Marilyn Jones
Keith F. Woeltje
Introduction
The goal of an infection surveillance, prevention, and control program is to prevent healthcare-associated infections (HAIs) in patients, employees and visitors and to achieve that prevention in a cost-effective manner [1]. Therefore, every infection control (IC) program should formally evaluate the effectiveness of prevention efforts and the cost-effectiveness of those efforts [2,3]. These efforts have been expanded to the concept of interventional epidemiology that affirms that the activities and decisions made by IC be viewed from a business perspective including global systems thinking [4].
The term epidemiology in the context of an IC control program refers to enumeration, distribution, and control of infectious diseases in its healthcare population (patients, visitors, and employees). Individuals charged with an IC program must have knowledge in the science of epidemiology including surveillance methodology, study design, statistical methods, infectious agents, and many other competencies [5]. It is no surprise that these skills are the same set used by public health professionals because IC was born out of public health in the late 1950s when there was mounting concern regarding infection agent transmission within the hospital.
In 1958, outbreaks of Staphylococcus aureus infections in hospitals prompted the American Hospital Association to recommend that hospitals set up IC programs [6]. A few years later, in the early 1960s, the Centers for Disease Control (now the Centers for Disease Control and Prevention [CDC]) organized an investigations unit section that would assist hospitals in investigating outbreaks. As the 1960s progressed, medical care became increasing complex. Antibiotic-resistant organisms and opportunist pathogens developed as increasing challenges to the infection prevention and control efforts within the hospital setting [4,7]. Nationwide adoption of hospital infection control programs did not occur until the early 1970s when the CDC and the Joint Commission on Accreditation of Hospitals (now Joint Commission on Accreditation of HealthCare Organizations [JCAHO]) recommended that hospitals have IC programs [6,8]. The landmark Study of the Efficacy of Nosocomial Infection Control (SENIC) project demonstrated that an active IC program that included surveillance with feedback of infection rates, along with a physician and nurse with infection control knowledge, resulted in a reduction of HAIs [9,10].
Because the historical development of IC programs had epidemiologic roots, personnel charged with running the IC program traditionally were expected to have strong skills not only in medical and nursing care but also in healthcare epidemiology. More recently, the IC field has appreciated the importance of the business and management skills as well. From a financial perspective, IC departments are viewed as nonrevenue-generating departments because there is no charge to the patient
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or payor. If careful demonstration of the value to the organization is not documented and shared with key leaders, including those who hold the purse strings, IC may find its financial resources limited if not diminished. To garner resources for the program and mission of preventing HAIs, an IC program must adopt the new approach of “interventional epidemiology” and “give sufficient weight to the economic impact of any project or activity undertaking”[4]. IC program personnel must incorporate effectiveness evaluation into routine project and program planning so that they can demonstrate the value of infec-tion prevention and control to the healthcare organization.
Components of an Infection Control Program
An infection control program has many facets; however, the central components to be addressed when developing a program are governance, personnel, and the IC plan including the surveillance plan. Also critical to an effective program are the internal and external collaborations, compliance activities, and interventions.
Governance
A successful IC program must have both medical and administrative support and participation to accomplish its goals. Often this is accomplished through a formalized IC committee that makes decisions and recommends policies for the facilities' IC program [11]. The IC committee reports to a governing body within the hospital, such as a medical executive group or the hospital's administrative board. This body reviews and acts on the committee's recommendations. The governing body may, in turn, request a review of a current topic in the community or a hospital-specific policy, practice, or issue brought forward from another hospital forum such as a surgical committee. Although JCAHO no longer requires an IC committee per se, the IC standards do call for the demonstration of collaboration between medical staff, administrators, multiple hospital specialties, and IC to assess and develop the IC program [12]. It is necessary for a hospital to demonstrate that infection prevention occurs in all aspects of services rendered throughout the institution and that all employees understand their job-specific infection prevention actions. In addition, some states require that hospitals have a formal IC committee as part of the hospital licensing rules.
Departmental Reporting Structure
Like the governance of IC, no single method of departmental reporting structure fits every healthcare facility. Across the country are many examples of effective programs that report to different functions, such as nursing, quality, patient safety, or medical services. Regardless of the chain of command, the critical components are the support of the program during routine operations and an appreciation of critical issues that require immediate attention and added resources, such as sentinel events, outbreaks, or community emergencies.
