113885-Article Text-317682-1-10-20150305
113885-Article Text-317682-1-10-20150305
113885-Article Text-317682-1-10-20150305
PROJECT REPORT
Mapako T1,2, Janssen MP3, Van Den Burg P4, Smid M4, Mvere DA2, Emmanuel JC2, Postma MJ1, Rusakaniko S5, Groningen HB6, Van Hulst M1,6
1. Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, Groningen,
The Netherlands
2. National Blood Service Zimbabwe, Harare, Zimbabwe
3. Julius Center for Health Sciences and Primary Care, MTA Department, University Medical Centre Utrecht, Utrecht, The Netherlands
4. Sanquin Blood Supply, Amsterdam, The Netherlands
5. Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Zimbabwe
6. Martini Hospital, Groningen, The Netherlands
ABSTRACT
Introduction Key Findings
Tracking blood safety status of member states by World Health The difference in geographical land sizes (Zimbabwe 10 times
Organisation is now a routine activity through Global Database larger) and population demographics (Zimbabwe predominately
for Blood Safety. To understand further the differences between youths) poses different challenges to Netherlands and Zimbabwe.
high income and low-income countries a detailed review may be The organisation and management structures of the Services are
warranted. In this review, the blood services of Netherlands and similar and both rely on 100% voluntary non-remunerated blood
Zimbabwe were compared. donors. Despite the high transfusion transmission infections (TTI)
rates in the general population in Zimbabwe the testing technology
Methodology is low as compared to Netherlands. However, Zimbabwe through
A study visit to Netherlands was undertaken and the key findings other strategies has managed to maintain low TTI prevalence in
from this visit were compared with equivalent data from Zimbabwe. donated blood. There are comparable efforts in blood process,
Key thematic points were summarised from the review of the reports testing and distribution activities. The support services such as
as well as the outcomes from key observations and informant haemovigilance, research and development activities are greatly
discussions. Lessons learnt and recommendations were drawn for comparable though the outputs magnitude will differ depending
each thematic area considered. of the level of investment.
Conclusion
Our findings seems to suggest that despite the differing income
status of countries, given the proper strategies blood services in low
resources settings can make comparable achievements
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Africa Sanguine September 2014, Volume 17, no. 1
INTRODUCTION
World Health Organisation (WHO) regularly provides universal five divisions; Blood Bank; Plasma Products; Diagnostic Services;
guidelines to member states on the need for blood safety and Reagents and Research. In comparison to NBSZ, which has
availability and how this can be achieved nationally.1 These departments of Medical Services; Laboratory Services; Finance;
recommendations are considered and implemented by countries; Human Resources and Administration; Public Affairs; Quality,
however, the level of implementation depends not only on Safety, Health and Environment; Planning, Information and
commitment but available resources needed to optimise blood Research. It was noted that the functions comprising finance,
safety. There are published blood safety status reports by WHO human resources, administration, planning and Information
through Global Database on Blood Safety (GDBS) for categories of Technology Communications are placed under corporate staff/
low/medium/high (LMH) income status of countries.2 services at Sanquin and they provide support to the divisions and
To further comprehend countries blood safety status between LMH advice the Executive Board. With the exception of plasma products
income countries a detailed analysis is warranted to enable better and diagnostic services the organisation and management
appreciation of the underlying contributing factors. In this study functions are comparable. How these functions are divided is
the aim was to assess the blood safety strategies of a low human guided by the strategic thrust for the period and the turnover (for
development (LHD) index, Zimbabwe, which is ranked 172 out of Sanquin) hence these fluid structures allow the Services to respond
187 and a very high human development (HHD) index, Netherlands, to varying needs and adjust operations accordingly. Currently
which is ranked 4 in the world.3 The focus is to understand the Sanquin is undergoing centralisation and this may demand further
blood safety strategies and determine the driving forces pushing merging/demerge of divisions. NBSZ, on the other hand is seeking
or threatening sustainability of these Services in their settings. This possible options for regional Plasma Contract Fractionation of
study recognises that the socio-economical environment of these its blood products, which may raise the question of a separate
Services differs substantially and hence restricts the analysis of the collection facility and donor panel for collection of high quality
strategic options available for optimising blood services, which and adequate plasma volumes suitable to meet international
may be not be applicable to both settings. standards required by Regulators for acceptance by an approved
fractionation facility. The idea of corporate staff/services for the
METHODS over-arching staff is one that may be worth considering for NBSZ
A study visit was undertaken to Sanquin Blood Supply in The so that the departments are streamlined into key business units for
Netherlands in February and March 2014. A transfusion clinical the main business focuses.
