Originally published March 2017
Since the introduction of the Surgical Safety Checklist (SSCL) by the World Health Organization (WHO) in 2008 and the Canadian Patient Safety Institute (CPSI) in 2009, there has been increased focus on the use of checklists to help improve the safety of operating rooms (ORs). In 2010, Accreditation Canada recognized the use of the surgical safety checklist as essential to patient safety and established it as a required organizational practice.
While healthcare facilities had pre-existing surgical safety protocols, these were not always consistently followed, often because of breakdowns in communication or a lack of standardized system protocols.1,2 The SSCL established a more comprehensive surgical team approach aimed at improving communication and consistency of care in ORs.
Read the CMPA/HIROC report on surgical safety
As a member of the National Patient Safety Consortium, the CMPA applies its medical-legal expertise to help improve surgical safety. In collaboration with the Healthcare Insurance Reciprocal of Canada (HIROC), in 2016 the CMPA jointly released the report Surgical Safety in Canada: A 10-year review of CMPA and HIROC medico-legal data [PDF],
which provides recommendations on system and practice improvements to support patient safety.
Medical-legal issues related to the use of the SSCL3 can be grouped by the 3 surgical phases of the Canadian Patient Safety Institute (CPSI) SSCL:
- Briefing: before the induction of anaesthesia
- Time out: before the first incision
- Debriefing: before the patient leaves the OR
The CMPA reviewed 54 closed medical-legal cases involving events that occurred between 2011 and 2015 and which included in-hospital SSCL-related issues. In many of the cases, peer experts found surgical safety processes to be inadequate, non-existent, or not followed by the OR team. The analysis also revealed that almost two-thirds of the surgical incidents (35/54 cases) occurred during the briefing or time-out phase, and the remaining ones occurred during debriefing (i.e. before the patient left the OR). The events analyzed in the review took place within a variety of surgical specialties and involved all members of the healthcare team.
Briefing and time-out phases
Recurring themes in the analyzed cases were the following: inadequate verification of the identity of the patient, the failure to confirm the planned procedure and site, the lack of documentation of informed consent, the absence of appropriate marking of the surgical site (when applicable), and the failure to display relevant imaging. These lapses were associated with wrong-site surgery in 15 cases and performing the wrong procedure in 6 cases.
A further concern of the experts in these cases was the absence of a timely review of the patient's documented clinical history or the results of pre-operative assessments. This often resulted in the physician or anesthesiologist overlooking relevant risk factors, consultant recommendations, or abnormal laboratory investigations that would have required immediate attention or follow-up.
Less commonly, checklist items that were overlooked in the briefing phase were checking patients’ allergy status and expiration dates, and failing to note that prophylactic antibiotics had not been administered.
Cases with issues involving sponge or instrument counts resulted in unintentionally retained surgical items. Either the surgical counts were not documented, were erroneously reported as correct, or imaging was not performed when there was a reported discrepancy in the surgical count. In one case where the surgical count was correct, an 18 cm forceps was overlooked and retained despite a final sweep of the cavity.
In some cases problems also arose when regularly used and additional surgical items, instruments, or instrument parts were not added to the surgical count. Retained surgical items often took weeks or months to identify following prolonged investigation of ongoing post-operative symptoms.
In a small number of cases, specimens procured intra-operatively were not processed appropriately due to breakdowns in the specimen management process. In other cases, inadequate communication of critical intra-operative events (e.g. respiratory arrest) with the post-operative team members resulted in delay to initiate mitigating therapies (e.g. hypothermia protocol).
An effective SSCL addresses team training, dynamics, and communication. It involves all members of the surgical team and requires leadership engagement. Supporting a patient safety culture, the SSCL facilitates communication across the care team and reduces the likelihood of certain surgical incidents.
“While it is recognized that optimal use of an SSCL will not prevent all surgical patient safety incidents, it is considered a fundamental step toward enhanced surgical safety.”4
The following cases illustrate SSCL-related issues.
Wrong procedure performed
A patient presents for a trigger finger release but mistakenly undergoes a carpal tunnel release.
