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Review of donor adverse events 2012-13

Whilst blood donation is generally a very safe process, there are recognised donor complications which can occur. Donor haemovigilance systems permit monitoring of donor safety and evaluation of the success of interventions designed to further improve donor safety. International benchmarking of donor adverse events is important but not straightforward because of different adverse event definitions, different collection processes and probably most importantly differences in reporting compliance. Estimates of adverse event incidence in blood donors based on published international studies range considerably from 5% to 33%[35],[36] and based on these rates Australia benchmarks favourably.

During 2012–13 there were a total of 1,322,883 donations, including 858,594 whole blood donations, 427,945 plasmapheresis donations and 36,344 plateletpheresis donations. Total donation associated events and serious donation-related events are shown in Figure 3 below.

total donation-associated events

Figure 3: Total donation-associated events and serious donation-related events 2008–09 to 2012–13

There were 33,208 adverse events reported with the vast majority of these being classified as mild, such as the donor feeling faint for a few minutes. Adverse events can occur during and after the donation. Events which occur in the donor centre are termed immediate events. Events which occur after the donor has left the donor centre are classified as delayed events. Serious adverse events are those events where the donor requires external medical or hospital referral for the management of the adverse event and such events may be either immediate or delayed. The overall reported rate of donation-related adverse events was 1:40 in 2012–13.

The Blood Service has implemented a number of strategies to enhance reporting compliance by donors as well as donor centre and Medical Services staff. In November 2012, new standard operating procedures were introduced in which reporting requirements for adverse events changed to include the mandatory reporting of all citrate related reactions in apheresis donors. This change coincided with the roll-out of e‑learning modules to all Collections and Medical Services staff to improve their understanding of the causes of adverse reactions, to enhance recognition and management of adverse reactions, and to emphasise the importance of adverse events reporting. Since January 2011 a donor wellness check has been in place whereby every time a donor returns to donate they are asked whether they experienced any problems related to their previous donation. Following this there has been a sustained increase in the number of delayed vasovagal reactions reported. The rate of delayed events for all collection types has increased by approximately 50%. The impact of this reporting can be seen in Table 22 and Figure 4.

Table 22: Impact of the donor wellness question—incidence of delayed vasovagal reactions
  Prior to the introduction of the wellness question After the introduction of the wellness question
  1/10/10–31/1/11 1/2/11–30/6/11 1/7/11–30/6/12 1/7/12–30/6/13
Whole Blood 0.17% 0.21% 0.26% 0.30%
Plasma 0.05% 0.10% 0.13% 0.14%
Platelets 0.06% 0.09% 0.10% 0.14%

impact of donor wellness question

Figure 4: Impact of donor wellness question—whole blood delayed vasovagal reactions September 2010–June 2013

Note: Includes events occurring between 1/7/12 and 30/6/13, but reported up until 30/9/13

Table 23 shows the rate of adverse events by donation type, and the rate per 10,000 donations for 2012–13.

Table 23: Donor adverse events per procedure, 2012–13
Procedure Total Donations Donations
with Events
Frequency Rate / 10,000 Donations
Whole Blood 858,594 26,450 1:32 308
All apheresis procedures 464,289 6,758 1:69 146
Plasmapheresis 427,945 5,127 1:83 120
Plateletpheresis 36,344 1,631 1:22 449
Total procedures 1,322,883 33,208 1:40 251

Vasovagal reactions and bruising/haematoma are the most frequent complications associated with blood donation. Plasmapheresis donations are associated with the lowest frequency of adverse reactions, and platelet donations with the highest frequency. The incidence of the different types of adverse events for all donations is shown in Table 24.

Table 24: Donation associated events by category and frequency, 2012–13
Donor Event Number % Total Events Frequency Rate / 10,000
Donations
Immediate vasovagal 25,711 77.42% 1:51 194
Delayed vasovagal 3,278 9.87% 1:404 25
Chest pain 56 0.17% 1:23,623 0.4
Citrate reaction* 468 1.41% 1:992 10
Haematoma 1,473 4.44% 1:898 11
Painful arm 620 1.87% 1:2,134 5
Nerve irritation 201 0.61% 1:6,582 2
Nerve injury 170 0.51% 1:7,782 1
Arterial puncture 39 0.12% 1:33,920 0.3
Delayed bleeding 34 0.10% 1:38,908 0.3
Thrombophlebitis 34 0.10% 1:38,908 0.3
Tendon damage 9 0.03% 1:146,987 0.1
Allergy 50 0.15% 1:26,458 0.4
Other injuries** 1,065 3.21% 1:1,241 8
Total 33,208 100.00% 1:40 251

Notes

  1. *Calculated for apheresis collections only.
  2. **Includes injuries sustained in falls during fainting, headaches during and after donation, cramps, palpitations or awareness of heart beat, nausea or abdominal pain during or immediately following procedure, onset of wheeze or asthma during donation, prolonged fatigue following donation.

