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University of Groningen

The current hospital transfusion practices and procedures in Uganda


Kajja, Isaac

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Kajja, I. (2010). The current hospital transfusion practices and procedures in Uganda. Groningen: s.n.

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Chapter 1 Introduction

1.1 INTRODUCTION

The safe and adequate supply of blood, its components and plasma products is indispensa-
ble to a variety of medical disciplines. These products are administered for corrective and
supportive purposes in patients who cannot benefit from any other treatment modality
other than hemotherapy. They correct illnesses presenting with bleeding disorders and
support restoration of oxygen carrying and release capacity of blood in anemic patients.
The principles of hemotherapy if well adhered to constitute an appropriate use of blood.
These include estimation of blood and blood component risks against benefits using the
best available evidence (decision making), proper identification of the causes of deficiency
of a given blood product (diagnosis), administration of the only component(s) which is (are)
deficient (optimal blood use), ensuring that the administered component is as safe as pos-
sible and monitoring of the outcomes (beneficial or adverse) of a blood transfusion. [1-3]
The world over, there are variations in appropriate blood utilization between institutions,
clinical settings in a given institution and between prescribing clinicians. This is due to
lack of guidelines on blood usage or lack of availability of blood components. Cost concerns,
inadequate education and training for prescribers lead to neglect and under-use of transfu-
sion alternatives like crystalloids and colloids. [4]
To minimize the irrational and inappropriate use of blood, it is necessary to establish a na-
tional transfusion policy which will streamline education programmes, lead to formation
of functioning hospital transfusion committees with authority to enforce guideline imple-
mentation, conduct clinical audits and ensure in-hospital hemovigilance. Improved trans-
fusion practices could also be strengthened by mandatory documentation of all
transfusion procedures and processes. This forms a basis for analysis of similarities and
differentials in institutional blood use. These findings lead to well analyzed transfusion re-
quirements, and use of well researched peri-operative transfusion schedules for the vari-
ous elective surgeries performed by a given institution. [5]
This thesis is based on research on the processes and procedures of the in-hospital transfu-
sion chain in Uganda. It starts with a baseline review of transfusion practices in a large na-
tional referral hospital affiliated to Makerere University College of Health Sciences,
Kampala with an aim of identifying the strengths, weak points, threats and opportunities
(SWOT) to improve the in-hospital transfusion chain. Challenges to the transfusion chain
in this hospital are in three distinctive processes; the blood ordering process, the blood se-
lection process and the bedside transfusion process. These include shortage of well trained
staff in the clinical and laboratory areas, irregular supply and use of poor quality test mate-
rials in the laboratory, inappropriate cold chain facilities, irregular supply of blood and
blood products from the distributing regional blood bank, giving unnecessary transfusions
despite overt shortages, and lack of well established and accountable in-hospital adminis-
trative structures charged with transfusion issues. Additionally, there are shortcomings in
documentation at the three clinical transfusion steps. The identified weaknesses at each
critical point in the chain are further explored to identify opportunities and strategies for
improving the quality of practices, safety and adequacy of blood supplies.

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Therefore, this thesis explores the administrative issues, practices and knowledge of Ugan-
dan clinicians as regards the informed consent process in blood transfusion. It gives an ac-
count of the design and compliance to the currently used blood request form in Mulago
Hospital. It explores the perceptions and opinions of clinicians and blood bank staff on fac-
tors affecting communication of in-hospital blood needs to blood banks. It points out the
weaknesses in the procurement and processing of blood by the Regional Blood Banks. It es-
tablishes the amount of blood loss in one of the commonly performed muscular-skeletal
surgical procedures in Uganda’s National Referral Hospital, open reduction and internal
fixation of femoral shaft fractures. It further provides evidence that the use of the surgical
blood order equation in ordering for peri-operative blood in surgery of femoral fractures
greatly protects patients from over-exposure to allogeneic blood products.
The research involved a mixed methodology approach in which qualitative and quantita-
tive methods were used, each answering specific research questions. The findings of this
thesis highlight the opportunities to address issues of blood safety and rational use of
blood products as emphasized by the 1975 first World Health Assembly resolution on the
utilization and supply of blood and blood components. [6]

1.2 LITERATURE REVIEW

1.2.1 Introduction
In-hospital transfusion practices can only expose safe blood products to patients if they are
based on the principles of a quality system and its essentials (QSEs). These are:
> organization management which is responsible for the development and implementa-
tion of the quality policies, define processes and procedures, and describe jobs for the
concerned staff.
> setting quality standards to ensure consistent and safe practices.
> documentation; which take the forms of informative documents like quality manuals,
instructive documents like standard operating procedures (SOPs) of taking a pre-trans-
fusion sample and documents that allow traceability of various procedures like a blood
request form.
> training of all hospital staff whose routine activities involve blood transfusion.
> periodic assessment of process, procedures and available resources.

Used appropriately blood saves lives and improves health. However, there are variations in
practices among clinicians and laboratory staff as regards the transfusion processes. This
lack of standardized practices leads to inappropriate use of blood and blood components in
some situations and compromises blood safety in others. [7, 8]
Safe transfusion therapy depends upon an interrelated series of processes; the blood order-
ing process, the blood selection process and the bedside transfusion process. Each of these
processes contains a number of steps, critical control points (decisions), which call for doc-
umentation in order to ensure quality practices. [8]

1.2.2 Blood ordering process


This takes place at the bedside. It follows a sequence of events that eventually guide the
hospital transfusion laboratory to select an appropriate blood component for the patient
(figure 1).

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The critical control points of this process include:


> establishing the diagnosis,
> a clear definition of the indication for hemotherapy,
> seeking and documentation of an informed consent from the intended blood recipient,
> establishment of the details of the required blood product with due consideration of
transfusion alternatives,
> effecting the order by documenting the above information on a well designed blood re-
quest form, accompanied by drawing a pre-transfusion cross-match sample and
> proper documentation and transportation of the pre-transfusion blood sample to the
laboratory for appropriate compatibility testing.

Each institution ought to establish guidelines on the documentation of the above critical
control points. This should include:
> documentation of the diagnosis in the patient’s file
> provision of an appropriate blood request form, based on a standard operating proce-
dure (SOP), onto which the details of the order are documented.
> documentation, in the patient file of the intended intervention and expected outcome of
the transfusion.
> a clear and concise labelling of the sample to avoid confusion and errors (wrong blood
in tube)

Figure 1 Flow chart of the ordering part


Patient File
of the in-hospital transfusion chain Patient diagnosis
diagnosis
(ward to laboratory)

Indication
setting

Patient File
Decision making
decision to
What, how much,
transfuse
when, how long

Yes
Alternative? No transfusion

No
Patient file
expected outcome

Ordering/request
Blood Request
Form

Sample taking and


labeling

Transport to
Laboratory

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1.2.2.1 Diagnosis of patient: is there a need to transfuse?


The clinical and laboratory assessment of a patient provide the basis for any hemotherapy.
Based on existing knowledge, the prescribing clinician develops scenario’s like anticipated
massive blood loss in an elective surgical procedure, impending multiple organ damage,
diminished oxygen carrying and delivery capacity of blood, need for prophylaxis or treat-
ment with haemostatic and coagulation factors. He accompanies these impressions with
appropriate laboratory tests, thus determination of hematocrit or hemoglobin levels con-
firm clinical indications on red blood cell needs while assessment of fibrinogen level, inter-
national normalized ratios (INR), active partial thrombin time (APTT) and platelet counts
and function tests would confirm clinical indications that require hemotherapy with coag-
ulation factors and platelet concentrates. [9-12]

1.2.2.2 Indication setting: what is the need?


Blood and blood product are collected from healthy donors after conducting an appropriate
selection procedure and special clinical laboratory tests. The blood components that are ac-
cessible in most developing and developed countries include whole blood (WB), red blood
cell concentrates (RCC), platelet concentrates (PC), frozen fresh plasma (FFP) and cryopre-
cipitate (CP). Other components that are not yet available in many transitional and low
human development index (HDI) countries, include apheresis derived components, leuko-
cyte reduced and irradiated cellular blood components and plasma derivatives such as Fac-
tor VIII concentrate, albumin and immunoglobulins. [5]
The red blood cells are indicated in the management of anemia in normovolemic patients to
improve oxygen carrying and delivery capacity and in exchange transfusion of newborns.
They should not be administered when the clinical condition allows use of other methods
of anemia treatment (iron substitutes, folic acid, vitamin B12 and erythropoietin). [9-11]
Platelets are indicated in thrombocytopenia (following massive transfusions, following
treatment regimes of antibiotics or antifungal drugs, irradiation or cytotoxic chemother-
apy). They are also indicated in congenital or acquired thrombocytopathies and in special
surgical conditions like neurosurgery. [12-14]
Fresh plasma (frozen and thawed) should be administered in multiple coagulation deficits.
It should not be used as a source of nutritional proteins or as volume expander in prefer-
ence to colloids or crystalloids. [15, 16]
Cryoprecipitate is indicated when there is a deficiency in specific clotting factors like Factor
VIII and von Willebrand Factor, in fibrinogen deficiencies and in disseminated intravascu-
lar coagulation (DIC). [17, 18]

1.2.2.3 The decision to transfuse or to use alternatives


In elective surgery, the decision to transfuse whole blood or any blood component is based
on estimates (anticipated blood loss, blood volume, haemoglobin and haematocrit esti-
mates, cardiopulmonary and circulatory ability to deliver oxygenated blood to the periph-
eral tissues and their ability to extract the oxygen). [7] With all these uncertainties clinicians
are bound to err. It is therefore plausible to apply guidelines in the decision making process
to assist the prescribing clinician in the optimal and appropriate use of blood. In order to
achieve acceptance and adherence to guidelines each country should generate its own
guidelines and these can later be harmonized at national and international consensus
meetings. [7, 19]
Eindhoven et al. [20], designed guidelines on perioperative transfusion which were evaluated
with a case-control study in patients undergoing elective primary total hip replacement in

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two hospitals, one with cases (using the guidelines) and the other with controls (using the
hemoglobin and hematocrit basis for transfusion). The new guidelines led to reduction in
the use of allogeneic blood and a decrease in the number of patients transfused in the hos-
pital with cases compared to the hospital with controls.
This compares well with the work of Yeh and co-workers [16] who prospectively analyzed
transfusion requests and then repeated the audit three months later after the clinicians
had undergone education on new transfusion guidelines. They found that there was a
74.6% decrease in frozen fresh plasma usage and a 50% decrease in inappropriate request
form writing.
The above two situations show that a guided decision making process greatly improves
blood usage and provides an opportunity to the prescribing clinician to make use of trans-
fusion alternatives as the situation warrants.
Nadia Rosencher et al. [21] in their study to assess blood management in elective orthopedic
surgery in Europe found that an accurate choice of a blood conservation strategy before the
surgical procedure reduced the risk of exposure to allogeneic blood and improved the cost
effectiveness of the selected method (pre-deposit autologous donation, acute normo-
volaemic haemodilution, cell saver or post-operative blood salvage).

1.2.2.4 Informed consent:


Blood transfusion like any other medical or surgical intervention carries potential risks to
the patient and has expected benefits. Patients therefore need to be informed of the reasons
for an intended blood transfusion so that they can consent to it. True informed consent is
only possible for elective or planned transfusions but not for emergency transfusions. [22]
The patient, or guardian, must be given sufficient information to make an intelligent
choice. This means that the patient should be competent and free to agree or to disagree to
a transfusion. [23, 24] The informed consent is a process not a single event [25] and consists of:
> providing the information on the expected benefits and potential risks.
> providing an opportunity to the patient to ask questions
> offering alternatives
> advising the patient without coercion.
> documentation of the consent or refusal to the proposed intervention (transfusion).

There are, however, contentious issues in the above process. According to the Canadian ex-
pert working group in their guidelines for red blood cell and plasma transfusions for adults
and children [19] consensus was reached on some issues related to obtaining informed con-
sent. They agreed that health care workers should inform patients about the possibility and
likelihood of blood transfusion, and solicit and answer questions that patients might have.
However, they failed to agree on the need to discuss allogeneic transfusion alternatives
during the consent process, given their inconsistent availability and varying effectiveness
in averting allogeneic blood exposure.
Rock and co-workers [26] in their retrospective review of 1,005 patient charts, agreed that the
patients had the right to a transfusion informed consent. However documentation of this
process was found in only 13.2 percent of the charts.
Another issue of great concern in the informed consent process is how much information
should be provided to the patients. Holland and Schmidt [27] indicated that, at a minimum,
patients should be provided with all the reasons for a transfusion as well as the alterna-
tives and risks stating that any complication that would occur with a frequency of
one percent or greater would be considered frequent and therefore should be disclosed.

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Further requirements to inform the patient are found in the recommendations of Justice
Krever from the Commission of Inquiry on the Blood System of Canada [28] where it is re-
quired that after treatment the patient is informed by the physician about the particular
blood component that was used.
Other issues that have not been resolved internationally and therefore remain to be regu-
lated by the local legal or ethical structure include the age of consent, the issue of a third
party in case of a language barrier between the clinician and the patient, the will of the un-
conscious patient as regards transfusion, religious obligations in a minor patient and cul-
tural forces in the decision making process.
In-service training, lobbying of clinical transfusion practices and instituting appropriate
monitoring systems leads to tremendous improvement in the informed consent process.
Saxena et al. [29] showed an improvement on consent documentation from 80 to 100 % over
a period of 5 months having employed a team of trained nurses to carry out the process of
seeking consent from blood recipients in that period.
The dispensation of an appropriate informed consent is based on well designed protocols
that spell out the responsibility of the clinician for seeking, timing, frequency of, documen-
tation of, and the environment in which informed consent should be sought. [30]

1.2.2.5 Blood loss at surgery


Many elective surgical procedures are accompanied by peri-operative blood loss necessitat-
ing intra-operative or post-operative transfusion with RBC alone to improve oxygen carry-
ing and delivery capacity or RBC plus plasma products and platelet concentrates as it
demands in massive transfusion. [17]
Careful assessment and management of patients prior to surgery will reduce peri-operative
morbidity and mortality in situations of restricted transfusions. This includes identifica-
tion and treatment of anemia, identification, stabilization or treatment of medical co-mor-
bidities, and identification and treatment of pre-existing bleeding disorders. [3, 4]
It is also important for each hospital to institute and facilitate methods that will minimize
peri-operative blood loss. These include use of anti-fibrinolytic drugs, employing appropri-
ate anesthetic techniques for particular surgical procedures, use of vasoconstrictors, use of
meticulous surgical techniques, use of pre-deposit autologous blood in carefully selected
patients, and appropriate positioning of patients during and after surgery. Additionally, a
significant amount of surgical blood loss can be tolerated as long as normovolaemia is
maintained with intravenous replacement fluids (colloids or crystalloids). [4, 7]
Many elective surgical procedures rarely require transfusion. However, for some major pro-
cedures, notably orthopedic or cardiovascular, blood should be ordered and made available
in advance.
Peri-operative orders and use vary between hospitals and individual clinicians due to dif-
ferences in surgical and anaesthetic techniques, attitudes to use of blood, cost and avail-
ability of blood products or transfusion alternatives. Therefore, it is important for each
hospital to scientifically evaluate the blood losses during the commonly performed surgical
procedures so as to guide the clinicians in making appropriate and evidence based orders
and hence maximize logistics allocated to blood preparation laboratories. In order to meas-
ure blood loss at surgery, [31-33] two methods can be used – the direct and the indirect meth-
ods. The direct method involves measuring collected blood in swabs, drainage bags and
suction bottles, while the indirect method measures blood loss by hemoglobin or hemat-
ocrit changes over the peri-operative time. It should be noted that the direct method does
not cater for blood hidden is draping linen, in the suction tubes or evaporations during sur-

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gery. On the other hand, the indirect method is a simple, inexpensive and non-invasive
method as long as the post-operative hemoglobin or hematocrit is measured in a normov-
olemic state.

1.2.2.6 Peri-operative Blood Order Schedule


Unlike emergency situations, planned surgical procedures provide an opportunity to insti-
tutions to come up with maximal surgical blood order schedules (MSBOS) for the various
operations. Reports show that a substantial amount of blood given intra-operatively and
postoperatively is transfused following demonstrable anemia. [34, 35] Preoperative cross-
matching of blood units for surgical patients is performed in anticipation of a potential
need which may not materialize and consequently many blood units cross-matched before
surgery are never transfused. [36] This leads to wasting of blood bank resources like increas-
ing the blood inventory that must be maintained, and unnecessary cross matching. It also
increases the number of units that become out dated and therefore wasted.
A maximal surgical blood ordering schedule is a guide to expected normal blood use for
elective surgical procedures, which lists the number of units of blood to be routinely cross-
matched or grouped, screened and held for each procedure preoperatively (WHO definition). [7]
The development and use of a maximal surgical blood ordering schedule enables the iden-
tification of surgical procedures that can be accommodated by the institutional human and
laboratory resources. [7, 8, 19] It also leads to:
> reduction in unnecessary compatibility testing.
> reduction in the returns of unused blood.
> reduction in wastage due to outdating
> more efficient management of the blood inventory.

The WHO [7, 19] recommends that each Hospital Transfusion Committee (HTC) develops a
maximal surgical blood ordering schedule for its elective surgical procedures in accordance
to national guidelines. This should involve, though over time, an evaluation of blood use
compared with blood orders for particular surgical procedures. It leads to establishment of
institutional cross-match-to-transfusion (C/T) ratios that save allogeneic blood while pre-
serving patient safety. The current Ugandan National Blood Transfusion Policy [37] does not
address this component.

1.2.2.7 Surgical Blood Order Equation


Nuttall et al. (36) retrospectively analyzed the predictors of perioperative red cell require-
ments in patients undergoing major orthopedic procedures and used these variables to de-
velop the surgical blood order equation (SBOE). The SBOE [38] is as follows:

Hemoglobin lost – (preoperative hemoglobin – minimal acceptable hemoglobin)


= Units required at surgery.

Values that are negative or less than 0.5 units are assigned an order to type and screen
blood only and values between 0.5 unit and less than 1 unit are rounded off to 1 unit.

Advantages of SBOE;
The SBOE has the following advantages [39]
> it maximizes the efficiency of blood use.
> it predicts the extent of perioperative blood use.

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Nuttall et al. [40] in a prospective double-blind randomized clinical trial compared the
(SBOE), with the maximal surgical blood order schedule (MSBOS) system for ordering allo-
geneic RBC units for 60 patients undergoing total hip arthroplasty and found that the
SBOE was more accurate (58% correct orders) than the MSBOS (7 % correct order, P =
0.0001). The SBOE had a lower cross-match-to-transfusion ratio than MSBOS (0.83 vs.
4.12). SBOE reduced the monetary costs and risks of allogeneic blood. In a related study,
Guenin et al. [41] prospectively evaluated 162 consecutive patients who underwent total hip
and total knee arthroplasty for determinant factors for perioperative blood transfusion.
They found that patient variables (age, weight and preoperative hemoglobin levels) signifi-
cantly determined the quantity of perioperative transfusion. They also found that there was
a considerable clinical and economic reward in using patient-based transfusion protocols
in determining perioperative blood unit requirements.

1.2.2.8 Patient sample collection


From the patient perspective, pretransfusion sample collection for various grouping and
cross matching tests marks the first step on the path to transfusion. Errors in this procedure
can be devastating, because they may lead to ABO mistransfusions and bacteraemia. [42]
Linden et al. [43] estimated that errors in pre-transfusion sample collection accounted for
15% of ABO mistransfusions reported in New York state. In a period of six years (1993 to
1999), Butch et al. [44] reported an unfortunate increasing trend of total laboratory errors re-
lated to patient sample collection from 10 to 20 percent. These errors are usually due to
poor phlebotomy technique, wrong labeling of the drawn samples or improper documenta-
tion of this activity.
Lumadue et al. [45] reported that at Johns Hopkins Hospital, Baltimore one in every 71 sam-
ples was mislabeled and one in every 2,800 was correctly labeled but mis-collected (a prop-
erly labeled tube containing blood of another patient – ‘wrong blood in tube’). This would
have lead to serious hazards if these errors had not been found. Development and adher-
ence to hospital guidelines on pre-transfusion sample collection reduces the frequency of
mis-labeled and mis-collected samples. [46, 47]

1.2.2.9 Blood request form


A blood request form (BRF) is a communication tool between the clinical setting and the
hospital blood bank laboratory, of information about a potential recipient of a blood prod-
uct. It contains the identification details of the patient, the diagnosis and indication setting
for the anticipated transfusion, the details of the currently requested product, history of
any previous transfusions, likelihood of isoimmunisation with Rhesus and other red cell
antigens for female patients in and above child bearing age and the identity of the pre-
scriber. [4, 6] The design of a blood request form has a profound effect on the compliance of
clinicians to this tool. Kajja et al. [48] in their analysis of the design and prescriber compli-
ance to the Mulago Hospital blood request form found that clinicians did not adequately
comply with even the old blood request form in use. A properly designed BRF followed by
training of users to emphasize importance of each section therein, results in improved
blood usage. Hui CH et al. [14] in their study of the impact of a new BRF that had been de-
signed in a self educating style for the prescriber, found an improvement in appropriate use
of fresh (frozen/thawed) plasma and platelets after introduction in a large tertiary teaching
hospital in Australia.

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1.2.3 Blood selection procedure


The blood selection procedure (Figure 2) consists of four steps: reception of the pre-transfu-
sion sample and blood request form at the laboratory, component selection for compatibil-
ity testing and issuing of the blood component. [49]
A properly drawn and labeled sample at the bedside can be messed up in the laboratory in
the following ways:
> wrong specimen used for cross matching
> wrong unit of blood selected for labeling
> wrong unit of blood issued to the ward
> wrong transport conditions of the issued unit of blood to the utility station.

Figure 2 - Flow chart of the selection Lab logbook


Reception at Reception of
part of the in-hospital transfusion chain
Laboratory request + sample
(laboratory to ward)

Sample and No
Contact with ward
Label OK

Yes

Component
selection

Lab patient file


Compatibility Xmatch outcome
No
testing unit numbers

OK

Yes

Transport to ward

There are two critical decision making steps that emerge out of the above four steps which
directly determine the outcome of the whole procedure. These include acceptability of the
sample (integrity and volume, the accompanying patient identity on the sample label) and
the compatibility of the unit of blood.
To guard against errors, documentation is needed for each of the above steps so as to trace
the outcomes of a selected blood component. It is important for laboratories to establish
strict labeling guidelines and procedures for the acceptance or rejection of improperly la-
beled specimens and to consider using procedures that force validation of a ABO/Rh status.
Strict adherence to labeling requirements can significantly decrease erroneous blood
grouping and compatibility testing, and diminish the likelihood of transfusing ABO incom-
patible blood components. [45] The American Association of Blood Banks (AABB) provides

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details for improving the labeling of pretransfusion testing specimens in Guidelines for the
Labeling of Specimens for Compatibility Testing. [50]

1.2.3.1 The cold chain


The maintenance of blood quality from donor to recipient calls for sound storage and trans-
port conditions within the hospital setting. There are several good reasons to ensure opti-
mal storage and transport conditions of the blood components: (i) preserve the biological
function of the constituents; (ii) decrease their metabolic activities; and (iii) reduce bacterial
growth of the blood components.
The transfusion cold chain requires acquisition of equipment like refrigerators, freezers,
agitators and transport boxes. A proper cold chain also requires organization and manage-
ment in an effective way as well as validation, calibration of the equipment, preventive
maintenance and repair, and training of the involved personnel. Last but not least, moni-
toring and continuous assessment are indispensable. Lack of the above quality systems af-
fects the quality of blood.

1.2.4 Bedside administration of blood


The bedside administration of blood process has a number of procedures (Figure 3). It be-
gins with reception of a unit of blood from the laboratory and ends in documentation of the
transfusion outcome. There are critical control points in this process that need to be docu-
mented. These include; unit identity and how these match with patient identity, patient
vital signs before starting the transfusion, time and date the transfusion is started, patient
vital signs and clinical status 15 minutes after starting the transfusion, outcome of the
transfusion and any other actions taken during or after a given transfusion. Neglect or
non-conformance to agreed upon procedures in the above process lead to bedside errors
which may become fatal to the blood recipient. The most commonly reported bedside error
is transfusion of blood to a wrong patient (mis-transfusion) followed by use of sub-stan-
dard facilities and techniques to administer blood to patients leading to bacterial contami-
nation of the product and subsequent bacteraemia to the patient. [42]
Other mishaps include lack of knowledge of what to monitor and of routine practice in
monitoring of blood transfusions, both of which result in undocumented and unreported
transfusion reactions which may be fatal to the patient and disastrous to the entire blood
supply system. [42, 51]
In the more advanced world, Linden et al. [52] estimated the rate of transfusion errors to be 1
in 12,000 in New York. Robillard et al. [53] report that the hemovigilance program in Quebec
identified ABO mis-transfusion as the commonest major adverse event occurring at a rate
of 1 in 13,000 transfusions. Andreu et al. [54] reported similar findings from the hemovigi-
lance program in France.

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Figure 3 - Flow chart of the transfusion Patient File


match with blood
part of the in-hospital transfusion chain Reception at ward
request
(ward)

No Transport to
OK
Laboratory

No Patient
identification

OK

Yes

Patient file
Patient vital signs vital signs

Patient file
Connection; start
start date & time
transfusion

----------------------------------

Patient file
Immediate
observation
observation

Discontinue Patient File


No transfusion Immediate
Ok?
Initiate observation
investigation

Yes

transfusion

Patient file
No Report to
OK? documentation Laboratory

Yes

Patient file
Observation of observation
outcome

Next step(s)

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Other published studies [55-57] have also reported weaknesses in performance of bed side
clerical checks, like matching the blood unit label with the patient wrist band. The factors
put forward to explain these errors include increasing patient to nurse ratios, elimination
of specialty nursing teams responsible for administration of blood, shorter lengths of hos-
pital stays and higher nursing turn over rates [42] These factors however cannot be general-
ized for all settings therefore there was need to explore the Ugandan situation.

In summary, bedside transfusion practice is affected by a number of factors which may be


intrinsic to the clinician like prior medical school training, working experiences or can be
external like availability of continuing medical education, peer recommendations, feed-
backs from hemovigilance teams, administrative support from hospital governance, finan-
cial incentives and patient attitudes and desires. [58]

1.2.5 Hospital Transfusion Committee


A Hospital Transfusion Committee (HTC) is a central administrative forum put forward to
discuss and create links between National transfusion services, Hospital blood bank and
the clinical staff. [59, 60] The creation of HTCs in blood prescribing and administering institu-
tions is a major World Health Organization (WHO) requirement. This serves as an avenue
of promoting scientifically sound transfusion practices at the bedside. [6] Health care insti-
tutions in the United States must review blood transfusion practices and adverse outcomes
in order to receive payments from the Centers for Medicare/Medicaid program. [60] This is
achieved by Hospital Blood Transfusion Committees. Hospital Transfusion committees
have not yet been created in most developing countries, The WHO Global Database on
Blood Safety (GDBS) [5] shows that HTCs are in 88% of the developed countries, but only
33% of the transitional and 25% of the developing countries.

Membership and facilitation of HTC


The creation and activities of a HTC should receive structural and financial support from
senior management at the level of the institutional owners, governing body, board of direc-
tors, or equivalent group. [6, 60, 61]
Committee representation should be from all major medical and surgical departments that
prescribe blood or practice blood conservation technologies (including surgery, anesthesia,
medicine, obstetrics, neonatology, pediatric and hematology). Representation should also
come from nursing services, pharmacy, biomedical engineering, and other supportive serv-
ices including the institution’s main blood supplier. The committee chair should be a physi-
cian who is knowledgeable in transfusion medicine. Committee meetings should follow a
set agenda and be documented by minutes that are submitted to medical and executive
leadership for their review and approval, and are protected from inappropriate ‘discovery’. [62-65]
For example, in California, medical staff committee minutes are protected under Evidence
Code Section 1157 and Government Code Section 6254. [66, 67] Each committee member signs
a confidentiality agreement.

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Roles of a HTC: [64, 65, 68]


Based on locally agreed terms of reference, a HTC is charged among others with a number
of roles.
> generally it sets the hospital transfusion policy and strategies, assesses the existing
situations, designs appropriate improvement strategies, harmonizes these strategies
among in-hospital transfusion stakeholder (departments or clinics) so as to standard-
ize and guarantee consistency of outcome measures.
> it develops and ensures implementation of in-hospital transfusion policy, processes
and procedures.
> it ensures appropriate and timely training of all hospital staff handling and prescrib-
ing blood components. Here, all staff are kept on track in transfusion developments
and safety.

A HTC institutes continuous and periodic blood utilization reviews. This has to be followed
with positive feedback to the concerned staff (departments) to improve blood practices.
The HTC is also charged with performance monitoring and improvement in all steps of the
in-hospital transfusion chain. It should achieve this by doing clinical audits on practices
based on accurate process description and preset standard operating procedures at each step.
The HTC is the central forum for monitoring and evaluation, reporting and staff education
on transfusion outcomes (beneficial and adverse).
It is the duty of a HTC to develop and implement blood conservation and management pro-
grams. This includes emphasis on the use of transfusion alternatives, setting transfusion
triggers in different situations and initiating research to define local peri-operative trans-
fusion schedules in elective surgeries.
The HTC periodically should disseminate its proceedings and any other blood transfusion
developments internally to the in-hospital stake holders (clinicians, nurses and patients)
and externally to the national blood transfusion service.

1.3 PROBLEM STATEMENT

More than 30 years after the first World Health Assembly resolution [6] that addressed the
issue of blood safety, equitable access to safe blood and blood products and their safe and
rational use, still remains a major challenge throughout the world. On one hand, National
blood supplies are rarely sufficient to meet the growing demands in the developed world
due to longevity of life, increasing sophisticated clinical procedures and stringent donor
screening strategies. On the other hand, supply of adequate and safe blood products is still
challenged by insufficient numbers of voluntary non remunerated blood donors and inade-
quate testing in the developing world. Evidence-based strategies for blood safety and avail-
ability have been successfully implemented in most developed countries and some
transitional and developing nations. However, despite the proven effectiveness of these
strategies, many countries are making slow progress towards their implementation. This
will have a direct impact on the achievement of the health-related millennium development
goals (MDG) to reduce child mortality, improve maternal health and combat HIV/AIDS.
Universal access to safe blood transfusion requires strengthening the implementation of
key strategies to ensure access to a safe and sufficient blood supply, to achieve 100% volun-
tary blood donation and to ensure 100% quality-assured testing of donated blood. There is
also need to optimize blood usage for patient health, develop quality systems in the clinical

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transfusion chain, strengthen the workforce, keep pace with new developments and build
effective partnerships. [4]

The World Health Organization GDBS [5] showed that blood donations versus demands re-
vealed a significant difference between low, medium and high HDI countries; 61% of the
global blood supply is donated in developed (high HDI) countries. Only 39% is donated in
the developing (low and medium HDI) countries where 82% of the world population lives.
Differences in blood donation rates largely reflect differences in the level of development of
health care systems in these countries.
Currently blood use in Ugandan hospitals depends on what is supplied. It is not demand
driven as per WHO recommendations. Uganda’s supply of homologous blood is inadequate
compared to the vast and growing medical and surgical demands. This is evidenced from
the statistics of the Uganda Blood Transfusion Service (UBTS) where annually around
170,000 units of blood are collected from voluntary non-remunerated donors. This falls
short of the WHO recommendation of 10,000 units per million population per year by
43.3%, which is an unacceptable situation for a population of 30 million Ugandans.

A review of patient records for the period January 2003 to December 2005 at Mulago Hospi-
tal, showed that 14,028 cold surgeries required peri-operative transfusion but only 7,488
(53.4 %) received at most 2 (two) units of whole blood to effect the procedure. For that period
therefore 46.6 % of scheduled cold surgeries were not performed due to lack of homologous
blood. In Uganda, no work has been done to establish the clinical epidemiology of blood
use. However, according to records from Uganda Blood Transfusion Services (UBTS), the
estimated national requirements of blood by hospitals is 200,000 units annually. Approxi-
mately 50% of blood is transfused to children under the age of 5 years due to severe anemia
in malaria, 25% to mothers due to obstetric hemorrhage and 25% is required by accident
victims and surgical or medical cases. The need for blood is estimated to increase at a rate
of 20% per year as the utilization of health services by the general public increases.

The above mentioned shortages exist in a setting where there is no clear view on (1) the
blood ordering procedures like informed consent, indication setting and decision making
with respect to the clinical use of blood; (2) the procedure of blood or blood component selec-
tion and standard approaches to compatibility testing in hospital transfusion laboratories
and (3) the unacceptably poor patient monitoring practices during a transfusion episode.
So, the real rational use of blood is not yet established in Uganda. Ideally, Hospitals should
be held responsible and accountable to the community (supplier and subsequent user of
blood) about the outcomes of blood transfusion. Apparently there are no hospital adminis-
trative structures with established policies to oversee such activities. This has resulted into
inconsistent transfusion practices with questionable safety.

This thesis explores the root causes of the observed in-hospital problems so as to form a
scientific basis for development of systems and quality assurance guidelines to improve
the clinical use of blood in Uganda.