At the consult visit, the surgeon diagnosed a stenosing tenosynovitis and discussed the trigger finger release with the patient. The surgeon’s dictated consult referred to the trigger finger diagnosis, and the patient consented to pulley release surgery. On the day of surgery, the patient’s name did not appear on the OR schedule and the paperwork had not arrived; consequently, the plastic surgeon did not have access to the patient’s health record including the consent or his consult notes. The hospital registration sheet, meanwhile, incorrectly stated carpal tunnel release. The patient was nervous and the surgeon did not spend time discussing the surgery, but rather focused on addressing the patient’s anxiety concerning the procedure.
Surgery done on wrong site
The OR team operated on the wrong knee when “time out” was not performed properly.
On the day of surgery, the orthopaedic surgeon met the patient outside the OR, confirmed the site and procedure, and marked the patient’s correct knee below the tibial turberosity. Once in the OR theatre and prior to prepping the patient, the team initiated a “time out” while the patient was still awake; this included confirming the patient’s identity, the site, and the procedure.
The time-out protocol had recently been introduced at the hospital with no specific team training. Furthermore, the team was using a new leg holder, and while everyone was focused on applying the holder properly, the wrong leg was being set up and the surgeon’s marking on the operative leg was no longer visible. At the subsequent correct surgery, the surgeons marked the limb at the patient's patella and two portal sites.
Surgical item unintentionally retained
Five months after surgery for metastatic colorectal cancer, an elderly man requires a second surgery to remove a retained gauze.
While excising an isolated metastatic lesion on the patient’s pelvic bone, the orthopaedic surgeon consulted with a general surgeon because the tumour was adherent to the patient’s bowel. The general surgeon resected and anastomosed part of the bowel, and left the OR before the end of the 12-hour surgery. In this long and complex procedure the surgical count was only carried out twice and reported as correct. As was the orthopaedic surgeon’s usual practice after a complex case, he ordered an abdominal X-ray to rule out retained surgical items. He reviewed the X-ray and noted there was a radio-opaque line over the sacrum. He consulted a radiologist who attributed the findings as likely representing anastomotic staples. No further imaging studies were done. Four months later the patient sought care for new onset abdominal pain. A CT scan identified the retained gauze.
Strategies to support appropriate use of the surgical safety checklist
Strategies to reduce surgical safety incidents are based on peer expert opinions in the reviewed cases.
For care providers
- Promote a culture of safety with open and respectful communication that encourages patients, families, and providers to speak up when they have concerns.
- Work as a team to customize the SSCL according to the facility and specialty.
- Support team members as they use the SSCL and discuss any issues involving common and necessary surgical tasks.
- Follow the hospital policy and procedure (if available) for surgical counts: count any items added to the field, document the count, and take appropriate measures in the event of a discrepancy. Document the measures taken to address the discrepancy.
- Use a structured communication tool during the transfer of care.
- Document the effective use of the SSCL and any issues.
For healthcare leaders
- Develop and implement clear surgical safety policies and procedures.
- Allocate appropriate resources for effective implementation and periodic evaluation of the SSCL to enable continuous quality improvement. Provide feedback to the healthcare providers.
- Foster a culture of safety by supporting multidisciplinary education programs to support policies related to teamwork, communication, and situational awareness.
For more information on surgical safety checklists, read the CMPA's report Surgical safety checklists: A review of medical-legal data [PDF].
- World Health Organization. WHO Guidelines for Safe Surgery 2009, Safe Surgery Saves Lives [Internet]. Geneva; 2009 [cited 2016 August 17]; Available from: http://apps.who.int/iris/bitstream/10665/44185/1/9789241598552_eng.pdf
- Christian CK, Gustafson ML, Roth EM, et.al. A prospective study of patient safety in the operating room. Surgery. 2006; 139:159-173
- SSCL-related issues are clinical care issues the SSCL is intended to address and which contributed to a surgical incident. The CMPA defines a surgical incident as a patient safety incident that occurs prior to, during, or after a surgical procedure.
- Canadian Medical Protective Association [Internet]. Ottawa (ON): CMPA;June 2015. Surgical safety checklists, A review of medical-legal data [cited 2017 March 2]. Available from: https://www.cmpa-acpm.ca/documents/10179/47890/com_16_SurgicalSafety_Checklist-e.pdf