The Role of Professional, Governmental, and Regulatory Organizations in Infection Prevention and Control

Barbara M. Soule

Karen K. Hoffmann

Tammy S. Lundstrom

INTRODUCTION

The modern era of infection prevention and control (IPC) began in the late 1950s and early 1960s when a new, virulent antibiotic-resistant strain of Staphylococcus aureus led to an epidemic that swept through U.S. hospitals. The epidemic quickly created a dramatic increase in the number of infections in newborns and obstetrical and surgical patients. Up to 25% of newborn infants developed superficial pyodermas or more serious deep infections, and approximately 1% of healthy postpartum mothers died of S. aureus sepsis (1).

These severe infections—with their associated morbidity and mortality—highlighted the deficiencies in care practices for patients at that time and focused the attention of healthcare providers on healthcare-associated infections (HAIs) (2). Two influential national agencies, the Centers for Disease Control and the American Hospital Association (AHA), came forward to assist hospitals with the epidemic and with their efforts to prevent HAIs (3). The collaboration between healthcare professionals, public health agencies, governmental agencies, and later professional organizations established ties that shaped the early evolution of IPC programs and forged relationships that continue to the present day.

This chapter describes the role and influence of professional, governmental, and regulatory entities on the practice of IPC and hospital epidemiology and on patient outcomes. The chapter also presents a case study that illustrates the interplay among those entities using the development and implementation of influenza immunization practices in healthcare as an example.

EARLY HISTORY

The Centers for Disease Control (now the Centers for Disease Control and Prevention [CDC]) and the AHA were the first entities to partner with healthcare organizations and professionals engaged in IPC. The CDC created a small unit of epidemiologists to provide assistance to hospitals struggling to understand and to contain the staphylococcal epidemic in the 1950s to 1960s, and in 1958, the CDC hosted the first national conference on preventing S. aureus infections (the National Conference on Hospital-Acquired Staphylococcal disease) (4). The conference resulted in published guidelines on isolation techniques for hospitals (5) and guidance for nurses who were filling the new role of infection control nurse (6). A pilot study of HAIs in community hospitals conducted in 1985 evolved into the National Nosocomial Infections Surveillance (NNIS) System (today the National Healthcare Safety Network [NHSN])—the only national HAI database in the United States (7,8,9). The CDC remains the primary governmental public health partner for infection preventionists (IPs) and hospital epidemiologists.

In the late 1950s and early 1960s, the AHA recognized the need to disseminate recommendations for controlling HAIs to its member hospitals (3,10,11). The AHA recommended that hospitals establish a committee on HAIs; create an HAI surveillance and reporting system; use strict aseptic practices during surgeries, in delivery rooms, and in nurseries; minimize the use of antibiotics; and identify infections that occurred in the hospital and in the community. These recommendations served as early guidelines for all hospital-based IPC programs. Subsequent reports and technical briefings addressed evolving IPC issues, such as HIV/AIDS and hepatitis B virus (HBV) (12,13). Today, the AHA continues to advocate for IPC issues nationally and through its state hospital associations.

The CDC, the AHA, and other similar organizations helped drive the agenda during the early years of IPC. By the late 1970s, almost 90% of hospitals were performing HAI surveillance and had an IPC committee, and almost half had an infection control nurse at least part-time (14). Interestingly, regulations or standards for IPC did not exist at that time, so early IPC efforts occurred voluntarily in hospitals (6).

As questions arose about the effectiveness and value of IPC, the CDC conducted a 10-year nationwide study. The Study on the Efficacy of Nosocomial Infection Control (SENIC) project produced strong evidence that effective IPC programs with specific surveillance, reporting, and staffing components could demonstrate a decrease in HAIs (15). Today, the CDC proactively leads IPC initiatives in collaboration with professional societies and other governmental agencies (Table 13.1), and the AHA keeps the prevention of HAIs on their list of priorities by sponsoring studies, educational initiatives, advocacy programs, and evidence-based guidelines to assist the field of IPC define the epidemiology of HAIs and use scientific practices to reduce HAI risk.