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1.4 STUDY JUSTIFICATIONS

Whatever the transfusion requirements of the Ugandan population of patients, the health
care system has to ensure availability of adequate and safe supplies of blood to all patients
requiring a transfusion and attending a rural, urban, government or non-government
health facility. After observing pitfalls in the hospital transfusion chain at the major refer-
ral and teaching institute Mulago Hospital, this thesis sought to further explore the root
causes of these problems so as to form a basis for development of systems and quality as-
surance guidelines to improve the clinical use of blood in Uganda.
It is anticipated that the information generated from this study will:
> assist the prescribing clinician in:
- streamlining the indication setting ensuring appropriate decision making before a -
transfusion is prescribed and ordered, and reconsidering the patients’ rights (in-
formed consent) as regards hemotherapy.
- considering appropriate transfusion alternatives.
- discriminating between optimal and rational use of blood and blood products.
> the creation of hospital transfusion committees to take up administrative, monitoring
and evaluation roles pertaining to clinical use of blood.
> form a basis for concerned stake holders to design in-hospital models that will ensure
patients’ access to safe and adequately used blood products.
> it is also anticipated that this thesis will form a basis for quality improvement in other
health care systems.
> the outcomes of this thesis will enhance collaboration between institutions on issues
of training, research, monitoring and evaluation.
> it will contribute to the promotion of community confidence in the health care systems
in Uganda.

1.4.1 Justification of the methodological approach used


Modern health care has shifted to a broader scope that involves evaluation of experiences of
health providers and ambient or biomedical factors that influence their working environ-
ment. This is a result of increasing patient expectations and diversity of health services
provided, which, in order to meet expectations, requires research on a wider range of poten-
tial research questions. [70, 71] Consequently, research and interventions involve use of para-
digms and methodologies that call for interdisciplinary collaboration in which qualitative
and quantitative research methodologies are complementary. [71]
Qualitative research is based on methodological traditions which enable understanding of
events in their natural settings, with emphasis on experiences, opinions, interpretations
and views of participants (inductive reasoning), while quantitative research typically starts
with a hypothesis that is then tested against reality using deductive reasoning. The two
methodologies complement each other, such that hypothesis generated may be tested
against data, thus oscillating between theory and data. This is an abductive method [72]
Combining methodologies may be achieved in three ways:
> qualitative research may be used to explore complex phenomena that are not amenable
to quantitative research, for instance exploring whether and why variations in a phe-
nomenon exist in a given population.
> qualitative research may precede quantitative research as an essential preliminary.
> qualitative research may be used to supplement quantitative research (as a form of val-
idation through triangulation of methods).

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In chapter 2 of this thesis, mixed methods were used in sequence. Focus group discussions
among different categories of clinicians provided sufficient information to generate a hy-
pothesis. To ensure generalizability of findings, the hypothesis was later explored by a
cross-section surveys in another group of clinicians. This was crowned with Key informant
interviews to another set of participants (patients). The different types and sources of infor-
mation extensively and reliably answered the attendant research questions.
In order to collect first-hand and valid information on bedside clinical practices, a non-par-
ticipant observation method was employed in chapter 4 of this thesis. Here clinicians were
remotely observed performing their transfusion activities without interference.
In chapter 8, a review of records (quantitative method) on time spent by blood in quarantine
in blood banks was followed by interviews (qualitative method) to concerned staff to under-
stand the factors responsible for the observed delays.
Studies represented in chapters 3, 5, 6 and 7 employed purely quantitative methods. Here,
it was necessary to quantify attributes like extent of clinicians’ compliance to an opera-
tional document, total blood loss and use in a given surgical procedure and clinicians’ lev-
els of knowledge of issues under study.
The mixed research strategy used in this thesis provided stronger evidence for conclusions
to be drawn through convergence and corroboration of findings.

1.5 RESEARCH QUESTIONS

Acceptable quality improvement in any process starts with well designed internal assess-
ments. This is followed by a detailed root-cause analysis of any identified weaknesses so as
to come up with appropriate strategies to improve the direct and indirect process influenc-
ing factors. The base-line study of the thesis revealed weaknesses in the three in-hospital
transfusion processes that led to the following questions:
> what is the current transfusion practice regarding processes, strategies, and documen-
tation in Ugandan hospitals?
> what is the accuracy of the surgical blood order equation in predicting peri-operative
blood needs?
> what problem areas do exit in the processing step of the vein to vein transfusion chain
that impact directly on the supply of blood products to Ugandan hospitals?
> what are the priority areas for improvement at the processing step?

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1.6 HYPOTHESES

Generally, the quality of in-hospital transfusion practices and procedures is influenced by


clinicians’ knowledge base, an enabling work environment and factors pertaining to sup-
ply and demand of blood products.
Following a baseline study which identified gaps in the three main hospital transfusion
processes, a series of hypotheses were generated and tested in line with this notion.

Hypotheses developed at the ordering stage:


> the dispensation of a pretransfusion informed consent is dependant on the clinicians’
level of knowledge of the consent process itself.
> the design of a blood request form influences the clinicians’ compliance this opera-
tional document.
> a well guided pre-operative blood order schedule leads to improved clinical use of
blood.
It is hypothesized that the current un-aided practice of peri-operative blood orders for cold
surgeries in Uganda is not accurate and leads to un-necessary transfusions during and im-
mediately after surgery. However, if the surgical blood order equation (SBOE) is adopted as
a mandatory peri-operative blood order aid, this would reduce blood wastage, in-hospital
blood testing and handling costs.

Hypotheses developed at the supply and demand interface:


> the key players at Uganda’s blood preparation-utility interface lack knowledge of im-
portant proceedings in their counterparts domains.
> the shortage of blood supply in Uganda’s hospitals is due to process delays in the pro-
cessing regional blood banks.

1.7 MAJOR OBJECTIVE

To study the current hospital transfusion practices and procedures so as to develop quality
systems to improve the clinical use of blood

Specific objectives
In-hospital blood usage activities include ordering, distributing, handling, dispensing, ad-
ministering and monitoring the effect of blood transfusions in patients. It is important to
streamline these activities because fatal hemolytic reactions are most commonly due to a
human error in the identification of the patient, the specimen, or the blood component, re-
sulting in an ABO-incompatible transfusion. The smooth running of these activities is af-
fected by a number of factors. These may be from within or outside the hospital setting.
Thus, the thesis sought
> to assess the current hospital transfusion practices in Ugandan hospitals as regards
processes, strategies and documentation.
> to assess the clinical utility of the surgical blood order equation in predicting periopera-
tive blood use in femoral fracture surgery.
> to isolate problems and identify priority areas for improvement in the processing stage
of the transfusion chain in Uganda.

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1.8 METHODS

Flowcharting was used as a general quality analytic assessment tool. Under this tool mixed
research approaches were used to assess shortcomings and opportunities of improvement
of particular procedures in the in-hospital transfusion processes. These included qualitative
and quantitative study designs with triangulation at the conceptualization, design, data
collection, data analysis and conclusion stages.

1.8.1 Study settings


The studies were carried out in Uganda’s regional blood banks, and regional referral and
district hospitals. These hospitals administer blood as a major component of patient care.
Regional referral hospitals have an 800-1500 bed capacity. They are affiliated to medical
training institutions and manned by a relatively senior staff. They are in close proximity to
their respective supplying regional blood bank.
The district hospitals have a capacity ranging from 50 to 200 beds. They are manned by a
relatively junior staff. They are distant from their blood supplying regional banks.
Uganda Blood transfusion Services runs centralized blood procurement, testing, process-
ing and distributing systems. This is achieved through regional blood banks. Each one of
these banks provides blood supplies to health institutions within its jurisdiction. They are
manned by an administrative and technical staff of similar training backgrounds and work
experiences.

1.8.2 Qualitative studies


The qualitative studies took the form of direct observation of clinicians performing the var-
ious bedside transfusion procedures without interference in the routines. They also in-
volved focused group discussions and key informant interviews among purposively
selected clinicians and blood bank staff on root cause analysis and strategies of improve-
ment of identified process problems.

1.8.3 Quantitative studies


The quantitative studies involve review of appropriate in-hospital and blood bank records
and documents, surveys among clinicians and blood bank staff, and prospective open ob-
servational and descriptive studies of selected bedside transfusion procedures.

1.8.4 Sampling procedures


For qualitative studies, participants in the group discussions and individual interviews
were purposively selected. Clinicians who prescribe or handle blood as a day to day activity
were included. Administrator and technicians in regional or hospital blood banks were in-
clude in the study because of their knowledge of the blood processing systems in the re-
spective banks.
Participants who satisfied the inclusion criteria for quantitative studies were recruited
consecutively until the desired sample sizes were obtained.

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1.8.5 Sample size estimation for quantitative studies


In chapters 2, 5 and 7, the number of questionnaires to the distributed to clinicians in the
cross-sectional surveys and number of patient with fractured femur to be enrolled for the
study were calculated using the formula for Sample Size estimation of Frequency in a Pop-
ulation [73]:

Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21- /2*(N-1)+p*(1-p)]

Where N is the population of clinicians involved in transfusion in the selected hospitals or


the total number of patients presenting with a fractured femur, p is the % frequency of the
outcome factor in question, confidence limit d set at 5%, design effect ( cluster survey-
DEFF) = 1, and confidence level taken at 80%.
A sample size of 91 was calculated for each study.
In chapter 6, openEpi, version 2, opensource calculator – SSCC [74] was used to calculate the
sample size of this un-matched case-control study. Here a two-sided confidence level
(1–alpha) = 0.95, Power (%chance of detection) was taken at 80, hypothetical proportion of
cases whose blood orders were accurately made was 65% while that of controls was as-
sumed at 40%. Ratio of cases to controls was 1:1. A sample of 62 cases and 62 controls was
calculated.
The quantitative studies represented in chapters 3 and 8 were primarily exploratory. No
power calculations were performed to predetermine sample sizes. All available records in
the specified periods were reviewed. Thus, a total of 1,756 blood request forms and records
of 4,126 blood unit delivered to a regional blood bank were reviewed.

1.8.6 Triangulation of research methodologies


This thesis employed triangulation of qualitative and quantitative research methods in an-
swering different research questions. Triangulation refers to a deliberate approach of col-
lecting, analyzing and interpreting data using a wide range of independent means.
According to Amin [72] the role of triangulation is to collect data which is as complete as pos-
sible and therefore generalizable. Use of multiple methodologies, data sources or different
personnel increases the investigator’s depth, breadth and understanding of the research
problems. The research methodologies (quantitative or qualitative) are tools to facilitate
understanding of a research problem, and researchers should be prepared to employ a bal-
anced and extensive repertoire of methods at their disposal. On one hand, the qualitative
methods may develop hypotheses, indentify pertinent subjects or variables and deepen the
understanding of trends. On the other hand, quantitative methods measure the magnitude
of the problem or trends and test generated hypotheses. Therefore, qualitative and quanti-
tative research methods are complementary. Chapters 2, 4 and 8 involved mixed research
methods in which participant observations, key informant interviews, focused group dis-
cussions and surveys were used. Chapters 5, 6 and 7 involved quantitative methodologies
in which surveys, review of patient documents and prospective observations of patient in-
dices were performed.

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Table 1 Summary of methods, study designs and outcomes in this thesis

Chapter Study design Population Data analysis Outcomes


2 Qualitative research, Junior and senior clini- Thematic content analy- Knowledge levels, opin-
FGDs and cross-sectional cians in six Ugandan sis STATA used, a 2-sided ions on administration
survey Hospitals Fisher’s exact test per- and improvement of IC
formed
3 Analysis of document de- Blood request forms SPSS used. A Pearson’s Quality of the design and
sign and a cross-sec- (n=1756) Correlation Index per- clinicians’ compliance to
tional audit of records. formed the BRF in use.
4 Qualitative research, Clinicians at Mulago Comparative content Quality of bedside blood
(participant observation) Hospital and UMCG analysis administration proce-
dures.
5 Open observational and Adults with unilateral Bivariate and multiple re- Total blood loss in peri-
descriptive femur fracture. gression analyses. operative period and
contributing factors.
6 Open observational and Adults with unilateral Sensitivity, specificity, Usefulness of a blood or-
descriptive fracture femur. positive and negative dering tool.
predictive values calcu-
lated
7 Descriptive cross-sec- Clinicians and blood Chi-square tests Level of knowledge, turn-
tional survey bank staff around time of effecting
a blood order and inter-
face improvement
strategies.
8 Cross-sectional review of Technical and support A bivariate Pearson Prod- Where and why delays
records and key inform- staff of Mbale and uct-Moment Correlation occur in processing
ant interviews Nakasero regional blood Index and contents blood.
banks analysis of qualitative
data

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1.8.7 Data analysis


The interviews and focused group discussions were carried out in English, recorded on an
audio recorder and transcribed verbatim (word by word). This was done by the first author
with assistance of two research assistants. Data analysis involved development of codes
and categories according to key concepts and issues (meaning units) from the transcripts.
Systematic comparison of emerging codes and categories across text was done, by means
thematic content analysis.
Continuous variables of quantitative data were summarized into means and standard devi-
ations. Statistical analyses included Chi square tests, 2-sided Fisher’s exact tests, bivariate
Pearson Product Moment Correlation Indices, bivariate and multiple regression analyses.
Statistical significance was taken as p value less than 0.05. Analyses were performed with
the help of the Statistical Package for Social Scientists version 11.0 (SPSS Inc., Chicago, IL,
USA) and STATA version 9.2 (Stata Corp., Texas, USA) software packages.

1.8.8 Theoretical and conceptual framework for the thesis


Blood transfusion is a major supportive entity to clinical treatments. Safety, adequacy and
costs directly affect its intended effectiveness in dealing with ailments that cannot be sup-
ported by any methods other than hemotherapy.
A study among clinicians, nurses and laboratory technicians was conducted in Ugandan
hospitals and regional blood banks using mixed research methods to explore the quality of
the existing transfusion practices and how personal, institutional or national factors im-
pact on these practices. This was achieved thorough studying the adequacy of the human
resource in terms of numbers and levels of knowledge of key transfusion medicine aspects.
The quality of documentation at the blood ordering process was also studied. The extent to
which the interface between supply and demand of blood influences clinical practices was
also explored. Strategies to improve these in-hospital transfusion processes were there-
after grounded from the research findings (field notes from participant observations, re-
sponses in interviews and deliberations in focus group discussions). As one of the
strategies to improve blood stock management in the hospital, the clinical utility of the
surgical blood order equation (SBOE) was explored among patients undergoing surgery for
fractured femurs in Mulago Hospital.
The thesis revealed that quality systems are key in ensuring safe transfusion practices. It
is hoped that this thesis will pave a way forward for the development of quality and techni-
cal standards of the (bedside-laboratory-bedside) hospital transfusion chain. So quality
systems and their management at the clinical interface lead to improved patient care.

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Figure 4 Model blood request form as advocated by WHO

Example of Blood Request Form


(WHO Department of Blood Safety, Geneva, CH)

Hospital: ____________________________ Date of request: __________________________

Patient Details
Family name: ________________________ Date of birth: _________________ gender: M / F

Given name: _________________________ Ward: __________________________________

Hospital reference No:: _________________ Blood group(if known): AB0: ______


RhD:______

History
Diagnosis : ___________________________ Antibodies: Yes / No
Reason for transfusion: _________________ Previous transfusion Yes / No
Haemoglobin: _________________________ Any reactions Yes / No
Previous
Relevant medical history: ________________ pregnancies/stillbirths/abortions Yes / No

Request
Group, screen and hold patient’s serum Red cells units
Provide product Plasma units
Date required: ________________________ Whole blood units
Time required: ________________________ Other units
Delivered to: __________________________

Name of Doctor: ______________________ Signature: _____________________________

Important: This blood form will not be accepted if it is not signed or any section is left blank
LABORATORY USE ONLY

Patient ABO
Donor typing Compatibility testing Rh D
Donation AB0 Rh AHG Room temp Date of Time of Date of issue Time of issue
Pack No Saline match match

Signature of tester:
_______________________

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1.8.9 Quality control


The research was carried out with help of the research assistants who were pre-trained be-
fore starting the study –
> a knowledgeable social scientist assisted in designing data collection tools and analyz-
ing qualitative data.
> qualitative data were recorded with a digital audio recorder, transcribed verbatim and
analyzed manually.
> a biostatistician assisted in the quantitative data analysis.
> in collaboration with the co-authors, all stage of the research project (designing, data-
collection, data analysis and report writing were carried out.

1.8.10 Ethical consideration


Acceptable research is based on mutual trust and cooperation. It is vested in the four prin-
cipals of medical ethics (autonomy, beneficence, nonmaleficence, justice). To ensure auton-
omy, free and informed consent to enroll into the study for competent participants and from
the next of kin of a helpless patient without deceit or coercion was sought. There was pro-
tection of patients and participants’ privacy and confidentiality.
In line with the principals of beneficence and justice, the research was conducted with ut-
most care and with an underlying aim of eventual establishment of a hospital transfusion
policy that would benefit all blood users in Uganda. The thesis addressed the principal of
nonmaleficence by:
> ensuring welfare of participants in interviews and focus group discussions with mini-
mization of embarrassment or guilt during responses.
> using appropriate research methodologies at study design, data collection, analysis, in-
terpretation and accurate reporting.

Therefore permission to conduct this research was obtained from the following institutions:
> department of Orthopedics, Makerere University.
> the Mulago Hospital Ethics and Research committee.
> the Faculty of Medicine Higher Degrees Research Committee.
> the Uganda National Council of Science and Technology.

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41 Geurin S, Collins C, Kapoor H, McClean I, Collins D. Blood transfusion requirement


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28 Isaac Kajja
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Summary of Published Chapters 2 till 8

CHAPTER 2 INFORMED CONSENT

Informed consent along the transfusion chain addresses the donor, recipient and partici-
pants in transfusion research. The responsibility of obtaining consent from a transfusion
recipient generally, but not always, belongs to the treating physician. This process is an un-
derstanding between the physician and the blood recipient about the nature of this treat-
ment, its benefits and risks, the alternatives to such treatment and the consequences of
refusal of treatment. It is vested in the four main principles of medical ethics: autonomy,
beneficence, non-malificence and justice. On one hand, the physician working under an ap-
propriate administrative structure filters his knowledge base through goals and values to
come up with a given treatment choice for the patient’s situation. He is under legal and eth-
ical obligation to communicate this choice to the patient without coercion. On the other
hand the blood recipient filters his or her knowledge, however limited, through his own set
goals and values to come up with a particular treatment choice and expected outcome. A
sound knowledge base is thus imperative for both parties for the consent process to be ap-
preciated. This paper sought to explore the clinicians’ level of knowledge, opinions on key
administrative issues and strategies to improve the informed consent process. It also ex-
plored the blood recipients’ experiences and perceptions of the consent process. In the
study, focus group discussions, interviews and surveys were used to collect data from a va-
riety of participants. Thus, there was triangulation in data sources (different participants),
research questions (knowledge, opinions, experiences and perceptions), data collection
methods (qualitative and quantitative) and data analysis.
It has been established that the informed consent process in Transfusion Medicine has not
yet taken root among the prescribers and recipients of blood in Uganda.

CHAPTER 3 ORDERING FOR BLOOD

The interface between the prescribing clinician at the bedside and the technician at the
hospital blood bank is linked by the patient’s pre-transfusion blood sample accompanied
by a blood request form from one end, and a unit of blood accompanied by compatibility
test report from the other end. The design of these operational documents directly affects
the quality of information communicated from the bedside to the laboratory and vice versa.
The following study explored the design of the blood request form (HF311) currently used
at the Mulago Hospital – a major referral and teaching hospital in Uganda. It also analyzed
the quality of information provided by clinicians to the blood bank staff. This was done by a
critical analysis of the wording and formatting of information on HF 311 compared to the
recommended World Health Organization (WHO) blood request form. The patient informa-
tion as documented by the prescribing clinicians was analyzed through a review of 1,756
blood request forms.
It was found that the prescribing clinicians do poorly comply to the currently used blood re-
quest form this hospital.

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CHAPTER 4 BEDSIDE ADMINISTRATION OF BLOOD

Bedside transfusion practices play a significant role in the outcome of any transfusion. Ide-
ally, these practices should be based on well established in-hospital quality systems. The
paper gives an account of a non-participant observation study conducted at Mulago Hospi-
tal, Uganda, and University Medical Center Groningen (UMCG), The Netherlands. The aim
of the study was to identify strengths, weaknesses, opportunities to improve and threats to
the bedside transfusion practices from the time a unit of blood is received from the hospital
transfusion laboratory to the time a given transfusion is accomplished.
Unlike at UMCG, there are no written process guidelines and therefore no standard operat-
ing procedures for the bedside transfusion practices at Mulago Hospital. This implies that
the critical procedures like blood handling, reception at the ward, warming, documentation
and patient monitoring are performed inconsistently and under different standards. This
is due to shortages in human and financial support toward these activities. It should be
noted that despite poor facilitation and staff shortages, the clinicians are dedicated to their
work and are willing to be trained to catch up with internationally acceptable standards.
This provides an opportunity to start implementing the quality system essentials in Trans-
fusion Medicine at Mulago Hospital.

CHAPTER 5 BLOOD LOSS IN SURGERY OF FEMORAL


FRACTURES

Establishment of blood order schedules for elective surgeries improve blood management
at the bedside. However, this must be based on well researched peri-operative blood loss for
a particular surgical procedure. Blood loss at surgery is commonly determined directly
from volumes of blood collected in suction machines or from volume increases in the surgi-
cal mops used during the procedure. This direct method has limitations; it does not cater
for evaporations during surgery and does not cater for blood spilling onto the floor or hid-
den blood in the suction tubes or drapes.
An observational and descriptive study was designed among adult patients undergoing
open reduction and internal fixation of femoral fractures at Mulago Hospital. This was
done with aims of establishing the amount of blood lost during the procedure and the fac-
tors that contribute to the loss.
It was found that patients undertaking this procedure loose a substantial amount of blood
in the peri-operative time due to lack of standard theater equipment to control bleeding.

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CHAPTER 6 CLINICAL UTILITY OF THE SURGICAL BLOOD


ORDER EQUATION

In chapter five we established the blood loss in the peri-operative time of a major surgical
procedure - open reduction and internal fixation (ORIF) of femoral fractures. In order to
streamline blood orders for this procedure, we followed this with another study aimed at
finding the clinical usefulness of the surgical blood order equation (SBOE).
A prospective interventional study among cases and controls was carried out in adult pa-
tients presenting with unilateral femoral fractures, whose main treatment option had been
decided by the lead surgeon as ORIF. In this study all peri-operative blood orders were
made before the surgical procedure. The cases were patients whose blood orders were made
basing on the SBOE while the control blood orders were made without any guidelines.
In these homogenous groups of patients, it was found that the introduction of the SBOE
greatly improved allogeneic blood use among patients undergoing ORIF for isolated and
unilateral fractures of the femur.

CHAPTER 7 INTERFACE BETWEEN PREPARATION AND


USE OF BLOOD

A well set and facilitated blood production and utilization interface leads to proper alloca-
tion of available resources in both domains. It also results in optimal and rational use of
blood therefore improving patient care.
Uganda, a low human development index country, runs a nationally coordinated blood
transfusion service. Given the health budget constraint and the dismal facilitation from in-
ternational donors, the Uganda Blood Transfusion Services (UBTS) cannot fully meet the
blood demands of Uganda’s 30 million population.
In order to ensure advocacy for and optimization of allocated logistics in the production
and utilization settings, a descriptive cross-sectional survey among prescribing clinicians
in six hospitals and blood bank staff in five regional blood banks was carried out. This had
a major aim of identifying possible problems at, and solutions to the problems at the clini-
cal interface. It was found that there is a clear communication gap between prescribers and
suppliers. Hence, on one hand blood banks have no real idea of what the needs to supply
are and how these develop over time. On the other hand the prescribers do not fully appreci-
ate the availability and use of blood products from their supplying banks.

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CHAPTER 8 BOTTLENECKS IN THE PREPARATION OF BLOOD

One of the major factors influencing in-hospital transfusion practices is the supply of blood
per se. A pre-conceived inadequate supply of blood forces prescribing clinician to over order
in anticipation that his or her patient needs will after all be partially met. We postulate that
the observed blood shortages in Uganda’s hospitals is not purely due to meager blood col-
lections from the community but partly due to process delays within the processing Re-
gional Blood Banks (institutional factors).
The following is an account of a records review on units of blood delivered to Nakasero Re-
gional Blood Bank for processing before distribution to hospital. This was done with an
aim of finding time spent by blood at the various work stations with in the bank. It was
then followed by a series of interviews among staff at Mbale and Nakasero Regional Blood
Banks to establish the factors contributing to a prolonged hold of blood in the banks before
dispatch to the utilizing hospitals.
It was established that blood spends a substantial amount of its shelf life in the processing
banks due to staff shortages, poor process facilitation and an uncomfortable work environ-
ment.

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Chapter 2

Informed Consent in Blood Transfusion:


Knowledge and Administrative Issues
in Uganda Hospitals

Isaac Kajja, Gabriel S. Bimenya, Cees Th. Smit Sibinga


Accepted: Transf and Apheresis Science, 2011

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ABSTRACT

Blood as a transplant is not free of risks. Clinicians and patients ought to know the pro-
ceedings of a transfusion informed consent. A mixed methodology to explore patients’ and
clinicians’ knowledge of, opinions on administration and strategies to improve transfusion
informed consent process was conducted. The clinicians’ level of knowledge was limited to
provision of information about, and the right to consent to a transfusion. They disagreed on
administrative issues but had acceptable opinions on improving the process. Patients per-
ceived this process as a way of assurance of blood safety. This process is important and
should no be omitted.

Keywords: informed consent, clinicians, transfusion

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INTRODUCTION

Seeking for informed consent is a process. It comprises provision of information on the ex-
pected benefits and potential risks of accepting or refusing hemotherapy; offers an oppor-
tunity to the patient or care-taker to ask questions, provides information on appropriate
transfusion alternatives, calls for advising the patient without coercion and documenta-
tion of the proceedings of the discussion [1-3]. Therefore, patients and persons responsible
for minors and the unconscious, need to be informed of the reasons for an impending
transfusion so that they can consent to it [4]. True informed consent is possible in planned
transfusions but not in emergency situations [1, 4]. This gives time to the patient to internal-
ize the provided information and thereafter make a sound decision.

Communication between the clinician and the patient is the basis of good consent process.
This calls for sound knowledge of the entire process by the clinician and will be reflected in
how much patients remember of the information conveyed during the process of obtaining
informed consent for transfusion, or even that the event occurred [5]. The other factors that
affect proper dispensation of the informed consent process are linguistic factors, cultural
barriers, the atmosphere in which the process takes place and confidentiality of the out-
comes of the discussions [6]. Besides, it is good clinical practice for blood prescribing health
facilities to regulate the administrative aspects of the informed consent process by includ-
ing: a written policy, the timing of the informed consent process, who may seek for the con-
sent, who may give consent, how often it should be sought and how it should be
documented. If addressed, these factors would eventually effect the clinicians’ compliance
to this demanding bedside exercise [5, 6].
There are a number of unresolved issues in the administration of the informed consent
process. The report of the Canadian Expert Working Group on guidelines for red cell and
plasma use, shows disagreement on the disclosure of transfusion alternatives during the
consent process [7]. The difference between transfusion risks that should be disclosed and
the risks that some schools of thought would consider minimal or theoretical is not always
obvious. Thus, Holland and Schmidt compromise at disclosure of any transfusion compli-
cation that occurs with a frequency of one percent or more [3]. Another disturbing issue is
the right to refuse a transfusion. This right applies also when refusal of a transfusion will
result in harm to the patient or even death [8].
Obtaining an informed consent for a transfusion in addition to a general treatment consent
secured on admission is another unresolved issue in the process: some people assert that
splitting the consent processes generates a large volume of information that is difficult to
manage; others argue that a combined consent only proves a clinician-patient contact, but
is not representative of a true blood transfusion informed consent [8, 9].
The Republic of Uganda National Blood Transfusion Policy [10] clearly state that patients
shall be informed of the known risks and benefits of blood transfusion and/or alternative
therapies and have the right to accept or refuse the procedure. However, this is not adhered
to by clinicians due to lack of standard operating procedures to guide the informed consent
process in hospitals. So blood is administered irrespective of whether a patient has con-
sented or not.

In the period January-March 2007, an observational study focusing on bedside transfusion


practices, was carried out in the department of Orthopaedics at Mulago Hospital, a 1500
bed national referral and teaching hospital in Uganda [11]. It was found that the informed

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consent process is one of the steps neglected by clinicians in the clinical transfusion chain.
In order to ascertain the clinical state of the consent process, firstly, the level of knowledge
of the clinicians on the informed consent in blood transfusion was explored. Secondly, cli-
nicians’ opinions on administrative issues and improvement strategies of the process were
studied. Thirdly, patients’ experiences and expectations of information before a transfu-
sion were collected and studied.

METHODS

In this study we used mixed research methods in sequence: May- August 2008 we carried
out qualitative studies; November 2008 - January 2009 quantitative methods followed to
broaden our understanding and generalizability of the results to the clinician population in
Uganda; the crowning was the interviews among twenty adult blood recipients.

Qualitative study designs and settings


Focus group discussions (FGDs) were used for collection of information on clinicians’ ways
of handling and improving the informed consent process in clinical use of blood. We also
conducted interviews among twenty randomly selected adult blood recipients to explore
their expectations and experiences regarding the informed consent.

The study was conducted in three hospitals of different health services delivery levels, each
with the necessary clinical and laboratory personnel to handle transfusions. They included
Mulago Hospital, Uganda’s 1500 beds National Referral and Teaching Hospital, Kawolo
Hospital, a 100 beds district hospital 35 kilometers east of Mulago and Mukono Health
centre IV a 50 bed hospital 20 kilometers east of Mulago. These hospitals are found on the
major highway connecting land-locked Uganda to the sea port of Mombasa and handle
many accident and emergency patients. These hospitals were chosen to ensure that clini-
cians included in the group discussions had day to day hands on clinical transfusion proce-
dures. The study was approved by the Uganda National Council of Science and Technology,
a body that oversees all ethical and legal issues pertaining to scientific research in Uganda.

Participants
Participants in the FGDs, (n=8 per group), were laboratory technicians, junior nurses (en-
rolled and registered) and junior doctors (interns and medical officers). These were purpo-
sively sampled because of their roles in transfusion procedures.

Twenty adult (aged 18 and above years) patients were interviewed on their perceptions of
key issues in the informed consent. These included 12 males and 8 females admitted in the
orthopedic ward of Mulago Hospital, medical and female wards of Kawolo Hospital and
Mukono Health Center IV. They all had anemia as one of their symptoms. They were en-
rolled on the criteria that they had received a unit of whole blood as part of their treatment
in the previous 48 hours of their hospital stay.

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Qualitative data collection


The clinicians who satisfied the selection criteria signed an informed consent to participate
in the study. Groups of 8 selected participants were engaged in 40-50 minute discussions at
their work places. These discussions were facilitated by two trained research assistants in
the presence of the principal investigator. Before discussions, the participants reviewed the
statement of the problem being researched. The discussions were then guided by a set of
questions on the topics of study. These had been piloted among two groups each compris-
ing of six residents in the Departments of Orthopedics and Pediatrics- Mulago Hospital.
The guide questions for interviews were piloted for effectiveness to elicit responses among
three blood recipients in the Department of Orthopedics Mulago Hospital. These were open
ended questions. The respondents were randomly selected from Mulago hospital, Kawolo
hospital and Mukono Health center IV. We sought an oral informed consent from the pa-
tients who satisfied the inclusion criteria before conducting face-to-face interviews.

The proceedings of the discussions and interviews were recorded using a digital voice
recorder. Immediately after each session there was a debriefing among the research team
to ensure clarity of the recordings, documentation of any new ideas and plan for the follow-
ing discussion. Recordings were transcribed verbatim. In both situations, we continued
with data collection until the saturation stage when no new information was forth coming.

Data Analysis
The transcripts were entered into computer files. Data analysis involved reading and
rereading of transcripts. This was followed by identification of meaning units comprising of
phrases with similar meanings which were then coded. Systematic comparison of codes
and categories across text was performed following procedures described by Pope and oth-
ers [12]. Emerging themes were then analyzed manually using the master sheet analysis
technique [13].

Quantitative study design and setting


In order to further our understanding of the themes that emerged from the analysis of the
focus group discussions, we conducted a descriptive cross-sectional survey using a ques-
tionnaire to find out the extent of knowledge on informed consent, opinions on administra-
tive issues of the consent process and strategies to improve clinician compliance to
informed consent in blood transfusion. Knowledge was assessed using five domains:
1. providing information on the expected benefits and potential risks of accepting or re-
fusing hemotherapy;
2. offering an opportunity to the patient or care-taker to ask questions and to provide an-
swers;
3. providing information on appropriate transfusion alternatives;
4. advising the patient without coercion;
5. documentation of consent or refusal of a transfusion.

For purposes of this study, the responses were arbitrarily scored as follows:
> responses in 0-1 domain were assigned a score 0, representing unacceptable knowl-
edge; responses in 2-3 of the domains were assigned a score of 1, representing an aver-
age level of knowledge;
> responses in 4-5 of the domains were assigned a score of 2, equivalent to an acceptable
level of knowledge.

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The questionnaire consisted of open-ended questions to ensure freedom and spontaneity of


expression of opinions and sections of close-ended questions to elicit specific responses. To
ensure clinical relevance, the questionnaire was piloted on eight orthopaedic surgeons and
two postgraduate orthopedic residents.
The questionnaires were delivered by hand to senior clinicians (senior consultants, con-
sultants, registrars, senior residents and senior nursing officers) in their work places in
five regional referral hospitals in Uganda. These included Jinja and Mbale hospitals in the
Eastern region; Mbarara in the Southwestern region; Gulu Hospital in the Northern region
and Mulago hospital in the Central region. These hospitals have clinicians of similar ex-
pertise and operate with equal facilities. They were conveniently sampled due to their prox-
imity to a regional blood bank, with assured availability of blood in the hospital. The
clinicians were selected on the criteria of being involved in day-to-day transfusion activities.

