable, 15 percent were undecided, and 15 percent thought it was not acceptable. As measures of iron balance, the serum ferritin and the red cell zinc protoporphyrin:heme ratios were significantly more abnormal in the non- iron-supplemented donors than in the iron-supplemented donors. However, there were no differences in iron balance according to the donation method.     

Assessment of donor fear enhances prediction of presyncopal symptoms among volunteer blood donors

BACKGROUND: Fear is an important contributor to the risk of presyncopal reactions to blood donation. However, concern that asking donors about their fears may increase the risk of reactions is a potential impediment to incorporating fear assessment into donor screening. STUDY DESIGN AND METHODS: Before donation, participants responded to a series of questions that either did (n = 488) or did not (n = 494) include questions related to fear of seeing blood drawn. Immediately after donation all participants provided ratings of presyncopal reactions. RESULTS: Among those asked predonation fear questions, fear was most strongly related to presyncopal symptoms when compared against other donor characteristics (e.g., age, number of prior donations, body mass index, estimated blood volume, blood pressure, and pulse). However, Mann‐Whitney U tests revealed that being asked about fear before donation was not associated with higher reports of presyncopal reactions for the sample as a whole, nor among novice donors. Further, regression analyses indicated that fear remained a significant predictor of presyncopal reactions in final models that included age and number of prior donations as significant predictors. CONCLUSION: Predonation assessment of fear of blood draws may help to identify donors who are most likely to benefit from brief interventions designed to enhance donor coping, reduce risk of presyncopal reactions, and increase donor retention.     

Analysis of Chinese donors' return behavior

BACKGROUND: It is important to understand donor return behavior. Converting first‐time donors to become repeat donors is essential for maintaining an adequate blood supply. STUDY DESIGN AND METHODS: Characteristics of 241,552 whole blood (WB) donations from first‐time and repeat donors who donated in 2008 at the five blood centers in China were compared. A subset of 54,394 WB donors who donated between January 1 and March 31, 2008, were analyzed for their return behavior in 2008 after the index donation using logistic regression. RESULTS: Of all donations, 64% were from first‐time donors. Donors with self‐reported previous donations tended to be male, older, and married; donated larger volume (≥300 mL); and were heavier in weight. Among donors who donated from January to March 2008, 14% returned for subsequent WB donations by the end of 2008. The number of previous donations and blood collection location were the two strongest predictors for making subsequent donations. Donors with one, two to three, and more than three previous donations were 3.7, 5.7, and 11.0 times more likely to return than first‐time donors. Those who donated in a blood collection vehicle were four times more likely to return than those who donated at a blood center. Being female, younger, and of a lower education level (middle school or less) were positively associated with subsequent return blood donation during the follow‐up period observed in this study. CONCLUSION: Most of the Chinese blood supply is from first‐time donors. Strategies aimed at encouraging current donors to become repeat donors are needed.     

Blood donor satisfaction and intention of future donation

BACKGROUND: New regulatory requirements for donor eligibility challenge blood centers to recruit and retain enough donors. This study evaluated correlations between overall satisfaction with the donation process and donor demographics and the effect of both on a donor's intent to return. STUDY DESIGN AND METHODS: An anonymous, self-administered questionnaire was given to donors at multiple sites of one blood center over a 3-week period. First-time and repeat donors were asked questions on demographic characteristics, satisfaction with the current donation process, motivation for current and future donations, and intent to return. RESULTS: More than 75 percent of donors rated the overall donation process at 9 or 10 on a scale of 10 (mean, 9.19; standard deviation, 1.09), with female, high school-educated, and first-time donors giving higher satisfaction ratings than male, college-educated, and repeat donors, respectively (all p < 0.001). Donor satisfaction was correlated with intent to return for another donation (p = 0.002). For the current donation, donors rated altruistic motivations most highly. Medical testing was the most highly rated incentive for future donations, followed by frequent donor programs and convenient donation times and locations; preferences varied by demographic subgroup. CONCLUSIONS: Blood donor satisfaction varies among demographic and donation history subgroups and is positively correlated with the intent to return for future donation. Although the primary motivation among all donors was altruism, incentives to future donation may need to be tailored according to demographic subgroups.     