TABLE 13.1 Selected World Health Organization (WHO) Programs for Healthcare-Associated Infections (HAI)

Program	Main HAI Prevention and Control Topic	Selected Guidelines/Documents
Blood transfusion safety¹	Prevention of transfusion-transmissible infections (including HIV, hepatitis B, hepatitis C, syphilis, and bacterial contamination of blood and blood products)	Blood transfusion safety: information sheet Prevention of healthcare-associated HIV infection: flyer WHO resource materials on blood safety: CD-ROM Guidelines on hand hygiene in healthcare Guide to implementation of the WHO multimodal hand hygiene improvement strategy Hand Hygiene Implementation Toolkit (32 tools): Tools for system change Tools for institutional safety climate Hand hygiene self-assessment framework “Hand Hygiene Moment 1—Global Observation Survey”: summary report Save Lives: Clean Your Hands: promotional video Occupational health: a manual for primary healthcare workers Protecting healthcare workers: preventing needlestick injuries toolkit Joint WHO/ILO guidelines on postexposure prophylaxis to prevent HIV infection Prevention of hospital-acquired infections Practical guidelines for infection control in healthcare facilities Infection prevention and control of epidemic- and pandemic-prone acute respiratory diseases in healthcare; WHO interim guidelines and an accompanying set of implementation tools for community and hospital healthcare Core components for infection prevention and control programs and an accompanying set of implementation tools for national and local programs First, do no harm: introducing auto-disable syringes and ensuring injection safety in immunization systems of developing countries WHO best practices for injections and related procedures toolkit Revised injection safety assessment tool WHO surgical safety checklist Checklist implementation manual Safe healthcare waste management: policy paper WHO core principles for achieving safe and sustainable management of healthcare waste Management of solid healthcare waste at primary healthcare centers: a decision-making guide
Clean Care is Safer Care²	HAI prevention and control, in particular surveillance and prevention of the endemic burden of HAI, with special focus on hand hygiene
Health worker occupational health³	Prevention of HAI among healthcare workers
Infection prevention and control in healthcare⁴	HAI prevention and control, in particular prevention and preparedness and response to epidemics that can be associated with or amplified by healthcare
Injection safety⁵	Prevention of blood-borne pathogen transmission through unsafe injection practices
Safe Surgery Saves Lives⁶	Reduction of complications due to surgery, including surgical site infections
Water, sanitation, hygiene, and health⁷	Promotion of environmental health in healthcare settings, in particular safe healthcare waste management
Websites for Programs
Note: These documents are all available in pdf on the above-mentioned website pages related to the corresponding WHO program.
¹http://www.who.int/bloodsafety/en/ ²http://www.who.int/gpsc/en/ ³http://www.who.int/occupational_health/topics/hcworkers/en/index.html ⁴http://www.who.int/csr/bioriskreduction/infection_control/en/index.html ⁵http://www.who.int/injection_safety/en/ ⁶http://www.who.int/patientsafety/safesurgery/en/index.html ⁷http://www.who.int/water_sanitation_health/hygiene/en/
Adapted from Allegranzi B, Pessoa-Silva CL, Pittet D. The World Health Organization approach to Healthcare Associated Infection prevention and control. In: Soule B, Memish Z, Preeti M, eds. Best Practices in Infection Control: An International Perspective. 2nd ed. Oak Brook, IL: Joint Commission International; 2012:11-18.

INTERNATIONAL INFECTION PREVENTION AND CONTROL ORGANIZATIONS

Various organizations around the world actively engage in infection prevention efforts. One example is the Gulf Cooperation Council (GCC), which is composed of seven countries in the Middle East. This organization has produced IPC guidelines, reporting mechanisms, surveillance methods, and prevention strategies that can be used by all member countries (16). Latin America also is very active in IPC. The Pan American Health Organization (PAHO) is an international public health agency with more than 100 years of experience in working to improve the health and living standards of countries throughout the Americas (17). PAHO specializes in the health of the Inter-American System and serves as the World Health Organization (WHO) Regional Office for the Americas. Since 2008, this organization has published and updated guidelines, manuals, and educational materials for Latin American IPs on such topics as surveillance strategies (18) and sterilization (19) as well as created assessment tools for IPC programs (20).