Personnel
Personnel needs are established based on the size, complexity, services, and the needs of the facility and the community. A hospital epidemiologist and at least one infection control professional (ICP) are the minimum personnel needed for an IC program. The hospital epidemiologist may be a physician and in many instances is an infectious diseases (ID) physician. The expert knowledge of an ID physician is especially useful; however, it is also necessary for the hospital epidemiologist to have specialized training in epidemiology and IC. The Society for Healthcare Epidemiology of America (SHEA) in conjunction with the CDC, some medical schools and other professional organizations offer specific training. The hospital epidemiologist often serves as the chair for the IC committee and is involved in the planning and implementation of the program. The position of hospital epidemiologist is typically not a full-time position or a hospital employee; the physician contracts with the hospital for epidemiology services [13].
The ICP usually is a registered nurse or a medical technologist. Specialized training programs for ICPs are offered by Association for Professionals in Infection Control and Epidemiology (APIC), the Community and Hospital Infection Control Association–Canada (CHICA), other international societies, and other organizations including state hospital associations and health departments. Professional and practice standards define the competency standards and professional accountabilities of the ICP [5]. After two years of IC practice and passing the voluntary, standardized examination demonstrates proficiency in basic infection prevention and control knowledge [14] physicians, technologists, and nurses are eligible to become Certified in Infection Control (CIC) by APIC (other international organizations may have other criteria).
Historically, one ICP for every 250 beds was recommended based on the SENIC study [9]. Advances in medicine, changes in healthcare delivery, and increasing regulatory and compliance requirements have outdated this figure [1]. A Delphi project sponsored by APIC noted that staffing decisions should consider the facility's size, needs, complexity, and patient population. In general, it recommended a ratio of 0.8 to 1.0 ICP for every 100 occupied acute care beds [15].
In addition to the hospital epidemiologist and at least one ICP, support personnel are needed to allow the
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trained IC staff to focus on surveillance, prevention, and control activities. Secretarial support for scheduling meetings; typing minutes, policies, correspondence, and other documents; and maintaining paperwork, in general, can greatly enhance a program's effectiveness. Additional services for forms creation, data entry, and data management should be available to the IC program [1]. The size of the facility and the complexity of the IC program will determine whether these are dedicated or shared personnel resources. Some facilities have found that sharing secretarial, chart abstraction, data entry, or database management personnel between departments such as IC, quality, and regulatory proves cost effective.
The Infection Control Plan
The annual IC plan is an essential roadmap for the activities that the IC program will undertake. The annual plan is developed based on the IC program's strategic or long-term plan and the institution's mission and strategic objectives. Strategic planning should encompass traditional business strategies, entrepreneurial thinking , and futurist exercises [16]. Institutional initiatives, new laws and regulatory requirements, and newly published methods for preventing infections should be incorporated. Components of the plan include the overall mission and goal of the program, the goals for the year, and the scope of the IC department including the department hours and the mechanism for providing 24-hour coverage.
Another foundational component of the annual IC plan is the surveillance plan. This plan should include the indicators to be followed during the year (e.g., intensive care unit catheter-associated bloodstream infection rates and surgical site infection rates in cardiac surgery), the rationale for choosing those indicators, case-finding methods, definitions, and data management methods including report distribution. Evaluation of the historical data and a review of services and populations served by the institution will guide the development of the IC surveillance plan [17]. The surveillance plan is not equivalent to the IC plan; that would mistakenly simplify the IC program to only a surveillance program. The IC plan should incorporate activities directly aimed at improving endemic rates. Although IC is charged with protecting against and investigating outbreaks, only approximately 5–10% of all HAIs is associated with outbreaks. The other 90–95% of HAIs is due to endemic or common causes; therefore, the majority of prevention efforts should be focused on reducing endemic HAIs and mitigating HAI risks [18,19,20].
A plan for IC-related educational activities should be a component of the IC plan. In addition to the routine requirements, such as new employee and annual education, a review of the questions and concerns posed by employees in the past will provide a foundation for new programs or highlights for the year. It may be helpful for the ICP to log calls to decipher common educational themes.
A schedule for review of policies and procedures should be included in the IC plan as well. Although this review often is seen as a tedious administrative task, it can be turned into a productive activity if it is accompanied with a departmental walk-thru that assesses the environment and practices for their impact on patient and employee HAI risk.
The IC plan should outline special studies and intervention projects. These ventures should be directly related to the missions and goals.
Incorporating routine activities, such as consultation to various committees, product evaluation, and community involvement, into the IC plan is critical because these activities account for considerable amounts of time. Painting a clear picture of the time and resources necessary for all IC activities should be an objective of the plan. However, unexpected circumstances arise, and the plan should have enough flexibility to accommodate unplanned events, such as outbreaks in the institution or community and unexpected regulatory mandates.
