By Kelly M. Pyrek
Editor's note: This article was part of a series published in the print issue of ICT in 2016 and may not reflect the most current developments.
Policies relating to newly emerging and highly infectious diseases in outpatient healthcare settings within the context of infection prevention and control are highly variable, according to public health experts, leaving many gaps in patient protection from healthcare-associated infections (HAIs). For example, only a minority of outpatient facilities are certified by the Centers for Medicare and Medicaid Services (CMS) and few are licensed by states or maintain accreditation status. As a result, many of these facilities are opened and operated without being held to minimum safety standards for infection control or other aspects of patient care, potentially putting patients at risk. In an October 2015 document, Outpatient Settings Policy Options for Improving Infection Prevention, the Centers for Disease Control and Prevention (CDC) outlined four key elements for states and their supporting HAI multidisciplinary advisory groups who are interested in more effective and proactive oversight of out-patient facilities: facility licensing/accreditation requirements; provider-level training, licensing and certification; reporting requirements; and establishment and effective application of investigation authorities.
As the CDC (2015) observes, "Compared to inpatient acute care settings, ambulatory care settings have traditionally lacked infrastructure and resources to support infection control and surveillance activities. Physician licensure, while beneficial, is not enough to ensure quality healthcare is delivered and patients are effectively protected. Dual licensure of both facilities and healthcare providers has the ability to ensure that healthcare is provided in a safe environment and the quality of care is held to the same standards throughout the state. While data de-scribing risks for HAIs are lacking for most ambulatory settings, numerous outbreak reports have described transmission of Gram-negative and Gram-positive bacteria, mycobacteria, viruses, and parasites. This highlights the need for more consistent surveillance data. In many instances, outbreaks and other adverse events were associated with breakdowns in basic infection control procedures (e.g., reuse of syringes leading to transmission of bloodborne viruses). Outpatient settings in particular warrant increased attention from local, territorial, and state health agencies, which are well-positioned to ensure that basic standards of infection control are understood and observed consistently across the healthcare system.
Facility licensure and accreditation requirements can help maintain public safety and ensure quality of healthcare delivery. In addition, they also can provide states with the number and type of facilities within their borders and additional influence over these facilities and their activities. In some states, facility licensing also acts as a source of revenue for the state health department, and is used to support infection control activities for these facilities.
As the CDC notes, "Only a minority of outpatient healthcare facilities are certified by CMS and relatively few are licensed by states or maintain accreditation status. As a result, many outpatient facilities are opened and operated without being held to minimum safety standards for infection control or other aspects of patient care, apart from sanctions and penalties following investigations into the practice. This leads to gaps in the ability of state, territorial, and local health departments to monitor and improve healthcare quality and prevent adverse events. Regard-less of licensure or accreditation, all outpatient healthcare facilities, including physician offices and specialty clinics, might be expected to follow, at a minimum, basic infection control practices outlined in Standard Precautions, as summarized in the CDC Outpatient Guide."
The CDC recommends the following:
- Maintain accurate information on the locations, numbers, and types of outpatient facilities within the state
- Require all outpatient healthcare facilities be registered
- Require all outpatient healthcare facilities to identify a licensed healthcare professional to serve as the infection control coordinator
- Enhance collaboration between the medical boards that license healthcare providers, the licensure agencies that license healthcare facili-ties, other state agencies, and accrediting agencies
- Ensure that accrediting agencies report adverse events or unsafe conditions identified during an accreditation survey to the appropriate lo-cal and/or state agency
- Require accrediting bodies to incorporate basic infection control practices in their initial accreditation, subsequent inspections, and applica-tions for renewed accreditation
- Designate license fees or fines for the support of education, technical assistance, and inspection/monitoring activities by the appropriate state/local agency
- Work with medical liability and healthcare insurance companies to encourage them to assess the infection control practices used by insured or participating healthcare providers and facilities
- Use standard approaches such as state agency survey protocols to measure adherence to Standard Precautions (e.g., use CDC-developed survey tools for expanded on-site assessments not limited to CMS-certified facilities or state-licensed surgery centers)
Libby Chinnes, RN, BSN, CIC, an infection prevention and control consultant who has worked with numerous outpatient healthcare facilities over the years, says that she has seen an overall improvement in how ambulatory care facilities are navigating the CMS and/or accreditation agency survey process. "Folks seem familiar with CMS’ Ambulatory Surgery Center Infection Control Surveyor Worksheet and requirements; however, many opportunities for improvement still exist -- many in cleaning, disinfection and sterilization, and how those activities, along with maintaining a clean environment, really tie back into patient safety and ultimately infection prevention. The Joint Commission has recently re-leased a High Level Disinfection (HLD) and Sterilization BoosterPak, available on their website, the goal of which is to ensure work practices are carried out per the standards and evidence-based guidelines to minimize risk of transmission of infection to patients. The boosterpak is applicable to not only hospital practice but also ambulatory centers as well as office-based surgery settings. Another excellent resource is: The Joint Commission’s Implementation Guide for NPSG.07.05.01 on Surgical Site Infections: The SSI Change Project."