Notes on East Anglian blood donors

The record cards of 10,000 donors were examined. Of these, 44.5 per cent were women, and women formed the majority of rhesus (Rh)-negative donors. In addition, 500 donor cards each of male and female donors were examined to obtain information regarding the age of donors when their first donation was given, how many donations were given by each donor, and how long they remained on the panel. The average number of donations per donor was six, given on the average over a four-year period. The age limits for blood donors are 18 to 64 years. Within these limits, only 5 per cent of the population will be blood donors. Responses to a questionnaire indicated three main reasons for not being current blood donors: lack of time, disqualification on health grounds, and lack of information regarding the time and place of blood donor sessions. The study indicates that publicity to recruit donors should be aimed to appeal to both sexes and that the most desirable age range for new donors is from 20 to 45 years of age. If the present policy of not encouraging individuals 60 years of age or older to be donors were changed to limit new donors to individuals less than 54 years old, the number of donations would be initially decreased by only 4.6 per cent. Any advertising campaign should give more information concerning exact places and times of sessions, and should aim to overcome general disinterest in the need for blood donors and the conviction that a personal donation is not really necessary. It might emphasize that giving up at most, an hour every six months is usually possible.     

Transmission of Babesia microti in Minnesota through four blood donations from the same donor over a 6-month period

BACKGROUND: Babesiosis is a tick-borne zoonosis caused by intraerythrocytic protozoa. More than 40 US cases of Babesia microti infection acquired by blood transfusion have been reported. This report describes the identification of a transfusion-associated case of babesiosis and the subsequent identification of the infected blood donor and three other infected recipients of cellular blood components from three other donations by this donor. STUDY DESIGN AND METHODS: Serum specimens from the donors of blood that had been made into cellular components received by the index recipient and from other recipients of such components from the implicated donor were tested by the indirect fluorescent antibody (IFA) assay for antibodies to B. microti. Whole blood from IFA-positive persons was tested by PCR for B. microti DNA. RESULTS: IFA testing of serum from 31 of 36 donors implicated a 45-year-old man (titer, 1 in 256), whose donation had been used for RBCs. He likely became infected when bitten by ticks while camping in Minnesota in June 1999 and had donated blood four times thereafter. As demonstrated by PCR, he remained parasitemic for at least 10 months. Of the five other surviving recipients of cellular blood components from the implicated donor, three recipients (one for each of the three other donations) had become infected through either RBC or platelet transfusions. CONCLUSIONS: Babesiosis should be included in the differential diagnosis of posttransfusion febrile illness, and effective means for preventing transmission by blood transfusion are needed.     

A study of the predonation hemoglobin and iron status among Hong Kong Chinese blood donors

BACKGROUND: Predonation hemoglobin (PDH) is used to safeguard donors’ welfare, and low hemoglobin (Hb) is known to be the most frequent reason for donor deferral. A study was initiated to assess the PDH and iron status of blood donors in Hong Kong. STUDY DESIGN AND METHODS: This observational study was designed with four groups of whole blood donors invited (Group 1—eligible first time donors, Group 2—eligible repeat donors with zero or one donation in preceding 12 months, Group 3—eligible repeat donors with at least two donations in preceding 12 months, Group 4—repeat donors being deferred for low PDH). Predonation blood samples were obtained for blood counts and iron status. Mann‐Whitney test, Kruskal‐Wallis test, and chi‐square test for trend were applied for statistical analysis. RESULTS: A total of 836 donors were recruited, of which 35 were excluded because of hemoglobinopathy. An inverse relationship between serum ferritin level and number of donations in the preceding 12 months was observed in both sexes. Iron deficiency was significantly seen in 35.1% of male and 65.3% of female deferred donors. More importantly, up to 7.2, 5.8, and 29.5% of the female donors in Groups 1, 2, and 3 were found to be iron deficient despite having a high enough PDH. CONCLUSION: This is the first study to assess PDH and iron status in Chinese blood donors. Iron depletion is noted with increasing number of blood donations in the preceding 12 months. Advice on iron repletion is a necessary step for donor welfare and strategies should be developed to ensure that donors have adequate PDH.     

