Departments of 1Haematology, 3Child Health and 6Surgery, Sultan Qaboos University Hospital; 4Department of Haematology, 2College of Medicine &
Health Sciences, Sultan Qaboos University, Muscat, Oman; 5Department of Planning & Studies, Oman Medical Specialty Board, Muscat, Oman
*Corresponding Author e-mail: arwa.alriyami@gmail.com
أول تنفيذ لسياسة املوافقة املسبقة لعملية نقل الدم يف ُعمان
دراسة تدقيقة على مدى اإللتزام يف مستشفى جامعي للرعاية الثالثية
اأروى الريامية، نايف الغافري، فهميدة �صياء، حممد احلنيني، عبد-احلكيم الروا�ض، �صالم الكندي، �صا�صني خو�صيه،
مرت�صى اخلابوري، هالل ال�صبتي، �صاهينا دار
abstract: Objectives: Transfusions are a common medical intervention. Discussion of the benefits, risks and
alternatives with the patient is mandated by many legislations prior to planned transfusions. At the Sultan Qaboos
University Hospital (SQUH), Muscat, Oman, a written transfusion consent policy was introduced in March 2014.
This was the first time such a policy was implemented in Oman. This study therefore aimed to assess adherence to
this policy among different specialties within SQUH. Methods: The medical records of patients who underwent
elective transfusions between June and August 2014 were reviewed to assess the presence of transfusion consent
forms. If present, the consent forms were examined for completeness of patient, physician and witness information.
Results: In total, the records of 446 transfused patients (299 adult and 147 paediatric patients) were assessed.
Haematology patients accounted for 50% of adult patients and 71% of paediatric patients. Consent was obtained for
75% of adult and 91% of paediatric patients. The highest adherence rate was observed among adult and paediatric
haematology specialists (95% and 97%, respectively). Consent forms were correctly filled out with all details
provided for 51% and 52% of adult and paediatric patients, respectively. Among inadequately completed forms,
the most common error was a lack of witness details (20–25%). Conclusion: In most cases, the pre-transfusion
consent policy was successfully adhered to at SQUH. However, further work is required to ensure full compliance
with the consent procedure within different specialties. Implementation of transfusion consent in other hospitals
in the country is recommended.
Keywords: Blood Transfusion; Informed Consent; Policy Compliance; Clinical Audit; Oman.
الدم نقل عملية اإجراء قبل املري�ض مع والبدائل واملخاطر املنافع مناق�صة �صائعًا. طبيًا تدخاًل الدم نقل عملية تعترب اأهداف: امللخ�ص:
�صيا�صة اإدخال مت عمان، �صلطنة م�صقط، ،)SQUH( قابو�ض ال�صلطان جامعة م�صت�صفى يف الت�رضيعات، من العديد فر�صته اإجراء ب�صفته
املوافقة اخلطيِّة امل�صبقة لعملية نقل الدم يف مار�ض 2014م. كانت هذه هي املرة االأوىل التي تنفذ فيها هذه ال�صيا�صة يف عمان. تهدف هذه
الدرا�صة اإىل تقييم االلتزام بهذه ال�صيا�صة بني التخ�ص�صات املختلفة يف SQUH. منهجية: متت مراجعة ال�صجالت الطبية للمر�صى الذين
خ�صعوا لعمليات نقل الدم بني يونيو واأغ�صط�ض عام 2014م لتقييم وجود ا�صتمارات املوافقة، مت فح�ض مناذج املوافقة اإن وجدت �صمن
معلومات املري�ض، الطبيب وال�صهود. نتائج: يف املجموع، مت تقييم �صجالت 446 مري�صا مت نقل الدم اإليهم )299 بالغ و 147 طفل مري�ض(.