Healthcare Provider Training, Licensure and Certification
Appropriate healthcare provider training ensures that healthcare professionals, in addition to maintaining their own licensing standards, keep pace with constantly updating information, evolving techniques, technology, and the increased demands of an ever-expanding and aging popu-lation. Lack of sufficient healthcare knowledge and skills can directly affect patient safety and quality of care, increasing patient morbidity and mortality. Additionally, consistently high turnover among healthcare workers stresses the need for maintaining a high level of healthcare knowledge within the industry.
Requirements for healthcare provider training, licensure, and certification are highly variable across the United States. While licensure requirements are generally clear for all physicians and registered nurses, requirement for continuing education and other forms of training vary greatly, as do licensing/certification requirements for allied health professionals. In addition to state licensure requirements, this may also include requirements by an employing facility. Physicians, nurses, and others who are employed by hospitals generally receive more frequent and standardized infection control training relative to their independent or outpatient-based colleagues. Allied health professionals, particularly those working in doctor’s offices and other outpatient settings that are not licensed, accredited or CMS-certified, may have received minimal formal pre-service training, with on-the-job training that may be minimal or incomplete. For many medical/dental technicians and assistants, annual OSHA-mandated bloodborne pathogen training may represent their only exposure to formal continuing education addressing infection control issues. Delegation of activities, including preparing and sometimes administering injections, is loosely governed by state physician and/or nurse practice standards, meaning that patients may receive care from staff with little training or without direct oversight. Additionally, outpatient facilities that are engaged in drug compounding may be doing so with unqualified personnel who lack appropriate training, credentials, and equipment. It is critical that all employees receive infection control training that reflects best practices and is appropriate for their duties to ensure patients are protected from adverse events. Training on injection safety is especially critical for unlicensed healthcare workers who may be involved in preparing or delivering vaccinations or other injections."
The CDC recommends the following:
- Require HAI prevention and infection control training as a condition of licensure for physicians, nurses, medical assistants, technicians, and others
- Require a minimum level of periodic continuing education credits related to infection control training for all licensed healthcare personnel
- Require every facility infection control coordinator to participate in an infection control continuing education training program approved by the state
- Expand licensure and/or certification requirements for all healthcare providers, with mechanisms for checking compliance
- Maintain a list of all licensed or certified healthcare providers that have practiced or are currently practicing in the state, including any punitive actions against them, in a manner that would allow its use by medical facilities to validate employee licenses or certifications
- Require state-approved basic infection control training for anyone engaged in healthcare work under the supervision of a licensed healthcare professional, including workers not licensed by the state
- Enact licensure and/or certification requirements for all providers, including health professionals working in short-term or temporary assignments
- Communicate healthcare worker vaccination recommendations to healthcare workers on a regular basis
Monitoring reported infection data enables public health authorities to detect changes in disease occurrence and distribution, identify changes in causes of disease, and detect changes in healthcare practices. Prompt reporting by facilities and healthcare providers protects patients and saves lives.
Requirements and systems for HAI reporting improve healthcare quality and patient safety by ensuring unsafe practices are discovered, identified, and corrected before further infections or disease outbreaks can occur. HAI reporting requirements for outpatient settings have lagged behind requirements for acute care settings, and vary by infection or event type and reporting system (e.g., National Healthcare Safety Net-work28 or NHSN).
The process of updating these requirements is also variable. For example, in Texas the state may change the HAI reporting requirements for ambulatory surgical centers by giving official notice 90 days before the start of reporting. In other states like New Hampshire,30 the state must go through the rule-making process to change HAI reporting.
General infectious disease reporting requirements (i.e., under each state or territory’s notifiable diseases and conditions listings) are applicable to outpatient settings. However, there may be different requirements depending on the types of a) facilities, b) healthcare providers, and c) laboratories performing clinical specimen testing. These reporting requirements are important for the state to be able to identify and track emerging infectious disease threats in order to provide the appropriate response. The ability to revise reportable disease lists when necessary helps the state keep pace with emerging diseases. Additionally, the definition of an outbreak — or potential outbreak — may be variable and not well-defined. Certain infectious diseases, for which even a single healthcare-associated case may signal a more widespread or serious problem, may require special attention. Reporting requirements for adverse events other than infections are also highly variable. Commonly, these are reported to state, territorial, and/or local health departments as patient complaints, which in turn may prompt investigations for unsafe medical practices or unsafe facility conditions.
