|Year : 2015 | Volume
| Issue : 2 | Page : 41-46
Implementation of surgical safety checklist for all invasive procedures
Akanksha Patel1, Vinay Sanghi2, Vibhu Ranjan Gupta3
1 Department of Quality, Fortis Escorts Heart Institute, New Delhi, India
2 Department of Cardiology, Fortis Hospital, New Delhi, India
3 Department of Medical Administration, Medanta - The Medicity, Gurgaon, Haryana, India
|Date of Web Publication||19-Jan-2016|
Dr. Akanksha Patel
Department of Quality, Fortis Escorts Heart Institute, Okhla, New Delhi
Source of Support: None, Conflict of Interest: None
Context: The purpose of this study was to analyze the implementation of the surgical safety checklist (SSCL) for all invasive procedures and compliance with the SSCL to determine further improvements.
Aims: To implement the SSCL for all invasive procedures within 6 months and achieve 80% compliance.
Settings and Design: Various invasive procedures selected that have comparatively risks of errors. Modified the SSCL based on essential requirements of the procedure.
Materials and Methods: The implementation of the SSCL was observed for all identified invasive procedures. Checklists were piloted, rolled out, and monitored.
Statistical Analysis Used: Plan-Do-Study-Act (PDSA) and Pareto principle were used for implementing the SSCL and analyzing the hurdles for implementation.
Results: During this exercise, the checklist for the various invasive procedures was finalized after a brainstorming sessions with various stakeholders. All the checklists were developed with the help of the World Health Organization (WHO) surgical safety principle between March 2013 and May 2013. Sensitization and training for the checklist were done among all relevant staff. All the checklists were piloted for June 2013 and the compliance of checklist usage was monitored. The sample for audit was decided. The rates of compliance for various procedures during the pilot phase of the study were 50% for dental extractions, 60% for cataract surgeries, 35% for endoscopy, 20% for cystoscopy, 40% for cardiac catheterization procedures, and 0% for bronchoscopy procedures. Compliance reviewed and changes made based on feedback received from users for checklist finalization. After the intervention, compliance monitoring for the same sample size at a defined frequency is done and shared with relevant stakeholders when required.
Conclusions: Implementation needs constant monitoring, retraining, and reinforcement until it becomes self-evident and accepted.
Keywords: Operation room (OR), Plan-Do-Study-Act (PDSA), surgical safety checklist (SSCL)
|How to cite this article:|
Patel A, Sanghi V, Gupta VR. Implementation of surgical safety checklist for all invasive procedures. J Nat Accred Board Hosp Healthcare Providers 2015;2:41-6
|How to cite this URL:|
Patel A, Sanghi V, Gupta VR. Implementation of surgical safety checklist for all invasive procedures. J Nat Accred Board Hosp Healthcare Providers [serial online] 2015 [cited 2019 Dec 7];2:41-6. Available from: http://www.nabh.ind.in/text.asp?2015/2/2/41/174347
| Introduction|| |
Surgical intervention is a requirement for various diseased conditions. Surgery is often the only therapy that can reduce the risk of mortality from common disease conditions. Each year more than 100 million people undergo surgical treatment due to traumatic injuries, malignancies, and other systemic reasons.  For diagnosis and treatment of diseases, apart from surgeries, minor surgical and nonsurgical invasive procedures are also very prevalent. The only intentions of these procedures are to save lives and to increase healthy life expectancy. But millions of errors are also been reported worldwide while surgical and noninvasive procedures are underway. Errors are not intentional but it leads to different categories of harm to patients ranging from minor reversible disabilities to loss of life. Surgical procedures are multidisciplinary in nature and involve the use of various equipment, multiple experts, numerous consumables, radiation, and various other requirements. Although surgical and procedural teams are credentialed and skilled, errors can happen due to a minor slip of total number of swabs used before and after the surgery, and this can lead to major medicolegal implications. The Safe Surgery Saves Lives initiative by WHO to reduce the number of surgical deaths across the world. These have proved to be common, deadly and preventable problems in all countries and settings  . To avoid such errors and to prevent medicolegal cases, hospitals can implement a simple, effective, tested, and useful tool called the World Health Organization (WHO) Surgical Safety Checklist (SSCL). Appropriate use of this practical tool ensures added benefits to patients during preoperative, intraoperative, and postoperative periods in a timely and efficient way. 
