The WHO surgical safety checklist: Effectiveness and quality of its implementation

Introduction

Background:

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

Checklists or protocols are a common tool for preventing humanerrors in complex and high intensity areas of work. In 2007, the WorldHealth Organization (WHO) launched the “safe Surgery Saves Lives†globalcampaign during which it identified key processes in the operative period whichcould potentially affect patient outcomes. These included inadequate anaesthetic safety practices,avoidable surgical infection and poor communication among team members. Based on theseprocesses, the WHO implemented a Surgical Safety Checklist for briefings in theoperating room.(3).

TheWHO surgical safety checklist

The checklist (Appendix – 1) consists of threemain parts which are implemented at three specific time-points during thesurgery: first part (sign-in) which is done before administering anaesthesia tothe patient, second part (time-out) which is done before taking the surgicalincision, and the third part (sign-out) done before shifting of the patient torecovery room. Each of these parts consists of certain elements/items, whichhave shown to improve surgical outcome, decrease complications including wrongsite of surgery and finally improve patient safety (4,5). At each of thesetime-points, important information can be checked, communicated and shared betweenall team members participating in the surgery. The team members comprise of onerepresentative from each of the following: the surgical team, the anaesthesiateam and the nursing team. The patient is also involved in part in the 1stbriefing.

Review of literature

Previous research indicatedthat the implementation of checklist has lead to a decrease in the number ofcommunication failures in the operating theatre. (6,7). It has also beingobserved that the use of the WHO Checklist is associated with the developmentof a better safety attitude among the operating personnel. (8) Allthe benefits of the checklist are only possible if the compliance andimplementation is proper. Butat the same time, it was also observed that introduction of check list did notnecessarily mean 100% compliance with it.(9)

The surgical safetychecklist at TMH

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

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

Objectives

Primary

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

a.      The overall compliance with thechecklist

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

2.      To look at the quality ofimplementation of the checklist by studying the level of interaction betweenthe three team members (surgeon, anaesthetist and OT nurse) involved in theimplementation 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 afterapproval from the hospital IEC.

Inclusion: Surgeries performed in any of the 13 major OTs during routineworking 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 anaverage of 2 surgeries per OT per day (10). Using a random numbertable, we will randomly select one OT each in the morning and in theafternoon   and will observe theimplementation of the first two parts of the checklist during a surgery carriedout in that particular OT. A member of the investigating team, (a trained researchnurse) will be present in the selected operation theatre from the time thepatient is wheeled in. The research nurse will passively observe the implementationof the check list. He/she will not actively participate or talk to the teammembers implementing the check list or correct any errors. In the similarmethod, the implementation of the third part of the checklist will be observedin 2 surgeries per day. The third part (sign out) may/may not be in thesurgeries where the first two part of the checklist was studied and will bedone using random number table.

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

Followingelements from the first part will be studied:

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

·       Specificinstruments for surgery available or not ( Improve OT utilization time and partof patient safety)

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

·       Preparationfor position (improve OT utilization time)

·        Pulse oximetry functioning or not (Patientsafety)

·       Isthere any anticipated difficult airway?(The team will recognise and effectively prepare for life-threatening loss ofairway

Following elements fromthe second part will be studied:

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

·       Antibioticprophylaxis given or not (To decrease surgical site infection)

·       Essentialimaging displayed or not (improve OT utilization time)

·       Pathologyform filled or not (improve OT utilization time and prevent samples fromgetting misplaced)

Following elements from the third part will be studied:

·       Instrument, sponge and needlecount correct ( Patient safety)

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

1.      There was compliance with thechecklist

2.      Whether the checklist prompted anychange in behaviour (e.g. checking the file for site of surgery, confirmingblood, procuring equipment, administering antibiotic)

3.      Whether members of all three teamsneeded for the checklist were present and participating actively in theimplementation of the checklist

Outcomes and analysis

Primary outcomes

1.      To analyse the effectiveness of thesurgical safety checklist

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

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

2.      To look at the quality ofimplementation of the checklist by studying the level of interaction betweenthe three team members (surgeon, anaesthetist and OT nurse) involved in theimplementation of the checklist. – this will be measured as the percentage ofcases in which members of all three teams needed for the checklist were presentand 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 beexpressed as percentage

Ethical aspects

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

Sample size andstatistical analysis

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