�صكل امل�صابون باأمرا�ض الدم %50 من املر�صى البالغني و %71 من االأطفال. ومت احل�صول على املوافقة لدى %75 من البالغني و 91%
من االأطفال املر�صى. لوحظ اأن اأعلى ن�صبة لاللتزام ب�صيا�صة اقتناء املوافقة اخلطيِّة قبل عملية نقل الدم كانت بني اأطباء ق�صم الدم للبالغني
واالأطفال )%95 و %97 على التوايل(. مت تعبئة ا�صتمارات املوافقة ب�صكل �صحيح بجميع التفا�صيل اخلا�صة بـ %51 و %52 من املر�صى
البالغني واالأطفال على التوايل. من بني النماذج غري املكتملة كان اخلطاأ االأكرث �صيوعًا عدم وجود تفا�صيل ال�صهود )%25-20(. خامتة: يف
معظم احلاالت، مت االلتزام ب�صيا�صة موافقة ما قبل نقل الدم بنجاح يف SQUH. ومع ذلك، هناك حاجة اإىل مزيد من العمل ل�صمان االلتزام
الكامل الإجراءات املوافقة امل�صبقة يف خمتلف التخ�ص�صات، ويو�صى بتنفيذ موافقة عملية نقل الدم يف امل�صت�صفيات االأخرى يف البلد.
كلمات مفتاحية: نقل الدم؛ موافقة م�صبقة؛ االمتثال لل�صيا�صات؛ املراجعة ال�رضيرية؛ عمان.
First Implementation of Transfusion
Consent Policy in Oman
Audit of compliance from a tertiary care university hospital
*Arwa Z. Al-Riyami,1 Naif Al-Ghafri,2 Fehmida Zia,1 Mohammed Al-Huneini,1 Abdul-Hakeem Al-Rawas,3
Salam Al-Kindi,4 Sachin Jose,5 Murtadha Al-Khabori,1 Hilal Al-Sabti,6 Shahina Daar4
Advances in Knowledge
- This study assessed adherence to transfusion consent policy at the Sultan Qaboos University Hospital, the first centre in Oman to
implement transfusion consent.
Application to Patient Care
- Written patient consent and discussion of the risks and benefits of transfusion procedures has become increasingly important.
- The authors of this study advocate wide implementation of transfusion consent in all hospitals in Oman as an integral part of
patient autonomy.
clinical & basic research
Sultan Qaboos University Med J, August 2016, Vol. 16, Iss. 3, pp. e293–297, Epub. 19 Aug 16
Submitted 10 Jan 16
Revision Req. 24 Feb 16; Revision Recd. 7 Mar 16
Accepted 17 Mar 16 doi: 10.18295/squmj.2016.16.03.005
First Implementation of Transfusion Consent Policy in Oman
Audit of compliance from a tertiary care university hospital
e294 | SQU Medical Journal, August 2016, Volume 16, Issue 3
Blood transfusion is a frequent inter-vention which should only be performed to avoid significant morbidity or mortality
if not given.1 Although blood transfusions are safe
in comparison to other medical and surgical
interventions, they nevertheless carry certain risks,
such as transfusion reactions, alloimmunisation,
immunomodulation and transfusion-transmitted
infections.2 Patient consent for blood transfusions
is a topic that has long stimulated debate among
healthcare practitioners.2,3 Previously, verbal informed
consent for a blood transfusion was often considered
sufficient to authorise the procedure; however, with
the recognition of transfusion hazards, effective and
documented counselling of risks and benefits has
become increasingly important.2,3 As such, patients
receiving blood transfusions should be provided
with sufficient information regarding the purpose,
anticipated benefits, alternatives to the blood trans-
fusion and their expected outcome without the
transfusion. Additionally, patients should be made
aware of frequent and significant transfusion-related
risks.4 Following this, the caregiver must obtain
patient consent which must be given voluntarily by
the patient or a parent or legally appointed guardian,
when applicable.5,6 Ideally, there should be witnessed
verification of the patient’s signature.6
Worldwide variation exists regarding the practice
of obtaining informed consent from patients prior
to a blood transfusion. While in many countries
this practice is not routine, it is mandated in others,
with the prescribing physician being responsible for
obtaining consent.6–9 Concerns regarding transfusion-
transmitted infections have resulted in legislation
in some jurisdictions in the USA which requires
physicians to obtain written informed consent for
blood transfusions.10 In the UK, there is a widespread
recommendation that patients must be informed
about blood transfusions, although this is not routinely
practiced.9,11 In Canada, requirements to inform
patients about blood transfusions are stated in Justice
Krever’s recommendation for the blood system.8,12 This
recommendation mandates that patients should be
informed about the benefits, risks and alternatives to
allogeneic blood transfusions and that this discussion
needs to be documented in patients’ medical records.12
Transfusion consent in Oman was first introduced
at the Sultan Qaboos University Hospital (SQUH),
Muscat, Oman, in March 2014. The transfusion
consent policy mandates that all patients—or their
eligible guardians in paediatric cases or with adult
patients unable to give informed consent—provide
pre-transfusion written consent by signing a consent
form which confirms that they have been given
information on transfusion of blood and/or blood
components by a qualified physician. The physician
must explain the risks and benefits of and alternatives
to blood transfusion prior to obtaining the consent.