Serious complications of blood donation

Serious complications related to blood donation are events resulting in any of the following:

  • hospitalisation if it is attributable to the reaction, based on the evaluation of hospital medical staff
  • attendance at a healthcare facility to manage a complication and to prevent ongoing impairment
  • involvement in an accident (with or without significant injury) if the accident was probably or definitely related to the donation
  • death following a donation complication if the death was probably, possibly or definitely related to the donation.

During 2012–13 there were 451 hospital referrals and 605 general practitioner (GP) referrals for donation-related complications (Table 25). There were no donation associated deaths. The commonest reason for both hospital and GP referral was slow recovery from a vasovagal reaction; nerve irritation due to a large haematoma was the commonest reason for referral for phlebotomy injury, followed by painful arm following donation (Table 26). Table 27 details donor complication rates by severity per 10,000 donations 2012–13.

Table 25: Summary of external medical referrals, 2012–13
  Number of
hospital
referrals
Incidence of hospital referrals
(% total collections)
Number
of GP
referrals
Incidence of
GP referrals
(% total collections)
Whole Blood 331 0.039 446 0.052
Plasmapheresis 101 0.024 140 0.033
Plateletpheresis 19 0.052 19 0.052
Total 451 0.034 605 0.046
Table 26: Reasons for external medical referrals, 2012–13
  Number of
hospital
referrals
Incidence of hospital referrals
(% total collections)
Number
of GP
referrals
Incidence of
GP referrals
(% total collections)
Vasovagal Reactions 396 0.030 255 0.019
Phlebotomy Injuries 15 0.001 274 0.021
Chest Pain 16 0.001 19 0.001
Other* 24 0.002 57 0.004
Total 451 0.034 605 0.046

Note: * Other includes injuries sustained during a faint, such as head injuries, fractures and dental injuries, and also constitutional symptoms such as extreme fatigue and palpitations on minimal exertion experienced by some donors in the days immediately following blood donation.

Table 27: Donor complications by type and severity per 10,000 donations, 2012–13
      Rate per 10,000 donations
      Whole Blood
(n=858,594)
Plasmapheresis
(n=427,945)
Plateletpheresis
(n=36,344)
Complications related to
blood outside blood vessels
Haematoma and bruising Moderate 5.22 4.58 9.91
Severe 0.75 0.61 2.2
Arterial puncture Moderate 0.01 0.16 0.00
Severe 0.06 0.02 0.00
Delayed bleeding Mild 0.23 0.28 0.28
Moderate 0.02 0.00 0.00
Pain/soft tissue injury Nerve irritation Moderate 0.63 0.3 0.83
Severe 0.24 0.09 0.00
Nerve injury Moderate 0.42 0.3 0.55
Severe 0.4 0.21 0.00
Tendon damage Moderate 0.02 0.00 0.00
Severe 0.08 0.00 0.00
Painful arm Moderate 1.37 0.58 0.83
Severe 0.58 0.61 0.28
Other complications with local symptoms Thrombophlebitis Moderate 0.04 0.02 0.00
Severe 0.16 0.12 0.00
Allergic reaction (localised) Mild 0.19 0.09 0.28
Moderate 0.10 0.05 0.00
Immediate vasovagal reaction Without injury Mild 190.71 50.38 140.6
Moderate 43.47 10.96 39.62
Severe 21.86 6.73 13.38
With injury Moderate 0.05 0.07 0.55
Severe 1.09 0.02 1.93
Delayed vasovagal reaction Without injury Mild 7.85 3.69 3.03
Moderate 6.00 3.25 3.58
Severe 15.62 7.20 7.43
With injury Moderate 0.02 0.00 0.00
Severe 0.96 0.16 0.28
Apheresis related complications Citrate reaction   - 4.95 70.99
Haemolysis   - 0.16 0.00

Donor gender and age and adverse reactions to donation

The frequency of donation associated events is higher in younger blood donors and in female blood donors, especially those under the age of 20 years. The frequency of reactions in 16–17 year old females is one in every eight donations, and in 16–17 year old males, one in every 14 donations. This trend is consistent with international published data.[37],[38] Safety and wellbeing of youth donors is a key area of focus for the Blood Service. There is a steady reduction in the likelihood of a donation reaction with increasing age (see Table 28 below).

