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. 2010 Jan;8(1):49–62. doi: 10.2450/2009.0089-09

Adverse reactions to blood donations: the READ project

Giovanni Garozzo 1,✉, Isabella Crocco 2, Barbara Giussani 3, Annalisa Martinucci 4, Stefano Monacelli 5, Vanda Randi 6
PMCID: PMC2809512  PMID: 20104279

Abstract

Background

In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations.

Materials and methods

Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2).

Results

Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital.

Conclusions

The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national.

Keywords: blood donation, adverse events to donation, Italian multicentre study

Background

The transfusion world has concentrated almost exclusively on the recording and management of unforeseen and unexpected adverse events (AE) related to the transfusion of blood components, from the transmission of viral diseases (HIV, HCV, HBV) to immediate and delayed transfusion reactions. There are numerous guidelines on the management of such AE, including those issued by the World Health Organisation. Furthermore, in Italy, particular consideration has been given to the prevention and management of transfusion reactions caused by ABO incompatibility; sentinel event number 5, for which we have some data at a regional level1, is part of the more general haemovigilance system

However, “haemovigilance also concerns donors and donations of blood and must enable the collection of information on reactions occurring during the donation of blood, the selection of donors (including the frequency and causes of exclusion), and epidemiological data on donors confirmed to be positive following screening for markers of infectious diseases”2.

In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly in Transfusion Structures (TS), while about 45% were collected in centres managed by various Associations and Federations3. Despite the large number of donations, there are only few and anecdotal data on the incidence of AE occurring in donors during or following donations and these have almost always been reported by individual centres4–7.

Relevant legislation and definitions

The current national and European legislation requires that AE related to donations, both of homologous and autologous blood, are recorded8–11.

As said, various TS are already organised in order to collect and analyse such data, but in the absence of a standardised form used throughout the country, there is wide variability and, consequently, great difficulty in processing and managing data which often cannot be compared. For this reason the National Blood Centre endorsed a project that, by involving some transfusion facilities in Italy, could enable data on AE related to donations to be collected using a standard form. It is hoped that the experience gained with this study could be useful to the National Blood Centre to spread a national recording system for these events through the Informatics System of Transfusion Services (SISTRA)12.

“Serious adverse events” and “serious adverse reactions” are defined as follows10:

  1. a “serious adverse event”: any untoward occurrence associated with the collection […] that might […] lead to disability or incapacity of the donor or patient or results in or prolongs hospitalisation or morbidity;

  2. a “serious adverse reaction”: an unintended response in a donor or patient, connected to the collection or transfusion of blood or blood components, which is fatal, life-threatening, incapacitating or disabling, or results in or prolongs hospitalisation or morbidity.

Serious adverse events and serious adverse reactions must always be notified.

The Standards of the Italian Society of Transfusion Medicine and Immunohaematology also set out that such AE must be recorded13.

Aim

The aim of the READ project is to create a network of TS involving a sufficient number of Donor Centres managed directly by the TS, by Associations of Donors, or jointly by the TS and Associations in order to be able to test and implement a standardised system for monitoring AE.

The experimental model, which could be used, perhaps after validation by the National Blood Centre, at a national level, consisted of standardised forms for collecting data.

While waiting for adequate computerised support, it was considered necessary to prepare printed paper forms, with an electronic version, in Word® or Excel® format, which enabled processing of the data collected. The data in these forms are processed in the single reference TS. The processed, summarised data are then sent to a co-ordinating centre in order that the relative statistics can be extracted.

Materials and methods

Data collection forms, integrated and standardised with the forms already available in the various TS involved and with those produced by European organisations (ISBT-EHN), were prepared (Figure 1).

Figure 1.

Figure 1

Figure 1

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Project READ

The plan was to collect data relative to about 90,000 donations, in 6 months; six TS were involved (Table I). The number of units of blood components collected was equally distributed between TS that collect donations directly and those that collect the donations indirectly via Donor Associations.

Table I.

Characteristics of the Transfusion Structures involved in the study: data updated to 31.12.2007

Centre Donors (n.) Male (%) Female (%) Total units collected (n.) Units/day Donor Association Collection
Bergamo 31,296 71.2 28.8 37,299 104 AVIS 100% Association
Bologna 22,928 73.8 26.2 40,229 114 AVIS 100% TS
Lucca 6,729 66.3 33.7 11,246 32 Fratres-CRI - Croce Verde 100% TS
Ragusa 9,160 62.8 37.2 14,182 44 AVIS 100% TS+Association
Ravenna 18,429 69.8 30.2 35,816 116 AVIS-ADVS 44% TS, 56%
TS+Association
Verona 12,087 74.5 24.5 35,651 125 AVIS - FIDAS 100% TS
Total 100,629 69.7 30.3 174,423 88
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Given the different requirement for recording and processing the data, two forms were prepared:

  1. READ 1, a form to record the single events, to be used in the individual donor centres, and a related Excel® spreadsheet for the entry and processing of data (Figure 1). The READ 1 form is a refinement of the various forms already in use in the TS and the EHN-ISBT form. In particular it allows for the distinction between various types of donations made, as well as the number of donations given before the recorded event: this enables an estimate of the incidence of AE in relation to different types of donation and of the incidence in first-time donors. An evaluation of the “grade” of the AE (mild, moderate, severe) is made, according to the definitions reported in Figure 3, allowing standardisation of the data.

