According to Grissinger and Dabliz [38], Steelman and Graling [19], and others [39, 40], major issues related to medication safety include:

Ambulatory Surgery Centers (ASCs) have additional challenges as they may lack pharmaceutical resources compared to tertiary care settings [19, 38]. One comprehensive review of ambulatory surgery facility-related medication errors in the State of Pennsylvania ([38], p. 89) found that of 502 events, the predominant medication error types were as follows:

Of the classes of medications cited in the study ([38], p. 89), antibiotics were most often cited—33.9 % of reported errors. Ambulatory facilities that do not have an onsite pharmacy or pharmacist should have a process for communicating with pharmaceutical professionals for clarification, information, and education for all staff. It is especially imperative that anesthesia providers, surgeons, and nursing staff have clear, direct, and unambiguous policies and communication processes that reduce the risk of error—particularly those related to miscommunication (or lack of effective communication).

Medication safety applies to all healthcare settings—inpatient and ambulatory as well as clinics and physicians’ offices [41, 42]. Perioperative clinicians should consider safety considerations in the many expanding arenas of practice, notably the interventional suites where an increasing number of procedures are performed jointly by perioperative/surgical professionals and interventional clinicians (e.g., radiology, cardiac catheterization, electrophysiology, and gastrointestinal interventional suites). Grissinger and Dabliz [38] reported on deaths caused by the injection of the wrong medication. One event that was discussed occurred in an interventional suite where basins containing clear, but different, solutions were not labeled. The patient was accidentally injected with a topical antiseptic solution rather than the correct contrast material. These types of never events can occur in any setting and constant vigilance by all staff is as important as any one staff member feeling free to question (e.g.) which medication is in what container.

Medication errors can take place in a wide variety of settings and clinicians must not limit themselves to preconceived notions of where or what can happen [43]. Although the focus of medication errors tends to be on drugs, clinicians should use caution in relation to infusions of blood and blood products. Oxygen delivery (e.g., via nasal cannula) is another related consideration, particularly in patients who may be restricted in their oxygen use (e.g., patients with chronic obstructive pulmonary disease). Strategies for the prevention of medication error never events are presented in Table 26.2.

Pressure ulcers occur as a result of skin compression, which impedes blood flow and damages underlying tissue; prolonged pressure can cause tissue decay. Although pressure ulcers are commonly associated with long-term care, extended periods of uninterrupted pressure and friction during surgical procedures put patients at risk for these injuries [44–46]. Table 26.3 lists the four stages of pressure ulcers according to the degree of tissue damage.

The Braden Scale [44] is the most common tool used for assessing risks for acquiring pressure ulcers; however, the Braden Scale does not capture all the critical risk factors for the development of injury in surgical patients [45]. The Munro [46] scale was created by a perioperative nurse to capture factors specific to surgical patients and has demonstrated promise for predicting patients at risk during surgery.

Primiano and fellow researchers [47] studied the prevalence of, and risk factors for, pressure ulcer development during general, orthopedic, neurological, cardiothoracic, gynecologic, and vascular procedures lasting longer than 3 h. They and others [48–50] found several risks for the development of pressure injuries:

Guidelines for patient positioning in the OR from the National Pressure Ulcer Advisory Panel [51] and the European Pressure Ulcer Advisory Panel [52–54] recommend using a pressure redistributing mattress on the OR bed. Some organizations report insufficient evidence to recommend a specific pressure redistribution intervention or product [55, 56], but a randomized controlled trial [57] did demonstrate that viscoelastic polymer pads reduced the incidence of pressure ulcer formation (compared to the standard OR bed mattresses). Recommendations for the prevention of pressure ulcer never events are listed in Table 26.4.

Although pressure injuries are often related to adverse events associated with positioning, another serious adverse event can occur when a patient falls during transfer from the gurney to the OR bed, during positioning on the OR bed, during Trendelenburg or reverse Trendelenburg positions, or when the patient becomes agitated, e.g., during induction or local anesthetic procedures. It is important to ensure that patients are secured with safety straps and that there are staff members on either side of the patient as well as the head and the feet during transfers and position changes [54]. Additional positioning considerations are listed in Table 26.5.