WORLD HEALTH ORGANIZATION

WHO has played a pivotal role in preventing infections in the international community. In 2007, the Fifty-Fifth World Health Assembly Resolution (WHA 55.18) recognized the importance of promoting patient safety, including IPC programs (21). At that time, the WHO’s ability to enforce IPC practices was solidified by the revised International Health Regulations—an international legally and binding instrument applicable to 194 WHO Member States across the globe (22). Because of its role in international health, WHO is in a unique position to support HAI prevention and control through regional and national offices, WHO Collaborating Centers, Ministries of Health, and other agencies. Key WHO initiatives for IPC include providing comprehensive tools for improvement strategies on the WHO website (23); the Safe Injection Global Network (launched in 1999) to ensure the safe and appropriate use of injections around the world (24); and the Clean Care is Safer Care campaign (began in 2009), which focuses on hand hygiene and has the formal support of more than 124 governments around the world (25). In 2011, WHO released a policy package to combat antimicrobial resistance (26) and launched the Global Infection Prevention and Control Network (27). A list of major WHO IPC initiatives and websites is featured in Table 13.2.

THE INTERNATIONAL NOSOCOMIAL INFECTION CONTROL CONSORTIUM

The International Nosocomial Infection Control Consortium (INICC) evolved in the 1990s, and for the past 11 years has developed programs to perform process and outcome surveillance to detect risk factors for infection in Latin American healthcare facilities and has worked to evaluate the cost-effectiveness of IPC (28). Staff in many hospitals around the globe have been involved in creating and maintaining the surveillance programs, and, as of 2012, more than 1,000 investigators from approximately1,000 healthcare centers in 200 cities and 39 countries throughout Africa, Asia, Europe, and Latin America actively participate and report their surveillance data (29,30).

EXTERNAL EVALUATION PROCESSES FOR STANDARDS AND PERFORMANCE

Three key steps characterize the external standards evaluation process (31). First, formal standards are created and adopted to define a set of performance expectations for organizations that will use the standards. Second, standards are audited externally to determine the degree of compliance by these organizations. Cruse recognized the positive effects of external auditing when he assessed surgical site infections (SSIs) using external observers (an IP and a physician) and the positive effects of providing incidence data and trends on SSI rates to surgeons (32). Accreditation and regulatory agencies also perform auditing by conducting scheduled and unannounced surveys to monitor compliance with their standards and to respond to complaints. Third, rewards are conferred or sanctions are imposed on organizations depending on the degree of compliance with standards. Examples include awarding, withholding, or revoking accreditation or licensure or issuing citations or fines and recommendations for improving the care the organization provides.

Many standards-setting organizations influence IPC practices. Although it is not possible to discuss all these organizations in detail, a number of organizations that have been particularly influential are covered in this chapter, and a summary of these and other organizations is provided in Table 13.2.

VOLUNTARY AND REGULATORY STANDARDS-SETTING ORGANIZATIONS: INFLUENCE ON INFECTION PREVENTION AND CONTROL

External evaluation and control of health services involves setting standards against which organizational operations and programs can be measured. During the Crimean War in the mid-1800s, Florence Nightingale developed early standards for IPC in her efforts to control the patient’s environment, to improve sanitation, and to reduce infections in the sick wards in the field hospital (33).

Today, some IPC standards in the United States, such as those from the National Quality Forum (NQF) (34) and the Agency for Healthcare Research and Quality (AHRQ) (35), are voluntary and are developed by consensus. These standards are used by organizations for professional self-examination and to determine competence in IPC program activities and outcomes. In the international community, organizations such as the Health Information and Quality Authority in Ireland (36) and the Canadian Standards Association (37) set voluntary standards to drive continuous improvement in IPC practices. Other standards are used to improve patient safety and to determine reimbursement for care. Those standards developed by The Joint Commission (TJC) (38) and the American Osteopathic Association (AOA) (39) are voluntary, whereas those from the Centers for Medicare & Medicaid Services (CMS) (40) are mandatory and required for healthcare licensure and/or payment.

