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​Overview and Implications

Selected Serious Events and select Never Events in Canada

Patients expect safe care, and healthcare providers strive to deliver care that results in better health and safe, effective outcomes for patients. However, events that harm patients do occur while care is being provided, or as a result of that care. While risk is an inherent part of care, we know that many of these events that cause harm can be prevented using current knowledge and practices. Many of these events occur only rarely, but all can have a severe impact on the lives and well-being of patients. Recently, Health Quality Ontario (HQO), and the Canadian Patient Safety Institute (CPSI) partnered with several jurisdictions and organizations in Canada to create a list of 15 Never Events. Never Events are patient safety incidents that result in serious patient harm or death and that are preventable using organizational checks and balances (HQO & CSPI, 2015). Two of the 15 Never Events are included in the clinical group - Selected Serious Events. They are:

  • patient death or serious harm arising from the use of improperly sterilized instruments or equipment provided by the healthcare facility; and
  • surgery on the wrong body part or the wrong patient, or conducting the wrong procedure.

Failure of sterile precautions

Failure of sterile precautions during medical and surgical procedures has resulted in the spread of infection and disease transmission. This has led to increased morbidity and mortality for patients as well as increased length of stay and increased costs (Siegel, Rhinehart, Chiarello et al., 2007, Ontario Agency for Health Protection and Promotion, 2013). 

Ineffective aseptic technique causes Healthcare Associated Infections (HAI)
The contamination of patients with microorganisms during invasive clinical procedures is largely an invisible process. However, a broad range of research provides clear evidence for an indirect and direct causal relationship between failed aseptic technique and HAI. For example, it has been demonstrated that approximately eight per cent of manually prepared saline flushes are contaminated prior to patient administration due to breaks in aseptic technique and blood culture samples have been found to have contamination rates of five to 10 per cent (Association for Safe Aseptic Practice, 2015). 

Terminology: sterile, aseptic and clean techniques

Historically, the practice of protecting patients from contamination and infection during clinical procedures has generated an inaccurate and confusing paradigm based on the terminology of sterile, aseptic and clean techniques. The use of accurate terminology is important in order to promote clarity in practice (NHMRC, 2010). The Australian Guidelines for the Prevention and Control of Infection in Healthcare (NHMRC, 2010) offers the following definitions:

Sterile 'Free from microorganisms' Due to the natural multitude of organisms in the atmosphere it is not possible to achieve a sterile technique in a typical healthcare setting. Near sterile techniques can only be achieved in controlled environments such as a laminar air flow cabinet or a specially equipped theatre. The commonly used term, 'sterile technique' (i.e. the instruction to maintain sterility of equipment exposed to air), is obviously not possible and is often applied inaccurately.

Asepsis 'Freedom from infection or infectious (pathogenic) material' An aseptic technique aims to prevent pathogenic organisms, in sufficient quantity to cause infection, from being introduced to susceptible sites by hands, surfaces and equipment. Therefore, unlike sterile techniques, aseptic techniques are possible and can be achieved in typical hospital and community settings.

Clean 'Free from dirt, marks or stains' Although cleaning followed by drying of equipment and surfaces can be very effective it does not necessarily meet the quality standard of asepsis. However, the action of cleaning is an important component in helping render equipment and skin aseptic, especially when there are high levels of contamination that require removal or reduction. To be confident of achieving asepsis an application of a skin or hard surface disinfectant is required either during cleaning or afterwards.

The aim of any aseptic technique is asepsis. For the purpose of this resource, "failure of sterile precautions" will be addressed through actions to maintain asepsis through appropriate use of aseptic technique.  

As defined above, aseptic technique is the purposeful prevention of transfer of microorganisms from the patient's body surface to a normally sterile body site or from one person to another by keeping the microbe count to an irreducible minimum. Aseptic techniques are measures designed to render the patient's skin, supplies and surfaces maximally free from microorganisms. Such practices are used when performing procedures that expose the patient's normally sterile sites (e.g., intravascular system, spinal canal, subdural space, urinary tract) in such a manner as to keep them free from microorganisms (NHMRC, 2010; PHAC, 2012).