Data analysis
Data from the survey were entered into a database and statistical analyses performed with
the help of computer software STATA version 9.2. (Stata Corp. Texas, USA) Significance
was define as p <0.05. A two-sided Fisher’s exact test was performed to find associations of
the clinicians’ knowledge and the hospital where they work to the various outcomes of in-
terest.

RESULTS

Six FGDs were held, four in Mulago Hospital departments of (orthopedics, pediatrics, ob-
stetrics and oncology) and two in Kawolo Hospital (pediatrics and obstetrics departments).
Each group composed of eight participants.

Clinicians’ knowledge of the informed consent process


Participants identified only two key elements in the informed consent process. First was
provision of information by the clinician to the patient on the use, known risks and benefi-
cial out comes of an eminent transfusion. Secondly, the right of the patient to accept or re-
fuse a transfusion. This is evident from the following quotation:

An informed consent means that you talk to the patients educate them on the reason for the
transfusion, its will benefits and risks.”

Out of the 90 questionnaires sent to senior clinicians, 65 (72.2%) were returned for analy-
sis. Most of the clinicians, 35 (53.8%), had an average knowledge of the informed consent
process which centered on two or three of the studied domains, only 4 (6.2%) clinicians had
an acceptable level of knowledge. (Table 1).
There was no statistically significant variation in the level of knowledge (p=0.34) among
clinicians of different hospitals.

The junior clinicians identified protection of the health worker prescribing a transfusion
against any future medico-legal issues resulting from such a procedure as the major role of
an informed consent.
The senior clinicians identified two major roles of an informed consent process in Transfu-
sion Medicine. Of the 65 respondents 33 (50.8%) felt that the informed consent process

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gives an opportunity to the clinician to educate the patient about the blood transfusion
processes and procedures, while 11 (16.9%) clinicians thought that the consent process is
purely for future medico-legal protection of the health worker engaged in the prescription
of blood. Eleven (16.9%) senior clinicians did not know the role of an informed consent
process in blood transfusion (Table1).
The perception of the role of the informed consent did not have an association with the core
knowledge of the consent process per se (p=0.244).

From the conducted (FGDs), it was apparent that the informed consent process is a step
that is irregularly performed or neglected in most of the blood- using hospitals. This is evi-
denced by the following quotation:

“It is not a practice in my unit to seek for consent for a blood transfusion“.
This inconsistence of the consent process for blood was reflected in the responses of senior
clinicians, where only 8 (12.3%) felt that the compliance to the informed consent process
was adequate. Twenty two (33.8%) and eight (12.3%) respectively assessed the compliance
as probably inadequate or certainly inadequate, while 5 (7.7%) did not know how to assess
this health provider quality. The clinicians’ level of knowledge did not determine the as-
sessment of the health worker compliance to the consent process (p=0.8).

Table 1 Senior clinician knowledge on components of, roles and self assessment of their compliance to the informed
consent process.
Variable Responses out of 65 clinicians n (%)
Knowledge
Unacceptable 26 (40.0)
Average 35 (53.8)
Acceptable 4 (6.2)
Roles
Opportunity to provide transfusion knowledge to patient 33 (50.8)
Medico-legal 11 (16.9)
Opportunity to provide transfusion knowledge and medico-legal 10 (15.4)
Don’t know 11 (16.9)
Compliance
Adequate 8 (12.3)
Fairly adequate 22 (33.8)
Not adequate 22 (33.8)
Certainly not adequate 5 (7.7)
Don’t know 8 (12.3)

Opinions on administrative issues of the informed consent


When the junior clinicians were asked about their opinions on who should seek for the in-
formed consent, two common themes emerged. Most of the participants felt that the doctor
on duty should seek for the consent since he or she makes the diagnosis and takes the deci-
sion to transfuse. Other participants felt that the nurse should seek for the consent since
she is always available on the ward and duly responsible for monitoring the transfusion it-
self.

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The 65 responding senior clinicians had open perspectives on who should seek for transfu-
sion consent: each clinician gave more that one alternative. Forty six (70.8%) felt that the
duty of seeking for the consent lies with the intern doctors. Only 10 (15.5%) and 6 (9.2%)
clinicians respectively, felt that medical student or student nurses should take this respon-
sibility. On the other hand 5 (7.7%) of the clinicians did not indicate any person duly re-
sponsible for seeking an informed consent for a transfusion (Table 2).

The junior clinicians did not agree on a particular time of the hospital stay when an in-
formed consent for blood should be sought. Some felt that it should be sought at the time of
admission to the hospital while others were of the opinion that the clinician should seek for
the consent as and when there is need for a blood transfusion.
There was inconsistence in the responses among the senior clinicians as regards timing of
the consent process. Forty four (67.7%) felt that a consent for a transfusion should be
sought as the need arises for blood, while eighteen (27.7 %) thought that there should be
one fully- embracing consent for all treatments and procedures sought at the time of ad-
mission to hospital.

Regarding the informed- consent documentation, the response pattern was Y-crossed; on
one hand all participants agreed that the proceedings should be recorded for any future
medico-legal questions but on the other hand,, there was a dichotomy on where this infor-
mation should be recorded. Many participants felt that a separate form should be designed
for the blood transfusion informed -consent procedure, while others thought that this in-
formation should be recorded in the patient’s clinical file like any other notes.
The above difference in opinions among junior clinicians was also noted from the senior
clinicians’ responses. Forty six (70.8%) recommended the process to be documented on a
pre-designed form, while 19 (29.2%) preferred documentation in the patient’s clinical
notes.

Table 2 Opinions on administrative aspects of the informed consent


Responsible clinician* Timing# Documentation€
n (%) n (%) n (%)
Intern doctor 46 (70.8) on hospital on a pre-designed
Junior doctor 37 (56.9) entry 18 (27.7) informed consent
Senior nurse 32 (49.2) form 46 (70.8)
Senior doctor 25 (38.5) when blood
Junior nurse 21 (32.3) is needed 44 (67.7)
Medical assistant 19 ((29.2) in the patient
Medical student 10 (15.5) do not know 3 (4.6) clinical notes 19 (29.2)
Student nurse 6 (9.2)
Not done 5 (7.7)
* = opinion on who should seeks for informed consent from the patient each clinician gave more than one alternative.
# = the clinicians’ opinions on time an informed consent should be sought.
€ = the opinions on where informed consent proceedings should be documented
n(%) = number and percentage of clinicians giving a particular opinion.

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Strategies to improve the informed consent process


All junior clinicians agreed that there should be a national policy and hospital guidelines
addressing the informed consent and emphasized the need for training of pre-service and
in-service health workers on components and importance of the transfusion informed -
consent process.

The senior clinicians had a broader perspective on the strategies that can be put in place to
improve the hospital transfusion -consent process. The main focus was on training of the
health worker which was opined by 39 (60.0%) out of the 65 responses (Table 3). Other sug-
gestions included: provision of a separate informed consent form; instituting a hospital
transfusion policy,
emphasizing supportive supervision of clinicians, sensitization of the public on matters of
the informed consent and ensuring recurrent clinical audits of transfusion practices.

Table 3 Strategies to improve clinician compliance to the informed consent process


Strategy responses from the 65 clinicians n (%)
Training 39 (60.0)
Provide separate informed consent forms to clinicians 15 (23.1)
Institute a hospital policy on informed consent 12 (18.5)
Improve support supervision of clinicians 7 (10.8)
Increase staffing 7 (10.8)
Sensitization of public on the right to an informed consent 7 (10.8)
No idea 5 (7.7)
Avail informed consent guidelines in clinical areas 4 (6.2)
Clinical audits 3 (4.6)

Patients’ experiences and expectations.


Not all interviewed patients were asked for consent for their transfusions. However, they
were cognizant of their right to some information before a transfusion is accepted.
“ I did not discuss anything with the doctors, they told me I had little blood, three hours later
the nurse gave me a pint of blood.”
“…..but sir, it is important to tell us something before we receive this blood because this blood
comes from another person, we are not sure of that person’s health.”
The main concern of the interviewed patients was reassurance on blood safety. They ex-
pected the clinicians to inform them about the quality of the blood they were yet to receive.
They also expected the clinicians to provide information regarding the benefits and risks of
accepting or refusing a transfusion
“I want to be sure that the blood I am going to receive is free of HIV or malaria.”
“Um…the doctor should reassure me that the blood is safe”
“…By the way, why don’t you inform us about the effects of refusing or accepting this blood?”

Regarding the administrative issues of the informed consent, most patients were of the
opinion that the informed consent should be sought as and when blood was confirmed
needed and that the proceedings of the informed consent discussion are documented in the
patient file.
The patients expect the doctors who reach the diagnosis and take decision to transfuse to
be duly responsible for seeking and documentation of the informed consent.

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“You doctors are too busy; you should discuss the information concerning blood when you are
sure that I need blood. I would advise that you write the outcome of this discussion somewhere
in my hospital file because I can turn around and say that you did not give me blood or you
gave me bad blood”

DISCUSSION

The study demonstrates a number of loopholes in the perceptions and practices of the
transfusion informed consent process in Ugandan hospitals. It is apparent that the knowl-
edge and practices of clinicians as regards the informed consent in Transfusion Medicine
in Uganda falls short of the standards and recommendations published by World Health
Organization (WHO) and practiced in other centers [14, 15]. The responses miss out issues like
provision of information about transfusion alternatives, giving an opportunity to the pa-
tient to ask questions and ensuring that the clinician addresses the whole process with a
non-coercive approach. Lack of full knowledge of the informed consent process is not
unique to Transfusion Medicine. Elizabeth and Warner [16] working in psychiatry, estab-
lished that although doctors were commonly involved in assessing capacity issues and
were responsible for many interventions requiring consent, their knowledge of these as-
pects was deficient. Even some consultant psychiatrist, whom they asked to give expert
opinions on these matters, were found wanting. The above gaps in knowledge are due to
lack of a detailed formal training on the various consent processes in medical and surgical
interventions at medical and paramedical schools. It is also due to lack of continuous pro-
fessional development in transfusion practices for clinicians.
The patients’ level of knowledge is lacking despite the fact that they are aware of their right
to information regarding the safety of the blood they are yet to receive. Normally, they do
not demand for this information. This is because they present late for treatments that re-
quire hemotherapy and feel that taking off time for the informed consent process before
blood is given may aggravate the disease process. Thus, one patient said: “I think I should be
given that information after I have got my unit of blood. This is because I can die due to delays
of the informed consent process.” They also appreciate that their clinicians are overwhelmed
by patient loads therefore take the doctors’ decisions as appropriate and final.
The clinicians and patients suggest internationally acceptable administrative issues of the
informed consent to be introduced. They suggest that any trained health worker can seek
consent from the patient or from his or her legal representative. The shortage of clinical
staff in hospitals in low human development index (L-HDI) countries explains, though
does not really justify the emerging contentions among clinicians on who should seek for
the informed consents. Many health facilities are manned by a handful of doctors and
nurses caring for a large patient load,
hence the assertion that any available clinician can take the consent from the patient. How-
ever, in well staffed institutions the senior clinician providing treatment is responsible for
making sure the patient understands all the benefits and risks of various treatment modal-
ities, including blood transfusion, before the patient signs consents [7, 17, 18]. The specialist
may delegate some of these tasks to junior clinicians.

The varying opinions on the timing of an informed consent for transfusion have merits and
demerits. Consent obtained on admission may not materialize into a transfusion during
hospital stay. Delayed consent may endanger a patient in urgent need of blood and whose

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condition deteriorates during hospital stay precluding him or her from giving consent for a
transfusion. In elective situations the process of informing patients and obtaining consent
takes place well in advance to allow them reflect on what they have learnt and request more
clarification, if needed. In emergency situations, especially life threatening conditions like
on-going traumatic

hemorrhage, a blood transfusion cannot wait for the detailed process of obtaining informed
consent [6]. Cultural factors influence dispensation of a consent process. Different cultures
regard certain topics differently thus, in some, a decision to undertake any treatment for a
patient is the responsibility of his her family [6]. There also cultural differences in how much
or what kind of information a patient wants to know. For example, in some cultures pa-
tients may not be routinely informed about risks of undertaking a blood transfusion. In
many Japanese and Eastern Europe cultures [19], physician paternalism overrides patient
autonomy in a number of medical interventions. The opposite is true for the western world.
It is imperative therefore, that cultural diversities pertaining to consent processes in med-
ical interventions are thoroughly explored in a given country so that dispensation of the in-
formed consent process retains patient confidence.
Emphasis on documentation of proceedings of the informed consent process for protecting
the attending clinician from any future legal or un-ethical claims This mirrors the findings
of Iglesia and others [20] in their work among health care personnel in which they found that
81.2% of the 277 respondents to an opinion survey considered the information provided
during the informed consent process as an instrument of legal protection of the health
worker against the demands and expectations of the patients. The consent process acts as a
tool to minimize chances of legal action resulting from a complication of hemotherapy by
providing prior information regarding the possible eventualities and getting the patient’s
agreement before proceeding further. This process must be documented. The documenta-
tion serves to provide evidence that the consent process actually occurred and provides the
details as to the precise information that was imparted to the patient. Additionally, each in-
formed consent form should have a place for the date and a signature of both the patient
and the person who obtained the consent. In enabling situations, like preparing for an elec-
tive transfusion, a third party should participate in the consent process and sign off the
consent form. Different hospitals use different approaches to document the consent
process, depending on the prevailing standard operating procedures. Melissa and others [21]
developed a separate informed consent form. However, given the Ugandan situation of lim-
ited supply of hospital stationery and low staffing for management of inventories, it would
be appropriate to document this information in the clinical notes instead of using a sepa-
rate form.
Clinicians expressed desire for a National Clinical Transfusion Policy under which guide-
lines and standard operating procedures for the informed consent process would be devel-
oped. This is a welcome idea because it harmonizes the practice and ensures easy design,
implementation and evaluation of transfusion audits [22].
Often, Ugandan clinicians have been found to have acquired their transfusion knowledge
passively from senior staff during day to day clinical activities like ward rounds. They do
not get formal medical school training in the appropriate steps of clinical use of blood.
Thus, many of them felt that pre-service and in-service training in clinically related trans-
fusion aspects is a cornerstone in improving the informed consent practices. This echoes
recommendations from other settings [23, 24]. Such trainings should be supported by an ef-
fective strategy for regular formative feedback and accurate summative evaluation to help

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clinicians achieve a high level competence. Because the senior clinicians themselves have a
key role to pass on informed consent principles from one cohort of students or junior clini-
cians to the next, it is imperative that they be equipped not only with the knowledge and
skills to obtain the informed consent but also with the knowledge and skills to be effective
mentors and evaluators of the junior clinicians and students.
It is apparent that in order to meet the patients’ expectations, clinicians in Uganda need
training in the transfusion informed consent process. This will guard against eventual
transfusion related litigations. This study also gives an opportunity to all stakeholders to
institute and regulate the proceedings of a pre-transfusion informed consent as an integral
part of the hospital policy.

Conflict of interest
The authors certify that they have no affiliation with or financial involvement in any organ-
ization or entity with a direct financial interest in the subject matter or materials discussed
in this manuscript. The authors have full control of the data gathered and presented and
agree to allow the journal to review theses if requested.

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REFERENCES
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2 Ingelfinger FJ. Informed but uneducated consent. N Engl J Med. 1972;287:465-66.
3 Holland PV. Informed consent for Transfusion recipients: How much is enough?
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Medicine, Dordrecht: Kluwer Academic Publishers, 1996, pp.17-24.
4 Rennie D. Informed consent by “ Well-nigh abject” adults. N Engl J Med 1990;
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6 Stowell CP. Informed consent for patients: Blood transfusion and Cellular therapies. In:
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7 Expert Work Group. Guidelines for Red blood cell and Plasma transfusion for adults and
children. Can Med Ass J. 1997;156 (11 suppl):S1-S24
8 Grainger B, Margolese E, Partington E. Legal and ethical considerations in blood trans-
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9 Rock G, Berger R, Filion D, Touhe D, Neurath D, Wells G, et al. Documenting a transfu-
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2005;13-14.
11 De Graaf JD, Kajja I, Bimenya GS, Postma MJ, Smit Sibinga CTh. Bedside practice of
blood transfusion in a large teaching hospital in Uganda: An observational study.
Asian J Transf Sci 2009; 3:60-65.
12 Pope C, Ziebland S, May N. Qualitative research in health care .Analyzing qualitative
data. Brit Med J 2000;320;114-16.
13 Sandelowski M. Focusing on research methods combining qualitative and quantitative
sampling, data collection and analysis techniques in mixed-methods. Research in
Nursing & Health, 2000;23:246-55.
14 The clinical use of blood. WHO revised interactive edition, 2005. Geneva, CH
15 Worthington R. Clinical issues on consent: some philosophical concerns. J Med Ethics
2002;28:377-380
16 Elizabeth J, Warner J. How much do Doctors know about consent and capacity? J Royal
Soc Med. 2002;95:601-03.
17 Freidman MT, Ebrahim A. Adequacy of physician documentation of red cell transfusion
and correlation with assessment of transfusion appropriateness. Arch Pathol Lab Med
2006;130:474-79.
18 Barnett AT, Crandon I, Lindo JF, Gordon-Strachan G, Robinson D, Ranglin D. An assess-
ment of the process of informed consent at the University Hospital of the West Indies. J
Med Ethics 2008;34:344-347
19 Horikawa N, Yamazaki T, Sagawa M. Changes in disclosure of information to cancer
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20 Iglesia LML, Pedro-Botel MJ, Pallas VO. Hernandez LE, Echarte JL, Solsona DJ. In-
formed Consent: Opinions of health care personnel from a teaching hospital. Rev Clin
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2000;135:26-33.
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23 Saxena S. Ramer L. Shalman I.A. A Comprehensive assessment programme to improve
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Chapter 3

Blood Request Form at a University


Teaching Hospital: Evaluating Design
and Clinician Compliance

I. Kajja, G.S. Bimenya, C.Th. Smit Sibinga


Published in: Int J Health Science 2008;1:69-73

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SUMMARY

Background: Delivering safe and adequate transfusion to patients is critically dependant


on sound communication of information to the blood bank laboratory. This aids laboratory
technicians to identify appropriate blood products. In developing countries this needs to be
streamlined.
Study design and methods: Comparative analytical study of the design of the Mulago
Hospital and a model WHO blood request form concurrently with a cross-sectional audit of
1,756 blood request forms presented to to assess adequacy of information provided by
blood prescribing clinicians to the blood bank.
Findings: Mulago Hospital uses an old form (blood requirements still represented in bot-
tles). Audit showed all sections of the form carry inadequate information. Clinician identi-
fication had the best attention (82·7%) while the section on amount of and time blood is
required had only 0·5% adequately filled. There was a significant correlation between ade-
quacy of information provided on clinician identification and time and date samples were
sent to the blood bank.
Interpretation: Transfusion prescribers do poorly comply with current Mulago Hospital
blood request form.

Keywords: Blood request form, audit, prescribing clinician, design, blood transfusion

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INTRODUCTION

The process of blood transfusion starts with making a diagnosis, establishing a reason for
the necessity of haemotherapy and eliciting relevant previous transfusion history, all of
which should be documented in the patient file. [1, 2] A pre-transfusion test sample is taken
from the patient and labeled. The information that accrues from the above procedures is
legibly documented on a blood request form by the prescribing clinician who properly iden-
tifies himself. The sample is then sent with the filled request form to the blood bank for
various compatibility tests and selection of appropriate blood product(s). [3-6]
The World Health Organization (WHO) recommends that each institution uses a blood re-
quest form for effective communication of the pretransfusion patient information to the
hospital blood bank laboratory. [7] WHO provides a model request form (RF) that acts as a
bench-mark for the various blood using institutions. This form (figure 1) has components
pertaining to hospital identification, patient identification, history of transfusion associ-
ated events, information regarding the current blood request and clinician identification.
In Mulago hospital all transfusion requests, in emergency and elective situations are com-
municated to the blood bank laboratory through a locally designed blood request form,
H F311 (figure 2).
We set out a study with two objectives: first to compare the design of the Mulago Hospital
blood request form with a standard WHO blood request form, and second, to do an audit on
the compliance of prescribing clinicians to the current Mulago blood request form H F311.

METHODS

Comparison of request forms


Mulago Hospital is a major University teaching and research hospital in Uganda. It has a
catchment area extending to all the East African countries. It is a 1500 bed hospital with an
approximate occupancy rate of 200%. Mulago Hospital uses a template request form to
communicate patient related events to the blood bank laboratory in preparation for trans-
fusions. Following approval of the Research and Ethics committee of Mulago Hospital a
critical analysis of the design of the H F311 was carried out, in comparison to a WHO refer-
ence form (RF). For purposes of this comparison the H F311 was divided into five sections
as they appear on the RF: hospital identification, patient identification, transfusion history,
current request and clinician identification. The general arrangement and the amount of
information provided by each form were then analyzed.

Audit of request forms


A cross-sectional audit on all blood request forms (n=1,756) that were received by the Mu-
lago Hospital blood bank over a period of 2 months (March 01 to April 30, 2007) was con-
ducted to find out the adequacy of information provided by the clinicians to the hospital
blood bank technicians. For purposes of this audit, the information on this form was
grouped into six (6) sections:
> patient identification (name, age, sex, registration number, hospital, ward and bed number).
> indication setting (diagnosis, hemoglobin, ABO group, Rhesus, reason for transfusion,
history of transfusion)
> risk of sensitization with Rhesus D positive red cells for female patients (number of
pregnancies, any still births, jaundiced babies)

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> amount of and time blood is required (immediately, intermediately and at a later time).
> clinician identification (name and signature)
> sample delivery to the hospital blood bank (time and date).

We considered information on a given item adequate if it was legible and completely


recorded, and inadequate for use by the blood bank staff, if recorded illegibly, incompletely
or not recorded at all.

Figure 1 – Example of a model blood request form as advocated by WHO (WHO RF).

Example of Blood Request Form


(WHO Department of Blood Safety, Geneva, CH)

Hospital: ____________________________ Date of request: __________________________

Patient Details
Family name: ________________________ Date of birth: _________________ gender: M / F

Given name: _________________________ Ward: __________________________________

Hospital reference No:: _________________ Blood group(if known): AB0: ______


RhD:______

History
Diagnosis : ___________________________ Antibodies: Yes / No
Reason for transfusion: _________________ Previous transfusion Yes / No
Haemoglobin: _________________________ Any reactions Yes / No
Previous
Relevant medical history: ________________ pregnancies/stillbirths/abortions Yes / No

Request
Group, screen and hold patient’s serum Red cells units
Provide product Plasma units
Date required: ________________________ Whole blood units
Time required: ________________________ Other units
Delivered to: __________________________

Name of Doctor: ______________________ Signature: _____________________________

Important: This blood form will not be accepted if it is not signed or any section is left blank
LABORATORY USE ONLY

Patient ABO
Donor typing Compatibility testing Rh D
Donation AB0 Rh AHG Room temp Date of Time of Date of issue Time of issue
Pack No Saline match match

Signature of tester:
_______________________

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Figure 2 Mulago Hospital blood request form (H F311).

H F311

REQUEST FOR BLOOD FOR TRANSFUSION


URGENT/NOT URGENT

Name _________________________________ Age ________ Sex ________ Registration No: ____________


Hospital ____________________________________ Ward __________Bed ______________
Patien t’s
Clinical diagnosis ____________________________________ Hb ________ Group _______ Rh ___________
Reason for transfusion: _______________________________________________________________________
History of previous transfusions ________________________________________________________________
__________________________________________________________________________________________
If female patient: No of pregnancies _________________any stillbirth ____________ jaundiced babies:_______
_________ bottles of blood required immediately, __________________________________________________
_________ bottles of blood required at _____________________ on __________________________________
_________ bottles of blood may be required later; please keep serum. __________________________________

N.B.: To be completed by doctor and sent with 3-5 c.c blood CLEARLY LABELLED to the Laboratory. Blood will be reserved for 24
hours only unless by special request. Please note that an urgent grouping and cross-matching will usually take at least one hour.

IN EVENT OF A REACTION – stop transfusion; notify the laboratory; return the bottle unwashed, immediately.

Clinician i/c _______________________________ Doctor’s Signature _____________________


Specimen sent at ____________________ on _________________

FOR LABORATORY USE ONLY


Specimen received at ____________________ on _________________________________
Patient’s Blood Group ___________________ Rh _____________________ Lab. No ___________________

DONOR BLOOD MATCHING

Bottle Group Expiry 37° c RT 37° c 37° c Time Read Signature


number Date I.C.T. Saline Saline Albumin allowed Time/Date

Statistical analysis
The statistical package for social sciences (SPSS, version 11·5) program was used for data
analysis. A bivariate Pearson Product-Moment Correlation Index was performed to find re-
lationship between the adequacy of information provided by the clinicians on any two sec-
tions of the form, with a significant correlation at the 0·01 level (2-tailed).

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RESULTS

In an effort to improve the quality of communication between the clinical and laboratory
setting on transfusion matters, each institution ought to establish a cyclical audit system
that is charged with data collection, analysis, doing comparisons, giving timely feedbacks
and effecting appropriate interventions. The current study brought out the following issues
on the design and clinician compliance to the Mulago Hospital blood request form, a cardi-
nal transfusion communication tool at this institution.

Design of the Mulago Hospital blood request form (H F311).


The HF311 has 27 while the WHO RF has 28 items that are supposed to be filled by the pre-
scribing clinician. On the WHO RF, but not on H F311, these are grouped into obvious sec-
tions. Moreover, unlike WHO RF, the H F311 does not have a precautionary note to the
clinician that the blood request form and pretransfusion test sample will not be accepted if
the form is not duly signed or if any space is left blank.

Hospital
Both forms provide a space for the name of the hospital.

Patient identification
The H F311 and WHO RF provide the necessary patient identifiers albeit differently. The
WHO RF asks for the family and given names while the H F311 just asks for a name. The
amount of time somebody has been on the world is represented as age by the H F311 while
the WHO RF specifies the date of birth.
Contrary to the H F311, the WHO RF misses the patient ward and bed number.

History
The H F311 asks for details on pregnancy related events as important indicators of proba-
ble Rhesus D sensitization. These include history of still births and jaundiced babies. This
is captured with one question about previous pregnancies on the WHO RF.
The outcomes of previous transfusions are requested by an open ended phrase on the
H F311 ‘History of previous transfusions’, while the WHO RF specifically asks for previous
adverse reactions following a transfusion.

Current request
Contrary to the WHO RF, the H F311 asks for more details on the amount and time at
which blood is required, represents the volumes in number of bottles but not donor units
(bags) and does not specify for the blood product required at a particular time. The final des-
tination of the currently requested bottle of blood is not indicated on the H F311, however
this is shown by the phrase “deliver to” on the WHO RF.

Clinician identification
Both forms adequately allow identification of the prescribing clinician by asking for name
and signature.

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Audit of the adequacy of information provided by clinicians.


The statistical outcomes of the 6 sections and the respective items are given in Table 1.
All the 1,756 blood request forms reviewed had two names of the patient and sex legibly
recorded. However, the other items were recorded at different rates of adequacy ranging
from 11·8 % patient bed number to 97·9% ward number (Table 1). Overall 9·9% (n = 173) of
the reviewed forms had patient identifiers adequately recorded. (Table 1 section Patient
identifiers)

Table 1 Percentage of compliance with total requested information on the blood request form (n = 1756) per section.
The percentage compliance for each item related to the total number of each item filled in.
Section and Item % adequacy of information
1. Patient identifiers 9·9
Name 100
Sex 100
Age 96·4
Registration number 76·6
Ward number 97·9
Hospital 94·5
Bed number 11·8
2. Indication setting 15·3
Diagnosis 90·5
Hemoglobin 25·5
Blood group 21·2
Rhesus D 18·5
Reason for transfusion 77·7
History of transfusion 50·5
3. Risk of sensitization for females 20·0
Number of pregnancies 30·8
Still births 24·7
Jaundiced babies 21·4
4. Amount of and time blood is required 0·5
Bottles (units) required immediately 42·5
Immediate time frame 17·1
Bottles (units) required intermediately 15·4
Time of intermediate requirement 14·0
Date of intermediate requirement 18·5
Bottles (units) required later 5·1
5. Clinician identification 82·7
Name of clinician in charge 88·1
Signature of clinician in charge 90·5
6. Specimen delivery to laboratory - time and date 64·7
Time sample sent 71·6
Date sample sent 79·3

The indication settings for transfusions were also poorly communicated with adequacy of
provided information ranging from 18·5% for Rhesus D factor to 90·5% for the diagnosis.
Hemoglobin level which is usually the trigger for transfusion in this institution was miss-

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ing in up to 74·5 %. Overall 15·3% (n = 266) of the reviewed forms had indicators for clinical
indication setting adequately recorded (Table 1 section Indication setting).
The obstetric factors that show previous risk of Rhesus D antigen sensitization in female
patients were not adequately recorded. History of pregnancy was missing in 69·2%, history
of still births missing in 75·3% and history of jaundiced babies not recorded in 78·6%.
Overall 20% (n =351) of the reviewed forms had indicators for risk of sensitization for fe-
males adequately recorded (Table 1 section Risk of sensitization for females).
The amount of and time blood was required by the clinicians was the poorest documented
section of the request form with only 0·5% (n = 8) adequately recorded (Table 1 section
Amount of and time blood is required). However, clinician identity and time samples were
delivered to the hospital blood bank received better attention compared to all other sections
with 82·7% and 64·7% rate of adequacies respectively. Overall 82·7% (n = 1452) was ade-
quately recorded (Table 1 section Clinician identification).
The recording of time and date of sending samples to the laboratory was adequately
recorded in respectively 71.6 and 79.3%, with an overall adequacy of 64·7% (n = 1136)
(Table 1 section Specimen delivery to laboratory – time and date).
The item ‘please keep serum’ was not recorded in any of the reviewed forms.
There was a significant correlation [Pearson’s correlation index 0·199 and significant corre-
lation at the 0·01 level (2-tailed)] between the adequacy of information provided on the clini-
cian identity and the time and date the samples were delivered to the hospital blood bank.

DISCUSSION

The design of any communication tool has a profound effect on the quality and quantity of
information provided. [8, 9] This study has shown that Mulago Hospital uses a blood request
form which has not been reviewed for since 1974 when the WHO edited use of SI units.
Tools that date to old times are usually not appreciated by current staff especially if there
are no routine training programmes on their use as is the case for this institution. [8]
This could be a reason to explain the inadequacy of information provided to the blood bank
by the current prescribing clinicians.
Detailed and clear patient identifiers are an important aspect to prevent adverse transfu-
sion events. [10-12] The H F311 does not stimulate the clinician to document both the family
and given names, and merely stating the age of an individual is not as accurate as record-
ing the date of birth as is the case with the WHO RF. These short falls in the design are po-
tential causes of patient identification errors in the clinical and laboratory settings. In a
study by Lumadue et al. [13] on mislabeled and miscollected samples in a large US hospital
survey it was found that among the 40,770 samples 1·4 % (1 in 71) were mislabeled. Even
of correctly labeled samples, clinicians did draw blood from a wrong patient in 0·035%.
These errors resulted from wrong patient identification. The current findings also relate
with the work of William et al. [11] who found that phlebotomy errors and inadequate patient
identification represent a substantial cause of hazards of transfusion in England. In an-
other comparable study, Andreu et al. [12] in a French hemovigilance program found that
human error at clinical and laboratory levels lead to major ABO mismatching of red cell
transfusions resulting into six fatalities. It should be noted that it is difficult in the Ugan-
dan situation to elicit the exact date of birth from the patient since these records are not
usually kept. However, observation has shown that in most cases the patient is not asked
for a date of birth, but just for the age.