In summary, the IC plan includes the mission, goals, and program scope; surveillance plan; education plan; policy and procedure review plan; and special studies.
Internal Collaborations
Collaborations are critical to the success of the IC program. Although largely immeasurable, the relationships that the ICP develop will positively contribute to its mission. No amount of policies or education will substitute for the trusting relationships that healthcare workers (HCWs) develop with the IC staff. Hospital personnel need to feel that they can be candid about concerns without fear of retribution or shame. Bear in mind that relationships and trust are between individuals, not departments or functions. Therefore, when developing an IC program, the IC staff should concentrate on meeting all department heads and key department leaders including frontline staff. IC employees should focus on understanding the department's issues and attempt to solve concerns even if they may not have a significant impact on HAI rates. When nuisance problems are resolved, individuals are much more likely to have the time, energy, and trust to work on the more challenging issues. Although it may seem elementary, the demonstration of trust and cooperation is the first and foremost critical step in the development of an effective IC program.
Internal departmental partnerships are as extensive as the number of departments within a facility because the IC program is an entitywide function. Each and every department should work with the IC program to incorporate IC activities into their own work. They should recognize that IC is everyone's job, not just the IC's. The affiliations that are paramount and closely aligned with the IC program will be discussed in detail.
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Occupational Health
JCAHO and some state regulations mandate the occupational health department's relationship with IC. Even if not required, the overlap of preventing HCWs and patients from being exposed to infectious exposures is an obvious link between the two departments. IC and occupational health work together on the development of the requirements for HCW immunizations, prevention of infectious disease exposures, and postexposure prophylaxis and secondary exposure prevention, including HCW work restrictions [21,22].
The more frequent occupational occurrences necessitate specific and on-going efforts of both IC and occupational health. Specifically, the treatment and prevention of sharps injuries and other body substance exposures through policy and engineering controls is necessary and mandated by the Occupational Safety and Health Administration (OSHA). Predetermined protocols for the treatment of exposures serve to provide rapid management, which is critical for the prevention of bloodborne pathogens, especially those involving human immunodeficiency virus [23]. Some exposure episodes are less straightforward than can be managed with a written protocol. In these instances, the hospital epidemiologist often serves as the consultant for the management of unusual occupational exposures. The prevention of sharps injuries necessitates an epidemiological approach to exposure incidence, including subanalysis within specific groups of HCWs (nurses, operating room personnel, physicians, housekeepers, etc.), specific devices, activities, and work areas. Formal evaluative reports presented to the IC committee or other governing body in addition to providing on-going feedback to the departments where injuries are occurring provides the mechanism for leadership input and resource allocation.
Depending on the community prevalence, tuberculosis prevention and control may account for only a fraction of program time or a significant amount of energy for both the occupational health and IC departments. This is an excellent example of why facility-specific personnel staffing evaluation is necessary and why IC and occupational health must be closely linked either formally through the internal chain of command or informally through collaboration and the IC committee (or similar function).
Patient Safety
Another critical internal collaboration is between IC and patient safety. Although IC is viewed as the first formal effort to protect patients, the discipline of patient safety came into its own after the 1999 publication of To Err Is Human by the Institute of Medicine [24,25]. Now JCAHO has incorporated IC into its National Patient Safety Goals by requiring evidence of compliance with the CDC's hand-hygiene recommendations and the reporting of infection-related adverse or sentinel events. Hospitals are now called on to investigate every death caused by an HAI using the specific model of root cause analysis (RCA). Although RCA may be an appropriate tool for rare IC occurrences, such as group A streptococcus surgical infections or an episode of aspergillous HAI, its value has yet to be demonstrated for a specific or single causative factor for infectious deaths due common cause or endemic HAI issues. Nevertheless, the RCA process can be used as a tool to uncover the many suboptimal process issues that contribute to high endemic rates. For example, a death caused byClostridium difficile is likely to be rooted in the on-going, common cause dilemma of horizontal transmission related to suboptimal hand hygiene and isolation precaution compliance, antibiotic treatments, and specific host factors rather than a single “root cause.” Because JCAHO mandates RCA for many healthcare facilities, IC personnel must collaborate with their partners in patient safety to perform these analyses. Because JCAHO surveys approximately 82% of acute care hospitals that account for 96% of the hospital beds in the United States [27], most IC personnel will likely participate in RCA procedures. IC personnel can partner with patient safety peers to assist in the epidemiological investigations of process and outcome measures such as falls, venous thrombus embolic events, and medication safety events.
