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First Implementation of Transfusion Consent Policy in Oman: Audit of

compliance from a tertiary care university hospital

Article in Sultan Qaboos University Medical Journal · August 2016

DOI: 10.18295/squmj.2016.16.03.005

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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
c li n i c a l & b a s i c r e s e a r ch

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

‫أول تنفيذ لسياسة املوافقة املسبقة لعملية نقل الدم يف عُمان‬

‫دراسة تدقيقة على مدى اإللتزام يف مستشفى جامعي للرعاية الثالثية‬

،‫ �سا�شني خو�سيه‬،‫ �سالم الكندي‬،‫احلكيم الروا�س‬-‫ عبد‬،‫ حممد احلنيني‬،‫ فهميدة �ضياء‬،‫ نايف الغافري‬،‫�أروى الريامية‬
‫ �شاهينا دار‬،‫ هالل ال�سبتي‬،‫مرت�ضى اخلابوري‬

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.

‫ مناق�شة املنافع واملخاطر والبدائل مع املري�ض قبل �إجراء عملية نقل الدم‬.ً‫ تعترب عملية نقل الدم تدخ ًال طبي ًا �شائعا‬:‫ �أهداف‬:‫امللخ�ص‬
‫ مت �إدخال �سيا�سة‬،‫ �سلطنة عمان‬،‫ م�سقط‬،)SQUH( ‫ يف م�ست�شفى جامعة ال�سلطان قابو�س‬،‫ب�صفته �إجراء فر�ضته العديد من الت�رشيعات‬
‫ تهدف هذه‬.‫ كانت هذه هي املرة الأوىل التي تنفذ فيها هذه ال�سيا�سة يف عمان‬.‫م‬2014 ‫اخلطية امل�سبقة لعملية نقل الدم يف مار�س‬ ِّ ‫املوافقة‬
‫ متت مراجعة ال�سجالت الطبية للمر�ضى الذين‬:‫ منهجية‬.SQUH ‫الدرا�سة �إىل تقييم االلتزام بهذه ال�سيا�سة بني التخ�ص�صات املختلفة يف‬
‫ مت فح�ص مناذج املوافقة �إن وجدت �ضمن‬،‫م لتقييم وجود ا�ستمارات املوافقة‬2014 ‫خ�ضعوا لعمليات نقل الدم بني يونيو و�أغ�سط�س عام‬
.)‫ طفل مري�ض‬147 ‫ بالغ و‬299( ‫ مري�ضا مت نقل الدم �إليهم‬446 ‫ مت تقييم �سجالت‬،‫ يف املجموع‬:‫ نتائج‬.‫ الطبيب وال�شهود‬،‫معلومات املري�ض‬
91% ‫ من البالغني و‬75% ‫ ومت احل�صول على املوافقة لدى‬.‫ من الأطفال‬71% ‫ من املر�ضى البالغني و‬50% ‫�شكل امل�صابون ب�أمرا�ض الدم‬
‫اخلطية قبل عملية نقل الدم كانت بني �أطباء ق�سم الدم للبالغني‬
ِّ ‫ لوحظ �أن �أعلى ن�سبة لاللتزام ب�سيا�سة اقتناء املوافقة‬.‫من الأطفال املر�ضى‬
‫ من املر�ضى‬52% ‫ و‬51% ‫ مت تعبئة ا�ستمارات املوافقة ب�شكل �صحيح بجميع التفا�صيل اخلا�صة بـ‬.)‫ على التوايل‬97% ‫ و‬95%( ‫والأطفال‬
‫ يف‬:‫ خامتة‬.)20-25%( ‫ من بني النماذج غري املكتملة كان اخلط�أ الأكرث �شيوع ًا عدم وجود تفا�صيل ال�شهود‬.‫البالغني والأطفال على التوايل‬
‫ هناك حاجة �إىل مزيد من العمل ل�ضمان االلتزام‬،‫ ومع ذلك‬.SQUH ‫ مت االلتزام ب�سيا�سة موافقة ما قبل نقل الدم بنجاح يف‬،‫معظم احلاالت‬
.‫ ويو�صى بتنفيذ موافقة عملية نقل الدم يف امل�ست�شفيات الأخرى يف البلد‬,‫الكامل لإجراءات املوافقة امل�سبقة يف خمتلف التخ�ص�صات‬
.‫ نقل الدم؛ موافقة م�سبقة؛ االمتثال لل�سيا�سات؛ املراجعة ال�رسيرية؛ عمان‬:‫كلمات مفتاحية‬

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.