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The ward and bed number that appear on the H F311 were not adequately communicated
by clinicians to the laboratory since these are not primary identifiers and patients can
change beds or wards during their hospital stay. This could have resulted from the fact that
Mulago Hospital is always overcrowded with many patients spending their entire hospital
stay lying on the floor of wards and corridors without a proper ward or bed number indication.
It is important to present the patient hemoglobin level, blood group and Rhesus D factor
status to the hospital blood bank. These are provided for on the H F311. However, they were
not adequately communicated due to the fact that at Mulago Hospital there is no policy on a
detailed laboratory work up on patients as they enter the hospital. In most cases these in-
dices are not known to the clinician before a pretansfusion test sample is drawn. Details of
previous transfusions like adverse transfusion reactions and patient antibody profile are
not asked for on the H F311 though they are an integral part of laboratory work-up before a
transfusion. We speculated that these items were missed from the H F311 since it was de-
signed before routine antibody screening became mandatory especially for female patients
of child bearing age. However, items like “reason for transfusion” and “relevant female ob-
stetric history” that are well presented by the H F311 were not adequately recorded.
Nonetheless, this could have resulted a limited access to transfusion order protocols in
wards and intensive care units where the blood requests are made.
The H F311 does not provide an opportunity to the clinician to specify the blood product re-
quired at a particular time. This is contrary to the WHO recommendation and is character-
istic for irrational blood use. It should be noted that due to infrastructural and logistical
shortcomings in Uganda minimal processing of blood into various components is done and
in most cases whole blood is transfused. The design of the H F311 stems from the bottle
(pint of whole blood) era and has so far not been adjusted. This directly affects the clinicians
ordering practices. The current situation easily relates to Raspollini E. et al. [8] study on the
clinician satisfaction with transfusion services where they found that the practices of the
prescribing physician were highly affected by the clarity of the blood request form, clarity of
other transfusion procedures and the convenience of blood requests and issuing times.
It was also observed at Mulago Hospital that often the blood request forms are filled in at
the hospital blood bank. Moreover, this is done by whoever delivers the sample to the blood
bank rather than by the prescribing clinician. This is certainly hazardous.
The other weakness in the design of the H F311 form that could have caused these gross
miss recordings is its lack of a penalty statement that the samples will be rejected by the
laboratory if the accompanying request forms and samples are not adequately and legibly
filled or labeled.
There was better documentation of the patient names, age, clinician identity and time and
date of sample delivery to the laboratory (Table 1). The format of the request form displays
these items next to each other, therefore making it easier to record them. It could also have
resulted from the basic training of the clinicians in this institution which emphasizes pa-
tient identification by two names and age, and counter signing of any official document.
The above scenario is in line with Smit Sibinga’s works on the clinical-laboratory flow of
transfusion events in Low Human Development Index (L-HDI) countries where he ob-
served a widespread practice of blood ordering conducted with a minimum of information
and written on any piece of paper available. [14]
In a related situation Dzik identified three potential erring points in the transfusion
process: patient sample collection, the decision to transfuse and bedside administration of
blood, that are compounded by poor clinician-laboratory communication which results in
serious transfusion hazards. [15]

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Audits and timely feed back to the clinicians about good transfusion practices lead to im-
provement in blood usage. Toy pointed out that cyclic audits and education to physicians
prescribing transfusions lead to identification of inappropriate transfusions, improvement
of bedside blood administration practices, avoids unnecessary cross-matches and reduces
outdating of precious donor blood. [16] The current audit has revealed that the blood pre-
scribers at Mulago Hospital do not adequately comply with even the old blood request tool
in use. In 17% it was difficult to trace clinicians who had made the prescriptions. So the at-
titude of the clinicians towards the current H F311 form needs a comprehensive explo-
ration in future research undertakings. The form needs a thorough revision to bring it up to
WHO standards. There should be periodic auditing of the blood ordering processes fol-
lowed by timely feedback to clinicians through continued professional development (CPD)
and education exercises.

ABBREVIATIONS
L-HDI Low Human Development Index.
H F311 Mulago Hospital request form.
RF Model World Health Organization blood request form.
SI Standard International
SOP Standard Operating Procedures.
WHO World Health Organization.

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REFERENCES
1 Brooks JP. Reengineering transfusion and cellular therapy processes hospital wide: en-
suring the safe utilization of blood products. Transfusion 2005;45:159s–71s.
2 Busch MP, Kleinman SH. Nemo GJ. Current and emerging infectious risks of blood
transfusion. JAMA 2003;289:959–962.
3 Goodnough LT. Risks of blood transfusion. Crit Care Med 2003;31(suppl 12):S678–686.
4 Zbigniew MS, and AuBuchon JP. The role of physicians in Hospital transfusion serv-
ices. Transfusion 2006;46:862–867.
5 Rossman SR (ed). Guidelines for the labeling of specimens for compatibility testing. AABB
Press, Bethesda, MD 2002.
6 Murphy MF and Kay JDS. Patient Identification: Problems and potential solutions. Vox
Sang 2004;87(suppl.2):S197–S202.
7 The Clinical Use of Blood. WHO revised interactive edition, Geneva CH, 2005.
8 Raspollini E, Pappalettera M, Riccardi D, Parravicini A, Sestili S, Rebulla P, Sirchia G.
Use of SERVQUAL to asses clinicians’ satisfaction with the blood transfusion services.
Vox Sang 1997;73:162–166.
9 Serious Hazards of Transfusion. Annual Reports Serious Hazards Of Transfusion
Scheme, Manchester, UK. (www.shotuk.org)
10 Kohn LT, Corigan JM, Donaldson MS (eds). To err is human: Building a safer health sys-
tem. Washington National Academy Press, Washington DC, USA 2000.
11 William DH, Murphy MF, Andreu G, Heddle N. Högman CF, Kekomaki R, et al. An in-
ternational study of the performance of sample collection from patients. Vox Sang
2003;85:40–47.
12 Andreu G, Morel P, Forestier F, Debeir J, Rebibo D, Janner G, et al. Hemovigilance net-
work in France: Organization and analysis of immediate transfusion incident reports
from 1994 to 1998. Transfusion 2002;42:1356–1364.
13 Lumadue JA, Boyd JS, Ness PM. Adherence to strict specimen-laboratory policy de-
creases the incidence of erroneous blood grouping of blood bank specimens. Transfu-
sion 1997;37:1169–1172.
14 Smit Sibinga CT. Detecting and monitoring reactions in the developing world. In:
Transfusion Reactions, Popovosky MA, ed. AABB Press Bethesda MD, USA 3rd edition.
2007; pages 549–565.
15 Dzik WH. Emily Cooley Lecture 2002. Transfusion safety in the Hospital. Transfusion
2002;43:1190–1198.
16 Toy PT. Audit and education in transfusion medicine. Vox Sang 1996;70:1–5.

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Chapter 4

Bedside Practice of Blood Transfusion in


a Large Teaching Hospital in Uganda:
An Observational Study

J.D. de Graaf, I. Kajja, G.S. Bimenya, M.J. Postma, C.Th. Smit Sibinga
Published in: Asian J Transf Science 2009;3:60-65

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ABSTRACT

Background: Adverse transfusion reactions can cause morbidity and death to patients who
receive a blood transfusion. Blood transfusion practice in Mulago Hospital, Kampala, Uganda
is analyzed to see if and when these practices play a role in the morbidity and mortality of pa-
tients.
Materials and Methods: An observational study on three wards of Mulago Hospital. Physi-
cians, paramedics, nurses, medical students and nurse students were observed using two
questionnaires. For comparison, a limited observational study was performed in the Uni-
versity Medical Centre Groningen (UMCG) in Groningen, The Netherlands.
Results: In Mulago Hospital guidelines for blood transfusion practice were not easily avail-
able. Medical staff members work on individual professional levels. Students perform poorly
due to inconsistency in their supervision. Documentation of blood transfusion in patient files
is scarce. There is no immediate bedside observation, so transfusion reactions and obstruc-
tions in the blood transfusion flow are not observed.
Conclusion: The poor blood transfusion practice is likely to play a role in the morbidity and
mortality of patients who receive a blood transfusion. There is a need for a blood transfusion
policy and current practical guidelines.

Key words: Blood transfusion, developing country, observational study, practice, transfu-
sion reactions

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INTRODUCTION

Blood transfusion is a tissue transplantation which can cause serious adverse reactions.
These reactions may potentially delay the recovery of the patient or may even lead to death of
patients. In Western countries, the frequency of adverse reactions which lead to major con-
sequences for patients is relatively low. In 2006 in The Netherlands with a 16.5 million pop-
ulation, 578,145 units of blood were collected and 556,509 blood units were issued, where
1.2% of the patients suffered from severe morbidity and 0.2% of the patients died as a con-
sequence of blood transfusion.[1] On the other hand, in Uganda with a population of 30 mil-
lion people, out of the 150,000 units of blood collected annually, 135,000 units are
administered. The remaining 15,000 units are discarded due to positive indicators of trans-
fusion transmissible infections. Reports to show the various outcomes of the transfusions
performed are hard to come by due to poor documentation.
There is limited information available on adverse transfusion reactions in developing coun-
tries. In many situations there is no proper and reliable documentation of the patient’s trans-
fusion history. A preliminary observation of patients undergoing transfusion in the Makerere
University teaching hospital Mulago in Kampala, Uganda, showed that the general condi-
tion of some patients deteriorates and others die after receiving a blood transfusion. How-
ever, it was not evident whether these changes in patient conditions were solely due to the
transfusions or to the underlying disease processes. Worse, these events were not routinely
recorded and analyzed for causal factors, which may include the blood transfusions per se.
We therefore analyzed the current bedside blood transfusion practices in Mulago Hospital,
with an underlying hypothesis that the handling and dispensing of clinical transfusion pro-
cedures has a direct relationship to transfusion outcomes. To put our local observations into
perspective a comparative analysis was performed at the University Medical Centre Gronin-
gen (UMCG), The Netherlands.

METHOD

Study design
The study was a SWOT (strengths, weaknesses, opportunities and threats) analysis on the
basis of an observational study on transfused patients and their hospital environment, car-
ried out in Mulago Hospital, Kampala, Uganda. This teaching hospital operates in a health-
care environment, classified by UNDP as a low Human Development Index (HDI) country.
Mulago Hospital is one of the main teaching hospitals in the countries surrounding Lake Vic-
toria in East Africa. Mulago Hospital has a bed capacity of 1,500 patients, but the occupancy
rate is around 200%.

Observational study
Following approval by the research and ethics committee of Mulago Hospital an observa-
tional study was carried out among medical and paramedical staff for a period of three
months from January to April 2007. The participants were purposively selected on the crite-
rion of being any clinician, nurse or student who participates in the clinical process of blood
transfusion. The study was carried out in the wards. Without interference with the normal
routine in these locations, the participants were observed reaching conclusions on the diag-
noses, taking decisions to transfuse, taking pre-transfusion samples, ordering for blood,
transporting samples and request forms to the hospital blood bank and administering the

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blood to the patients. The staff members involved in blood transfusion were physicians, sen-
ior house officers, medical students, paramedical students, nurses and student nurses.
The observed patients (n = 41) were admitted at three different wards: the orthopedic ward,
the Acute Care Unit for children and the gynecology and obstetrics ward. The observations
were substantiated with two questionnaires. The first questionnaire was for collection of
general information about the blood transfusion practice, like documentation, storage and
transport conditions and the presence of guidelines. The second questionnaire was designed
for the collection of patient data like history, symptoms, diagnosis, treatment plan and phys-
ical condition during interventions. The questionnaires were pre-tested for validity during
the first week of the study by the observer and a senior doctor.
The observed staff members and patients were randomly chosen from those situations ad-
hering to one strict criterion: the patient should receive a transfusion according to the treat-
ment plan.

Figure 1 Flow chart for the reception of the blood unit on the ward (A) and the transfusion of the blood unit (B)
(Smit Sibinga in: Popovsky 2007). [2]

From A
Reception at ward

Patient file
No Transport to Connection; start start date & time
OK? transfusion
laboratory

Yes
Patient file
Immediate
observation
observation
No Patient
identification

No Discontinue
OK?
transfusion

OK?
Yes

Yes
Transfusion
Patient file
Patient vital signs vital signs

Patient file
No Reporting
OK? documentation
laboratory

To B
Yes

Patient file
Observation of
observation
outcome

Next step(s)

A B

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Comparison
To enable comparison, a similar approach was followed in the University Medical Centre
Groningen (UMCG), in the north of The Netherlands. This is a teaching hospital operating in
a highly advanced health care environment in a high human development index country (high
HDI). The hospital has 1,300 patient beds and has an occupancy rate of around 100%. The
study in the UMCG was carried out in the oncology day care centre, orthopedic ward and trau-
matology ward, the departments that use blood most often in this institution.
The bedside blood transfusion practice, from the reception of the blood unit on the ward till
the end of the blood transfusion chain, was analyzed following a specific flow chart [Fig-
ure 1].[2]

RESULTS

Mulago Hospital Guidelines


The current guidelines for blood transfusion published by Ministry of Health in Uganda were
designed in 1989. These guidelines fall short in addressing key points in the bedside use of
blood and put little emphasis on the creation and active participation of hospital transfusion
committees in clinical use of blood. The Ministry of Health is currently designing new blood
transfusion guidelines.
The current guidelines have not been well introduced and disseminated, and are not readily
accessible on the wards in Mulago Hospital. Staff members, whether medical or paramed-
ical, work with the knowledge and experience gathered during their education and on-the-
job training. There is no uniformity and as a result staff members work on various
professional levels. The absence of guidelines further enhances variation of practice. There is
incomplete documentation, which seriously hampers traceability of data related to the trans-
fusion episodes. So, there are no written process descriptions and hence no standard operat-
ing procedures to follow, describing the step-by-step order of the practice at the bedside.

Reception of the blood unit on the ward and patient identification


The units, which are issued by the hospital blood bank, are transported by hand to the ward
by a ward or theatre staff member, e.g. a resident physician, nurse or student on duty on that
ward. This staff member is also responsible for patient identification. Units are not stored or
kept under appropriate conditions after arrival on the ward. Units selected for patients un-
dergoing surgical interventions are kept in a domestic refrigerator. These are not appropriate
for storage of blood since they do not have uniform temperatures and are not fitted with any
control devices like audible alarms in case of temperature changes. These refrigerators run
a serious danger of being contaminated with microorganisms, as cleaning and disinfection
are not a common procedure.
On the wards the staff member will bring the unit to the patient without a formal identifica-
tion procedure such as explicitly asking for name or date of birth of the patient. Patients do
not wear a wristband with uniquely identifiable information, as these have not yet been in-
troduced in Uganda.

Blood unit warming and patient vital signs


After the blood unit is received at the ward, it is warmed in the armpit of a relative for up to
30 minutes or in the bed of the patient for up to 3 hours. It is not a common practice for staff
to record vital signs (temperature, pulse rate, blood pressure and respiration rate) before con-

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nection of the blood unit to the patient. This hampered interpretation of whatever symptoms
developed during or after the transfusion. Hence, the root cause of a transfusion related re-
action could not easily be traced.

Connection of the blood unit and immediate observation


The blood unit is connected by one of the medical staff members (either junior or senior mem-
ber, whoever is involved). First a small bore needle or catheter is inserted in a vein and after
that the infusion set is connected with the blood unit. A 0.9% sodium chloride drip is not
used and the set is not rinsed before connecting to the unit of blood. This is done by all med-
ical staff members and medical students, but medical students hardly know how to perform
the procedure. These students learn without direct supervision or proper training, basically
by trial and error. Standard principles of asepsis are poorly and inconsistently observed, as
is the position of the needle in the vein. There were episodes observed where a needle or a con-
nection set was not available and the transfusion had to be postponed. Meanwhile, a relative
was urged to buy a needle or a giving set on the market.
There is no immediate and continuous observation of the patient. Therefore transfusion re-
actions and obstructions of the blood transfusion system and flow were not constantly ob-
served. At certain points during the study it was observed in the department of Pediatrics
that a unit of blood was shared among two or three children and ran simultaneously or in
succession.

Transfusion and observation of the outcome


During the transfusion there is no observation of the patient. After the transfusion, there is
no observation and recording of the outcome. However, bedside observations of transfusions
were noted in emergency cases and as a component of the routine patient observations dur-
ing the daily or sometimes only weekly ward rounds.

Documentation in the patient file


The documentation of the transfusion is very limited; of all transfusions observed around
50% were documented in the patient file, but only briefly and inaccurately. The documenta-
tion consisted of the fact that a blood transfusion had been given, the volume of the given
unit and the names and amounts of administered drugs prior to, concomitant with and/or
post transfusion. The identification number of the blood unit, the starting time and duration
of the procedure were documented occasionally, but not consistently. Cross match informa-
tion and the pre and post transfusion vital signs were not recorded at all. The ultimate out-
come of the transfusion was not documented in the patient file.

University Medical Centre Groningen Guidelines


According to the European Union (EU) Directive 2002/98/EC, all procedures for blood trans-
fusion on the ward must be described and detailed in accessible guidelines.[3] The guidelines
are available through the ICT network of the hospital and are followed by all medical staff
members. All medical staff members have to prove their competence to perform the blood
transfusion procedures. Without this proof, which is a test observed by an authorized senior
staff member, they are not allowed to perform the blood transfusion procedure. So all med-
ical staff members at UMCG work professionally and on the same level.

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Reception of the blood unit on the ward and patient identification


Blood units are transported to the ward by a laboratory technician of the hospital blood bank
carried by hand in a temperature-controlled environment (container) or by a fast tube post
system. For acceptance of the blood unit one of the registered medical staff members has to
sign the accompanying issue form. The identification number on the blood unit, the blood
group and Rhesus type of the unit, the expiry date and the patient data are compared with
the data on the issue form and with the data in the medical file of the patient. This is all done
by two registered medical staff members (check and double check). Then the patient is iden-
tified with help of the bar coded patient identification wristband and by asking name and
date of birth of the patient.

Blood unit warming and patient vital signs


In the UMCG a blood unit is warmed only in special indications and the warming is done
using adequately controlled equipment. Before connection of the blood unit vital signs are
measured and documented in the patient file.

Connection of the blood unit and immediate observation


The blood unit is connected by a registered medical staff member. First a large bore needle or
catheter is inserted and thereafter the blood unit is connected. An infusion Y-set enables con-
nection of the blood unit on one arm and a normal 0.9% sodium chloride solution on the other
arm of the Y-set. So the blood transfusion system is rinsed easily and a saline drip could serve
as a rescue in case of an acute adverse event or between two subsequent transfusions.
Ten minutes after the start of the transfusion the patient is observed for adverse transfusion
reactions and the findings are documented in the patient file. During the observation patients
are also frequently asked how they feel.

Transfusion and observation of the outcome


After the transfusion the patient is observed and asked about the physical condition. How-
ever, hardly any documentation of the outcome of the transfusion is done anymore in the
nursing file. Post transfusion hemoglobin is measured and documented in the patient file. In
the UMCG, subsequent bedside observations of the outcome are the immediate observations
in case of specific acute health problems or the clinical observations during the daily ward
rounds. There is specific evaluation of the outcome of the blood transfusions based on the re-
quirements of the national hemovigilance system.[1]

Documentation in the patient file


The UMCG works with an advanced digital documentation system. All laboratory results, x-
rays, medication requests and interventions are documented in a digital patient file, which
is accessible to registered medical staff members managing the patient. Medical staff mem-
bers are obliged to keep the file up to date. Besides the digital documentation system, every
admitted patient has a nursing file, which contains all the written information about per-
formed bedside procedures.

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DISCUSSION

The observational SWOT analysis revealed a series of weaknesses in the bedside transfusion
chain of Mulago Hospital, which provide opportunities for improvement. The weaknesses
observed in the bedside transfusion chain are marked in Figure 2. To enhance the quality of
healthcare it is important that these weaknesses are identified and improved. However, it
was observed that most staff involved seemed not really conscious of the importance of the
work done, showing limited attention for both the unit of blood and the recipient of this pre-
cious gift of life.

Figure 2 Flow chart for the reception of a unit of blood at the ward (A), and the transfusion of the unit (B). The observed
weak points in the chain are marked.

From A
Reception at ward

Patient file
No Transport to Connection; start start date & time
OK? transfusion
laboratory

Yes Patient file


Immediate
observation
observation
No Patient
identification

No Discontinue
OK?
transfusion

OK?
Yes

Yes
Transfusion
Patient file
Patient vital signs vital signs

Patient file
No Reporting
OK? documentation
laboratory

To B
Yes

Patient file
Observation of
observation
outcome

Next step(s)

A B

Reception of the blood unit on the ward and patient identification


Transportation of blood units in open air, over a length of time and distances in Mulago Hos-
pital may cause warming of the blood unit due to the high ambient temperature. This tem-
perature increase causes bacterial growth and hemolysis of the blood.[4,5] The environment of
the UMCG, with a well functioning cold chain, ensures a controlled temperature for trans-
portation of a unit of blood and guards against these iatrogenic compromises on blood safety.

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It should be noted, however, that the cold chain for preserving transport and storage condi-
tions is not yet developed in Mulago Hospital and needs urgent attention from all stake-
holders. Transportation in cool boxes and appropriate storage of the blood units on the ward
or operation theatre are simple solutions to improve the quality of the blood units. The stor-
age of unused blood under inappropriate conditions at Mulago Hospital also compromises
the quality of the blood product. This can be followed by either bacterial or fungal growth in
the blood bag, hemolysis, disturbed electrolyte balance, depletion of nutrients or accumula-
tion of cell metabolites in the bag.
In Western countries 2/3 of the mistakes and errors made in the blood transfusion chain are
identification mistakes.[6,7] Therefore it is important that the right blood unit is given to the
right patient. This can be accomplished by an appropriate identification procedure. The WHO
advises an identification procedure performed by two persons of whom at least one is a reg-
istered professional. During the identification process the name and date of birth of the pa-
tient must be asked, and the patient medical file and the identification wristband are
checked.[8] Such identification protocol should be introduced and followed by a training pro-
gram for the medical and nursing staff and the medical and nursing students. This should
then be strengthened by regular audits. These WHO guidelines on patient identification are
easily adhered to at the UMCG whose blood administering units are well staffed. On the other
hand the units that use a lot of blood at Mulago Hospital like the department of pediatrics
are poorly staffed and cannot afford to station two staff members to confirm identity of one
patient for a given transfusion. This, however, can be mitigated by a well-designed training
program of the pre-service and in-service staff in patient identification principles. This train-
ing should be given during education and later during special in-service trainings.

Blood unit warming and patient vital signs


Blood units in the UMCG in The Netherlands are only warmed in specific indications, for ex-
ample if the transfusion is intended for patients with clinically significant cold agglutinins.
The warming is performed in specially designed equipment. In this way the blood is warmed
before it enters the body, so there is little chance of blood contamination or hemolysis.[4,5,7]
Keeping the patient warm is considered more important than warming the blood unit.
In Mulago Hospital all units are warmed, which is not necessary. The methods used to warm
blood at Mulago Hospital, like placing it in the armpit of a relative or in the bed of the patient,
increase the chances of bacterial contamination and damage (pinholes) to the plastic bag,
hence compromising the safety of the transfused products in this institution.
To measure the outcome of a blood transfusion there is a need for reference points. These ref-
erence points are the vital signs of the patient and the patient’s hemoglobin level. Therefore
vital signs of the patient should be measured before connection of the blood unit. It is diffi-
cult to interpret adverse transfusion reactions if the vital signs are not recorded prior to start-
ing the blood transfusion. The measurement of reference points is an easy and inexpensive
improvement of the blood transfusion practice, provided there is an adequate documenta-
tion system in place.

Connection of the blood unit and immediate observation


In The Netherlands there is a special training program for medical students. The students are
constantly supervised and they are not allowed to perform procedures by themselves. To in-
crease the quality of healthcare, the procedures are performed by qualified medical or nurs-
ing staff members. In particular, blood units should be connected by registered medical staff
members and medical students should constantly be supervised when doing this type of

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work. Blood as a tissue transplant predisposes recipients to adverse reactions, therefore it is


paramount to observe transfused patients for adverse transfusion reactions. In the UMCG
the blood transfusion protocol states that the patient be checked 10 minutes after starting the
transfusion. In this way immediate adverse transfusion reactions can be observed. There-
after the patient should be regularly observed.
In Mulago Hospital these vital steps of transfusion are overlooked. We postulate that this
could be due to lack of prior training to the attending medical and nursing staff or due to the
patient overload on the poorly staffed wards. This patient overload does not allow time for
the attending medical staff to give the required supervision to the students as they perform
bedside transfusion activities. The inadequate documentation of these baseline events un-
dermines the interpretation of the subsequent transfusion observation. In the absence of ad-
equate observation and documentation medical personnel do not react instantly or properly
to any outcome. The hospital should therefore design a transfusion policy and strategy, which
should include guidelines on immediate observations and documentation of a patient un-
dergoing a transfusion. It is also important to provide appropriate training of nursing and
medical staff on recognizing adverse transfusion reactions.
In addition to observing for adverse transfusion reactions, it is important to observe for the
rate of flow of the blood. In Mulago Hospital, unlike at UMCG, flow rate of transfusions, es-
pecially of packed red cells, were observed to be interrupted on several occasions. This could
have been due to the poor and inconsistent quality of transfusion sets and needles used, but
could also be explained by the common un-attended positioning of the limbs with transfusion
intravenous lines that cause kinks in the cannulas and infusion sets with subsequent inter-
ruptions in the blood flow. Besides, red cells (packed) in Uganda are very viscous because
hardly any plasma or fluid is left on the cells during processing. Therefore more blood trans-
fusions stop running. This obstruction of the flow problem should be resolved as soon as pos-
sible to facilitate an optimal effect of the treatment.

Transfusion and observation of the outcome


Observation of the outcome of a blood transfusion is a developing process in Western coun-
tries, yet largely absent in developing countries. For the remaining treatment of the patient
it is important to directly observe the outcome of the blood transfusion.

Documentation in the patient file


For the recovery process of the patient it is paramount to document all critical steps. If some-
thing goes wrong all documented steps can be traced and analyzed in the patient file. In The
Netherlands documentation is regulated by law and therefore always will be done. Addi-
tionally, in an increasing number of hospitals electronic patient files have been introduced.
In Mulago Hospital there is little documentation and this is mostly poorly legible. The qual-
ity of the patient file is also poor, so papers or documents are easily lost. To improve the qual-
ity of healthcare, and blood transfusion as an integral part, much improvement needs to be
made by developing an appropriate documentation system.

Guidelines
In the absence of available and/or accessible hospital guidelines for blood transfusion it is
hard to teach medical students appropriately. In most Western countries policies and guide-
lines are available and accessible. These guidelines should contain various aspects, which
are mentioned in the guidelines for blood transfusion developed by WHO.[8] Therefore a pol-
icy should be developed for blood transfusion together with appropriate guidelines.

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Conclusion and recommendation


In a developing world situation, like Mulago Hospital, Kampala, Uganda
> the blood transfusion practice on the ward is far from optimal.
> the blood transfusion practice is likely to play a role in morbidity and mortality of pa-
tients who receive a blood transfusion.

To improve the blood transfusion practice there is need for a blood transfusion policy and
strategy, including appropriate guidelines. After the introduction of such policy it is impor-
tant to provide training to medical and nursing staff, as well as to students and laboratory
staff. It is crucial that medical students are constantly supervised during their internship.
To show the importance of a well-developed blood transfusion policy there is a need to clearly
present the consequence of a less developed blood transfusion practice. In particular, adverse
transfusion reactions should be observed accurately, documented and evaluated. Subse-
quently this may serve as a strong rationale to improve the blood transfusion system. In the
end this will help to adequately motivate the professionals to support the development and
introduction of formal transfusion policies and guidelines, and to adequately adhere to the
latter.
Comparison with the blood transfusion policy of the UMCG gives an indication of a well-de-
veloped blood transfusion chain. However, the blood transfusion policies of the two hospi-
tals are so different, that it can only be concluded that a well-planned step-by-step
improvement in Mulago Hospital is needed, where the UMCG could serve as a reference.
The improvement of the clinical blood transfusion practice in Mulago Hospital will be a chal-
lenging task, because of the economic situation and the mindset in Uganda. There is little
money available for the organization of seminars, courses and for the organization of a blood
transfusion committee. There are also limited resources available to improve the patient files
and to introduce proper patient identification through the use of wristbands.
With the help of international professionals in the field of transfusion medicine it might be
possible to improve the blood transfusion practice in some aspects in the near future and ob-
served adverse reactions could be treated in a timely and effective manner. However, struc-
tured organization and infrastructure as well as the implementation of quality principles in
the hospital and a change in the mindset are paramount to such development.

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REFERENCES
1 TRIP 2006. TRIP report 2006. Available from: www.tripnet.nl. ISBN-10: 978-90-78631-
02-6.
2 Smit Sibinga CTh. Detecting and monitoring reactions in the developing world; In:
Popovsky MA, editor. Transfusion reactions. 3rd ed. AABB Press Bethesda; MD, USA:
2007. p. 549-65.
3 Directive 2002/98/EC. Official Journal of the European Union 2003;33:30-40.
4 Williamson JR, Shanahan MO, Hochmuth RM. The influences of temperature on red
cell deformability. Blood 1975;46:611-21.
5 Fischer TM. Shape memory of human red blood cells. Biophys J 2004;86:3304-13.
6 Pagliaro P, Rebulla P. Transfusion recipient identification. Vox Sang 2006;91:97-101.
7 Serious Hazards of Transfusion, annual report 2005. The Serious Hazards of transfu-
sion Steering group. ISBN 0 9532 789 8 0.
8 The Clinical Use of Blood. Handbook. World Health Organization, Department of Blood
Transfusion Safety, Geneva, CH 2005.

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Chapter 5

Blood Loss and Contributing Factors in


Femoral Fracture Surgery

Kajja I, Bimenya G.S., Eindhoven G.B.M., ten Duis H.J., Smit Sibinga C.T.
Published in: Afr Health Sci 2010;10:18-25

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ABSTRACT

Background: Substantial blood losses frequently accompany orthopedic procedures.


Methods: We prospectively noted peri-operative hemoglobin changes in 93 patients un-
dergoing surgery for femoral fracture with an aim of establishing blood loss and related fac-
tors.
Results: The mean total blood loss assessed 72 hours after the surgical procedure was 3.31
(SD 1.56) units of whole blood. A multiple regression analysis revealed diathermy use and a
simple fracture pattern as significant factors in reducing blood loss (p<0.01).
Conclusions: Open intramedullary fixation of femur fractures leads to considerable peri-
operative blood loss. This is can be reduced by use of diathermy during surgery.

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INTRODUCTION

Studies of major orthopedic surgery procedures demonstrate a considerable intra-operative


blood loss [1, 2, 3]. The amount of blood loss during surgery varies with patient and institution
for a given surgical procedure [1, 2], which limits standardization of peri-operative blood or-
ders. However, such blood losses are usually controlled by use of appropriate surgical tech-
niques including meticulous cauterization of bleeding vessels with diathermy.
Blood order schedules that result into grouping, cross-matching or holding of blood units
which peri-operative use may not materialize [4, 5], stress the limited hospital blood bank fi-
nancial and human resources, and limit access of the sparse blood units to those most in
need. It is therefore important for each institution to establish the intra-operative blood
losses and needs for the various surgical procedures performed in order to increase the effi-
ciency of limited blood supplies. This is particularly important in the developing world.
However, it may be difficult to ascertain the appropriate amount of blood loss as this varies
with patient, surgeon or institutional factors [6,7]. Such factors include irrational peri-opera-
tive blood transfusions in some institutions which makes it even harder to compute the
exact amount of blood lost during surgery. In order to measure blood loss at surgery [8, 9, 10],
two methods can be used – the direct and the indirect methods. The direct method involves
measuring collected blood in swabs, drainage bags and suction bottles, while the indirect
method measures blood loss by hemoglobin or hematocrit changes over the peri-operative
time.
At Mulago Hospital, a 1500 bed national referral and major teaching hospital in Uganda,
whole blood units are routinely transfused during and after orthopedic surgical proce-
dures, the commonest of which is open reduction and internal fixation of femoral shaft
fractures. It is a known fact that one transfused whole blood unit of 450mls leads to a 1g/dl
elevation in the hemoglobin level measured after full hemodynamic equilibrium at 72 hours
after surgery.
The orthopedic department at Mulago Hospital uses the SIGN [Surgical Implant Generation
Network] intramedullary nail technique [11] – an open intramedullary locking nail system
for internal fixation of femoral shaft fractures. This is performed without use of fluo-
roscopy or a traction fracture table. The procedure is accompanied by massive intra-opera-
tive and post-operative hemorrhage and therefore consumes a substantial amount of blood
in the peri-operative time. Unfortunately, there is limited or no information to facilitate or
to streamline the appropriate blood orders in this resource limited setting. This has lead to
unavoidable wastage of blood units especially when such units can not be used within the
peri-operative time.
The objectives of this study are first to determine the peri-operative blood loss during open
reduction and internal fixation of unilateral femoral shaft fractures. In this study, peri-op-
erative time ranged from 24 hours before to 72 hours after the surgical procedure. Second,
we determined the factors that contribute to this blood loss.

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MATERIALS AND METHODS

Study setting
The study was conducted in the wards and operating theatre of the department of Orthope-
dics at Mulago Hospital, the major referral hospital in Kampala, Uganda. Patients with
fractures of the femur who present to this hospital do not undergo surgery until after a
minimum of five days due to shortages in theater space and staffing. During this time the
fractures are maintained under skin traction to control fracture site bleeding and pain. Two
to five days before surgery the attending surgeons conduct preparatory pre-operative ward
rounds during which they haphazardly make orders for the units of blood to be used in the
peri-operative time. This resource constrained hospital has erratic supplies of blood which
are competed for by many categories of patients. The shortage of blood often leads to post-
ponement of surgical procedures. If the blood is available in the hospital blood bank, it is
delivered to the operating theater a day before or on the morning of surgery and kept in a
domestic refrigerator with uncontrolled temperatures until the anesthesiologist requests
for it during surgery or 24 to 48 hours after surgery.

Study design
The study was designed as an open observational and descriptive study. Over a period of
11 months a consecutive cohort of 93 patients undergoing open reduction and internal fix-
ation of unilateral fracture of the femoral shaft, was prospectively followed from the time a
decision was made to operate up to three days after the surgical procedure. During this
time, the age, gender, fracture type, hemoglobin change in levels measured 24 hours before
surgery and 72 hours after surgery, representing blood loss, peri-operative blood orders
and use were recorded. We also observed the surgical technique and the use of diathermy
for dissection and cauterization during the surgical procedures.