Regulatory standards also have been developed by such Federal agencies as the U.S. Occupational Safety and Health

Administration (OSHA) (41), the U.S. Food and Drug Administration (FDA) (42), and the U.S. Environmental Protection Agency (EPA) (43). These agencies were established to protect human health and the environment by writing and enforcing regulations based on laws passed by Congress that delegated standards setting, interpretation, and oversight to a specific federal or state agency. For example, the U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP drug standards incorporated into federal law are enforced in the United States by the FDA “FDAF”. D, and these standards are developed and used by more than 130 countries (44). IPs and others rely on USP Chapter 797, which pertains to the safe preparation, storage, and handling of compounded sterile preparations up to the point before administration to patients (45). In 2012, CMS issued a memorandum based on USP 797 to define the requirements under which repackaging of single-dose vials for multiple patients would meet compliance with CMS Conditions of Participation (CoPs) for all healthcare settings (46).

TABLE 13.2 Selected Organization References and Websites

Organization Type	Website	Description
QUALITY
Agency for Healthcare Research and Quality (AHRQ)	http://www.ahrq.gov	Quality and patient safety guidelines and literature
The American Health Quality Association	http://www.ahqa.org/pub/inside	Reference documents for quality
American Society for Quality (ASQ)	http://asq.org	Reference documents for quality
CDC Division of Healthcare Quality Promotion (DHQP)	http://www.cdc.gov/ncezid/dhqp/index.html	Guidelines and associated recommended measures
Hospital Compare	http://hospitalcompare.hhs.gov/	Public comparison of mortality rates for various conditions abstracted from administrative data sets
Institute for Healthcare Improvement (IHI)	http://www.ihi.org	Guidance documents for implementing evidence-based practices
Institute of Medicine (IOM)	http://www.iom.edu	Healthcare-related publications, including medical errors and national quality progress
The Leapfrog Group	http://www.leapfroggroup.org	Publicly reported quality and patient safety measures
National Association for Healthcare Quality (NAHQ)	http://www.nahq.org	Reference documents for quality
National Committee for Quality Assurance (NCQA)	http://www.ncqa.org	Quality standards for health plans
National Initiative for Children’s Healthcare Quality (NICHQ)	http://www.nichq.org	Quality measures specific to children
National Quality Forum (NQF)	http://www.qualityforum.org	National voluntary consensus measures for a variety of conditions, including HAIs
INFECTION PREVENTION AND CONTROL
Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)	http://www.apic.org	Resources for infection prevention and control (IPC) and healthcare epidemiology (HE), including guidelines
Center for Infectious Disease Research & Policy-University of Minnesota	http://www.cidrap.umn.edu	Resources for IPC and HE, including guidelines
Centers for Disease Control and Prevention (CDC)	http://www.cdc.gov	Resources for IPC and HE, including guidelines
Infectious Diseases Society of America (IDSA)	http://www.idsociety.org	Resources for IPC and HE, including guidelines
National Foundation for Infectious Diseases (NFID)	http://www.nfid.org	Resources for infectious diseases
The Society for Healthcare Epidemiology of America (SHEA)	http://www.shea-online.org	Resources for IPC and HE, including guidelines
World Health Organization (WHO)	http://www.who.int/en	Resources for IPC and HE and current data on outbreaks
PATIENT SAFETY
Agency for Healthcare Research and Quality (AHRQ)	http://www.ahrq.gov	Quality and patient safety information; patient safety network
American Hospital Association (AHA)	http://www.aha.org	Resources for hospitals
American Society for Healthcare Risk Management (ASH RM)	http://www.ashrm.org	Resources for risk management
American Society of Health-System Pharmacists (ASHP)	http://www.ashp.org/patient-safety/index.cfm	Resources for patient safety related to medication
Anesthesia Patient Safety Foundation (APSF)	http://www.apsf.org/	Resources for patient safety related to anesthesia
ECRI Institute (formerly the Emergency Care Research Institute)	http://www.ecri.org	Resources for patient safety