Surgical site infection (SSI) is an infection occurring in an incisional wound within 30 days of a surgical procedure, according to the Centers for Disease Control and Prevention (CDC) [58]. The occurrence of a surgical site infection during the postoperative period may significantly affect patient recovery and hospital resources leading to longer length of stay, readmission, and possible delay in resumption of normal daily activities and return to employment. This surgical complication can be devastating to the patient and family, as well as to healthcare institutions that can be penalized financially for SSI readmissions through decreased reimbursement and other financial penalties. There is no single factor which predicts whether a patient may develop a surgical site infection and plans developed to reduce SSIs should embrace a variety of factors along the patient’s continuum of care.

Individual patient characteristics may be associated with improved surgical outcomes. Four preoperative specific factors have been identified by the Strong for Surgery team in Washington State: adequate nutrition, glycemic control, smoking cessation, and appropriate medications [59–61]. Strong for Surgery provides a presurgery checklist to doctor’s offices to help with education, communication, and standardization of best practices, and hence to improved clinical outcomes. Other preoperative patient factors related to surgical site infection include specific medication use, such as steroids or immunotherapy which may naturally compromise wound healing, and colonization with Staphylococcus aureus, increasing chances of developing methicillin-resistant Staphylococcus aureus (MRSA) [62].

Bacteria are becoming increasingly resistant to antibiotics making SSI prevention even more challenging. The use of intranasal mupirocin ointment for Staphylococcus aureus decolonization has resulted in statistically significant reduction of S. aureus SSIs [63]. Staphylococcus decolonization is routinely used prior to cardiac surgery and total joint arthroplasty and is becoming more common in other procedures. Bundles comprised of decolonization, preoperative showers, and antibiotic prophylaxis should be considered [64]. Several protocols have specifically targeted decolonization of methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) using intranasal mupirocin and chlorhexidine washes and demonstrate [65, 66] effectiveness for reducing MRSA/MSSA colonization.

Skin is a major potential source of microbial contamination in the surgical environment. When implementing a program to reduce SSI, one must look at the patient and the provider to manage reduction of skin flora. Evidence suggests that preoperative antiseptic showers reduce bacterial colonization and may be effective at preventing SSIs [67]. No one antiseptic has been found to be better than another for preventing SSI. A 2010 study by Edmiston et al. [68] provided clear evidence for using chlorhexidine gluconate (CHG) preoperatively to reduce the risk of surgical site infection. In a 2013 study, Graling and Vasaly [69] found that 4 % CHG delivered preoperatively by cloth bath reduced surgical site infections in general and vascular surgery. A recent study by Edmiston et al. [70] provides evidence for a standardized showering regimen to achieve maximal skin surface concentrations of CHG 4 % in surgical patients preoperatively.

The optimal use of preoperative antibiotics has been a focus in a number of major projects looking to reduce complications of healthcare. These include the Prevention of Surgical Site Infection , Institute for Healthcare Improvement , 5 Million lives campaign [71], and The Joint Commission’s Surgical Care Improvement Project (SCIP) [72].

The Centers for Disease Control and Prevention’s (CDC) classic 1999 Guidelines for Prevention of Surgical Site Infection [73] provide category IA evidence for preoperative antibiotic prophylaxis. Prophylactic antimicrobial agents should be administered only when indicated and should be selected based on the efficacy against the most common pathogens causing SSI for a specific operation and published recommendations. Appropriate and timely administration of preoperative antibiotics for routine surgical cases is also a perioperative patient quality measure defined by The Surgical Care Improvement Project (SCIP) , a national program aimed at reducing perioperative complications and is a quality benchmark metric for Centers for Medicare and Medicaid Services [72].