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: [email protected]
 First Implementation of Transfusion Consent Policy in Oman
Audit of compliance from a tertiary care university hospital

B
lood transfusion is a frequent inter- information on transfusion of blood and/or blood
vention which should only be performed components by a qualified physician. The physician
to avoid significant morbidity or mortality must explain the risks and benefits of and alternatives
if not given.1 Although blood transfusions are safe to blood transfusion prior to obtaining the consent.
in comparison to other medical and surgical The consent process should be witnessed by another
interventions, they nevertheless carry certain risks, healthcare provider, such as a physician or a nurse,
such as transfusion reactions, alloimmunisation, and all information, including any refusal of blood
immunomodulation and transfusion-transmitted and blood components, should be documented in
infections.2 Patient consent for blood transfusions the patient’s electronic medical records. For non-
is a topic that has long stimulated debate among chronically transfused patients, consent is renewed
healthcare practitioners.2,3 Previously, verbal informed upon each patient admission. Furthermore, the policy
consent for a blood transfusion was often considered requires that consent be obtained prior to a planned
sufficient to authorise the procedure; however, with elective transfusion during the same admission
the recognition of transfusion hazards, effective and period. Patients on long-term blood support (e.g.
documented counselling of risks and benefits has patients with underlying haemoglobinopathies and
become increasingly important.2,3 As such, patients those undergoing chemotherapy) should provide
receiving blood transfusions should be provided consent annually with an option to withdraw their
with sufficient information regarding the purpose, consent at any time during that period. In emergency
anticipated benefits, alternatives to the blood trans- situations where the patient or their guardian is unable
fusion and their expected outcome without the or unavailable to provide consent, pre-transfusion
transfusion. Additionally, patients should be made consent requirements are waived; in these cases,
aware of frequent and significant transfusion-related patients or guardians are retroactively informed about
risks.4 Following this, the caregiver must obtain the requirements of and reasons for performing the
patient consent which must be given voluntarily by blood transfusion.
the patient or a parent or legally appointed guardian, Prior to implementation of the policy, hospital-
when applicable.5,6 Ideally, there should be witnessed wide educational sessions were initiated to raise
verification of the patient’s signature.6 awareness of the new policy, procedures for trans-
Worldwide variation exists regarding the practice fusion consent, patient rights, the elements of consent,
of obtaining informed consent from patients prior how consent is given and the validity of consent and
to a blood transfusion. While in many countries its documentation. A pocket guide was made available
this practice is not routine, it is mandated in others, and distributed to all nurses and physicians in the
with the prescribing physician being responsible for hospital to aid implementation of the policy. This study
obtaining consent.6–9 Concerns regarding transfusion- therefore aimed to assess adherence to the transfusion
transmitted infections have resulted in legislation consent policy among different specialties at SQUH.
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 Methods
recommendation that patients must be informed This cross-sectional retrospective quantitative study
about blood transfusions, although this is not routinely included all chronically and non-chronically trans-
practiced.9,11 In Canada, requirements to inform fused patients who underwent elective transfusions
patients about blood transfusions are stated in Justice between June and August 2014. The medical records
Krever’s recommendation for the blood system.8,12 This of these patients were examined for the presence of
recommendation mandates that patients should be a transfusion consent form. In addition, the forms
informed about the benefits, risks and alternatives to were examined for completeness of patient, physician
allogeneic blood transfusions and that this discussion and witness information and medical records were
needs to be documented in patients’ medical records.12 examined for any documentation of refusal of
Transfusion consent in Oman was first introduced consent. Blood bank records of all blood components
at the Sultan Qaboos University Hospital (SQUH), transfused during June–August 2014 were reviewed
Muscat, Oman, in March 2014. The transfusion for information regarding issued blood components
consent policy mandates that all patients—or their to ensure the inclusion of all patients during the
eligible guardians in paediatric cases or with adult study period.
patients unable to give informed consent—provide
Data collected were entered into Microsoft Excel,
pre-transfusion written consent by signing a consent
Version 2010 (Microsoft Corp., Redmond, Washington,
form which confirms that they have been given
USA) and analysed using the Statistical Package for

