Clinical audit report on surgery consent

N. Loganayaki^1*, Jaisha K²

¹Assistant Nursing Superintendent, Kauvery Hospital, Hosur, Tamil Nadu

²Nursing Supervisor, Kauvery Hospital, Hosur, Tamil Nadu

*Correspondence

Introduction

Informed consent is a foundational pillar of modern healthcare, rooted in the ethical principle of patient autonomy. Patients have the right to make fully informed decisions about what happens to their bodies. Legally and ethically, a valid consent process requires that a patient is competent, acts voluntarily, and is given sufficient information to make an enlightened choice.

Purposes

To assess whether informed surgical consent is completed correctly, completely, and before the procedure.
To verify that consent documentation reflects the planned procedure and supports patient safety, communication, and medico-legal requirements.
To identify gaps in consent practice and implement corrective and preventive actions (CAPA).

Aims and Objectives

Verify patient identification and procedure/site documentation.
Check documentation of diagnosis, proposed procedure, benefits, material risks, alternatives, and consequences of refusal where applicable.
Confirm consent is signed/dated by the appropriate person and clinician before surgery.
Assess whether the patient/authorized representative had an opportunity to ask questions and whether language/communication needs were addressed.
Check completeness of witness/interpreter documentation where required.
Measure overall compliance and prioritize high-risk gaps.

Audit Standards / Checklist

S.No	Audit Checklist criterion	Expected standard
1	Consent form existing in patient file	Adhere to Legal Compliance and appropriate forms in needed casefiles
2	Consent form filled with patient details ( Name, Age and UHID No)	Correct patient identifiers documented
3	Anaesthesia Consent obtained appropriately	Explained about anaesthesia procedure and type of anaesthesia
4	Site Marking done	Site and side documented where applicable, before shifting to OT
5	Diagnosis and Indication mentioned	Clinical indication documented
6	Surgery and Procedure name documented	Exact/planned procedure clearly stated
7	Explained to a patient/patient attender in a known language	Patient and Patient attender understands clearly
8	Risk and benefits are explained and documented including material risks if applicable	Relevant risks/complications documented or explained per policy, Benefits and reasonable alternatives addressed
9	Surgeon/Witness signature obtained	Authorised representative documented when applicable
10	SNDT followed appropriately	Patient/representative and clinician signatures with date/time

Source

NABH 6th Edition
JCI 2nd edition
Kauvery Hospital Policy and Procedures (KHO)

Audit Methodology

Design: Retrospective record audit and concurrent audit.
Sample size: Minimum 75% of surgery cases.
Sampling: Random sample across elective and emergency
Data source: Patient medical records, Surgical booklet & consent forms.
Scoring: Each applicable criterion marked Compliance/Non-compliance / Not applicable.
Audit Period: 01/08/2026 to 31/08/2026.
Re- Audit Period: 01/09/2026 to 30/09/2026.

Compliance percentage in Aug 2026

S.No	Audit Checklist criterion	No.of Compliance	Total Cases Audited	% of Compliance
1	Consent form existing in patient file	124	124	100%
2	Consent form filled with patient details ( Name, Age and UHID No)	124	124	100%
3	Anaesthesia Consent obtained appropriately	124	124	100%
4	Site Marking done	104	124	83%
5	Diagnosis and Indication mentioned	119	124	95%
6	Surgery and Procedure name documented	124	124	100%
7	Explained to a patient/patient attender in a known language	116	124	93%
8	Risk and benefits are explained and documented Including Material risks if applicable	106	124	85%
9	Surgeon/Witness signature obtained	103	124	83%
10	SNDT followed appropriately	79	124	63%

Key Findings

Significant non-adherence to the SNDT (Signature, Name Date and Time) were noticed.
Risk/benefit discussion is not consistently documented.
Witness sign missed in consent.
Significant cases site marking was missed.
Communication gap noted due to language barrier.

Root Cause Analysis (6M Method)

Man (People): Variation in clinician documentation habits and understanding of required consent elements.
Method (Process): Consent checklist is available but completion is not consistently embedded into the pre-operative workflow.
Material (Documentation): Forms may have fields that are left blank when verbal discussion occurs but is not documented.
Measurement (Monitoring): Limited routine audit feedback at unit/department level.
Mother Nature (Environment): Emergency workload, time pressure, language barriers, or availability of interpreters may contribute.
Machine (System or Technology): Lack of mandatory Alerts No hard stop / escalation when consent is incomplete before transfer to OT.

Corrective & Preventive Action Plan (CAPA)

Finding	Corrective Action	Preventive Action	Responsibility	Target
SNDT 63%	Review all non-compliant cases and identify where breakdown occurred	Integrate SNDT into OT checklist/time-out and require team confirmation before incision	OT In-charge + Surgeons + Anesthesia	1 week
Risk/benefit 85%	Return incomplete forms for correction where clinically appropriate	Add mandatory prompts for risks, benefits and material risks to consent documentation	Surgical dept.	1 week
Signature 83%	Daily review of incomplete consent forms	Preoperative nurse/OT checklist to verify surgeon/witness signatures	Nursing + OT	Immediate
Site marking 63%	Immediate counselling of doctors/OT staff regarding missed cases	Make site marking a mandatory pre-OT verification point; use “No site marking = No procedure” rule except approved emergency circumstances	Ward In charges + OT + Quality	Immediate
Language explanation 93%	Counsel staff regarding documentation of patient understanding	Add field: “Language used for explanation” and patient/attender acknowledgement	Doctors + Nursing + Surgery dept. Physician Assistants	1 week
Diagnosis 95%	Correct identified incomplete forms	Pre-OT document verification	OT In charges + Surgery dept. Physician Assistants	Immediate

Strong Monitoring Strategy

Daily: OT/pre-op nurse verifies consent completeness before patient enters the procedure area.
Daily: Nursing Supervisors Team audits a defined sample (Previous and on the day surgery cases) and reports compliance by surgeon.
Weekly: Department dashboard shows overall compliance, top gaps, and repeat non-compliance.
Escalation: Incomplete consent → return to responsible clinician for correction before procedure unless emergency policy applies.
Feedback: Shared results during surgery/OT meetings; recognize units or clinicians achieving sustained ≥95% compliance.

Re-audit – Compliance percentage in Sep 2026

S.No	Audit Checklist criterion	No. of Compliance	Total Cases Audited	% of Compliance
1	Consent form existing in patient file	193	193	100%
2	Consent form filled with patient details ( Name, Age and UHID No)	193	193	100%
3	Anaesthesia Consent obtained appropriately	193	193	100%
4	Site Marking done	191	193	99%
5	Diagnosis and Indication mentioned	193	193	100%
6	Surgery and Procedure name documented	193	193	100%
7	Explained to a patient/patient attender in a known language	193	193	100%
8	Risk and benefits are explained and documented Including Material risks if applicable	193	193	100%
9	Surgeon/Witness signature obtained	189	193	98%
10	SNDT followed appropriately	187	193	97%

Conclusion

Consent documentation is a key patient-safety and governance process, not only a form-completion activity.
Standardization, point-of-care verification, regular audit, feedback, and escalation should work together.
Focused improvement efforts on the lowest-performing criteria and repeated audits helps to demonstrate sustained improvement.

Clinical audit report on surgery consent

Clinical audit report on surgery consent

N. Loganayaki1*, Jaisha K2

Nightingale Journals

N. Loganayaki^1*, Jaisha K²