Antibiotics should be administered by the intravenous (IV) route and the initial preoperative dose timed to establish optimal tissue and serum concentrations prior to incision. Therapeutic levels of the antibiotic agent should be maintained in serum and tissues throughout the operation and until, at most, a few hours after the incision is closed in the operating room. Team members should standardize protocols using national guidelines, using preprinted or computerized standing orders, verify administration during time-out processes, and have the preoperative nurse or anesthesia professional assign dosing responsibilities [63]. Team members play important roles throughout the perioperative period; Table 26.6 identifies actions by patients and staff in the perioperative, intraoperative, and postoperative periods.

Another safety measure is hand hygiene, which has been recognized as a primary method of decreasing healthcare-acquired infections [75]. Hand hygiene, handwashing, and surgical hand scrubs are the most effective way to prevent and control infections and represent the least expensive means of achieving both [76]. Despite this, studies have showed remarkably low hand hygiene rates by surgical providers as they enter in the OR to prepare their equipment, insert intravenous lines and catheters, etc. [77].

Preparation of the surgical incision site may include hair removal and application of a surgical skin antiseptic. Hair removal should only be performed when necessary. When hair removal is performed, clipping hair lowers the risk of SSI development rather than shaving hair with a razor [67]. The effectiveness of any skin antiseptic used for the surgical skin prep can be affected by a number of factors. The effectiveness of each solution depends on concentration, temperature, particular germ or virus, and contact time. Following manufacturers’ recommendations for use optimizes results. Skin antiseptics should be chosen for the individual patient based on patient assessment, the procedure type, and a review of the manufacturer’s instructions for use and contraindications [78].

Preparation of the surgical site is one factor in creating a safe environment. The physical environment within a surgical suite should support patient care to reduce the risk of developing a surgical site infection. The AORN Guidelines for a safe environment of care provide guidance for the design and maintenance of building structures to accommodate a perioperative procedure as well as guidelines for hazardous waste and storage conditions [79–81].

Another environmental concern is the movement of people and supplies. Traffic patterns should facilitate movement of patients, personnel, supplies, and equipment through the OR suite, with restriction levels intended to provide the cleanest environment possible. The number and movement of individuals during an operative procedure should be kept to a minimum. Evidence suggests that bacterial shedding increases with activity and that air currents may pick up contaminated particles shed from patients, personnel, and drapes and distribute them to sterile areas [82]. Additionally, an optimal surgical environment maintains temperature and humidity to deter microbial growth. Perioperative personnel should use an Environmental Protective Agency-registered disinfectant to clean surfaces and equipment, and physically inspect surfaces and equipment prior to preparing the OR for surgery [74].

There are several practices that reduce the spread of transmissible infections when preparing for surgery or working in the OR [83]. Perioperative personnel should don clean scrub attire and wear personal protective equipment (PPE) to protect both the patient and provider from microbial contamination and blood borne pathogen exposure. To deter passage of microorganisms, particulates, and fluids between sterile and unsterile areas, PPE should be resistant to tears, punctures, and abrasions [83]. Sterile drapes provide a barrier that minimizes the passage of microorganisms from unsterile to sterile areas and reduces the risk of healthcare-associated infections [73]. All surgical instruments should be sterilized according to published guidelines and manufacturers’ instructions. Instruments should be prepared using immediate use steam sterilization (formerly called “Flash” sterilization) only if they are required for immediate use and not for convenience, or to avoid purchasing additional instruments, or to save time. Implementing sterile techniques when preparing, performing, or assisting with surgical procedures is the cornerstone of maintaining sterility and preventing microbial contamination. Studies looking at colorectal surgery have shown that isolation techniques and the use of closing trays discourage the seeding of enteric contents to the incision site has been reported to reduce the incidence of SSI [83, 84].

Additional clinical trials have shown that hypothermia increases the incidence of serious adverse consequences including surgical site infections [85]. Several recent studies have shown the use of evidence-based surgical care bundles in patients undergoing colorectal surgery significantly reduced the risk of SSI; included in these bundles is maintaining normothermia [61, 84, 86]. Perioperative personnel should evaluate a patient’s risk for unplanned, inadvertent hypothermia and implement strategies such as temperature monitoring and patient warming in order to adjust environmental conditions according to patient needs [87].