Predicting blood donor arrival

BACKGROUND: Keeping waiting time at blood donation short is important for making donation a good experience for the donors and hence to motivate for repeat donations. At the Blood Bank of Oslo, fixed appointments are used, and few donors arrive without appointments. On average, 59 percent of scheduled donors arrive, but day-to-day variations are large. Methods for predicting the number of donors that will arrive on a given day would be valuable in reducing waiting times. STUDY DESIGN AND METHODS: Information about candidate explanatory variables was collected for all appointments made in a 971-day period (179,121 appointments). A logistic regression model for the prediction of blood donor arrival was fitted. RESULTS: Among 18 explanatory variables, the most important were the time from appointment making to appointment date; the contact medium used; the donor age and total number of donations; and the number of no-shows, arrivals, and deferrals during the preceding 2 years. Compared to taking only the average arrival rate into account, prediction intervals were reduced by 43 percent. CONCLUSION: Statistical modeling can provide useful estimates of blood donor arrival, allowing for better planning of donation sessions.     

Nineteen years of experience with autotransfusion for elective surgery in children: more troublesome than we expected

BACKGROUND: Under the rationale that children undergoing elective surgery are the best candidates for autologous blood donors because of their long life expectancy, aggressive donations of autologous blood, even from infants, have been reported. A number of problems are associated with the procedure, however, whereas the risks of homologous blood are very low. STUDY DESIGN AND METHODS: From 1987 through 2005, of 5792 patients referred to blood transfusion services at two Japanese university hospitals for autologous blood donations, 314 children younger than 16 years old served as subjects for assessment. RESULTS: Of 314 children, 7 were not suitable as autologous donors. In most cases this was due to uncooperative behavior. Over a follow-up period of 19 years, the authors encountered 53 cases (17.3%) of donation-related problems, and this rate was higher than the 6 percent rate recorded for adult cases (316/5305). Nine children suffered crucial complications such as vasovagal reactions, and one 14-year-old boy required a vasopressor drug. Important findings were that 6 of these were first-time donors, and the amount of blood drawn was under 10 percent of their estimated blood volume. CONCLUSION: Of 53 donation-related problems, 9 (17.0%) were accompanied by marked hypotension. Drawing autologous blood from children has become easier with advanced devices; however, lessening of anxiety and tension are essential for the safety of children's autologous blood donation programs. Aggressive donation should be avoided.     

The median whole-blood donation time in the best-case scenario: findings at one blood center

BACKGROUND: Whole-blood donation times in a donor population when there are no impediments to blood donation at any point can be used to determine the shortest median whole-blood donation time. This statistic is relevant to blood donors and collection staff. STUDY DESIGN AND METHODS: Small, over-staffed blood drives in August 2004 were evaluated via operation records and supervisor interviews to determine if there were any impediments to whole-blood donation at any point in the process. Four-hundred ninety-two whole-blood donations from 33 blood drives were not impeded and were evaluated for whole-blood donation times. Registration records (entry time) and blood donor records (phlebotomy start and end time) provided three objective time points for the process, the median post-phlebotomy interval at the phlebotomy station was estimated, and 10 minutes was assigned for the refreshment period. RESULTS: The median donation time for the whole-blood donation process was 50 minutes. The 25 to 75 percent range was 46 to 56 minutes, and the 10 to 90 percent range was 42 to 64 minutes. First-time blood donors had blood donation times that were 5 to 6 minutes longer than in repeat blood donors (55.5 min vs. 50 min), and women had slightly longer donation times than men (51 min vs. 49 min). Five percent of the donors had donation times that exceeded 69 minutes. CONCLUSION: The median whole-blood donation time and range under the best circumstances was defined based on the process in place in our blood center in August 2004.