Table 28: Adverse donation reactions in male donors by age, including odds ratio, 2012–13
Age group Number of
events
Total donors
in age group
Frequency Rate/1000
donations
Odds ratio
(95% CI)
16–17yrs 1,265 17,975 1:14 70.38 5.1054
(4.8093 - 5.4198)
18–20yrs 1,207 29,941 1:25 40.31 3.0125
(2.8419 - 3.1933)
21–23yrs 1,063 32,106 1:30 33.11 2.4219
(2.2778 - 2.5751)
24–30yrs 2,208 79,977 1:36 27.61 2.2009
(2.1047 - 2.3014)
31–40yrs 1,680 102,119 1:61 16.45 1.2262
(1.1679 - 1.2874)
41–50yrs 1,206 144,297 1:120 8.36 0.623
(0.5908 - 0.6569)
51–60yrs 958 187,052 1:195 5.12 0.3715
(0.3511 - 0.3931)
61–70yrs 458 122,149 1:267 3.75 0.2791
(0.2577 - 0.3023)
71+ 22 13,690 1:622 1.61 0.1591
(0.1147 - 0.2208)
Total 10,067 729,306 1:72 13.80  
Table 29: Adverse donation reactions in female donors by age, including odds ratio, 2012–13
Age group Number of
events
Total donors
in age group
Frequency Rate/1000
donations
Odds ratio
(95% CI)
16–17yrs 2,725 22,067 1:80 123.49 4.3722
(4.1913 - 4.5607)
18–20yrs 2,580 32,402 1:13 79.62 2.665
(2.5555 - 2.7792)
21–23yrs 2,217 36,498 1:16 60.74 1.9849
(1.8994 - 2.0742)
24–30yrs 3,501 76,385 1:22 45.83 1.5296
(1.4759 - 1.5852)
31–40yrs 2,271 80,623 1:36 28.17 0.8963
(0.8599 - 0.9343)
41–50yrs 1,951 112,654 1:58 17.32 0.5426
(0.5199 - 0.5662)
51–60yrs 2,305 140,209 1:61 16.44 0.4877
(0.4686 - 0.5076)
61–70yrs 1,286 85,449 1:66 15.05 0.4417
(0.4189 - 0.4657)
71+ 86 7,216 1:84 11.92 0.3635
(0.2973 - 0.4443)
Total 18,922 593,503 1:31 31.88  

Performance in relation to international blood services

There are significant challenges in benchmarking Australia's adverse events rate with event rates reported by international blood services as a result of variations in the classification of donation associated events and also because of variations in reporting requirements between blood services and variable compliance with these requirements. Estimates of adverse event incidence in blood donors based on published international studies range from 5 to 33% [35],[36] and based on these rates the Blood Service benchmarks favourably. However there remains considerable value in benchmarking initiatives to reduce adverse events. For this reason the Blood Service regularly benchmarks with blood services in America, Canada, Europe and Asia Pacific. Taking into consideration the significant challenges identified above, the focus is primarily on the review of strategies and initiatives being implemented to reduce adverse event rates and the impact of such interventions on local adverse event trends, rather than a comparison of absolute adverse event rates. The Blood Service is participating in work led by the ISBT Haemovigilance Working Party to improve the comparability of absolute adverse event rates.

Interventions directed at reducing the risk of adverse events

  1. Donor education via http://donateblood.com.au and on the Donor Questionnaire Form provides advice on preparation for blood donation (pre-donation salty snacks and adequate fluid intake) and on strategies to minimise the risk of a reaction during and after donation (use of applied muscle tension, rest and fluid intake, avoidance of strenuous physical activity and alcohol post donation)
  2. Provision of specific information cards to donors at the time of an adverse event detailing immediate management and preventative actions relevant to subsequent donations
  3. Permanent deferral of donors with significant risk of recurrence of serious adverse reactions
  4. Use of a mid-donation saline protocol for plasma donors which includes the administration of 500mL of saline to reduce the risk of vasovagal reactions
  5. Using a stepwise approach to increasing collection volume for plasmapheresis donors donating plasma for fractionation based on nomograms* for per cent Total Blood Volume
  6. Using a stepwise approach for plasmapheresis donors donating Clinical Fresh Frozen Plasma with end saline, also based on a nomogram for Total Blood Volume
  7. Using a "whole blood nomogram" with reduced volume whole blood collection for donors with low total blood volume
  8. Use of specific guidelines for managing young donors – females under 20 years of age are not recruited to plasma donation
  9. Provision of pre-donation oral calcium supplements for plateletpheresis donors to reduce the frequency and severity of citrate reactions
  10. Communication with comparable international blood services to ensure 'best practice' protocols
  11. Formal clinical governance processes including review of staff scope of practice and training, the conduct of clinical audits, robust data capture and analysis of adverse events, regular management and external review of donor adverse event trends with corrective action taken as required
  12. Implementation of initiatives to reduce the risk of iron deficiency associated with blood donation, including supporting research to identify other potential mitigation measures
  13. External review and approval of donor selection guidelines and collection protocols by the TGA.