Emergency Medicine Patient Safety Foundation (EMPSF)	http://www.empsf.org	Resources related to emergency medicine
National Institutes of Health; U.S. National Library of Medicine	http://www.nlm.nih.gov	PubMed, MeSH, ClinicalTrials.gov, MedLine Plus, and other sites for patient safety literature
National Patient Safety Agency (NPSA), United Kingdom	http://www.npsa.nhs.uk	International resources for patient safety
National Patient Safety Foundation (NPSF)	http://www.npsf.org	Resources for patient safety
National Quality Forum (NQF)	http://www.qualityforum.org/	Measures_List.aspx
National voluntary measures for a variety of medical conditions Partnership for Patient Safety	http://www.p4ps.org	Resources for patient safety
Patient Safety Institute	http://www.ptsafety.org	Resources for patient safety
Premier Safety Institute	http://www.premierinc.com/safety/	Resources on patient and healthcare worker safety topics
U.S. Department of Defense Patient Safety Program	http://health.mil/dodpatientsafety/ProductsandServices/Toolkits.aspx	Resources for patient safety
Veterans Administration National Center for Patient Safety (NCPS)	http://www.patientsafety.gov	Resources for patient safety
REGULATORY
Centers for Medicare & Medicaid Services (CMS)	http://www.cms.gov	Conditions of Participation for inclusion in Medicare and Medicaid programs; website publicly displays quality comparative data for hospitals
National Fire Protection Association (NFPA)	http://www.nfpa.org/index.asp	Sets codes/regulations to reduce fire hazards
The CDC’s National Institute for Occupational Safety and Health (NIOSH)	http://www.cdc.gov/niosh	Conducts research and makes recommendations regarding prevention of healthcare personnel injuries
U.S. Occupational Safety & Health Administration (OSHA)	http://www.osha.gov	Regulates the health of healthcare personnel, including blood-borne pathogens and respirator use
U. S. Department of Transportation	http://www.dot.gov	Regulates transportation in the United States, including medical waste
U.S. Environmental Protection Agency (EPA)	http://www.epa.gov	Regulates air and water discharges and disinfectants used on surfaces
U.S. Food and Drug Administration (FDA)	http://www.fda.gov	Regulates single-use medical devices, antiseptics, and disinfectants used on medical devices
U.S. Government Accountability Office (GAO)	http://www.gao.gov	Investigates how the US government spends money
U.S. Nuclear Regulatory Commission	http://www.nrc.gov	Regulates nuclear devices and materials used in laboratories and patient testing
U.S. Regulations	http://www.regulations.gov	Searchable site of all US regulations
ACCREDITATION
American Osteopathic Association (AOA)	http://www.osteopathic.org	Professional organization for osteopathic physicians; alternative to The Joint Commission for deemed status
Det Norske Veritas (DNV) Healthcare	http://www.dnvusa.com/	Standards based on the International Organization for Standardization
The Joint Commission	http://www.jointcommission.org	Standards for hospitals, critical access hospitals, long-term care, ambulatory care, behavioral healthcare, home care, laboratories, office-based surgery, and other settings
Joint Commission International	http://jointcommissioninternational.org	Standards for international organizations, including hospitals, ambulatory care, care continuum, clinical laboratories, home care, long-term care, medical transport, primary care centers
CONSUMER
Americans Mad and Angry	http://www.americansmadandangry.org	Consumer stories regarding medical errors, including HAIs
Committee to Reduce Infection Deaths (RID)	http://www.hospitalinfection.org	Consumer stories regarding HAIs
Consumers Advancing Patient Safety (CAPS)	http://patientsafety.org	Tips for consumers
Consumers Union	http://www.consumersunion.org	Campaign to require public reporting of HAIs
Federation of State Medical Boards	http://www.docinfo.org	Quality information on doctors
Healthgrades	http://www.healthgrades.com	Ratings for doctors, dentists, hospitals
Public Citizen	http://www.citizen.org/Page.aspx?pid=524	Information on physician accountability; drugs, devices, and supplements; and healthcare delivery
OTHER RESOURCES
Library of Congress	http://www.loc.gov	Research arm of Congress; largest library in the world, including US legislation
U.S. Government Printing Office Federal Register	http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR	Searchable site of agency regulations

