Hospital Harm: Selected Serious Events

Overview

Healthcare Excellence Canada has developed this Hospital Harm Improvement Resource – a compilation of resources to support patient safety and improvement efforts.

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 (NE). Never Events are patient safety incidents that result in serious patient harm or death and that are preventable using organizational checks and balances (HQO & CPSI, 2015).

The selected serious events included in this resource are:

• Failure of sterile precautions during surgical and medical care during:

  • surgical operation*

  • infusion or transfusion

  • kidney dialysis or other perfusion

  • injection or immunization

  • endoscopic examination

  • heart catheterization

  • aspiration, puncture, and other catheterization

  • Contaminated medical or biological substances

• Failure in suture or ligature during surgical operation

• Endotracheal tube wrongly placed during anesthetic procedure

• Performance of inappropriate operation*

* Correspond with Never Events #1 and #4: NE #1 surgery on the wrong body part or the wrong patient or conducting the wrong procedure. NE #4 patient death or serious harm arising from the use of improperly sterilized instruments or equipment provided by the healthcare facility.

Failure of sterile precautions

The purpose of maintaining sterile precautions is to reduce the number of microbes present to as few as possible. The sterile field is used in many situations outside the operating room as well as inside the operating room when performing surgical cases. Sterile fields should be used outside the operating room when performing any procedure that could introduce microbes into a patient. A few examples of this would be inserting a foley catheter, an arterial line, and a central line. Inside the operating room, sterile fields are created relative to the back table, the mayo stand, and finally the patient and the surgical site itself (Tennant, 2021). 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).

Aseptic, Sterile, 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 (National Health and Medical Research Council - NHMRC, 2019). The Australian Guidelines for the Prevention and Control of Infection in Healthcare (NHMRC, 2019) 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.

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, 2019; PHAC, 2012).

To practice safely it is essential that healthcare workers understand the principles and practice of aseptic technique. An example of an aseptic technique is Aseptic Non-Touch Technique (ANTT), a comprehensively defined practice framework for aseptic technique developed by the Association for Safe Aseptic Practice (The-ASAP, 2015).

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).

Contaminated medical or biological substances

The tainted blood tragedy is one of the worst public health disasters that Canada has ever faced. When AIDS appeared in the early 1980s and soon became an epidemic, the entire Canadian blood supply system was affected. More than 1,100 transfused Canadians were infected by HIV, of whom 700 had hemophilia and other bleeding disorders, and 400 were transfusion recipients for other reasons (trauma, surgery, childbirth, cancer). Up to 20,000 were infected with the hepatitis C virus (HCV) through blood and blood products before testing was introduced in 1990 (Canadian Hemophilia Society, retrieved April 2021). This tragedy led to the Royal Commission of Inquiry on the Blood System in Canada, led by Justice Horace Krever. In 1997, Justice Krever tabled his report in the House of Commons, putting forward a set of 50 recommendations that, to this day, guide the blood system to ensure safety for all Canadians (Canadian Blood Services-Transfusion, 2019).

The transplantation of a human tissue allograft introduces the risk of complications to the recipient including the fatal and nonfatal transmission of infectious organisms such as bacteria, fungi, viruses, parasites, and prions. Tissue banks are considered to be manufacturers of human biologics where donor tissue is processed and enhanced using good manufacturing practices and good tissue practices to optimize safety and clinical outcomes. As biological manufacturers of tissue allografts that present a risk of disease transmission, tissue bank practices that reduce and eliminate infectious organisms must be effective, evidence-based and validated (Canadian Blood Services- Organs and Tissues, 2016).

Failure in suture or ligature during surgical operation

Most of the knot and suture failures exist due to technical errors in tying and wrong selection of sutures or knots in different scenarios. Common failure modes of knots and sutures are suture breakage, knot loosening, knot breakage, and tissue breakage. Failure of any of these factors can destroy the repair construct (Öçgüder, 2018).

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).

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 has also been 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).

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). The Pennsylvania Patient Safety Authority study (Yonash, 2020) showed that the frequency of WSS varied according to a range of variables, including error type (e.g., wrong side, wrong site, wrong procedure, wrong patient); year; facility type; hospital bed size; hospital procedure location; procedure; body region; body part; and clinician specialty. Many clinicians, patient safety professionals, and organizations take the position that WSS events are preventable and should never occur (Yonash, 2020).

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).

Importance to Patients and Families

Patients expect hospital care to be safe, and for most hospital stays it is. However, a small proportion of patients experience some type of unintended harm as a result of the care they receive. Hospital patients are particularly vulnerable because many are very frail and hospital care is increasingly complex. When patients are harmed in hospital, they can experience increased length of stay and are at an increased risk for morbidity and mortality. In addition to what these patients and their families go through, their continued need for treatment also has a cost to the system, in that it keeps other people from getting the help they need (CIHI & CPSI, 2016). Patients need to take an active role in their healthcare to prevent errors. Although wrong-site surgery is rare it still can occur. Communication between the healthcare team and the patient is important (Pennsylvania Patient Safety Authority, 2018).

Patient Story

Brampton Civic Hospital operates on wrong leg

A Brampton family is frustrated after their 72-year-old grandmother had the wrong leg cut open during surgery on Christmas Day at the city's new hospital. Amar Kaur Brar, 72, fractured her thigh bone when she slipped from the stairs at the family's Brampton home, her granddaughter Kanwaljot Brar, 21, told The Sun yesterday. "In the operating room, doctors cut Amar's right leg open," Brar said, adding the cut ran almost the entire length of her grandmother's thigh. When they realized that the bone in Amar's right leg was okay, they stitched her up and performed surgery on her left leg….

Success Stories

At the foundation of successful patient safety and quality improvement efforts is a culture of patient safety within the hospital or surgical center. A strong safety culture can help minimize medical errors and strong support from leadership is crucial to truly moving the needle on patient safety and quality.