The consent process should be witnessed by another
healthcare provider, such as a physician or a nurse,
and all information, including any refusal of blood
and blood components, should be documented in
the patient’s electronic medical records. For non-
chronically transfused patients, consent is renewed
upon each patient admission. Furthermore, the policy
requires that consent be obtained prior to a planned
elective transfusion during the same admission
period. Patients on long-term blood support (e.g.
patients with underlying haemoglobinopathies and
those undergoing chemotherapy) should provide
consent annually with an option to withdraw their
consent at any time during that period. In emergency
situations where the patient or their guardian is unable
or unavailable to provide consent, pre-transfusion
consent requirements are waived; in these cases,
patients or guardians are retroactively informed about
the requirements of and reasons for performing the
blood transfusion.
Prior to implementation of the policy, hospital-
wide educational sessions were initiated to raise
awareness of the new policy, procedures for trans-
fusion consent, patient rights, the elements of consent,
how consent is given and the validity of consent and
its documentation. A pocket guide was made available
and distributed to all nurses and physicians in the
hospital to aid implementation of the policy. This study
therefore aimed to assess adherence to the transfusion
consent policy among different specialties at SQUH.
Methods
This cross-sectional retrospective quantitative study
included all chronically and non-chronically trans-
fused patients who underwent elective transfusions
between June and August 2014. The medical records
of these patients were examined for the presence of
a transfusion consent form. In addition, the forms
were examined for completeness of patient, physician
and witness information and medical records were
examined for any documentation of refusal of
consent. Blood bank records of all blood components
transfused during June–August 2014 were reviewed
for information regarding issued blood components
to ensure the inclusion of all patients during the
study period.
Data collected were entered into Microsoft Excel,
Version 2010 (Microsoft Corp., Redmond, Washington,
USA) and analysed using the Statistical Package for
Arwa Z. Al-Riyami, Naif Al-Ghafri, Fehmida Zia, Mohammed Al-Huneini, Abdul-Hakeem Al-Rawas, Salam Al-Kindi, Sachin Jose,
Murtadha Al-Khabori, Hilal Al-Sabti and Shahina Daar
Clinical and Basic Research | e295
the Social Sciences (SPSS), Version 22.0 (IBM Corp.,
Chicago, Illinois, USA). Descriptive statistics were
used to summarise the results and associations were
tested using Fisher’s exact test. A P value of <0.0500
was considered statistically significant.
Ethical approval for this study was obtained
from the Medical Research & Ethics Committee of
the College of Medicine & Health Sciences at Sultan
Qaboos University (MREC #961).
Results
During the study period, 446 transfused patients from
different specialties were assessed, including 299 adult
and 147 paediatric patients. Of these, 49% of the adult
and 70% of the paediatric patients were on chronic
transfusion support. Haematology patients accounted
for 50% of adult patients, while the remaining adults
were admitted by general medicine, surgery or
obstetrics and gynaecology teams. The majority of
transfused patients in the paediatric age group were
haematology patients (71%), with the rest admitted
under the care of general paediatric, paediatric surgery
and neonatology teams [Table 1].
Consent was obtained for a total of 359 subjects
(75% of adult and 91% of paediatric patients) [Table 2].
Paediatric and adult haematology specialists demon-
strated the greatest adherence to the policy (97%
and 95%, respectively). In contrast, only 55% of
transfused patients under the care of adult non-
haematology services had documented transfusion
consent forms. However, paediatric non-haematology
specialists showed a higher adherence rate (76%).