internship was conducted at Martini Ziekenhuis / Hospital, There is a shared need to engage and constantly inform stakeholders,
Groningen, Netherlands. The findings from this study visit were as demonstrated by existence of the informative, interactive and
compared with equivalent data from National Blood Service educative websites of both Sanquin and NBSZ. This is a good practice
Zimbabwe (NBSZ). The data used was obtained through key that needs to be maintained. On both websites annual reports4,5
informant discussions with executives and senior staff at Sanquin of the Services are available, which allows interested stakeholders
and review of the annual performance data as reported in Sanquin easy access to relevant donor and blood safety information. The
annual reports, which are publicly available.4 Similarly, data from media is strongly engaged in both settings, which helps to promote
NBSZ is publicly available from annual reports5 and author’s the Service’s brands. This high level of transparency is crucial to the
experience and knowledge of working and interaction with NBSZ. sustainability of these services, which depend on voluntary non-
Data was collected using Excel spread sheet and then analysed. Key remunerated donors and public perceptions.
thematic points were summarised from the review of the reports The emphasis on blood safety for both the donors and patients
as well as the outcomes from key informant discussions. Lessons is at the heart of the organisations as indicated in their mission
learnt and recommendations were drawn for each thematic area statements, vision and core values.4,5 There is recognition in
considered. both settings that cost-effectiveness should be at the core of
operational considerations. Sanquin is aiming to cut cost by 6%
KEY FINDINGS by 2015 (11.6 million Euro) through centralisation and operations
Description of settings realignment (staff rationalisation) due to the declining trend in
Sanquin Blood Supply Foundation is a not-for-profit organisation blood usage. NBSZ is pursuing similar cost cutting measures though
responsible for blood supply in The Netherlands, which has an the performance of the cost containment committee needs to
area size of 41,526 km². The same is true for NBSZ, which has a be strengthened as this same trend is taking place in Zimbabwe,
national mandate to provide all blood requirements in Zimbabwe where demand is declining. Though the declining trend in the
and which area size is 9.4 times more (390,580 km²) than that of demand and clinical use of blood is similar, the underlying factors
The Netherlands. The country size difference, communication and may be different. In Zimbabwe it is mainly due to availability and
infrastructure present differing challenges for blood donor access affordability and the financially constrained healthcare system;
to donation sites and hospitals blood accessibility from respective whereas in The Netherlands, this is attributable to continuing
distribution sites. The population of Netherlands is 16.7 million, education of clinicians on appropriate clinical use of blood and
the majority of who are adults, which is 27% higher than Zimbabwe effective haemovigilance. This area of clinician’s education and
population at 13.1 million, who are predominately youth. These training is important and NBSZ is in the process of rolling out
population structure differences also pose different challenges in education and training, within the current financial limitations. It
blood safety programmes. was noted that in The Netherlands, although there is decline in
the demand and use of red blood cells, there is an increase in the
Management and Organisation demand and use of plasma derived medicinal products (PDMPs).
Both Services are similarly structured with Boards in place This change in patterns of use requires a review of structures and
(Supervisory Board for Sanquin) and Executive Management functions in a more cost-effective organisational and management
Committee (Executive Board for Sanquin). The Boards have the model. One model could be to consider collection of sufficient
overall responsibility for monitoring the organisation’s operations. quality plasma to meet national needs through plasmapheresis of
There are Board sub-committees in both settings. Sanquin has source plasma.