Minnesota hospitals and ambulatory surgery centers performed 2 .6 million invasive procedures during the 2012-13 reporting year, including procedures in the operating room, radiology, diagnostic/labs, and other settings. Dr. Mark Migliori, chair of the perioperative safety committee at Abbott Northwestern Hospital in Minneapolis, part of Allina Health, believes a culture of safety is a prerequisite for delivering good care for every patient, every procedure, every time.

"Patients deserve for safety to be front and center," said Dr. Migliori. "It is the essential first step. They are entrusting us with their care and implicit in that trust is that we will be their guardian when they are under our care." He believes surgeon leadership is critical in building a culture of safety in the operating room. While Minnesota hospitals and surgical centers have done a great job of developing multidisciplinary teams where everyone has a voice, some traditional hierarchies still persist.

"On one hand, the surgeon should have the same role as other team members in building a culture of safety," said Dr. Migliori. "In reality though, the surgeon has the capability to level the hierarchy within the operating room. By acting as a servant leader yourself — sharing power, putting the needs of others first and helping people develop and perform as highly as possible — it sends the message to the rest of the team that their professionalism demands the emphasis on safety." By fostering a culture that enables staff to feel comfortable to speak up, Dr. Migliori feels listening goes a long way in giving people a voice.

"One of the most obvious steps we can take is to listen — to let staff talk," he says. "We create so many barriers to let someone give their opinion. We need to break down those barriers and then give them a place to carry their idea forward." As a leader, Dr. Migliori hears the suggestion or concern and then gives the staff member ownership to carry the idea forward. He also feels it is important to recognize people when they speak up, as it creates a positive outcome. That's why he feels it is important to talk about near misses and recognize the person who caught it. "It sends the message that people are watching and this is important," says Dr. Migliori.

Dr. Migliori gives the example of the early days of implementing one of components of the Universal Protocol — the team briefing process. As chief of staff, he embraced the concept, yet was initially resistant to the idea that everyone needed to introduce themselves, feeling that people on the team already knew one another. Others felt strongly about its importance and so the team kept that critical piece of the protocol in place. He soon realized its significance. "It helps people talk. When the tech introduces herself, it gives her a reason to talk. So next time there's a reason to speak up for safety, she's less intimidated to do so," he explained. "When you don't know someone well, you're less likely to speak up and question them."

Dr. Migliori says a strong leader is one who has balance. Balance between confidence and humility; competence and being unsure enough to look at a situation from a different angle; and someone who is passionate and yet can observe and allow others to impact. A strong leader is always looking to give a voice to those who don't have one, and advocating for those who are the most vulnerable, whether it is staff, a patient or someone else.

Building a culture of safety takes continuous improvement. Hospitals and staff must be willing to constantly re-evaluate what they're doing and say, what can we do to make it better? Dr. Migliori feels it's good to have the awareness that mistakes can happen at any time. It's realizing that while you're good, it's not good enough. "Any organization that does safety work has glimpses of a safety culture," he says. "It's maintaining it that is hard. And that takes energy and humility."

Collaboration and communication are key to driving forward a culture of safety. Dr. Migliori encourages surgeon leaders to discard old approaches where members of the team are separate and instead create opportunities for groups to come together and have a dialogue around safety. "We must create the constant message that we're in this together. It all falls to communication and doing everything you can to enable voices to be heard," he says. "I'm so appreciative of the effort to make safety culture bigger than hospital versus hospital, but rather something that if we want to provide care in Minnesota, this is the standard."

(Minnesota Department of Health, 2014)

Utilization of Safety Crosses as a Quality Management Tool in Sterile Processing Department

At Markham Stouffville Hospital the Sterile Processing Department is responsible for the decontamination, cleaning, reprocessing and sterilization of instruments and equipment for the entire hospital. The Sterile Processing Department follows stringent criteria, best practice guidelines and standards to ensure the delivery of quality safe services to stakeholders such as the Operating Room and the Emergency Department. The department's commitment to safety and quality aligns with the hospital's belief statement "we must deliver safe, high quality care".

Although the department strives to exceed standards of practice, frontline staff identified the following two gaps:

1. Audit results such as instrument set error rate, missing chemical indicators, sterilization record accuracy and the frequency of sharps being found on used/soiled trays were inconsistently tracked and shared with frontline staff.

2. The lack of a systematic process such as a weekly audit tool to capture all reprocessing volume/activities, including thermal and high level disinfection, sterilization, weekly testing, and maintenance, and descaling of reprocessing equipment such as instrument, ultrasonic and cart washers.

Simultaneously, while the Sterile Processing Department was exploring solutions to the above concerns, some of the acute inpatient units were implementing Releasing Time to Care. Releasing Time to Care is a process used to capture and report quality outcome indicators such as falls and pressure ulcer rates. The Sterile Processing Department, after visiting these acute inpatient units, adopted the Safety Crosses as a format to capture and disseminate the audits results as outlined above in Gap 1. The team also developed a weekly departmental audit tool to monitor and report their various departmental reprocessing volumes and activities as noted above in Gap 2.

After many months of hard work, the department now boasts a quality board that proudly displays their four Safety Crosses: instrument/set errors, missing chemical indicators (internal and external), sterilization completion and accuracy rates and sharps sent to the Sterile Processing Department by end-users. The quality board also serves as a mode to track and report the department's weekly reprocessing activities and volume. Staff now has immediate access to reports and audits results. They are also a part of the process because they actively complete the Safety Crosses on a daily basis. Through education, completion of iReports and direct follow-ups with sending departments, the team has noticed a decline in the frequency in which sharps are returned to Sterile Processing Department.

(Health Standards Organization, 2013)