Traditionally, healthcare-associated infections have been considered a “stand-alone” problem and specific professional profiles have been developed as well as legislation and policies aimed at infection prevention and control (ICP).
Core competencies (i.e., competencies that should be a minimum prerequisite for all professionals in this field) have been defined by the European Centre for Disease Prevention and Control (ECDC) for infection control and hospital hygiene professionals  matching the profile of a medical doctor (an ICP practitioner) or a nurse (an ICP nurse) working in Europe. Competencies are grouped into domains which are in turn grouped into four areas: program management, quality improvement, surveillance and investigation of healthcare-associated infections, and infection control activities.
In Italy, central regulation about infection control has for years been based on just two documents issued by the Ministry of Health, one in 1985 (Fighting against Hospital Infection)  and the other in 1988 (Fighting against Hospital Infection: the surveillance) ; so, at the local level, policies have varied.
In all the European Region, decisions about infection prevention and control have often been made at the institutional level, with or without national or continental recommendations in mind, with available resources and dominant clinical cultures playing a pivotal role .
The large number of international guidelines targeting specific healthcare-associated infections that have been proposed over time by different agencies has resulted in varying applications and outcomes.
In particular, the WHO has provided “WHO Guidelines on Hand Hygiene in Health Care” , “Global Guidelines for the Prevention of Surgical Site Infection” , and “Guidelines for the prevention and control of carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in health care facilities” .
In the EU, things changed with the “Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections”  in which HAIs were covered as a safety problem. The recommendation provides guidance on patient empowerment and promotes a culture of patient safety. In terms of HAI-related actions, it states that member states should use case definitions agreed upon at the EU level to allow consistent reporting; European case definitions for reporting communicable diseases were updated in 2012 . The council recommendation triggered the development of national strategies and reporting and learning systems in many member states. The ECDC network for the surveillance of healthcare-associated infections (HAI-Net) supports member states in establishing or strengthening active surveillance systems. Decisions made at the level of the EU contributed to the improvement of HAI surveillance systems through the adoption of a common, specific case definition for HAI and a framework for national surveillance.
The 2011 Cross-border Patients’ Rights Directive  highlights the importance of transparency and provides guidelines for setting up national contact points for the diffusion of information about care standards, taking into account advances in medical science and good medical practices.
In fact, HAIs are recognized as part of the safety problems for patients and thus they should be addressed.
The ECRI Institute’s “Top 10 Patient Safety Concerns” is a list released in 2019 identifying top-priority safety concerns such as newly identified risks, existing concerns that have changed due to developments in technology or new care delivery models, and persistent issues that need focused attention or present new opportunities for intervention. Unsurprisingly, the list includes three infection-related issues: “Antimicrobial Stewardship in Physician Practices and Aging Services,” “Early Recognition of Sepsis across the Continuum,” and “Infections from Peripherally Inserted IV Lines” .
In 2016, the WHO issued international, evidence-based guidelines regarding the core components of IPC programs . The guidelines were developed by international experts to prevent HAIs and combat antimicrobial resistance, while taking into account the strength of available scientific evidence, the impact on cost and resources, as well as patient values and preferences. The guidelines provide a framework for implementing or developing IPC programs, applicable to any country and adaptable to local context, available resources, and public health needs.
4.1 The Prevention and Control of Healthcare-Associated Infection: A Challenge for Clinical Risk Management
Guidelines for tackling HAIs uniformly address the issue with a systemic approach. A systemic approach reframes IPC endeavors as components of a wider and more complex system which manages patient safety and quality of care .
Individually reliable components may generate unsafe outcomes when interacting within the system as a whole, even if they are functioning appropriately. A proper surgical intervention or evidence-based antiblastic therapy may be undermined by IPC that is not effective throughout the care continuum.
Consequently, safety is an emergent property of the system, not dependent on the reliability of the individual components but on the management of the interactions between every part of the system, including people, devices, processes, and administrative control .
Multiple studies indicate that the most common types of adverse events affecting hospitalized patients are adverse drug events, HAIs, and surgical complications .