Note: *A nomogram is a chart or graph used to show relationships between several variables (such as height and weight) to enable a third value (the collection volume, which is based on the total blood volume) to be read directly at the intersection point of the first two values.

Planned initiatives directed at reducing the risk of adverse events

  1. Youth donors (aged 16 and 17 years) will be restricted to one donation per annum from 1 January 2014 to reduce the risk of iron deficiency and number of vasovagal reactions
  2. Pain experienced during a difficult phlebotomy does contribute to vasovagal reactions. A trial involving the use of vein visualisation technology conducted in 2013–14 and the impact on donor adverse event rates will be analysed
  3. Two pilots of iron supplementation to reduce the risk of iron deficiency associated with blood donation commenced in 2013–14.

Case study 3: Delayed vasovagal reaction in a regular blood donor

The donor, a 53 year old woman, contacted the Blood Service approximately 6 hours after a whole blood donation to report that she had fainted 5 hours after donation, and continued to feel light‑headed and weak.

The donor was in good health and was not taking any medication. She had been a blood donor for 14 years and had made 33 uneventful donations. On the day of donation she had eaten breakfast and lunch and had drunk 4-5 glasses of water and a cup of tea during the morning prior to her 2pm appointment. This was no different from her usual pre-donation preparation. She reported on her questionnaire and at interview that she was feeling healthy and well, and had no recent illnesses. The donor weighed 69kg and her height was 166cm (estimated total blood volume 4.1L). Her pre-donation blood pressure was 138/82mmHg and her pre-donation capillary Hb was 136g/L.

The donation commenced at 2.21pm and 471mL of whole blood was collected in 8 minutes. She felt well immediately following donation, and after resting briefly on the couch, she went to the refreshment area where she drank one glass of cordial and ate a muffin. She remained in the refreshment area for about 5 minutes. Following donation she went shopping for about 2 hours and then travelled home by bus. She felt well throughout this time. Her only fluid consumption after leaving the blood donor centre was a half a glass of water consumed whilst she was preparing the evening meal.

The donor started feeling unwell immediately following her evening meal during which she had drunk approximately half a glass of red wine. She fainted when she stood up to go to the bathroom. Her partner informed her that she was unconscious for "about 30 seconds". Immediately after regaining consciousness she attempted to move to a chair, and she fainted again. She remained on the floor for about 20 minutes and then moved to a chair. It was at this stage she contacted the Blood Service Medical Officer.

The Medical Officer advised the donor to remain semi-recumbent, to attempt to drink at least 2 glasses of cold water over the next 20 minutes, and instructed the donor in the use of applied muscle tension (repeated contraction of the thigh muscles which reduces peripheral venous pooling associated with vasovagal reactions and enhances venous return). She was advised to increase her intake of cool fluids over the next 3 hours, and to avoid hot baths or showers and was advised that she must not drive for at least the next 8 hours.

At follow up the next day, the donor reported that her symptoms of dizziness and sweating had resolved rapidly after she had used applied muscle tension; she had complied with the advice to drink additional cold, non-alcoholic fluids, and felt "back to normal" within 90 minutes.

Delayed vasovagal reaction is a well-recognised complication of blood donation, occurring in 0.34% of whole blood donors. It is thought that they occur as a result of failure of the donor's normal compensatory reflexes to respond to the volume loss associated with donation. Inadequate fluid intake post donation, prolonged standing, high environmental temperature, and alcohol ingestion all increase the risk of a delayed vasovagal reaction. Delayed reactions occur more frequently in female donors than in male donors (incidence 0.58% in females compared to 0.10% in male donors) and are more likely to be associated with loss of consciousness than immediate vasovagal reactions. Unlike immediate vasovagal reactions, the risk of a delayed reaction is not significantly higher in first time and inexperienced donors compared to experienced and older donors. It is possible that experienced donors are less vigilant about following advice to increase their fluid intake following donation, thereby increasing the risk of a delayed reaction.

Donors are provided with information on the risk of delayed reactions and advice on prevention, in particular advice on maintaining post donation fluid intake, and avoidance of known precipitants such as overheating, prolonged standing and drinking alcohol.