An established and validated HcAI definition to guide both daily clinical practice and infection surveillance is needed.
HcAIs are defined as infections that occur during hospitalization or in a place of care and assistance, neither present clinically,
nor in incubation, at the time of admission or including those which occur after discharge, despite being causally traceable by
incubation time, etiologic agent and modality of transmission to the same hospitalization.
In recent years, the number of HcAIs has increased; as a result of the increase in the age of the population, the greater number
of examinations and invasive procedures are being carried out during hospitalization and, finally, the increasingly frequent
development of phenomena of antibiotic -resistance.
The incidence of a HcAI depends strongly on the type of hospital, the patient population studied, the definition of HcAI
adopted and the detection systems used. It is therefore a phenomenon of broad relevance not only clinical, but also economic
and social if only the costs, associated with the HcAI that the literature documents and reports as extremely high, are taken into
account. For example, in the European Union, additional health costs and loss of productivity of at least 1.5 billion euros are
estimated each year, due to infections caused by antimicrobial resistant bacteria.
Moreover, a HcAI needs agreed-upon and uniform nomenclature to avoid potentially confusing terminology, such as
“community onset,” “community associated,” “outpatient infections,” “infections among nonhospitalized patients,” “nonnosocomial,”
and “infections in the first 48 hours of hospitalization” [1].
The Study on the Efficacy of Nosocomial Infection Control (SENIC), conducted on some USA hospitals between 1975 and
1976, is the only study that has estimated the rate of hospital infections at the national level. In this study, the rate of infected
patient amounted to 5.2% while the rate of infections was observed to be 6.6%. Thereafter many prevalence studies have been
conducted in the USA and in Europe so as to estimate the impact of HcAI. In 2002 in the USA, the HAI rate was set at 4.5%,
which means that every day, 9.3 out of 1000 patients are at risk for HcAI which results in 1.7 million infected patients. The
European Center for Disease Prevention and Control (ECDC) has estimated that around 4.544.100 HcAI episodes occur in
Europe, with an estimated prevalence of 7.6% between 1995 and 2010, i.e. around 37.000 deaths in a year. It was estimated that
more than 220.000 HcAI episodes occur in Canada every year which lead to 8.500-12.000 deaths every year.
In the USA, there are many institutions and societies that act at the national level to control the HAI, to name but a few:
CMS (Center for Medicare and Medicaid Services), CDC (Center for Disease Control), OSHA (Occupational Safety and Health
Administrations), QIO (Quality Improvement Organization), etc.
The CMS is an institution that deals with the governmental healthcare system and that, in recent years, started coordinating
the HAI control.
In 2007, it developed a program to improve the quality of assistance: the Plan to Implement a Medicare Hospital Value-
Based Purchasing Program. This project involves the use of incentives for the high-performance actions in several domains
such as patient safety, the treatment process, the outcomes, the patient experience, and the efficacy of coordinated treatments.
Despite this, from the CMS 2008 inspections conducted on about 70% of the hospitals to evaluate the acknowledgement of the
new guidelines, it came out that the HcAI were within the first 12 principal deficiencies. In 2008, the CMS in cooperation with
the CDC has developed a new payment of benefits plan. Some indicators (the PoA indicators) have been identified so as to
evaluate if a certain primary or secondary diagnosis was made at the time of admission.
The activity of all these institutions implemented the construction of the 2009 Action Plan. This project represents a real
attack, at all levels, to the HcAI and all the main organizations in the field of health took part in its preparation. The activity of
the Action Plan was articulated in 5 working groups and had seven main goals to achieve in five years, each goal had its indicator.
This special issue has the primary aim of evaluating the risks of acquiring a HcAI. As its secondary objectives, the special
issue aims at evaluating if the introduction of the preventive actions, therapies and new measures of clinical risk management in
the HcAI control has efficacy in reducing the HcAI prevalence.
The papers collected in this special issue aim at identifying the epidemiology of HcAI, the main related risk factors and the
possible use of antibiotic-therapies or the ongoing related-measures to prevent and/or to treat the related adverse events.
Over the years, inappropriate use and abuse of antibiotic drugs around the world have led to the selection of multi-resistant
pathogenic microorganisms making infections a major health problem due to relative increases in costs, prolongation of hospitalizations,
as well as morbidity and mortality risk. This is one of the themes dealt in the paper by Orsi et al.; they present a
retrospective matched cohort study conducted through the analysis of hospital admissions at Sant’Andrea Teaching Hospital in
Rome from April to December 2015. The healthcare facility has 450 beds, 13,729 annual admissions, 6,264 Day Hospital hospitalizations
and 1,076,469 outpatient accesses, showing an annual HAI prevalence of 6.34%. The present study demonstrates
once again that HAIs caused by multidrug-resistant organisms are associated with higher mortality, longer hospital stays, and
increased costs. Economic assessment may provide valuable information for implementing health policies and prevention of
healthcare-associated infections due to alert organisms [2].
CRBSIs are defined as a bloodstream infection originated from an intravenous catheter. Intravascular device use is frequently
associated with local and systemic infectious complications, such as insertion site infection, septic thrombophlebitis,
endocarditis, bacteriemia, sepsis, metastatic infections (pulmonary abscess, cerebral abscess, pancreatic abscess, osteomyelitis,
arthritis, endophthalmitis) and intravascular catheter-related bloodstream infections (CRBSIs). Caroleo et al. analyzed this important
topic describing four cases of O. anthropi CRSBIs occurred almost simultaneously in Oncology Unit, the goal of this
paper is to establish the role of the root cause analysis and clinical risk management in adverse events’ prevention and in
healthcare quality implementation. The experience presented by these authors demonstrated that clinical audit and root cause
analysis process, by determining the infection source, led to adopt prevention measures: a) in order to avoid the catheters contamination,
a single-dose of flush sterilization solution has been used; b) both hand hygiene accuracy and information regarding
guidelines-based CRBSIs prevention and surveillance strategies among healthcare workers have been implemented [3].