HAIs are unintended, unwelcome consequences of healthcare that, if serious, can have dreadful effects, and are often similar to other adverse events, in that they can prolong the length of stay, cause harm to the patient, and are preventable to a large extent.
Notwithstanding the fact that HAIs are injuries related to management of care processes rather than complications of disease , healthcare workers perceive HAIs differently from adverse events. When not discussed further or brought under a higher level of scrutiny—even if they are reported to the patient and the family—HAIs will be probably presented as complications of care and not as preventable events.
It has been proposed that this difference in approach toward HAIs originates from factors such as the widespread belief that antibiotics can solve infection-related problems, the weakness of evidence supporting HAI-preventing interventions, the sense of responsibility felt by healthcare staff, and the perceived intractability of the problem .
With this mindset, HAIs pose a significant challenge to the way in which clinical risk management is deployed in healthcare systems.
The International Classification for Patient Safety taxonomy (ICPS)  aids in the detection of failures, contributing factors, and near misses within an incident analysis framework. Learning and reporting systems are based on “lagging” indicators  as they refer to the post hoc detection of critical occurrences and aim to enhance incident detection capability and the potential to learn from failures. Consequently, these systems are very unlikely to detect the risks posed to patient safety by HAIs. Since they are designed to be event-focused rather than hazard-based, learning and reporting systems are fed with only events that have already occurred for subsequent identification and analysis. Moreover, the preconditions for HAIs to occur are products of a silent behavior occurring most of the time when the patients are not “on-board” of healthcare processes. While both the active failure (i.e., the point of error) and the latent failure (i.e., the origin of error) are often easy to identify, in the case of an adverse event, the scene changes completely when an HAI is involved. Even with an understanding of bacterial spread, it is most often difficult to identify the source of a particular HAI within a healthcare organization, and so healthcare professionals have the tendency to view the problem as ineluctable. However, HAIs and other types of adverse events often happen due to the recurrence of similar circumstances. Therefore, in order to improve safety, clinicians and managers need to look more carefully at the context, and apply the lessons learnt.
Risk management is about reducing the probability of negative patient outcomes or adverse events by systematically assessing, reviewing, and then seeking ways to prevent, occurrence. Fundamentally, risk management involves clinicians, managers, and healthcare providers in identifying the conditions surrounding practice that put patients at risk of harm and in acting to prevent and control these circumstances to manage and reduce risks .
Successful approaches for preventing and reducing HAIs involve applying a risk management framework to manage both the human and systemic factors associated with the transmission of infectious agents. This approach ensures that infectious agents, whether common (e.g., gastrointestinal viruses) or evolving (e.g., influenza or multiresistant organisms), can be managed effectively .
Involving patients and their carers is essential for the successful prevention of infection and control in clinical care. Patients need to be sufficiently informed to be able to participate in reducing the risk of transmission of infectious agents.
Although infection prevention specialists (IPs) have long assessed risks related to populations served, services provided, surveillance data, and outbreaks, and lapses in desired practices, new accreditation standards, and rules require that risk assessment and goal-setting should be systematic for an effective approach to infection prevention and control.
Risk assessment and goal-setting need to form a more structured, formal process to enhance a well-designed and thoughtful approach to infection prevention. In the case of HAIs, it may be misleading to place the emphasis solely on the reporting of adverse events and the detection of near misses. In order to fruitfully integrate clinical risk management and IPC, surveillance must be merged with an epidemiological approach within a risk assessment framework.
Risk is defined as the combination of the probability of occurrence of a hazard generating harm in a given scenario and the severity of that harm. Risk is therefore contextual and can only be assessed with respect to a given scenario. Pragmatically, risk is the interaction between a hazard and present vulnerabilities.
Over the years, healthcare organizations and government agencies have developed numerous strategies and guidelines to combat infection. But before organizations can draw up an effective prevention plan, they must consider the existing risks; organizations need a comprehensive and structured approach to assess hazards and vulnerabilities related to HAIs within a healthcare system.
The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) and Joint Commission International (JCI) standards require accredited organizations to perform an assessment to evaluate their infection risks and set goals and objectives based on the results of the assessment .