Potential errors have catastrophic effects on physicians and hospitals. Reducing such errors through a reminder checklist is an innovative idea. Checklists are fundamental to the aviation industry; they are used to evaluate the mechanical integrity of the plane and its electronic systems on multiple occasions in the cockpit before, during, and after the flight.  Implementation of the checklist was shown to lower the incidence of surgery-related deaths and complications by one-third in a pilot study that included eight sites across all six WHO regions including the St Stephen's idea. These checklists are fundament.  For successful implementation, the checklist needs to be adapted based on the requirements of the hospital. The checklist basically consists of three phases: Sign in: Preprocedural verification process of the correct site, procedure, and patient, along with the availability of special equipment and/or implants. The process also involves ensuring the availability of all relevant documents, images, and studies; time-out: A pause, just prior to performing a surgical or other procedure, during which any unanswered questions or confusion about the patient, procedure, or site are resolved by the entire surgical or procedural team. Even when there is only one person doing the procedure, a brief pause to confirm the correct patient, procedure, and site is appropriate;  sign out: Before the patient leaves the OR there is a further check, usually conducted by the nursing staff. The instrument, sponge, and needle counts are checked; equipment is checked; and specimens are checked for appropriate labeling. The team then must discuss any key concerns for recovery management of the patient. Higher management and leadership commitment toward surgical safety is a prime requirement.
The best practices are adopted for patient safety and to prevent errors. Surgical safety is an important aspect of patient safety. Although we are using SSCL for all surgical cases performed in the operation theater the implementation of a safety checklist for other invasive procedures as such procedures also bear the risk of error.
To implement SSCL for all invasive procedures within 6 months an 80% compliance rate has to be achieved for various procedures such as cardiac catheterization procedures, endoscopy, bronchoscopy, cystoscopy, dental extractions, and cataract surgeries.
To ensure patient safety and identify and prevent errors by virtue of the SSCL.
| Materials and Methods|| |
The SSCL requirement in different areas of a hospital was established by reviewing the entire hospital surgical and invasive procedures. After various brainstorming sessions with the leaders and stakeholders, it was finalized that the SSCL should be implemented for cardiac catheterization procedures such as endoscopy, cystoscopy, bronchoscopy, cataract surgery and dental Extractions. After approval, the checklists were piloted and rolled out into different facilities; compliance with the SSCL was routinely measured. Plan-Do-Study-Act (PDSA) methodology was used for the final rollout of the SSCLs [Figure 1].
Plan (planning and approval of SSCL for all invasive procedures): Duration March 2013-May 2013
Planning to implement the SSCL for all the invasive procedures
- Finalization of checklist after discussing with various stakeholders.
- Formulation of policy [Table 1].
- Circulation and approval of policy by stakeholders.
- Training of various teams involved.
Checklists, such as catheterization procedure safety checklist, SSCL-endoscopy, SSCL-cystoscopy, bronchoscopy procedural safety checklist, operative checklist for dental extraction only, and SSCL for cataract surgery were adopted from various internationally accepted checklists such as NHS (National Patient Safety Agency), Woodstock General Hospital, Vancouver Coastal Health.
Do (pilot of checklists: June 2013)
A sample size of 30 patients was used for endoscopy and cystoscopy and 50 patients were used for cardiac catheterization procedures. All procedures (cataract surgery, bronchoscopy, and dental extractions) were monitored for checklist implementation due to lesser volumes.
Study (modification of checklist based on pilot exercise: June 2013)
Deficiencies were identified, corrected, and implemented. Retraining of staff was done and department-specific induction was updated for the SSCL.
Act (modification of checklist implemented based on pilot exercise: July 2013)
The finalized checklist was implemented and frequency of monitoring of compliance was established for ensuring patient safety.
| Results|| |
Before March 2013, operation room (OR) was the only area where the SSCL was being used in spite of the fact that following procedures also bear similar risks to the patient and dental extractions were monitored for checklist implementation due is similar to the use of helmets; everyone knows the side effects but is negligent. In the process of implementing the checklists through PDSA approach, we faced major problems in the pilot phase [Table 2]. Although everyone was briefed adequately about the procedure, the completion and compliance observed were very low. Checklist [Figure 2] utilization and completion rates were monitored in June 2013 (pilot phase).
|Figure 2: Example of the SSCL for endoscopy, bronchoscopy, and cardiac catheterization procedure|
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To identify the factors and analyze the reasons behind low compliance rates, we applied Pareto analysis. We listed the probable factors associated with low compliance rates and audited for the same via 100 observations simultaneously (equally distributed between all procedures based on volumes) in the first week of July [Table 3]. The analysis revealed that the major contributing factors were behavior and negligence [Figure 3]. Logistic factors were addressed. Various sensitization sessions were held with the clinicians for addressing their concerns.