Inclusion and exclusion criteria


All patients with an isolated fracture of the femoral shaft, sixteen years and older, were in-
cluded in the study after obtaining a written informed consent. Study recruitment was
done at the time when the decision to operate was made by the attending surgeon, who
placed peri-operative blood orders. Patients presenting more than one month after the in-
jury, with old non-unions of the femur, for repeat surgery for a fractured femur, with patho-
logical fractures of the femur, with an open fracture femur, with bilateral femoral shaft
fractures and patients with multiple skeletal injuries were excluded from the study due to
the wide variation in intra-operative blood losses in these groups of patients. Also excluded
were patients with medical and surgical co-morbidities, patients on cancer chemotherapy,
patients with history of a bleeding disorder and female patients in their menses. No patient
received any thrombo-embolic prophylactic drug during hospital stay. Patients were ran-
domly allocated to surgeons. The study protocols were approved by the Mulago Hospital
Research and Ethics Committee and the Uganda National Council for Science and Technology.

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The SIGN nail procedure


This is a solid and circular inter-medullary locking nail. It has three oval slots, one proxi-
mal and two distal and one proximal circular hole. The slots allow dynamization of the
locked system to stimulate bone healing while the hole limits migration of the nail in the
vertical axis. The nail is fixed without an intra-operative x-ray support (fluoroscopy) since it
is supplied with a special targeting device that assists in locating and locking of slots and
holes proximally and distally.

Blood loss
The amount of blood lost due to the surgical procedure was represented by hemoglobin lost
(Hb-lost) in the peri-operative time and calculated according to equation 1, where Pre-opHb
is pre-operative hemoglobin (g/dl) measured 24 hours before surgery; Post-opHb is hemo-
globin in g/dl level measured 72 hours after surgery; BU is hemoglobin in g/dl that was
provided by transfused allogeneic whole blood units in the peri-operative time. (1 Unit
equivalent to 1g/dl).

Pre-opHb – Post-opHb + BU = Hb-lost …………………………equation 1.

For patients who did not receive allogeneic blood the amount of blood lost was calculated
using equation 2

Pre-opHb – Post-opHb = Hb-lost ………………………….equation 2.

Blood sample collection


Following a written informed consent from each of the participants, up to 2.0 mls of blood
were collected under aseptic conditions from the cubital vein at the elbow, using a Becton
Dickinson vacutainer® system containing EDTA-K3.Blood was collected 24 hours before
and 72 hours after the surgical procedure when hemodynamic equilibration was assumed
to have occurred. The tube was shaken to allow proper mixing of blood with the anticoagu-
lant, legibly labeled with first and given name, age, sex and hospital number of the patient.
A laboratory request form for hemoglobin determination was filled by the staff drawing the
blood, who delivered both the sample and the form to the hospital central laboratory.

Hemoglobin determination
A technician determined the hemoglobin levels immediately after blood delivery, using the
Coulter STKS (Coulter corporation, Hialeah, FL, USA) photometric system (cyanmethemo-
globin method). The Coulter STKS was calibrated daily according to the manufacturer’s rec-
ommendations.

Blood use in the peri-operative time


The decision of the anesthesiologists to transfuse peri-operatively was based on visual as-
sessment of the extent of soaking of the operation swabs with blood and volumes of sucked
blood from the operation site. This also depended on the extent of pallor of the finger nail
beds, palms and mucous membranes. Whole blood units were used, each measuring 450
mls and equivalent to 1g/dl rise in hemoglobin level.

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Factors relating to blood loss


For all participating patients, the x-ray fracture patterns, surgical technique used for fixing
the fracture and use of diathermy during surgery were documented.

Fracture type
The fractures were classified into 3 types according to the AO System (Arbeitsgemein schaft
für Osteosynthesefragen, an Association for the study of internal fixation system) which de-
pends on the extent of comminution. Types A (the least comminuted fractures) are simple
spiral, oblique or transverse fractures. Types B are wedged spiral, wedged bending or
wedged fragmented fractures where Type C (the most severely comminuted) are either com-
plex spiral, complex segmental or complex irregular fractures.

Surgical techniques
All patients (n=93) were operated under general anesthesia, in a supine position and with-
out use of a traction fracture table. The surgical techniques under observation included in-
cising of skin and other tissues and control of surgical bleeding. One group (n=24) involved
the use of monopolar diathermy for incising the dermis and other tissue layers and cauteri-
zation of bleeding vessels while the other group (n=69) involved the use of a scalpel for all
incisions from skin to bone and a standard surgical knot tying for the bleeders. All surger-
ies were performed through a straight lateral incision for manipulation of the bone seg-
ments to achieve reduction and the nails were introduced either antegrade (through the
fossa piriformis) or retrograde through the inter trochelia notch of the ipslateral knee ac-
cording to the surgeon’s discretion. After the bone reduction and fixation with the intra-
medullary nail, the inner soft tissue layers were closed with standard absorbable suture
materials (chromic catgut number 2 or vicryl number 1) which ever was available. The skin
was closed with non-absorbable suture material nylon number 1 in all cases. The surgical
procedures were performed by surgeons (n=4) of similar training background and work ex-
perience.

Statistical methods
The continuous outcome variable peri-operative blood loss was tested for normality using
the Normal Q-Q plot and the Shapiro-Wilk W test and showed a normal distribution.
Total blood losses from patients operated by the same surgeon were not considered as inde-
pendent observations. This lack of independence was adjusted for in the statistical analy-
ses. For analytical purposes, continuous independent variables – age and pre-operative
hemoglobin level were grouped as follows; age was grouped into quartiles of years (≤ 25,
26-32, 33-46 and 47+), while pre-operative hemoglobin was categorized into two groups (<
12 or ≥ 12) g/dl.
The statistical analysis consisted of bivariate regression analysis models of independent
variables to establish their differentials in mean blood loss. Variables that were found to
have a significant influence on the mean blood loss were included in a multiple regression
analysis to determine their extent of influence after adjusting for other competing factors.
All statistical analyses were performed with the help of computer software STATA version
9.2 with significance define as p<0.05.

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RESULTS

Demographics
Ninety three patients were recruited presenting with unilateral fracture of the femoral
shaft. There were more males 67 (72%) compared to females 26 (28%). Mean (SD) age was
40 (19.4) years, about three quarters were below 47. Mean pre-operative hemoglobin level
was 12.6 (range 9.0-17.1)g/dl. Mean preoperative hemoglobin level was higher among
males 12.94 (range 9.0-17.1) g/dl compared to females, 12.00 (range10.5-14.3) g/dl,
(p=0.046). Most patients [n=46 (49.5%)] had type A fracture, where 20 (21.5%) and 27
(29.0%) patients had type B and type C fractures respectively.
Majority of patients, 56/93 (60.2%), were operated by surgeon A, whereas the other three
surgeons operated 9, 15 and 13 patients respectively.
Sixty nine (74.2%) patients were operated using the traditional surgical dissection and
standard surgical knotting for bleeding vessels, while 24 (25.01%) were operated with the
assistance of monopolar diathermy for dissection of tissues and cauterizing bleeding ves-
sels (Table 1).

Table 1 Patient demographics and baseline characteristics


Variable Number of patients (total = 93)
Sex Male 67
Female 26
Age ≤25 years 24
26-32 years 23
33-46 years 23
47+ years 23
Pre-operative hemoglobin <12 g/dl 41
≥12 g/dl 52
Patients operated by Surgeon A 56
Surgeon B 9
Surgeon C 15
Surgeon D 13
Used Diathermy Yes 24
No 69
Blood ordered Yes
No 34
Surgical technique Antegrade 49
Retrograde 44
Fracture type Type A 46
Type B 20
Type C 27

Blood use
A total of 42 units were transfused to 26 patients, ten of whom received 1 unit and sixteen
received two units each. Among the 26 patients who received blood (Table 2), patients in age
group 33-46 years (n=11) received the highest number of transfusions – [18/42 transfused
units (42.8%)], while only one unit was administered to patients in the 26-32 year group
(p=0.01). Thirty one units were administered to patients with a pre-operative hemoglobin
<12g/dl compared to 11 units transfused to patients with a pre-operative hemoglobin

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≥12g/dl (n=8) (p=0.001). Six out of the 24 (25%) patients who were operated with the
diathermy technique for dissections and cauterization of bleeding vessels received 11 units
of blood whereas 20 out of the 69 (35%) patients operated with the traditional surgical tech-
niques of tissue dissection and surgical knotting, used a total of 31 units of blood. Seven-
teen of the 49 (34.7%) patients whose SIGN nails were introduced with an antegrade
technique, received 28 units of blood compared to 14 units transfused to the nine of the
forty four (20.5%) who underwent a retrograde technique. Thirty three patients did not re-
ceive blood, although 70 units had been ordered and cross matched pre-operatively (Table1).

Table 2 Variations in blood use by patient and theatre factors.


Factor patients who used number of units number of units p
blood (n=26) (n=42) per patient value
Sex male 17 28 1.62
female 9 14 1.56 0.42
Age ≤25 years 6 8 1.33
26-32 years 1 1 1.00
33-46 years 11 18 1.64
47+ years 8 15 1.86 0.01
Pre-operative hemoglobin <12 g/dl 18 31 1.72
≥12 g/dl 8 11 1.38 0.001
Surgical technique Antegrade 17 28 1.62
Retrograde 9 14 1.56 0.12
Fracture type Type A 11 18 1.64
Type B 7 11 1.57
Type C 8 13 1.63 0.67
Diathermy used Yes 6 11 1.83
No 20 31 1.55 0.86
Bold = significant

Blood loss
Mean hemoglobin level measured 72 hours postoperatively was 9.75 g/dl (range 5.4-16.0).
Male patients had a higher pre- and postoperative hemoglobin level compared to the female
patients (12.94/10.19 vs 12.00/8.63 g/dl).
Mean total blood loss assessed 72 hours after the surgical procedure was 3.31 (SD 1.56)
units of whole blood. A bivariate regression analysis (Table 3) of patient and operation the-
ater variables by total blood loss showed a statistically significant difference in the mean
blood loss between male and female; 3.16 and 3.68 units respectively (p=0.03). Compared
to patients in age group ≤25 years, patients in 26-32 years group lost less blood, while pa-
tients in age group 33-46 years lost more blood (p=0.034 and 0.047 respectively).
Patients operated with diathermy lost less blood compared to those whose operated with
the traditional surgical techniques (2.68 to 3.53 units), which was statistically significant
(p <0.01). Patients whose SIGN nails were introduced with an antegrade technique lost
more blood compared to those with a retrograde technique (difference in mean=0.33 units,
p=0.02). Fracture type significantly affected total blood loss, where patients with types B
and C fractures were losing more blood compared to those with type A (p<0.01). Pre-opera-
tive hemoglobin had no significant effect on total blood loss.

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Factors related to blood loss


Bivariate regression analysis showed sex, age, use of diathermy, surgical technique and
fracture type to significantly affect blood loss. However, following a multiple regression
analysis and after adjusting for other significant factors on bivariate analysis, two factors
(diathermy use and fracture type) were individually found to influence blood loss.
Diathermy use significantly reduced peri-operative blood loss (p<0.01) according to the fol-
lowing model:
> blood loss with diathermy was 2.85 – 0.8 (units of total blood loss without use of
diathermy). This means that for every unit of blood lost per patients in the group operated
without diathermy, there was a 0.8 unit reduction in the amount of blood lost by the group
with diathermy.

Likewise, the severity of comminution of the fracture was found to significantly affect total
blood loss (p<0.01). Thus, compared to fracture type A, total blood loss in units varied with
positive proportionalities and according to the following model:
> blood loss for type B fracture = 2.85 + 1.05 (blood loss for type A fracture).
> blood loss for type C fracture = 2.85 + 1.53 (blood loss for type A fracture).

This means that for every unit of blood lost in the peri-operative time of facture type A, there
was a 1.05 and 1.53 unit increase in blood loss for type B and type C fractures respectively.

Table 3 Regression analysis of predictor variables of Total blood loss.


Bivariate regression analysis Multiple regression analysis
Difference in mean adjusted differentials
Variable total blood loss p value in mean total blood loss p value
Sex (Ref - Female)
Male 0.52 0.03 0.05 0.43
Age (Ref - ≤25 years)
26-32 years -0.94 0.03 -0.49 0.20
33-46 years 0.39 0.047 0.37 0.11
47+ years 0.03 0.89 0.07 0.81
Pre-operative hemoglobin (Ref - <12 g/dl)
≥12 g /dl 0.18 0.36
Use of diathermy (Ref - No)
Yes -0.84 <0.01 -0.81 <0.01
Surgical technique (Ref - Antegrade)
Retrograde -0.33 0.02 0.005 0.97
Fracture type (Ref - type A)
Type B 1.16 <0.01 1.05 <0.01
Type C 1.71 <0.01 1.53 <0.01
Constant 2.85
The reference is given in ( )
Bold = significant. The blood loss is measured in units of 450mls.

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DISCUSSION

Generally orthopedic procedures are accompanied by loss of larger amounts of blood. This
is partly due to the intrinsic difficulty in stopping hemorrhage in a bleeding bone but is
also due to patient and institutional factors [12, 13]. Our study demonstrates that a substan-
tial amount of blood (up to 3.31 units of 450ml whole blood) is lost due to surgery of frac-
tures of the femur performed in a developing world operating theater. Open reduction and
internal fixation of fractures of the femur is still performed widely in the developing world
due to shortage of resources to support minimal interventional surgery like closed in-
tramedullary nailing for such injuries [11]. The use of appropriate surgical techniques and
facilities like diathermy, fluoroscopy and fracture tables reduces operation time and intra-
operative blood loss [14,15]. However, these facilities are not easily accessible in hospitals in
developing countries. This explains the higher blood loss among patients whose proce-
dures were performed without diathermy. A similarly higher loss was observed by Kearns
et al [15] in their work on hip hemiarthroplasties operated using scalpel alone for incision
compared to incisions performed with diathermy. Wu et al [16] have also established a com-
paratively higher rate of blood transfusion in revision femoral fracture surgeries performed
with an open technique. It is anxiety created by these losses that drives attending clini-
cians sometimes to irrational peri-operative transfusions.

A fracture of the femur is a major traumatic event which provokes a local and systemic in-
flammatory response that is characterized by activation of circulating granulocytes to pro-
duce pro-inflammatory cytokines one of which is soluble thrombomodulin [17,18]. This
cytokine binds to thrombin and the formed complex converts protein C into the natural an-
ticoagulant activated protein C which consumes the clotting factors [19,20]. We believe that
the delay in the fixation of fractured femurs at our institution with its attendant continued
mobility at the fracture site must have been accompanied by sustained production of this
cytokine. In addition, open reduction and internal fixation of the fractured femur is accom-
panied by a second hit phenomenon of more pro-inflammatory cytokine release [18]. This ad-
ditive effect of soluble thrombomodulin could have lead to excessive natural anticoagulant
consumption resulting into disturbed hemostasis hence the observed substantial blood
loss among our patients. Abrahan et al [21] in a series of 21 delayed and open intramedullary
femoral fracture fixations also found an increased peri-operative blood loss. Their study
was conducted in a theater without traction fracture tables or fluoroscopy, which is compa-
rable to our theater situations.
This study has also established that the greater the damage to the bone the higher the peri-
operative blood loss. This is due to the fact that open reduction and fixation of severely
comminuted femoral shaft fractures is a technically demanding procedure therefore car-
ries a prolonged operation time to achieve a reduction and has an increased tendency to dis-
rupt the endosteal and periosteal blood vessels.
Although the other studied patient factors had no statistically significant relationship to
the peri-operative blood loss (after the multiple regression analysis), there was a distinct
difference in the loss among the different age groups. The observed higher losses among
the elderly patients is in line with the advanced age related reduction in haemostatic abili-
ties that are essential in stopping surgical hemorrhage [22].
There are two main limitations of the present study. First, the differentials in blood losses
of patients operated by a particular surgeon were not considered as independent variables
so we cannot completely account for the salient difference between individual skills in con-

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trolling surgical bleeding. However, this lack of independence was adjusted for in the sta-
tistical analyses. Second, due to lack of operational guidelines on transfusion triggers at
our institution, the haphazard use of blood by anesthesiologists in this group of patients
could have resulted in the observed high peri-operative blood loss.
In conclusion, isolated femoral shaft fractures in relatively young healthy patients treated
by open reduction and internal fixation in a developing world operation theatre, leads to a
substantial peri-operative blood loss. The major contributing factors to this loss are; the
fracture pattern and lack of standard theater facilities (diathermy) necessary to limit peri-
operative blood loss.
Based on the above observations, the administrative structure of Mulago hospital should
designs strategies first, to ensure that patients presenting with femoral fractures are oper-
ated as they come so as to shorten time between admission and surgical intervention. Sec-
ondly, to improve surgical technology by equipping the orthopedic theatres with
fluoroscopy, fracture tables and ensuring that diathermy is used as a standard method of
controlling surgical bleeding in all cases.

ACKNOWLEDGEMENT
The authors thank the colleagues at Mulago Hospital for their cooperation and understanding.

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REFERENCES
1 Carson JL, Ternin ML, Magaziner J, et al. Transfusion Trigger Trial for functional out-
come in cardiovascular patients undergoing surgical hip fracture repair (FOCUS).
Transfusion 2006;6:2192-2196.
2 Pilot P, Ester MJB .Aart DV, et al. The use of autologous blood to improve exercise capac-
ity after total hip arthroplasty: a preliminary report. Transfusion 2006;:1484-1490.
3 Waters JH, Dyga RM. Post-operative blood salvage: Outside the controlled world of the
blood bank. Transfusion 2007;7:362-365.
4 Sazama K. The ethics of blood management. Vox Sang 2007;2:95-106.
5 Yeh CJ, Wu CF, Hsieh LL, Lin SF, Lin TC. Transfusion audit of fresh frozen plasma in
Southern Taiwan. Vox Sang 2006;1:270-275.
6 Hughes K Chang CY, Sedrak J, Torres A. A clinically practical way to estimate surgical
blood loss. Dermatol Online J 2007;13:17.
7 Larsson C, Saltredts S, Pahlen S, Andolf E. Estimation of blood loss after cesarean sec-
tion has a low validity and a tendency to exaggeration. Acta Obs et Gynecol
2006;85:14448-14452.
8 Eipe N, Ponniah M. Perioperative blood loss assessment: how accurate. Ind J Anaesthe-
sia 2006;50:35-39.
9 Gardner AJS, Dudley HAF. The measuring of blood loss at operation. Brit J Anaesthesia
1962;34:653-656.
10 Ravi P, Kiran M D, Conor P, Senagore A J,Millward BL, Fazio VW. Operative blood loss
and use of blood products after laparascopic and conventional open colorectal opera-
tions. Arch Surgery 2004;139:39-42.
11 Biss TT, Hanley JP. Recombinant activated factor VII (rFVIIa/NovoSeven®) in in-
tractable hemorrhage: Use of a clinical scoring system to predict outcome. Vox Sang
2006;90:45-52.
12 Petre JM, Mason P, Neal C, David Z, Jon JPW. Analysis of transfusion predictors in
shoulder arthroplasty. J Bone Joint Surgery American Volume 2006;88:1223-1230.
13 Salido JA, Marín LA, Gómez LA, Zorrilla P, Martínez C. Preoperative hemoglobin levels
and the need for transfusion after prosthetic hip and knee surgery: analysis of predic-
tive factors. J Bone Joint Surgery American volume, 2002;84:216–220
14 Andreas K, Tsakayannis D, Lino D.Use of diathermy in thyroid surgery. Arch Surgery
2004;39:997-1000.
15 Kearns SR, Gilmore M, McCabe JP,Kaark and Curtin W. Diathermy versus scalpel inci-
sions for hemiarthroplasty: A randomized prospective trial. J Bone Joint Surgery British
volume 2004;86-B (Suppl II):129.
16 Wu CC, Shih CH, Chen W J, Tai C L. Treatment of Ununited Femoral Shaft Fractures
Associated With Locked Nail Breakage: Comparison Between Closed and Open Revi-
sion Techniques. J Orth Trauma 1999;3:494-500.
17 Pape HC, Van Griensven M, Giannoudis P,et al. Impact of intramedullary instrumenta-
tion versus damage control for femoral fracture on inflammatory parameters: Prospec-
tive randomized analysis by the EPOFF study group. J Trauma Inj Crit Care
2003;55:7-13.
18 Pallister I, Katja E. The effect of surgical fracture fixation on the systemic inflamma-
tory response to major trauma. J Am Acad Orthop Surgeons 2005; 13:93-100.
19 Kearon C, Comp P, Donketis J, Royds R, Yamada K, Gent M. Dose-response study of re-
combinant human soluble thrombomodulin (ART-123) in the prevention of venous
thrombo-embolism after total hip replacement. J Thromb Haemostasi, 2005;3:962-968.

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20 Sosothikul D, Seksaru P, Ponqsewalak S, Thisyakorn U, Lusher J. Activation of en-


dothelial cells,coagulation and fiblinolysis in children with Dengue virus infection.
Thromb Haemostasis, 2007;7:627-634.
21 Abrahan LM, Te CV, Cruz, FD. Delayed Open Intramedullary Nailing of Femoral Shaft
Fractures. Techn in Orthopaedics 2006, 21:88-98.
22 Boldt J, Huttner I, St Suttne, Kumle B, Piper SN, Berchthold CT. Changes of haemosta-
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young patients? Brit J Anaesthesia 2001;87:438-440.

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Chapter 6

Surgical Blood Order Equation in


Femoral Fracture Surgery

Kajja I, Bimenya GS, Eindhoven GB, ten Duis HJ and Smit Sibinga CT
Published in: Transf Med 2010; doi: 10.1111/j.1365-3148.200.01033x

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ABSTRACT

Aim: The study aimed at establishing the clinical utility of the surgical blood order equa-
tion (SBOE) in patients undergoing femoral fracture surgery.

Background: A blood ordering schedule defines peri-operative blood use in elective sur-
gery. It lists the number of units of blood needed for each procedure preoperatively.

Materials and methods: A case-control study was performed among homogenous groups
of patients (n = 62 each) undergoing open reduction and internal fixation of femoral frac-
tures. Correct prediction of blood use in the group of patients using the SBOE was com-
pared to the group whose blood orders were made without any guideline.

Results: The surgical blood ordering equation was exactly correct in the ordering blood for
46 (74.2%) of 62 patients (cases). The current un-aided blood ordering method was exactly
correct in ordering blood for 27 (43.5%) of 62 patients (controls). Use of the SBOE resulted
in a significantly lower crossmatch-to-transfusion (C/T) ratio compared to that of the cur-
rent ordering system (1.45 vs. 2.45) and saved the hospital transfusion laboratory 465 US
dollar of cross match and inventory management costs in this cohort of patients.

Conclusion: The surgical blood order equation is a more accurate and cost saving tool in
predicting blood use. It should replace the current un-aided method of ordering for peri-op-
erative blood in femoral fracture surgery at Mulago hospital. However, its introduction to
other hospitals should be preceded by more rigorous research to strengthen its external va-
lidity.

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INTRODUCTION

A blood ordering schedule (BOS) is a guide to expected blood use for elective surgical proce-
dure which lists the number of units of blood to be routinely cross-matched, grouped,
screened and held for each surgical intervention preoperatively (Galloway et al. 2008).
The development and use of a BOS enables the identification of surgical interventions that
can be accommodated by the institutional human and laboratory resources (Guerin et al.
2007; Strengers 2008) This leads to reduction in unnecessary compatibility tests, returns
of un-used blood, wastage due to out dating and ensures a more efficient management of
blood bank inventories.
Each Hospital Transfusion Committee should develop a blood ordering schedule (Eipe and
Ponniah. 2006) for its elective surgical procedures in accordance to its national guidelines.
In a retrospective study Nuttall et al. 1996, analyzed the predictors of peri-operative red cell
requirement in patients undergoing major orthopedic procedures. Later, 1998, they used
these variables to develop the surgical blood order equation (SBOE) which is as follows:

Hemoglobin lost due to a given surgical procedure – (preoperative hemoglobin - minimal


acceptable hemoglobin) = Units of blood required at surgery for that procedure.

In this study, the minimum acceptable hemoglobin is the threshold for a transfusion based
on the patient’s age and decided by the ordering physician.
From the equation, values that are negative or less than 0.5 units are assigned an order to
type and screen for antibodies only and values between 0.5 unit and less than 1 unit are
rounded off to 1 unit which is then ordered for. This equation assumes a 1 gmdL-1 rise in
hemoglobin for every 450ml unit of whole blood administered.
This SBOE has been shown to maximize the efficiency of blood use due to its relatively
higher and accurate predictive rate for peri-operative blood use in spine surgery (Nutall et
al. 2000).
To date, in resource limited countries like Uganda no BOS has been developed to assist cli-
nicians make appropriate blood orders for any elective surgical procedure. Therefore, the
clinicians order for peri-operative blood without any established guidelines. At Mulago
Hospital, a national referral and major teaching hospital in Uganda, whole blood units are
routinely transfused during and following orthopedic surgical procedures. The commonest
orthopedic procedure performed at this hospital is open reduction and internal fixation of
femoral shaft fractures using the SIGN [Surgical Implant Generation Network] nail tech-
nique ( Ikem et al. 2007) – an intramedullary locking nail system. At this hospital, a unit of
whole blood measures approximately 450mls. This is administered to adults with medical
or surgical conditions requiring a transfusion as there is limited access to components like
packed Red cells which are reserved for children with anemia due to malaria who consume
50% of the blood supplies. All transfused blood products in this hospital are not leukocyte
reduced.

The study compared the accuracy of the Surgical Blood Order Equation (SBOE) in predicting
allogeneic blood use during the peri-operative time of open reduction and internal fixation
of isolated femoral fracture using the SIGN nail technique with the current un-aided order-
ing method. In this study, peri-operative time was the period 24 hours before to 72 hours
after surgery. This was done with a major underlying aim of guiding surgeons and anesthe-
siologists in making appropriate blood orders before the procedure is performed.

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MATERIALS AND METHODS

Study design
Following approval from the Institutional Research and Ethics Committee, a case-control
study was conducted among patients who had given an informed consent for recruitment.
This was performed over two periods. The first seven months involved observing and col-
lecting data from patients whose blood orders were made without any guidelines (Con-
trols). This was followed by a face-to-face training of surgeons on how to use the surgical
blood order equation. The surgeons then used the SBOE to order for peri-operative blood for
sixty two patients in the subsequent five months. During these two periods, a group of four
orthopedic surgeons of similar training background and work experience performed open
reduction and internal fixation of femoral fractures at Mulago Hospital. For each patient,
pre-operative (24 hours before surgery) hemoglobin level, peri-operative blood orders and
use, and post-operative hemoglobin (taken 72 hours after surgery) were documented. He-
modynamic stability was assumed to have taken place 72 hours after surgery hence the
time for establishing the post-operative hemoglobin. All hemoglobin assessment were per-
formed using 2mls of venous blood collected aseptically in a Becton Dickinson vacutainer®
system containing EDTA-K3 and tested with the Coulter STKS (Coulter corporation,
Hialeah, FL, USA) photometric system (cyanmethemoglobin method). The Coulter STKS
was calibrated daily according to the manufacturer’s recommendations.

Patients
All patients with an isolated fracture of the femoral shaft, sixteen years and older, were in-
cluded in the study after obtaining a written informed consent. Study recruitment was
done at the time when the decision to operate was made by the attending surgeon, who
placed peri-operative blood orders. Patients presenting more than one month after the in-
jury, with old non-unions of the femur, for repeat surgery for a fractured femur, with patho-
logical fractures of the femur, with an open fracture femur, with bilateral femoral shaft
fractures and patients with multiple skeletal injuries were excluded from the study due to
the wide variation in intra-operative blood losses in these groups of patients. Also excluded
were patients with medical and surgical co-morbidities, patients on cancer chemotherapy,
patients with history of a bleeding disorder and female patients in their menses. No patient
received any thrombo-embolic prophylactic drug during hospital stay. Patients were ran-
domly allocated to surgeons.
Blood for use in the peri-operative time was routinely ordered for by the lead surgeon dur-
ing the pre-operative preparatory ward rounds. The orders were based on the patients’ pre-
operative hemoglobin levels and anticipated peri-operative blood losses. A pre-transfusion
sample of blood was drawn and delivered to the hospital blood transfusion laboratory for
preparation of units of blood. The laboratory procedures included reception of the pre-
transfusion sample, establishing the blood group of the patient, selection of a unit of blood,
compatibility testing and holding of the prepared unit until it is required in the operating
theatre. At Mulago Hospital, the cost of these procedures (including labor, reagents, sup-
plies and indirect costs) is estimated to be 15 USD per unit of whole blood. Transfusions
were carried out by the anesthesiologists during or immediately after surgery.
The fracture type for each patient was also noted. These had been classified according to
the AO system (Arbeitsgemein schaft für Osteosynthesefragen) for the study of internal fixa-
tion, which depends on the extent of comminution. Types A (the least comminuted frac-
tures) were simple spiral, oblique or transverse fractures. Types B were wedged spiral,

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wedged bending or wedged fragmented fractures where Type C (the most severely commin-
uted) were either complex spiral, complex segmental or complex irregular fractures.
In a recent study Kajja et al (In Press) had found that patients undergoing open reduction
and internal fixation of unilateral femur fractures with a SIGN nail technique at Mulago
hospital lose an estimated mean (SD) 3.31 (1.56) gmdL-1 of hemoglobin because of this sur-
gical procedure. This study compares the application of the surgical blood order equation to
calculate the number of units of blood required in the peri-operative time among cases
(n=62) with the number if units used following the un-aided ordering of blood in controls
(n=62). In this study, correct blood use stands for an accurate pre-operative prediction of the
amount of blood to be used in the peri-operative time by either ordering strategy. The over-
all accuracy of the SBOE and the current routine ordering for blood included (1) comparing
the exact number of units of blood administered in the peri-operative time to a patient with
the number of units ordered and (2) the correct negative prediction of blood use in the peri-
operative time. An accurate positive prediction means that the patient received the exact
number of units of blood predicted by a particular strategy while an accurate negative pre-
diction represented a patient who did not receive a peri-operative transfusion and for whom
no blood was ordered. The sensitivity and specificity of the SBOE were then calculated ac-
cording to details in appendix 1.

Statistical analysis
The un-matched case-control ANOVA was used to analyze variations in the continuous
variables – age, pre-operative and post-operative hemoglobin level between the cases and
the controls. Differences in sex and fracture type distribution were tested by logistic regres-
sion while differential in blood ordering and use between the two groups were assessed
with a chi square test. A bivariate Pearson Product-Moment Correlation Index was per-
formed to find the relationship between the set minimum acceptable hemoglobin level and
blood use among the cases. Blood orders placed by the same surgeon were not considered
as independent observations. This lack of independence was adjusted for in the statistical
analyses. All statistical analyses were performed with the help of computer software SPSS
version 12.0 (SPSS Inc., Chicago, IL, USA) with significance defined as p<0.05. Results are
expressed as mean+/-SD unless otherwise stated.

RESULTS
Over the two periods, a total of 124 patients presenting with unilateral fractures of the
femur shaft were recruited. Sixty two were recruited as control in the first seven months
and their blood orders were placed without any guidelines. Following training of the partic-
ipating surgeons, another 62 patients were recruited as cases. Their peri-operative blood
orders were placed with the help of the SBOE. The two groups of patients were homogenous
in the sex distribution, fracture types, mean age and pre-operative hemoglobin (Table 1).
A total of 46 units of whole blood were ordered for 35 (56.5%) patients among cases com-
pared with 75 units that were ordered for 40 (64.5%) patients among the controls. This dif-
ference was statistically significant (p = 0.0028). The minimum acceptable hemoglobin
level, as stated by surgeons in the group that used the SBOE to calculate blood needs,
ranged from 7 to11 gmdL-1. This did not influence the subsequent blood use among cases
(p = 0.56).

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Thirty one units of whole blood were administered to patients in each group during the
peri-operative time (24 cases- 17 males and 7 females which compares well with 20 con-
trols-14 males and 6 females). Among the transfused cases, 17 received one unit each and 7
received two units each. This contrasts with the blood use among controls were 7 patients
received a unit each and 13 received two units each. This difference was not statistically
significant (p = 0.062). There was homogeneity between the two groups in blood use with
respect to fracture type. Thus among cases, 13, 6 and 5 units of blood were administered to
patients with fracture types A, B and C respectively. A comparable situation was observed
among the controls were 9, 5 and 6 units of blood were administered to patients with frac-
ture types A, B and C respectively. It was also observed in both groups that the higher the
pre-operative hemoglobin the less likelihood of peri-operative blood use.

Table 1 Patient demographics and baseline characteristics


Cases N (%) Controls N (%) p value
Sex
(Ref-males) 46 (74.2) 45 (72.6)
females 16 (25.8) 17 (27.4) 0.84
Age mean (SD) Years 37.1(SD 17.2) 41.1 (SD 19.4) 0.33
Preoperative HB
(mean (SD) gmdL-1) 12.2 (SD 2.0) 12.7 (SD 1.9) 0.16
Fracture types
(Ref-Type A) 32 (51.6) 36 (58.0)
Type B 17 (27.4) 13 (21.0) 0.38
Type C 13 (21.0) 13 (21.0)
Blood orders (whole blood) 45 units 76 units 0.0028
Blood use (whole blood) 31 units 31 unit
Post-operative HB
(mean (SD) gmdL-1) 9.8 (SD 1.9) 10.1 (2.1) 0.78
HB = Hemoglobin level in gmdL-1
Ref = Reference category of a given variable.
Bold = statistically significant.