An Infection Prevention and Control (IPC) Risk Assessment (RA) describes the infection risk which is unique to that particular institution. This Infection Control Risk Assessment (ICRA) will help the institution assess the complexity of the identified risk and define actions that can possibly reduce the effects . In a healthcare organization, infection risks can originate from a variety of areas, such as lack of hand hygiene, unsafe injection practices, poor cleaning, disinfection, sterilization of instruments and scopes, and inadequate environmental cleaning. To understand which risks are the most threatening, the current situation needs to be analyzed.
Operationally, the risk scoring will help determine the severity and the prioritization of each hazard and vulnerability identified: a risk can be categorized as high, medium, or low depending on the estimated severity of harm. Risk assessment is an ongoing process as infection risk changes over time and often rapidly. An infection control risk assessment must consider different elements before establishing IPC policies and procedures, goals, and objectives. A comprehensive, hospital-wide risk assessment plan documenting how the healthcare facility is prioritizing patient and healthcare worker safety is essential in any healthcare organization. It is the first step in a systematic process to raise awareness and to create and implement a PCI Plan .
The important issues are whether a known or potential risk is likely to occur, its significance should it occur, and whether the organization is adequately prepared to handle it so that the negative effects are eliminated or minimized. The hospital identifies risks for acquiring and transmitting infections through thoughtful examination of what could cause harm to patients, staff, families, and visitors.
Ideally, RA in IPC is best performed by an experienced IPC practitioner, maybe with input from staff in the clinical area concerned. The IPC practitioner may need assistance from clinicians, laboratory staff, or data managers, depending on the location and type of hazard being investigated.
Risk assessment should be performed when:
a new IPC service is established, in particular standard precautions, transmission-based precautions, infection surveillance, cleaning, laundry and waste management, reprocessing of reusable instruments, and renovation projects
a new piece of clinical equipment or an instrument is procured
a new procedure or diagnostic test is implemented
a problem in IPC practice or policy, or a related issue is identified
at least annually to re-evaluate the IPC program priorities
Conducting a risk assessment is a crucial task for healthcare organizations. The point of the process is not to identify and compile risks, but to serve as the basis for developing actionable goals and measurable objectives for the infection control program. In other words, assessment should form the foundation of the organization’s infection prevention plan.
Once the most menacing risks have been identified in a healthcare facility and understood, goals and measurable objectives can be developed to combat these threats.
The Joint Commission’s Infection Prevention and Control standards require organizations to use the risk assessment process to set goals for a comprehensive infection control plan. Specifically, Standard IC.01.04.01 states that “based on the identified risks, [the organization] sets goals to minimize the possibility of transmitting infections” . The standard includes the following elements of performance:
The organization’s written infection prevention and control goals include the following:
Addressing prioritized risks.
Limiting unprotected exposure to pathogens.
Limiting the transmission of infections associated with procedures.
Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies.
Improving compliance with hand hygiene guidelines.
A goal is a broad statement indicating the change we want to make. It identifies a main issue and it is not measurable. For example, goals may include:
A measurable objective specifies quantifiable results in a specific length of time. It defines the who, what, when, where, and how of our strategy.
Successful risk management in IPC needs the following key elements that will help to produce effective projects:
An active IPC committee that assists with risk assessment and implementation of IPC measures.
Robust policies and procedures that lay the foundation for good institutional IPC practice.
Committed leadership supporting IPC.
A safety culture.
4.2 Risk Management Tools
Risk management tools are applicable in infection risk assessment including both reactive and proactive methods. The first, based on the information of internal reporting, will analyze the causes of adverse events (AEs) already occurred, as epidemics or serious infections, in order to propose some corrective actions. They include the following.
4.2.1 Root Cause Analysis
Root cause analysis (RCA) is a process for identifying the basic or causal factor(s) underlying variation in performance that can produce unexpected and undesirable adverse outcomes. A root cause analysis focuses primarily on systems and processes, not individual performance. The objective of an RCA must not be to assign individual blame; rather, through RCA, a team works together to understand a process and the causes or potential causes of variation that can lead to error, identifying process changes that would make such variation less likely to recur.