To practice safely it is essential that healthcare workers understand the principles and practice of aseptic technique. Although aseptic technique is recognized universally as an essential clinical competency, actual education and competency assessment has historically been neglected.  There is significant variability in understanding, interpretation, practice and ultimately effectiveness of aseptic technique. To help reduce the gap in appropriate aseptic technique the Association for Safe Aseptic Practice has developed the Aseptic Non Touch Technique (ANTT), a comprehensively defined practice framework for aseptic technique (The-ASAP, 2015). The ANTT Clinical Practice Framework is based upon a set of principles, safeguards and rules for aseptic technique and applies to all clinical procedures from surgery to community care. 

Sterilizations of medical and surgical instruments and equipment: Infection is a major risk of surgery and despite modern technologies and procedures, infections related to improper equipment reprocessing still occur.

Achieving effective disinfection and sterilization is essential for ensuring that medical and surgical equipment/devices do not transmit infectious pathogens to clients/patients/residents or staff. The goals of safe reprocessing of medical equipment/devices include:

  • preventing transmission of microorganisms to personnel and clients/patients/residents.
  • minimizing damage to medical equipment/devices from foreign material (e.g., blood, body fluids, saline and medications) or inappropriate handling (Ontario Agency for Health Protection and Promotion, 2013).

Performance of inappropriate operation

Surgery on the wrong body part or the wrong patient, or conducting the wrong procedure: Surgery is one area of healthcare in which preventable medical errors and near misses can occur. Of great concern is wrong-site surgery (WSS), which encompasses surgery performed on the wrong side or site of the body, wrong surgical procedure performed, and surgery performed on the wrong patient. WSS is also defined as a sentinel event (i.e., an unexpected occurrence involving death or serious physical or psychological injures, or the risk thereof) by the Joint Commission which found WSS to be the third-highest-ranking event (Mulloy & Huges, 2008).   Based on statistics provided by HIROC, wrong patient, site, treatment/procedure made up 2.07 per cent of all claims reported to HIROC by insured healthcare organizations (HIROC, personal communication, February 9, 2017).

Wrong site surgeries have been associated with the failure to identify incorrect information in the documents related to surgery, such as the schedule, consent, and patient's history and physical examination. The opportunities for wrong site surgery are minimized when all the information is in agreement, and when all members of the operating room (OR) team assume a personal responsibility for the procedure (Pennsylvania Patient Safety Authority, 2007)

Distractions and/or interruptions related to human communication, equipment such as surgical alarms or technology (e.g. phone calls, pagers) are a threat to patient safety in the OR as they have been found to contribute to patient safety incidents and have been reported to be linked to wrong-side surgery and wrong-site surgery. Guidelines and tools have been developed by perioperative professional associations and patient safety agencies to limit and/or ameliorate the negative impact of distraction and these include application of the "sterile cockpit" concept from aviation, reducing distractions from technology and noise, use of surgical safety checklists and briefings and teamwork training. Engagement of surgeons and multidisciplinary teams is necessary to address the problem of distractions in the OR (Pennsylvania Patient Safety Authority, 2014).

Unnecessary/obsolete procedure involves the performance of a surgery that was deemed unnecessary given the clinical situation. It may also involve the performance of a procedure or the use of a technique that is no longer considered to be standard. The performance of an unnecessary or an obsolete procedure may be related the failure of monitoring individual surgeon's practices or due to a misinterpretation of diagnostic tests (HIROC, 2016). According to statistics from HIROC, unnecessary/obsolete procedure makes up 0.21 per cent of all claims reported to HIROC by insured healthcare organizations (HIROC, personal communication, February 9, 2017).

Endotracheal tube wrongly placed during anesthetic procedure

Endotracheal intubation is a routine procedure in anesthetic care. Immediate verification of endotracheal placement of the ETT is necessary as esophageal or endobronchial intubation is a significant source of avoidable anesthetic-related morbidity and mortality (Miller, 2015).  Serious complications can occur from inadvertent placement of the endotracheal tube in a main stem bronchus, such as hypoxemia caused by atelectasis formation in the unventilated lung and hyperinflation and barotrauma with development of a pneumothorax of the intubated lung.  Proper positioning of the endotracheal tube in relation to the carina is clinically important (Sitzwohl et al, 2010).

Goal

Reduce the incidence of serious selected events captured in this clinical group.

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