The cross match-to-transfusion (C/T) ratio for the cases was 1.45 compared to 2.45 for the
controls. This difference was statistically significant (p = 0.031) The laboratory procedures
of blood preparation and handling cost 675 US dollars for the cases and 1140 US dollars for
the controls. The introduction of the SBOE therefore saved 465 US dollars of laboratory lo-
gistics for a cohort of sixty two patients (cases).
From Table 2 and using the formulae in appendix 1, the sensitivity of the SBOE was estab-
lished as 74.2%, specificity was found to be 56.5% and overall accuracy was calculate as
65.3%. The overall accuracy of the current un-aided method of ordering for blood was cal-
culated as 34.7%.
There was no difference in the mean post-operative hemoglobin levels (measured 72 hours
after surgery) between the cases and controls (9.8 gmdL-1 vs 10.1gmdL-1; p = 0.78).

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Table 2 Correct prediction of blood use.


Correctly predicted blood use
Yes No
Cases (SBOE) TP = 46 FN = 16 62
Controls (Un-aided orders) FP = 27 TN = 35 62
Totals 73 51 124
SBOE = Surgical Blood Order Equation.
True positive (TP) = Cases whose blood use was correctly predicted by the SBOE
False positives (FP) = Controls whose blood use was correctly predicted by the current
un-aided blood ordering method.
True negatives (TN) = Controls whose blood use was wrongly predicted by the current
un-aided blood ordering method.
False negative (FN) = Cases whose blood use was wrongly predicted by the SBOE.

DISCUSSION

Ideally, initiation of peri-operative transfusion should be guided by measured oxygen needs


of a patient. However, mixed venous oxygen saturation and oxygen extraction ratios re-
quire invasive monitoring and are therefore not applicable in many situations (Eindhoven
et al., 2005). Guidelines on peri-operative blood use have been introduced in a number of
settings (American society of Anesthesiologist Task force on perioperative blood transfu-
sion and adjuvant therapies, 2006; Canadian Expert working Group 1997). They all empha-
size restrictive blood use without detrimental effects on the patient safety. Restrictive
transfusion strategies have been used to order and effect blood administration in the peri-
operative time. In a large (n=4,892) observational study Corwin et al., 2004 demonstrated
that 44% of all patients in intensive care units (ICUs) received transfusions of red cells. In
their study, multiple regression analysis suggested that administration of red cells was an
independent risk factor for a worse clinical outcome due to inhibition of host defense func-
tions and altered cell mediated immunity. In a large prospective randomized comparison of
’restrictive’ (7.0 gmdL-1) versus ‘liberal’ (10.0 gmdL-1) transfusion thresholds in critically
ill patients, Herbert et al., 1999 randomized 838 critically ill patients to the restrictive
group (n=418) and liberal group (n=420). The 30 day mortality was no different between the
two groups [18.7% restrictive and 23.3% liberal (p=0.11)]. They demonstrated a signifi-
cantly lower mortality during hospitalization with restrictive transfusion compared to the
liberal group (22.3% vs 28.1%, p=0.05) and concluded that restrictive transfusion approach
was as good as and possibly better than a liberal transfusion trigger.

At the University Medical Center Groningen, The Netherlands, Eindhoven et al., 2005 have
designed a transfusion guideline (the 6-8-10-flexinorm) which has been proved through a
case-control study to improve transfusion orders and red cell usage in orthopaedic pa-
tients. They recommend that a transfusion should be considered if there is a hemoglobin
level <6 gmdL-1 in a healthy person of less than 60 years and in a nomovolemic state. They
also recommend a transfusion threshold of 8gmdL-1 for older nomovolemic patients and a
10 gmdL-1 trigger for cardio-pulmonary decompensated patients. The current study pres-
ents results of blood use in a young and health population-mean age 37.1 years for cases
and 41.1 years for controls. From the above studies it is appropriate to use a restrictive or-
dering strategy SBOE in our studied population of patients.

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Despite the comparable baseline characteristics, peri-operative blood use, and post-opera-
tive hemoglobin levels between patient groups, the SBOE was found to be more effective
than the current un-aided blood ordering strategy in the following ways: (1) the introduc-
tion of the SBOE reduced the cross match-to-transfusion (C/T) ratio from 2.45 to 1.45. This
led to cost saving on the hospital blood bank logistics. We postulate that this assisted in
the management of the blood inventory and led to availability of blood to patient with dare
needs without compromising the patient safety in the case group – acceptable post-opera-
tive hemoglobin levels in both patient groups. We also postulate that these savings were re-
allocated either to other laboratory activities or other hospital expenses during the second
period of the study. This compares very well with the findings of Nutall et al., 1998 work in
total hip arthroplasty. (2) The SBOE resulted in an indirect improvement in the bedside
blood management. This is shown by the fact that only 7 patients among the transfused
cases received two units each compared to 13 patients in the control group who received
two units each. Surgeons and anesthesiologists alike are anxious to begin surgery without
blood physically present in the operating room (Palmar et al., 2003). This presence of blood
in the OR increases the likelihood and number of transfusions. The fact that the surgeons
and anesthesiologists in our study were cognizant of an on going study of a restrictive
transfusion strategy could have led to the reduction of blood use per patient in the cases.
However, this was a disguised blessing given the comparable post-operative hemoglobin
levels between cases and controls. (3) Despite the low sensitivity and specificity, the SBOE
showed an acceptable high accuracy in predicting blood use in femoral fracture surgery
(65.3%) compared to the current un-aided blood ordering strategy (34.7%). This compare
well with the findings of Nutall et al., 1998; 2000 during their work on total hip arthro-
plasty.
There are a number of limitations to this study. Although our study was prospective and
addressed some patient factors, it was carried out in the National Referral and Teaching
Hospital (Makerere University, Kampala, Uganda) which is better staffed and equipped
compared with many other hospitals nationwide. In addition, internal validation of the
clinical utility of the SBOE was performed in a population of patients presenting to a major
referral centre, it was not externally validated on other patient populations who present to
centers in which the transfusion practices in open reduction and internal fixation of fe-
murs might differ.
The above limitations can be mitigated by a large multi-center prospective randomized
clinical trial comparing morbidity and mortality outcomes of restrictive (blood orders
guided by SBOE) against liberal (un-aided blood orders) transfusion strategies among pa-
tients scheduled for open reduction and internal fixation of femur shaft fracture, conducted
in operation theatres of resource limited countries. This will provide a basis for 1) defini-
tion of the need for peri-operative transfusion, 2) ensuring that the transfusions are con-
ducted in a consistent manner and 3) provide guidelines for red cell transfusion triggers in
the perioperative time for these patients.
In conclusion, the current study has established that the SBOE results in a more efficient
utilization of the blood inventory, as evidenced by a lower C/T ratio with this method than
with the current un-aided method of ordering, and in lowered costs, while safety is main-
tained.
Therefore, we recommend that the current routine approach of ordering for peri-operative
blood be replaced with a scientifically tested tool the (SBOE) to ensure easy training of
young clinicians, proper monitoring and evaluation of peri-operative blood use among dif-

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ferent surgeons. This should be preceded by randomized clinical trials in more hospitals to
ensure internal and external validity of the SBOE in a developing country setting.

ACKNOWLEDGEMENT
The authors wish to thank the colleagues at Mulago Hospital for their cooperation and un-
derstanding.

APPENDIX 1
Accuracy predictions
Accuracy (SBOE) = Number of correct predictions = TP +TN
Number of studied patients TP +FP+TN+FN
Accuracy(un-aided method) = Number of negative predictions = FP + FN
Number of studied patients TP +FP+TN+FN
Sensitivity = Number of true predictions using SBOE = TP
Total Number of cases TP+FN
Specificity = Number true negative predictions without
SBOE = TN
Total Number of controls TN+FP
True positive (TP) = Cases whose blood use was collectly predicted by the SBOE
False positives (FP) = Controls whose blood use was collectly predicted by the current
un-aided blood ordering method.
True negatives (TN) = Controls whose blood use was wrongly predicted by the current
un-aided blood ordering method.
False negative (FN) = Cases whose blood use was wrongly predicted by the SBOE.

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7 Hebert, P.C., Wells, G.& Blajchman, M.A. A multi-center randomized, controlled clini-
cal trial of transfusion requirements in critical care investigators, Canadian Critical
Care Trial Group N Engl J Med 1999;340:409-417.
8 Ikem, I.C., Ogunlusi, J.D.& Ine, H.R. (2007) Achieving interlocking nails without using
an image intensifier, International Orthopaedics,31: 487–490.
9 Kajja, I., Bimenya, G.S., Eindhoven G.B.M., ten Duis, H.J., Smit Sibinga C.T. Blood loss
and contributing factors in femoral fracture surgery. Afr Health Sciences. 2010;40:18-
25
10 Nuttal, G.A., Santrach, P.J., Oliver, W.C., Horlocker,T.T., Shaughnessy, W.J., Cabanela,
M.E. , Bryant, S. The predictors of red cell transfusion in total hip arthroplasties. Trans-
fusion 1996;36:144-149.
11 Nuttal GA, Santrach PJ, Oliver WC, Horlocker,T.T., Shaughnessy, W.J., Cabanela, M.E.,
Bryant, S. A prospective randomized trial of the surgical blood order equation for order-
ing red blood cells for total hip arthroplasty patients, Transfusion 1998;38: 828-833.
12 Nuttal GA, Santrach PJ, Oliver WC, Horlocker,T.T., Shaughnessy, W.J., Cabanela, M.E.,
Bryant, S. Possible guidelines on preoperative autologous blood donation before total
hip arthroplasty, Mayo Clinic Proc 2000;75: 10-17.
13 Palmer, T., Wahr, J.A., Michael O’Reilly, M., Greenfield, M.V.H. Reducing Unnecessary
Cross-Matching: A Patient-Specific Blood Ordering System Is More Accurate in Predict-
ing Who Will Receive a Blood Transfusion Than the Maximum Blood Ordering System.
Anesth Analgesia 2003;96:369–75
14 Strengers P. Regulatory requirements and standards on clinical appropriateness of
blood component transfusion, Blood Transf 2008;6:184–185.

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Chapter 7

The Interface Between Blood Preparation


and Use in Uganda

I, Kajja, G.S. Bimenya & C.Th. Smit Sibinga


Published in: Vox Sang 2010;98:e257-e262

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ABSTRACT

Background and objectives: The interface between preparation and use of blood impacts
directly on the outcome of hemotherapy. The present study explores the knowledge and
opinions of key players at, practical realities at, and quality improvement strategies of this
interface.

Materials and methods: We surveyed clinicians (n=81) and blood bank staff (n=25) to as-
sess their knowledge on key issue in their counterparts working domains, the turn around
time on effecting a blood order from a hospital transfusion laboratory and strategies to im-
prove communication of blood needs to blood banks.

Results: Out of the 81 clinicians, 20 knew the four available blood products while only 17
knew the three uses of these products. Twenty three blood bank staff reported the patient
condition as the main factor on which blood orders are based. Forty four (54.3%) clinicians
reported reception of a blood product within an hour of placing the order. Addressing infra-
structure and human resource were some of the strategies suggested to improve this step
of the transfusion chain.

Conclusions: The knowledge of staff at the extreme ends of the clinical interface in their
counterparts working domain is far from adequate. However, they have well formed opin-
ions on strategies to improve this interface.

Key words: clinical interface, blood banks, blood transfusion laboratories.

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INTRODUCTION

The blood preparation-utility interface has the blood bank staff with their activities on one
end and the clinicians with patients on the other end. Within this interface is the hospital
transfusion laboratory. Each of these entities has a specific administrative structure and a
well defined set of duties. The successes or failures in the proceedings of a given entity di-
rectly impact on the outcomes of the entire interface. The preparing institution (National
Blood Transfusion Services) is challenged with building a professionally competent staff to
bridge the source of blood (community) to the ultimate users (clinicians with patients). The
hospital transfusion laboratory is charged with maintaining the safety and efficacy of the
requested blood product before delivering it appropriately to the utility stations in the hos-
pital. It is an obligation for the clinicians at the other end of the interface, to value and
treasure the contribution of supportive and preventive hemotherapy in their clinical prac-
tices and account for the appropriate use of blood to the donor and community at large [1].

Transfusion of blood elements is an important therapeutic procedure in daily clinical prac-


tice which contributes to modern patient management. The preparation of these elements
goes through a number of procedures like donor recruitment, their medical examination,
donation, processing and testing, transportation and storage of blood products. These take
place outside the scope of the hospital therefore escape knowledge and appreciation of cli-
nicians who are the subsequent prescribers of the products [2].
Presently only few clinicians fully realize the on-going scientific advancements in the blood
bank world. This causes the quality of patient care to lag behind recent developments since
a given clinician will not know the currently available blood product for a given patient con-
dition [2, 3]. On the other hand, blood bank staff minimally appreciates the actual clinical
blood needs of the hospitals within their domains. This is due to lack of comprehensive re-
ports describing the clinical epidemiology of blood use [4]. Blood bank representatives have
to strive to gain insight into the clinical situations, while clinicians have to be continually
informed about the quantity, quality and safety of the available blood products in the bank. [2]

With technical and financial assistance from international resources, a number of African
countries are striving to establish nationally coordinated blood transfusion services char-
acterized by more centralized procurement and processing,
in-hospital component selection and compatibility testing and a guided clinical use of
blood. This will ensure modern patient care which demands excellent and safe products,
maximal expertise involvement from both clinicians and blood bank staff, and efficient
communication between the involved institutes [5].

Currently the high human development index (HDI) countries are able to optimally use
blood by supplying their hospitals with products like leukocyte depleted red cells, platelets,
neutrophils for granulocyte therapy and plasma products like immunoglobulin cryoprecip-
itate and frozen fresh plasma. However, the low and medium human development index
countries still face logistic and technical challenges in blood component production [5].
Uganda - a low-HDI country - runs a nationally coordinated blood service which is commu-
nity based and 100% reliant on voluntary non-remunerated blood donors. Currently, the
supply of homologous blood in Uganda is inadequate compared to the vast and growing
medical and surgical demands. This is evidenced from the statistics of the Uganda Blood
Transfusion Services (UBTS) where annually 170,000 units of blood are collected from non-

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remunerated donors. This falls short of the WHO requirement of 10,000 units per million
population per year by 43.3% which is an unacceptable situation for a population of 30 mil-
lion Ugandans. Out of the above collections, the UBTS is able to supply its hospitals with
whole blood, red cell concentrates, and to limited extend platelets and frozen fresh plasma.
This institution has been developed with financial and technical support from the ministry
of health inUganda and international organizations. It is questionable as to how such
blood services will be sustained after external funding sources are no longer available.

In order to optimize the allocated logistics for blood procurement and supply by the UBTS
regional blood banks, we explored clinicians knowledge of availability and use of blood
products supplied by the UBTS. Second, we studied the opinions of blood bank staff on the
factors that they presumed to influence clinician blood ordering practices. Third, we ex-
plored the time intervals from making blood orders in the clinical setting to reception of a
processed blood product from the hospital transfusion laboratory, ready for transfusion.
We also analyzed strategies suggested by both clinicians and blood bank staff on how to
improve the communication of blood needs and supply between the clinical setting and the
regional blood bank.

MATERIALS AND METHODS

Following approval from the Uganda National Council of Science and Technology, a body
that oversees all ethical and legal issues pertaining to scientific research in Uganda, we
conducted a descriptive cross-sectional survey among clinicians and regional blood bank
staff. We used standardized questionnaires to collect information from both groups.

Study setting
The study was conducted in referral (n=3), district and sub-district hospitals (n=3). The re-
ferral (RR) hospitals are affiliated to medical training institutions; Mulago National Refer-
ral Hospital to Makerere University College of Health Sciences, Mbarara Regional Referral
Hospital to Mbarara University of Science and Technology, Jinja Hospital to Jinja School of
Nursing and Midwifery. They are also in close proximity to the regional blood banks and
have relatively senior clinicians. On the other hand the district and sub-district hospitals in
Kawolo, Kayunga and Mukono have relatively junior clinicians and are further away from
their supplying regional blood banks.
In Uganda blood is procured through mobile units and in fixed sites from non-remuner-
ated voluntary donors. The regional blood banks are responsible for activities of donor mo-
tivation and mobilization, donor selection and blood donations, testing, processing and
storage of blood, and distribution of blood and products to hospitals in a given region. The
distributed products include whole blood, red cell concentrates, and in the central region
also platelets and frozen fresh plasma. These are prescribed for improving oxygen trans-
port, blood volume expansion or treatment of coagulopathies. There is a hospital transfu-
sion laboratory which is responsible for pre-transfusion component selection and
compatibility testing in each of the health facility involved in the study.

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The questionnaires and participants


The questionnaire consisted of open-ended questions to ensure freedom and spontaneity of
expression of opinions and sections of close-ended questions which were intended to elicit
specific responses. To ensure clinical relevance, the questionnaire for clinicians was piloted
on six orthopaedic surgeons at Mulago National Referral Hospital and five doctors at Ka-
wolo District Hospital. The questionnaire for the blood bank staff was piloted among six
staff members at Mulago Hospital blood transfusion laboratory. They were then delivered
by hand to 90 participants in three regional referral hospitals (Mulago in the central region,
Jinja in the eastern region, Mbarara in the western region ) and three district and sub-dis-
trict hospitals in the central region (Kawolo district hospital, Kayunga district hospital and
Mukono heath centre). The questionnaires for the blood bank staff (n=25) were delivered to
all five regional blood banks in Uganda (Nakasero in the central region, Mbarara in the
southern, Mbale in the eastern, Fort Portal in the western and Gulu in the northern part of
the country). The participating clinicians were selected from different specialties on the cri-
teria that they were involved in prescription and administration of blood or blood products
in their day-to-day activities. On the other hand all senior staff at the five regional blood
banks participated in the study. These included the directors, senior laboratory technicians
and senior nursing officers (n=25).

Data analysis
For analytical purposes the responses of clinicians as regards availability and use of blood
products were categorized and scored. Knowledge of 0-1 available product was assigned a
score 0 representing unacceptable knowledge, knowledge of 2-3 products was assigned a
score of 1 representing an average level of knowledge, where as knowledge of 4 products
was assigned a score of 2 equivalent to acceptable level of knowledge. If a clinician knew 0-
1 use of the available blood products, he was scored 0, if he knew 2 of the three main uses of
the supplied products, his level of knowledge was scored 1, where as a clinicians knowledge
was scored 2 if he knew all the three main uses of the available blood products.
The time taken from making an order for blood in a clinical setting to reception of a unit of
blood from the hospital blood transfusion laboratory was categorized as follows: less than
1 hour, one to six hours, six to twelve hours, twelve to twenty four hours and more than
twenty four hours.
Chi square tests were performed to define the differences in the level of knowledge among
clinicians and turn around time for receiving a unit of blood after it has been ordered for in
different hospital settings. All statistical analyses were performed with the help of com-
puter software SPSS version 11.0 and significance defined as p less than 0.05. Content
analysis of suggested strategies to improve communication of blood needs and supply was
manually performed.

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RESULTS

Two regional blood banks (RBB) supply blood and blood components to the six hospitals in-
volved in the study. Nakasero RBB in Kampala to Mulago and Jinja Regional Referral Hos-
pitals, Kawolo, Kayunga and Mukono district hospitals and Mbarara RBB to Mbarara
Regional Referral Hospital (Table 1)
Of the 90 questionnaires circulated to clinicians in the different hospitals, eighty one (90%)
clinicians in different disciplines responded. These included 41 clinicians in district or
sub-district (DD) hospitals and 40 from regional referral (RR) hospitals. All twenty five
questionnaires circulated to the five regional blood banks were responded to.

Table 1 Regional blood bank; annual component production and issues to studied Hospitals.
Production: Nakasero RBB, Kampala
Component Number of Units (n)
Whole blood 24,479
RCC 47,448
Platelets 4,525
FFP 1,424
Issues from Nakasero RBB to Hospitals n (%)
Mulago (RR) Jinja (RR) Kawolo (DD) Kayunga (DD) Mukono (DD)
Whole blood 8,568 (35%) ,470 (1.9%) 220 (0.9%) 270 (1.1%) 293 (1.2%)
RCC 17,556 (37%) 1,500 (3.2%) 403 (0.8%) 521 (1.1%) 555 (3.2%)
Platelets 1,629 (36%) 145 (3.2%) 38 (0.8%) 49 (1.1%) 54 (1.2%)
FFP 712 (50%) 46 (3.2%) 12 (0.8%) 16 (1.1%) 20 (1.4%)
Production: Mbarara RBB, Mbarara
Component Number of units (n)
Whole Blood 14,786
RCC 44,352
Platelets 3,697
FFP 1,183
Issues from Mbarara RBB to hospital n (%)
Mbarara (RR)
Whole blood 5,470 (37%)
RCC 16,410 (37%)
Platelets 1368 (37%)
FPP 400 (38%)
RBB = Regional blood bank.
RR = Regional Referral Hospital.
DD = District hospital.
RCC = Red Cell Concentrates.
FPP = Frozen Fresh Plasma.

Clinicians working in (RR) hospitals had more knowledge of the available blood products
compared to those working in (DD) hospitals. (Table 2) Thus, twenty out of forty (50%) clini-
cians from regional referral hospitals knew all 4 available products. On the contrary, none
of the responding clinicians from district or sub-district hospitals knew more than three
available blood products. This difference in level of knowledge was statistically significant
(p<0.001).

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There was a significant difference in level of knowledge of the use of blood products among
clinicians working in different settings (p<0.001). Seventeen out the 40 clinicians from the
(RR) hospitals knew all three major applications of the supplied products, whereas all re-
spondents from (DD) hospitals knew only up to two applications.

Table 2 Clinician knowledge of availability and use of blood products.


Clinicians in district or clinicians in regional
sub-district hospitals (n=41) referral hospitals (n=40)
Knowledge of available product
0 to 1 product 7 4
2 to 3 products 34 16 (p<0.001)
all 4 products 0 20
Knowledge of use of product
0 or 1 use 26 6
2 uses 15 17 (p<0.001)
3 uses 0 17

The blood bank staff thought that the major contributing factors to the clinical prescription
practices were the patient clinical condition - asserted highly influential by 23 out of the 25
respondents and the clinician knowledge base which was asserted highly influential by 20
staff (Table 3). On the other hand most of the blood bank staff (20/25), felt that hospital
transfusion committees had no influence on the ordering practices of clinicians.

Table 3 Factors influencing clinical ordering practices as perceived by the blood bank staff.
Responding blood bank staff (n=25)
highly influential minimally influential no influence
Patient clinical condition 23 1 1
Clinician knowledge base 20 5 0
Availability of blood 12 9 4
Availability of guidelines 10 7 8
Influence from hospital transfusion committee 2 3 20

It was noted that there is a general delay in reception of blood from the hospital transfusion
laboratories in RR hospitals. Only 11 out of the 40 (27.5%) respondents from (RR) hospitals
receive a unit of blood in their respective clinical settings within one hour of placing the order
(Table 4). On the other hand, thirty three out of the 41(80.5%) clinicians in (DD) hospitals re-
ported that they receive a unit of blood within one hour of placing the order. These difference
in time lapse between hospitals of different levels was statistically significant (p<0.001).

Table 4 Time taken from making a blood order by the clinician to reception of a unit of blood in the clinical setting
from the blood bank.
District or sub-district Hospital Regional Referral Hospital
I don’t know 1 0
More than 24 hours 0 7
12 to 24 hours 0 8 (p<0.001)
6 to 12 hours 0 3
1 to 6 hours 7 11
Less than 1 hour 33 11

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In order to improve exchange of information between the clinical settings and blood banks,
the respondent strategies were noted in four domains (Table 5). Infrastructure develop-
ment entailing items like installation of in-hospital telecommunication systems and com-
puterization of blood ordering and issuing process was suggested by 39 out of 81 clinicians
and 15 out 25 blood bank staff. Up to 41 clinicians and 13 blood bank staff alluded to the
strategy of human resource development. They suggested issues like pre-service introduc-
tion courses in transfusion medicine with appropriate skill and competence assessment
sessions, in-service continued medical education, increase in clinical and laboratory
staffing like recruiting standby blood bank couriers and timely audits on clinical and labo-
ratory practices with appropriate feed back to the concerned staff.
The establishment of hospital transfusion committees was especially emphasized by blood
bank staff (20/25). They asserted that this would be an opportune avenue to inform hospi-
tals about the quality and quantity of available blood products plus any other developments
in the blood bank. Additionally, these hospital transfusion committees would facilitate
flow of information from hospitals to the blood bank on issues of blood need and use.
Fifty two (64.2%) clinicians emphasized the need to improve supplies in the laboratories.
They felt that improved availability of laboratory utilities like blood grouping reagents of
which supply is usually erratic in most of the hospital transfusion laboratories in Uganda,
would reduce the blood transfusion laboratory turn around time for processing a given
blood order.

Table 5 Strategies to improve communication between clinical setting and blood banks.
suggestions by suggestions by blood
clinicians (n=81) bank staff (n=25)
Infrastructure development 39 (48.1%) 15 (60%)
Human resource development 41 (50.6%) 13 (52%)
Establishing hospital transfusion committees 9 (11.1%) 20 (80%)
Availing recurrent utilities 52 (64.2%) 5 (20%)

DISCUSSION

Optimal patient management with hemotherapy requires a sound communication of clini-


cal blood needs to a well administered blood blank. This study has demonstrated deficiency
of knowledge of the available blood products among prescribers in district compared to re-
gional referral Ugandan hospitals. It has also shown that the knowledge of clinicians as re-
gards use of these products is far from adequate. Regional blood banks are not able to
supply sufficient blood and blood products to hospitals in their respective jurisdictions.
The limited products are stocked in transfusion laboratories of RR hospitals which handle
a larger load of patients with greater clinical needs. This gives an opportunity to clinicians
working in RR hospitals to fully appreciate the available products. Regional referral hospi-
tals are also affiliated to training institutions. This gives an added advantage to their clini-
cians to continually review the cardinal uses of blood products hence the observed
knowledge gap from their counterparts in DD hospitals. This is comparable to Dhingra and
others [6] who found that lack of exposure greatly affected the knowledge and utilization of
an autologous blood transfusion strategy among physicians working in different special-
ties and at different levels in a large teaching hospital in India.

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The blood bank staff collectively asserted that knowledge base of the prescribing clinicians
and the patient clinical condition are a key determinant of a transfusion order especially in
low human development index (L-HDI) countries with minimal laboratory facilities. How-
ever, these need to be regulated by guidelines designed and constantly reviewed by hospital
transfusion committees in order to ensure patient safety [3].

This study has demonstrated that there is a delay in the reception of a unit of blood in the
clinical setting after placing the order in a RR hospital compared to a DD hospital. This is
attributed to a higher demand for blood in RR hospitals with a larger patient load which
overstretches the limited blood supplies, as well as human and utility resources in their re-
spective transfusion laboratories. It is explained by the fact that the clinical settings in DD
hospitals are found within the same building as their respective blood transfusion labora-
tories. This partly ensures faster delivery of blood products to the wards or theaters. On the
contrary, blood transfusion laboratories in RR hospitals are distant from utility stations
because of the pavilion lay out. Additionally, blood is delivered by hand to the clinical set-
tings. Therefore, the person delivering a unit of blood from the laboratory is bound to be
distracted by whatever causes along the way, hence the observed delays.
It should be noted that RR hospitals handle more patients requiring components like
platelets that are produced on request since they are not easily obtained or stored. This also
accounts for the differentials in the turn around times of blood delivery to utility stations
between the two hospital settings.

Recruitment of a well trained, motivated and sufficient in-hospital staffing as suggested by


the participants, is an appropriate strategy in facilitating communication between the cli-
nicians and the blood bank. Gonzalezi-Porras and others [7] in their study on errors in pre-
transfusion sample collection and labeling (a major communication step between
clinicians and hospital transfusion laboratories) demonstrated that the quality of this step
improves with educational interventions among concerned staff. They also noted that the
error rates were higher in samples collected by bedside nursing staff compared to those col-
lected by designated blood bank staff. This fits well with the suggestion by a number of
participants in our study of recruiting specific blood bank couriers who assist in the rou-
tine to and fro communications and are of paramount importance in acute in-hospital de-
mand of large amounts of blood like in massive trauma.
Installation of in-hospital telecommunication systems as suggested by respondents is a
welcome approach in enhancing communication of blood needs and supplies. However, in-
corporating new technologies in blood supply systems and processes has to answer questions
of acceptability, availability and affordability to all hospitals [8]. A number of studies [9-11]
have shown that introduction of new technologies in transfusion systems impacts directly
on the organizational and financial metrics of an institution. Therefore, this has to be
taken cautiously especially in L-HDI countries like Uganda whose hospitals record serious
perennial budget deficits.

Advocacy for installation of hospital transfusion committees is an appropriate strategy in


improving communication between clinicians and blood transfusion laboratories and re-
gional banks.
These determine who is permitted to draw blood samples for pre-transfusion tests, the pa-
tient and sample identification protocols, how samples should be transported to the blood
transfusion laboratories, the acceptable laboratory turn around time before a unit of blood

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is released from reception of the pre-transfusion sample and how blood products should be
delivered to utility stations and by whom. Hospital transfusion committees are also re-
sponsible for drawing local guidelines on reporting transfusion outcomes to the blood
transfusion laboratory and regional bank and handling of un-used blood products [12, 13].

In summary, the communication of blood needs by clinicians in Ugandan hospitals is far


from adequate mainly due to lack of knowledge of available products and lack of in-hospital
communication aids. Secondly, there is no administrative structure in place to regulate the
flow of information from clinical settings to the regional blood banks. Thirdly there is an
overt delay of delivery of blood products from the blood transfusion laboratories to utility
stations especially in regional referral hospitals. Finally, the participants in this study out-
line appropriate strategies to improve the flow of information between clinicians and re-
gional blood banks.
We recommend a nationwide survey to establish the epidemiology of blood use in Ugandan
hospitals. This in turn will guide the allocation of logistics on procurement, processing and
distribution of blood products in Uganda. We think these strategies and recommendations
can easily be achieved if they are prioritized in the hospitals and National fiscal budgets.

ACKNOWLEDGEMENT
The authors would like to thank all participants in the study for their loyal and valuable in-
puts. They also would like to acknowledge the valuable contribution of Mr. APM Los, Med-
ical Sociologist, for helping to design the standardized and balanced questionnaires and
advising on the statistical evaluation of the collected material.

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REFERENCES
1 Smit Sibinga CTh: The challenge for component therapies. Transfusion Today
2008;77:24-26.
2 Koopman AWM and Van de Wiel A: Communication mechanisms between the bedside
and the blood bank. In: Smit Sibinga CTh, Das PC and Snyder EL (ed): Trigger Factors
in Transfusion Medicine. Kluwer Academic Publishers, Dordrecht 1996:13-16.
3 The Clinical Use of Blood. WHO revised interactive edition, 2005. Geneva, CH
4 Tinegate HN, Thompson CL, Jones H, Stainby D: Where and when is blood transfused?
An observational study of the timing and location of red cell transfusion in the north of
England. Vox Sang 2007;93:229-32.
5 World Health Organisation Global database on Blood safety. Available at:
www.who.int/bloodsafety/GDBS_Report_2001-2002.pdf. Accessed August 3, 2009.
6 Dhingra-Kumar N, Sikka M, Madan N, Sood SK: Evaluation of awareness and utiliza-
tion of autologous blood transfusion programme. Transf Med 1997; 7:197-202.
7 Gonzalez-Porras JR, Graciani IF, Alvarez M, Pinto J, Conde MP, Neto MJ, Corral M:
Tubes for pretransfusion testing should be collected by blood bank staff and hand la-
beled until the implementation of new technology for improved sample labeling. Re-
sults of a prospective study. Vox Sang 2008;95:52-56.
8 Rodeina D, Bradley G, Gutierrez A, Heaser J, Dharmaraj V: Tracking blood products in
blood centers using radio frequency identification: A comprehensive assessment. Vox
Sang 2009;97:50-60.
9 Dzik WH: Transfusion safety in the hospital. Transfusion 2003;43:1190-1199.
10 Bate DW, Cohen M, Leape LL, Overhage JM, Shabot MM, Sheridan T: Reducing the fre-
quency of errors in medicine using information technology. JAMA 2001;8:299-308.
11 Dzik WH: New technology for transfusion safety. Br J Haematol 2007;2:181-90.
12 McClelland DBL: Blood transfusion committees and other approaches to improving
clinical transfusion practices. In: Smit Sibinga CTh, Das PC, Heiniger HJ (ed): Good
manufacturing practices in transfusion medicine. Kluwer Academic Publishers, Dor-
drecht 1994 p129-137
13 Sweeney JD: Control of blood utilization. Transfusion and Apheresis Sci-
ence.2008;39:139-144.

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Chapter 8

Bottlenecks of Blood Processing


in Uganda

Kajja I, Kyeyune D, Bimenya GS and Smit Sibinga CTh


Published in: Transf Medicine, 2010 doi:10.1111/j.1365-3148.2010.01015.x

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ABSTRACT

Aim: To identify where and why delays occur in Uganda blood banks.

Background: The timely provision and supply of safe and efficacious blood components to
hospitals depends on sound systems in the processing blood banks. Poorly managed sys-
tems lead to apparent blood shortages in hospitals and increases discard rates due to ex-
piry before dispatch.

Materials and methods: We reviewed records of 4,126 units of whole blood delivered by
the mobile collection teams to a major regional blood bank in the period March 1st to June
30th 2009, to ascertain the time intervals between the critical steps in the processing
chain. This was followed by interviews with staff in two blood banks to establish the causes
of process delays.