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Africa Sanguine September 2014, Volume 17, no. 1
Donor mobilizations and blood collection On average 10% of donors are new donors in Netherlands
NBSZ and Sanquin rely on 100% voluntary non-remunerated blood compared to 44% in Zimbabwe. This large disparity is due to the
donation as recommended by WHO1 to meet National requirements fact that in Zimbabwe, about 70% of collections come from donors
of labile blood products. Meeting the National requirements for aged 16-20 years old. These are highly mobile donors hence the
PDMP from recovered plasma used for fractionation, that is plasma loss rate is high. This also affects donor retention as discussed
recovered from whole blood donations and used to produce earlier. The donors in Netherlands starts donating at 18 years and
PDMPs, has reportedly fallen short in nearly every country in the are mainly composed of adult donors who are stable hence easier
developed world and may presently not be feasible in low income to retain. NBSZ need to pursue its strategy to re-align the donor
countries. Annually, Sanquin, collects blood from approximately base to a more sustainable structure balanced on youth and adult
400 000 donors, compared to approximately 50 000 active blood base. In both settings there are incentive schemes that assist in the
donors in Zimbabwe, as reflected in the data collected between retention of donors and these need to be maintained. The desire
2009 and 2012. Over the same period, the annual whole blood for Netherlands to increase youth donors may benefit from the
(WB) donations in Netherlands averages 540 000 from this donor NBSZ pioneered successful youth projects that consist of the peer
base, compared to 60 000 units from the donor base in Zimbabwe. promoters and the Pledge 25 Club that has since been copied all
This results in 24 donations per 1 000 inhabitants in The over the world.6,7
Netherlands and 4 donations per 1 000 population in Zimbabwe. The blood safety measures for the new donors are comparable.
WHO’s estimate for national blood adequacy is 10 donors per In Netherlands all new donors undergo medical examination first
1 000 inhabitants. If Zimbabwe were to adopt the guideline and a sample is provided for transfusion transmissible infections
recommendations set by WHO, this would result in unacceptable (TTI) testing and blood typing. If a donor is cleared from this initial
expiry of blood and a drain on limited financial resources. NBSZ assessment, then they are called within two weeks to provide their
is currently developing strategies to ensure a sustainable national first-time donation. In Zimbabwe, new donors are risk profiled
blood service, which can provide a safe, accessible, adequate and historically based mainly on age at donation. New donors aged
affordable unit of blood and at the same time address the goal 16-20 and those above 45 years provide usable blood. For those
of working towards developing a model for sourcing plasma using donors aged 21-44 years old, an unusable blood is collected (a
plasmapheresis in order to meet international standards of safety blood pack without anti-coagulant).8 In both settings these are
and sufficient volumes for contract fractionation. A blood donor all measures to safeguard blood supplies and informed by risk
in Netherland donates at least 1.6 units of WB annually versus 1.8 considerations and settings practicalities. In Zimbabwe where 80%
units in Zimbabwe. This frequency is interesting, as it provides an of donors are at mobile clinics and the mobile drives might be
impression that donor retention in Zimbabwe is higher than (or about 300km, the Netherlands blood safety management model
at least comparable) to Netherlands. However when one looks at may be difficult to implement. These variations based on the
other retention measures then the apparent differences become need to optimise blood safety have the inevitability of resulting
clearer. If the percentage of repeat donors per year is examined in different definitions of new donor or first-time donor. One may
more closely, it becomes apparent that in the Netherlands this argue that the first-time donation in Netherlands is not really
is approximately 90% versus 56% in Zimbabwe. On average, 53% ‘first’ as logically this is a ‘second’ interaction with the donor. The
of donors in Zimbabwe provide at least two usable units and the statistical challenges that arose from this scenario are obvious.