Upon assessment of the completeness of the consent
forms among paediatric patients, 52% were filled out
adequately with all of the required information. Adult
and paediatric haematology specialists had correctly
filled out consent forms in 77% and 66% of cases,
respectively [Table 2].
A statistically significant difference was found
between haematology and non-haematological special-
ists with regards to the completeness of consent forms
for both adults and paediatric patients (P = 0.0001
each). In both patient groups, the most common error
was a lack of witness name and/or signature (20–25%).
In paediatric consent forms, 26% lacked the physicians’
name in comparison to 13% of adult consent forms
[Figure 1]. The names and signatures of the patients’
parents or guardians were present in 95% and 97% of
paediatric consents, respectively.
Discussion
Over recent years, patients have become more involv-
ed in their medical and surgical treatments. Despite
Table 1: Characteristics of patients who underwent elective
transfusions at the Sultan Qaboos University Hospital,
Muscat, Oman, by admitting department* (N = 446)
Patient group n (%)
Adults (n = 299)
Haematology 149 (50)
Non-haematology 150 (50)
Surgery 54 (36)
Gynaecology and obstetrics 50 (33)
Medicine 48 (32)
Paediatric (n = 147)
Haematology 105 (71)
Non-haematology 42 (29)
Neonatology 22 (52)
General paediatrics 11 (26)
Paediatric surgery 9 (21)
*Assessed for the presence of transfusion consent in their clinical records.
Table 2: Transfusion consent and degree of completeness
of consent forms among patients who underwent elective
transfusions at the Sultan Qaboos University Hospital,
Muscat, Oman, by admitting department (N = 446)
Patient group n (%)
Consent taken Completeness
of form
Adults (n = 299) 225 152
Haematology 142 (95) 114 (77)
Non-haematology 83 (55) 38 (25)
Paediatrics (n = 147) 134 76
Haematology 102 (97) 69 (66)
Non-haematology 32 (76) 7 (17)
Figure 1: Chart showing the degree of completeness of
various components of consent forms among patients
who underwent elective transfusions at the Sultan
Qaboos University Hospital, Muscat, Oman (N = 359).
MRN = medical record number.
First Implementation of Transfusion Consent Policy in Oman
Audit of compliance from a tertiary care university hospital
e296 | SQU Medical Journal, August 2016, Volume 16, Issue 3
this, inconsistencies have been reported in the
practice of obtaining consent for blood transfusions.
Transfusion consent has been mandated in some
countries, while obtaining specific consent for a
transfusion remains a novel concept in others.
Furumaki et al. found that patients who were provided
with information were more likely to have a better
understanding of the risks and benefits of transfusion.13
However, research indicates that only 50–60% of
transfusion patients recall having a discussion with
their physicians or giving their consent for a blood
transfusion; this indicates that current processes to
aid informed patient decision-making fall short.7,9,14
Court et al. reported limited patient awareness of a
transfusion having occurred at all, indicating a lack
of communication between healthcare providers and
their patients.7 In Oman, written patient consent
for blood transfusions was not in practice at any
government hospital before 2014 and SQUH was the
first hospital in the country to implement a transfusion
consent policy.
The findings of the current study show excellent
adherence to the consent policy in the SQUH
haematology specialty for both adult and paediatric
cases. Further effort is hence required to enhance
adherence in other specialties at SQUH. One
explanation for the lower adherence to consent policy
observed among non-haematology specialties in the
current study could be a failure in documenting consent
in medical records. Similar audits at other institutions
have shown a lack of documentation of transfusion
consent, raising the need for efforts to improve the
documentation process.15 At SQUH, the preliminary
results of the current survey were presented to heads
of departments and members of the blood transfusion
committee; action plans were put in place for the re-
education of staff hospital-wide. In addition, a quarterly
nursing-specific course on transfusion practices was
initiated, with emphasis on aspects related to
transfusion reactions and the consent process. An
introductory session of transfusion policies in the
hospital was prepared specifically for new physicians
and residents. Moreover, re-assessment of policy
adherence via a second survey is planned following the
implementation of these remedial actions.
In addition, the findings of the present study have
highlighted issues relating to the proper completion of
transfusion consent forms. Lack of witness information
was a common issue and the importance of this
element should be emphasised in future policies. This
finding may potentially be due to language or cultural
barriers. It is important that the witness understands
the language in which the consent explanation is given
in order to be able to document consent properly.