A root cause is the most fundamental reason (or one of several fundamental reasons) a failure or underperformance has occurred. In contrast with the usual use of the word, “cause” does not carry an assignment of blame or responsibility in the context of RCA. Here, the focus is on a positive, preventative approach to changes in a system and its processes following a sentinel event, a near-miss sentinel event, or a cluster of less serious yet potentially harmful incidents. Although root cause analysis is associated more frequently with the investigation of a single event, the methodology can also be used to determine the cause of multiple occurrences of low-harm events. When analyzing events as a cluster, RCA can result in the identification of common error causes.
Root cause analysis is designed to answer the following three questions: (1) What happened? (2) Why did it happen? (3) What can be done to prevent it from happening again? .
4.2.2 Significant Event Audit
A significant event audit (SEA) is a process in which individual episodes, whether beneficial or deleterious, are analyzed in a systematic and detailed way to ascertain what can be learnt about the overall quality of care and to indicate any changes that might lead to future improvements. Put simply, an SEA is a qualitative method of clinical audit. In this respect, it differs from traditional audits that tend to deal with larger scale, quantifiable patient data sets and involve criteria and standards which can be measured and compared against. However, SEA should still involve a systematic attempt to investigate, review, and learn from a single event that is deemed to be significant by the healthcare team.
The seconds are performed before the occurrence of AEs and aim to reduce their frequency and/or severity. The seconds should be applied above all in risky environments such as in the ICU. The following subsections provide further detail.
4.2.3 Process Analysis
A process is defined as a sequence of successive steps in the service of a goal. Each step is a producer of a specific contribution that needs to be identified in terms of issues, content, and quality-security. The analysis can involve either an existing, high-stakes practice that generates actual or potential dysfunctions or a new practice to be verified before it is implemented.
The steps of analysis are:
describing a process from start to finish: its objectives, successive steps, actors, etc.
identifying and analyzing the critical points
proposing improvements to management for the organization, especially in terms of interfaces between services
This analysis is carried out by all the stakeholders involved and can be completed using the method presented in the nest subsection .
4.2.4 Failure Modes and Effects Analysis
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures in order to recognize the parts of the process that need change. FMEA includes the following steps: failure modes (i.e., What could go wrong?), failure causes (i.e., Why would the failure happen?), failure effects (i.e., What would be the consequences of each failure?). Teams use FMEA to evaluate processes for possible failures and to prevent such failures by correcting the processes proactively instead of reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process before its implementation and in assessing the impact of a proposed change to an existing process.
4.3 The Best Practices Approach
The United Nations Population Fund’s (UNFPA) “Glossary of Monitoring and Evaluation Terms” defines “best practices” as planning or operational practices that have been proven successful in particular circumstances and which are “used to demonstrate what works and what does not and to accumulate and apply knowledge about how and why they work in different situations and contexts.”
UNESCO describes best practices as having four common characteristics: being innovative; making a difference; having a sustainable effect; having the potential to be replicated and to serve as a model for generating initiatives elsewhere.
Even if there is not a universally accepted definition, a best practice is a practice that, upon rigorous evaluation, has demonstrated success, has had an impact, and can be replicated. Some best practices in the ICP field are presented in the following subsections.
4.3.1 Hand Hygiene
Hand hygiene has long been recognized as the single most effective way to prevent the spread of infections.
The most common cause of HAIs is transient flora acquired and spread by direct contact with patients or with environmental surfaces. If transferred to susceptible sites such as invasive devices (e.g., central venous and urinary catheters) or wounds, these organisms can cause life-threatening infections.
Several studies have demonstrated the effect of hand cleansing on HAIs rates and on the reduction in cross-transmission of antimicrobial-resistant pathogens.
Ease of access to hand washing facilities (e.g., soap and water) and alcohol-based hand rubs can influence the transmission of HAIs.
In 2009, the World Health Organization produced guidelines on hand hygiene in healthcare in which are outlined the “five moments” to perform hand hygiene:
before touching a patient
before a clean or aseptic procedure
after risk of body fluid exposure
after touching a patient
after touching a patient’s surroundings
Hand hygiene must also be performed before putting on gloves and after their removal.