Results: The average duration between blood collection and final labeling (release from
quarantine for final storage) was 15.4 (SD 10.8) days. In time-line, the step between matrix
generation and grouping was (median duration 8 days) while grouping to labeling was
shortest (median duration 2 days). Blood expiry had the highest discard rate (0.17%) among
the non Transfusion Transmissible Infection marker causes. A minimally facilitated small
staff contributed to the process flaws.

Conclusion: A considerable amount of blood does not reach hospitals because of process
delays between collection and ultimate dispatch. This is caused by a thin staff working
with inadequate materials, out-of date methods, and in an overcrowded environment. Pro-
vision of adequate staff and improved financial allocations to the Uganda Blood Transfu-
sion Services will mitigate this situation.

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INTRODUCTION

The World Health Organization started more than 30 years ago the recognition of blood
transfusion as an essential part of patient care with adoption of the Resolution WHA28.72
by the World Health Assembly (WHO, 1975). In this respect, and with technical and finan-
cial assistance from the European Union and the USA, Uganda has taken steps to mobilize
human and material resources to develop a nationally coordinated blood transfusion serv-
ice. Like any other low human development index (LHDI) country, Uganda Blood Transfu-
sion Service (UBTS) is challenged by a low availability of voluntary non remunerated blood
donors-VNRBD; insufficient transport and storage facilities; low capacities in testing of do-
nated blood and quality assurance in testing laboratories, and the unregulated clinical use
of blood (WHO,2002).
In Uganda Blood is collected through fixed and mobile donor sites. These include schools,
donor clubs, massive community drives and camping sessions. It is then delivered to re-
gional blood banks where it is screened for safety, grouped and stored before dispatch to
hospitals. Blood is usually supplied as whole blood. However, component production is
slowly taking root in most of the regional blood banks (Kajja et al. 2010). Timely provision
of safe and efficacious blood and blood components to hospitals depends on sound logistics
and administrative systems in the processing blood banks. Delays at any processing step
in the blood bank leads to poor supply of blood to the consumers and increases the discard
rates due to expiry before dispatch.
Over a period of four years, there has been a nationwide increase in the amount of blood col-
lected annually in Uganda (110,000 units in 2005 to 170,000 units in 2009). However this
has not mitigated the blood shortages in the hospitals supplied by the regional banks. In
the period from July 2008 to June 2009, the national total blood requests amounted to
189,400 units. However, only 156,393 units (82.5%) were supplied. It is postulated that
blood is held for a long time in banks before distribution to hospitals hence the shortages.
This is followed by a reduction in the shelf life of blood released from quarantine within the
banks and hospital transfusion laboratories, therefore increasing the discard rates.
The purpose of this study was to identify where and why the delays occur in Uganda’s Re-
gional blood banks. It is anticipated that such analysis will strengthen the transfusion
chain, improve the supply of blood to hospitals and enhance patient care.

MATERIALS AND METHODS


Following ethical approval from The Uganda National Council of Science and Technology, a
mixed (quantitative and qualitative) study was conducted in two regional blood banks -
Nakasero and Mbale, respectively serving the central and eastern regions of Uganda. This
was done by analyzing the flow of blood from collection to hospital dispatch (Fig 1). First, it
involved the review of records in one bank. To ensure generalizability of findings, the
records review was followed by in-depth interviews with the technical and support staff in
the processing laboratories of the two banks.

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Figure 1 Critical steps in the production line.

Transportation of
collected blood to
blood bank

Matrix
generation by
IT department

TTI marker ABO/Rh


testing testing

Labeling/
quarantine
release

Storage of
finished
product

Table 1 Regional blood banks: Annual collections and demands from hospitals.
Regional blood bank Population Collections in Demands in
Served x106 units@ of Blood (n) units$ of Blood (n)
Nakasero 9.00 59,198 65,160
Mbarara 5.38 31,970 36,720
Mbale 5.50 25,024 27,840
Gulu 3.42 19,480 21,960
Fortportal 2.64 16,810 18,960
Kitovu 1.67 9,498 9,880
Arua 3.42 8,020 8,880
TOTAL 170,000 189,400
@ = units of donated whole blood.
$ = units of blood products (whole blood, Red cell concentrates, platelets, fresh frozen plasma) demanded by hospitals
served by a particular regional blood bank.

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Study settings
Uganda Blood Transfusion Services runs a centralized administrative system. It has seven
regional blood banks serving a population of about 31 million (Table 1). All regional blood
banks collect a total of 170,000 units of whole blood annually and are able to fulfill about
83% of hospital blood demands. Nakasero regional blood bank serves a population of 9
million people, collects 59,198 units annually, (90.8%) of its 65,160 annual hospital de-
mands. Mbale serves 5.5 million people, collects 25,024 units an equivalent of (89.8%) of
its 27,840 annual hospital demands. Each of the two banks has fixed and mobile donor
sites from where blood is collected. At the end of a donor session blood is either transported
to the bank or kept at designated collection centers awaiting transport to the bank in a day
or two. When blood is delivered to the bank, it is immediately quarantined for processing.
Each unit of blood is accompanied with two sample tubes; one for screening for Transfu-
sion Transmissible Infections-TTI (HIV 1 and 2, Hepatitis B, Hepatitis C and Syphilis) and
the other for ABO/Rhesus grouping. It is also accompanied with a card bearing donor de-
mographic and clinical details. A unique but similar number is stuck on a given unit of
blood with its test samples and donor card. The donor cards are forwarded to the informa-
tion technology (IT) section for donor data entry and generation of a matrix (a computer
generated arrangement of donor numbers in rows and columns). The sequential arrange-
ment of samples in racks for TTI screening and ABO/Rh grouping is a replica of the com-
puter generated matrix. Results from screening and grouping are thereafter used first in
sorting out units of blood that are positive for any of the TTIs which are discarded, and sec-
ond for the final labeling of the units with their ABO/Rh groups. After labeling the blood
leaves the quarantine and is stored ready for distribution to hospitals. In case of sample
tube shortages at the collection site, a given unit of blood will be accompanied by one in-
stead of two tubes. This tube is first used by the TTI screening section then forwarded to
the ABO/Rh grouping section (Fig. 1). Moreover, both sections have to wait for the computer
generated matrix for this particular unit of blood. Quality control of the suitability of a unit
of blood is performed at the labeling and distributing steps. Here issues like expiry, volume
of blood in bag, hemolysis and quality of the bag containing blood are addressed.

Figure 2. Time intervals between the key preparatory activities.

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Table 2 Discard rates out of the 19,700 units collected from March 1st to June 30th 2009
Reason for discard Rates n (%)
TTI marker reactivity:
Sero-positive for HBV 681 (3.46%)
Sero-positive for HCV 453 (2.30%)
Sero-positive for HIV 152 (0.77%)
Sero-positive for syphilis 71 (0.36%)
Others:
Expiry of blood 33 (0.17%)
Inadequate blood in collection bag 26 (0.13%)
Hemolysis 10 (0.05%)
Leakage of collection bag 2 (0.008%)
TOTAL NUMBER OF UNITS DISCARDED 1,428 (7.2%)

The records
We reviewed records of 4,126 of the 19,700 units of whole blood collected and delivered by
the mobile collection teams to Nakasero regional blood bank in the period from March 1st
to June 30th 2009, to ascertain the time intervals between the critical steps in the process-
ing chain (figure 1). This allowed identification of major contributing step(s) – transporta-
tion, matrix formation (IT), testing (TTI markers and ABO/Rh), final labeling (quarantine
release) and final storage for dispatch to the hospitals - to the delays in blood processing.
Simultaneously, the rates and reasons for discarding blood during the same period were
noted.

The in-depth interviews


Based on the results of the average time a unit of blood spends at a given critical production
point as evidenced from record reviews, ten participants were purposefully selected for in-
depth interviews. These were people working at the critical production points of the blood
banks. They included drivers, laboratory technicians and administrators. The interviews
conducted at the participant work places lasted 50-60 minutes each. These were facilitated
by a trained research assistant in the presence of the principal investigator. Before the in-
terview, the principal investigator reviewed the objectives of the study to the interviewee
and an oral consent was obtained from the interviewee. The interviews were guided by a set
of predetermined and standardized open-ended questions focusing on experiences and per-
ceptions on staffing, quality of their working environment, methods and machines used,
and how these impact on the turnaround time that a unit of blood spends in their respec-
tive blood bank before distribution to hospitals. The proceedings of the interviews were
recorded using an audio recorder. Immediately after each session there was a debriefing
among the research team to ensure clarity of the recordings, documentation of any new
ideas or issues and plan for the next interview. The recordings were transcribed verbatim.

Data analysis
Continuous variables were represented by their respective median values. Statistical pack-
age for social sciences (SPSS, version 12.0; SPSS Inc. Chicago, IL, USA) program was used
for data analysis. A bivariate Pearson Product-Moment Correlation Index was performed to
find the relationship between the periods blood spends at different points in the blood
bank, with a significant correlation at the 0.01level (2-tailed).

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Qualitative data analysis involved reading and re-reading of transcribed text in order to
identify key ideas. Sections of text carrying particular meanings were labeled and coded.
The coded units were then systematically compared and summarized into categories of text
with similar messages (Pope et al. 2000). Obvious and visible meanings of the categorized
text were noted (Manifest content analysis). This was followed by further synthesis and in-
terpretation of the obvious meanings (latent content analysis) to generate themes (Grane-
heim & Lundman, 2004; Kondracki et al., 2002).

Figure 3 Example of codes, categories and themes from content analysis of narratives about delays in blood preparation.




 



     


   
       
   

 
         
      

      


      

     



 

  
    
 
     

     

  
  

   
 
 
  
  
  
  
   
   
 
     
  

          



  
   
   
  


   


 
 

          

 

 
 
 
 

  

  
   
 

   


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Figure 4 Features of the information technology system in use at Nakasero and Mbale regional blood banks.

  

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RESULTS

Records
During the study period, 19,700 units of whole blood were collected and delivered to
Nakasero Blood bank. Out of these, 1,428 (7.2%) units were discarded. Among the non TTI
maker causes of blood discard at Nakasero regional blood bank, blood expiry contributed
the highest proportion while blood leakage from the collection bag was responsible for the
least proportion of discarded blood (0.17% against 0.007%) - (Table 2).
The 4.126 units of blood whose records were followed from collection to dispatch to hospi-
tals, showed that the step, matrix generation till grouping, was longest (Median duration =
8 days). The steps, blood delivery to bank till matrix generation, and grouping till labeling,
took the least amount of time (median duration = 2days respectively) (Fig 2). There were
statistically significant but negative correlations between time spent by a unit of blood at a
given step in the chain and the time spent by the same unit at subsequent steps (all p val-
ues < 0.001). This means that if a unit of blood spent less time at step A (Fig 3), it would
spend more time at steps B, C, D, E, and vice-versa.

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Responses from interviews explaining causes of process delays


Inadequate transport Facilities
On many occasions teams collecting blood from distant camping sites (more than 100kms
from the regional blood bank) spend two to four days. Camping sessions are a major
method of blood collection. Here blood is collected on daily basis, kept in cool boxes and de-
livered to the bank at the end of the camping session. One driver remarked:
“Each team has one vehicle so if we go camping there is no way we are going to move up and
down with a few units, we deliver the whole lot at the end of the camp.”
“Sometimes we get hemolysed samples because of poor storage during transportation, if you are
using automated testing methods; you will not get results for these sample. So you do it manu-
ally. It is time consuming and may give erroneous results.”
The other causes of process delays as alluded to by the respondents to the interviews are
summarized in figure 2.

Staff shortages
Intrinsic problems within staff were considered key in prolonging the process. These in-
clude: 1. inadequate staff compared to the work load. 2. Despite availability of an IT system
with acceptable features (Fig 4), there is lack of enough trained staff to use this system.
During the study period, it was observed that two persons attend a given shift in the IT,
grouping and labeling sections. These shortages in staff are illustrated by the quotes:
“It is only the two of us who do this work, if I fall sick the section head may or may not call an-
other person from another section to fill up the gap, but that section is also affected”
“We all need to be trained on the supplied soft ware for our IT section so that if something goes
wrong we don’t have to wait for the data managers to come and fix it.”

Manual processing methods


The manual or semi-automated equipment used in the processing of blood were identified
as another cause of delays. These are characterized by frequent mechanical breakdowns
and erratic power supplies. This is reflected in the following narratives:
“When we get power shortage in the washing section, the procedure becomes complicated and
time wasting.”
“We should get an automated system to assist in the rapid testing other than using this manual
method in some of our tests. This will save time and protect us since we shall not be exposed to
these samples”
“… at the grouping stage, we prepare the incubation aliquots manually.”

Limited work space


The limited working space was identified as another cause of delay in the work flow. This is
characterized by mix up of documents necessitating rechecks on results before submission
to the following step. Comment from IT and TTI sections clearly show this:
“The small working place affects our speed. Sometimes plenty of cards come, you have to sort
them out according to the teams and you may mix them up, you may miss one or two which fall
off your table.” “Then you have to re-check and re-sort to ensure that you don’t make mistakes,
one mistake affects the whole matrix so you must take care in a narrow place”

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Inadequate supplies
The inconsistent supply of consumables was reported as another cause of delay in the pro-
cessing of blood. As a government institution, UBTS procures consumables according the
Public Procurement and Disposal of Public Assets guidelines (2003). This involves proce-
dures like advertisement, bidding, contracts approval and award before supplying the
items. This takes time as has been alluded to by one senior laboratory technician:
“If we don’t have reagents for a particular test then we can’t produce results, we have to wait for
the supply”
“The public procurement processes are really time consuming. It takes approximately six weeks
from requisition to supply of an item.”
Other identified bottlenecks in the procurement of consumables are the delayed and in-
complete submission of requirements for a particular period by the various laboratory sec-
tions to the designated procurement officer. This hinders prior planning and delays
initiation of a long process.

DISCUSSION

Donated blood must go through some process – though with time limits – that adds value to
it so that it can serve the recipient hemotherapy needs. In any transfusion organization,
this process involves a blend of people, machines and materials, methods and environ-
ment. The current study has identified weaknesses in the above blend for Uganda’s re-
gional blood banks that limit provision of adequate and timely blood products to patients
when needed. The rate limiting steps in this setting are delivery of blood from collection
centers to the banks, matrix generation, testing for transfusion transmissible infections
and ABO/Rh blood grouping. The identified blood bank bottlenecks are compounded by
weaknesses at the clinical interface. Kajja et al. 2010 established that in Uganda, clinical
staff does not appreciate the quality and quantity of the available blood products in their re-
spective regional banks. Likewise, the blood bank staff does not fully appreciate the clinical
transfusion needs and constraints. This fragile clinical interface falls short of motivating
the overseeing administrative structures in the regional blood banks to produce adequate
and timely blood products.
In a resource constrained Uganda, with limited numbers of voluntary non-remunerated
blood donors (VNRBDs) and transport facilities, it would be cost-effective to transport
blood in bulk from collection sites to the processing banks. However, this causes reduced
supply of blood to hospitals and reduces the shelf life and quality of blood. In related work
by Hassall et al 2009; 2010 at Coastal Province General Hospital Mombasa, Kenya, it was
found that blood waiting long in blood banks before transfusion losses quality in the fol-
lowing ways; it carries increased bacterial contamination rates of the small pediatric blood
units particularly with laboratory pathogens, has increased red blood cell hemolysis rates
and has high extracellular potassium levels. The combination of unclean working condi-
tions, warm ambient temperatures (20-300C) in sub-saharan Africa, high relative humidity
(80%-90%) and unreliable refrigeration all combine to produce significant quality hazards
to blood products.
The workload at matrix generation, testing and grouping sections overwhelms the avail-
able staff - two people attending a shift per section. This leads to the observed stalling in
the process flow at the banks. Noteworthy however, the existing staff is dedicated to its
work. They attempt to speedup activities at a given step following delays in the previous

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preparatory steps. This is shown by the significant inverse proportionality (p<0.001) of


time spent by a unit of blood at a given step to the time it spends at the subsequent steps.
The UBTS is a semi-autonomous institution. It has no control over recruitment of employ-
ees. Its staff is recruited by the public service commission through the Ministry of Health.
As a National policy, there are limits to recruitments. These bureaucracies directly impact
on the number of staff that can be available to the transfusion services. Additionally, still
some people do not take up offered jobs at the bank due to poor remunerations. This leaves
most of the work to few staff. Additionally, all staff in information technology (IT) section is
not fully trained on the software currently in use. This leaves the work of matrix generation
to a few staff therefore delaying testing and grouping steps. The narrow job structures and
training gaps are not unique to Uganda blood banks. According to the World Health Organ-
ization Global Database on Blood safety (2002), and Kaseje’s report (2006) on Health care in
Africa, Low Human Development Index (L-HDI) countries are still challenged by inade-
quacy of the human resource in the health sector due to remuneration constrains and the
rampant brain drain to greener pastures.
In Uganda, transfusion services are 100% centrally budget funded. The UBTS does not
run any cost recovery programs from either the supplied hospitals or the transfused pa-
tients. As pointed out by Hensher and Jeffrey (2000), this single income stream has an in-
herent weakness in situations of delayed or limited funding. Here the supply of
consumables and other recurrent utilities will be affected and this impacts directly on flow
rates of processes using those items. This weakness has been clearly demonstrated in this
study.
A Blood Transfusion Service is unique in the sense that it handles a precious and perish-
able product. The procedures of procuring its operational utilities should not be equated to
those of any other organization as is the case in Uganda – (according to Public Procurement
and Disposal of Public Assets Regulations). Therefore, we recommend an urgent review of
the rules and regulations governing the procurement of consumables for blood bank labo-
ratories in Uganda. We also recommend administrative emphasis to staff on the impor-
tance of timely and comprehensive submission of annual requirements to the concerned
procurement sections. This will ensure adequate supply of consumables throughout the
year.
The low level of revenue available to the Ministry of Health to cater for the entire national
health budget does not allow UBTS to access or use fully automated machines in their op-
erations. Therefore, they resort to the slow manual methods in some procedures like test-
ing for syphilis and blood grouping. Unlike manual method, automated methods have been
found to carry the following advantages; they give accurate, consistent and reliable results
irrespective of work load, are faster than manual methods therefore reduce the turnaround
time a unit of blood spends in quarantine, and offer a faster storage and transfer of data be-
tween sections of the laboratory. Additionally, but in the long run, automated methods are
cheaper than the manual methods. The initial capital expenses are out-weighed by the run-
ning costs of the manual methods which use more antiserum, require more staff and carry
a compromised patient safety outlook due to operator fatigue especially towards the end of
busy shifts (Gershon et al.,1996; Sazama, 1996)
Douglas (1982), recommended that the most important step in improvement of quality of
compatibility testing is the management of stressful conditions in transfusion laborato-
ries. This has been emphasized in the American Association of Blood Bank (AABB) stan-
dards for blood banks and transfusion services (2009). The current design of the work
places in the IT, blood grouping and testing sections does not provide adequate space for

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easy and fast execution of tasks. We postulate that the psychological stress of working in
such an environment could impact strongly on the work flow rate in these areas hence the
observed delays.
The major limitation of this study was failure to find an isolated room to conduct the inter-
views in the congested laboratories. This could have affected free and spontaneity of flow of
information from interviewees. However, it reaffirms the urgent necessity to address the
unfriendly work environment in the blood banks.
In summary, this study has established that blood looses a substantial amount of its shelf
life in processing blood banks due to; inadequate staffing, shortages in materials and
equipment, and poor work environments. In order to cater for the unique nature of blood
processing as a service, we recommend the following: First, the Government of Uganda
should review the staff ceiling on UBTS accompanied by modest staff remuneration and
appropriate training. Secondary, government of Uganda should develop a procurement
model unique to transfusion services. This will ensure continuous and timely provision of
the recurrent blood bank supplies and utilities. Thirdly, there should be improved funding
towards procurement of fixed assets for the transfusion services. This will lead to a shift
from use of manual to automated equipment in the banks. It will also ensure a constant
upgrading of the IT software so that it is compatible with any newly acquired equipment.
Fourth, and as a long term plan, there should be expansion of the existing facilities (blood
bank buildings) to cater for the current lack of work space and furniture in many regional
blood banks. This should be closely followed by training of blood bank staff on standard
laboratory hygiene and safety principles.

ACKNOWLEDGEMENTS
The authors would like to thank all staff of the participating Regional Blood banks for their
loyal and valuable inputs. They also acknowledge the valuable contribution of Mr. Abwooli
Gilbert, Laboratory technologist Nakasero regional blood bank, for helping in data collec-
tion, Mr. APM Los, Medical Sociologist Sanquin Consulting Services, The Netherlands, for
designing and standardizing the guide questions of interviews and advising on the statisti-
cal evaluation of the collected materials.

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REFERENCES
1 Douglas R. The difficult crossmatch: A consideration of staff not methods. Transfusion,
1982;22:333-336.
2 Facilities and safety. In Standards for Blood Banks and Transfusion Services, 2009 Ed 26;
page 84.AABB Press. Bethesda, Maryland.
3 Gershon, H.G., Galenza, J., Heather, M., Whitehead, R.& Godolphin, W. The implemen-
tation and use of automated group and screen procedures in a hospital transfusion lab-
oratory. Transf Med Reviews 1996 ;10:144-151.
4 Graneheim, UH and Lundman BQualitative content analysis in nursing research: con-
cepts, procedures and measures to achieve trustworthiness
Nurse Educ Today .2004;24:105-112
5 Hassall,O., Maitland, K., Pole,L., Mwarumba,S., Denje,D.,Wambua,K.,Lowe,B.,
Parry,C., Mandaliya,K.& Bates,I. Bacterial contamination of pediatric whole blood
transfusions in a Kenyan hospital. Transfusion 2009;49:2594-2598.
6 Hassall,O., Maitland, K., Fegan, G., Thitiri, J., Pole, L., Mwakesi, R., Denje, D., Wambua,
K., Mandaliya, K.& Imelda Bates, I. The quality of stored umbilical cord and adult-do-
nated whole blood in Mombasa, Kenya Transfusion 2010;50:611-616.
7 Hensher, M & Jeffrey, E. Financing blood transfusion services in sub-Saharan Africa: a
role of user fees. Health Policy and Planning; 2000;15:287-295. Oxford University Press
8 Kajja,I., Bimenya, G.S., Smit Sibinga, C.T. The interface between blood preparation and
use in Uganda. Vox Sang 2010;98: e257–e262
9 Kaseje D. Health care in Africa: Challenges, opportunities and an emerging model for
improvement. 2006 Available at http://wilsoncenter.org/topics/docs/Kaseje2.pdf ac-
cessed 2.10.2009.
10 Kondracki. N.L., Wellman, N.S., Amundson, D.R. Content analysis: review of methods
and their applications in nutrition education. J Nutr Educ Behaviour 2002;34;224-230.
11 Pope, C., Ziebland, S., May, N. Qualitative research in health care .Analyzing qualitative
data. Brit Med Jl 2000;320;114-116.
12 Resolution WHA28.72. Utilization and supply of human blood and blood products.
Twenty-eighth World Health Assembly, 1975 Geneva, World Health Organization.
13 Sazama KCurrent Good Manufacturing Practices for transfusion medicine. Transf Med
Reviews, .1996;10:286-295.
14 The Republic of Uganda- Public Procurement and Disposal of Public Assets (PPDA)
Regulations No. 70 of 2003. Available on www.ppda.go.ug Accessed 28th January, 2010.
15 World Health Organization Global database on Blood safety, 2002. Available at
www.who.int/bloodsafety/GDBS_Report_2001-2002.pdf. Accessed 3rd August 2009

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Chapter 9

Discussion
This thesis examined the current hospital transfusion practices. It also addressed factors
that directly or indirectly influence these practices. These included; information flow be-
tween suppliers and users of blood, adequacy of blood supplies, quality of bedside blood or-
dering and administration procedures, adherence to available operational documents and
usefulness of a restrictive blood ordering strategy in surgical practice. It has been estab-
lished that there are shortcomings in the quality of in-hospital systems that are key in
management of the transfusion chain in the clinical setting. These include lack of organi-
zational management structures, inadequate human resources, un-answered customer is-
sues, inadequate equipment and consumables, poor documents and records keeping and
an un-conducive work environment. Strategies to address some of the above problems have
been identified, including a strategy of improved blood management, the surgical blood
order equation as a useful tool in peri-operative blood ordering in femoral fracture surgery
and a better containment of the time line in the procurement process.

9.1 ORGANIZATIONAL AND MANAGEMENT ISSUES

The observations have established that there are no responsible persons to oversee, or poli-
cies to regulate in-hospital transfusion processes in Uganda.
In Uganda it is not standard practice to seek an informed consent from patients or respon-
sible persons to minors before administration of blood. The other example that shows
shortfalls in administrative structures is the irregular pretransfusion testing sample ac-
quisition in Ugandan hospitals. There are no strict policies to regulate recruitment of par-
ticular staff for a particular task, like trained phlebotomists would be charged with
drawing a pre-transfusion test sample. Any clinician, including students, can perform this
procedure with no accurate process description or standard operating procedures (SOPs).
This compromises patient safety because of the many human and clerical errors that can
occur at this stage. An example to this effect is poor patient and test tube identification that
leads to a sample of blood ending in a wrong tube therefore initiating a chain of events that
end up in an incompatible transfusion with fatal effects. Additionally, there are no regula-
tory standards in the hospital transfusion laboratories to ensure quality control at pre-
transfusion sample reception. This affects the quality of the compatibility tests and the
patients’ transfusion outcome. Poor and incomplete reporting and documenting of adverse
transfusion events and mishaps form another paucity in the current in-hospital transfu-
sion practices in Uganda. Fortunately, a number of participating clinicians have appreci-
ated this organizational and management gap. They have suggested an urgent need for
formation and facilitation of hospital transfusion committees (HTCs) which will be respon-
sible for the development, approval and implementation of policies, processes and proce-
dures.

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An established hospital transfusion administrative structure such as a functional HTC is a


prerequisite in the proper running of in-hospital transfusion practices. It is responsible for
policy development and approval, general transfusion administration, attending to clinical
consultations and education, training and skills development of all concerned staff and a
continuous monitoring and evaluation of the entire in-hospital transfusion chain as the
core of a hemovigilance system focused on improvement of practices.
To date much effort has been directed to development and implementation of policies to en-
sure safety and adequacy of blood products in the procurement setting. Minimal attention
has been put to blood safety procedures in the clinical setting more so in the developing
world. As early as 1975 Cohen and Pierskal [1] in their study on simulation models of blood
bank inventory management, had found that well selected policies on blood ordering, cross
match and issuing greatly influenced optimal blood bank stock management. They found
that compared to the last in first out (LIFO), a first in first out (FIFO) policy on blood bank
stocks was characterized by lower in-hospital blood shortages and outdates. The concerns
of blood safety in the procurement setting have been intensified due to the HIV/AIDS out-
break and other emerging TTIs. This is characterized by increased use of technological ad-
vancements in blood production and processing environments which is not reciprocated in
the clinical setting. [2]
The presence of a functional HTC creates a favorable environment in the clinical setting for
researchers to conduct studies that impact directly on patient safety and influence policy
reviews. [3] Whitsett and Robichaux [4] were able to indentify blood administration problems
through an audit of bedside practices in which they compared directly observed incidents
against information derived from administrative incident reports. Saxena and others [5]
were able to investigate and provide constructive feedback to concerned clinicians about
underutilization of red blood cell concentrates and platelets in Los Angeles County Univer-
sity of Southern California Medical Center. In an effort to assess the consequences of possi-
ble transfusion-transmitted diseases as well as cost-benefit estimation of new blood safety
interventions, Kamper-Jo/rgehsen and others [6] were able to establish survival rates in a
population of 1,118,261 blood recipients over a 20 years follow-up.
From the findings in this thesis and as has been alluded to by the work of Shulman and
Saxena [7], it is apparent that HTCs are critical in overseeing in-hospital transfusion activi-
ties. They should be urgently established in Uganda to define policies concerning issues
like (list is not exhaustive):
> consent for transfusion
> refusal of transfusion
> pretransfusion testing orders (use of Type and Hold ,Type and Screen, Type and Cross-
match)
> surgical blood order schedules
> ordering practices including when to initiate transfusion, what product to administer,
rate of administration.
> clinical alternatives to blood transfusion
> patient identification (both at time of specimen collection and at time of blood product
transfusion)
> blood product administration practices (e.g., connecting the blood, which type on infu-
sion set to use, what IV fluid is compatible)

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The HTC should then take the initiative to train in service physicians and nurses on the op-
erationalization of these policies. Additionally, HTCs should advocate for curricular re-
views in various medical, nursing, laboratory and paramedical training institutions so that
basic training on appropriate bedside transfusion practices is properly addressed and at an
early stage of career development.

9.2 HUMAN RESOURCES

In order to provide quality bedside and laboratory transfusion services, each hospital
should develop and implement a staffing plan which identifies how many employees, with
what level of training are needed to meet workload requirements. [8, 9] This study has identi-
fied shortages of staff at the bedside, hospital transfusion laboratories and blood bank lab-
oratories. This affects the quality of service delivery, thus many clinicians assert that the
informed consent process is such a time consuming activity which can not be undertaken
with the patient load that has to be attended to by a limited staff. Other bedside procedures
like pre-transfusion sample acquisition and administration of blood are inconsistently
done because of shortage of trained staff and lack of supervision of the students who actu-
ally perform these procedures, albeit inconsistently.
Hospital transfusion laboratories are also poorly staffed. This is reflected by the delays be-
tween ordering for blood and delivery of a cross-matched unit to the utility stations [ward,
theatre or intensive care unit (ICU)] in larger hospitals with a high patient load but with
limited laboratory staff.
The shortage of staff stretches up to the supplying Regional Blood Bank. Thus one of the
bottlenecks of blood processing in these banks is limited staff in the grouping and TTI test-
ing sections. It has been observed that collected blood spends a considerable amount of
time in these banks and is not made available in a timely manner to hospitals whose de-
mands are on the rise.
Paucity of the human resource in the health sector directly impacts on the quality of service
delivery and indirectly affects key health indicators. In their cross-country econometric
study and after controlling for other determinants in a logistic regression, Anand and
Bärnighausen [10] confirmed that the number of staff in the health sector significantly deter-
mined maternal, infant and under-five mortality rates.
The human resource crisis is caused by many factors such as inadequate production, in-
ability to hire due to limited budgets, brain drain, poor motivation, conflict of interests, and
misuse of resources, including time. An overwhelming majority of health workers are con-
centrated in urban areas leaving many rural health facilities which care for up to 80% of
Uganda’s population with a limited number of clinicians.
In comparative audits of bedside transfusion practices in the United Kingdom Taylor and
others [11] indentified a progressive improvement in measurable bedside practices after im-
plementation of effective human and organizational structures in the studied Hospitals.
The participants in the study have identified strategies to address shortages in quality and
quantities of the human resource. These include review of medical training curricula to en-
sure production of health workers who are equipped with knowledge and skills required to
meet the demands of safe transfusion practices. Secondary, there is need to review human
resource policies that enforce rigid ceilings on recruitments. This will improve bedside and
laboratory quality of care. Third, continued professional development has been singled out
as a strategy of keeping in-service staff abreast with developments in Transfusion Medi-

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cine. This should be based on simple, accessible, locally designed and administratively ap-
proved training materials. The established structure should give room for some staff to at-
tend training workshops and seminars while others cover the routine work processes.
The plans to respond to this crisis should be supported by political commitment and appro-
priate allocation of resources. All political and social opportunities capable of helping to
raise awareness on the shortage of staff in the transfusion services should be pursued.

9.3 CUSTOMER ISSUES

The customers of in-hospital transfusion services include clinicians who prescribe, and pa-
tients who subsequently receive blood. Each of these two has particular expectations.
Amidst anxiety and lack of medical knowledge, the patients expect to receive a safe and ef-
ficacious blood component. The clinicians expect the transfusion services in and outside
the hospital to supply timely, adequate, safe and cost-effective blood products to his or her
patient. It is important to assess customer satisfaction with a product or a service. This
helps policymakers and blood center managers reshape their systems by focusing on activ-
ities that have the greatest impact on satisfaction while deemphasizing costs associated
with those with the least customer satisfaction. It also gives confidence to hospitals (clini-
cians and patients) to look to their blood suppliers to keep them abreast of changes in regu-
lations, technologies, and treatments. It further suggests that hospitals look to their blood
suppliers to assist them in resolving blood-related issues associated with difficult
patients. [12, 13] This thesis has demonstrated failed customer satisfaction at the clinician-
patient interface. Thus, despite the fact that patients are cognizant of their right to get in-
formation concerning blood safety, the bedside practices are still based on the paternalistic
principal other than participatory decision making before a transfusion. The patients
painfully surrender their right to the clinicians whom they trust and assume to know it, all
albeit working without transfusion guidelines. This contravenes the ethical principal of pa-
tient autonomy and is bound to lead to litigation in situations of cultural or religious con-
flicts.