corresponding figure from Netherlands was not readily available It will become critical then that further definitions to capture
from the Annual Reports (but presumed to be greater than 80%). these variations are developed and reported on so that there will
Further, in Zimbabwe the year-to-year donor retention is on be consistence and comparability of data definitions in different
average 34% and the corresponding data is not readily available settings.
for Netherlands (but presumed to be greater than 80%)
Donor retention is a critical indicator of donor management and Blood processing and testing
each Blood Service should attempt to use a standard definition. In both settings there is production of components that includes at
This assessment indicates that to use only average donations as an minimum RBC, FFP, Cryoprecipitate and platelets. The production
indicator of donor retention may be inappropriate especially when systems are comparable, but in Netherlands the product lines are
there is need to compare different settings. It may be worthwhile quite varied compared to Zimbabwe. This gives patients more
for Sanquin to consider to expand their donor retention measures choice of available products.
and report on these as explained above. There is testing of the four TTI markers (HIV, HBV, HCV and Syphilis)
In Zimbabwe donations are either WB or apheresis for platelets universally recommended by WHO.9,10 NAT is used in Netherlands
(about 150 annually). In Netherlands there are WB, apheresis and in Zimbabwe 4th generation serological testing technology is in
(plasma and platelets) donations (about 325 000 annually). Due use. Additional test are done in Netherlands including HTLV, which
to lack of plasma market in Zimbabwe the majority (75%) of this is since 2013 is only being tested in new donors as a cost-containment
discarded and this is despite the fact that there is severe shortage measures which is also informed by the fact that the production
of plasma derivative products in Zimbabwe. Concerted efforts process reduces the infection level substantially. This is important
are need in Zimbabwe to ensure that plasma is used for plasma as the available best evidence guides operations. ABO and Rhesus
derivative production to help the need patients in Zimbabwe typing are done but there is more extensive typing in Netherlands.
and we note that NBSZ alone has no capacity to address this The donor blood group distributions are comparable with Sanquin
problem as it needs to meet the good manufacturing practice having 48%, 39%, 9% and 3% (NBSZ, 52%, 25%, 20%, 5%) for O, A,
(GMP) requirements for the plasma supply. This would require B and AB blood groups respectively. There is more typing (forward
the involvement of Government of Zimbabwe and all international and back typing) of new donors (sample have different cap colour,
partners. There is an opportunity for NBSZ to expand apheresis also multiple sample sources are used) in Netherlands and this
services further for patient management as observed at Sanquin. substantially reduces blood group discrepancies for the donor
This will be additional possible source of revenue and also helps to current and future donations.
maintain the staff skills.
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Africa Sanguine September 2014, Volume 17, no. 1
Zimbabwe may need to consider this Netherlands approach to Sanquin delivers blood to hospitals in contrast to Zimbabwe where
reduce the current high number of blood group discrepancies that hospitals are responsible for their own blood collections. It has
has been observed. In both settings, testing is centralised at one been argued that the Netherlands supply system may not be cost
facility and this ensures similar testing quality standards nationally. effective as indications are that hospitals may not be strategically
The prevalence of four universal TTI markers in donated blood ordering blood to minimise delivery trips as Sanquin bears this once
averages (2005-2012) per 100 000 for new (n) and repeat (r) donors off cost. Mechanism to enforce hospital to make structured cost-
as follows in Netherlands for Syphilis (n=31.9, r=2.8; Zimbabwe, effective ordering schedules may be required in the Netherlands.
n=411.1, r=194.4); HCV (n=17.1, r=0.2; Zimbabwe, n=190.1, r=84); In both setting the cost of blood and blood products is an issue that
HBV (n=52.1, r=1.6; Zimbabwe, n=1645.4, r=366.7); HIV (n=3.8, attracts political, media and public scrutiny. The principled position
r=0.5; Zimbabwe, n=681.2, r=229). It is important to note the that has been taken by the Services, which are commensurate with
serological testing algorithms are similar, however in Netherlands the expected level of blood safety, needs to be maintained. Blood
there is use of NAT and there is confirmatory testing using western safety should be the main considerations first and how this can be
blotting and PCR. In Zimbabwe, the confirmation is done using financed will be a matter of all partners’ engagements.