Healthcare providers may or may not know when to involve the health department regarding lapses in infection control practices. Healthcare providers may benefit from receiving clear direction from the state, territorial, local, and tribal health department regarding their responsibility and the appropriate process to report possible outbreaks of infection and reports of reportable diseases or other adverse events.
The CDC recommends the following:
- Develop standards and criteria for publically reporting outbreaks and investigations
- Educate outpatient healthcare facilities and healthcare personnel regarding appropriate mechanisms for reporting reportable diseases and adverse events
- Clarify the conditions (e.g., numbers and types of infections) which may constitute a potential outbreak and trigger reporting requirements for an outpatient facility
- Pursue additions to reportable diseases list to include HAIs, or other serious or life threatening events, such as unsafe injection practices
- Encourage reporting of unsafe healthcare practices, including consideration of whistleblower protections
- Use regulations or other official policy instead of legislation for listing reportable diseases instead of legislation in order to allow the state health department to more readily make changes to emerging threats and pathogens
With momentum for antibiotic/antimicrobial stewardship surging in the inpatient arena, experts are calling for coordinated efforts to pro-mote appropriate prescribing of antibiotics for non-hospitalized patients in clinics, offices and other ambulatory care settings. Programs can range in size and scope and can be implemented by a variety of stakeholders. Regardless of the clinical setting, the overarching goal is to pro-mote adherence to clinical practice guidelines to provide the best standard of care and to minimize the spread of antibiotic-resistant bacteria.
Antibiotic use is the most important modifiable driver of antibiotic resistance, and antibiotic-resistant infections lead to higher healthcare costs, poor health outcomes, and more toxic treatments, according to the CDC (2013). Shapiro, et al. (2014) note that more than half of antibiotic prescribing in outpatient settings is unnecessary, and most of this inappropriate use is for acute respiratory infections, such as pharyngitis, sinusitis, or bronchitis. The researchers sought to determine patterns of ambulatory antibiotic prescribing in US adults, including the use of broad-spectrum versus narrow-spectrum agents, to provide a description of the diagnoses for which antibiotics are prescribed and to identify patient and physician factors associated with broad-spectrum antibiotic prescribing. Shapiro, et al. (2014) used data for patients aged =18 years from the National Ambulatory and National Hospital Ambulatory Medical Care Surveys (2007–09) -- nationally representative surveys of patient visits to offices, hospital outpatient departments and emergency departments (EDs) in the USA, collectively referred to as ambulatory visits. They determined the types of antibiotics prescribed, including the use of broad-spectrum versus narrow-spectrum antibiotics, and examined prescribing patterns by diagnoses.
The researchers found that antibiotics were prescribed during 101 million (95% CI: 91–111 million) ambulatory visits annually, representing10 percent of all visits. Broad-spectrum agents were prescribed during61%of visits in which antibiotics were prescribed.
The most commonly prescribed antibiotics were quinolones (25% of antibiotics), macrolides (20%) and aminopenicillins (12%). Antibioticswere most commonly prescribed for respiratory conditions (41% of antibiotics), skin/mucosal conditions (18%) and urinary tract infections (9%). In multivariable analysis, among patients prescribed antibiotics, broad-spectrum agents were more likely to be prescribed than narrow-spectrum antibiotics for respiratory infections for which antibiotics are rarely indicated (e.g. bronchitis), during visits to EDs and for patients more than 60 years. The researchers emphasized that antibiotic stewardship interventions targeting respiratory and non-respiratory conditions are needed in ambulatory care.
Clinical practice guidelines for common infections and other expert-driven advice can help establish standards of care, focus quality improvement efforts, and improve patient outcomes. For example, in a paper published Jan. 19, 2016 in Annals of Internal Medicine, the American College of Physicians (ACP) and the CDC issued advice for prescribing antibiotics for acute respiratory tract infections (ARTIs) in adults.
"Inappropriate use of antibiotics for ARTIs is an important factor contributing to the spread of antibiotic-resistant infections, which is a public health threat," says ACP president Wayne J. Riley, MD, MPH, MBA, MACP. "Reducing overuse of antibiotics for ARTIs in adults is a clinical priority and a high value care way to improve quality of care, lower healthcare costs, and slow and/or prevent the continued rise in antibiotic resistance."