Quality
The quality department and IC also are closely aligned because both departments are charged with improving patient outcomes. Many quality departments are authorized by the hospital to measure quality indicators and report those results to organizations such as the Institute for Healthcare Improvement (IHI) (100,000 lives and impact campaigns) and the Centers for Medicare and Medicaid Services (CMS). At 56 hospitals participating in a collaborative, compliance with the CMS infection prevention indicators in the Surgical Care Improvement Project (SCIP) demonstrated a 27% mean reduction of SSI rates [28,29]. Often the quality measures are based on IC and healthcare epidemiology studies that demonstrated the effectiveness of the individual intervention, such as timely and appropriate surgical prophylactic antibiotics [30,31,32,33,34,35,36].
In addition to having overlapping indicator interest with IC, quality personnel often are versed in the models of improvement, such as Continuous Quality Improvement (CQI), Plan-Do-Check-Act (PDCA), Six Sigma, and Lean. IC frequently uses the epidemiologic methods for improving endemic and epidemic HAI rates; however, these quality tools can enhance IC's problem-solving armamentarium. ICPs can lean on the quality professionals who often are proficient in leading and facilitating teams for direct assistance or guidance.
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Risk Management
Another hospital department with which IC routinely joins forces is risk management. Every HAI-related death or permanent disability should be reported to the patient safety department and to the risk management department. IC also should report outbreaks and other potentially litigious situations to risk management to protect the institution and its HCWs. In addition to reporting duties, risk management relies on IC departments to implement standards of care that prevent HAIs and thereby reduce liability. Risk management may also request that IC departments review the medical records of patients who have filed or threatened lawsuits that may have infection implications. Policies and procedures from years ago may need to be reviewed to validate that the standard of care for the period is being followed.
Microbiology
A high-quality microbiology department is a true asset to the IC department. Skilled microbiologists and technicians understand the importance of specific clinical specimens, and those individuals will alert IC. Microbiology policies for alerting the IC department should be developed to leave no ambiguity regarding notification of common yet significant pathogens, such as methicillin-resistant Staphylococcus aureus, Clostridium difficile, or more unusual findings such as acid-fast bacilli in respiratory specimens or gram-negative diplococci on a stain of cerebral spinal fluid. Due to the stringent requirements for laboratory certification, most U.S. facilities have reliable methods to identify microbiologic pathogens. External laboratories may be used particularly for specialty tests that require specialized equipment, media, or reagents. During outbreaks, the microbiology staff is consulted for advice regarding environmental sampling and for planning additional specimen processing, such as the heightened screening of a population.
Clinical Care Areas
IC must collaborate with personnel from all clinical areas to ensure that patient care is provided with the utmost attention to infection prevention. Established procedures for IC must be implemented in routine practice. The clinical care areas must be alert for problems that would not be detected by routine surveillance methods such as gastroenteritis or rashes among patients and employees, insects and varmints, humidity and temperature abnormalities, or product defects. Areas with high-risk patients, high-risk procedures, and high volume should command special attention from IC. Examples of such areas include the operating room, intensive care units, emergency departments, interventional radiology, and cardiac procedure areas.
IC must collaborate with many other critical departments, such as environmental safety, education, emergency preparedness, and pharmacy. An appreciation of the literature and the standards of practice put forth by each professional discipline will aid in the development of infection prevention approaches.
External Partnerships
IC has a direct partnership with the community public health department. At most facilities, the IC department is charged with the notification of reportable diseases. In community outbreaks or disasters, public health and IC work side by side to protect the public's health. Depending on the facility's mission the IC department may be directly involved and collaborate with the public health department for community outreach programs, such as health fairs or educational campaigns. Bioterrorism or emergency preparedness collaborations occur more recently at state and local levels. Relationships with other hospitals, surgical centers, long-term care facilities, and other service providers within the community provide two-way feedback regarding patients' HAI acquisition.
Compliance Issues
The IC department must evaluate many compliance standards or regulations. They may be mandatory such as the OSHA bloodborne pathogen standard; others, such as the CDC's infection prevention guidelines, are not legally required but recommended for good practice. Even when not specifically mandated, guidelines such as the CDC's recommendations often are held as a standard of care and therefore should be carefully evaluated. Failure to adopt recommended practices may place the institution at risk if adverse events occur and are legally pursued. However, different agencies may have conflicting recommendations, or some recommendations may not be based on sound epidemiologic or medical principles (i.e., evidence based). When these situations occur, IC personnel should evaluate the literature and studies cited for the recommendations to propose the best practices for patients and employees thru its governance (such as the IC committee). Professional organizations that have standards for the prevention of HAIs include APIC and SHEA in the United States and CHICA in Canada, as well as the Infection Control Nurses Association in the United Kingdom and the Asia Pacific Society for Infection Control. (Additionally, specialty care organizations such as the Association of Operating Room Nurses, American Society for Gastrointestinal Endoscopy, Society of Gastroenterology Nurses and Associates, the Association for Vascular Access, and the Intravenous Nurses Society have standards or guidelines on preventing
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infection.) Governmental and nongovernmental regulatory agencies that promote recommendations include JCAHO, CDC, OSHA, CMS, Food and Drug Administrations, Agency for Healthcare Research and Quality, the National Quality Forum, and state and local governments including health departments.