an alternative but comparable (sensitivity) testing assay. Despite
the general population epidemiological differences of these TTIs Quality Assurance
in both settings, the donations testing results may also need to In both settings quality assurance is at the forefront of operations.
be cautiously interpreted taking these testing variations into Formal quality recognition is being pursued or maintained at these
considerations. It was noted that the issue of indeterminant Services. It was noted that Sanquin ceased its formal recognition
results is prevalent in both settings. Consecutively (three of ISO 9001 on quality management systems partly because of cost
times) indeterminant donations from the donor would result in considerations and the need to be guided by EU directives, which
permanent donor deferral in Zimbabwe and in Netherlands an are continuously monitored by government. It remains a point of
indeterminant results from a new sample collection would lead to discussion on whether formal quality management systems being
the permanent donor deferral. The challenges of communicating pursued in Zimbabwe need to be maintained or focus should
the indeterminant results and deferral decision to donors are be directed to meet applicable GMP requirements for blood
similar but keeping them on donor list would waste resources establishments that has the potential of opening plasma market
as indeterminants will still ‘pop-up’ and products are unusable. opportunities in Zimbabwe.
NBSZ current efforts to do further research on indeteminants may There is strong emphasis in both settings that quality management
draw lessons from Sanquin experience which do the confirmation system should be embraced and owned by all staff. We noted the
and still the donor results remains indeterminant. Under those organisational management differences with respect to quality
circumstances, the logical decision for NBSZ is pursue and maintain management systems that might need to be considered further.
its permanent deferral policy. In both setting, post-donation
counselling services are provided. In Sanquin, medical doctors and Research, Education and Training
state registered nurses do this and counselling partners are used The quest for evidence based decision-making process in both
in Zimbabwe. settings is noted through their vibrant research programmes.
In the Netherlands, the non-serological discard rate is 0.2% Sanquin research program is more mature and has outputs at high
and 0.4% (2012) for the serological waste. This is in contrast to levels with 12 PhD theses and 175 peer-reviewed publications just
Zimbabwe where the non-serological discard can be as high in 2012. The current transfusion research capacity (T-REC) building
as 8% and serological wastage is around 1.7% (2012). There project in which NBSZ is a partner is increasingly building a strong
are opportunities to further reduce the discards in Zimbabwe base for scientific research and these needs to be maintained. It
especially on the non-serological discards to the below 2% was noted that NBSZ need to promote its research outputs more
threshold recommended by WHO as blood expiries constitute the through say highlighting these on its website and systematically
bulk of the non-serological discards. The high serological discards evaluate how past research efforts have been used to strengthen
in Zimbabwe might be a reflection of equally high TTI prevalence blood safety policies in Zimbabwe.
in the general population especially for HIV and HBV despite all Sanquin has various training programmes in place both internally
the stringent pre-donation selection interviews. It is important to and collaboratively. There is need to maintain contact on training
note that in Zimbabwe the discard rate for HBV is twice that of opportunities in both settings especially on the masters programme
HIV, which may be a reflection of either a high general population that is being developed for donor health management. Continual
HBV prevalence (not well studied) or that the current risk factor sharing of resources and experience will also assist both Services
exclusion is not very effective for HBV or perhaps its the testing to appreciate the emerging trends in blood safety.
HBV dynamics. This demands further understanding of whether
this can be reduced further. Information/Data Management Systems
Both settings use commercial information management systems
Distribution of blood and blood products to manage blood banking data (eProgressa in Netherlands and
In both settings there is inventory management system in place. eDelphyn in Zimbabwe), which is available on wide area network.