ARTIs, including the common cold, uncomplicated bronchitis, sore throat, and sinus infection, are the most common reason for doctor's office visits. According to unpublished CDC data, an estimated 50 percent of antibiotic prescriptions may be unnecessary or inappropriate in the outpatient setting, which equates to more than $3 billion in excess costs. Antibiotics also are responsible for the largest number of medication-related adverse events and the cause of about one in five visits to emergency departments for adverse drug reactions.
Physicians should not prescribe antibiotics for patients with the common cold. Physicians should advise patients that symptoms can last up to two weeks and to follow up if symptoms worsen or exceed the expected time of recovery. Physicians should also explain the risks and benefits of symptomatic therapy and that antibiotics are not needed and may have side effects. Symptomatic therapy is recommended for management of common cold symptoms. For patients with uncomplicated bronchitis, physicians should not perform testing or prescribe antibiotics unless pneumonia is suspected. Patients may benefit from symptomatic relief with cough suppressants, expectorants, antihistamines, decongestants, and beta agonists. For patients with sore throat, physicians should recommend analgesic therapy such as aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, and throat lozenges, which can help reduce pain. Physicians can reassure patients that the usual course of a sore throat is less than one week and that antibiotics are not usually needed because they do little to improve symptoms and may have side effects. Uncomplicated sinus infection usually resolves without antibiotics, even in patients with a bacterial cause. The majority of patients diagnosed with sinus infection experience more side effects than benefits from antibiotics. Most patients with sinus infection should be managed with supportive care. Analgesics may be offered for pain and antipyretics for fever.
The ACP and the CDC say that physicians should reserve antibiotic treatment for sinus infection for patients with persistent symptoms for more than 10 days, onset of severe symptoms or signs of high fever (greater than 102.2°F) and nasal discharge or facial pain lasting for at least three consecutive days, or onset of worsening symptoms following a typical viral illness that lasted five days which was initially improving.
Drekonja, et al. (2015) sought to evaluate the effect of outpatient antimicrobial stewardship programs on prescribing, patient, microbial out-comes, and costs. Through their systematic review, the researchers identified 50 studies eligible for inclusion, with most (29 of 50; 58%) reporting on respiratory tract infections, followed by multiple/unspecified infections (17 of 50; 34%). We found medium-strength evidence that stewardship programs incorporating communication skills training and laboratory testing are associated with reductions in antimicrobial use, and low-strength evidence that other stewardship interventions are associated with improved prescribing. Patient-centered outcomes, which were in-frequently reported, were not adversely affected. Medication costs were generally lower with stewardship interventions, but overall program costs were rarely reported. No studies reported microbial outcomes, and data regarding outpatient settings other than primary care clinics are limited. Drekonja, et al. (2015) conclude that low- to moderate-strength evidence suggests that antimicrobial stewardship programs in outpatient settings improve antimicrobial prescribing without adversely effecting patient outcomes. They say that effectiveness depends on program type. Most studies were not designed to measure patient or resistance outcomes. Data regarding sustainability and scalability of interventions are limited.
Infection Prevention and Control
It may surprise you that a recent study found that only 1 out of 5 nurses followed standard precautions. In the study, only 17.4 percent of ambulatory care nurses reported compliance in all nine standard precautions for infection prevention, according to the paper published in the January 2016 issue of the American Journal of Infection Control. Researchers from Northwell Health (formerly North Shore Long Island Jewish Health System) conducted a study of 116 ambulatory care nurses to measure self-reported compliance with standard precautions, knowledge of hepatitis C virus (HCV), and behavioral factors influencing compliance.
The highest rate of compliance was reported with always wearing gloves (92 percent), followed by always wearing a face mask (70 per-cent). Only 63 percent of participants reported that they always wash hands after removal of gloves and 82 percent reported that they always wash hands after provision of care.
The study also found knowledge of HCV was variable, with more than 1 in 4 (26 percent) erroneously believing that it is commonly spread through sexual contact, 14 percent incorrectly believing that HCV causes premature death, 12 percent not knowing HCV antibodies can be present without an infection, and 11 percent not knowing there are multiple HCV genotypes.
“Self-reported data might be an overestimate of actual compliance and that makes these results of particular concern for potential expo-sure to bloodborne diseases,” concluded the study authors. “Overall, the ambulatory care nurses chose to implement some behaviors and not others, and this behavior puts them at risk for acquiring a bloodborne infection.”