This work has also demonstrated lack of customer satisfaction at the blood supplier-clini-
cian interface. There is lack of communication to the clinicians of the rigor and costs in-
volved in donor motivation and mobilization, their medical examination, collection,
processing, testing and storage of blood products. Additionally, the transfusion service
does not adequately inform her customers of the spectrum of available blood components.
These information gaps have lead to suboptimal ordering and blood use in Ugandan hospi-
tals. Satisfaction with the routine delivery schedule is a measure of blood center reliability.
Reliability of blood centers is important to hospitals because an inadequate blood supply
may pose a danger to patients, since the proper amount and type of blood may not be avail-
able when needed. Blood shortages can lead to longer hospital stays and poor outcomes if
elective procedures must be postponed to wait for adequate supplies of blood. Such short-
ages increase costs and present numerous possible risks for patients, [14] thereby contribut-
ing to an increase in the national burden of disease.
As suggested by many participants in this thesis, the solution to these communication and
supply gaps lies in development of functioning Hospital Transfusion Committees (HTCs).
These can lobby and advice hospital top management to install modern communication
systems to assist a proper flow of information from blood utility stations (wards, theatres

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and intensive care units) to hospital transfusion laboratories. The HTCs will also act as
conveyers of information between the hospital settings and the supplying blood banks.
From one end, the blood banks will provide information on existing stocks and relevant sci-
entific advancements to the clinicians through the HTCs, while from the clinical setting the
HTCs will update the blood banks with the epidemiology of and trends in blood needs. This
will ensure adequate and timely allocation of transfusion service logistics for proper pa-
tient management.

9.4 EQUIPMENT AND SUPPLIES

It has been established that there are shortages of equipment and supplies both in the hos-
pitals and in the blood banks. These directly affect the quality of transfusion practices in
Ugandan hospitals. Regarding the bedside blood ordering process and the procedure of ac-
quiring the pretransfusion sample in particular, it has been observed that the collection
tubes are always in short supply, so clinicians use the same needle and syringes for draw-
ing and transportation of samples to test laboratories. There are no transportation facili-
ties for samples in Ugandan hospitals that guarantee compliance with the basic cold chain
conditions needed. Whoever is performing this procedure handles the sample by hand.
This compromises the quality of the samples and is bound to lead to erroneous testing and
compatibility results. In blood selection and compatibility testing procedures, particularly
in transfusion laboratories of large hospitals, the reagents are in short supply. The labora-
tory technicians go around this by diluting the reagents in ratios of 1:3 so as to cover the
workloads of high blood demands However, diluted reagents may not detect weak red cell
antigens at blood typing and compatibility testing, which can result into hemolytic reac-
tions in blood recipients.

The blood cold chain is broken in the hospital settings due to use of inappropriate trans-
portation and storage facilities for blood. Thus, blood is transported by hand, without cool
boxes and over long distances between test laboratories and utility stations. It is stored in
domestic refrigerators, in situations of poor hygiene and asepsis, and frequent power shut-
downs therefore under un-controlled temperatures. The bedside process of administration
of blood to patients is also characterized by shortages of consumables like infusion sets,
skin disinfectants and protective gloves. These shortages compromise the intended use
and quality of blood transfusions. Technological advances have improved the quality of the
transfusion chain within the hospital setting. Thus, introduction of the Bar code system [15]
has improved patient, pretransfusion sample and unit identification. Use of the pneumatic
tube system [16, 17] ensures quick delivery of acceptable pretransfusion test samples from the
bedside to the test laboratories. Currently Uganda’s health expenditure per capita per
annum is 1 US dollar. Therefore, health care facilities chronically run under budget deficits
that lead to shortage of hospital drugs, transfusion alternatives, consumables and equip-
ment. The above shortages are an example of the situation in many Sub-Saharan coun-
tries [18] and are comparable to the finding in the war ravaged Afghanistan. [19]

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9.5 DOCUMENTATION

Collection and documentation of information is an integral part of quality management. It


must be based on a well planned, written and managed institutional or organizational pol-
icy. Documentation provides a framework for understanding and communication through-
out the organization. [20] Documents describe how processes and procedures are intended to
work, how they interact, where they must be controlled, what their requirements are, and
how to implement them. Records provide evidence that the process or procedure was per-
formed and provide information needed to assess the quality of products and services as in-
tended. Written policies, process descriptions, procedures, work instructions, labels,
forms, and records are all part of the facility’s documentation system. [20, 21]
This thesis has established that the blood ordering process is poorly documented. Thus,
some blood orders are placed without a documented clinical diagnosis, the reason for
transfusion, hemoglobin level or the expected transfusion outcome. This is mainly due to
the fact that most Ugandan hospitals have not come up with a regulatory policy on blood
ordering that would clearly define the requirements at this stage.
Documents should be developed in a format that conveys information clearly and that pro-
vides staff with the necessary instructions and templates for recording data. [22] A blood re-
quest form (BRF) is an important tool of communication of blood needs to the hospital
transfusion laboratories. The design and management of the currently used blood request
form at Mulago Hospital influences the clinicians’ performances during blood ordering. It
represents patient identifiers – family name and given name as Name only, a better identi-
fier – date of birth as Age. It elicits the ‘would be’ detailed history of any previous transfu-
sions as just history of transfusion. Its design is also out of date as the amount blood
requested is represented in bottles instead of units or bags. In the bid to control the utiliza-
tion of this poorly supplied document, copies of the form are kept in the hospital transfu-
sion laboratory and filled by whoever delivers a test sample to the laboratory. The
inadequate design and management of this document confuses the prescribing clinician
hence the observed non compliances to the document. [23] It is imperative therefore that Mu-
lago Hospital in accordance to a well written National transfusion policy periodically re-
views, modifies and reapproves its transfusion documents as needed to keep them current.
It should also ensure that documents are legible, identifiable, and readily available in the
locations where they will be used.

It has been established that during the process of component selection and compatibility
testing, the time the request reaches the laboratory, the quality of test samples and the time
when the unit of blood is signed, are inconsistently documented. This implies that it is dif-
ficult to conduct an internal audit so as to control and improve processes, since these criti-
cal control points are not documented. The quality of documentation during the process or
procedure of blood administration to the patient was also found wanting. There are no
process instructions or predesigned forms such as a transfusion reaction form (TRF) to as-
sist clinicians document time a transfusion is started, the baseline vital signs, events oc-
curring during or outcomes of a transfusion. Lack of documentation at this stage impacts
directly on patients’ safety and the total bedside quality management. A clinically effica-
cious transfusion should be infused over a maximum period of time (run a unit of 450 ml of
red cell concentrates 3 to 4 hours or 150-300 ml per hour in adults). Participating hospitals
in this thesis use too narrow bore intravenous needles for blood infusion due to shortage of
supplies. This implies that transfusions run over variable and prolonged periods which re-

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sults in compromised safety and quality of the transfused product. Despite their compro-
mised potency and safety, the clinician monitoring such transfusions cannot discontinue
them since he does not have a documented baseline commencement time. The clinician at-
tending to a patient receiving a blood product cannot easily attribute any adverse reaction
that may occur during or immediately after a transfusion to the infused product since there
is no record of baseline vital signs. It would be difficult to ensure a proper vein to vein trace-
ability and therefore develop a hemovigilance program if the events occurring during the
blood administration process are not recorded.
The identified weaknesses in the hospital documentation systems offer opportunities to
first and foremost do process mapping of all transfusion activities using flow charts. The
process maps can then be used as templates to describe the identified processes (process
descriptions) and write simple, clear and accessible standard operating procedures (SOPs).
These will list the critical steps that need documentation and provide information regard-
ing the aims and scope of each step. This should be followed by training of clinicians and
laboratory staff on the developed documents and finally perform periodic staff competence
assessment to certify staff abilities in and adherence to using the SOPs.

This thesis provides an evidence based opportunity to stake holders to start designing
other critical documents like hospital transfusion quality manuals, process and procedure
instruction manuals, transfusion reaction forms, bedside delivered and un-used blood reg-
istries which are non existent at the moment in many hospitals in Uganda. A well designed
documentation policy will ensure harmonization of these documents at National level so
that they capture uniform and consistent data that will form a foundation for initiating a
nationwide hemovigilance program. [22]

9.6 WORK ENVIRONMENT

Each institution, hospital or transfusion service must have a policy that guides provision of
a safe environment to donors, patients and staff. This environment should be conducive for
the smooth running of procedures. [24] It has been found that staff in hospitals and blood
banks perform their tasks in narrow and crowded spaces. This affects the quality of their
work output. Small and crowded work spaces are characterized by poor hygiene and tidi-
ness, and a high rate of human errors which call for urgent attention by the laboratory or
ward manager if patient safety is to be assured. Thus, regional referral hospitals with con-
gested and busy transfusion laboratories, registered prolonged turnaround time of effect-
ing a blood order from the utility stations (wards, theatres or ICUs). It was also noted that
regional blood banks with narrow and crowded work space for the information technology
and blood testing sections, registered a long quarantine time before blood is released to
hospitals. These delays in the supplying banks and laboratories influence the ordering
practices of clinicians. Here clinicians are forced to place larger orders than they actually
need. They then store the un-used blood in uncontrolled domestic ward refrigerators under
uncontrolled temperatures, hygiene and asepsis. The delays lead to deterioration of pa-
tients’ conditions especially in emergency situations and postponement of elective surgical
procedures with the subsequent increased hospital stays. The above situations compound
each other in compromising blood safety therefore increasing the risks of a transfusion in
such a setting with as a consequence an increase in the burden of disease.

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Work space problems were also identified in operating theatres. Due to lack of operating
theatre space, a patient presenting with a fractured femur can only undertake his or her
surgical procedure not less than five days from the day of admission to hospital. This de-
layed surgery is accompanied by excessive blood loss during and after surgery, leading to
increased use of allogeneic blood in the peri-operative period.

This thesis also points out gaps in communication between work stations or departments
along the vein to vein chain of blood transfusion. Thus, the clinicians’ knowledge about
availability and use of the blood products in their respective supplying banks was found
wanting. Likewise the Regional Blood Bank staff does not understand the dynamics of
blood needs at the clinical setting. [26] This lack of knowledge flow affects execution of duties
on both side of the interface. On one hand the clinicians sub optimally place their blood or-
ders, while on the other hand the blood bank establishment inappropriately allocates its
procurement and distribution logistics. This is partly alluded to from the direct quotation
of one key informant interviewee: “...we do not issue blood according to what has been or-
dered. Many times the clinicians over order. So our issues depend on what we have in stock.” , il-
lustrating the current supply driven transfusion system in Uganda.
As has been suggested by a number of participants in the studies done, that the above prob-
lems can be mitigated by increased allocation of funding in capital developments of blood
establishments. This will ensure construction of premises that will allow effective clean-
ing, minimize the risk of product contamination and provide a safe working environment
to staff. These will provide adequate space, light, running water and constant power supply
with backup generators to guard against blood wastage in case of interruption in electricity
supply.

In the congested clinical settings, procedures should be in place to address general infra-
structure, patient and staff safety. These will include strategies to handle electric accidents,
fires and preparedness to deal with any other disasters and incidents through appropriate
contingency planning. In the laboratory setting efforts should be centered on management
of bio-hazardous waste and protecting staff against blood borne pathogens. This is evi-
denced in one laboratory technician remarks: “I wish the blood bank administration could
provide immunization against Hepatitis B and Hepatitis C for its entire laboratory staff. This
would make us feel confident to handle these samples.” A policy to regulate and enforce hospi-
tal laboratory discipline should be developed. This will limit and control movement, in par-
ticular unauthorized, into blood and blood product storage areas. These areas should be
fitted with audible and visual temperature alarms to alert staff in case temperatures in
blood storage cabinets deviates from set ranges. There should be developed simple, clear
and accessible SOPs describing actions to be taken in case work environment hazards and
temperature changes do occur.

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9.7 BEDSIDE BLOOD MANAGEMENT

One of the strategies to improve the bedside process of blood ordering is to standardize the
procedure of peri-operative blood ordering and use in elective surgery. Efficacious blood use
in elective surgery requires that hospitals develop systems to establish the exact amounts
of blood lost during the commonly offered surgical interventions. This should be followed
by scientifically testing the accuracy of blood order schedules for each of these surgical pro-
cedures. Likewise hospitals ought to develop and implement guidelines on blood ordering
and use in emergency situations like massive transfusions on obstetrics and following
trauma.

The magnitude of peri-operative blood loss in open reduction and internal fixation (ORIF) of
femoral fractures is influenced by a number of patient, physician and institutional factors.
This thesis has established institutional and patient factors as major contributors to blood
loss during and immediately after this procedure. Lack of enough theatre space delays ac-
cess to surgery in this institution. These delays before surgery in trauma are characterized
by consumption coagulopathies that are followed by excessive intra- and postoperative
hemorrhage. Additionally, lack of theatre equipment like fracture tables and diathermy
which are a standard in operative fracture management in the more developed word, con-
tribute to massive intra-operative blood loss due to technical difficulties in carrying out the
surgery. These shortages lead to prolonged operation time and often increased blood loss
during surgery.
Forty seven out of the ninety three enrolled patients for ORIF (Chapter 5) had severely com-
plicated fractures types B and C. It is technically difficult to reduce these types of fractures
especially if the procedure is delayed. This takes a lot of operation time and is often accom-
panied by excessive peri-operative blood loss, hence blood transfusion.
From the above shortcomings in the operating theatre (OR), and the un-controlled peri-op-
erative blood ordering and use, it is apparent that there is a compromised quality of life of a
patient undertaking surgery in such a setting, which seriously impacts on the hospital bur-
den of disease.
In the bid to address the peri-operative blood order and use in ORIF of femur fractures, the
surgeons readjusted their transfusion triggers at a lower pre-operative hemoglobin level
and in accordance to the SBOE. This resulted into saving of the hospital blood transfusion
resources in doing un-necessary cross matches and managing a large inventory.

9.8 CONCLUSIONS

This thesis has unearthed major loopholes in the bedside transfusion practices and at the
blood supplier-user interface that need urgent attention by all stake holders.

Transfusion informed consent


> The knowledge base of Ugandan clinicians as regards the transfusion informed con-
sent is not adequate.
> There is no administrative framework in Ugandan hospitals to ensure dispensation of
a transfusion informed consent
> The blood recipients have no experience about transfusion consent because this is a
neglected process in bedside transfusion practices in Uganda.

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Blood ordering
> There is a suboptimal documentation of the blood ordering process in Uganda’s major
teaching hospital. This directly affects the quality of the blood selection process in the
hospital blood bank.
> The inadequate communication of patient information to the blood bank is partly due
to the outdated blood request form that is currently used, but also due to the un-accept-
able management of this document (blood request forms are filled from the blood bank
but not at the bedside).
> A patient undertaking elective surgery for a major procedure like open reduction and
internal fixation of an isolated unilateral femur fracture in Mulago Hospital theater
looses a substantial amount of blood at surgery. This is partly due to delayed surgery
but also due to lack of proper theater equipment to reduce blood loss at surgery.
> The introduction of the Surgical Blood Order Equation as a guide to peri-operative
blood ordering in femora fracture surgery has reduced significantly the cross-match-
to-transfusion ratio for this procedure. This has been accompanied by considerable
cost-savings on the hospital blood bank logistics.

Administration of blood to patients


> The bedside process of administering blood to patients at Mulago Hospital is far from
optimal. There are continuing inconsistencies in the performance of procedures like-
blood transportation to the utility stations, blood reception, patient identification,
monitoring of a patient undertaking a transfusion and documentation of transfusion
events.

The interface between blood users and suppliers


> There is paucity of knowledge among clinicians about the available blood products in
there respective supplying hospital and regional blood banks.
> The clinicians do not fully appreciate the value of the use of the supplied blood products.
> The blood bank staff does not fully appreciate the clinical blood needs of the hospitals
they supply.
> The blood banks do not supply adequate and timely blood products to hospitals due
staff shortages, and inadequate managerial and infrastructural facilitation.

The identified loopholes in the hospital transfusion practices result from institutional fac-
tors like lack of a proper administrative organizational mechanism to oversee and imple-
ment good clinical practices, lack of appropriate equipment and poor work environment.
They also come up as a result of clinician factors like lack of basic Transfusion Medicine
knowledge that is necessary to carry out critical bedside procedures. Overall the observa-
tions made clear that the absence of a defined and developed hospital quality and quality
management system with adequate documentation and a mechanism for daily monitoring
and evaluating practices that include blood transfusion needs an urgent top down address.

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9.10 RECOMMENDATIONS

A
In line with the WHO Executive Board recommendations to the Sixty-third World Health
Assembly, [26] Uganda as a WHO Member State in good standing should update her national
legislations and related regulatory structure on clinical use of blood. This will entail devel-
opment of National regulatory authorities with administrative instruments to ensure con-
trol in the areas of quality and safety of blood products across the entire transfusion chain.
At hospital level, this will involve creation and facilitation of Hospital Transfusion Com-
mittees (HTCs). These should consist of hospital staff from various blood prescribing de-
partments and at least a member from the UBTS Regional Blood Bank. They will be
charged with development, implementation, monitoring and evaluation of policies and
strategies to streamline the in-hospital transfusion processes.
It should be noted that cooperation and support from the hospital high authorities is para-
mount in the proper running of HTC activities.

B
In order to ensure internationally acceptable health care to blood recipients, Uganda
should develop locally acceptable hospital standards (quality and technical) to streamline
the various procedures in the three main processes. They should be realistic, reliable, valid,
clear and measurable.
They should include standards on:
> reaching a diagnosis and setting the indication for blood.
> seeking an informed consent for blood transfusion
> making a blood order
> taking and labeling a pre-transfusion sample
> transportation of blood samples and products within the hospital setting
> storage of blood products in the laboratory, wards, theaters and intensive care units
> reception of pre-transfusion samples in the hospital transfusion laboratories
> blood component selection
> issuing of blood components from the transfusion laboratory
> reception of blood at the utility station with accompanying patient identification
> connection and starting a transfusion
> patient monitoring during a transfusion
> managing adverse transfusion reactions

Based on the developed standards, the HTC should come up with simple guidelines that
should be compiled in a pocket book and disseminated to all technical and clinical staff en-
gaged in transfusions.

C
Documentation is the mainstay of quality improvement of any health service. The culture
of documenting all steps in a transfusion event should be developed and institutionalized
in all Ugandan health facilities that administer blood to patients. Items or situations to be
documented should carefully be selected to guard against over-documentation. Focus
should be centered on the critical control points of the three in-hospital transfusion
processes. There should be an enabling environment to develop and promote this culture.
This includes:

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> writing policies to provide support, guidance and reinforcement of documentation as


an integral part of improving quality in transfusion practices.
> leadership (e.g. from HTCs) to set priorities and promote a learning atmosphere for all
concerned staff. This will also advocate for supportive policies and allocation of re-
sources to the documentation exercise.
> defining core values of documenting transfusion events. These should be promoted
and practiced to ensure quality care through adequate traceability.
> sufficient allocation of competent human and adequate material resources for conduct-
ing the documentation exercise.
> designing up to date operational documents like a standard Blood Request Form or
Transfusion Reaction Form.
> instituting a standard way of record keeping and archiving of transfusion events.

D
The formulated standards and guidelines should be communicated to the health workers
in hospitals and students in training institutions. This will be achieved by:
> reviewing training curricula of all health professionals to include key issues in hospital
transfusion practices addressed by the technical and quality standards.
> training of all levels of health workers dealing with blood transfusion.

To ensure appreciation of challenges in the production and utilization settings by upcom-


ing clinicians, residents, medical and paramedical students rotations (sometime of their
training) should rotate in Regional Blood Banks. Likewise, blood bank staff should conduct
bedside training sessions for clinicians and students on new Transfusion Medicine devel-
opments.
Before any health worker is allowed to perform any in-hospital transfusion procedure,
he/she should undertake and satisfy the requirements of a competence test for that proce-
dure. This may be an oral or a practical test which needs to be documented.

E
There should be an agreed upon periodic audit of practices of clinicians, nurses and labora-
tory technicians. This should be conducted jointly by members of the HTC and a blood
bank staff member. It should always be followed by timely and constructive feedback to the
concerned staff or department. This will build confidence and respect for each other which
are prerequisites for quality improvement in health care.

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20 Nevalainen DE. Documentation and Record keeping: The key to compliance. In: Smit
Sibinga CT, Das PC and Heiniger HJ editors. Good manufacturing practice in transfu-
sion medicine. Dordrecht, The Netherlands: Kluwer Academic Publishers Group;1994.
p. 177-194.

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21 Berte LM. Quality management and quality tools. In: Saxena S, Shulman IA, eds. The
Transfusion Committee: Putting Patient Safety First. Bethesda, MD:AABB Press, 2006.
p 67-87.
22 van der Tuuk Adriani WPA, Smit Sibinga CTh. The Pyramid model as a structured way
of quality management. Asian J Transf Sci 2008;2:6-8
23 Kajja I, Bimenya GS, Smit Sibinga CT. Blood request form at a University teaching hos-
pital: evaluating design and clinician compliance. Int J Health Sci. 2008;1:69-73.
24 Facilities and safety. In: Standards for Blood Banks and Transfusion Services, 26th Ed.
Bethesda, MD:AABB Press, 2009.p. 84.
25 Kajja I, Bimenya GS, Smit Sibinga CT. The interface between blood preparation and use
in Uganda. Vox Sang 2010;98:e257-e262.
26 Availability, safety and quality of blood products. The World Health Organization Exec-
utive Board 126th Session; Agenda Item 4.16, Document 126.R14; 22 January 2010.

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Summary

In Uganda the demand of blood by hospitals outstrips its supply. Therefore, Uganda Blood
Transfusion Services faces the daunting challenge of making sufficient supplies of blood
products while ensuring quality and safety of these products. National data on clinical use
of blood are limited, but the baseline observations at the inception of this thesis identified
issues like unnecessary transfusions, unsafe transfusion practices and errors (particularly
at the patient’s bedside). In the bid to improve quality of health care delivery to blood recipi-
ents and therefore effectively use the limited blood products, it was justifiable to conduct a
study that scientifically identified and defined quality gaps in practices and procedures of
in-hospital transfusion services.

The studied procedures onto which this thesis is based include blood recipient ethical is-
sues, the bedside procedures of ordering and administering blood, studying the usefulness
of a blood order schedule for a major surgical procedure, the communication or interface
between clinicians and their supplying blood banks, and identifying bottlenecks in blood
preparation and how these impact on the in-hospital transfusion processes.

The study was conducted in Uganda’s Hospitals and Regional Blood Banks. Participants
included staff (blood prescribers and laboratory technicians), administrators and blood re-
cipients. Outcome measures centered first on participants’ levels of basic knowledge of key
transfusion issues, opinions and perceptions of factors influencing the quality of practices
and procedures and opinions on establishment of quality systems in hospitals. Second, the
quality of procedural documentation was explored. The thesis also had an insight in the
bedside management of blood in elective surgery. To ensure a deep and broad understand-
ing of the research questions, mixed research methods were employed. Here, multiple par-
ticipants, various data source and a number of data analysis strategies were used. In order
to strengthen validity of findings, there was triangulation at interpretation findings and at
report writing.

The factors that influence transfusion practices and procedures as identified by this thesis
range from problems within hospital technical staff, through paucity of administrative
structures to bottlenecks in the processing blood banks. Staff, though dedicated, is not al-
ways aware of the special attention needed when prescribing and transfusing blood. This is
compounded by lack of a hospital transfusion policy. Therefore, there are no instructive
procedures, monitoring and evaluation strategies or well defined persons responsible for
in-hospital transfusion quality assurance. Additionally, documentation of what is to be and
has been done is still under-developed. These in-hospital problems are made worse by the
process delays in the production blood banks that are characterized by poor supply of blood
products to hospitals.

In order to address these issues, a step-by-step quality improvement strategy should be de-
veloped. First, a small working group of clinicians, laboratory technicians and administra-
tors should be created to design the policy and strategies (blood transfusion plan) for
clinical use of blood. Second, start creating Hospital Transfusion Committees with appro-
priate terms of reference. These should be supported by the hospital high authority. Third,

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design simple education materials for the three major in-hospital transfusion processes
with their respective standard operating procedures (SOPs) and related outcome docu-
ments like Blood request forms. Disseminate these materials through continuous profes-
sional trainings for in-service staff and curriculum reviews for medical and paramedical
schools. Forth, start implementing evidence based blood conservation strategies like the
surgical blood order equation in elective surgery. Fifth, embark on updating the National
Transfusion Policy to embrace and support the development of National clinical standards
and guidelines.

These steps will be achieved when the concept of quality assurance is formally, philosophi-
cally and integrally incorporated into the structure and functioning of Uganda’s health sys-
tems, consistently implemented, and supported by a culture of quality, as reflected in
organizational values and policies that advocate quality of care.

As a final remark, in clinical practice, quality is a culture, not a fashion and a journey, not a
destination. When well understood and implemented, it provides a paramount mode to ef-
fectuate the old and indispensible Hippocratic adagio – First Do No Harm.

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Samenvatting

In Uganda is de vraag naar bloed in de ziekenhuizen vele malen groter dan de toelevering.
Om die reden ziet de Uganda Blood Transfusion Service (UBTS) zich voor de bijkans onmo-
gelijke taak geplaatst om voor voldoende bloed te zorgen en tegelijkertijd de kwaliteit en de
veiligheid van de bloedproducten te waarborgen. Landelijke gegevens over het klinisch ge-
bruik van bloed zijn zeer beperkt. Echter, de uitgangswaarnemingen die bij aan het begin
van dit onderzoek zijn gedaan, hebben belangrijke zaken als onnodige transfusies, onvei-
lige transfusie praktijken en fouten (met name aan het ziekbed) aan het licht gebracht.

Bij de inspanning om de kwaliteit van de gezondheidszorg voor ontvangers van bloed te


verbeteren en daarmee het effectieve gebruik van de schaarse bloedproducten, was het ge-
rechtvaardigd een wetenschappelijk onderzoek te doen waarmee de kwaliteitsgebreken in
de praktijk en de procedure van de ziekenhuis bloedtransfusie keten konden worden ge-
ïdentificeerd en onderzocht.

De onderzochte processen en procedures omvatten o.m. de ethische aspecten rond het ont-
vangen van bloed, het proces van het bestellen en toedienen van bloed aan het ziekbed, het
nut van het invoeren van een gecontroleerd bloedbestel schema voor grote chirurgische in-
grepen, de communicatie (interfase) tussen klinici en de toeleverende bloedbanken, identi-
ficatie van de zwakke punten in het proces van de bewerking van afgenomen bloed en het
effect van deze aspecten op het transfusieproces in het ziekenhuis.

Het onderzoek is gedaan in ziekenhuizen en regionale bloedbanken in Uganda. Deelne-


mers waren behandelend specialisten en laboratorium personeel, administratief personeel
en patienten. In de eerste plaats is bij de deelnemers gekeken naar het niveau van basis-
kennis van de belangrijkste transfusie processen en procedures, meningen over en belevin-
gen van factoren die de kwaliteit van de praktijk en procedures beïnvloeden, en meningen
over het opzetten van een kwaliteitssysteem in de ziekenhuizen. In de tweede plaats werd
de kwaliteit van het bestaande documentatie systeem onderzocht. Het proefschrift geeft
een inzicht in het gebruik van bloed in de electieve chirurgie.

Om een goed begrip van de gestelde onderzoeksvragen te krijgen is gebruik gemaakt van
gemengde onderzoeksmethoden. Gebruik is gemaakt van meerdere deelnemergroepen,
verschillende bronnen van gegevens en een aantal analyse strategieën. Om de waarde van
de bevindingen te versterken is gebruik gemaakt van triangulatie bij de interpretatie van
de gegevens en het schrijven van de verslagen van enquêtes en interviews.

De factoren zoals die in de studie zijn geïdentificeerd, die de processen en procedures van
de klinische transfusiepraktijk beïnvloeden variëren van problemen bij het laboratorium
personeel in de ziekenhuizen en mager ontwikkelde administratieve structuren tot beper-
kingen in de bewerking van bloed in de bloedbanken. Alhoewel toegewijd, is het personeel
zich niet altijd bewust van de specifieke aandacht nodig bij het voorschrijven en toedienen
van bloed. Dit wordt nog versterkt door een gebrek aan transfusiebeleid in de ziekenhuizen.
Derhalve zijn er geen voorschriften, strategieën voor documentatie en evaluatie en ont-
breekt het ook aan een speciaal voor de bewaking van de kwaliteit van de transfusiepraktijk

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aangestelde persoon. Bovendien is documentatie van wat gedaan is of gedaan moet worden
nog steeds onderontwikkeld. De ziekenhuisproblemen worden nog verergerd door vertra-
gingen in de bewerking van afgenomen bloed in de bloedbanken, met als gevolg een be-
perkte aanlevering van bloedproducten aan de ziekenhuizen.

Om de aandachtspunten goed aan te pakken is een stapsgewijze aanpak nodig, gericht op


verbetering van de bestaande situatie. Ten eerste zou er een kleine werkgroep van klinici,
laboratorium personeel en administratief personeel moeten worden gevormd, die een be-
leid en een bloedtransfusie plan moet ontwikkelen. Ten tweede de instelling van zieken-
huis transfusie commissies met duidelijke taakomschrijving. Deze commissies moeten de
steun van de ziekenhuis directie hebben om goed te kunnen functioneren. Ten derde het
ontwikkelen van eenvoudig onderwijs materiaal voor de drie hoofdprocessen van de zie-
kenhuis transfusieketen en de daarbij behorend procedures, werkvoorschriften en uit-
komst documenten, zoals een bloedaanvraag formulier. Verspreiding van dit materiaal
door continue beroepstraining van het betrokken personeel en herziening van de onder-
wijsprogramma’s voor medische en paramedische instituten. Ten vierde de introductie van
‘evidence based’ bloedbesparende mogelijkheden zoals de chirurgische bloedbestel formule
in de electieve chirurgie. Ten vijfde het initiëren van een bijstelling en actualiseren van het
landelijk transfusie beleid en de ondersteuning van de ontwikkeling van landelijke klini-
sche transfusie standaarden en richtlijnen.

Deze doelen kunnen bereikt worden wanneer het beginsel van kwaliteitsborging zowel filo-
sofisch als integraal wordt ingebed in de structuur en het functioneren van de gezond-
heidszorg in Uganda, stelselmatig en ondersteund door een kwaliteitscultuur als
weerspiegeling van de organisatorische waarden en een beleid dat kwaliteit in de gezond-
heidszorg voorstaat.

Tenslotte – ook in de klinische praktijk is kwaliteit een cultuur en niet een mode verschijn-
sel; een reis en niet een bestemming. Wanneer dat goed wordt begrepen en doorgevoerd, zal
een belangrijke mogelijkheid toegevoegd kunnen worden om het oude en onvervangbare
adagium van Hippocrates te effectueren – “primum est non nocere”.

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Acknowledgements

I would like to express my gratitude to my three promoters Prof. Dr. Cees Th. Smit Sibinga,
Prof. Gabriel Sebishimbo Bimenya and Prof. Dr. Henk Jan ten Duis for their guidance to me
in carrying out the work in this thesis.
Special thanks to Prof. Dr. Cees Th. Smit Sibinga my main promoter from the University
Medical Centre Groningen (UMCG) who assisted in seeking for the funding and ethical
clearance from the research and development board of the UMCG. He guided me right from
conceptualization to the final write-up of the thesis, and introduced me to the international
scientific world. Thank you so much.
Prof. Gabriel Sebishimbo Bimenya, my main promoter at Makerere University, who despite
physical weaknesses was always there to provide the invaluable inspiration and guidance
in perfecting the needed skills.
Prof. Dr. Henk Jan ten Duis, who introduced me into the field of blood less surgery and
traumatology. It was amazing to experience how little blood is used in the major trauma de-
partment of the UMCG, without affecting outcome of this special clinical care.
Special thanks also go to Prof. Dr. Lou F. M. H. de Leij the vice Dean Research and Develop-
ment studies for initiation and supporting the funding of the PhD project from the Faculty
of Medical Sciences, UMCG.

I would also like to give my deepest and heartfelt gratitude to the following:
> All members of the research and ethics committee for Higher Degrees of Makerere Col-
lege of Health Sciences who cleared the ethical requirements for the research work on
behalf of Makerere University.
> Prof Florence Mirembe for perfecting the research proposals and for her continued in-
spiration and support.
> Prof Elly Katabira, the former Dean of Research Makerere College of Health Sciences
for his invaluable parental advice.
> Dr Fredrick Makumbi, School of Public Health Makerere University College of Health
Sciences, who continuously guided me in appreciating and applying research methods
and biostatistics principles.
> Colleagues in the Department of Orthopedics, Makerere University for their under-
standing: thank you very much for your assistance in so many different ways.
> Mr. APM Ton Los, Academic Institute for International Development of Transfusion
Medicine, Groningen, The Netherlands for guiding me in the development of research
tools.
> All participants in the qualitative and quantitative studies.

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About The Author

Isaac Kajja was born in Mukono, Uganda on March 13, 1969. He attended Namilyango Col-
lege, Mukono, Uganda and holds a Bachelors degree in Medicine and Surgery (MB,CHB),
and a Masters degree in Orthopedics (M.MED Ortho) of Makerere University, Kampala,
Uganda. He is a fellow of the College of Surgeons of East, Central and Southern Africa
(COSECSA)

Isaac Kajja is a Member of Association of Surgeons of Uganda, Uganda Orthopedic Associ-


ation and Africa Society for Blood Transfusion.

He has been involved in Hospital administrative tasks as a medical superintendent, cura-


tive services as an orthopedic surgeon in a major National referral hospital. He has taught
Orthopedics at Makerere University College of Health Sciences for the last seven years. He
is a Reviewer of Africa Sanguine the journal of the Africa Society for Blood Transfusion.
Isaac Kajja is a Rotarian who is married to Justine. They enjoy a family with five children.

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