e294 | SQU Medical Journal, August 2016, Volume 16, Issue 3

 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

Table 1: Characteristics of patients who underwent elective Table 2: Transfusion consent and degree of completeness
transfusions at the Sultan Qaboos University Hospital, of consent forms among patients who underwent elective
Muscat, Oman, by admitting department* (N = 446) transfusions at the Sultan Qaboos University Hospital,
Muscat, Oman, by admitting department (N = 446)
Patient group n (%)
Patient group n (%)
Adults (n = 299)
Consent taken Completeness
Haematology 149 (50) of form
Non-haematology 150 (50) Adults (n = 299) 225 152
Surgery 54 (36) Haematology 142 (95) 114 (77)
Gynaecology and obstetrics 50 (33) Non-haematology 83 (55) 38 (25)
Medicine 48 (32) Paediatrics (n = 147) 134 76
Paediatric (n = 147) Haematology 102 (97) 69 (66)
Haematology 105 (71) Non-haematology 32 (76) 7 (17)
Non-haematology 42 (29)
specialists showed a higher adherence rate (76%).
Neonatology 22 (52)
Upon assessment of the completeness of the consent
General paediatrics 11 (26) forms among paediatric patients, 52% were filled out
Paediatric surgery 9 (21) adequately with all of the required information. Adult
and paediatric haematology specialists had correctly
*Assessed for the presence of transfusion consent in their clinical records.
filled out consent forms in 77% and 66% of cases,
the Social Sciences (SPSS), Version 22.0 (IBM Corp., respectively [Table 2].
Chicago, Illinois, USA). Descriptive statistics were A statistically significant difference was found
used to summarise the results and associations were between haematology and non-haematological special-
tested using Fisher’s exact test. A P value of <0.0500 ists with regards to the completeness of consent forms
was considered statistically significant. for both adults and paediatric patients (P = 0.0001
Ethical approval for this study was obtained each). In both patient groups, the most common error
from the Medical Research & Ethics Committee of was a lack of witness name and/or signature (20–25%).
the College of Medicine & Health Sciences at Sultan In paediatric consent forms, 26% lacked the physicians’
Qaboos University (MREC #961). 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
Results paediatric consents, respectively.
During the study period, 446 transfused patients from
different specialties were assessed, including 299 adult
Discussion
and 147 paediatric patients. Of these, 49% of the adult
and 70% of the paediatric patients were on chronic Over recent years, patients have become more involv-
transfusion support. Haematology patients accounted ed in their medical and surgical treatments. Despite
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 Figure 1: Chart showing the degree of completeness of
various components of consent forms among patients
transfused patients under the care of adult non-
who underwent elective transfusions at the Sultan
haematology services had documented transfusion Qaboos University Hospital, Muscat, Oman (N = 359).
consent forms. However, paediatric non-haematology MRN = medical record number.