Evidence suggests that compliance with proper hand hygiene after contact with a patient’s surroundings is generally very poor in hospitals, as healthcare workers underestimate the role of environmental surfaces in the transmission of HAIs.
Effective hand hygiene relies on appropriate technique as much as on selection of the correct product. Inappropriate technique may only partially remove or kill microorganisms on hands, despite the superficial appearance of having complied with hand hygiene requirements.
To wash hands correctly, both hands and wrists need to be fully exposed to the product and therefore should be free from jewellery and long-sleeved clothing—in other words, they should be bare below the elbow. Each healthcare facility should develop policies regarding jewellery, artificial fingernails, or nail polish worn by healthcare workers.
Alcohol-based hand rubs are recommended because of their ease of use and availability at the point of care. They are suitable for use except when hands are visibly soiled or potentially contaminated with body fluids, or when caring for patients with vomiting or diarrheal illness. Soap and water should be used in these instances, as well as after contact with patients with C. difficile infection or their environment, as alcohol hand rubs are not effective in reducing spore contamination.
When using alcohol gel, hands should be free of dirt and organic material and the solution must come into contact with all the surfaces of the hand; hands should be rubbed vigorously until the solution has evaporated. When washing hands with a liquid soap, the solution should come into contact with all the surfaces of the hands and hands should be rubbed together for a minimum of 10–15 s. Particular attention should be paid to the tips of the fingers, the thumbs, and the areas between the fingers. Hands should be thoroughly rinsed and then dried with a good-quality paper towel .
Each year, the “WHO SAVE LIVES: Clean Your Hands” campaign aims to progress the goal of maintaining a global profile on the importance of hand hygiene in healthcare and to bring people together in support of hand hygiene improvement around the world.
4.3.2 Antimicrobial Stewardship
Antibiotics, like all medication, may have side effects, including adverse drug reactions and Clostridioides difficile infection (CDI). Nevertheless, the misuse of antibiotics has also contributed to the growing problem of antibiotic resistance. Unlike other medications, the potential for the spread of resistant organisms means that the misuse of antibiotics can adversely influence the health of patients who are not even exposed to them.
The relationship between the unrestrained use of antimicrobials in all human health settings as well as agriculture and animal husbandry and the emergence of bacterial resistance is well documented .
Infection prevention and control practices are recognized as a key part of an effective response to antimicrobial resistance, as they reduce the need for antimicrobials and the opportunity for organisms to develop resistance. Vaccination can also reduce antimicrobial resistance by preventing infectious diseases, even primary viral infections, often inappropriately treated with antibiotics .
Programs dedicated to improving antibiotic use, commonly referred to as “Antibiotic Stewardship Programs” (ASP), can both optimize the treatment of infections and reduce adverse events associated with antibiotic use, thus improving not only the quality of patient care but also patient safety by increasing the frequency of correct prescriptions for both therapy and prophylaxis.
Successful antimicrobial stewardship programs have been associated with reduced facility resistance rates as well as reduced morbidity, mortality, and costs.
Antibiotic stewardship consists of the implementation of policies that support optimal antibiotic use through interventions which are tailored and prioritized depending on the needs of the hospital, the organizational context, and factors such as size of the facility, staffing, and resources.
A systemic integration of antimicrobial, infection prevention, and diagnostic stewardship (AID) has been proposed in order to reduce the need for antimicrobials and the opportunity for organisms to develop resistance . It is necessary for cross-disciplinary borders and approach infection management in an integrated, multidisciplinary manner. Microbiology laboratories and clinical microbiologists can provide significant contributions to ASPs, including the dissemination of antimicrobial susceptibility reports and enhanced culture by means of fast microbiology  and diagnostic stewardship . Participating in ASPs is mainly seen as a task for clinical microbiologists and/or infectious disease specialists, together with (hospital) pharmacists. However, such an endeavor deeply involves bedside doctors and nurses, boards of directors, and diagnostic laboratories since patients commonly transition between different healthcare settings. Antimicrobial stewardship programs require multidisciplinary efforts which depend also on the support of the hospital’s administration, the allocation of adequate resources, and the cooperation and engagement of prescribers.
Only a comprehensive healthcare network using an integrated approach may contain the spread of antimicrobial resistance. From this perspective, infection management is thus a responsibility for all stakeholders involved in such a network.
