PART 03 DONOR VIGILANCE

The data contained in this report has been collected and the report compiled by the Blood Service using data gathered from adverse events reported via the Donor Adverse Event (DAE) database. Collections staff who are responsible for the immediate management of adverse reactions which occur at the blood donor centre register such adverse events. Medical Services staff are responsible for registering events which are reported to the Blood Service after the donor has left the donor centre. Events are classified by a centralised team according to standard definitions which are largely based on definitions endorsed by the ISBT Haemovigilance Working Party. Donors are followed up by Medical Services staff according to the type and severity of reaction reported (refer to Appendix III: Definitions of donor adverse events). Donor haemovigilance data and trends are regularly monitored by the Donor and Product Safety Advisory Committee and the Blood Service Clinical Governance Committee to evaluate the impact of changes in donor selection criteria, donation processes and interventions to improve donor safety. There is also regular reporting to the Blood Service Executive and Board.

Review of donor adverse events 2011-12

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%[26],[27] and based on these rates Australia benchmarks favourably.

During 2011-12 there was a total of 1,342,883 donations, including 945,490 whole blood donations, 357,701 plasmapheresis donations and 39,282 plateletpheresis donations collected by the Blood Service. Total donation associated events and serious donation related events are shown in Figure 4 below.

There were 29,525 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 1:45 in 2011-12.

Figure 4: Total donation associated events and serious donation related events

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 September 2010, new standard operating procedures were introduced in which reporting requirements for adverse events changed to include the mandatory reporting of events classified as mild reactions. This change in reporting requirements occurred concurrently with the introduction of an electronic reporting system to replace a paper-based system. In January 2011 a donor wellness check was introduced whereby every time a donor presents to donate they are asked whether they experienced any problems related to their previous donation. The main purpose of the donor wellness check is to identify delayed donor reactions.

In the 12 month period following the introduction of the donor wellness check there was nearly a 50% increase in the reporting of delayed events associated with whole blood donations and a 120% increase in the reporting of delayed events associated with plasma donations. These changes were associated with an apparent increase in reaction rates, as shown in Figure 4. Table 11 shows the impact of the introduction of the donor wellness question from 31 January 2011.

Table 12 shows the rate of adverse events by donation type, and the rate per 10,000 donations.

Table 11: Impact of the donor wellness question

	Prior to the introduction of the wellness question		After the introduction of the wellness question
	Total Delayed events 1/10/10 - 31/1/11	Serious Delayed events 1/10/10 -31/1/11	Total Delayed events 1/10/11 - 31/1/12	Serious Delayed events 1/10/11 - 31/1/12
Whole Blood	0.17%	0.03%	0.25%	0.03%
Plasma	0.05%	0.05%	0.11%	0.01%
Platelets	0.06%	0.03%	0.06%	0.02%

Table 12: Donor adverse events per procedure 2011-12

Procedure	Total Donations	Donations with Events	Frequency	Rate / 10,000 Donations
Whole Blood	945,900	25,110	1:38	265
Plasmapheresis	357,701	3,283	1:109	92
Plateletpheresis	39,282	1,131	1:35	288
All apheresis procedures	396,983	4,414	1:90	111
Total procedures	1,342,883	29,524	1:45	220

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 at 1:109, and platelet donations with the highest frequency at 1:35 (Table 12). The incidence of the different types of adverse events for all donations is shown in Table 13.

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 2011-12 there were 331 hospital referrals and 373 general practitioner (GP) referrals for donation-related complications (Table 14). There were no donation associated deaths. The most common reason for both hospital and GP referral is slow recovery from a vasovagal reaction. Nerve irritation due to a large haematoma was the most common reason for referral for phlebotomy injury, followed by painful arm after donation (Table 15). Table 16 details donor complication rates by severity per 10,000 donations 2011-12.

