Patients move through different care settings or phases of care within the perioperative environment and the goal is to quantify risk at the process level for each of these phases of care. The methodology described in this section may not be practical for patients in all care settings, but it provides a framework in which to think about providing care for each patient in a way that minimizes risk. Having a system allows all providers to communicate and share information within the clinical setting at the point of care. Although risk factors can produce complications in any care setting, it is often unclear how these risk factors are linked to specific care processes. Each setting is associated with processes that are common to the care setting and others that are unique to the particular disease or diagnosis. Examples of common processes include:

These common processes could involve virtually all areas (phases of care) the patient progresses through during an episode of illness. The phases of care are listed in Table 33.2.

Each phase of care may contain a few steps/processes or many, and each step may present a risk if it is not executed properly. Something as simple as placing an order for laboratory tests has inherent risk since the wrong test may be ordered, review of the test result may not happen, or the test may be ordered on the wrong “Mr. Smith.” The system described in the following subsection is a methodology for quantifying risk for each process and at each process step if desired. It is based upon making a judgment about how often something goes wrong, how bad the outcome may be when it does, and how easy it is to detect or predict the adverse event or mistake. While many steps in many processes may indeed be the same for most patients, some steps have risks that are higher for some patients than others, and the increased risks are usually due to comorbidities . After looking at the processes and steps, we determine which aspects of this episode of care are particularly important/risky for this patient.

Another way of looking at the issue of risk is to understand that there is an inherent risk for any procedure—the process risk or “being in the hospital” risk. Additional risks are produced by comorbidities and risk factors associated with an individual patient, their care providers, and the hospital or environment of care [15, 16].

The questions listed in Table 33.3 may be used to assess these risks .

The next step is to quantify risk in each phase of care by mapping the overall process and identifying each step in the phase of care. The risk may then be quantified using the tool Failure Mode Effects Analysis (FMEA) . A FMEA is a well-described and proven methodology used by industrial engineers and quality managers. It can be adapted to the surgical setting in order to assess and quantify patient risk. The FMEA utilizes three parameters to calculate a Risk Priority Number (RPN) for each risk that has been identified (Figs. 33.1 and 33.2). The three factors are: frequency of occurrence, severity, and likelihood of detection. Each of the three factors is usually given a scale range of 1–10 with the RPN being the product of the three factors, ranging from 1 to 1000. Risk factors that are low frequency or low severity or have a high likelihood of detection would be assigned low numbers, while higher numbers would be assigned to risk factors with high frequency, or high severity, or a low likelihood of detection. We prefer this methodology in the clinical setting since the ability to detect or predict the risk is important from a safety standpoint. Most organizations with formal enterprise risk management (ERM) systems utilize a simpler version with only the parameters of frequency (likelihood) and severity (impact) to derive a risk score in the range of 1–100 (in the case of a scale of 1–5 rather than 1–10 for each factor, the range would be 1–25). For both RPN and risk score numbers, the scales of 1–5 for each parameter are easier to use and to make decisions, while the scales of 1–10 afford more precision and are preferred in engineering work.

The FMEA methodology may be utilized to assess risk for each process/step in each phase of care for an individual patient. This is done by comparing the risk of an average patient to the risk of the specific patient being treated. It is important to keep in mind that the numbers assigned to each risk factor are estimates derived by the team performing the assessment, data from registries, databases, or published journal articles utilized to assist in making the estimates. Although the risk is the same most of the time in the pre-op phases of care, it could certainly be increased for a patient with complex problems who requires dialysis and imaging studies for staging prior to lung resection. Planning each step in the pre-op time period would be very important for the patient, and knowing where to look for potential problems is the value of this methodology.

Another example is the intraoperative phase of care in an obese patient with an albumin 1.9 g/dL undergoing an exploratory laparotomy for small bowel obstruction. The RPN for the wound closure process is calculated twice:

In this example, we estimated that without obesity, the severity (S) of wound dehiscence would rate 5 on a scale of 1–10, the frequency (F) would rate 3, and the detectability (D) would rate 1, amounting to an RPN value of 15. For the obese patient with a low albumin, the severity rate is 7, frequency 5, and detectability 1, leading to an RPN of 35. The risk for this patient having a wound dehiscence is therefore over twice as high as the average patient, so using retention sutures might be a good idea.

