The Modified Surgical safety checklist-Effectiveness and quality of its implementation

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 anaesthesia safety practices, avoidable surgical infections and poor communication among team members. Based on these processes, the WHO implemented a Surgical Safety Checklist (SSC) 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 starting closure. 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 1st briefing. WHO has always encouraged modifications. The checklist must focus on the most critical issues, be brief and fit the local flow of care. WHO has emphasized testing changes prior to rolling them out and using local data feedback, simulation, and training as strong drivers for the implementation. 

The surgical safety checklist at TMH

The WHO has recommended that the checklist should be modified to suit local needs as mentioned above. Accordingly, at Tata Memorial Hospital (TMH), a modified version of the WHO checklist (Appendix-2) has been implemented since 2009 in Main OR and a modified version of SSC in Minor ORs. After 5 years of its implementation, we want to evaluate the effectiveness of the checklist in the minor OR 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.

Need of SSC in minor OR

In our outpatient surgical and day care unit, a diverse array of procedures takes place, encompassing activities such as direct laryngoscopy, biopsies, examination under anesthesia, microlaryngeal surgeries, bronchoscope-guided biopsies, chemoport insertions, tracheostomies, simple breast surgeries, cystoscopies, and bone marrow aspiration and biopsies, among others. The patient turnover is notably high, with a majority arriving for their procedures on the same day from their homes. This environment poses distinct challenges, including suboptimal adherence to fasting guidelines, patients potentially not being fully optimized concerning their underlying health conditions, and a considerable number of surgical and anesthesia and nursing teams involved. Consequently, strict adherence to the surgical safety checklist (SSC) holds paramount importance in this context.

Methodology:

There are 3 operation theatres in our minor OT complex carrying out an average of 10 surgeries per OT per day (10). Using a random number table, we will randomly select one of the 3 OTs and 5 patients in that particular OT in the morning and will observe the implementation of the 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.

Out of the two parts of the checklist, we intend to study 8 elements in the first two parts i.e. sign-in, sign-out of the checklist, which are crucial to patient safety.

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)

·       Patient Consent

·       Viral Markers checked?

·       Pulse oximetry functioning or not

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

·       Fasting adequacy

·       Any known allergy

·       Any other concerns from the team

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, checking consent, viral markers, putting pulse oxymeter on patient, asking about fasting and allergy, examining the airway)

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

Sample size and statistical analysis

This is an observational study. A convenience sample of 200 cases (surgeries) will be selected. We plan to study 5 surgeries per working day. 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.