In many healthcare settings, the witness is usually
the nurse responsible for administering the blood
components; at SQUH, the feasibility of this approach
is limited as nurses do not always speak the same
language as their patients. This problem is applicable
to other aspects of the consent process as well and
raises the need for specific hospital policies to address
this issue.
Recently, the distribution of transfusion informa-
tion pamphlets has been recommended as a means of
improving information delivery, since patient rarely
report being informed of the specifics of the transfusion
or its benefits/risks.6,7 Nevertheless, it is important to
note that these pamphlets cannot be given to illiterate
patients or those with sight disabilities; furthermore,
Court et al. found that although patients reportedly
valued pamphlets as a source of information, over
half of the patients who remembered discussing blood
transfusions with their caregivers felt that the best
source of information was a physician.7 Educational
pamphlets were recently designed for distribution
at SQUH in order to aid physicians during informed
consent discussions. However, it was emphasised to the
healthcare providers that written information should
not replace verbal discussion with the patient during
the consent process. Implementation of the consent
process in other hospitals in Oman is advocated by the
researchers as a vital step towards patient autonomy
and to establish a method for the on-going monitoring
of transfusion processes.
There is a lack of published data assessing the
amount of information given to patients before
obtaining transfusion consent or patients’ levels of
understanding of the information provided during the
consent process.7 Informed consent for transfusion
presumes that the patient has been given sufficient
information, was able to comprehend the information
provided and was given the opportunity to ask
questions before making their decision. Furthermore,
patients need to agree to undergo the intervention
based on the information provided. In the current
study, the degree of information provided or the
patients’ comprehension of the provided information
was not assessed. Previous studies have shown that
there is variability in the amount of information
delivered to patients during the informed consent
discussion.16,17 The current study lays the groundwork
for further assessment of these aspects in the future.
Although blood transfusion consent policies
have been applied in nearby countries as a result of
accreditation requirements, to the best of the authors’
knowledge, this study is the first from Oman to assess
the degree of adherence to an informed consent
policy. However, a few limitations of the study should
Arwa Z. Al-Riyami, Naif Al-Ghafri, Fehmida Zia, Mohammed Al-Huneini, Abdul-Hakeem Al-Rawas, Salam Al-Kindi, Sachin Jose,
Murtadha Al-Khabori, Hilal Al-Sabti and Shahina Daar
Clinical and Basic Research | e297
be considered. First, the generalisability of this study
may be limited since the subjects consisted of a
patient cohort from a single institution. However,
transfusion consent in Oman was only implemented
at SQUH at the time of writing. The extent to which
these findings can be replicated in a wider patient
and physician population remains to be determined
pending implementation of the policy at other
hospitals. Second, the policy was introduced at SQUH
relatively recently and it will thus understandably
take further education of physicians and patients
before a better level of adherence can be achieved.
Third, the study assessed neither the degree of patient
comprehension of information provided during the
consent process, nor the details of what the physicians
discussed with their patients. Further studies on these
aspects are recommended.
Conclusion
This study describes the first experience of transfusion
consent policy application in Oman and found high
adherence among haematology specialties. Further
effort is required to expand adherence in other medical
and surgical specialties. Greater efforts should be made
to provide information to patients about the benefits
and risks of and alternatives to blood transfusion.
Distribution of information pamphlets at SQUH is
in process and will be followed by a second survey to
assess the effectiveness of this in policy adherence.
However, the adequacy of communication delivered
and patient understanding during the consent
process has yet to be assessed. The authors advocate
implementation of the consent process in other
hospitals in Oman as a vital step towards increased
patient autonomy and to establish a method for on-
going monitoring of the transfusion process.
c o n f l i c t o f i n t e r e s t
The authors declare no conflicts of interest.
f u n d i n g
No funding was received for this study.
a c k n o w l e d g e m e n t s
This study was previously presented as a poster
abstract at the American Association of Blood Banks
(AABB) Annual Meeting in Anaheim, California,
USA, on 24–27 October 2015. An abstract of the
poster was published in Transfusion in 2015 (Vol. 55,
Iss. S3, P. 166A).
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