This study assessed the quality of consent form completion by health professionals at a hospital. Audits of 170 retrospective and 170 live consent forms found that compliance ranged from 73-94% for retrospective forms. Interventions like consent form editing, awareness sessions, and daily auditing improved compliance to 89-100% for live forms. Consent compliance improved by 5-27% across departments and 6-13% for different consent types after implementing quality improvements to the consent process.

1.  SUBMITTED BY:
 Dr Dipti Tawde
 MBA Health & Hospital Management
 UNDER THE GUIDANCE OF:
 Dr. Amol Vaidya
 Asst. Manger Medical Services
 Fortis Hospital Mulund

2.  To achieve excellence in clinical practice and
a high level of health care provision, consent
processes need to be clear and precise. In
particular, patients who are to undergo
elective operations must be fully informed
before consenting to treatment. The aim of
this study is to assess the quality of consent
form completion by different health
professionals in our department and to
identify areas for potential improvement.

3.  The Informed Consent (SIC) is a
comprehensive process that establishes an
information based agreement between the
patient and his doctor to undertake a clearly
outlined medical or surgical intervention. It is
neither a casual formality nor a casually
signed piece of paper.

4.  We audited total 340 different consent forms,
170 retrospective form and 170 live consent
form after quality improvement interventions
using a set proforma to produce a final score
for each form, in order to assess the quality
of consent completion and to recommend
changes.
 We then implemented changes in our current
clinical practice and subsequently re-audited
our performance.

5. From 16 May 2015 to 31 May 2015 Auditing of retrospective consent forms.
From 1 June 2015 to 15 June 2015 Quality improvement Interventions applied.
From 15 June to 30 June 2015 Auditing of live consent form to see the
improvement.

6.  To assess the quality of consent form
completion by different health professionals
in hospital and to identify areas for potential
improvement

7.  We audited total 340 different consent forms,
170 retrospective form and 170 live consent
form after quality improvement interventions
using a set proforma to produce a final score for
each form, in order to assess the quality of
consent completion and to recommend changes.
 A special audit toll has been prepared and
according to completion of consent form 0, 1, NA
scoring is done.
 And at the end compliance of consent form is
calculated in percentage.
 The Following audit toll has been used to give
the scoring.

8. Audit to be done by MS. One file to be audited daily (25 per month). If for any audit point either/any criteria is not complied, please mark 0
S. No.
DATE
UHID/IPID Number
1 Does the consent form bear the name and signature/thumb impression of person giving the consent (patient/surrogate) Check consent form
2
For surrogate consent, is the name of the signatory & relationship with the patient, recorded on the consent form
Check consent form
3 Does the consent form bear the name and signature/thumb impression of person witnessing the consent NA for HIV and some other consents. Write NA if not applicable
4 Does the consent form bear the name and signature/thumb impression of interpreter Applicable if interpreter used, else NA
5 Does the consent form bear the name and signature of person obtaining consent Check consent form
6 Does the consent form bear the Date and time for each signature on the consent Check consent form
7 Does the consent form contain the Name of procedure/treatment/test for which consent is being obtained Check consent form
8 Are the potential major complications of undergoing the planned procedure documented in the consent form Check consent form
9 Does the consent form contain the name of the person who will perform the procedure for which consent is being obtained Check consent form
10 For procedure(s) carried out in the Ward/ICU, is the consent taken by either Treating Consultant or Registrar or Ward RMO? Check consent form
11
Was the doctor/ team member who explained & obtained the consent, physically present during the surgical/invasive procedure, procedure or a member of the defined
Team as per list available with Medical Admin
See consent form & OT/ Procedure notes
12
Is the anesthesia consent signed by the Anesthesiologist or an anesthesia team member
Check consent form & Anesthesia Notes
13
Is the procedure/ treatment/ test actually performed by the person, named to carry out the procedure in the consent form or his team member (applicable only to post-op
cases)
Check OT/Procedure Notes
14 Is the actual procedure/ treatment/ test carried out same as the one named in the consent form (applicable only to post-op cases) Check OT/Procedure Notes
15 Are any abbreviations used on the consent form Check consent form
16 In case the procedure was high risk, has a separate high-risk consent been obtained, in addition to the procedure consent Applicable only for High Risk procedures, else NA
17 Does the High Risk Procedure bear the signature of both the Surgeon & Anesthesiologist? Applicable only for High Risk procedures, else NA
18
For procedures carried out frequently &/or regularly on the same patient (e.g. Dialysis), is a fresh written informed consent obtained at least once every 30 days

9.  After auditing the retrospective consent form
from by using audit tool the consent
compliance is of following percentage.

10. 82%
87%
82%
86%
89%
94%
86%
75%
80%
85%
90%
95%
Compliance according to different Consent
Compliance
according to
different Consent

11. 89%
78% 78%
83%
73%
90% 87%
0%
20%
40%
60%
80%
100%
Compliance according to Department
Compliance
according to
Department

12.  Editing the consent forms.
 Awareness and informative lecture session
are conducted for RMO, Surgeon, anesthetics,
nurses, counselors who are involved in
consent taking.
 Prepared dos and don’ts list to be keeping in
each file.
 Ideal fully complete consent form displayed in
each nursing station for reference.
 Daily auditing of consent form.

13. 95%
99%
95%
98%
100%
94%
95%
90%
92%
94%
96%
98%
100%
102%
Compliance of different consent form
Compliance of
different consent
form

14. 94%
99% 99%
89%
92%
100%
96%
80%
85%
90%
95%
100%
105%
consent complience according to department
consent complience
according to
department

15.  After comparing retrospective consent form
and live consent form compliance, after
implementation of Quality improvement
interventions following results are seen.

16. CONSENT TYPE
COMPLIANCE
Retrospective data % Live data % after
intervention
Improvement
achieved %
Surgical 82 95 13
Anesthesia 87 99 12
High-risk 82 95 13
HIV 86 98 10
Blood Transfusion 89 100 11
Radiology 94 100 6
Surgical interventional
procedures
86 95 9

17. 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
95% 99% 95% 98% 100%100% 95%
Retropective data
consent compliance
After intervention
consent compliance

18. CONSENT
COMPLAIANCE
DEPARTMENTWISE
Retrospective data
%
Live data % after
intervention
Improvement
achieved %
Cardiology 89 94 5
Orthopedic 78 99 11
Oncology 78 99 11
Urology 83 89 6
Neurology 73 100 27
OBGY 90 92 2
General Sx 87 96 9

19. 0
20
40
60
80
100 89
78 78
83
73
90 87
complience before
intervention
complience after
intervention

20.  After auditing retrospective data we found
that consent compliance was not up to the
mark and after applying necessary
intervention compliance of consent is
increased and awareness and importance of
taking complete consent is created among
the clinical stuff.
 This is very useful in tackling the medicolegal
issue which may occur in day to day working
of hospital