Many principles seem to be very simple, yet it’s violation of simple principles that leads to major errors.
Introduction
In the last 20 years, patient safety and the prevention of adverse events (AEs) has emerged as a major target for improving actions in healthcare. The report “To err is human: building a safer health system,” issued by the Washington Institute of Medicine (Kohn et al. 1999) described the magnitude of the problem represented by medical errors and preventable AEs and identified recurrent safety biases and poor interstaff communication as major problems. This report alerted the scientific community and increased public interest in this issue.
In May 2004, the World Health Organization (WHO) campaign “Safe surgery saves lives” started creating initiatives to improve the safety of surgery around the world, with the purpose of demonstrating the close relationship between safety measures and the numbers of human lives saved. In 2009, the WHO Guidelines and Checklist for Safe Surgery were issued for the prevention of AEs in operating rooms (WHO 2009).
After an international validation process, that confirmed GLs and checklists to be effective in reducing surgical complications and mortality, the WHO asked members to activate national programs and to provide nation-based manuals for safe surgery. All the countries adhered to the initiative and, in the following years, a number of nation-based manuals were introduced in hospitals.
The WHO Safety Checklist in Practice
Substance and Structure
In complex organizations (aviation or the nuclear power industry) and in military settings, checklists, briefings and debriefings are routinely used to successfully complete tasks and improve communication. These tools transmit to individuals the message that the process they are involved in is intended to be disciplined, responsibility is shared among team-members and staff are supported against the risk of errors or omissions.
Due to the great number of different workers involved, their different educational backgrounds, acute patient conditions and the enormous amount of information processed in decision-making, together with the high technological level and the multiplicity of critical steps, operating theaters represent the prototype for complexity in medicine. Given the complex processes that are needed to safely manage anesthetized patients and the great variety of technological instrumentation, anesthesiology was among the first disciplines to adopt checklists in clinical practice (Hart and Owen 2005).
The WHO Guidelines for safety in the OR were conceived with the same spirit and the same methodological approach. The structure includes ten objectives for safety (Box 18.1) and a checklist divided in three parts (Box 18.2).
1. Objective 1: The team will operate on the correct patient at the correct site.
2. Objective 2: The team will use methods known to prevent harm from administration of anesthetics.
3. Objective 3: The team will recognize and effectively prepare for life-threatening loss of airway or respiratory function.
4. Objective 4: The team will recognize and effectively prepare for the risk of high blood loss.
5. Objective 5: The team will avoid inducing an allergic or adverse drug reaction for which the patient is known to be at significant risk.
6. Objective 6: The team will consistently use methods known to minimize the risk for surgical site infection.
7. Objective 7: The team will prevent unadverted retention of instruments and sponges in surgical wounds.
8. Objective 8: The team will secure and accurately identify all surgical specimens.
9. Objective 9: The team will effectively communicate and exchange critical information.
10. Objective 10: Hospitals and public health systems will establish routine surveillance of surgical capacity, volume and results.
Sign in – Before induction of anesthesia:
patient’s identity and informed consent should be confirmed
a mark on the surgical site should be present
functioning of pulse oximeter and anesthesia machine, and availability of the necessary drugs should be checked
patient’s known allergies, risk of difficult airway management/aspiration and risk of intraoperative bood loss >500 ml should be identified.
Time out – Before skin incision:
team members should have introduced themselves by name and role
patient’s identity and the type of procedure should be confirmed
antibiotic prophylaxis should be confirmed
critical events should be anticipated
essential imaging should be displayed.
Sign out – Before the patient leaves the OR:
the name of the performed procedure should be confirmed
the count of instruments, sponges and needles should be completed
correct specimen labelling should be checked
any equipment problems should be addressed
surgeon, anesthetist and nurse should review key concerns for postoperative recovery and management.
Objectives represent ten basic targets that should be reached with the aim of minimizing serious complications, regardless of the kind of surgical intervention, the patient’s health status and the operating environment.
Each part of the checklist corresponds to a critical step of the normal flow of work, in preparation for which operators should brief each other:
Part 1 (with at least anesthetist and nurse): before the induction of anesthesia (“Sign in”)
Part 2 (with nurse, anesthetist and surgeon): before the incision of the skin (“Time out”)
Part 3 (with nurse, anesthetist and surgeon): before the patient leaves the operating room (“Sign out”).
The conclusion of any step coincides with a critical moment, after which the consequence of not having undertaken preventive measures can turn into damage (e.g. checking the anesthesia machine for technical failure must be done before anesthesia induction). The purpose of the briefing is to make team members aware and informed that the required measures have been implemented.
Both the objectives and the checklist have unconditional value whatever surgical context they are applied to. However different practice settings should adapt them to their own circumstances and, for individual patients or specific patient groups, they must be optimized.
Implementation
Implementing GLs and checklists in the daily practice of constantly busy, occupied operating theaters was revealed to be both a valuable organizational improvement and an engaging task. Together with significant reduction of the AE rate, obstacles and barriers hampering its implementation emerged (Patterson 2009, Fourcade et al. 2011). Critics emphasized that the WHO checklist is unworthy, time-consuming, uselessly duplicates items with existing checklists and is substantially ineffective in improving communication. Nevertheless, its effectiveness in reducing complications and saving human lives has been confirmed worldwide.
Two main aspects were shown to be crucial for successful implementation of the safety guidelines:
they should be shared among operators, not “suffered” by them
they should be adjusted to the hospital reality life.
Adapting the ten safety objectives and the checklist to suit the surrounding conditions is indispensable to avoid incomplete or biased results. Adapting measures will vary in accordance with the hospital size and mission, the subspecialties of surgery performed and the types of patients that are admitted (general, cardiovascular, pediatric, etc.).
The WHO Safety GLs and Checklist Applied to Geriatric Surgery
In geriatric surgery, the challenges coming from the intrinsic complexity of the surgical processes intersect with those related to elderly patients’ specificities, such as age-related pathophysiological changes, alterations in pharmacodynamics and kinetics, comorbidity, poly-pharmacy, cognitive impairment, reduced mobility, tissue frailty and others. The combination of these criticalities may result in increased probability of AEs. This makes intraoperative clinical risk management (CRM) more difficult in the elderly than in the general surgical population: both the ten safety objectives and the three checklist steps need to be adapted to the special needs of these patients.
The Safety Objectives
The following points should be carefully considered when implementing the WHO safety objectives in geriatric surgery:
Objective 1: The team will operate on the correct patient at the correct site
cognitive impairment or dementia can deeply affect patients’ capability to confirm their details; alternative methods to ascertain patient’s identity (such as identification bracelets) should be used
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