It is vital that infection control and prevention measures are integrated into a unified AID program to improve overall infection management. Without the proper infection prevention measures, other interventions such as ASPs and Diagnostic Stewardship Programs (DSP) will not achieve the optimal effect.
Stewardship interventions can be listed in three categories: broad, pharmacy-driven, and infection and syndrome specific. Broad interventions include:
Antibiotic timeouts accompanied by a reassessment of the continuing need for and choice of antibiotics when more information is available.
Prior authorization, restricting the use of certain antibiotics bound to preventative evaluation performed by an antibiotic expert.
Prospective auditing and feedback, with reviews of antibiotic therapy by an expert in antibiotic use not involved in the treatment (e.g., a day-2 bundle with face-to-face case audits performed by the antimicrobial stewardship team) .
Pharmacy-driven interventions include:
Automatic changes from intravenous to oral antibiotic therapy in appropriate situations.
Dose adjustments in cases of organ dysfunction (e.g., renal adjustment).
Dose optimization including dose adjustments based on therapeutic drug monitoring.
Automatic alerts in situations where therapy might be unnecessarily duplicative.
Time-sensitive automatic stop orders for specified antibiotic prescriptions.
Detection and prevention of antibiotic-related drug interactions.
Infection and syndrome-specific interventions are intended to improve prescribing for specific syndromes and situations such as community-acquired pneumonia and urinary tract infections, skin and soft tissue infections, empiric coverage of methicillin-resistant Staphylococcus aureus (MRSA) infections, Clostridioides difficile infections, and treatment of culture proven invasive infections; however, prompt and effective treatment for severe infection or sepsis should be provided in any case .
Antimicrobial stewardship programs need to be monitored both at the process level (i.e., Are policies being followed as expected?) and at the outcome level (i.e., Have antibiotic use and patient outcomes improved?) [2, 52].
4.3.3 Care Bundles
“Care bundling” is an approach developed by the United States Institute of Healthcare Improvement  to help healthcare workers consistently deliver the safest possible care for patients undergoing treatments known to increase patients’ risk of healthcare-associated infections. A bundle is a set of evidence-based practices (generally three to five) that improve patient outcomes when performed collectively and reliably.
The elements of a bundle are well-established practices, combined into a structured protocol that is agreed upon and is the responsibility of the whole clinical team. Characteristics of a bundle include the following:
All elements are necessary and make up a cohesive unit of steps that must be completed in their entirety to succeed; while getting some of them right may be an improvement, it is not as good as getting them all right. The more reliably all the bundle elements are delivered, the better the outcomes .
Each element is based on randomized and controlled trial evidence.
The bundle involves an all-or-nothing measure which makes implementation clear-cut.
Existing care bundles can be used as tools and developed further by each facility to meet its needs.
Two examples of bundles are described below.
22.214.171.124 CAUTI Maintenance Bundle
One example of a bundle procedure for the maintenance of urinary catheters includes the following steps:
Perform a daily review of the need for the urinary catheter.
Check the catheter has been continuously connected to the drainage system.
Ensure patients are aware of their role in preventing urinary tract infection, or if the patient is unable to be made aware, perform routine daily meatal hygiene.
Empty urinary drainage bags frequently enough to maintain urine flow and prevent reflux, using a separate urine collection container for each patient and avoiding contact between drainage bags and the container.
Perform hand hygiene and put on gloves and apron before each catheter care procedure; on procedure completion, remove gloves and apron and perform hand hygiene again.
126.96.36.199 Ventilator Bundle
Ventilated patients are at high risk for several serious complications: ventilator-associated pneumonia (VAP), venous thromboembolism (VTE), and stress-induced gastrointestinal bleeding. Five elements of care have been identified for the prevention of these events in ventilated patients and are supported by solid level-one trials:
elevation of the head of the bed (HOB) to between 30° and 45°
daily sedative interruption and daily assessment of readiness to extubate
peptic ulcer disease (PUD) prophylaxis
deep venous thrombosis (DVT) prophylaxis (unless contraindicated)
daily oral care with chlorhexidine