The Bambino Gesù Hospital’s (OPBG) experience about the improvement of HcAI control could lead to a reduction in expenditure
related to prolonged hospitalization, outcomes and compensation for claims. In fact, according to several international
studies, health-care associated infections have a notable impact both in social and economic terms. The aim of the study carried
out in a pediatric hospital was to evaluate the effectiveness of the introduction of the mortality review committee on the improvement
of the assistance provided at the OPBG in the period examined, especially related to preventable deaths that follow
HAIs. Since 2010, as shown in the present study and in other works that evaluated HAI prevalence, in the OPBG, there was a
very low rate of mortality due to infections associated with health-care. In fact, possible areas of intervention were identified
that could potentially lead to an improvement in the quality of care provided. These improvements involved the prevention and
management of healthcare-related infections [4].
Quality of care and related analysis of litigation of a high-income hospital such as the Umberto I general hospital in Rome is
the aim of the paper by La Russa et al. [5]. The Umberto I general hospital counts on 1,200 beds for a total of 38,000 annual
hospitalizations, 27,000 Day Hospital admissions and 2,303,046 outpatient accesses. In particular, the authors carried out a
study on HAI claims with the aim of outlining a methodological approach to the litigation management and characterizing the
economic impact of infections on health facilities resources. The proposed approach is based on an integrated evaluation of
HAI claims by determining the risk of loss and technical estimates. The first task was to create a scoring system based on objective
parameters evaluable from the medico-legal point of view, the Advanced Loss Eventuality Assessment (ALEA). For the
determination of the technical estimates, it instead adopted a systematic procedure based on common evaluation systems of
personal impairment in order to quantify the claim reserves on current liabilities for claims reported but not yet settled [5].
Prevention and surveillance programs showed to be helpful tools for infections control, having allowed to increase patients’
safety and healthcare system quality. Quality of medical care is defined as the capacity of the healthcare system to achieve several
medical and non-medical goals. In this regard, several studies suggested a key role of quality medical records in determining
medical care process, risk management and preventing liability. The problem of the HcAI has been largely debated in the
last years. Albano et al., presented a number of cases in which surgical site infections (SSIs) were analyzed. SSIs are frequent
complications that occur in 2-5% of patients who undergo surgery. More than 60% of SSIs have been estimated to be preventable
by using evidence-based guidelines. Guidelines-based medical records filling was demonstrated to reduce HAIs-related
litigation, improve patient medical care appraisal, therefore HS quality. The most frequent type of infections, SSIs and isolate
meticillin-resistant Staphylococcus Aureus (MRSA), are more likely to be seen as preventable, and, in a judicial trial, medical
records are the only elements able to demonstrate standard care adhesion for infection control [6].
Di Paolo et al. discussed the forensic perspectives in approaching HcAIs, ranging from legal responsibilities of the
healthcare professional and the duty of care they have incumbent upon them in ensuring prevention of HcAIs, to the role of
forensic pathologists in assessing the cause of death in cases of HcAIs fatalities and, finally, ethical issues such as the emerging
role of patients and families’empowerment and autonomy in prevention and control of HcAIs. Authors concluded that HcAI are
a major problem for patient safety in every health-care facility and system around the world and their control and prevention
represent a challenging priority for health care institutions and workers committed to making health care safer. The burden of
HcAI implies longer hospital stay, increased morbidities, additional financial burden, high costs for patients and their families,
and excess deaths. Clinicians are at the forefront in the war against HcAIs, however, also forensic pathologists have a remarkable
role [7].
Finally, Albolino et al. presented the Italian law that establishes that health professionals should comply, as far as possible
and within the bounds of each specific case, with the recommendations included in the guidelines drafted by public and private
healthcare organizations and institutions, as well as scientific societies and technical-scientific associations registered on the list compiled and regulated by Ministerial decree and updated every two years. In the absence of recommendations, healthcare professionals
should follow good clinical practice.
According to the 2011 definition provided by the Institute of Medicine (IOM), clinical guidelines are “Statements that include
recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment
of the benefits and harms of alternative care options”. The definition of good clinical practice (GCP) is more complicated.
In Italy, a Ministerial Decree refers to “an international ethical and scientific quality standard for designing, recording and reporting
trials that involve the participation of human subjects”. The European Union Network for Patient and Quality of Care is
drawing up a project to define and implement patient safety procedures, in conjunction with the Italian National Agency for
Regional Health Services (AGENAS) as associated partner and National Contact Point. Patient safety practices have been defined
as “those that reduce the risk of adverse events related to exposure to medical care across a range of diagnoses or conditions”.
Patient safety practices are transversal to clinical pathologies, the literature indicates the list of the ones strongly recommended
as evidence-based, thus these are clearly indicated to be applied in the framework of the new Italian law. In conclusion,
the law delineates a global patient care system, pointing to the opportunities for engagement and partnering of the healthcare
system with health institutions, professional health associations, health training institutions, health-associated civil society
groups, and citizens [8].
In this special issue, researchers discussed clinical, pharmacological, economic and juridical aspects of relevance for advancing
in these particular topics. HcAIs represent a major public health problem, widespread in patients of all ages. Of every
hundred hospitalized patients, seven in developed and ten in developing countries can acquire one of the HAIs Studies dedicated
to advanced techniques will provide systematic reviews of new horizons opened in HcAIs, to understand and explain
clinical events of social-economic relevance.