A second example involves a morbidly obese patient undergoing a colon resection:

The obesity in this case increases the frequency of a retained sponge as well as reducing the detectability, so that the RPN is 5× higher in the obese patient.

A third example involves mapping out the key processes in a coronary artery bypass operation (CABG) during the intraoperative phase [17, 18]. The 15 processes listed in Table 33.4 each include several different steps.

One could list all steps in each of these processes and develop a RPN number for each step. In this example, we choose to evaluate protamine administration to reverse heparin that is part of the hemostasis process. Giving protamine can produce a reaction resulting in acute pulmonary hypertension and right ventricular failure in patients with risk factors including insulin-dependent diabetes mellitus, history of previous cardiac surgery, previous vasectomy, and/or fish or seafood allergy. The calculations would be as follows:

The history of insulin-dependent diabetes in this patient increases the RPN by a factor of 2.6, thereby alerting the team to be cautious in giving protamine and not removing the cannulae until later in the process of giving the protamine.

The FMEA methodology is a powerful tool to use in assessing risks, and it can result in improved patient safety and fewer errors. The recommended method is summarized in Table 33.5.

The high complexity of performing surgery and the increasing need for complicated device technology increase the potential for medical errors and adverse events to occur. Safety systems must be in place to help reduce the chance of these errors occurring [19]. One method to determine the current state of patient safety in the surgical arena is through a patient safety culture assessment. There are some assessment tools developed explicitly for surgery, and there are tools developed that include the surgical area of care [20]. Two of the best-known tools were created by the Agency for Healthcare Research and Quality (AHRQ) [21]. The safety culture survey is given to the staff to complete and is then analyzed with the facility receiving a report benchmarking it with similar facilities. The data in the report may be utilized to make improvements in the patient safety culture of the organization.

Unfortunately, it is not possible to predict and prevent errors in the surgical arena, but there are many educational and process changes that can help to reduce the likelihood of harm occurring [22]. There has been a movement in healthcare to put processes in place which will provide redundant checks prior to and during a surgical procedure. The Joint Commission (TJC) developed the Universal Protocol for use in all surgical settings in facilities that they accredit [23]. The Universal Protocol includes verification of information when the patient arrives for the procedure through the start of the procedure, the marking of the operative site, and a time-out before the procedure begins to assure that all the necessary information, equipment, and supplies are ready in the operative area. Surgical checklists have been developed from TJC Universal Protocol , or from the World Health Organization (WHO) , for all areas where procedures are performed [24]. Although these checklists have been in place for many years, they are not always utilized in the correct manner [25]. A study by Araujo and Oliveria [26] concluded that 38 % of the articles reviewed showed a relationship between the use of the surgical checklist and a reduction in surgical morbidity and complications, while 46 % of the articles suggested a need for surgical safety improvement. Urbach et al. showed clearly that without engagement of the surgical team, the benefits of the surgical checklist are greatly diminished [27] and despite great efforts, only minimal gains are achieved [28].

Another potential risk in the surgical arena is the risk of fire (see Chap. 20). Seifert et al. [29] state that the surgical team must be aware of the potential for fires and complete an assessment to determine that the three elements of fire—fuel, oxygen, and ignition source—are controlled. The Association of periOperative Registered Nurses (AORN) has developed a five question perioperative fire risk assessment that can be utilized to evaluate the location of the surgery, types of anesthesia, antiseptic cleansers, and energy sources which could lead to a fire [30]. Seifert et al. also stress that education of the surgical team is essential in not only knowing how to prevent a fire but also in knowing the role of each team member should a fire occur.