    The READ 1 form, which requires a very detailed report of the events, can and should be considered as a work instrument for continuous improvement of the quality systems in use at the individual TS independently of their type of management (public or by Associations), enabling an evaluation of the training credits of the staff involved, and for improvement of the performances of the TS and of the Associations and Federations of Donors that collect the donations. Finally, this form also provides for a distinction between donors of homologous blood and donors of autologous blood, thus also allowing its use in TS in which self-donation is practised.

  2. READ 2, a form for processing the data arriving from the individual TS and managed by the coordinating centre. This form (Figure 2) includes the general, summarised data, as planned by the EHN-ISBT, managed by the various co-ordinating centres, TS which receive data from Donor Centres, Regional Blood Centres, and the National Blood Centre, in order to compare Italian data with European data. Only the general data related to the AE, divided according to degree of severity, are reported in this form.

    In order to improve the understanding of the data and to standardise reporting, a document listing the complications of donations, as well as their description and severity, was prepared (Figure 3)14.

Figure 3.

Figure 3

Figure 3

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Project READ

Figure 2.

Figure 2

Figure 2

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Project READ

Results

Between February and August 2008 six TS collected information related to the donation of 89,332 units of blood components: 68,968 units of whole blood, 17,449 plasmapheresis, 60 plateletpheresis, 1,886 plasma plateletpheresis, 735 erythro-plasmapheresis, 214 erythro-plateletpheresis, and 20 double red cell apheresis.

Overall 523 AE were recorded, of which 51% occurred in men and 49% among women: the percentage of male donors in the TS involved was 69,7%, while the percentage of female donors was 30,3%. The distribution of the AE by age was as follows: 22% in the age range from 18–25 years old, 24% in the group 26–35 years, 30% in the group 36–45 years, 15% in the group 46–55 years, and 9% in the group 56–65 years old.

Seventeen percent of the AE occurred in first-time donors, 30% in donors of 2–5 previous donations, 17% in those who had made 6–10 previous donations, 8% in those who had made 11–15 previous donations and 27% in those who had made more than 15 previous donations.

The AE rates according to the various types of donation were 0.41% for whole blood, 0.84% for plasmapheresis, 17% for plateletapheresis, 3.55% for plasma-plateletapheresis, 1.63% for erythro-plasmapheresis, 0.93% for erythrom-plateletpheresis, and 5% for double red cell apheresis, for an overall mean rate of 0.59%.

The total number of symptoms recorded was 978. The symptoms lasted between 1 minute and 5 hours, with a mean duration of 17 minutes. One hundred and forty-seven symptoms (15%) were related to venipuncture: of these, 145 were haematomas and 103 required local therapy, one was an arterial puncture and one was a mild lesion to a nerve. There were no cases of thrombophlebitis. There were 749 vasovagal symptoms, accounting for 77% of all symptoms: 703 occurred within the donation centre and 46 after leaving the centre, but within 24 hours.

The symptoms were defined as severe (grade C) in 47 cases; 14 of these symptoms were recorded in relation to apheresis procedures (cold feeling: 3, citrate-related paraesthesia: 11); two AE were not among those listed in the form, but both were classified as mild. No important rare event was notified.

Of the 978 symptoms, 164 were considered to be grade C: 103 of these 164 symptoms were related to haematomas; the remaining 61 events included the paraesthesia and cold feeling (treated with oral or intravenous calcium, but easily resolved). In conclusion, only 47 of the 978 symptoms recorded were actually serious enough to be considered severe.

The donations in which AE were recorded were completed in 81% of the cases and suspended in the other 19% of cases. Fifty-nine percent of the donors who had an AE did not require therapy, whereas the other 41% did. Three donors needed a brief period of observation (less than 4 hours) in hospital (in the Accident and Emergency Department).

Discussion

To the best of our knowledge, our project is the first multicentre nationwide study on AE in donors of blood components.

After having designed the data registration forms, these were used in the various TS from February 2008. Controls of the data registration were conducted in order to make changes to the forms if necessary; however, the forms did not require revision.