Postoperative care considerations should be reviewed at the conclusion of the procedure by the surgical team using a debriefing process [23]. Additionally, determining the surgical wound class assists clinicians in gauging the risk for infection. Surgical wound classification is determined using the wound classification scheme from the CDC. The CDC recommends four surgical wound classifications :

This classification scheme reflects the probability of infection and should be determined by the surgeon at the end of the surgical procedure. AORN has developed the Surgical Wound Classification Decision Tree (Fig. 26.2) to assist in decision making for surgical wound classification [88].

Wound classification is subject to change; therefore, it should be assigned in consultation with the surgeon at the end of the procedure and documented in the perioperative record ([89], p. 491–511). Postoperative incision care is a significant factor in reducing SSIs; practices include sterile dressing changes as needed and removal of drains (e.g., chest tubes) and catheters (e.g., urinary drainage catheters) as soon as possible [90].

A variety of energy sources and modalities are employed during surgery. Considerable information is available about energy modalities, their mechanism of action, their unique characteristics, and their safety risks. Ball [91] offers an extensive description (with illustrations) of the many modalities employed in the perioperative setting. Additionally, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) created the Fundamental Use of Surgical Energy™ (FUSE) curriculum in 2010 to address the safe use of endoscopic energy sources [92–94]. Table 26.7 (Surgical Energies and Considerations) lists various types of energy sources and considerations for their safe use. These energy sources may be employed in the traditional ‘open’ surgical manner as well as the video-assisted, endoscopic, and interventional routes. Although there are extensive available information and initiatives developed by professional organizations such as SAGES [92] and AORN [96, 97], energy-related patient injuries continue to occur [98].

One of the oldest and most common sources of energy is electrosurgery , which directs the flow of electrons from an electrosurgical unit (ESU) through a delivery device (i.e., the electrocautery pencil) to the patient’s tissue, where the tissue is either ‘cut’ or coagulated. Two modes can be employed:

It is not unusual to employ both monopolar and bipolar devices during one surgery—for example, performing simultaneous endoscopic vein harvesting with a bipolar device while dissecting the mammary artery with a monopolar device during coronary bypass grafting. Patients undergoing a procedure that employs monopolar energy would require the application of a dispersive pad, regardless whether other, bipolar, devices are also employed. When applying a dispersive pad, commonly performed by the circulating nurse, the clinician should place the pad on clean, dry skin overlying healthy muscular tissue (which conducts electricity better than adipose tissue), and as near as possible to the surgical site. Areas on the patient’s skin with excessive hair, scar tissue, tattoos, or over bony prominences or distal to a tourniquet should be avoided for pad placement because hair, scar, bone, or poorly vascularized (e.g., distal to the tourniquet) can increase impedance of electrical energy flow, create heat, and potentially burn tissue [96, 99]. If needed, hair can be clipped to access a suitable site for the pad. Surgery performed on more than one site may require the use of two dispersive pads. A common site that allows the placement of two pads is the buttocks; a pad on each thigh may also be feasible when performing surgery on both legs [96].

Electrical devices can cause burn injuries to both patients and staff. Patients undergoing head and neck surgery (where there may be accumulated oxygen under the patient’s drapes) are at especial risk for upper body and airway burns that can be triggered by the electrical energy device [100]. Electrical and other energy sources can also lead to fires that can threaten not only the immediate surgical team but also surrounding units. The subject of fire is only briefly mentioned in this section; the topic is more fully discussed by Bruley (see Bruley, Chap. 10).

Electrosurgical energy also presents nonthermal risks to patients. For example, the use of electrosurgical energy can interfere with a patient’s electrocardiogram (ECG) and potentially adversely affect the performance of a pacemaker or implantable cardioverter defibrillator (ICD) ; reprogramming of the device(s) may be required and the perioperative staff should have contact information for the device manufacturer’s representative. Shortly after surgery, the pacemaker and/or ICD function should be evaluated by the responsible implanting physician (or surrogate) and the manufacturer’s representative. A bipolar, or a battery-powered, cautery device may be feasible if more extensive cautery is not needed. Precautions related to interference with device function are applicable to many additional implanted electronic devices [101] (e.g.):

Ultrasonic devices employ mechanical vibration of high-frequency sound waves (greater than 20,000 Hz) that enable the user to cut and coagulate tissue. The tip of the hand piece comes in various shapes: blade, ball, and hook [91]. Some of the advantages of ultrasonic devices are as follows:

Surgical smoke has become increasingly scrutinized for the hazards found within the plume—viruses; toxic gases; cellular (living and dead) contaminants; and vapors such as benzene, formaldehyde, and hydrogen cyanide [95, 96, 102]. Evacuation of surgical smoke increasingly is seen as a safety practice [91].