Clinical and Basic Research | e295

 First Implementation of Transfusion Consent Policy in Oman
Audit of compliance from a tertiary care university hospital

this, inconsistencies have been reported in the In many healthcare settings, the witness is usually
practice of obtaining consent for blood transfusions. the nurse responsible for administering the blood
Transfusion consent has been mandated in some components; at SQUH, the feasibility of this approach
countries, while obtaining specific consent for a is limited as nurses do not always speak the same
transfusion remains a novel concept in others. language as their patients. This problem is applicable
Furumaki et al. found that patients who were provided to other aspects of the consent process as well and
with information were more likely to have a better raises the need for specific hospital policies to address
understanding of the risks and benefits of transfusion.13 this issue.
However, research indicates that only 50–60% of Recently, the distribution of transfusion informa-
transfusion patients recall having a discussion with tion pamphlets has been recommended as a means of
their physicians or giving their consent for a blood improving information delivery, since patient rarely
transfusion; this indicates that current processes to report being informed of the specifics of the transfusion
aid informed patient decision-making fall short.7,9,14 or its benefits/risks.6,7 Nevertheless, it is important to
Court et al. reported limited patient awareness of a note that these pamphlets cannot be given to illiterate
transfusion having occurred at all, indicating a lack patients or those with sight disabilities; furthermore,
of communication between healthcare providers and Court et al. found that although patients reportedly
their patients.7 In Oman, written patient consent valued pamphlets as a source of information, over
for blood transfusions was not in practice at any half of the patients who remembered discussing blood
government hospital before 2014 and SQUH was the transfusions with their caregivers felt that the best
first hospital in the country to implement a transfusion source of information was a physician.7 Educational
consent policy. pamphlets were recently designed for distribution
The findings of the current study show excellent at SQUH in order to aid physicians during informed
adherence to the consent policy in the SQUH consent discussions. However, it was emphasised to the
haematology specialty for both adult and paediatric healthcare providers that written information should
cases. Further effort is hence required to enhance not replace verbal discussion with the patient during
adherence in other specialties at SQUH. One the consent process. Implementation of the consent
explanation for the lower adherence to consent policy process in other hospitals in Oman is advocated by the
observed among non-haematology specialties in the researchers as a vital step towards patient autonomy
current study could be a failure in documenting consent and to establish a method for the on-going monitoring
in medical records. Similar audits at other institutions of transfusion processes.
have shown a lack of documentation of transfusion There is a lack of published data assessing the
consent, raising the need for efforts to improve the amount of information given to patients before
documentation process.15 At SQUH, the preliminary obtaining transfusion consent or patients’ levels of
results of the current survey were presented to heads understanding of the information provided during the
of departments and members of the blood transfusion consent process.7 Informed consent for transfusion
committee; action plans were put in place for the re- presumes that the patient has been given sufficient
education of staff hospital-wide. In addition, a quarterly information, was able to comprehend the information
nursing-specific course on transfusion practices was provided and was given the opportunity to ask
initiated, with emphasis on aspects related to questions before making their decision. Furthermore,
transfusion reactions and the consent process. An patients need to agree to undergo the intervention
introductory session of transfusion policies in the based on the information provided. In the current
hospital was prepared specifically for new physicians study, the degree of information provided or the
and residents. Moreover, re-assessment of policy patients’ comprehension of the provided information
adherence via a second survey is planned following the was not assessed. Previous studies have shown that
implementation of these remedial actions. there is variability in the amount of information
In addition, the findings of the present study have delivered to patients during the informed consent
highlighted issues relating to the proper completion of discussion.16,17 The current study lays the groundwork
transfusion consent forms. Lack of witness information for further assessment of these aspects in the future.
was a common issue and the importance of this Although blood transfusion consent policies
element should be emphasised in future policies. This have been applied in nearby countries as a result of
finding may potentially be due to language or cultural accreditation requirements, to the best of the authors’
barriers. It is important that the witness understands knowledge, this study is the first from Oman to assess
the language in which the consent explanation is given the degree of adherence to an informed consent
in order to be able to document consent properly. policy. However, a few limitations of the study should

e296 | SQU Medical Journal, August 2016, Volume 16, Issue 3

 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

be considered. First, the generalisability of this study References

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acknowledgements
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).

Clinical and Basic Research | e297

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