In the past decade, agency requirements for demonstrating the implementation of evidence-based practices and measures that prevent harm have proliferated. Although these requirements may have imposed a considerably increased data burden for hospitals that do not use electronic records systems, the requirements have forced the deployment of improved processes that are expected to result in improved care or health outcomes. For example, before the CMS requirement of timely surgical prophylactic antibiotic delivery, on-time delivery was occurring at an average rate of 56% [37] despite the fact that the literature to support this practice is more than 15 years old [30]. For example, prior to the CMS requirement of collecting and reporting appropriate timing of surgical prophylaxis, appropriate prophylaxis was only occuring at rate of 56%. Despite the fact that the literature to support this practice is more than 15 years old [30], it took regulatory mandates to improve compliance.
Intervention Implementation
The goal of preventing HAIs is accomplished by intervention implementation. The improvement should be chosen [38] using surveillance data; reviewing high-risk, high-volume, problem-prone procedures and processes; and evaluating current regulatory and practice standards. Worthy projects, process owners, and collaborators should be objectively evaluated for readiness to change current practices. According to the principles of change leadership, people will not make needed sacrifices but will hold onto the status quo and resist new strategies without a sense of urgency or need to change [39]. When leaders of areas that need improvement are satisfied with the current performance, the IC team should seek change by first creating an uncomfortable feeling with the status quo. Dissatisfaction with the present condition is essential to instill the motivation for change. Alternatively, IC personnel should find a project that demonstrates the need for improved practices or outcome to partners and key leaders.
Once the project has been selected, IC and the process owners should use an improvement model that is consistent with its organizational model. Different improvement methodologies have advantages and disadvantages; however, ensuring that team members understand the tools and use a systematic method for evaluating the problem and implementing a solution is more important than the superiority of the model. At a minimum, the model should call for the multidisciplinary team to establish a goal and a target for success and determine the measurement component that will demonstrate the project's effectiveness.
Evaluation of Interventions
An intervention and its evaluation should be designed concurrently. The evaluation should include whether the project was successful as determined by the original goal and target established by the team. It also should include a cost analysis that compares the cost of the intervention with the savings associated with avoided HAIs. Intervention costs should include the time of the intervention team members, the development of the education program, the time of staff required to complete the education, and engineering control such as products and equipment retrofitting.
When an improvement project implements multiple interventions at the same time, the interventions cannot be individually assessed for effectiveness. However, this should not preclude the evaluation of the intervention as a package (most HAI prevention interventions are multifactorial). Often improvements are seen initially, but the success begins to fade over time because the intervention change was not firmly rooted in a new manner of performance. In other words, there was a regression to the old processes [39]. Therefore, continued assessment of the intervention should be incorporated.
The define-measure-analyze-improve-control (DMAIC) improvement model of Six Sigma recognizes the need for a formal process for monitoring the improvement and for developing a response plan if the improvement deteriorates. In most intervention projects, IC should continue to track the HAI rates (outcome measure) while the clinical areas quantify the process measures. For example, IC should monitor central venous catheter-associated bloodstream infection (CVC-BSI) rates while the intensive care unit staff monitors the percentage of femoral lines or the percentage of CVCs placed using maximal barrier precautions. When the process measures are carefully chosen, their monitoring is critical because they have a direct relationship with the desired outcome [40]. In most instances, the process measures worsen before the outcome measure is affected. By tracking the process, the healthcare team can intervene before an adverse HAI outcome occurs.
Conclusion
The components to a successful IC program include clearly defined governance, knowledgeable
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personnel, and a plan for improving HAI rates and infection prevention practices. A predetermined plan guides activities and facilitates the IC team to stay focused on goals without getting unnecessarily sidetracked to other projects or “flavor of the month” campaigns. Positive relationships with the hospital personnel and external agency representatives will directly influence the IC's ability to meet its mission to prevent HAIs in patients, employees, and visitors and to achieve that prevention in a cost-effective manner.
References