The data recorded included, for the first time as an AE, the occurrence of haematomas. No data on haematomas have previously been reported in the Italian scientific literature. Indeed, we did think that considering haematomas as an AE would lead to difficulties in managing the data, particularly with regards to “severe” cases, given that even the application of cutaneous medication led to the event being notified as “severe, grade C”, according to a rigid compliance with the definition. However, we considered it obvious that the appearance of a haematoma could lead to a possible “worsening” of the condition with subsequent development of other, related AE [for example: arterial puncture (only one case reported), thrombophlebitis (no reports), haematoma-induced lesion to a nerve (no reports), pseudo-aneurysm of the brachial artery (no reports), arterio-venous fistula (no reports), compartment syndrome (no reports), axially vein thrombosis (no reports)] and that only in these cases should they be notified and considered grade C, or “severe”. In any case, even considering problems of compensation, which we believe to be the main reason for the inclusion of this AE in the ISBT-EHN list to which we referred15, recently updated Italian legislation provides for insurance cover16. On the other hand, the authors of the ISBT-EHN list planned that “haematomas” would be recorded as AE only in cases that they were present for a prolonged period15.

Another difficulty that we encountered was the limited data for some types of donation, for example plateletpheresis (only carried out in one TS), double red cell apheresis and double units from plateletpheresis: the small number of units obviously prevented data and percentage of AE from being significant. Further, specific studies are, therefore, necessary for these types of donations.

As far as concerns the relation between AE and type of donation, it was found that the incidence of AE was about 5 times higher with multicomponent donations than with donations of whole blood (2.02 vs 0.41 every 100 donations), and 2 times higher than that with donations of single products by apheresis; however, these findings could also be affected by the limited amount of data.

One finding that we believe is important to highlight is a gender-related difference in the incidence of AE, with the incidence being higher among women than among men, since 49% of the AE occurred in women, who accounted for only about 30% of the donors in the six TS involved in the project. In this regard, revision 1 of the READ 1 form included a field related to the weight of the donor, since this parameter appears to be involved in the occurrence of AE17–18.

The mean age of the donors who developed AE was 37 years. It was not possible to calculate the incidence of AE in first-time donors since there was no way of correlating the number of AE that occurred with the total number of first-time donors.

Overall, 978 symptoms were recorded, with some donors having more than one; of these only 910 were recorded on the READ 2 forms, since this passage was not required for 68 of the symptoms. Figure 4 shows the number of AE with their degree of severity: only 47 symptoms were designated as severe AE, complicating 0.03% of all the donations monitored.

Figure 4.

Figure 4

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Total symptoms recorded: 978. The number of real, severe AE was 30, for an incidence of 0.03% among all the donations monitored

Of the donors developing an AE, 41% needed treatment (Figure 5); three donors required brief monitoring in hospital (in the Accident and Emergency Department). In two cases oxygen therapy was inappropriately administered (personal communication).

Figure 5.

Figure 5

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Therapy used to manage the 310 AE that were treated; the arrows indicate: (1): therapy for haematomas, (2): reduction of reinfusion, (3): transfer to the Accident and Emergency Department, (4): oxygen therapy

Conclusions

Besides the fact that the data collected represent only a small part of the Italian reality and cannot, therefore, be readily compared with national data collected in much more substantial surveys19–21, the following problems related to the performance of the haemovigilance programme were noted: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities.

These problems must be resolved at various levels: local, regional and national, as proposed in other nations22. As far as regards local interventions, it is essential that periodic meetings are conducted to train and educate the staff, both of the TS and the Donor Associations, and to spread the AE recording forms. Furthermore, a local representative (a nurse or doctor) must be identified. This person should be responsible for collecting the data for the READ 1 forms, processing them and spreading them locally in order to promote continuous improvement of the individual Donation Centres: the unpleasant experience of an AE undoubtedly causes greater reluctance to make another donation23–25.

At the level of TS, a person responsible for coordinating the Donation Centres and processing the data must be identified. The data must be made available to all the facilities referring to the TS, enabling direct comparisons and general improvement. Furthermore, the TS representative must send the summarised data (READ 2 form, with grade C AE) to the appropriate regional bodies, where another representative must be identified to coordinate all the TS at a regional level and then send the data to the National Blood Centre (Figure 6). The approach that we propose, which can certainly be improved, represents the basis for a useful and profitable involvement of the various transfusion facilities.

Figure 6.

Figure 6

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Flow chart of information

Table II.

Numbers of the different types of donation

Type of donation Number
Whole blood 68,968
Plasmapheresis (P) 17,449
Plateletpheresis (PLT) 59
Double plateletpheresis (2PLT) 1
Subtotal - apheresis (P+PLT+2PLT) 17,509
Plasma-plateletpheresis (P-PLT) 1,886
Erythro-plasmapheresis (R-P) 735
Erythro-plateletpheresis (R-PLT) 214
Double red cell apheresis (2R) 20
Subtotal - multicomponent (P-PLT+R-P+2R) 2,641
Total 89,332
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