THE JOINT COMMISSION AND JOINT COMMISSION INTERNATIONAL

TJC is a voluntary, nongovernmental not-for-profit organization created through a coalition of several major healthcare organizations. TJC’s standards originated from the American College of Surgeons’ (ACS) Minimum Standards for Hospitals, which in turn were based on Ernest A. Codman’s outcome-based monitoring system (47). Codman’s system involved tracking each patient to determine whether treatments were effective, and, if they were not, to determine the reasons so subsequent patients could be treated more effectively. The ACS began conducting on-site hospital inspections using these standards in 1918, and in 1953, TJC (known as the Joint Commission for the Accreditation of Healthcare Organizations [JCAHO] at that time) took over these surveys. In 1965, Congress passed the Social Security Amendments with a provision that TJC-accredited hospitals were “deemed” to be in compliance with the Medicare CoPs and could receive Medicare and Medicaid funds (48). Today, TJC continues to “deem” organizations across the care continuum through its survey and accreditation process.

TJC published its first standards for IPC in 1976 (49). When these standards were published, some professionals noted the lack of a substantive body of scientific information to indicate whether following these would reduce HAIs (3). A recent study demonstrated that accredited hospitals score significantly higher than nonaccredited hospitals on 13 of 16 quality measures, including several measures related to the prevention of pneumonia (50). More recent IPC standards have added requirements for risk assessment, evaluation of goals and strategies, assessment of IPC data, and improving performance and sustaining improvement (38). In 2012, TJC added a standard to encourage organizations to improve influenza immunization rates among healthcare personnel (HCP) (Infection Control [IC] Standard IC.02.04.01) (51). This standard requires organizations to establish an annual influenza vaccination program for licensed independent practitioners and staff and to establish goals to incrementally increase immunizations among staff to achieve a 90% immunization rate or better by 2020 (which is based on a goal established by the U.S. Department of Health & Human Services [HHS] Action Plan to Prevent Healthcare-Associated Infections) (52). The current edition of the IC standards became effective January 1, 2013 (38), and these are reviewed and revised periodically. TJC works closely with CMS to ensure that most of the TJC IC standards align with the CoPs and Conditions for Coverage (CfCs), thus making it easier for healthcare organizations to meet the requirements of both organizations. TJC also develops National Patient Safety Goals (NPSGs). NPSG 7 focuses on reducing HAIs, and the 2013 NPSGs address hand hygiene, multidrug-resistant organisms, central line-associated bloodstream infections (CLA-BSI), SSIs, and catheter-associated urinary tract infections (CA-UTIs). Surveyed organizations are required to meet the NPSGs to be accredited. In addition, Joint Commission International (JCI) promulgates standards and International Patient Safety Goals (IPSG .5) for the prevention and control of infections that apply to organizations accredited in the international community (53).

AMERICAN OSTEOPATHIC ASSOCIATION

The AOA was founded in 1897 to advance the tenets of osteopathic medicine and to provide support for doctors of osteopathy medicine (54). The AOA serves more than 78,000 osteopathic medical physician members in the United States, promotes public health and academic scientific research, provides education, and offers guidance on providing cost-effective and ethical medical care. The AOA is the primary accrediting agency for all osteopathic medical colleges and healthcare facilities using a voluntary process. And as of 1966, HHS recognized the AOA as the official body to accredit osteopathic hospitals under Medicare (55

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