There is opportunity to use distribution data to inform blood There are other complementary databases in use in Netherlands
collections on shorter periods in Zimbabwe and this will help to for Hemovigilance, laboratory testing and quality management
moderate supplies to avert wastages and intermittent shortages. systems that are linked through servers for data sharing and
Having a dedicated logistics inventory management appointment repositories. There is opportunity for NBSZ to consider such other
might be useful in Zimbabwe to strengthen this area as observed complementary databases, which may assist mainly in hemovigilance
in Netherlands. The Sanquin Blood Supply cold chain consists of and quality management systems (strive towards paperless).
simple to use but effective cold chain equipment consisting of Given the huge amount of data the Services generate, it was a
cooler boxes, cooling trays and packs. Such simple low-cost may be discussion point on whether the data management/use can also
considered in Zimbabwe settings. be enhance through a data management function that would assist
all departments in Sanquin as is the current position in Zimbabwe.
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Africa Sanguine September 2014, Volume 17, no. 1
Clinical transfusion medicine • Enhance education and training and follow-up on the outputs
In both settings clinical blood transfusion is guided by the blood from these initiatives.
transfusion guidelines. It was noted that in Netherlands all key • Intensify cost-recovery measures for the blood banking
stakeholders jointly author and publish these guidelines and this operations. Initiatives like the EU / UNICEF coupon systems
enhances ownership and compliance to the standards. The Martini that adds directly to the procurement of the blood products
hospitals have its own transfusion management system that is further recommended to be vigorously pursued. This is
handles internal blood orders and for blood stock management. This important in view of the cash-constrained public sector.
hospital system is not yet linked with Sanquin blood information • In line with its innovation aspirations, this needs to be
management system and orders are made through fax and phone strengthened further so that there is documented evidence of
as necessary. For this hospital, it manages its own blood deliveries innovation products.
from Sanquin and there was evidence of continual engagement • NBSZ to pursue avenues for Plasma Fractionation at various
of the hospital and Sanquin. NBSZ is pursuing options of linking levels (region & WHO).
hospitals to its e-Delphyn blood bank management system and • NBSZ to intensify its support engagement and place strongly
engagement with hospitals are continually being strengthened. the patient at the forefront in order to strengthen its GMP call
Martin hospital for 2013 had 5 189 red blood cells transfusion, for support. As NBSZ it is primarily there for the need patients
276 platelets and 395 fresh frozen plasma almost equivalent to hence this should form the basis of all strategic engagements.
the capacity of referral hospitals like Parirenyatwa Hospital in • Strengthen Hemovigilance system with hospitals and ensure
Zimbabwe. The hospital information management system allows that that there are service level contracts.
analysis of blood usage data as needed and this is currently a
challenge in Zimbabwe as most hospitals do not have such shared Key areas for Sanquin to consider consolidating:
systems in place. The introduction of electronic temperature • Broaden the definitions of donor retention calculation and
management tags allowed about 29 red blood cells to be saved in report these.
2013 after non-usage from the ward based on 30-minute rule. The • Maintain a strong collaborative focus with other blood services
existing surgery list that suggests how many blood units are to be and organisations internationally. This will allow further
reserved for each planned operation. This greatly helps in stock developments in blood safety programmes.
management. • Pursue and provide strategic leadership internationally on
The hospital has a hospital transfusion committee in place how plasma derivatives may be made available affordably to
with participation of Sanquin blood supply staff. All transfusion resource-constrained settings.
reactions are reported to TRIP through the established forms. • Introduce a data management function at corporate level to
The mature HTCs programme in Netherlands can be useful as a coordinate all data repositories and ensure this feeds into the
learning point for Zimbabwe to strengthen blood bank and clinical monitoring and evaluation systems of Sanquin.
transfusion interface. It was noted that blood service having service • Review cost-effectiveness of blood delivery system to hospitals
level agreement with hospital is critical to ensure interaction and
cooperation of the parties. REFERENCES
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