Table 13: Donation associated events by category and frequency for 2011-12

Donor Event	Number	% Total Events	Frequency	Rate / 10,000 Donations
Immediate vasovagal	24,225	82.05%	1:55	180
Delayed vasovagal	2,771	9.39%	1:485	21
Chest pain	48	0.16%	1:27,977	0.4
Citrate reaction*	233	0.79%	1:5,763	2
Haematoma	1,137	3.85%	1:1,181	8
Painful arm	431	1.46%	1:3,116	3
Nerve irritation	123	0.42%	1:10,918	1
Nerve injury	204	0.69%	1:6,583	2
Arterial puncture	50	0.17%	1:26,858	0.4
Delayed bleeding	39	0.13%	1:34,433	0.3
Thrombophlebitis	31	0.1%	1:43,319	0.2
Tendon damage	3	0.01%	1:447,628	0.02
Allergy	16	0.05%	1:83,930	0.1
Other injuries**	213	0.72%	1:6,305	2
Total	29,524	-	1:45	219

Notes

1. *Calculated for apheresis collections only
2. **Includes severe headache during or immediately following donation (38 reports), generalised cramps (18 reports), palpitations/awareness of heart beat (17 reports), nausea and abdominal pain (10 reports), onset of wheeze/asthma during donation (8 reports), extreme fatigue following donation (7 reports)

Table 14: Summary of external medical referrals 2011-12

	Number of hospital referrals	Incidence of hospital referrals (% total collections)	Number of GP referrals	Incidence of GP referrals (% total collections)
Whole Blood	284	0.030	293	0.031
Plasmapheresis	37	0.010	65	0.018
Plateletpheresis	10	0.025	15	0.038
Total	331	0.031	373	0.036

Table 15: Reasons for external medical referrals 2011-12

	Number of hospital referrals	Incidence of hospital referrals (% total collections)	Number of GP referrals	Incidence of GP referrals (% total collections)
Vasovagal Reactions	258	0.019	112	0.008
Phlebotomy Injuries	33	0.002	177	0.013
Chest Pain	17	0.001	20	0.001
Other*	23	0.002	64	0.005
Total	331	0.025	373	0.028

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 16: Donor complication rate by severity per 10,000 donations 2011-12

			Rate per 10,000 donations
			Whole Blood	Plasmapheresis	Plateletpheresis
			(n=945,145)	(n=350,350)	(n=39,039)
Complications related to donation	Haematoma	Moderate	6.82	8.93	28.43
		Severe	0.47	0.29	1.54
	Arterial puncture	Moderate	0.45	0.09	0.00
		Severe	0.04	0.00	0.00
	Delayed bleeding	Mild	0.24	0.40	0.00
		Moderate	0.02	0.00	0.00
Pain/soft tissue injury	Nerve irritation	Moderate	0.79	0.86	1.28
		Severe	0.11	0.09	0.00
	Nerve injury	Moderate	1.34	0.94	0.77
		Severe	0.34	0.23	0.26
	Tendon damage	Mild	0.02	0.00	0.00
		Moderate	0.01	0.00	0.00
	Painful arm	Mild	0.87	1.37	2.31
		Moderate	1.94	1.71	1.02
		Severe	0.36	0.31	0.00
Other complications with local symptoms	Thrombophlebitis	Moderate	0.04	0.11	0.00
		Severe	0.16	0.17	0.00
	Allergy (local)	Mild	0.18	0.14	0.00
		Moderate	0.01	0.03	0.26
Immediate vasovagal reaction	Without injury	Mild	161.51	43.13	133.46
		Moderate	43.68	12.24	48.93
		Severe	19.72	5.71	9.99
	With injury	Mild	0.00	0.00	0.00
		Moderate	0.11	0.00	0.26
		Severe	0.61	0.17	0.77
Delayed vasovagal reaction	Without injury	Moderate	4.75	2.25	2.05
		Severe	10.18	3.94	3.07
	With injury	Moderate	0.01	0.03	0.00
		Severe	0.90	0.29	0.00
Apheresis related complications	Citrate reaction		0.00	1.54	45.85
	Haemolysis		0.00	0.03	0.00

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 (odds ratio 3.5 for 16-17 year males, and 6.3 for 16-17 year old females). This trend is consistent with international published data.[28]^,[29] Safety and well-being 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 Figure 5 and Figure 6). Refer to Appendix V for the supporting data for the calculation of the odds ratio.

Figure 5: Odds ratio for vasovagal reactions associated with all donation types 2011-12 (females)

Figure 6: Odds ratio for vasovagal reactions associated with all donation types 2011-12 (males)

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% - 33% and based on these rates we benchmark favourably. However there remains considerable value in benchmarking initiatives to reduce adverse events. For this reason the Blood Service regularly benchmarks with Blood Services across America, Canada, Europe and the Asia-Pacific region. 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://www.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[viii] 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 '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 prevent 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 Therapeutic Goods Administration.