Monitoring of the SSCL was done till September 2013 and then continued at a defined frequency yearly [Figure 4], [Figure 5], [Figure 6].
|Figure 4: Utilization and completion compliance for checklist for cardiac catheterization procedures|
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|Figure 5: Utilization and completion compliance for checklist for cataract and dental extractions|
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|Figure 6: Utilization and completion compliance for checklist for endoscopy, bronchoscopy, and cystoscopy|
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Checklist utilization monitoring was done by medical coordinators (Medical Administration Department) and quality at the gap of 6 months. The SSCL increases team coordination and communication. During the implementation and monitoring phase, we identified two near-miss incidents that explained the practicality and importance of the SSCL. One of these was a wrong patient transfer to the cardiac catheterization laboratory and the other was prevention of wrong tooth extraction on the same side.
| Discussion|| |
Each identified department implemented the SSCL in its routine procedures. Initially during implementation, it was a big challenge to chase clinicians for its implementation. Explaining why and showing how to implement SSCL is vital step.  The initial phase was checklist introduction, training, and postimplementation monitoring. Implementation was done by a quality improvement tool, that is, PDSA cycle that involved several small PDSAs for each step. Implementation of the SSCL by PDSA cycle method was also evidenced in the WHO studies.  For continuous enforcement, the audits were conducted for defined sample size, and audits showed initial low compliances in pilot but after addressing factors associated with compliance that was majorly behavioral and negligence about the SSCL. As also reported in the WHO SSCL implementation report, 55% thought it caused unnecessary time delay.  Trainings, sensitization sessions taken, and videos for how to do and how not to do the SSCL run in various meetings. We were able to achieve 80% of the target for all identified procedures (cardiac catheterization procedures, endoscopy, bronchoscopy, cystoscopy, dental extractions, and cataract surgeries).
For the catheterization procedures we observed up to 90% completion compliance regarding the checklist. In a similar study of the SSCL for cardiac catheterization procedure, compliances for pre- and postintervention observed were 20% and 76%, respectively; it was an observational audit for a sample size of 20 for preimplementation and 34 for postimplementation.  For cataract surgeries, 100% completion of the checklist was noticed in a majority of audits, as volumes also play an important factor for completion. When the volume of surgeries was lesser, 100% completion rate was observed. In another study for cataract surgeries, a survey was conducted among cataract surgeons; 90% of the surgeons responded and revealed that 67% use a team brief. However, only 54% use a checklist, which addresses the selection of the correct intraocular implant. The study recommended a wider adoption of checklists, which address risks relevant to cataract surgery, in particular, the possibility of selection of an incorrect intraocular lens (IOL).  For invasive procedures such as endoscopy, bronchoscopy, and cystoscopy, the completion compliance ranges from 60% to 100%. For endoscopic procedures, another study showed PDSA approach for implementing the SSCL. After intervention, there was a significant increase in the percentage of checklists fully completed from 53% to 66%. There was a statistically significant decrease in the number of checklists left blank after intervention from 10% to 2%. 
Postoperative complication rates fell by 36%, and death rates with similar amount.  We targeted almost all invasive and minor surgical procedures for the SSCL and monitored them simultaneously. During the implementation of the SSCL, we also identified two near-misses, one in the catheterization laboratory (wrong patient shifted identified by the SSCL) and one during a dental extraction procedure (wrong tooth extraction on the same side prevented by the SSCL). For oral surgical procedures in a study demonstrated usability of checklist as 2 out of 102 critical incidences were identified by a safety checklist.  If at least five major complications are prevented within the first year of using the checklist, a hospital will realize a return on its investment within that time frame.  This is because cost of implementation is far lesser than the estimated cost of wrong surgery, postoperative infections, and litigations.
The audits were limited to completion compliance with the SSCL. As true compliance with the surgical safety protocol can only be measured by observation audits but as a part of the first phase of implementation, we only measured the completion compliance rate.
Documentation completion does not necessarily equate to effective use of the checklist: The checklist could still be a "tick box" exercise for some users and measured compliance may not reflect its effective use by the team.  This limitation can be addressed by a prospective observational study in real time of checklist use by teams.
Constant reinforcement, retraining, and leadership involvement are vital till the SSCL is adopted and accepted.
| Conclusion|| |
It is encouraging that all the risk-bearing procedures and surgeries adopted the SSCL for better patient safety. We may not be able to predict the probability of occurrence of harm due to nonusage of the SSCL in a particular facility but the WHO data for safe surgery gives handsome incidences and harm categories due to the lack of SSCL protocol. The checklist use is directly proportional to the reduction in surgical morbidity and mortality rates and positive impact on team work, which plays an important role in improving patient safety.
Further investigations should be encouraged to see the impact of checklists on all procedural and surgical safety, particularly in relation to arm categories due to lack of the SSCL protocol. Checklist use is a dire surgical safety, and a checklist should be included in view of patient safety.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3]