Standard precautions are the minimum infection control practices that should be used in the care of all patients at all times, whether or not they appear to be infectious. They are used to protect healthcare workers and patients from transmission of diseases that can be spread by contact with blood, body fluids, non-intact skin, and mucous membranes. The nurses surveyed in this study were assessed based on these nine precautions:
1. I provide nursing care considering all patients as potentially contagious
2. I wash my hands after the removal of gloves
3. I avoid placing foreign objects on my hands
4. I wear gloves when exposure of my hands to body fluids is anticipated
5. I avoid needle recapping
6. I avoid the disassembling of a used needle from a syringe
7. I use a face mask when exposure to air-transmitted pathogens is anticipated
8. I wash my hands after the provision of care
9. I discard used sharp materials into sharps containers
"The designated infection preventionist (IP) in the surgery center, especially if having received additional education in this role, may not feel that they have enough time to properly do their job especially if serving in other roles such as nursing director of the center, risk manager, or multiple roles including staffing of the center," says Libby Chinnes."Administrators may not realize or perceive the value of infection prevention, and therefore prioritize infection control activities low on their radar not allocating enough time to the infection preventionist’s role to adequately perform. The IP role is highly specialized even with OR background and that role will need to be filled by someone who will pursue ongoing training in the field as well as having leadership support at the facility level for the training needed."
In November 2015, the CDC updated its Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care. This document outlines basic infection prevention recommendations for ambulatory care settings and reaffirms Standard Precautions as the foundation for preventing transmission of infectious agents during patient care in all healthcare settings.
In this outpatient guide, the CDC outlined key administrative recommendations:
1. Develop and maintain infection prevention and occupational health programs.
2. Assure availability of sufficient and appropriate supplies necessary for adherence to Standard Precautions (e.g., hand hygiene products, personal protective equipment (PPE), injection equipment).
3. Assure at least one individual with training in infection prevention is employed by or regularly available (e.g., by contract) to manage the facility’s infection prevention program.
4. Develop written infection prevention policies and procedures appropriate for the services provided by the facility and based upon evi-dence-based guidelines, regulations, or standards.
The outpatient guide also recommended action steps for the education and training of healthcare personnel:
1. Provide job- or task-specific infection prevention education and training to all HCP. This includes those employed by outside agencies and available by contract or on a volunteer basis to the facility.
2. Training should focus on principles of both HCP safety and patient safety.
3. Training should be provided upon hire and repeated annually and when policies or procedures are updated/revised.
4. Competencies should be documented following each training.
The CDC's outpatient guide also outlines key recommendations relating to the basics of standard precautions and transmission-based cautions, such as hand hygiene, PPE, sharps safety, environmental cleaning and disinfection and sterilization of medical devices. The guide can be accessed at: http://www.cdc.gov/HAI/pdfs/guidelines/Ambulatory-Care-04-2011.pdf
Chinnes says that in order for ambulatory facilities to boost compliance with infection control principles and practices, they should obtain their leadership's commitment for making infection prevention a priority. She says it's also essential for clinicians and the facility's IP to make a strong business case for the resources needed, whether it's hours needed to perform IP duties and time to attend educational seminars routinely, or to secure instructional resources such as the APIC Text of Infection Control and Epidemiology and AORN Guidelines for Perioperative Practice. Identifying and working with physician champions to help get buy-in from other physicians on such issues as with reducing surgical site infections or use of safe injection practices, can go a long way toward improving safety, Chinnes says. She also recommends the use of multidisciplinary teams and process improvement tools to obtain collaboration, rather than just have the IP as the sole voice of infection prevention in the surgery center. To share ideas that work, Chinnes recommends involvement in collaboratives to reduce SSIs such as those offered by the Institute of Healthcare Improvement (IHI) and other organizations. And although it might seem obvious, Chinnes says it's imperative to not only educate healthcare workers and reinforce evidence-based guidelines as the facility’s policies and procedures, but also to regularly observe practices in the OR for compliance with these evidence-based guidelines. And finally, Chinnes advises ongoing surveillance and feedback of information to practitioners and staff for improvement.
Centers for Disease Control and Prevention (CDC). Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care. November 2015.
Centers for Disease Control and Prevention (CDC). Outpatient Settings Policy Options for Improving Infection Prevention. October 2015.
Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States. Sept. 16, 2013.
Drekonja DM, Filice GA, Greer N, Olson A, MacDonald R, Rutks I, Wilt TJ. Antimicrobial stewardship in outpatient settings: a systematic re-view. Infect Control Hosp Epidemiol. 2015 Feb;36(2):142-52. doi: 10.1017/ice.2014.41.
Shapiro DJ, Hicks LA, Pavia AT, Hersh AL. Antibiotic prescribing for adults in ambulatory care in the USA, 2007-09. J Antimicrob Chemother. 2014;69(1):234-40.