These examples include a large element of human factors that greatly influence the risks that are present in the surgical environment [31]. Adverse events in surgery commonly occur due to a lack of communication, a delay in diagnosis or failure to diagnose, or a delay in treatment [32]. The entire team must adopt a culture of safety and be ever vigilant prior to, during, and after the procedure. Everyone must work as a team and be willing to speak up should a team member determine that something is not as it should be [33]. If the culture of the organization is not a patient safety culture, members of the team may not feel comfortable speaking up if a person of perceived power is about to make a mistake. The patient safety culture in the surgical arena is characterized by the elements listed in Table 33.6.

Advances in healthcare technology have improved the accuracy and minimized the risk to patients through the use of new technology. However, the introduction of new technically advanced equipment also comes with added or different risks. For example, there is currently concern about the adequate cleaning of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes, based on reports of a fatal drug-resistant pathogen and inadequate sterilization of these scopes [34]. Endoscopes are frequently utilized throughout the United States, with an estimated 15,000 operations performed a year with contaminated ERCP scopes [35]. Ineffective cleaning and sterilization is more than a personnel competency issue. Manufacturing design of equipment has parts that are inaccessible for cleaning and allow for the retention of tissue and other debris from the operation. If such problems are attributed to personnel competency issues, they are often related to not following the standardized or recommended procedure for cleaning the equipment. Furthermore, developing an ongoing system for assessing technical competency of invasive procures using rehearsal and warm up is valuable [36].

Many procedures have been standardized, and other technology is utilized to minimize the potential for errors to occur. The use of electronic health records (EHR) has increased the standardization of documentation, including order sets for patient conditions and treatment. The EHR has provided an electronic interconnectedness among practitioners who can now readily review the documentation of other practitioners. However, as the recent MedStar data-hacking event suggests, there are inherent dangers with HIT interconnectedness. Through the use of the EHR and other electronic communication devices, practitioners can select hyperlinks and in some cases QR codes that will lead them to more information concerning any topic. A QR code (abbreviated from Quick Response code ) is the trademark for a type of matrix barcode, made up of black square dots arranged in a square grid on a white background. Any imaging device, such as a scanner, camera, or smartphone , can read the QR code and open or link to information or connect to a database. The barcode idea has also been utilized in the administration of medications, where every medication has a barcode that is scanned in conjunction with a barcode for the patient who is to receive the medication. This use was intended to eliminate medication errors and has been very successful. However, none of these technological systems are infallible, with common “work-arounds,” which negate the purpose of the safety system [37]. Identification of work-arounds to determine why current policies and procedures fail to work is therefore an essential element of safety [38].

The operating room contains a large quantity of supplies, stock, and instruments needed to perform the surgical procedures. However, there are several issues with surgical supplies that are challenging. One of the largest supply issues is the use of the wrong implant or equipment during the procedure [39]. Procedures are delayed if the correct supplies are not available, or if a surgical instrument is dropped or is missing from the surgical pack. Such problems can potentially cause harm to the patient [40]. Another issue is that in some cases the supplies being utilized are expired, a situation in violation of the Food and Drug Administration requirement that all drugs and medical materials administered to humans be used within their expiration date [41].

Another issue is the use of counterfeit medical supplies. The Veterans Administration (VA) received counterfeit surgical devices and supplies when they started utilizing reverse auctions where sellers compete to provide goods or services at the lowest price to fulfill their contracts [42]. This resulted in unauthorized distributers utilizing counterfeit supplies, some of which may have been stolen from other hospitals. These products may not have been stored at proper temperatures, maintained in appropriate packaging, and so forth.

Reducing risks in the perioperative environment requires management and leadership from hospital administration, surgeons, and anesthesiologists. An effective way of providing structure for this goal is to establish a perioperative governing council comprised of leaders from all three areas. The goals of the council are to build trust among the medical staff, keep physicians abreast of perioperative initiatives, identify opportunities to increase physician satisfaction and ease of practice, and support initiatives to improve the efficiency and effectiveness of the operating room. The governing council should establish a set of bylaws and written policies and procedures dealing with the kinds of perioperative issues listed in Table 33.7.