Another form of energy, radiation , is generally employed as a diagnostic imaging modality but is increasingly used as an integral component of therapeutic interventions performed in hybrid ORs and endovascular suites for repair of aneurysms and other cardiac and vascular abnormalities.

Radiologic energy/fluoroscopy is employed in a growing array of imaging-based procedures that carry their own inherent risks but also as a diagnostic tool to look for, and identify, possible retained surgical items. Radiation safety remains an important component of these newer, innovative technologies. Tracking and documenting radiation exposure levels as well as ensuring that surgical team members protect themselves (and the patient’s body parts not requiring radiation exposure) with lead barriers, glasses, and coverings (e.g., tops, skirts, gloves, and thyroid shields) is an important safety consideration [103]. Perioperative colleagues should also be considered by posting signs on the OR door(s) alerting staff members that radiologic procedures are being performed [104].

Although the various energies themselves (e.g., electricity, laser, microwave, radiofrequency) pose their own inherent safety risks, the surgical route and technique may create additional safety challenges. For example video-assisted laparoscopic and other endoscopic procedures differ from traditional ‘open’ surgeries in a number of ways. One is that when emergencies occur—e.g., sudden hemorrhage—there needs to be a prompt and efficient transition in technique and access in order to control the bleeding; this may require a new incision, a new set of instruments, and different mechanisms for controlling bleeding (e.g., placing a hand on the bleeding site cannot be achieved laparoscopically).

Additional considerations include the use of fluids or gases to distend the abdomen via the laparoscopic route and the potential risks to the patient that an overdistended abdomen may pose. These potential complications may not themselves constitute a never event but one’s awareness of risks and preparation for contingency planning to address complications is consistent with Kizer and Stegun’s [1] definition of an event that should never occur.

The study by Gawande and colleagues published in 2003 [105] was one of the first to illustrate the serious consequences of retained surgical items (RSI, formerly called retained foreign bodies); these included infection, prolonged hospital stay, reoperation, fistula, and death. The study authors reviewed medical-malpractice claims by patients with retained surgical sponges or instruments to identify the following major risk factors for RSI:

Interestingly, the patient’s sex, changes in nursing personnel, the presence of multiple teams, and the amount of blood loss were not associated in this study with an increased risk of RSI.

Lincourt et al. [106] and Wang et al. [107] confirmed the study’s [105] findings of significant increased risk for RSI in:

Increased BMI was not a significant finding in the Lincourt [106] and Wang [107] studies, and Rowlands [108] actually found an inverse relationship between increased BMI and risk of RSI. Rowlands also found that complex procedures, an increased number of personnel, and a greater number of specialty teams posed higher risks for RSI. None of these findings is surprising to clinicians who have participated in a trauma or emergency procedures—and it would not be surprising if a blood-soaked, compressed sponge was not visualized in the retroperitoneum or pleural cavity of a patient with a small or large BMI—if surgical team members failed to follow policies or guidelines, or, if behavioral or environmental factors adversely affect team function.

Three behavioral and environmental categories were designated by Rowlands and Steeves [109], who reviewed the perioperative stories of perioperative registered nurses (RNs) and surgical technologists (STs) relating the counting procedures during surgery. These general areas and examples included:

Related causes of failure to prevent RSI were the focus of a healthcare failure mode and effect analysis by Steelman and Cullen [110]. They identified the following as the most frequently cited reasons:

Several recommendations address the underlying issues and risks:

Additional recommendations are listed in Table 26.8.