Introduction

Background:

The delivery of healthcare is complex and hence riddled with the potential for errors due to human factors, system failure or combination of both. Surgery forms an important treatment modality with millions of surgical procedures performed world over. Complications are not uncommon and occur in 3% to 16% of all surgical procedures with permanent disability or mortality rates ranging between 0.4% to 0.8% of all surgical procedures.^(1,2) These figures are from the Western world and it is likely that the incidence of these complications is higher in developing countries like India. Many of these complications may be due to preventable/modifiable causes.

Checklists or protocols are a common tool for preventing human errors in complex and high intensity areas of work. In 2007, the World Health Organization (WHO) launched the “safe Surgery Saves Lives” global campaign during which it identified key processes in the operative period which could potentially affect patient outcomes. These included inadequate anaesthetic safety practices, avoidable surgical infection and poor communication among team members. Based on these processes, the WHO implemented a Surgical Safety Checklist for briefings in the operating room.^(3). 

The WHO surgical safety checklist

The checklist (Appendix – 1) consists of three main parts which are implemented at three specific time-points during the surgery: first part (sign-in) which is done before administering anaesthesia to the patient, second part (time-out) which is done before taking the surgical incision, and the third part (sign-out) done before shifting of the patient to recovery room. Each of these parts consists of certain elements/items, which have shown to improve surgical outcome, decrease complications including wrong site of surgery and finally improve patient safety ^(4,5). At each of these time-points, important information can be checked, communicated and shared between all team members participating in the surgery. The team members comprise of one representative from each of the following: the surgical team, the anaesthesia team and the nursing team. The patient is also involved in part in the 1^st briefing.

Review of literature

Previous research indicated that the implementation of checklist has lead to a decrease in the number of communication failures in the operating theatre. (^6,7). It has also being observed that the use of the WHO Checklist is associated with the development of a better safety attitude among the operating personnel^{. (8)} All the benefits of the checklist are only possible if the compliance and implementation is proper. But at the same time, it was also observed that introduction of check list did not necessarily mean 100% compliance with it^.(9)

The surgical safety checklist at TMH

The WHO has recommended that the checklist should be modified to suit local needs. Accordingly, at TMH, a modified version of the WHO checklist (Appendix-2) has been implemented since 2009

After 5 years of its implementation, we want to evaluate the effectiveness of the checklist by finding out which essential items in the peri-operative period were picked up by the OT team members only after they were brought up during the conduct of the checklist. In addition, errors in areas where safety is a concern are partly attributable to inadequate communication and poor teamwork.  Hence we will also study the level of interaction between the three team members (surgeon, anaesthetist and OT nurse) during the implementation of the checklist.

Objectives

Primary

1.      To analyse the effectiveness of the surgical safety checklist by measuring

a.      The overall compliance with the checklist

b.      The number of items important in the peri-operative period, which were picked up by the OT team members only after they were brought up during the conduct of the checklist.

2.      To look at the quality of implementation of the checklist by studying the level of interaction between the three team members (surgeon, anaesthetist and OT nurse) involved in the implementation of the checklist.

Secondary

1.       To examine which member of the operating team (surgeon, anaesthetist, nurse) initiates the each part of the checklist

Methodology:

Study Design: Prospective observational study

Methods: The study will commence after approval from the hospital IEC.

Inclusion: Surgeries performed in any of the 13 major OTs during routine working hours (8.30 am to 5 pm)

Exclusion: Emergency procedures performed outside routine working hours

There are 13 operation theatres in our main OT complex carrying out an average of 2 surgeries per OT per day ⁽¹⁰⁾. Using a random number table, we will randomly select one OT each in the morning and in the afternoon   and will observe the implementation of the first two parts of the checklist during a surgery carried out in that particular OT. A member of the investigating team, (a trained research nurse) will be present in the selected operation theatre from the time the patient is wheeled in. The research nurse will passively observe the implementation of the check list. He/she will not actively participate or talk to the team members implementing the check list or correct any errors. In the similar method, the implementation of the third part of the checklist will be observed in 2 surgeries per day. The third part (sign out) may/may not be in the surgeries where the first two part of the checklist was studied and will be done using random number table.

Out of the three parts of the checklist, we intend to study 10 elements in the first two parts i.e. sign-in, time-out of the checklist and 1 element in the sign-out or the third part of the checklist, which are crucial to patient safety and which are often over-looked. The third part of the checklist may be as mentioned previously be studied in different OT.

Following elements from the first part will be studied:

·        Confirmation of patient, name and side of operation (As part of patient safety to avoid operation on wrong patient and wrong side)

·        Specific instruments for surgery available or not ( Improve OT utilization time and part of patient safety)

·        Confirmation of blood from blood bank (the team will recognise and effectively prepare for risk of high blood loss)

·        Preparation for position (improve OT utilization time)

·         Pulse oximetry functioning or not (Patient safety)

·        Is there any anticipated difficult airway?(The team will recognise and effectively prepare for life-threatening loss of airway

Following elements from the second part will be studied:

·        Verbally confirmation of patient, name and side of operation. (The team will effectively communicate and exchange critical patient information for the safe conduct of the operation)

·        Antibiotic prophylaxis given or not (To decrease surgical site infection)

·        Essential imaging displayed or not (improve OT utilization time)

·        Pathology form filled or not (improve OT utilization time and prevent samples from getting misplaced)

Following elements from the third part will be studied:

·        Instrument, sponge and needle count correct ( Patient safety)

For each of these items, the research nurse will document whether

1.      There was compliance with the checklist

2.      Whether the checklist prompted any change in behaviour (e.g. checking the file for site of surgery, confirming blood, procuring equipment, administering antibiotic)

3.      Whether members of all three teams needed for the checklist were present and participating actively in the implementation of the checklist

Outcomes and analysis

Primary outcomes

1.      To analyse the effectiveness of the surgical safety checklist

a.      The overall compliance with the checklist: this will be measured as the percentage of cases in which the surgical safety checklist was implemented

b.      The number of items important in the peri-operative period, which were picked up by the OT team members only after they were brought up during the conduct of the checklist: this will be measured as the percentage of total items which prompted a change in management

2.      To look at the quality of implementation of the checklist by studying the level of interaction between the three team members (surgeon, anaesthetist and OT nurse) involved in the implementation of the checklist. – this will be measured as the percentage of cases in which members of all three teams needed for the checklist were present and participating actively. This will be measured separately for the sign-in, time-out and sign-out parts of the checklist

Secondary outcomes

1.       To examine which member of the operating team (surgeon, anaesthetist, nurse) initiates the the checklist – this will be expressed as percentage

Ethical aspects

This is an observational study with no patient interaction. We will request for waiver of informed consent

Sample size and statistical analysis

This is an observational study. A convenience sample of 200 cases (surgeries) will be selected. We plan to study 2 surgeries per working day for the first and second part of checklist and 2 addition surgeries per working day for the third part of checklist; therefore, we will complete the study in around 6 months. Data will be expressed as percentages for categorical data and means / medians for continuous data.